issue-1996-05-14•Federal Register final rules — 1996-05-14
Federal Register final rules — 1996-05-14
issue-1996-05-14Federal Register final rules — 1996-05-14Regulation
Published Federal Register documents, not public-inspection drafts. The GPO XML/text rendition is a research aid; the linked complete official PDF retains the printed layout and all graphics. Graphics are retained in that PDF and are not independently reproduced in this text rendition. Publication does not establish that every provision remains legally in force.
FR Doc. X96-10514 Nonferrous Metals Manufacturing Point Source Category
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Page 24242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: X96-10514]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 421
Nonferrous Metals Manufacturing Point Source Category
CFR Correction
In title 40 of the Code of Federal Regulations, parts 400 to 424,
revised as of July 1, 1995, page 468, the first Sec. 421.35 is removed.
BILLING CODE 1505-01-D
Complete official Federal Register PDF
FR Doc. 96-2086 Special Conditions: Cessna Aircraft Model 750 Airplanes; Operation With Fly-by-Wire Rudder
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24208-24212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2086]
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DEPARTMENT OF TRANSPORTATION
14 CFR Part 25
[Docket No. NM-121, Special Conditions No. 25-ANM-113]
Special Conditions: Cessna Aircraft Model 750 Airplanes;
Operation With Fly-by-Wire Rudder
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final special conditions.
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SUMMARY: These special conditions are issued for the Cessna Aircraft
Model 750 airplane. This airplane will have novel and unusual design
features, relating to its electronic rudder flight control system, when
compared to the state of technology envisioned in the airworthiness
standards of part 25 of the Federal Aviation Regulations (FAR). These
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that provided by the airworthiness standards of part 25.
EFFECTIVE DATE: May 1, 1996.
FOR FURTHER INFORMATION CONTACT:
Mark I. Quam, FAA, Standardization Branch, ANM-113, Transport Standards
Staff, Transport Airplane Directorate, Aircraft Certification Service,
1601 Lind Avenue SW., Renton, Washington 98055-4056; telephone (206)
227-2145, facsimile (206) 227-1149.
SUPPLEMENTARY INFORMATION:
Background
On October 15, 1991, Cessna Aircraft Company (Cessna), 6030 Cessna
Blvd., P.O. Box 7704, Wichita, KS 67277-7704, applied for a new type
certificate in the transport airplane category for the Model 750
(Citation X) airplane. The Cessna 750 is a twin-engine, swept-wing
business jet aircraft that is configured for approximately 8-12
passengers. The airplane has two Allison Engine Company AE 3007C
turbofan engines rated at 6400 pounds of sea level, static takeoff
thrust. The airplane has a maximum operating altitude of 51,000 feet
and a range of approximately 3300 nautical miles.
[[Page 24209]]
The Cessna 750 has a yaw control system provided by a lower rudder
and an upper rudder. Each rudder surface has an independent full-time
control system, except that they share mechanical input at the rudder
pedals. The lower surface is controlled by mechanical input to
hydraulically-powered actuators. The upper surface is electronically
controlled.
The lower rudder is positioned by two identical power control units
(PCUs) installed one above the other, in parallel, in the vertical fin.
The PCUs are each powered by an independent hydraulic system. Both the
pilot and co-pilot rudder pedals are connected to the PCUs through
conventional \1/8\'' diameter stainless steel cables, bellcranks, and
PCU input bungees. Dual mechanical load paths are provided from the
input sector to the PCUs to ensure that no single mechanical disconnect
can result in loss of both rudder pedal and electric trim input to the
PCUs. Rudder pedal travel of +/- 2.9 inches provides a maximum lower
rudder deflection of +/- 30 degrees. The lower rudder system has dual
rudder authority limiters designed to limit deflection, depending on
the airplane's dynamic pressure. The purpose of the rudder limiter is
to protect the airplane structure against overload. Both rudder
authority limiters, each controlled by an independent rudder limit
module, operate simultaneously so that a failure of one system will not
allow the lower rudder to deflect to an unwanted position. Dual yaw
damper actuators are linked in series to the lower rudder system to
provide Dutch roll damping and turn coordination.
The upper rudder is driven electrically by the stand-alone yaw
stability augmentation systems (YSAS) which consist of two identical
systems. Each YSAS consists of a yaw stability augmentation computer
(YSAC), two dual rotary variable transformer (RVT) sensors, and a servo
motor which is a part of an electromechanical actuator (EMA). Either
one of two YSASs continuously provides Dutch roll damping of the
airplane, as well as tracking of the upper rudder to the mechanical
command from the rudder pedals through electronic sensing of the rudder
pedal torque tube position in the cockpit. The maximum upper rudder
deflection is +/-18 degrees. Upper surface position limiting is
accomplished by electrical and mechanical stops at the surface.
In normal conditions, the manual yaw command from either the pilot
or co-pilot rudder pedals is transmitted through the cable system and
the PCU input bungees to the rudder PCUs. The PCUs then drive the lower
rudder surface in proportion to the input command. At the same time,
the rudder pedal command is electrically sensed at the rudder pedal
torque tube and transmitted to the active YSAS for tracking the upper
rudder. The position of each rudder surface may be displayed to the
pilot along with the authority limiter position. In normal operation,
both the lower and upper rudder systems provide yaw damper function at
the same time. If the yaw damper function on either rudder system
completely fails, the other system will provide adequate control to
maintain the yaw stability of the airplane.
Type Certification Basis
Under the provisions of Sec. 21.17 of the FAR, Cessna must show,
except as provided in Sec. 25.2, that the Model 750 (Citation X) meets
the applicable provisions of part 25, effective February 1, 1965, as
amended by Amendments 25-1 through 25-74. In addition, the
certification basis for the Model 750 includes Sec. 25.1316, System
lightning protection, as amended by Amendment 25-80; part 34, effective
September 10, 1990, plus any amendments in effect at the time of
certification; and part 36, effective December 1, 1969, as amended by
Amendment 36-1 through the amendment in effect at the time of
certification. These special conditions form an additional part of the
type certification basis. The certification basis also includes Special
Conditions No. 25-ANM-99, dated 5/8/95, pertaining to protection from
High Intensity radiated fields, and may include other special
conditions that are not relevant to these special conditions.
If the Administrator finds that the applicable airworthiness
regulations (i.e., part 25, as amended) do not contain adequate or
appropriate safety standards for the Cessna Model 750 because of a
novel or unusual design feature, special conditions are prescribed
under the provisions of Sec. 21.16 to establish a level of safety
equivalent to that established in the regulations.
Special conditions, as appropriate, are issued in accordance with
Sec. 11.49 of the FAR after public notice, as required by Secs. 11.28
and 11.29, and become part of the type certification basis in
accordance with Sec. 21.17(a)(2).
Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, the special condition would also apply to the
other model under the provisions of Sec. 21.101(a)(1).
Discussion
The type design of the Cessna 750 contains novel or unusual design
features not envisioned by the applicable part 25 airworthiness
standards and therefore special conditions are considered necessary in
the following areas:
1. Upper Rudder Control System Operation Without Normal Electrical
Power. The Cessna Model 750 upper rudder control system is required in
order to maintain safe flight. The Cessna design has four yaw dampers,
including lower rudder dual yaw dampers that are hydraulically powered,
and an upper rudder with dual YSASs that are electrically powered. If
all hydraulic power is lost to the lower rudder (manual revision), then
availability of the upper rudder yaw damper function becomes critical.
Section 25.1351(d) of the FAR, Operation without normal electrical
power, requires safe operation in VFR conditions for at least five
minutes with inoperative normal power. This rule was structured around
a traditional design utilizing mechanical control cables for flight
control, while the crew took time to sort out the electrical failure,
start engine(s) if necessary, and re-establish some of the electrical
power generation capability.
Service experience with traditional two-engine airplane designs has
shown that the loss of electrical power generated by the airplane's
engines is not extremely improbable. The electrical power system of the
Cessna 750 must therefore be designed with standby or emergency
electrical sources of sufficient reliability and capacity to power the
upper rudder control system in the event of the loss of normally
generated electrical power. The need for electrical power for the
Cessna Model 750 upper rudder control system was not envisioned by part
25 since, in traditional designs, cables and hydraulics are utilized
for the flight control system. Therefore, Special Condition No. 1 is
needed.
2. Design Maneuver Requirements. In a conventional airplane, pilot
inputs directly affect control surface movement (both rate and
displacement) for a given flight condition. In the Cessna Model 750,
the pilot provides only a portion of the input to the upper rudder
control surface, and it is possible that the pilot control
displacements specified in Sec. 25.351 of the FAR may not result in the
maximum displacement and rates of displacement of the upper rudder. The
intent of these noted rules may not be
[[Page 24210]]
satisfied if literally applied. Therefore, Special Condition No. 2 is
needed.
3. Interaction of Systems and Structures. The Cessna Model 750 has
a full-time electronic upper rudder flight control system affecting the
yaw axis. The current rules are inadequate for considering the affects
of this system, and its failures, on structural performance. Therefore,
Special Condition No. 3 is needed.
As discussed above, these special conditions are applicable
initially to the Cessna Model 750 (Citation X) airplane. Should Cessna
apply at a later date for a change to the type certificate to include
another model incorporating the same novel or unusual design feature,
the special conditions would apply to that model as well under the
provisions of Sec. 21.101(a)(1).
Discussion of Comments
Notice of proposed special conditions No. SC-96-1-NM was published
in the Federal Register on March 22, 1996 (61 FR 11779). No comments
were received.
Under standard practice, the effective date of final special
conditions would be 30 days after the date of publication in the
Federal Register. However, as the certification date for the Cessna
Aircraft Model 750 airplane is imminent, the FAA finds that good cause
exists for making these special conditions effective upon issuance.
Conclusion
This action affects only certain unusual or novel design features
on one model series of airplanes. It is not a rule of general
applicability and affects only the manufacturer who applied to the FAA
for approval of these features on the airplanes.
List of Subjects in 14 CFR Part 25
Aircraft, Aviation safety, Reporting and recordkeeping
requirements.
The authority citation for part 25 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701-44702, 44704.
The Special Conditions
Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for the Cessna Aircraft Model 750
airplanes.
1. Upper Rudder Control System Operations Without Normal Electrical
Power. In lieu of compliance with Sec. 25.1351(d), it must be
demonstrated, by test or combination of test and analysis, that the
upper rudder control system provides for safe flight and landing with
inoperative normal engine electrical power (electrical power sources
excluding the battery and any other standby electrical sources). The
airplane operation should be considered at the critical phase of flight
and include the ability to restart the engines and maintain flight for
a minimum of 30 minutes in Instrument Meteorological Conditions (IMC).
Discussion: The Cessna Model 750 fly-by-wire upper rudder control
system requires a continuous source of electrical power in order to
maintain yaw control. Section Sec. 25.1351(d), Operation without normal
electrical power, requires safe operation in visual flight rules (VFR)
conditions for at least five minutes with inoperative normal power.
This rule was structured around a traditional design utilizing
mechanical control cables for flight control while the crew took time
to sort out the electrical failure and was able to re-establish some of
the electrical power generation capability. In order to maintain the
same level of safety associated with traditional designs, the Cessna
750 upper rudder control system design shall be demonstrated to operate
for at least 30 minutes without the normal source of engine-generated
electrical power. It should be noted that service experience has shown
that the loss of all electrical power that is generated by the
airplane's engines is not extremely improbable.
The emergency electrical power system must be designed to supply
the upper rudder control system without the need for crew action
following the loss of the normal electrical power system.
For compliance purposes:
1. A test demonstration of the loss of normal engine-generated
power is to be established such that:
a. The failure condition should be assumed to occur during night
instrument meteorological conditions (IMC), at the most critical phase
of flight relative to the electrical power system design and
distribution of equipment loads on the system.
b. The upper rudder control system can provide for continued safe
flight and landing using emergency electrical power (batteries, etc.)
for at least 30 minutes of operation in IMC. An engine restart should
be included in this demonstration.
c. Availability of APU operation should not be considered in
establishing emergency power system adequacy.
2. Since the availability of the emergency electrical power system
operation is necessary for maintaining safe flight with the upper
rudder, the emergency electrical power system must be available
immediately prior to each flight.
3. The emergency electrical power system must be shown to be
satisfactorily operational in all flight regimes.
2. Design Yaw Maneuver Requirements.
In lieu of compliance with Sec. 25.351 of the FAR, the airplane
must be designed for loads resulting from the yaw maneuver conditions
specified in subparagraphs (a) through (d) of this paragraph, at speeds
from VMC to VD. Unbalanced aerodynamic moments about the
center of gravity must be reacted in a rational or conservative manner
considering the airplane inertia forces. In computing the tail loads,
the yawing velocity may be assumed to be zero.
(a) With the airplane in unaccelerated flight at zero yaw, it is
assumed that the cockpit rudder control is suddenly displaced to
achieve the resulting rudder deflection, as limited by:
(1) the control system or control surface stops; or
(2) a limit force of 300 pounds from VMC to VA and 200
pounds from VC/MC to VD/MD, with a linear variation
between VA and VC/MC.
(b) With the cockpit rudder control deflected so as always to
maintain the maximum rudder deflection available within the limitations
specified in subparagraph (a) of this paragraph, it is assumed that the
airplane yaws to the overswing sideslip angle.
(c) With the airplane yawed to the static equilibrium sideslip
angle, it is assumed that the cockpit rudder control is held so as to
achieve the maximum rudder deflection available within the limitations
specified in subparagraph (a) of this paragraph.
(d) With the airplane yawed to the static equilibrium sideslip
angle of subparagraph (c) of this paragraph, it is assumed that the
cockpit rudder control is suddenly returned to neutral.
3. Interaction of Systems and Structures.
Airplanes equipped with fly-by-wire control systems that affect
structural performance, either directly or as a result of a failure or
malfunction, must account for the influence of these systems and their
failure conditions in showing compliance with the requirements of 14
CFR part 25, Subparts C and D.
(a) General. The following criteria will be used in determining the
influence of the upper rudder control systems and their failure
conditions on the airplane structure.
[[Page 24211]]
(b) System fully operative. With the system fully operative, the
following apply:
(1) Limit loads must be derived in all normal operating
configurations of the systems from all the limit conditions specified
in 14 CFR part 25, Subpart C, taking into account any special behavior
of such systems or associated functions or any effect on the structural
performance of the airplane that may occur up to the limit loads. In
particular, any significant nonlinearity (rate of displacement of
control surface, thresholds, or any other system nonlinearities) must
be accounted for in a realistic or conservative way when deriving limit
loads from limit conditions.
(2) The airplane must meet the strength requirements of 14 CFR part
25 (Static strength, residual strength), using the specified factors to
derive ultimate loads from the limit loads defined above. The effect of
non linearities must be investigated beyond limit conditions to ensure
the behavior of the system present no anomaly compared to the behavior
below limit conditions. However, conditions beyond limit conditions
need not be considered when it can be shown that the airplane has
design features that make it impossible to exceed those limit
conditions.
(3) The airplane must meet the aeroelastic stability requirements
of Sec. 25.629.
(c) System in failure condition. For any failure condition in the
system not shown to be extremely improbable, the following apply:
(1) At the time of occurrence. Starting from 1-g level flight
conditions, a realistic scenario, including pilot corrective actions,
must be established to determine the loads occurring at the time of
failure and immediately after failure. The airplane must be able to
withstand these loads multiplied by an appropriate factor of safety
that is related to the probability of occurrence of the failure. The
factor of safety (F.S.) is defined in Figure 1.
[GRAPHIC] [TIFF OMITTED] TR14MY96.003
Pj--Probability of occurrence of failure mode j (per hour)
(i) These loads must also be used in the damage tolerance
evaluation required by Sec. 25.571(b) if the failure condition is
probable.
(ii) Freedom from flutter, divergence, and control reversal must be
shown up to the speeds defined in Sec. 25.629(b)(2). For failure
conditions which result in speed increases beyond VC/MC,
freedom from flutter, divergence, and control reversal must be shown to
increased speeds, so that the margins intended by Sec. 25.629(b)(2) are
maintained.
(iii) Notwithstanding subparagraph (1) of this paragraph, failures
of the system that result in forced structural vibrations (oscillatory
failures) must not produce loads that could result in catastrophic
fatigue failure or detrimental deformation of primary structure.
(2) For the continuation of the flight. For the airplane in the
system failed state, and considering any appropriate reconfiguration
and flight limitations, the following apply:
(i) Static and residual strength must be determined for loads
derived from the following conditions at speeds up to VC, or the
speed limitation prescribed for the remainder of the flight:
(A) The limit symmetrical maneuvering conditions specified in
Secs. 25.331 and 25.325.
(B) The limit gust conditions specified in Sec. 25.341 (but using
the gust velocities for VC) and in Sec. 25.345.
(C) The limit rolling conditions specified in Sec. 25.349 and the
limit unsymmetrical conditions specified in Secs. 25.367 and 25.427(b)
and (c).
(D) The limit yaw maneuvering conditions specified in Special
Condition No. 2.
(E) The limit ground loading conditions specified in Secs. 25.473
and 25.491.
(ii) For static strength substantiation, each part of the structure
must be able to withstand the loads specified in subparagraph (2)(i) of
this paragraph, multiplied by a factor of safety depending on the
probability of being in this failure state. The factor of safety is
defined in Figure 2.
[GRAPHIC] [TIFF OMITTED] TR14MY96.004
Qj--Probability of being in failure condition j
Qj=(Tj)(Pj) where:
Tj=Average time spent in failure condition j (in hours)
Pj=Probability of occurrence of failure mode j (per hour)
Note: If Pj is greater than 10-3 per flight hour, then
a 1.5 factor of safety must be applied to all limit load conditions
specified in Subpart C.
(iii) For residual strength substantiation as defined in
Sec. 25.571(b), structures affected by failure of the system and with
damage in combination with the system failure, a reduced factor may be
applied to the loads specified in
[[Page 24212]]
subparagraph (2)(i) of this paragraph. However, the residual strength
level must not be less than the 1-g flight load, combined with the
loads introduced by the failure condition, plus two-thirds of the load
increments of the conditions specified in subparagraph (2)(i) of this
paragraph, applied in both positive and negative directions (if
appropriate). The residual strength factor (R.S.F.) is defined in
Figure 3.
[GRAPHIC] [TIFF OMITTED] TR14MY96.005
Qj--Probability of being in failure condition j
Qj=(Tj)(Pj) where:
Tj=Average time spent in failure condition j (in hours)
Pj=Probability of occurrence of failure mode j (per hour)
Note: If Pj is greater than 10-3 per flight hour, then
a residual strength factor of 1.0 must be used.
(iv) If the loads induced by the failure condition have a
significant effect on fatigue or damage tolerance, then their effects
must be taken into account.
(v) Freedom from flutter, divergence, and control reversal must be
shown up to a speed determined from Figure 4. Flutter clearance speeds
V' and V'' may be based on the speed limitation specified for the
remainder of the flight, using the margins defined by Sec. 25.629(b).
[GRAPHIC] [TIFF OMITTED] TR14MY96.006
Qj=Probability of being in failure condition j
V'=Clearance speed as defined by Sec. 25.629(b)(2).
V''=Clearance speed as defined by Sec. 25.629(b)(1).
Qj=(Tj)(Pj) where:
Tj=Average time spent in failure condition j (in hours)
Pj=Probability of occurrence of failure mode j (per hour)
Note: If Pj is greater than 10-3 per flight hour, then
the flutter clearance speed must not be less than V''.
(vi) Freedom from flutter, divergence, and control reversal must
also be shown up to V' in Figure 4 above, for any probable system
failure condition combined with any damage required or selected for
investigation by Sec. 25.571(b).
(vii) If the mission analysis method is used to account for
continuous turbulence, all the systems failure conditions associated
with their probability must be accounted for in a rational or
conservative manner in order to ensure that the probability of
exceeding the limit load is not higher than the value prescribed in
Appendix G of 14 CFR part 25.
(3) Consideration of certain failure conditions may be required by
other sections of 14 CFR part 25, regardless of calculated system
reliability. Where analysis shows the probability of these failure
conditions to be less than 10-9, criteria other than those
specified in this paragraph may be used for structural substantiation
to show continued safe flight and landing.
(d) Warning considerations. For upper rudder control system failure
detection and warning, the following apply:
(1) The system must be checked for failure conditions, not
extremely improbable, that degrade the structural capability below the
level required by part 25 or significantly reduce the reliability of
the remaining system. The crew must be made aware of these failures
before flight. Certain elements of the control system, such as
mechanical and hydraulic components, may use special periodic
inspections, and electronic components may use daily checks, in lieu of
warning systems, to achieve the objective of this requirement. These
certification maintenance requirements must be limited to components
that are not readily detectable by normal warning systems and where
service history shows that inspections will provide an adequate level
of safety.
(2) The existence of any failure condition, not extremely
improbable, during flight that could significantly affect the
structural capability of the airplane, and for which the associated
reduction in airworthiness can be minimized by suitable flight
limitations, must be signaled to the flight crew. For example, failure
conditions which result in a factor of safety between the airplane
strength and the loads of 14 CFR part 25, Subpart C, below 1.25, or
flutter margins below V'', must be signaled to the crew during the
flight.
(3) Dispatch with known failure conditions. If the airplane is to
be dispatched in a known upper rudder control system failure condition
that affects structural performance, or affects the reliability of the
remaining system to maintain structural performance, then the
provisions of this special condition must be met for the dispatched
condition and for subsequent failures. Operational and flight
limitations may be taken into account.
Issued in Renton, Washington, on May 1, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service, ANM-100.
[FR Doc. 96-2086 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-12144 Elimination of Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24226-24233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12144]
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[[Page 24227]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 600 and 601
[Docket No. 95N-0411]
RIN 0910-AA71
Elimination of Establishment License Application for Specified
Biotechnology and Specified Synthetic Biological Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
biologics regulations to eliminate the establishment license
application (ELA) requirement for certain biotechnology and synthetic
biological products subject to licensing under the Public Health
Service Act (PHS Act). This final rule also exempts these biotechnology
and synthetic biological products from certain biologics regulations
and harmonizes the requirements applicable to these products with those
applicable to similar drug products which are approved under the
Federal Food, Drug, and Cosmetic Act (the act). This final rule is part
of FDA's continuing effort to achieve the objectives of the President's
``Reinventing Government'' initiatives, and it is intended to reduce
unnecessary burdens for industry without diminishing public health
protection.
EFFECTIVE DATE: May 24, 1996.
FOR FURTHER INFORMATION CONTACT: Sharon A. Carayiannis, Center for
Biologics Evaluation and Research (HFM-630), Food and Drug
Administration, 1401 Rockville Pike, suite 400S, Rockville, MD 20852-
1448, 301-594-3074.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 29, 1996, FDA proposed to amend
the biologics regulations to eliminate the ELA requirement for well-
characterized biotechnology products licensed under the PHS Act. In
that document, FDA proposed to use the general phrase ``well-
characterized biotechnology product,'' to describe products that would
be eligible for a single license application so that the regulatory
language would accommodate categories of products that might later be
considered to be well-characterized as scientific knowledge progresses.
FDA requested specific comments on whether a definition of a well-
characterized biotechnology product should be included in the
regulations and, if so, what the scope of such a definition should be.
The agency noted that technical advances over the last 15 years
have greatly increased the ability of manufacturers to control and
analyze the manufacture of many biotechnology-derived biological
products. After over a decade of experience with these products, the
agency has found that it can review the safety, purity, potency, and
effectiveness of most well-characterized biotechnology products without
requiring submission of a separate ELA. Accordingly, FDA proposed
procedures under which CBER would approve most well-characterized
biotechnology products by requiring a single biologics license
application. FDA noted that the proposed procedures would significantly
reduce burdens without reducing the safety or effectiveness of these
products.
In the Federal Register of December 8, 1995 (60 FR 63048), the
agency first published an interim definition of a well-characterized
therapeutic recombinant DNA-derived and monoclonal antibody
biotechnology product and announced that, under Sec. 610.2, the
Director of CBER was no longer requiring that manufacturers of these
products submit samples and protocols to CBER for lot-by-lot release.
While the interim definition was intended to be used as a basis for
determining which products would be exempted from CBER lot-by-lot
release, FDA also used the interim definition to prepare draft guidance
on reporting post-approval changes for biotechnology products (as
published in the Federal Register of January 29, 1996 (61 FR 2739 at
2748), ``Draft Guidance; Changes to An Approved Application for Well-
Characterized Therapeutic Recombinant DNA-Derived and Monoclonal
Antibody Biotechnology Products''.)
In addition, FDA held a scientific workshop on December 11 through
13, 1995, to discuss the characterization of therapeutic recombinant
DNA-derived and monoclonal antibody products, including whether FDA's
interim definition should be changed or expanded to include other
categories of products that would be considered well-characterized.
After considering the public comments received on the interim
definition, the discussion at the workshop, and the many requests the
agency has received for further clarification of the term ``well-
characterized,'' FDA has determined that it may not be possible to
achieve a sufficiently clear and specific understanding of this term to
adequately apprise potential applicants of the applicability of the new
procedures. Accordingly, in this final rule, FDA is specifying, in lieu
of the term ``well characterized biotechnology product,'' the
categories of products to which this final rule will be applicable (see
comment Nos. 1 and 6).
FDA intends to evaluate the application of lot-by-lot release for
additional products and to announce in the Federal Register a revised
determination of which products will be exempted from lot-by-lot
release. FDA also plans to issue guidance on the characterization of
product categories specified in this rule. FDA anticipates that these
documents will replace the notice published in the Federal Register of
December 8, 1995 (60 FR 63048).
This final rule is part of FDA's continuing effort to achieve the
objectives of the President's ``Reinventing Government'' initiatives.
One goal of these initiatives is to harmonize regulations administered
by FDA's Center for Biologics Evaluation and Research (CBER) and Center
for Drug Evaluation and Research (CDER), to reduce unnecessary burdens
for industry without diminishing public health protection.
II. Proposed Rule
In the January 29, 1996, proposed rule, FDA proposed to amend
Sec. 601.2(a) and to add a new paragraph (c) to create a licensing
scheme for well-characterized biotechnology products that differs from
the current licensing scheme for biological products in four
fundamental ways. First, an applicant seeking marketing approval for a
product that falls within the scope of the rule would submit a single
biologics license application to CBER and would be issued a single
license. Second, for these products, many of the establishment and
product standards set forth in parts 600 through 680 (21 CFR parts 600
through 680) would not be applied. The current good manufacturing
practice (CGMP) regulations found at parts 210 and 211 (21 CFR parts
210 and 211), in addition to the information included in a chemistry,
manufacturing, and controls (CMC) section of the biologics license
application, would constitute the bulk of the applicable establishment
standards for these products. Third, in lieu of reviewing an ELA, FDA
proposed to evaluate whether establishment standards had been met by
reviewing information submitted in the biologics license application
and by inspecting the facilities in which the product is manufactured
for compliance with applicable requirements, including CGMP's. Fourth,
FDA proposed to amend Sec. 600.3(t) to broaden the term
[[Page 24228]]
``manufacturer'' as it is used in parts 600 through 680 to include an
applicant for a license for a well-characterized biotechnology product
who may or may not own the facilities engaged in significant
manufacturing steps. This amendment would allow a single license
applicant to take responsibility for compliance with the requirements
in parts 600 through 680 applicable to manufacturers and would
eliminate the requirement that each contract facility engaged in
significant manufacturing obtain its own license. Instead, each well-
characterized biotechnology product could be covered by a single
biologics license application, which lists all manufacturing locations,
regardless of how many separate companies are involved in its
manufacture. In addition, FDA requested comments on whether the
definition of ``manufacturer''in Sec. 600.3(t) should also be expanded
to include license applicants for products other than well-
characterized biotechnology products.
III. Responses to Letters of Comment
FDA allowed 30 days for comment on the proposal of January 29,
1996. Written comments received in response to the proposal are on file
in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FDA received seven comments in response to the proposed rule. The
comments, which addressed a number of issues, were received from
manufacturers of biotechnology products, a blood establishment, and a
biotechnology trade association. Comments received and FDA's responses
to the comments are discussed below. All of the comments supported the
proposal, although many comments contained suggestions or requests for
clarification. All of the letters supported FDA's efforts to achieve
the President's ``Reinventing Government'' initiatives and agreed that
the proposed changes will contribute to the goal of reducing
unnecessary burdens for industry and the agency without diminishing
public health protection.
1. Two comments requested that FDA define well-characterized
products in the final rule to clearly identify those entities subject
to the rule and to allow for public comment and administrative review.
However, one of these comments also suggested that FDA publish a
companion guidance document, updated as necessary, to provide
interpretation of this definition based on current technology and
scientific knowledge. Two comments requested that a definition be
included in a guideline rather than the regulation so that it can be
readily revised as the technology advances. One comment stated that the
proposal left uncertainty as to which products would be eligible for
the single license application.
In response to comments received, FDA has revised its proposed
administrative approach and is specifying, in Sec. 601.2(a) and new
paragraph (c), the categories of products subject to the rule. FDA has
decided to list the product categories in the regulation in order to
minimize uncertainty about which products are eligible for the new
procedures.
2. Five comments suggested that products in addition to those
identified in FDA's interim definition of a well-characterized
therapeutic recombinant deoxyribonucleic acid (DNA) derived and
monoclonal antibody biotechnology product could be considered well-
characterized and requested that FDA broaden the scope of the proposed
rule to include additional product categories. Particular categories
suggested by one or more comments include: Proteins, including those
isolated from natural sources; products (including vaccines and in
vitro diagnostics) made using synthetic peptides, recombinant DNA
technology and monoclonal antibody technology; products made using
chemical synthesis; DNA plasmid products; highly purified and
inactivated vaccines; polysaccharides; and any other biologic product
for which the applicant submits data from studies that demonstrate that
the manufactured product meets prescribed standards of safety, purity,
and potency. One comment suggested that in vitro diagnostic products
using biotechnology components should not be treated differently than
well-characterized biotechnology drugs. One comment requested that FDA
specify that blood, blood components (including plasma and stem cells),
and plasma derivatives (where the raw material is human based) are
products which should not be included.
FDA agrees that the elimination of the ELA requirement should apply
to product categories beyond those originally identified in the
agency's interim definition of a well-characterized therapeutic
recombinant DNA-derived and monoclonal antibody biotechnology product.
FDA is expanding the scope of this final rule to include additional
products, based on the technology of the manufacturing process and the
proposed use of the products. At this time, FDA has determined that it
has sufficient experience in reviewing investigational and product
applications to eliminate the ELA requirements for the following
categories of products: Therapeutic DNA plasmid products; therapeutic
synthetic peptide products of 40 or fewer amino acids; monoclonal
antibody products for in vivo use; and therapeutic recombinant DNA-
derived products. Methodologies are now available to characterize these
products in a much more rigorous fashion, allowing the products to be
more clearly evaluated by end product testing. FDA believes that
eliminating the submission for the facility and establishment
information will not adversely affect the public health.
FDA disagrees that vaccines and in vitro diagnostic (IVD) products
should be included within the scope of this rule at this time because
these products raise additional concerns in assessing safety, purity,
and potency. For vaccines, safety is a critical concern due to the
intended use in a healthy population. For IVD products, FDA believes
that the product and establishment standards necessary to ensure
continued safety, purity, and potency may differ from those applicable
to products included in this rule.
FDA agrees that blood and blood components, including plasma,
plasma derivatives, and stem cells, are products which should not fall
within the scope of this rule. FDA believes that license applications
for these and other naturally derived products should continue to
include establishment information at this time. FDA believes that a
license application that includes detailed information on the
facilities and controls may be necessary to assess the continued
safety, purity, and potency of these products. Because these products
involve complex issues, such as a risk of contamination with infectious
agents, their review requires special expertise and adequate time in
order to assess the adequacy of controls in place at the facility. In
addition, end product testing of naturally derived products may not be
sufficient to detect contamination with infectious agents. FDA intends
to continue to assess the need to expand the scope of the rule to
include additional categories of products as science and technology
advance and as the agency gains experience in regulating biological
products under this new scheme.
3. One comment suggested that the use of a single biologics
application be applied to all biologic products. Another comment
suggested that IVD products be eligible for the single license
application.
[[Page 24229]]
As outlined in the President's November, 1995, National Performance
Review, ``Reinventing the Regulation of Drugs Made From
Biotechnology,'' FDA will use a standardized, single application form
for all biological and drug product approvals, regardless of which
Center regulates them. FDA will make the harmonized form available for
public comment through a subsequent rulemaking and will develop
guidance to assist applicants in completing the new application form
when it is available.
4. One comment suggested that FDA develop a guideline delineating
the responsibilities of center and field inspection personnel to avoid
confusion. One comment suggested that FDA application reviewers
participate in facility inspections to provide continuity.
FDA recognizes that close cooperation between center and field is
essential to the success of this approach. CBER and the field offices
intend to coordinate pre- and post-licensure inspections to provide
consistency in program and policy approaches. In addition, FDA plans to
develop guidance on facility standards for biotechnology manufacturing
facilities to clarify regulatory requirements and FDA policy.
5. One comment requested that companies have the option to submit
descriptions of systems design, equipment validation, etc., for FDA
review and comment prior to the time of inspection because it would be
advantageous to both industry and FDA.
FDA agrees that the submission of facility information, such as
systems design, and early dialogue is advantageous to both industry and
FDA. Accordingly, the agency intends to continue to review this
information, when requested, and provide comments early in the
development process, prior to and after the submission of the license
application. Companies should contact the Division of Establishment
Licensing, CBER, to arrange such reviews.
6. One comment stated that the use of an interim definition of
products that would be eligible for single license application under
Sec. 601.2(c) creates the possibility that FDA might refuse to file a
biologics license application for a product that the applicant believes
is well-characterized, even though the application might include
sufficient data to demonstrate that the product meets prescribed
standards for safety, purity, and potency. Another comment suggested
that the determination as to whether a product is well-characterized
should be made during the Phase 2 clinical trials or as early in the
process as is practical.
As discussed above in the response to comment No. 1 of this
document, FDA has decided to clearly identify, by category, those
products subject to the rule, and thereby reduce uncertainty as to
whether a product falls within the scope of the rule. This clear
identification of products should also eliminate the concerns regarding
a refusal to file action and the need to provide sufficient data to
support an applicant's claim that its product is ``well-
characterized.'' Applicants seeking licensure of a product that falls
within a category listed in 601.2(c) will not be required to make an
initial showing that the product is ``well-characterized'' to use the
new procedures. Companies may seek guidance from FDA at any time on the
type of application that should be submitted, and FDA encourages early
communication.
7. One comment agreed with FDA's proposal to exempt well-
characterized products from Sec. 610.62, which sets out requirements
for position and prominence of the proper name of the product on the
package label. The comment suggested that this labeling change should
be voluntary for currently licensed products, that companies should be
allowed to phase in changes over a 24 month time period, and that
preapproval should not be required.
The comment may have misunderstood the applicability of
Sec. 201.10(g) (21 CFR 201.10(g)). Section 201.10(g) applies to
biological products licensed under section 351 of the PHS Act, as well
as to drugs approved under the act. Accordingly, labels that comply
with preexisting requirements should not require revisions to comply
with the requirements in this final rule.
8. One comment suggested that manufacturers submitting a biologics
license application should be permitted to cross-reference information
already supplied in an approved ELA.
FDA agrees that avoiding unnecessary duplication of information in
applications is desirable. FDA will permit a biologics license
applicant to cross-reference information already submitted in an
approved ELA at this time. However, the agency may reassess the
viability of this approach in the future. Should the information in the
approved ELA become outdated, cross-reference may no longer be
appropriate.
9. One comment agreed with FDA's proposed revision of the
definition of ``manufacturer'' in Sec. 600.3(t). Three comments
requested that FDA apply an expanded definition of ``manufacturer'' to
all biologic license applicants and not limit application of this
definition exclusively to well-characterized products. One of the
comments favoring a broader definition suggested the following language
for Sec. 600.3(t): ``Manufacturer'' means any legal person or entity
engaged in the manufacture of a product subject to license under the
act; ``Manufacturer'' also includes an applicant for a license for a
product, or a license holder, who is responsible for assuring that the
product and establishment standards are met.
FDA agrees with the comments requesting the broader definition of
``manufacturer'' and is revising Sec. 600.3(t) to include any license
applicant who assumes responsibility for compliance with the applicable
product and establishment standards in parts 600 through 680. FDA
believes that this change will facilitate contract manufacturing
arrangements for all biological products by allowing an applicant who
does not own all the facilities where significant manufacturing is
performed to apply for licensure. The revised Sec. 600.3(t) will define
``manufacturer'' as the term is used in parts 600 through 680. Contract
firms engaged in the manufacture, processing, packing, or holding of a
biological drug will continue to be subject to applicable CGMP
requirements and the amendment to Sec. 600.3(t) will not affect other
definitions of ``manufacturer'' contained in other applicable statutes
and regulations. FDA intends to revise current guidance on contract
manufacturing arrangements for applicants interested in pursuing such
arrangements under the new definition.
10. One comment requested that Sec. 610.63, which addresses package
label and container label requirements for products manufactured under
an arrangement involving two or more establishments, be exempted from
applicability to well-characterized biotechnology products because such
products would involve a single license holder. The comment suggested
that it would be unnecessary to require that the labeling show the
names of multiple participating manufacturers.
The agency does not agree that Sec. 610.63 should be exempted from
applicability to the products covered in this rule. Divided or shared
manufacturing arrangements could still exist between holders of
biologics licenses for products subject to this rule if this was an
arrangement the companies desired, and in these cases Sec. 610.63 would
apply.
However, FDA agrees that it is unnecessary to identify contract
[[Page 24230]]
manufacturers on the package label and container label of a biological
product subject to this final rule. FDA has applied Sec. 610.63 to
require label identification of licensed manufacturers only. As
discussed below, FDA intends to consider the need for revisions to
Sec. 610.63 in separate rulemaking. FDA also intends to revise the
November 25, 1992, Policy Statement Concerning Cooperative
Manufacturing Arrangements for Licensed Biological Products to address
contract, divided, and shared manufacturing arrangements under the new
regulatory scheme.
11. One comment suggested that Secs. 610.60, 610.61, 610.63,
610.64, and 610.65 be eliminated for all biologic products and be
replaced by labeling requirements described in part 201 (21 CFR part
201), subpart A.
FDA agrees that harmonizing the labeling requirements for biologics
and drugs approved under the act, where appropriate, is desirable. It
is important to note that biologic products are already subject to most
provisions in subpart A of part 201. FDA is considering revising the
labeling requirements in Secs. 610.60 through 610.65 as part of the
agency's comprehensive review and rewrite of the general biologics
regulations.
12. One comment stated that Sec. 600.10(a), which describes the
requirements for an establishments to designate a ``responsible head,''
should not apply to well-characterized products as currently written.
FDA agrees that Sec. 600.10(a), as currently written, imposes
unnecessary burdens for many modern biological manufacturers and has
made a commitment to publish a proposed rule to revise this regulation
within 9 months of the publication of the President's November, 1995,
National Performance Review, ``Reinventing the Regulation of Drugs Made
From Biotechnology.'' FDA intends to revise the requirements to allow
more flexibility to assign control and oversight responsibility within
a company.
13. One comment requested that Sec. 600.22(g), which authorizes
inspectors to inspect and copy, as circumstances may require, any
records to be kept under to Sec. 600.12, be amended because Sec. 600.12
will not apply to well-characterized biotechnology products under this
rule.
The agency believes that it is not necessary to amend
Sec. 600.22(g) because the CGMP requirements in parts 210 and 211 that
apply to products subject to this rule include recordkeeping
requirements and state that records are subject to photocopying as part
of an FDA inspection (see Sec. 211.180(b)).
14. One comment requested clarification of Sec. 601.3(b), which
describes the information required on the product license form. One
comment requested that FDA eliminate the requirement for an
establishment license number in the product license application (PLA)
for well-characterized products because a contract manufacturing site
engaged in multiproduct manufacture for different manufacturers may
produce several licensed products. The comment stated that the
establishment number would not be meaningful under such circumstances.
FDA believes that it is unnecessary to include an exemption for
Sec. 601.3(b)(4) in this rule. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of an interim form, FDA
3439, which contains a section in which all locations performing
manufacturing or testing of the product are to be identified. If a
location has a license number, that number should be included as part
of that identification, as should the location's registration number.
If there is no license number for the location, it cannot be included,
as is currently the case for a new establishment filing its first PLA
and ELA.
15. One comment requested that Sec. 601.22, which permits initial
and partial manufacturing of products in short supply at other than a
licensed establishment, be amended to include a statement clarifying
the relevant referenced regulations when Sec. 601.22 is applied to
well-characterized products.
FDA agrees and is making conforming amendments to Sec. 601.22 to
specify that persons conducting the initial and partial manufacturing
of a product that is subject to this rule shall be subject to all
regulations of subchapter F except Secs. 601.1 to 601.6, 601.9, 601.10,
601.20, 601.21; 601.30 to 601.33; 610.60 to 610.65, 600.10(b) and (c),
600.11, 600.12, 600.13, 610.11, and 610.53.
16. One comment stated that Sec. 601.45, which requires, for
certain products, submission of promotional materials to the agency,
should not apply to well-characterized biotechnology products. The
comment suggested that the proposed rule under which promotional
labeling materials would not have to be submitted for agency
consideration within 120 days following marketing approval be applied
to well-characterized products. The comment also suggested that
submission of advertisements and promotional labeling be regulated
under Sec. 314.81(b)(3)(i) (21 CFR 314.81(b)(3)(i)).
The comment may have misunderstood the applicability of
Sec. 601.45. Section 601.45 applies solely to biological products
subject to subpart E, Accelerated Approval of Biological Products for
Serious or Life Threatening Illnesses. For biological products not
subject to subpart E, FDA has proposed to revise requirements for
submission of advertisements and promotional labeling to CBER to
reflect procedures found in Sec. 314.81(b)(3)(i), in the proposal of
January 29, 1996 (61 FR 2733 at 2739).
17. One comment requested that Sec. 610.9, which permits
manufacturers, under certain conditions, to modify a particular test
method or manufacturing process, be exempted from applicability to
well-characterized biotechnology products. The comment also suggested
that this regulation be eliminated as part of the proposed revisions to
Sec. 601.12, published in the Federal Register (61 FR 2739).
FDA disagrees with the comment. The comment may have misunderstood
Sec. 610.9. This regulation allows manufacturers the flexibility to
modify methods or processes specified in regulations, if the
modification can be shown to provide equivalent assurance of safety,
purity, potency, and effectiveness. Because this regulation adds
flexibility without compromising the safety, purity, potency, or
effectiveness of biological products, FDA believes that it should apply
to all biological products.
18. One comment suggested that a broad interpretation of
Sec. 610.15, which describes the requirements for use of constituent
materials, may require development of sophisticated purification
methods to reduce the level of ``contaminating'' immunoglobulins to the
one part per million level if applied to cell culture products such as
monoclonal antibodies. The comment suggested that Sec. 610.15 be
amended to be applicable only to vaccine products and products intended
to be antigenic.
Section 610.15(b) applies by its terms to cell culture-produced
vaccines intended for injection. For guidance on the use of a serum in
the medium for production of monoclonal antibodies, consult the Draft
``Points to Consider in the Manufacture and Testing of Monoclonal
Antibody Products for Human Use,'' announced in the Federal Register of
August 3, 1994 (59 FR 39571).
19. One comment suggested that Sec. 600.81 (the comment references
``Sec. 601.81,'' but the subject is consistent with Sec. 600.81), which
describes the requirements for product distribution reports, is
duplicative, provides no
[[Page 24231]]
value to the manufacturer or to FDA in ensuring the public health, and
should be eliminated. The comment requested that distribution
information for well-characterized biotechnology products be regulated
under Sec. 314.81(b)(2)(ii).
FDA disagrees with this comment. Section 600.81 differs from
Sec. 314.81(b)(2)(ii) in that Sec. 600.81 requires submission of
product distribution reports every 6 months; requires information on
bulk lot number, fill lot number and label lot number; states that FDA
may require more detailed information, as needed; and states that FDA
may require, on written notice, submission of reports at times other
than those stated in the regulation. FDA believes that the requirements
in Sec. 600.81 assist the agency in determining adverse reaction rates
for vaccines and other biological products, and are of use in
monitoring product safety. It should be noted that Sec. 600.90 permits
a licensed manufacturer to apply to FDA for a waiver from any of the
requirements of Sec. 600.81.
20. Several comments addressed issues beyond the scope of this
rulemaking. Comments included issues related to reporting of errors and
accidents (Sec. 600.14), lot release, methods for evaluating product
characteristics, and establishing product specifications.
Revisions to Sec. 600.14 Reporting of errors and other biologics
regulations are currently under consideration and are outside the scope
of this rulemaking. However, FDA will consider all comments received as
a part of the agency's comprehensive rewrite of the general biologics
regulations.
IV. Summary of Changes for the Final Rule
In response to comments received, FDA is making the following
changes in this final rule:
In lieu of the term ``well-characterized biotechnology
product,'' FDA is specifying, in Sec. 601.2(a) (21 CFR 601.2(a)) and
new paragraph (c), the categories of products to which the rule will
be applicable, including therapeutic DNA plasmid products;
therapeutic synthetic peptide products of 40 or fewer amino acids;
monoclonal antibody products for in vivo use; and therapeutic
recombinant DNA-derived products. The definition of manufacturer has
been modified to include an applicant for a license for any
biological product where the applicant assumes responsibility for
compliance with the applicable product and establishment standards.
The final rule also sets forth an amendment to 21 CFR 601.22
clarifying that section's applicability to the categories of
products specified in new Sec. 601.2(c).
V. Implementation Issues
Any therapeutic DNA plasmid product, therapeutic synthetic peptide
product of 40 or fewer amino acids, monoclonal antibody product for in
vivo use, and therapeutic recombinant DNA-derived product for which a
PLA and an ELA are pending on the effective date of these regulations,
will be reviewed as submitted. No new submission will be necessary to
implement this rule change for these products. If found acceptable for
licensure, FDA will issue a biologics license in lieu of issuing both a
product and establishment license.
Applicants already holding an approved ELA and PLA for a product
within the scope of this rule will not be required to file supplements
to comply with the new requirements. The approved PLA for the product,
together with the limited portions of the approved ELA relevant to the
new requirements for the biologics license application, will be deemed
to constitute an approved biologics license application under the new
regulations.
The agency recognizes that there are a variety of contractual
arrangements that could be affected by this rule. For example, an
innovator company may have contracted with another company to make a
product. Under the previous regulatory scheme, a contract manufacturer
could hold both the establishment license and the product license.
Under the new regulatory scheme, an innovator company may wish to hold
the license. FDA anticipates that firms desiring an arrangement where
the innovator holds the license could surrender the original licenses
to the agency and request reissuance of a new biological license to the
innovator under the provisions of this final rule. FDA urges license
holders or those wishing to change their licensing arrangements to
contact the agency for additional guidance on how this can be
accomplished.
VI. Effective Date
The final rule is effective May 24, 1996. As provided under 5
U.S.C. 553(d) and 21 CFR 10.40(c)(4), the effective date of a final
rule may not be less than 30 days after publication, except for, among
other things, ``a regulation that grants an exemption or relieves a
restriction'' (Sec. 10.40(c)(4)(i)). Because, as described below, this
rule will decrease the regulatory burdens for specified biotechnology
and synthetic biological products, FDA believes that an immediate
effective date is appropriate.
VII. Analysis of Impacts
A. Reduction in Burden
The harmonization of the requirements will reduce burden on
industry because companies manufacturing specified biotechnology and
synthetic products that are regulated by both CBER and CDER will be
able to submit applications for products in a consistent format.
Companies developing and manufacturing products within the scope of
this rule will no longer have to prepare an ELA to submit to the agency
for approval. The amount of information that applicants will need to
provide in a biologics license application will be less than that
currently required in a PLA and ELA. These changes will enable
companies to devote more resources to ensuring that manufacturing
processes are properly validated and fewer resources to submitting
documentation to the agency. These changes will especially benefit
biotechnology companies that lack experience preparing ELA's and PLA's.
According to the biotechnology industry, preparation and submission of
an ELA may add substantially to the cost of obtaining approval of a
biotechnology product.
The inclusion of parts 210 and 211 in this final rule as
establishment standards will not impose any additional burden on
industry. Human drugs, including products subject to this rule, are
already subject to the CGMP's in parts 210 and 211.
B. Review Under Executive Order 12866 and the Regulatory Flexibility
Act
FDA has examined the impact of the final rule under Executive Order
12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impact; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is a significant regulatory action as defined by the Executive
Order and is subject to review under the Executive Order because it
deals with a novel policy issue.
In accordance with the principles of Executive Order 12866, the
overall result of the final rule will be a substantial reduction in
burdens on
[[Page 24232]]
applicants filing for approval of a product subject to this rule. In
addition, FDA anticipates that the final rule will facilitate
applicants' ability to improve their licensed products and methods of
manufacture by decreasing the burden and cost associated with filing an
application.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because, as stated above, the overall result of the
final rule will be a substantial reduction of the regulatory and
reporting burdens, the agency certifies that the final rule will not
have a significant negative economic impact on a substantial number of
small entities. Therefore, under the Regulatory Flexibility Act, no
further analysis is required.
C. Review Under the Paperwork Reduction Act of 1995
This final rule contains information collection requirements that
were submitted for review and approval to the Director of the Office of
Management and Budget (OMB) as required by section 3504(b) of the
Paperwork Reduction Act of 1995. As part of this review, FDA provided
individuals and organizations an opportunity to comment to OMB on the
information collection requirements in the proposed rule. All comments
received agreed that FDA's proposal to eliminate the ELA requirements
for certain biotechnology products would reduce the burden to industry
without diminishing the public health protection. As a result of
information provided, FDA has revised the number of estimated
applicants yearly from 1 to 15. The estimate for completing the
application has not changed, however. This number remains at 40. These
information collection requirements were approved and assigned OMB
control number OMB No. 0910-0316. The expiration date for this approval
is December 31, 1997. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.
The title, description and respondent description of the
information collection are shown below with an estimate of the annual
reporting burden. Included in the estimate is the time for reviewing
instructions, gathering and maintaining the data needed, and completing
and reviewing the collection of information.
Title: Elimination of Establishment License Application for
Specified Biotechnology and Synthetic Biological Products.
Description: FDA is eliminating the requirement that an ELA be
submitted and approved by FDA for specified biotechnology and synthetic
biological products that are licensed by CBER. For these products, in
place of the ELA, a company would be required to prepare and submit
additional information for inclusion in a single biologics license
application, which will be the same as the information included in the
``Chemistry, manufacturing, and controls'' (CMC) section of a new drug
application. This regulation will harmonize the approval and other
regulatory requirements applicable to specified biotechnology and
synthetic biological products licensed under the PHS Act and drugs
approved under the new drug provisions of the act.
Description of Respondents: All applicants for a biological product
license to be approved under the Public Health Service Act.
Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Total Annual Hours per
CFR Section Respondents Responses Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
601.2(c) 15 1 15 40 600
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this information collection.
Reporting or Disclosure: These estimates are an approximation of
the average time expected to be necessary for the collection of
information. They are based on such information as is available to FDA.
-
D. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
List of Subjects
21 CFR Part 600
Biologics, Reporting and recordkeeping requirements.
21 CFR Part 601
Administrative practice and procedure, Biologics, Confidential
business information.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR parts 600 and 601 are amended as
follows:
PART 600--BIOLOGICAL PRODUCTS: GENERAL
1. The authority citation for 21 CFR part 600 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 519, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352,
353, 355, 360, 360i, 371, 374); secs. 215, 351, 352, 353, 361, 2125
of the Public Health Service Act (42 U.S.C. 216, 262, 263, 263a,
264, 300aa-25).
2. Section 600.3 is amended by revising paragraph (t) to read as
follows:
Sec. 600.3 Definitions.
* * * * *
(t) Manufacturer means any legal person or entity engaged in the
manufacture of a product subject to license under the act;
``Manufacturer'' also includes any legal person or entity who is an
applicant for a license where the applicant assumes responsibility for
compliance with the applicable product and establishment standards.
* * * * *
PART 601--LICENSING
3. The authority citation for 21 CFR part 601 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 513-516, 518-520,
701, 704, 721, 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 374,
379e, 381); secs. 215, 301, 351, 352 of the Public Health Service
Act (42 U.S.C. 216, 241, 262, 263); secs. 2-12 of the Fair Packaging
and Labeling Act (15 U.S.C. 1451-1461).
4. Section 601.2 is amended by designating the text of paragraph
(a) as introductory text of (a) and by adding a clause at the end of
the introductory text, new paragraphs (a)(1) through (a)(4), and (c) to
read as follows:
Sec. 601.2 Applications for establishment, product, and biologics
licenses; procedures for filing.
(a) * * * In lieu of the procedures described in this paragraph,
applications for the following specified
[[Page 24233]]
categories of products shall be handled as set forth in paragraph (c)
of this section:
(1) Therapeutic DNA plasmid products;
(2) Therapeutic synthetic peptide products of 40 or fewer amino
acids;
(3) Monoclonal antibody products for in vivo use; and
(4) Therapeutic recombinant DNA-derived products.
* * * * * -
(c)(1) To obtain marketing approval for a therapeutic DNA plasmid
product, therapeutic synthetic peptide product of 40 or fewer amino
acids, monoclonal antibody product for in vivo use, or therapeutic
recombinant DNA-derived product, an applicant shall submit to the
Director, Center for Biologics Evaluation and Research, a biologics
license application on a form prescribed by the Director, Center for
Biologics Evaluation and Research. For such products, a separate
establishment license application shall not be required. An application
for a license for such a product shall include:
(i) Data derived from nonclinical laboratory and clinical studies
that demonstrate that the manufactured product meets prescribed
standards of safety, purity, and potency; with respect to each
nonclinical laboratory study, either a statement that the study was
conducted in compliance with the requirements set forth in part 58 of
this chapter, or,
(ii) If the study was not conducted in compliance with such
regulations, a brief statement of the reason for the noncompliance;
(iii) Statements regarding each clinical investigation involving
human subjects contained in the application, that it either was
conducted in compliance with the requirements for institutional review
set forth in part 56 of this chapter or was not subject to such
requirements in accordance with Secs. 56.104 or 56.105 of this chapter,
and was conducted in compliance with requirements for informed consent
set forth in part 50 of this chapter;
(iv) A full description of manufacturing methods;
(v) Data establishing stability of the product through the dating
period;
(vi) Sample(s) representative of the product to be sold, bartered,
or exchanged or offered, sent, carried or brought for sale, barter, or
exchange;
(vii) Summaries of results of tests performed on the lot(s)
represented by the submitted samples; and
(viii) Specimens of the labels, enclosures, and containers proposed
to be used for the product.
(2) An application for license shall not be considered as filed
until all pertinent information and data have been received from the
applicant by the Center for Biologics Evaluation and Research. The
applicant shall also include either a claim for categorical exclusion
under Sec. 25.24 of this chapter or an environmental assessment under
Sec. 25.31 of this chapter.
(3) Approval of the biologics license application and issuance of
the biologics license shall constitute a determination that the
establishment and the product meet applicable standards established in
this chapter to ensure the continued safety, purity, and potency of
such products. Applicable standards for the maintenance of
establishments for the manufacture of a product subject to this
paragraph (c) shall include the good manufacturing practice
requirements set forth in parts 210 and 211 of this chapter. The
following sections in parts 600 through 680 of this chapter shall not
be applicable to such products: Secs. 600.10(b) and (c), 600.11,
600.12, 600.13, 601.1, 601.30, 601.31, 601.32, 610.11, 610.53, and
610.62 of this chapter.
(4) The term ``product license application,'' as it is used in
those sections of parts 600 through 680 of this chapter that are
applicable to products subject to this paragraph (c) shall include a
biologics license application for a therapeutic DNA plasmid product,
therapeutic synthetic peptide product of 40 or fewer amino acids,
monoclonal antibody product for in vivo use, or therapeutic recombinant
DNA-derived product.
(5) To the extent that the requirements in this paragraph (c)
conflict with other requirements in this subchapter, this paragraph (c)
shall supersede such other requirements.
5. Section 601.22 is amended by adding a sentence after the second
sentence to read as follows:
Sec. 601.22 Products in short supply; initial manufacturing at other
than licensed establishment.
* * *For persons and places authorized under this section to conduct
the initial and partial manufacturing of a product for shipment solely
to a manufacturer of a product subject to licensure under
Sec. 601.2(c), the following additional regulations shall not be
applicable: Secs. 600.10(b) and (c), 600.11, 600.12, 600.13, 610.11,
and 610.53 of this chapter * * *.
Dated: May 6, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-12144 Filed 5-10-96; 10:13 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-12132 Prohibition Against Certain Flights Within the Territory and Airspace of Afghanistan
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24430-24431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12132]
[[Page 24429]]
_______________________________________________________________________
Part VI
Department of Transportation
_______________________________________________________________________
Federal Aviation Administration
_______________________________________________________________________
14 CFR Part 91
Prohibition Against Certain Flights Within the Territory and Airspace
of Afghanistan; Final Rule
Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Rules
and Regulations
[[Page 24430]]
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 91
[Docket No. 27744; Special Federal Aviation Regulation (SFAR) No. 67]
RIN 2120-AG10
Prohibition Against Certain Flights Within the Territory and
Airspace of Afghanistan
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; extension of expiration date.
-----------------------------------------------------------------------
SUMMARY: This action amends Special Federal Aviation Regulation (SFAR)
67 to extend the prohibition on flight operations within the territory
and airspace of Afghanistan by any United States air carrier and
commercial operator, by any person exercising the privileges of an
airman certificate issued by the FAA, or by an operator using an
aircraft registered in the United States unless the operator of such
aircraft is a foreign air carrier. This action is taken to prevent an
undue hazard to persons and aircraft engaged in such flight operations
as a result of the ongoing civil war in Afghanistan.
DATES: Effective Date: May 10, 1996. Expiration date: May 10, 1997.
FOR FURTHER INFORMATION CONTACT: Mark W. Bury, International Affairs
and Legal Policy Staff, AGC-7, Office of the Chief Counsel, Federal
Aviation Administration, 800 Independence Avenue, SW., Washington, D.C.
20591. Telephone: (202) 267-3515.
SUPPLEMENTARY INFORMATION:
Availability of Document
Any person may obtain a copy of this document by submitting a
request to the Federal Aviation Administration, Office of Rulemaking,
Attention: ARM-1, 800 Independence Avenue, SW., Washington, D.C. 20591,
or by calling (202) 267-9677. Communications must identify the number
of this SFAR. Persons interested in being placed on a mailing list for
future rules should also request a copy of Advisory Circular No. 11-2A,
which describes the application procedure.
Background
The Federal Aviation Administration (FAA) is responsible for the
safety of flight in the United States and for the safety of U.S.-
registered aircraft and U.S. operators throughout the world. Section
40101(d)(1) of Title 49, United States Code, declares, as a matter of
policy, that the regulation of air commerce to promote safety is in the
public interest. Section 44701(a) of Title 49, United States Code,
provides the FAA with broad authority to carry out this policy by
prescribing regulations governing the practices, methods, and
procedures necessary to ensure safety in air commerce.
In the exercise of these statutory responsibilities, the FAA issued
SFAR 67, prohibiting flight operations within the territory and
airspace of Afghanistan by any United States air carrier or commercial
operator, any person exercising the privileges of an airman certificate
issued by the FAA, or any operator using an aircraft registered in the
United States unless the operator of such aircraft is a foreign air
carrier. Notice of SFAR 67 was published at 59 FR 25282 (May 13, 1994).
The FAA issued SFAR 67 based upon a determination that the ongoing
civil war in Afghanistan justified the imposition of certain measures
to ensure the safety of U.S.-registered aircraft and operators that are
conducting flight operations in the vicinity of Afghanistan's territory
and airspace. SFAR 67 was originally scheduled to expire after one
year. Notice of the extension of SFAR 67 for an additional year was
published at 60 FR 25980 (May 15, 1995).
Fighting between government and opposition forces continues
throughout Afghanistan at a level and intensity similar to that noted
when SFAR 67 was originally issued. Opposing forces in this long-
running civil war possess a wide range of sophisticated weapons that
potentially could be used to attack civil aviation aircraft overflying
Afghanistan at cruising altitudes. These weapons include Russian-made
fighter and attack aircraft armed with cannons and air-to-air missiles,
and surface-to-air missile (SAM) systems. Although aircraft primarily
have been used for ground attacks against airfields and other key
facilities, air-to-air encounters also have been observed. Press
reports also suggest that a number of Afghan military and civilian
aircraft have been shot down using SAMs. Large areas of the country
continue to be the scene of factional fighting. Fluctuations in the
level and intensity of combat create an unsafe environment for
transiting civilian aircraft.
Advisories have been issued by the International Civil Aviation
Organization (ICAO) urging civil air carriers to avoid Afghan airspace.
In a letter dated April 8, 1994, Assad Kotaite, President of the ICAO
Council, issued a notice urging air carriers to discontinue flights
over Afghanistan. In a subsequent letter of November 14, 1994,
President Kotaite warned of the continuing risks associated with
flights over Afghanistan, including operations using certain routes
developed by the Afghan Government or neighboring countries. On
September 18, 1995, in yet another letter addressing flight safety over
Afghanistan, Dr. Kotaite advised that ``the safety of international
civil flight operations through the Kabul FIR can not be assured.''
These advisories reflect the uncertain nature of the situation and
underscore the danger to flights in Afghan airspace.
There also are indications that at least two rebel factions, in
Afghanistan intend to deliberately target civil aircraft. In a
statement released in September 1995, forces opposed to the Rabbani
Government warned all international air carriers that they would force
or shoot down any plane that ventured into airspace they controlled
without first obtaining proper clearance from them. This follows a
similar warning issued in 1994 by the Opposition Council. Air corridors
over central and southern Afghanistan have been closed frequently as a
result of these threats. Although it seems unlikely that any faction in
the civil war would deliberately target a foreign-flagged commercial
air carrier, their growing frustration with the airlift of arms,
ammunition and other supplies to the Kabul regime creates a potentially
hazardous environment whereby an airliner might be misidentified and
inadvertently targeted. The FAA has received reports that scheduled
passenger flights have been intercepted by opposition fighter aircraft.
Other reports indicate that charter flights have been forced to land in
Kandahar; one of these aircraft and its crew continue to be held there.
At the very least, central Afghan government control over
installations critical to navigation and communication can not be
assured. The use of combat aircraft and SAMs by all factions in the
conflict calls into question the security/safety of Afghan airspace for
civilian aircraft. An environment for long-term stability in this
troubled region has yet to emerge.
Prohibition Against Certain Flights Within the Territory and Airspace
of Afghanistan
On the basis of the above information, and in furtherance of my
responsibilities to promote the safety of flight of civil aircraft in
air commerce, I have determined that continued action by the FAA is
required to prevent the injury to or loss of certain U.S.-registered
aircraft and U.S. operators conducting flights in the vicinity of
[[Page 24431]]
Afghanistan. I find that the current civil war in Afghanistan continues
to present an immediate hazard to the operation of civil aircraft in
the territory and airspace of Afghanistan. Accordingly, I am ordering
the amendment of SFAR 67 to extend for an additional year the
prohibition on flight operations (excluding those operations approved
by the U.S. Government and certain emergency operations) within the
territory and airspace of Afghanistan by any United States air carrier
and commercial operator, by any person exercising the privileges of an
airman certificate issued by the FAA, or by an operator using an
aircraft registered in the United States unless the operator of such
aircraft is a foreign air carrier. This action is necessary to prevent
an undue hazard to aircraft and to protect persons and property on
board those aircraft. Because the circumstances described in this
notice warrant immediate action by the FAA to maintain the safety of
flight, I also find that notice and public comment under 5 U.S.C.
553(b) are impracticable and contrary to the public interest. Further,
I find that good cause exists for making this rule effective
immediately upon issuance. I also find that this action is fully
consistent with my obligations under 49 U.S.C. 40105(b)(1)(A) to
exercise my duties consistently with the obligations of the United
States under international agreements. The Department of State has been
advised of, and has no objection to, the action taken herein.
The rule now contains an expiration date of May 10, 1997, but may
be terminated sooner or extended through the publication of a
corresponding notice if circumstances so warrant.
Regulatory Evaluation
Over the past 10 years, there have been a number of instances
worldwide where civilian aircraft were either shot at or shot down. In
some instances, the shooting was intentional, while in others the
aircraft was misidentified as an enemy aircraft. One such reported
incident, described earlier, involved Afghan government forces
mistakenly shooting at a civilian aircraft. This incident highlights
the risk that one side in the Afghan civil war will misidentify a U.S.
civil aircraft overflying Afghanistan as a hostile aircraft. One
faction involved in the fighting in Afghanistan has specifically stated
that it would target the aircraft of an Afghan air carrier. This stated
threat increases the risk of a U.S. aircraft being misidentified and
shot down.
Navigating around Afghanistan will result in increased variable
operating costs (i.e., maintenance, fuel, and crew) primarily for U.S.
operators who conduct flights between Europe and India. The FAA
estimates that the weighted-average variable operating cost for a wide-
body aircraft is approximately $3,100 per hour. Based on data received
from two U.S. carriers, the amount of additional time it takes to
navigate around Afghanistan using alternate routes ranges from 10
minutes by flying over Iran to between one and four hours by flying
over Saudi Arabia (depending on flight's origin and destination).
Some U.S. operators use the alternate route over Iran, thereby
incurring little, if any, additional flying time and operating costs.
Two U.S. operators use routes over Saudi Arabia, which result in
additional costs of approximately $3,100 to $12,400 per flight.
Based on the potentially small costs of navigating around
Afghanistan and the potentially devastating result of a U.S. air
carrier being shot down, the FAA has determined that the SFAR is cost-
beneficial.
Regulatory Flexibility Determination
The Regulatory Flexibility Act of 1980 (RFA) was enacted by
Congress to ensure that small entities are not unnecessarily and
disproportionately burdened by Federal regulations. The RFA requires a
Regulatory Flexibility Analysis if a proposed rule would have
``significant economic impact on a substantial number of small
entities.'' FAA Order 2100.14A outlines the FAA's procedures and
criteria for implementing the RFA. The FAA has determined that none of
the U.S. air carriers affected by the SFAR are ``small entities'' as
defined by FAA Order 2100.14A Thus, the SFAR would not impose a
``significant economic impact on a substantial number of small
entities.''
International Trade Impact Assessment
The SFAR could have an adverse affect on the international flights
of U.S. air carriers and commercial operators primarily because it
could increase their operating costs relative to foreign carriers who
continue to overfly Afghanistan. However, because of the narrow scope
of the SFAR and the small incremental cost of some of the alternate
routes available to U.S. operators, the FAA has determined that the
SFAR would have little effect on the sale of U.S. aviation products and
services in foreign countries.
Paperwork Reduction Act
This rule contains no information collection requests requiring
approval of the Office of Management and Budget pursuant to the
Paperwork Reduction Act (44 U.S.C. 3507 et seq.)
Federalism Determination
The SFAR set forth herein will not have substantial direct effects
on the states, on the relationship between the national government and
the states, or on the distribution of power and responsibilities among
the various levels of government. Therefore, in accordance with
Executive Order 12612 (52 FR 41685; October 30, 1987), it is determined
that this regulation does not have federalism implications warranting
the preparation of a Federalism Assessment.
Conclusion
For the reasons set forth above, FAA has determined that this
action is not a ``significant regulatory action'' under Executive Order
12866. This action is considered a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979).
Because revenue flights to Afghanistan are not currently being
conducted by U.S. air carriers or commercial operators, the FAA
certifies that this rule will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 91
Afghanistan, Aircraft, Airmen, Airports, Air traffic control,
Aviation safety, Freight.
The Amendment
For the reasons set forth above, the Federal Aviation
Administration is amending 14 CFR part 91 as follows:
PART 91--GENERAL OPERATING AND FLIGHT RULES
1. The authority citation for part 91 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40103, 40113, 40120, 44101, 44111,
44701, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306,
46315, 46316, 46502, 46504, 46506-46507, 47122, 47508, 47528-47531.
2. Section 5 of Special Federal Aviation Regulation (SFAR) No. 67
is revised to read as follows:
5. Expiration. This Special Federal Aviation Regulation expires
May 10, 1997.
Issued in Washington, DC, on May 9, 1996.
David R. Hinson,
Administrator.
[FR Doc. 96-12132 Filed 5-9-96; 4:52 pm]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-12091 Delegations of Authority and Organization
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24223-24226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12091]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 5
Delegations of Authority and Organization
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
regulations for delegations of authority to set forth the current
organizational structure of the agency as well as the current addresses
for headquarters and field offices. This action is necessary to ensure
the continued accuracy of the regulations.
EFFECTIVE DATE: May 14, 1996.
FOR FURTHER INFORMATION CONTACT: Ellen Rawlings, Division of Management
Systems and Policy (HFA-340), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4976.
SUPPLEMENTARY INFORMATION: The regulations are being amended in 21 CFR
5.100 and 5.115 to reflect the current organizational structure of the
agency and to provide current addresses for headquarters and for field
and district offices.
Notice and comment on these amendments are not necessary under the
Administrative Procedure Act because this is a rule of agency
organization (5 U.S.C. 553(b)).
List of Subjects in 21 CFR Part 5
Authority delegations (Government agencies), Imports, Organization
and functions (Government agencies).
[[Page 24224]]
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR Part
5 is amended as follows:
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION
1. The authority citation for 21 CFR Part 5 continues to read as
follows:
Authority: 5 U.S.C. 504, 552, App. 2; 7 138a U.S.C. 2271; 15
U.S.C. 638, 1261-1282, 3701-3711a; secs. 2-12 of the Fair Packaging
and Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-
149, 467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156;
secs. 301, 302, 303, 307, 310, 311, 351, 352, 354-360F, 361, 362,
1701-1706; 2101-2672 of the Public Health Service Act (42 U.S.C.
241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265,
300u-300u-5, 300aa-1-300ff); 42 U.S.C. 1395y, 3246b, 4332, 4831(a),
10007-10008; E.O. 11490, 11921, and 12591 secs. 312, 313, 314 of the
National Childhood Vaccine Act of 1986, Pub. L. 99-660 (42 U.S.C.
300aa-1 note).
2. Section 5.100 is revised to read as follows:
Sec. 5.100 Headquarters.-
The central organization of the Food and Drug Administration
consists of the following:
Office of the Commissioner\1\
---------------------------------------------------------------------------
\1\Mailing address: 5600 Fishers Lane, Rockville, MD 20857.
---------------------------------------------------------------------------
Immediate Office
Office of the Administrative Law Judge.
Office of Executive Operations.
Office of Equal Employment Opportunity and Civil Rights.
Office of Chief Counsel.
Office of Internal Affairs.
Office of External Affairs.
Office of AIDS and Special Health Issues.
Office of Consumer Affairs.
Office of Health Affairs.
Office of Legislative Affairs.
Office of Public Affairs.
Office of Women's Health.
Office of International Affairs.
Industry and Small Business Liaison Staff.
Office of Management and Systems
Office of Planning and Evaluation.
Office of Management.
Office of Information Resources Management.
Office of Policy
Regulations Policy and Management Staff.
Policy Development and Coordination Staff.
Policy Research Staff.
International Policy Staff.
Office of Operations-
Office of Science
Office of Orphan Products Development
National Center for Toxicological Research\2\
---------------------------------------------------------------------------
\2\Mailing address: Jefferson, AR 72079-9502.
---------------------------------------------------------------------------
Office of the Center Director
Environmental Health and Program Assurance Staff.
Equal Employment Opportunity Staff.
Technology Advancement Staff.
Office of Planning and Resource Management
Planning Staff.
Financial Management Staff.
Evaluation Staff.
Office of Research
Division of Reproductive and Developmental Toxicology.
Division of Genetic Toxicology.
Division of Biochemical Toxicology.
Division of Nutritional Toxicology.
Division of Biometry and Risk Assessment.
Division of Chemistry.
Division of Microbiology.
Division of Neurotoxicology.
Office of Research Support
Veterinary Services Staff.
Information Technology Staff.
Division of Administrative Services.
Division of Facilities Engineering and Maintenance.
Office of Regulatory Affairs
Office of the Associate Commissioner
Equal Employment Opportunity Staff.
Strategic Initiatives Staff.
Office of Resource Management
Division of Planning, Evaluation, and Management.
Division of Information Systems.
Division of Human Resource Development.
Division of Management Operations.
Office of Enforcement
Division of Compliance Management and Operations.
Division of Compliance Policy.
Division of Medical Products Quality Assurance.
Office of Regional Operations
Division of Federal-State Relations.
Division of Field Science.
Division of Emergency and Investigational Operations.
Division of Import Operations and Policy.
Office of Criminal Investigations\3\
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\3\Mailing address: 7500 Standish Pl., rm. 250N, Rockville, MD
20855.
---------------------------------------------------------------------------
Northeast Area Office.\4\
---------------------------------------------------------------------------
\4\Mailing address: 10 Exchange Pl., 18th Floor, Jersey City, NJ
07302.
---------------------------------------------------------------------------
Mid-Atlantic Area Office.\5\
---------------------------------------------------------------------------
\5\Mailing address: 7500 Standish Pl., rm. 250N, Rockville, MD
20855.
---------------------------------------------------------------------------
Southeast Area Office.\6\
---------------------------------------------------------------------------
\6\Mailing address: 8525 North West 53d Terrace, suite 204,
Miami, FL 33166.
---------------------------------------------------------------------------
Midwest Area Office.\7\
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\7\Mailing address: 801 Warrenville Rd., suite 500, Lisle, IL
60532.
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Southwest Area Office.\8\
---------------------------------------------------------------------------
\8\Mailing address: 10901 West 84th Terrace, suite 201, Lenexa,
KS 66214-3338.
---------------------------------------------------------------------------
Pacific Area Office.\9\
---------------------------------------------------------------------------
\9\Mailing address: 4365 Executive Dr., suite 230, San Diego, CA
92121.
---------------------------------------------------------------------------
Center for Biologics Evaluation and Research\10\
---------------------------------------------------------------------------
\10\Mailing address: 1401 Rockville Pike, suite 200N, Rockville,
MD 20852-1448.
---------------------------------------------------------------------------
Office of the Center Director
Equal Employment Opportunity Staff.
Congressional and Public Affairs Staff.
Scientific Advisors and Consultants Staff.
Office of Communication, Training, and Manufacturers Assistance
Division of Congressional and Public Affairs.
Office of Management
Division of Management Services.
Division of Applied Information Technology.
Division of Planning, Evaluation, and Budget.
Office of Compliance
Division of Case Management.
Division of Regulations and Policy.
Division of Inspections and Surveillance.
Office of Therapeutics Research and Review
Division of Cytokine Biology.
Division of Cellular and Gene Therapies.
Division of Hematologic Products.
Division of Monoclonal Antibodies.
Division of Clinical Trial Design and Analysis.
Division of Application Review and Policy.
Office of Vaccines Research and Review
Division of Allergenic Products and Parasitology.
Division of Bacterial Products.
Division of Viral Products.
Division of Vaccines and Related Products Applications.
[[Page 24225]]
Office of Establishment Licensing and Product Surveillance
Division of Product Quality Control.
Division of Veterinary Services.
Division of Biostatistics and Epidemiology.
Division of Establishment Licensing.
Office of Blood Research and Review
Division of Blood Applications.
Division of Transfusion Transmitted Diseases.
Division of Hematology.
Center for Drug Evaluation and Research\11\
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\11\Mailing address: 5600 Fishers Lane, WOC II, rm. 6027,
Rockville, MD 20857.
---------------------------------------------------------------------------
Office of the Center Director
Associate Director for Policy.
Regulatory Policy Staff.
Associate Director for Medical Policy.
Division of Drug Marketing, Advertising and Communications.
Executive Operations Staff.
Equal Employment Opportunity Staff.
Office of Management
Division of Management and Budget.
Division of Management Services.
Division of Drug Information Resources.
Division of Information Systems Resources.
Office of Training and Communications
Freedom of Information Staff.
Division of Training and Development.
Division of Communications Management.
Medical Library.
Office of Compliance
Division of Labeling and Nonprescription Drug Compliance.
Division of Prescription Drug Compliance and Surveillance.
Division of Manufacturing and Product Quality.
Division of Scientific Investigations.
Office of Pharmaceutical Science
Office of New Drug Chemistry
Microbiology Team.
Division of New Drug Chemistry I.
Division of New Drug Chemistry II.
Division of New Drug Chemistry III.
Office of Generic Drugs\12\
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\12\Mailing address: 7500 Standish Pl., rm. 150, Rockville, MD
20855.
---------------------------------------------------------------------------
Division of Chemistry I.
Division of Chemistry II.
Division of Bioequivalence.
Division of Labeling and Program Support.
Office of Clinical Pharmacology and Biopharmaceutics
Pharmacometrics Staff.
Division of Pharmaceutical Evaluation I.
Division of Pharmaceutical Evaluation II.
Division of Pharmaceutical Evaluation III.
Office of Testing and Research
Division of Research and Testing.
Division of Clinical Pharmacology Research.
Division of Drug Analysis.
Office of Review Management
Office of Drug Evaluation I
Division of Neuropharmacological Drug Products.
Division of Oncologic Drug Products.
Division of Cardio-Renal Drug Products.
Office of Drug Evaluation II
Division of Metabolic and Endocrine Drug Products.
Division of Pulmonary Drug Products.
Office of Drug Evaluation III
Division of Gastro-Intestinal and Coagulation Drug Products.
Division of Anesthetic, Critical Care, and Addiction Drug Products.
Division of Medical Imaging and Radiopharmaceutical Drug Products.
Office of Drug Evaluation IV
Division of Anti-Infective Drug Products.
Division of Anti-Viral Drug Products.
Office of Drug Evaluation V
Division of Anti-Inflammatory, Analgesic, and Dental Drug Products.
Division of Dermatologic and Ophthalmologic Drug Products.
Division of Over-The-Counter Drug Evaluation.
Office of Epidemiology and Biostatistics
Quantitative Methods Research Staff.
Division of Pharmacovigilance and Epidemiology.
Division of Biometrics I.
Division of Biometrics II.
Division of Biometrics III.
Division of Biometrics IV.
Center for Devices and Radiological Health\13\
---------------------------------------------------------------------------
\13\Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
---------------------------------------------------------------------------
Office of the Center Director
Office of Systems and Management
Division of Planning, Evaluation, and Information Services.
Division of Resource Management.
Division of Computer Services.
Division of Information Resources.
Office of Health and Industry Programs\14\
---------------------------------------------------------------------------
\14\Mailing address: 1350 Piccard Dr., Rockville, MD 20850.
---------------------------------------------------------------------------
Office of Compliance\15\
---------------------------------------------------------------------------
\15\Mailing address: 2094 Gaither Rd., Oak Grove Center,
Rockville, MD 20850.
---------------------------------------------------------------------------
Division of Program Operations.
Division of Bioresearch Monitoring.
Division of Enforcement 1.
Division of Enforcement 2.
Division of Enforcement 3.
Office of Device Evaluation\16\
---------------------------------------------------------------------------
\16\Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
---------------------------------------------------------------------------
Division of Cardiovascular, Respiratory and Neurological Devices.
Division of Reproductive, Abdominal, Ear, Nose, and Throat, and
Radiological Devices.
Division of General and Restorative Devices.
Division of Clinical Laboratory Devices.\17\
---------------------------------------------------------------------------
\17\Mailing address: 2098 Gaither Rd., Rockville, MD 20850.
---------------------------------------------------------------------------
Division of Ophthalmic Devices.
Division of Dental, Infection Control, and General Hospital Devices.
Office of Science and Technology\18\
---------------------------------------------------------------------------
\18\Mailing address: 12720 Twinbrook Pkwy., Bldg. 1, Rockville,
MD 20857.
---------------------------------------------------------------------------
Division of Mechanics and Materials Science.
Division of Life Sciences.
Division of Physical Sciences.
Division of Electronics and Computer Science.
Division of Management, Information, and Support Services.
Office of Health and Industry Programs\19\
---------------------------------------------------------------------------
\19\Mailing address: 1350 Piccard Dr., Rockville, MD 20850.
---------------------------------------------------------------------------
Division of Device User Programs and Systems Analysis.
Division of Small Manufacturers Assistance.
Division of Mammography Quality and Radiation Programs.
Division of Communication Media.
Office of Surveillance and Biometrics\20\
---------------------------------------------------------------------------
\20\Mailing address: 1350 Piccard Dr., Rockville, MD 20850.
---------------------------------------------------------------------------
Division of Biostatistics.
Division of Postmarket Surveillance.
Division of Surveillance Systems.
Center for Food Safety and Applied Nutrition\21\
---------------------------------------------------------------------------
\21\Mailing address: 200 C St. SW., Washington, DC 20204.
---------------------------------------------------------------------------
Office of the Center Director
Office of Policy, Planning, and Strategic Initiatives.
[[Page 24226]]
Office of Programs
Office of Cosmetics and Colors
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Food Labeling
Division of Programs and Enforcement Policy.
Division of Technical Evaluation.
Division of Science and Applied Technology.
Office of Pre-Market Approval
Division of Product Policy.
Division of Petition Control.
Division of Health Effects Evaluation.
Division of Molecular Biological Research and Evaluation.
Division of Product Manufacture and Use.
Office of Plant and Dairy Foods and Beverages
Division of Programs and Enforcement Policy.
Division of Microanalytical Evaluations.-
Division of Programs and Enforcement Policy.
Division of Virulence Assessment.
Division of Pesticides and Industrial Chemicals.
Division of Natural Products.
Division of Food Processing and Packaging.
Office of Seafood
Division of Special Programs.
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Special Nutritionals
Division of Programs and Enforcement Policy.
Division of Science and Applied Technology.
Office of Special Research Skills
Division of Toxicological Research.
Division of Microbiological Studies.
Office of Systems and Support
Quality Assurance Staff.
Office of Constituent Operations
Consumer Education Staff.
Legislative Activities Staff.
Industry Activities Staff.
International Activities Staff.
Office of Field Programs
Division of Enforcement.
Division of HACCP Programs.
Division of Cooperative Programs.
Division of Field Program Planning and Evaluation.
Office of Management Systems
Division of Information Resources Management.
Division of Planning and Resources Management.
Office of Scientific Analysis and Support
Division of Mathematics.
Division of General Scientific Support.
Division of Market Studies.
Center for Veterinary Medicine\22\
---------------------------------------------------------------------------
\22\Mailing Address: 7500 Standish Pl., MPN-2, Rockville, MD
20855.
---------------------------------------------------------------------------
Office of the Center Director
Office of Management
Division of Program and Information Systems.
Division of Program Communications and Administrative Management.
Office of Surveillance and Compliance
Division of Compliance.
Division of Animal Feeds.
Division of Surveillance.
Division of Voluntary Compliance and Hearings Development.
Office of New Animal Drug Evaluation
Division of Biometrics and Production Drugs.
Division of Chemistry.
Division of Therapeutic Drugs for Food Animals.
Division of Therapeutic Drugs for Non-Food Animals.
Division of Toxicology and Environmental Sciences.
Office of Science
Division of Residue Chemistry.
Division of Animal Research.
3. Section 5.115 is revised to read as follows:
Sec. 5.115 Field Structure.
NORTHEAST REGION
Regional Field Office: 850 Third Ave., Brooklyn, NY 11232.
Northeast Regional Laboratory: 850 Third Ave., Brooklyn, NY 11232.
New York District Office: 850 Third Ave., Brooklyn, NY 11232.
New England District Office: One Montvale Ave., Stoneham, MA 02180.
Buffalo District Office: 599 Delaware Ave., Buffalo, NY 14202.
MID-ATLANTIC REGION
Regional Field Office: 900 U.S. Customhouse, Second and Chestnut Sts.,
Philadelphia, PA 19106.
Philadelphia District Office: 900 U.S. Customhouse, Second and Chestnut
Sts., -Philadelphia, PA 19106.
Baltimore District Office: 900 Madison Ave., Baltimore, MD 21201.
Cincinnati District Office: 1141 Central Pkwy., Cincinnati, OH 45202-
1097.
New Jersey District Office: Waterview Corporate Center, 10 Waterview
Blvd., 3d Floor, Parsippany, NJ 07054.
SOUTHEAST REGION
Regional Field Office: 60 Eighth St. NE., Atlanta, GA 30309.
Southeast Regional Laboratory: 60 Eighth St. NE., Atlanta, GA 30309.
Atlanta District Office: 60 Eighth St. NE., Atlanta, GA 30309.
Nashville District Office: 297 Plus Park Blvd., Nashville, TN 37217.
New Orleans District Office: 4298 Elysian Fields Ave., New Orleans, LA
70122.
Florida District Office: 7200 Lake Ellenor Dr., suite 120, Orlando, FL
32809.
San Juan District Office: 466 Fernandez Juncos Ave., San Juan, PR
00901-3223.
MIDWEST REGION
Regional Field Office: 20 North Michigan Ave., rm. 550, Chicago, IL
60602.
Chicago District Office: 300 South Riverside Plaza, suite 500, South
Chicago, IL 60606.
Detroit District Office: 1560 East Jefferson Ave., Detroit, MI 48207.
Minneapolis District Office: 240 Hennepin Ave., Minneapolis, MN 55401.
SOUTHWEST REGION
Regional Field Office: 7920 Elmbrook Dr., suite 102, Dallas, TX 75247-
4982.
Dallas District Office: 3032 Bryan St., Dallas, TX 75204.
Denver District Office: Bldg. 20, Denver Federal Center, Sixth and
Kipling Sts., -P.O. Box 20587, Denver, CO 80255-0087.
Kansas City District Office: 11510 West 80th St., Lenexa, KS 66214-
3340.
St. Louis Branch: 808 North Collins Alley, St. Louis, MO 63102.
PACIFIC REGION
Regional Field Office: Oakland Federal Office Bldg., suite 1180-N,
1301 Clay St., Oakland, CA 94512-5217.
San Francisco District Office: 1431 Harbor Bay Pkwy., Alameda, CA
94502-7070.
Los Angeles District Office: 19900 MacArthur Blvd., suite 300, Irvine,
CA 92715-2445.
Seattle District Office: 22201 23d Dr. SE., Bothell, WA 98201-4421.
Dated: May 1, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-12091 Filed 5-13-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-12089 Establishment of Class E Airspace; San Andreas, CA
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Page 24223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12089]
-----------------------------------------------------------------------
14 CFR Part 71
14 CFR Part 71
[Airspace Docket No. 95-AWP-27]
Establishment of Class E Airspace; San Andreas, CA
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action establishes a Class E airspace area at San
Andreas, CA. The development of a Global Positioning System (GPS)
Standard Instrument Approach Procedure (SIAP) to Runway (RWY) 31 has
made this action necessary. The intended effect of this action is to
provide adequate controlled airspace for Instrument Flight Rules (IFR)
operations at Calaveras Co-Maury Rasmussen Field Airport, San Andreas,
CA.
EFFECTIVE DATE: 0901 UTC August 15, 1996.
FOR FURTHER INFORMATION CONTACT:
William Buck, Airspace Specialist, Operations Branch, AWP-530, Air
Traffic Division, Western-Pacific Region, Federal Aviation
Administration, 15000 Aviation Boulevard, Lawndale, California, 90261,
telephone (310) 725-6556.
SUPPLEMENTARY INFORMATION:
History
On March 13, 1996, the FAA proposed to amend part 71 of the Federal
Aviation Regulations (14 CFR part 71) by establishing a Class E
airspace area at San Andreas, CA (61 FR 10296). This action will
provide adequate controlled airspace to accommodate a GPS SIAP to RWY
31 at Calaveras Co-Maury Rasmussen Field Airport, San Andreas, CA.
Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments to the proposal were received. Class E airspace
designations are published in paragraph 6005 of FAA Order 7400.9C dated
August 17, 1995, and effective September 16, 1995, which is
incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document will be published subsequently in
this Order.
The Rule
This amendment to part 71 of the Federal Aviation Regulations (14
CFR part 71) establishes a Class E airspace area at San Andreas, CA.
The development of a GPS SIAP to RWY 31 has made this action necessary.
The intended effect of this action is to provide adequate controlled
airspace for aircraft executing the GPS RWY 31 SIAP at Calaveras Co-
Maury Rasmussen Field Airport, San Andreas, CA.
The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation--(1) is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 10034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule will not have a significant economic impact on
a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:
PART 71--[AMENDED]
1. The authority citation for 14 CFR part 71 continues to read as
follows:
Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p.389; 14 CFR 11.69.
Sec. 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9C, Airspace Designations and
Reporting Points, dated August 17, 1995, and effective September 16,
1995, is amended as follows:
Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.
* * * * *
AWP CA E5 San Andreas, CA [New]
Calaveras Co-Maury Rasmussen Field Airport, CA
(lat. 36 deg.08'46'' N, long. 120 deg.38'53'' W)
That airspace extending upward from 700 feet above the surface
within a 7.3-mile radius of the Calaveras Co-Maury Rasmussen Filed
Airport.
* * * * *
Issued in Los Angeles, California, on April 29, 1996.
George D. Williams,
Manager, Air Traffic Division, Western-Pacific Region
[FR Doc. 96-12089 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-12088 Amendment of Class E Airspace; Visalia, CA
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24222-24223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12088]
-----------------------------------------------------------------------
14 CFR Part 71
[Airspace Docket No. 96-AWP-6]
Amendment of Class E Airspace; Visalia, CA
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action amends the Class E airspace area at Visalia, CA.
The abandonment of Ianni Strip, CA has made this action necessary. This
action will remove reference of Ianni Strip, CA from the Class E
airspace description for Visalia, CA.
EFFECTIVE DATE: 0901 UTC August 15, 1996.
FOR FURTHER INFORMATION CONTACT: William Buck, Airspace Specialist,
System Management Branch, AWP-530, Air Traffic Division, Western-
Pacific Region, Federal Aviation Administration, 15000 Aviation
Boulevard, Lawndale, California, 90261, telephone (310) 725-6556.
SUPPLEMENTARY INFORMATION:
History
On March 11, 1996, the FAA proposed to amend part 71 of the Federal
Aviation Regulations (14 CFR part 71) by revising the Class E airspace
area at Visalia, CA. The abandonment of Ianni Strip, CA has made this
action necessary.
Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments to the proposal were received.
Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9C dated August 17, 1995, and effective September 16,
1995, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
The Rule
This amendment to part 71 of the Federal Aviation Regulations (14
CFR part 71) amends the Class E airspace area a Visalia, CA. The
abandonment of Ianni Strip, CA has made this action necessary. This
action will remove the reference of Ianni Strip, CA from the Class E
airspace description for Visalia, CA.
The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation--(1) is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 10034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule will not have a significant economic impact on
a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:
PART 71--[AMENDED]
1. The authority citation for 14 CFR part 71 continues to read as
follows:
Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389; 14 CFR 11.69.
Sec. 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9C, Airspace Designations and
Reporting Points, dated August 17, 1995, and effective September 16,
1995, is amended as follows:
Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.
* * * * *
AWP CA E5 Visalia, CA [Revised]
Visalia Municipal Airport, CA
(lat. 36 deg.19'07'' N, long. 119 deg.23'34'' W)
Visalia VOR/DME
(lat. 36 deg.22'02'' N, long. 119 deg.28'56'' W)
Swanson Ranch NR1 Airport, CA
(lat. 36 deg.24'00'' N, long 119 deg.37'03'' W)
That airspace extending upward from 700 feet above the surface
within a 5-mile radius of the Visalia Municipal Airport and within
1.8 miles each side of the Visalia VOR 302 deg. radial, extending
from the 5-mile radius to 7 miles northwest of the VOR and within 4
miles each side of the Visalia VOR 150 deg. radial, extending from
1.7 mile southeast
[[Page 24223]]
17.4 miles southeast of the Visalia VOR and within 2.3 miles each
side of the 245 deg. bearing from the Visalia Municipal Airport,
extending from the 5-mile radius to 8 miles southwest of the
airport; excluding the airspace within 1-mile radius of the Swanson
Ranch NR1 Airport.
* * * * *
Issued in Los Angeles, California, on April 29, 1996.
George D. Williams,
Manager, Air Traffic Division, Western-Pacific Region.
[FR Doc. 96-12088 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-12085 Special Conditions: Dassault Aviation, Mystere Falcon 50 Airplane; High-Intensity Radiated Fields
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24212-24214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12085]
-----------------------------------------------------------------------
[[Page 24213]]
DEPARTMENT OF TRANSPORTATION
14 CFR part 25
[Docket No. NM-124; Special Conditions No. 25-ANM-114]
Special Conditions: Dassault Aviation, Mystere Falcon 50
Airplane; High-Intensity Radiated Fields
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final special conditions; request for comments.
-----------------------------------------------------------------------
SUMMARY: These special conditions are issued for the Dassault Aviation,
Mystere Falcon 50 airplane modified by K-C Aviation of Appleton,
Wisconsin. This airplane will be equipped with a Flight Visions FV-2000
Head-up Display System that provides critical data to the flightcrew.
The applicable regulations do not contain adequate or appropriate
safety standards for the protection of these systems from the effects
of high-intensity radiated fields. These special conditions contain the
additional safety standards that the Administrator considers necessary
to establish a level of safety equivalent to that established by the
existing airworthiness standards.
DATES: The effective date of these special conditions is May 3, 1996.
Comments must be received on or before June 28, 1996.
ADDRESSES: Comments on these final special conditions, request for
comments, may be mailed in duplicate to: Federal Aviation
Administration, Office of the Assistant Chief Counsel, Attn: Rules
Docket (ANM-7), Docket No. NM-124, 1601 Lind Avenue SW., Renton,
Washington, 98055-4056; or delivered in duplicate to the Office of the
Assistant Chief Counsel at the above address. Comments must be marked:
Docket No. NM-124. Comments may be inspected in the Rules Docket
weekdays, except Federal holidays, between 7:30 a.m. and 4:00 p.m.
FOR FURTHER INFORMATION CONTACT: Dale Dunford, FAA, Flight Test and
Systems Branch, ANM-111, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98055-
4056; telephone (206) 227-2239; facsimile (206) 227-1100.
SUPPLEMENTARY INFORMATION:
Comments Invited
The FAA has determined that good cause exists for making these
special conditions effective upon issuance; however, interested persons
are invited to submit such written data, views, or arguments as they
may desire. Communications should identify the regulatory docket and
special conditions number and be submitted in duplicate to the address
specified above. All communications received on or before the closing
date for comments will be considered by the Administrator. These
special conditions may be changed in light of comments received. All
comments submitted will be available in the Rules Docket for
examination by interested persons, both before and after the closing
date for comments. A report summarizing each substantive public contact
with FAA personnel concerning this rulemaking will be filed in the
docket. Persons wishing the FAA to acknowledge receipt of their
comments submitted in response to this request must be submitted with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. NM-124.'' The
postcard will be date stamped and returned to the commenter.
Background
On June 27, 1995, K-C Aviation of Appleton, Wisconsin, applied for
a supplemental type certificate to modify Dassault Aviation, Mystere
Falcon 50 airplanes. The Dassault Aviation, Mystere Falcon 50 is a
business jet with three aft mounted turbine engines. The airplane can
carry three crew and 19 passengers depending on the configuration, and
is capable of operating to an altitude of 49,000 feet. The proposed
modification incorporates the installation of a digital avionics system
that will present critical functions on the Head-up Display System
(HUD), which are potentially vulnerable to a high-intensity radiated
fields (HIRF) external to the airplane
Supplemental Type Certification Basis
Under the provisions of Sec. 21.101 of the Federal Aviation
Regulations (FAR), K-C Aviation must show that the altered Dassault
Aviation, Mystere Falcon 50 airplane continues to meet the applicable
provisions of Sec. 21.29; and part 25, effective February 1, 1965, as
amended by Amendments 25-1 through 25-34 and Sec. 25.255 of Amendment
25-42; Sec. 25.979 (d) and (e) of Amendment 25-38; Sec. 25.1013(b)(1)
of Amendment 25-36; Sec. 25.1351(d) of Amendment 25-41;
Sec. 25.1353(c)(6) of Amendment 25-42; part 36 of the FAR effective
December 1, 1969, as amended through Amendment 36-9; Special Federal
Aviation Regulations (SFAR) 27 effective February 1, 1974, as amended
through Amendment SFAR 27-1; and Special Conditions 25-86-EU-24. In
addition, the certification basis may include other special conditions
that are not relevant to these proposed special conditions.
If the Administrator finds that the applicable airworthiness
regulations (i.e., part 25, as amended) do not contain adequate or
appropriate safety standards for the Dassault Aviation, Mystere Falcon
50 airplane because of a novel or unusual design feature, special
conditions are prescribed under the provisions of Sec. 21.16 to
establish a level of safety equivalent to that established in the
regulations.
Special conditions, as appropriate, are issued in accordance with
Sec. 11.49 of the FAR after public notice, as required by Secs. 11.28
and 11.29, and become part of the type certification basis in
accordance with Sec. 21.17(a)(2).
Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, the special conditions would also apply to the
other model under the provision of Sec. 21.101(a)(1).
Novel or Unusual Design Features
The Dassault Aviation, Mystere Falcon 50 airplane incorporates a
Flight Visions FV-200 Head-up Display system that provides critical
data to the flightcrew. These systems may be vulnerable to HIRF
external to the airplane.
Discussion
There is no specific regulation that addresses protection
requirements for electrical and electronic systems from HIRF. Increased
power levels from ground-based radio transmitters and the growing use
of sensitive electrical and electronic systems to command and control
airplanes have made it necessary to provide adequate protection.
To ensure that a level of safety is achieved equivalent to that
intended by the regulations incorporated by reference, special
conditions are proposed for the Dassault Aviation, Mystere Falcon 50,
which would require that new technology electrical and electronic
systems, such as the HUD, etc., be designed and installed to preclude
component damage and interruption of function due to both the direct
and indirect effects of HIRF.
High-Intensity Radiated Fields (HIRF)
With the trend toward increased power levels from ground-based
transmitters, plus the advent of space and satellite communications,
coupled with electronic command and control of the airplane, the
immunity of critical
[[Page 24214]]
digital avionics systems to HIRF must be established.
It is not possible to precisely define the HIRF to which the
airplane will be exposed in service. There is also uncertainty
concerning the effectiveness of airframe shielding for HIRF.
Furthermore, coupling of electromagnetic energy to cockpit-installed
equipment through the cockpit window apertures is undefined. Based on
surveys and analysis of existing HIRF emitters, an adequate level of
protection exists when compliance with the HIRF protection special
condition is shown with either paragraphs 1 or 2 below:
1. A minimum threat of 100 volts per meter peak electric field
strength from 10 KHz to 18 GHz.
a. The threat must be applied to the system elements and their
associated wiring harnesses without the benefit of airframe shielding.
b. Demonstration of this level of protection is established through
system tests and analysis.
2. A threat external to the airframe of the following field
strengths for the frequency ranges indicated.
------------------------------------------------------------------------
Peak (V/ Average
Frequency M) (V/M)
------------------------------------------------------------------------
10 KHz-100 KHz.................................... 50 50
100 KHz-500 KHz................................... 60 60
500 KHz-2000 KHz.................................. 70 70
2 MHz-30 MHz...................................... 200 200
30 MHz-100 MHz.................................... 30 30
100 MHz-200 MHz................................... 150 33
200 MHz-400 MHz................................... 70 70
400 MHz-700 MHz................................... 4,020 935
700 MHz-1000 MHz.................................. 1,700 170
1 GHz-2 GHz....................................... 5,000 990
2 GHz-4 GHz....................................... 6,680 840
4 GHz-6 GHz....................................... 6,850 310
6 GHz-8 GHz....................................... 3,600 670
8 GHz-12 GHz...................................... 3,500 1,270
12 GHz-18 GHz..................................... 3,500 360
18 GHz-40 GHz..................................... 2,100 750
------------------------------------------------------------------------
As discussed above, the proposed special conditions would be
applicable initially to the K-C Aviation modified Dassault Aviation,
Mystere Falcon 50. Should K-C Aviation apply at a later date for a
change to the supplemental type certificate to include another model
incorporating the same novel or unusual design feature, the special
conditions would apply to that model as well under the provisions of
Sec. 21.101(a)(1).
Conclusion
This action affects only certain design features on the Dassault
Aviation, Mystere Falcon 50 airplane. It is not a rule of general
applicability and affects only the manufacturer who applied to the FAA
for approval of these features on the airplane.
The substance of these special conditions for this airplane has
been subjected to the notice and comment procedure in several prior
instances and has been derived without substantive change from those
previously issued. It is unlikely that prior public comment would
result in a significant change from the substance contained herein. For
this reason, and because a delay would significantly affect the
certification of the airplane, which is imminent, the FAA has
determined that prior public notice and comment are unnecessary and
impracticable, and good cause exists for adopting these special
conditions immediately. Therefore, these special conditions are being
made effective upon issuance. The FAA is requesting comments to allow
interested persons to submit views that may not have been submitted in
response to the prior opportunities for comment described above.
List of Subjects in 14 CFR Part 25
Aircraft, Aviation safety, Reporting and recordkeeping
requirements.
The authority citiation for these special conditions is as follows
Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
The Special Conditions
According, the following special conditions are issued as part of
the supplemental type certification basis for the K-C Aviation modified
Dassault Aviation, Mystere Falcon 50 series airplanes.
1. Protection from Unwanted Effects of High-Intensity Radiated
Fields (HIRF). Each electrical and electronic system that performs
critical functions must be designed and installed to ensure that the
operation and operational capability of these systems to perform
critical functions are not adversely affected when the airplane is
exposed to high-intensity radiated fields.
2. For the purpose of these special conditions, the following
definition applies: Critical Functions. Functions whose failure would
contribute to or cause a failure condition that would prevent the
continued safe flight and landing of the airplane.
Issued in Renton, Washington, on May 3, 1996.
Stewart R. Miller,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service, ANM-100.
[FR Doc. 96-12085 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-12055 Agreements for the Development of Foreign Markets for Agricultural Commodities
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24205-24206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12055]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Rules
and Regulations
[[Page 24205]]
DEPARTMENT OF AGRICULTURE
Commodity Credit Corporation
7 CFR Part 1485
Agreements for the Development of Foreign Markets for
Agricultural Commodities
AGENCY: Commodity Credit Corporation (CCC).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Commodity Credit Corporation (CCC) is adopting as a final
rule the provisions of the proposed rule published January 10, 1996,
(61 FR 704) regarding implementation of the Market Promotion Program
(MPP) authorized by Section 203 of the Agricultural Trade Act of 1978,
7 U.S.C. 5623. Specifically, this rule extends the period of time
following the expiration of the marketing year during which
participants may pay for approved market development activities and
still be entitled to receive reimbursement from CCC. This period of
time is extended from 30 days to 4 months. This change eases
administrative requirements by affording program participants
additional time to obtain invoices and other documentation which
supports the completion of overseas market development activities.
EFFECTIVE DATES: May 14, 1996.
FOR FURTHER INFORMATION CONTACT: Sharon McClure or Denise Fetters at
(202) 720-5521.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
This final rule is issued in conformance with Executive Order
12866. Based on information compiled by the Department, it has been
determined that this rule:
(1) Would have an annual effect on the economy of less than $100
million;
(2) Would not adversely affect in a material way the economy, a
sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities;
(3) Would not create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency;
(4) Would not alter the budgetary impact of entitlements, grants,
user fees, or loan programs or rights and obligations of recipients
thereof; and
(5) Would not raise novel legal or policy issues arising out of
legal mandates, the President's priorities, or principles set forth in
Executive Order 12866.
The Department of Agriculture is committed to carrying out its
statutory and regulatory mandates in a manner that best serves the
public interest. Therefore, where legal discretion permits, the
Department actively seeks to promulgate regulations that promote
economic growth, create jobs, are minimally burdensome and are easy for
the public to understand, use of comply with. In short, the Department
is committed to issuing regulations that maximize net benefits to
society and minimize costs imposed by those regulations.
Regulatory Flexibility Act
It has been determined that the Regulatory Flexibility Act is not
applicable to this final rule since CCC is not required by 5 U.S.C. 553
or any other provision of law to publish a notice of rulemaking with
respect to the subject matter of this rule.
Paperwork Reduction Act
The final rule does not impose any new reporting or record keeping
requirements. The information collection requirements for participating
in the MPP were approved for use by the Office of Management and Budget
under OMB control number 0551-0027.
Executive Order 12372
This final rule is not subject to the provisions of Executive Order
12372 which requires intergovernmental consultation with state and
local officials. See the Notice related to 7 CFR part 3015, subpart V,
published at 46 FR 29115 (June 24, 1983).
Executive Order 12778
This final rule has been reviewed under the Executive Order 12778,
Civil Justice Reform. The rule would have pre-emptive effect with
respect to any state or local laws, regulations, or policies which
conflict with such provisions or which otherwise impede their full
implementation. The rule would not have retroactive effect.
Administrative proceedings are not required before parties may seek
judicial review.
Background
On February 1, 1995, the CCC published final rules at 60 FR 6352
governing the MPP. These new rules were applicable beginning with a
participant's 1995 marketing year. Following publication, CCC
participated with interested parties in five information sessions
designed to familiarize participants with the new regulations and offer
participants an additional opportunity to identify any problem areas.
At these sessions, there was considerable discussion concerning the
requirement that participants must completely pay for approved
activities not later than 30 days following the end of a participant's
activity plan year in order to receive reimbursement, 7 CFR
Sec. 1485.16(h)(3). As a result of these discussions, CCC published a
proposed rule on January 10, 1996, to amend the current requirement in
7 CFR Sec. 1485.16(h).
General Comments
The public was given 30 days to submit written comments on the
proposed rule. During this period, CCC received 5 letters from
nonprofit U.S. trade organizations. All commenters strongly supported
the proposed rule which would allow participants to transfer funds to
pay for activities not later than 4 months following the end of the
activity plan year and still be entitled to receive reimbursement from
CCC. The proposed rule is adopted as final. Since this final removes a
restriction, it is being made effective upon publication in the Federal
Register.
List of Subjects in 7 CFR Part 1485
Agricultural commodities, Exports.
Accordingly, 7 CFR Part 1485 is amended to read as follows:
[[Page 24206]]
PART 1485--AGREEMENTS FOR THE DEVELOPMENT OF FOREIGN MARKETS FOR
AGRICULTURAL COMMODITIES
1. The authority citation for Part 1485 continues to read as
follows:
Authority: 7 U.S.C. 5623, 5662-5664 and sec. 1302, Pub. L. 103-
66, 107 Stat. 330.
Subpart B--Market Promotion Program
2. In Sec. 1485.16, paragraph (h) is revised to read as follows:
Sec. 1485.16 Reimbursement rules.
* * * * *
(h) CCC will reimburse for expenditures made after the conclusion
of participant's activity plan year provided:
(1) The activity was approved prior to the end of the activity plan
year;
(2) The activity was completed within 30 calendar days following
the end of the activity plan year; and
(3) all funds were transferred to pay for the activity within 4
months following the end of the activity plan year.
Signed at Washington, D.C. on May 8, 1996.
Timothy J. Galvin,
Acting Administrator, Foreign Agricultural Service and Vice President,
Commodity Credit Corporation.
[FR Doc. 96-12055 Filed 5-13-96; 8:45 am]
BILLING CODE 3410-10-M
Complete official Federal Register PDF
FR Doc. 96-12047 Radio Broadcasting Services; Caldwell, College Station and Gause, TX
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Page 24244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12047]
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FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 91-58, RM-7419, RM-7797, RM-7798]
Radio Broadcasting Services; Caldwell, College Station and Gause,
TX
AGENCY: Federal Communications Commission.
ACTION: Final rule.
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SUMMARY: This document denies a Petition for Reconsideration filed by
Roy E. Henderson directed to the Report and Order in this proceeding.
See 60 FR 52914, published October 11, 1995. With this action, the
proceeding is terminated.
EFFECTIVE DATE: May 14, 1996.
FOR FURTHER INFORMATION CONTACT: Robert Hayne, Mass Media Bureau, (202)
418-2177.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Memorandum Opinion and Order in MM Docket No. 91-58, adopted April 26,
1996, and released May 9, 1996. The full text of this decision is
available for inspection and copying during normal business hours in
the FCC Reference Center (Room 239), 1919 M Street, NW., Washington,
DC. The complete text of this decision may also be purchased from the
Commission's copy contractors, International Transcription Service,
Inc., (202) 857-3800, 1919 M Street, NW., Room 246, or 2100 M Street,
NW., Washington, DC 20037.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Federal Communications Commission.
Douglas W. Webbink,
Chief, Policy and Rules Division, Mass Media Bureau.
[FR Doc. 96-12047 Filed 5-13-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-12045 Radio Broadcasting Services; Honor, MI
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Page 24243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12045]
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FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 95-135; RM-8681]
Radio Broadcasting Services; Honor, MI
AGENCY: Federal Communications Commission.
ACTION: Final rule.
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SUMMARY: This document allots Channel 264A to Honor, Michigan, in
response to a petition filed by Jacqueline F. Bourgard. See 60 FR
45390, August 31, 1995. The coordinates for Channel 264A at Honor are
44-41-26 and 86-01-05. There is a site restriction 3 kilometers (1.8
miles) north of the community. Canadian concurrence has been obtained
for this allotment. With this action, this proceeding is terminated.
DATES: Effective June 20, 1996. The window period for filing
applications will open on June 20, 1996, and close on July 5, 1996.
FOR FURTHER INFORMATION CONTACT: Kathleen Scheuerle, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report
and Order, MM Docket No. 95-135, adopted April 24, 1996, and released
May 6, 1996. The full text of this Commission decision is available for
inspection and copying during normal business hours in the Commission's
Reference Center (Room 239), 1919 M Street, NW., Washington, DC. The
complete text of this decision may also be purchased from the
Commission's copy contractors, International Transcription Services,
Inc., 2100 M Street, NW., Suite 140, Washington, DC 20037, (202) 857-
3800.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Part 73 of title 47 of the Code of Federal Regulations is amended
as follows:
PART 73--[AMENDED]
1. The authority citation for part 73 continues to read as follows:
Authority: Secs. 303, 48 Stat., as amended, 1082; 47 U.S.C. 154,
as amended.
Sec. 73.202 [Amended]
2. Section 73.202(b), the Table of FM Allotments under Michigan, is
amended by adding Honor, Channel 264A.
Federal Communications Commission.
Andrew J. Rhodes,
Acting Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-12045 Filed 5-13-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-12043 Radio Broadcasting Services; Ingalls, KS
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24243-24244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12043]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 95-180; RM-8730]
Radio Broadcasting Services; Ingalls, KS
AGENCY: Federal Communications Commission.
[[Page 24244]]
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Commission, at the request of Dana J. Puopolo, allots
Channel 242C1 to Ingalls, Kansas, as the community's second local aural
transmission service. See 61 FR 2469, January 26, 1996. Channel 242C1
can be allotted to Ingalls, Kansas, in compliance with the Commission's
minimum distance separation requirements without the imposition of a
site restriction. The coordinates for Channel 242C1 at Ingalls are 37-
49-48 and 100-27-06. With this action, this proceeding is terminated.
DATES: Effective June 21, 1996. The window period for filing
applications will open on June 21, 1996, and close on July 22, 1996.
FOR FURTHER INFORMATION CONTACT: Pam Blumenthal, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Report and Order, MM Docket No. 95-180, adopted April 24, 1996, and
released May 7, 1996. The full text of this Commission decision is
available for inspection and copying during normal business hours in
the FCC Reference Center (Room 239), 1919 M Street, NW., Washington,
DC. The complete text of this decision may also be purchased from the
Commission's copy contractor, ITS, Inc., (202) 857-3800, 2100 M Street,
NW., Suite 140, Washington, DC 20037.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Part 73 of title 47 of the Code of Federal Regulations is amended
as follows:
PART 73--[AMENDED]
1. The authority citation for part 73 continues to read as follows:
Authority: Secs. 303, 48 Stat., as amended, 1082; 47 U.S.C. 154,
as amended.
Sec. 73.202 [Amended]
2. Section 73.202(b), the Table of FM Allotments under Kansas, is
amended by adding Channel 242C1 at Ingalls.
Federal Communications Commission.
Andrew J. Rhodes,
Acting Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-12043 Filed 5-13-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-12030 Coast Guard Board for Correction of Military Records; Procedural Regulation
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24233-24235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12030]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Office of the Secretary
Coast Guard
33 CFR Part 52
[OST Docket No. OST-95-878]
RIN 2105-AC31
Coast Guard Board for Correction of Military Records; Procedural
Regulation
AGENCY: Office of the Secretary, Coast Guard, DOT.
ACTION: Final Rule.
-----------------------------------------------------------------------
SUMMARY: The Department is amending its regulation with respect to
reconsideration of final decisions of the Board for Correction of
Military Records of the Coast Guard (BCMR). This action is taken on the
Department's initiative in order to streamline processing of these
cases and to clarify the circumstances under which final decisions can
be reconsidered. The amendment will make it possible for the BCMR to
expedite the processing of reconsideration requests and it will
increase the resources available to meet the requirement that all cases
be decided within 10 months of the receipt of a completed application.
EFFECTIVE DATE: June 13, 1996.
FOR FURTHER INFORMATION CONTACT: Robert H. Joost, Chairman, Board for
Correction of Military Records of the Coast Guard, C-60, Office of the
General Counsel, U.S. Department of Transportation, 400 Seventh Street,
SW, Washington, D.C. 20590-0001. Telephone: (202) 366-9335.
SUPPLEMENTARY INFORMATION:
Comments on Proposed Rulemaking
Proposed rulemaking was published on pages 63489-63491 of the
Federal Register of December 11, 1995 [60 FR 63489], and invited
comments for 60 days ending February 9, 1996. Comments were received
from the following sources: (1) Eugene R. Fidell, Esq., an attorney in
private practice; and (2) Michael J. Calabro, Esq., an attorney in
private practice. The comments and the actions taken in response to the
comments are summarized below.
Both attorneys expressed concern with respect to the amount of time
that
[[Page 24234]]
may be consumed in processing a reconsideration request. The BCMR
appreciates this concern, but believes that delay, which is a problem
in the current reconsideration process, would be significantly reduced
under the proposed rule. The proposed rule, by eliminating duplicative
review of a reconsideration application, as required by the current
Sec. 52.67(c), and by providing for an expedited process in handling
facially defective reconsideration requests, will require less time per
reconsideration request than the current rule.
One of the commenting attorneys questioned the authority given to
the Chairman in proposed Sec. 52.67(b) on the ground that the enabling
statute (10 U.S.C. Sec. 1552) requires BCMR decisions to be made by the
Secretary acting through a board. That is true, but it is only true
with respect to an original decision. Section 1552 of title 10 does not
provide for, nor does it prohibit, the reconsideration of original
decisions. Reconsideration authority has been added by the BCMR's
regulations and its parameters can therefore be determined by those
regulations.
Comments were also offered on other aspects of the correction board
process for the Coast Guard. One attorney asked that the BCMR's basic
time limit regulation be updated, even though that was not a subject
addressed in the proposed rule. Both attorneys made suggestions with
regard to administrative matters that do not bear on the proposed rule
and do not require a rules change to implement: appropriate
designations and numbering for docketed reconsideration requests; the
formalization and publication of the Secretary's delegate's authority;
improvement of the system for indexing and retrieval of redacted Coast
Guard BCMR decisions; availability of redacted decisions to all who are
interested by bulletin board, CD-ROM, or mailed to subscribers on a
mailing list, in return for a reasonable fee. None of these comments
bear on the reconsideration regulation that is being considered in this
rulemaking process. Therefore, while these matters remain under
consideration, they are not addressed at this time.
Final Rule
This final rule explicitly authorizes the Board to consider
applications for reconsideration upon a showing that the Board
committed legal or factual error in the original determination that
could have resulted in a determination other than that made.
This final rule also authorizes the Chairman not to docket
applications for reconsideration that do not meet the threshold
requirements for reconsideration, i.e., applications that only (1)
present evidence or information previously considered by the Board, (2)
present new evidence or information that is clearly not material to the
result in the case, (3) present new evidence or information that could
have been submitted earlier with the exercise of reasonable diligence,
or (4) make arguments as to legal or factual error that are clearly not
material to the result. The phrase ``otherwise comes to the attention
of the Board'' has been deleted, however, as unnecessary.
This final rule also provides that no Board member who considered
an applicant's original application for correction would participate in
the consideration of that person's application for reconsideration.
There will, to the extent practicable, be a related prohibition on the
staff member; the person who drafted the original decision would not
draft the reconsideration decision. In light of these safeguards, it
would not be necessary for the Secretary's designate to approve each
denial of a reconsideration request, thus expediting the review
process.
Section-by-Section Analysis-
Section 52.67, Reconsideration, is rewritten to add the new
requirements outlined above, and to simplify the procedure on
reconsideration.
Paragraph (a) provides that reconsideration of an application may
occur if the applicant meets at least one of two sets of criteria. The
first of these, paragraph (a)(1), directs reconsideration if an
applicant presents evidence or information that was not previously
considered by the Board if that evidence or information could result in
a different determination and if it ``could not have been presented to
the Board prior to its original determination if the applicant had
exercised reasonable diligence.'' The second of these, paragraph
(a)(2), directs reconsideration if an applicant presents evidence or
information that the Board committed legal or factual error in the
original determination that could have resulted in a different result.
Paragraph (b) directs the Chairman to docket a reconsideration
request if it meets the requirements of paragraph (a)(1) or (a)(2). If
neither of these requirements is met, the Chairman shall not docket the
request, and shall return the application to the applicant with a
statement that no action is being taken due to a failure to meet the
threshold requirements for docketing.
Paragraph (c) provides that the Board shall consider each
application for reconsideration that has been docketed under paragraph
(b). This paragraph also provides that the final decision on
reconsideration shall involve a different Board than the one that
initially considered the application. -
Paragraph (d) provides that the Board's final action on docketed
application for reconsideration shall be the same as if they were
original applications for correction.
Paragraph (e) provides that an applicant's request for
reconsideration must be filed within two years after the issuance of a
final decision, subject to other legal rules such as the Soldier's and
Sailor's Civil Relief Act. The two-year statute of limitations
parallels the time period allowed by Article 73 of the Uniform Code of
Military Justice for petitioning for a new trial after the approval of
a court-martial sentence on the grounds of newly discovered evidence or
fraud on the court. If the Chairman dockets an applicant's request for
reconsideration under paragraph (b), the two-year requirement may be
waived if the Board finds that it would be in the interest of justice
to consider the request despite its untimeliness.
Regulatory Process Matters
This is not a significant rule under Executive Order 12681 or the
Department's Regulatory Policies and Procedures. The costs of a purely
procedural change in the Board's rule would be negligible. The rule
will not have a significant economic effect on a substantial number of
small entities, as defined in the Regulatory Flexibility Act. There are
no Federalism factors to warrant the preparation of a Federalism
assessment.
List of Subjects in 33 CFR Part 52
Administrative practice and procedure, Archives and records,
Military personnel, Military records.
Issued this 8th day of May 1996, at Washington, D.C.------
Federico Pena,-
Secretary of Transportation.
-For the reasons set forth in the preamble, the Office of the
Secretary of the U.S. Department of Transportation amends 33 CFR Part
52 as follows:
PART 52--[AMENDED]
1. The authority citation for Part 52 is revised to read as
follows:-
Authority: 10 U.S.C. 1552; 49 U.S.C. 108; Pub. L. 101-225, 103
Stat. 1908, 1914.
2. Section 52.67 is revised to read as follows:
[[Page 24235]]
Sec. 52.67 Reconsideration.
(a) Reconsideration of an application for correction of a military
record shall occur if an applicant requests it and the request meets
the requirements set forth in paragraph (a)(1) or (a)(2) of this
section.
(1) An applicant presents evidence or information that was not
previously considered by the Board that could result in a determination
other than that originally made. Evidence or information may only be
considered if it could not have been presented to the Board prior to
its original determination if the applicant had exercised reasonable
diligence; or
(2) An applicant presents evidence or information that the Board,
or the Secretary as the case may be, committed legal or factual error
in the original determination that could have resulted in a
determination other than that originally made.
(b) The Chairman shall docket a request for reconsideration of a
final decision if it meets the requirements of paragraph (a)(1) or
(a)(2) of this section. If neither of these requirements is met, the
Chairman shall not docket such request.
(c) The Board shall consider each application for reconsideration
that has been docketed. None of the Board members who considered an
applicant's original application for correction shall participate in
the consideration of that applicant's application for reconsideration.
(d) Action by the Board on a docketed application for
reconsideration is subject to Sec. 52.64(b).
(e) An applicant's request for reconsideration must be filed within
two years after the issuance of a final decision, except as otherwise
required by law. If the Chairman dockets an applicant's request for
reconsideration, the two-year requirement may be waived if the Board
finds that it would be in the interest of justice to consider the
request despite its untimeliness.
[FR Doc. 96-12030 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-62-P
Complete official Federal Register PDF
FR Doc. 96-11971 Medical; VA Health Professional Scholarship Program, Correction
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24236-24237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11971]
=======================================================================
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AH99
Medical; VA Health Professional Scholarship Program, Correction
AGENCY: Department of Veterans Affairs.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This document corrects a repayment formula for health care
professionals who fail to comply with service obligation under the VA
Health Professional Scholarship Program.
EFFECTIVE DATE: May 14, 1996.
FOR FURTHER INFORMATION CONTACT: Meryl Bullard, Health Education
Specialist (143), Veterans Health Administration, Department of
Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420;
Telephone (202) 565-7122. (This is not a toll-free number.)
There is no Catalog of Federal Domestic Assistance number for the
program affected by this proposal.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug abuse, Foreign relations,
Government contracts, Grant programs-health, Grant programs-veterans,
Health care, Health facilities, Health professions, Health records,
Homeless, Medical and dental schools, Medical devices, Medical
research, Mental health programs, Nursing homes, Philipines, Reporting
[[Page 24237]]
and recordkeeping requirements, Scholarships and fellowships, Travel
and transportation expenses, Veterans.
Approved: May 7, 1996.
Thomas O. Gessel,
Director, Office of Regulations Management, Department of Veterans
Affairs.
Accordingly, 38 CFR part 17 is corrected by making the following
correcting amendment:
PART 17--MEDICAL
1. The authority citation for Part 17 continues to read as follows:
Authority: 38 U.S.C. 501, 5705.
2. In Sec. 17.610, the formula portion of paragraph (c) is amended
by removing ``A=3O'' and adding, in its place, ``A=3''.
[FR Doc. 96-11971 Filed 5-13-96; 8:45 am]
BILLING CODE 8320-01-P
Complete official Federal Register PDF
FR Doc. 96-11970 Veterans Education: Increase in Rates Payable Under the Montgomery GI BillActive Duty, 1995-96
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24237-24239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11970]
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 21
RIN 2900-AH79
Veterans Education: Increase in Rates Payable Under the
Montgomery GI Bill--Active Duty, 1995-96
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: By statute, the monthly rates of basic educational assistance
payable to veterans and servicemembers under the Montgomery GI Bill--
Active Duty must be adjusted each fiscal year. In accordance with the
statutory formula, the regulations governing rates of basic educational
assistance payable under the Montgomery GI Bill--Active Duty for fiscal
year 1996 (October 1, 1995 through September 30, 1996) are changed to
show a 2.9% increase in these rates.
EFFECTIVE DATE: October 1, 1995.
FOR FURTHER INFORMATION CONTACT: June C. Schaeffer, Assistant Director
for Policy and Program Administration, Education Service, Veterans
Benefits Administration (202) 273-7187.
SUPPLEMENTARY INFORMATION: Under the formula mandated by 38 U.S.C.
3015(g) for fiscal year 1996, the rates of basic educational assistance
under the Montgomery GI Bill--Active Duty payable to students pursuing
a program of education full time must be increased by the percentage
that the total of the monthly Consumer Price Index-W for July 1, 1994,
through June 30, 1995, exceeds the total of the monthly Consumer Price
Index-W for July 1, 1993, through June 30, 1994. Under this formula,
the changes to the regulations governing monthly rates reflect a 2.9%
increase.
It should be noted that some veterans will receive an increase in
monthly payments that will be less than 2.9%. The increase does not
apply to additional amounts payable by the Secretary of Defense to
individuals with skills or a specialty in which there is a critical
shortage of personnel (so-called ``kickers''). It does not apply to
supplemental educational assistance. It also does not apply to amounts
payable for dependents. Veterans who previously had eligibility under
the Vietnam Era GI Bill receive monthly payments that are in part based
upon basic educational assistance and in part based upon the rates
payable under the Vietnam Era GI Bill. Only that portion attributable
to basic educational assistance is increased by 2.9%.
Although 38 U.S.C. 3015(g) requires only that the full-time rates
be increased, these revisions include increases for other training
also. Monthly rates payable to veterans in apprenticeship or other on-
job training or cooperative training are set by statute at a given
percentage of the full-time rate. Hence, any rise in the full-time rate
automatically requires an increase in the rates for these types of
training.
38 U.S.C. 3015 (a) and (b) require that the Department of Veterans
Affairs (VA) pay part-time students at appropriately reduced rates.
Since the first student became eligible for assistance under the
Montgomery GI Bill--Active Duty in 1985, VA has paid three-quarter-time
students and one-half-time students at 75% and 50% of the full-time
rate, respectively. Students pursuing a program of education at less
than one half but more than one-quarter-time have had their payments
limited to 50% or less of the full-time rate. Similarly, students
pursuing a program of education at one-quarter-time or less have had
their payments limited to 25% or less of the full-time rate. Changes
are made consistent with the authority and formula described in this
paragraph.
The changes set forth in this final rule are applied retroactively
from the effective date of the statutory changes.
Substantive changes made by this final rule merely reflect
statutory requirements and adjustments made based on previously
established formulas. Accordingly, there is a basis for dispensing with
prior notice and comment and delayed effective date provisions of 5
U.S.C. 552 and 553.
The Secretary of Veterans Affairs hereby certifies that this final
rule will not have a significant economic impact on a substantial
number of small entities as they are defined in the Regulatory
Flexibility Act, 5 U.S.C. 601-612. This final rule directly affects
only individuals and does not directly affect small entities. Pursuant
to 5 U.S.C. 605(b), the amended regulations, therefore, are exempt from
the initial and final regulatory flexibility analyses requirements of
sections 603 and 604.
The Catalog of Federal Domestic Assistance number for the
program affected by this final rule is 64.124.
List of Subjects in 38 CFR Part 21
Administrative practice and procedure, Armed forces, Civil rights,
Claims, Colleges and universities, Conflict of interests, Defense
Department, Education, Employment, Entitlement programs--education,
Entitlement programs--veterans, Health care, Loan programs--education,
Loan programs--veterans, Manpower training programs, Reporting and
recordkeeping requirements, Schools, Travel and transportation
expenses, Veterans, Vocational education, Vocational rehabilitation.
Approved: May 1, 1996.
Jesse Brown,
Secretary of Veterans Affairs.
For the reasons set out in the preamble, 38 CFR part 21 (subpart K)
is amended as set forth below.
PART 21--VOCATIONAL REHABILITATION AND EDUCATION
Subpart K--All Volunteer Force Educational Assistance Program (New
GI Bill)
1. The authority citation for part 21, subpart K continues to read
as follows:
Authority: 38 U.S.C. 501(a), chs. 30, 36, unless otherwise
noted.
2. In Sec. 21.7136, paragraph (b)(3) is amended by removing
``$323.90'' and adding, in its place, ``$333.30'' and by removing
``1994, and before October 1, 1995'' and adding, in its place, ``1995,
and before October 1, 1996''; paragraph (c)(3) is amended by removing
``$263.18'' and adding, in its place, ``$270.81'' and by removing
``1994, and before October 1, 1995'' and adding, in its place, ``1995,
and before October 1, 1996''; and paragraphs (b)(1), (b)(2), (c)(1),
and (c)(2) are revised, to read as follows:
Sec. 21.7136 Rates of payment of basic educational assistance.
* * * * *
(b) Rates. (1) Except as provided in paragraphs (b)(2), (b)(3), and
(d) of this section, the monthly rate of basic educational assistance
payable for training that occurs after September 30,
[[Page 24238]]
1995, and before October 1, 1996, to a veteran whose service is
described in paragraph (a) of this section is the rate stated in the
following table.
------------------------------------------------------------------------
Monthly
Training rate
------------------------------------------------------------------------
Full time..................................................... $416.62
\3/4\ time.................................................... 312.46
\1/2\ time.................................................... 208.31
Less than \1/2\ but more than \1/4\ time...................... 208.31
\1/4\ time or less............................................ 104.15
------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015)
(2) If a veteran's service is described in paragraph (a) of this
section, the monthly rate payable to the veteran for pursuit of an
apprenticeship or other on-job training that occurs after September 30,
1995, and before October 1, 1996, is the rate stated in the following
table.
------------------------------------------------------------------------
Monthly
Training period rate
------------------------------------------------------------------------
First six months of pursuit of program........................ $312.46
Second six months of pursuit of program....................... 229.14
Remaining pursuit of program.................................. 145.82
------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015, 3032(c))
* * * * *
(c) * * *
(1) Except as provided in paragraphs (c)(2), (c)(3), and (d) of
this section, the monthly rate of basic educational assistance payable
to a veteran for training that occurs after September 30, 1995, and
before October 1, 1996, is the rate stated in the following table.
------------------------------------------------------------------------
Monthly
Training rate
------------------------------------------------------------------------
Full time..................................................... $338.51
\3/4\ time.................................................... 253.88
\1/2\ time.................................................... 169.25
Less than \1/2\ but more than \1/4\ time...................... 169.25
\1/4\ time or less............................................ 84.62
------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015, 3032(c))
(2) The monthly rate of educational assistance payable to a veteran
for pursuit of an apprenticeship or other on-job training that occurs
after September 30, 1995, and before October 1, 1996, is the rate
stated in the following table.
------------------------------------------------------------------------
Monthly
Training period rate
------------------------------------------------------------------------
First six months of pursuit of program........................ $253.88
Second six months of pursuit of program....................... 186.18
Remaining pursuit of program.................................. 118.48
------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015, 3032(c))
* * * * *
3. In Sec. 21.7137, paragraph (c)(2) introductory text is amended
by removing ``1994, and before October 1, 1995'' and adding, in its
place, ``1995, and before October 1, 1996''; paragraph (c)(2)(i) is
amended by removing ``$592.88'' and adding, in its place, ``$604.62'';
paragraph (c)(2)(ii) is amended by removing ``$445.16'' and adding, in
its place, ``$453.96''; paragraph (c)(2)(iii) is amended by removing
``$296.44'' and adding, in its place, ``$302.31''; paragraph (c)(2)(iv)
is amended by removing ``$148.22'' and adding, in its place,
``$151.15''; and paragraphs (a)(1) and (a)(2) are revised, to read as
follows:
Sec. 21.7137 Rates of payment of basic educational assistance for
individuals with remaining entitlement under 38 U.S.C. ch. 34.
(a) Minimum rates. * * *
(1) Except as provided in paragraphs (a)(2), (b), and (c) of this
section, the monthly rate of basic educational assistance for training
that occurs after September 30, 1995, and before October 1, 1996, is
the rate stated in the following table.
----------------------------------------------------------------------------------------------------------------
Monthly rate
---------------------------------------------------
Additional
Training No One Two for each
dependents dependent dependents additional
dependent
----------------------------------------------------------------------------------------------------------------
Full time................................................... $604.62 $640.62 $671.62 $16.00
3/4 time.................................................... 453.96 480.46 503.96 12.00
1/2 time.................................................... 302.31 320.31 335.81 8.50
Less than 1/2 but more than 1/4 time........................
(3) 302.31
1/4 time....................................................
(3) 151.15
Cooperative................................................. 454.90 475.30 494.90 9.20
----------------------------------------------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015(c), (f), (g))
(2) For veterans pursuing an apprenticeship or other on-job
training, the monthly rate of basic educational assistance for training
that occurs after September 30, 1995, and before October 1, 1996, is
the rate stated in the following table.
----------------------------------------------------------------------------------------------------------------
Monthly rate
---------------------------------------------------
Additional
Training period No One Two for each
dependents dependent dependents additional
dependent
----------------------------------------------------------------------------------------------------------------
1st 6 months of pursuit of program.......................... $415.21 $427.59 $438.46 $5.25
2nd 6 months of pursuit of program.......................... 285.52 294.87 302.57 3.85
3rd 6 months of pursuit of program.......................... 169.62 175.74 180.47 2.45
Remaining pursuit of program................................ 157.72 163.49 168.74 2.45
----------------------------------------------------------------------------------------------------------------
[[Page 24239]]
(Authority: 38 U.S.C. 3015(d), (f), (g))
* * * * *
[FR Doc. 96-11970 Filed 5-13-96; 8:45 am]
BILLING CODE 8320-01-P
Complete official Federal Register PDF
FR Doc. 96-11963 Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; State of Connecticut
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24239-24242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11963]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 52 and 81
[CT23-1-7084; FRL-5443-5]
Approval and Promulgation of Implementation Plans and Designation
of Areas for Air Quality Planning Purposes; State of Connecticut
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is responding to an adverse comment concerning EPA's
proposal to redesignate Hartford, Connecticut as attainment for carbon
monoxide. EPA is not changing its action to redesignate the area as
attainment that took effect on January 2, 1996. EPA is also correcting
an incorrect entry in the attainment status tables associated with this
action.
EFFECTIVE DATE: January 2, 1996.
FOR FURTHER INFORMATION CONTACT: Wing H. Chau, Air Quality Planning
Unit, Office of Ecosystem Protection, United States Environmental
Protection Agency, Region I, Boston, Massachusetts 02203, (617) 565-
3570.
SUPPLEMENTARY INFORMATION: On October 31, 1995, EPA published a direct
final rule (60 FR 55316) which announced that this rule would take
effect in 60 days, or January 2, 1996, unless EPA received adverse
comment on the rule within 30 days in response to a notice of proposed
rulemaking published on the same day (60 FR 55354). EPA also committed
to withdraw the direct final rule in the event it received adverse
comment, and to respond to any adverse comments in a subsequent final
rulemaking action. EPA did receive a timely adverse comment on this
rule. EPA failed, however, to withdraw the final rule within the 60
days given in the direct final rule, and the rule took effect on
January 2, 1996.
In this notice, EPA is responding to the comment it received, but
for the reasons stated below, EPA is not changing the final rule in
response to that comment. Had EPA withdrawn the direct final rule prior
to its going into effect, EPA would have taken final action based on
the proposal to promulgate a rule identical to the direct final rule
that went into effect. Rather than now take the action of withdrawing
the direct final rule only to repromulgate simultaneously an identical
rule, however, EPA in this action is deciding to maintain the rule
unchanged. EPA believes that withdrawal and repromulgation are
unnecessary since the results would be identical to that obtained
simply by leaving the rule unchanged and responding to the comments in
this notice. This notice provides interested parties an opportunity to
review how EPA addressed the comment and to petition for judicial
review of EPA's action in this final rulemaking within 60 days of
publication of this notice, as provided in section 307(b)(1) of the
Act.
Also, in the October 31, 1995 direct final rulemaking, the revised
Code of Federal Regulations (CFR) Sec. 81.307 designation table for
carbon monoxide identified a number of towns in the Litchfield,
Middlesex, and Tolland Counties as ``Nonattainment * * * Moderate
12.7 ppm''. The table should have shown these areas as
attainment areas for CO. The revised Sec. 81.307 designation table
associated with this final rulemaking reflects the appropriate
attainment status of the towns mentioned above. The USEPA regrets any
inconvenience these errors may have caused.
I. Summary of Action and Responses to Comments
EPA did receive one comment from the New York Mercantile Exchange
(NYMEX), dated November 29, 1995. NYMEX is the world's largest exchange
of energy futures, and NYMEX is concerned that the redesignation of the
Hartford area might affect gasoline formulation requirements and
disrupt futures contracts entered into based on gasoline formulation
requirements in effect prior to the redesignation. The comment
questioned whether EPA had offered interested persons any meaningful
opportunity to comment on this proposal, and asserted that EPA should
have provided ``far more than the limited period of notice afforded in
these redesignation approvals'' to avoid disruption in the petroleum
industry and energy futures markets when changing environmental
requirements.
As a legal matter, this SIP action is subject to the procedures of
the Administrative Procedures Act (``APA'')
[[Page 24240]]
for informal rulemaking. 5 U.S.C. Sec. 553; General Motors Corp. v.
U.S., 110 S. Ct. 2528, 2533 (1990). It is well-settled that the APA
``established the maximum procedural requirements which Congress was
willing to have the courts impose upon agencies in conducting
rulemaking procedures.'' Vermont Yankee Nuclear Power v. NRDC, 435 U.S.
519, 524 (1978). In this action EPA published a notice of proposed
rulemaking to redesignate the Hartford area as attainment for carbon
monoxide, and gave the public thirty days to comment on that proposal.
60 FR 55354 (October 31, 1995). In a simultaneous final rule EPA
informed the public that if no comment had been received within thirty
days of the accompanying proposal, the redesignation would take effect
within sixty days of the final rule. 60 FR 55316 (October 31, 1995).
EPA provided the public thirty days to comment, which is an adequate
period for public review. Indeed, NYMEX availed itself of that
opportunity to comment. Although it is unclear from the comment letter,
NYMEX may have been complaining that EPA should delay the effective
date this rule for more than thirty days following this final notice.
The APA is clear that EPA must only wait thirty days to make a rule
effective. 5 U.S.C. Sec. 553(d). EPA has fully discharged its legal
obligation to provide the public adequate notice of this action.
As a factual matter, the state of Connecticut had been developing
this redesignation proposal for much longer than thirty days. The state
published a notice concerning the redesignation on July 15, 1994, held
a public hearing on August 17, 1994 and submitted it to EPA on
September 30, 1994, fully 13 months before EPA published its notice
proposing to approve the state's request for redesignation. NYMEX and
its clients had ample opportunity to anticipate this change as a
practical matter. NYMEX's comment suggests that its gasoline futures
contracts trade ten months in advance. It would not be practical for
EPA to give ten months' notice on all such SIP actions, nor is it
legally required. For industries that are sensitive to changes in SIP
requirements and need substantial lead-time to anticipate them, EPA
encourages them to monitor SIP developments at the state level.
II. Final Rulemaking Action
The USEPA maintains the approvals associated with the October 31,
1995 direct final rulemaking (60 FR 55316) which included the
redesignation of the Hartford/New Britain/Middletown CO area to
attainment, Connecticut's 1990 base year CO emission inventory, and
Connecticut's oxygenated fuel program as it applies to the Hartford/
Britain/Middletown area.
Nothing in this action should be construed as permitting or
allowing or establishing a precedent for any future request for
revision to any SIP. Each request for revision to the SIP shall be
considered separately in light of specific technical, economic, and
environmental factors and in relation to relevant statutory and
regulatory requirements.
The CO SIP is designed to satisfy the requirements of part D of the
CAA and to provide for attainment and maintenance of the CO NAAQS. This
final redesignation should not be interpreted as authorizing the State
to delete, alter, or rescind any of the CO emission limitations and
restrictions contained in the approved CO SIP. Changes to CO SIP
regulations rendering them less stringent than those contained in the
EPA approved plan cannot be made unless a revised plan for attainment
and maintenance is submitted to and approved by EPA. Unauthorized
relaxations, deletions, and changes could result in both a finding of
non-implementation (section 179(a) of the CAA) and in a SIP deficiency
call made pursuant to sections 110(a)(2)(H) and 110(k)(2) of the CAA.
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000. SIP approvals under section 110 and subchapter I, part D of the
CAA do not create any new requirements, but simply approve requirements
that the State is already imposing. Therefore, because the federal SIP
approval does not impose any new requirements, it does not have any
economic impact on any small entities. Redesignation of an area to
attainment under section 107(d)(3)(E) of the CAA does not impose any
new requirements on small entities.
Redesignation is an action that affects the status of a
geographical area and does not impose any regulatory requirements on
sources. Accordingly, I certify that the approval of the redesignation
request will not have an impact on any small entities.
Unfunded Mandates
Under Sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 25,
1995, EPA must undertake various actions in association with proposed
or final rules that include a Federal mandate that may result in
estimated costs of $100 million or more to the private sector, or to
State, local, or tribal governments in the aggregate.
Through submission of this state implementation plan or plan
revision, the State and any affected local or tribal governments have
elected to adopt the program provided for under section 175A and
section 187(a)(1) of the Clean Air Act. The rules and commitments
approved in this action may bind State, local and tribal governments to
perform certain actions and also may ultimately lead to the private
sector being required to certain duties. To the extent that the
imposition of any mandate upon the State, local or tribal governments
either as the owner or operator of a source or as mandate upon the
private sector, EPA's action will impose no new requirements under
State law; such sources are already subject to these requirements under
State law. Accordingly, no additional costs to State, local, or tribal
governments, or to the private sector, results from this action. EPA
has also determined that this final action does not include a mandate
that may result in estimated costs of $100 million or more to State,
local, or tribal governments in the aggregate or to the private sector.
Opportunity for Judicial Review
Under Section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 15, 1996. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)
List of Subjects
40 CFR Part 52
Environmental protection, Air pollution control, Carbon monoxide,
Hydrocarbons, Nitrogen dioxide, Ozone, Reporting and record keeping
requirements, Volatile organic compounds.
[[Page 24241]]
40 CFR Part 81
Environmental protection, Air pollution control, National parks,
Wilderness areas.
Note: Incorporation by reference of the State Implementation
Plan for the State of Connecticut was approved by the Director of
the Federal Register on July 1, 1982.
Dated: February 29, 1996.
John P. DeVillars,
Regional Administrator, Region I.
Title 40 of the Code of Federal Regulations, Chapter I, Part 81
is amended as follows:
PART 81--[AMENDED]
1. The authority citation for part 81 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart C--Section 107 Attainment Status Designations
2. In Sec. 81.307 by revising the table for ``Connecticut--
CarbonMonoxide'' to read as follows:
Sec. 81.307 Connecticut.
* * * * *
Connecticut--Carbon Monoxide
----------------------------------------------------------------------------------------------------------------
Designation Classification
Designated area ---------------------------------------------------------------------------
Date1 Type Date1 Type
----------------------------------------------------------------------------------------------------------------
Hartford-New Britain-Middletown
Area:
Hartford County (part).......... 1/2/96 ....................... 1/2/96 .......................
Bristol City, Burlington ........... Attainment ........... .......................
Town, Avon Town, Bloomfield
Town, Canton Town, E.
Granby Town, E. Hartford
Town, E. Windsor Town,
Enfield Town, Farmington
Town, Glastonbury Town,
Granby Town, Hartford City,
Manchester Town,
Marlborough Town, Newington
Town, Rocky Hill Town,
Simsbury Town, S. Windsor
Town, Suffield Town, W.
Hartford Town, Wethersfield
Town, Windsor Town, Windsor
Locks Town, Berlin Town,
New Britain city,
Plainville Town, and
Southington Town.
Litchfield County (part):
Plymouth Town
Middlesex County (part):
Cromwell Town, Durham Town, E. ........... Attainment. ........... .......................
Hampton Town, Haddam Town,
Middlefield Town, Middleton
city, Portland Town, E. Haddam
Town.
Tolland County (part): ........... Attainment. ........... .......................
Andover Town, Boton Town,
Ellington Town, Hebron Town,
Somers Town, Tolland Town, and
Vernon Town
New Haven--Meriden--Waterbury Area:
Fairfield County (part):
Shelton City.................... ........... Attainment. ........... .......................
Litchfield County (part):
Bethlehem Town, Thomaston Town, ........... Attainment.
Watertown, Woodbury Town
New Haven County:
New York--N. New Jersey--Long Island
Area:
Fairfield County (part):
All cities and townships except ........... Nonattainment.......... ........... Not classified
Shelton City
Litchfield County (part):........... ........... Nonattainment.......... ........... Not classified
Bridgewater Town, New Milford
Town
Not classified
.................................. Nonattainment.......... ........... Moderate > 12.7 ppm
Nonattainment.......... ........... Moderate > 12.7 ppm
Nonattainment.......... ........... .......................
AQCR 041 Eastern Connecticut
Intrastate:
........... Unclassifiable/ ........... .......................
Attainment.
Middlesex County (part):
All portions except cities and
towns in Hartford Area.
New London County:
Tolland County (part):
All portions except cities and
towns in Hartford Area.
Windham County:
AQCR 044 Northwestern Connecticut
Intrastate:
........... Unclassifiable/ ........... .......................
Attainment.
[[Page 24242]]
Hartford County (part):
Hartland Township
Litchfield County (part):
All portions except cities and
towns in Hartford, New Haven,
and New York Areas.
----------------------------------------------------------------------------------------------------------------
1 This date is November 15, 1990, unless otherwise noted.
[FR Doc. 96-11963 Filed 5-13-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-11959 Airworthiness Directives; McDonnell Douglas Helicopter Systems Model 369, 369A, 369D, 369E, 369F, 369FF, 369H, 369HE, 369HM, 369HS, and 500N Helicopters
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24220-24222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11959]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 96-SW-02-AD; Amendment 39-9615; AD 96-10-09]
RIN 2120-AA64
Airworthiness Directives; McDonnell Douglas Helicopter Systems
Model 369, 369A, 369D, 369E, 369F, 369FF, 369H, 369HE, 369HM, 369HS,
and 500N Helicopters
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: This amendment adopts a new airworthiness directive (AD) that
is applicable to McDonnell Douglas Helicopter Systems (MDHS) Model 369,
369A, 369D, 369E, 369F, 369FF, 369H, 369HE, 369HM, 369HS, and 500N
helicopters. This action requires initial and repetitive inspections of
each main rotor blade (blade) root for either cracks or paint and
sealant cracking or separation between the lower surface root end
fitting and the doubler. This amendment is prompted by one accident in
which a blade separated from the helicopter, as well as eight other
reports of cracked blades. The actions specified in this AD are
intended to prevent failure of a blade resulting in separation of the
blade and subsequent loss of control of the helicopter.
DATES: Effective May 29, 1996.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of 15 days after the date of publication in the Federal Register.
Comments for inclusion in the Rules Docket must be received on or
before July 15, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Office of the Assistant Chief Counsel, Attention:
Rules Docket No. 96-SW-02-AD, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.
The service information referenced in this AD may be obtained from
MDHS, Technical Publications, Bldg. 530/B111, 5000 E. McDowell Rd.,
Mesa, Arizona 85215-9797. This information may be examined at the FAA,
Office of the Assistant Chief Counsel, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137; or at the Office of the Federal Register, 800
North Capitol Street NW., suite 700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Mr. John Cecil, Aerospace Engineer,
ANM-120L, Los Angeles Aircraft Certification Office, Northwest Mountain
Region, 3960 Paramount Blvd., Lakewood, California, telephone (310)
627-5322, fax (310) 627-5210.
SUPPLEMENTARY INFORMATION: This amendment adopts a new AD that is
applicable to MDHS Model 369, 369A, 369D, 369E, 369F, 369FF, 369H,
369HE, 369HM, 369HS, and 500N helicopters. One accident occurred in
August 1995 in which one blade separated from the rotor system while
the helicopter was on the ground. Additionally, there were eight
reports of blade cracking prior to the one accident, all of which were
discovered during either routine inspections or inspections resulting
from reported abnormal vibrations. Subsequent investigations revealed
that bonding separation occurred between the lower surface root end
fitting and the doubler. This condition, if not corrected, could result
in failure of a blade resulting in separation of the blade and
subsequent loss of control of the helicopter.
[[Page 24221]]
The FAA has reviewed McDonnell Douglas Helicopter Systems Service
Information Notice No. HN-239, DN-188, EN-81, FN-67, and NN-008, dated
October 27, 1995, which describes procedures for a one-time visual
inspection of the blade root end for chordwise cracking and paint or
sealant cracking between the lower surface root end fitting and the
doubler, and then repetitive inspections at intervals of 100 hours
time-in-service (TIS).
Since an unsafe condition has been identified that it is likely to
exist or develop on other MDHS Model 369, 369A, 369D, 369E, 369F,
369FF, 369H, 369HE, 369HM, 369HS, and 500N helicopters of the same type
design, this AD is being issued to prevent failure of a blade at the
root end due to fatigue cracking that initiates at the outboard bolt
hole and usually travels in a chordwise direction. This AD requires,
within 10 hours TIS after the effective date of this AD, a one-time
visual inspection of each blade root end near the doubler paying
particular attention to chordwise cracks and paint or sealant cracking
or separation between the lower surface root end fitting and the
doubler. Additionally, this AD requires repetitive visual inspections
of each blade, at intervals not to exceed 100 hours TIS, for bond
separation between the lower surface root end fitting and doubler
paying particular attention to chordwise cracks. The actions are
required to be accomplished in accordance with the service information
notice described previously.
Due to the critical need to ensure the integrity of the main rotor
system, and to comply with the requirements of this AD within 10 hours
TIS, this rule must be issued immediately to correct an unsafe
condition in the affected helicopters.
Since a situation exists that requires the immediate adoption of
this regulation, it is found that notice and opportunity for prior
public comment hereon are impracticable, and that good cause exists for
making this amendment effective in less than 30 days.
Comments Invited
Although this action is in the form of a final rule that involves
requirements affecting flight safety and, thus, was not preceded by
notice and an opportunity for public comment, comments are invited on
this rule. Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments as they may desire.
Communications should identify the Rules Docket number and be submitted
in triplicate to the address specified under the caption ADDRESSES. All
communications received on or before the closing date for comments will
be considered, and this rule may be amended in light of the comments
received. Factual information that supports the commenter's ideas and
suggestions is extremely helpful in evaluating the effectiveness of the
AD action and determining whether additional rulemaking action would be
needed.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. All comments submitted will be
available, both before and after the closing date for comments, in the
Rules Docket for examination by interested persons. A report that
summarizes each FAA-public contact concerned with the substance of this
AD will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this rule must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket No. 96-SW-02-AD.'' The postcard will be date stamped and
returned to the commenter.
The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
The FAA has determined that this regulation is an emergency
regulation that must be issued immediately to correct an unsafe
condition in aircraft, and that it is not a ``significant regulatory
action'' under Executive Order 12866. It has been determined further
that this action involves an emergency regulation under DOT Regulatory
Policies and Procedures (44 FR 11034, February 26, 1979). If it is
determined that this emergency regulation otherwise would be
significant under DOT Regulatory Policies and Procedures, a final
regulatory evaluation will be prepared and placed in the Rules Docket.
A copy of it, if filed, may be obtained from the Rules Docket at the
location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety. Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 USC 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding a new airworthiness directive
to read as follows:
AD 96-10-09 McDonnell Douglas Helicopter Systems: Amendment 39-
9615. Docket No. 96-SW-02-AD.
Applicability: Model 369, 369A, 369D, 369E, 369F, 369FF, 369H,
369HE, 369HM, 369HS, and 500N helicopters, certificated in any
category.
Note 1: This AD applies to each helicopter identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For helicopters that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must use the authority
provided in paragraph (c) to request approval from the FAA. This
approval may address either no action, if the current configuration
eliminates the unsafe condition, or different actions necessary to
address the unsafe condition described in this AD. Such a request
should include an assessment of the effect of the changed
configuration on the unsafe condition addressed by this AD. In no
case does the presence of any modification, alteration, or repair
remove any helicopter from the applicability of this AD.
Compliance: Required as indicated, unless accomplished
previously.
To prevent failure of a main rotor blade (blade) resulting in
separation of the blade and subsequent loss of control of the
helicopter, accomplish the following:
(a) Within 10 hours time-in-service (TIS) after the effective
date of this AD, perform a visual inspection of each blade root end
for cracking and paint or sealant cracking, paying particular
attention to chordwise cracking, and for separation between the
lower surface root end fitting and doubler, in accordance with Part
I of the Accomplishment Instructions of McDonnell Douglas Helicopter
Systems Service Information Notice (SIN) HN-239, DN-188, EN-81, FN-
67, and NN-008, dated October 27, 1995. If any blade crack is noted,
before further flight, remove the blade and replace it with an
airworthy blade. If paint or sealant cracking or separation is
noted, accomplish the inspection in paragraph 3E of Part II of the
Accomplishment Instructions of SIN HN-239, DN-188, EN-81, FN-67, and
NN-008, dated October 27, 1995, using a piece of Mylar/viewfoil that
is no thicker than .004-inch and that is cut to a size between 0.9
inch
[[Page 24222]]
and 1.1 inches wide and between 3.9 inches and 4.1 inches long. If
any corner of the Mylar can be inserted between the lower surface
root end fitting and doubler surface to a depth of 0.1 inch or
greater, remove the blade from service and replace it with an
airworthy blade.
(b) Thereafter, at intervals not to exceed 100 hours TIS, remove
the blades and inspect for cracking, paying particular attention to
chordwise cracking, and separation between the lower surface root
end fitting and doubler in accordance with Part II of the
Accomplishment Instructions of McDonnell Douglas Helicopter Systems
SIN HN-239, DN-188, EN-81, FN-67, and NN-008, dated October 27,
1995. If missing or cracked adhesive or paint is detected at the
lower surface root end fitting to doubler bonding line, accomplish
the inspection in paragraph 3E of Part II of the Accomplishment
Instructions of SIN HN-239, DN-188, EN-81, FN-67, and NN-008, dated
October 27, 1995 using a piece of Mylar/viewfoil that is no thicker
than .004-inch that is cut to a size between 0.9 inch and 1.1 inches
wide and between 3.9 inches and 4.1 inches long. If any corner of
the Mylar can be inserted between the lower surface root end fitting
and doubler surface to a depth of 0.1 inch or greater, remove the
blade from service and replace it with an airworthy blade.
(c) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Los Angeles Aircraft Certification
Office, FAA. Operators shall submit their requests through an FAA
Principal Maintenance Inspector, who may concur or comment and then
send it to the Manager, Los Angeles Aircraft Certification Office.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Los Angeles Aircraft Certification Office.
(d) Special flight permits will not be issued.
(e) The inspections shall be done in accordance with McDonnell
Douglas Helicopter Systems Service Information Notice (SIN) HN-239,
DN-188, EN-81, FN-67, and NN-008, dated October 27, 1995. This
incorporation by reference was approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. Copies may be obtained from McDonnell Douglas Helicopter
Systems, Technical Publications, Bldg. 530/B111, 5000 E. McDowell
Rd., Mesa, Arizona 85215-9797. Copies may be inspected at the FAA,
Office of the Assistant Chief Counsel, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas; or at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC.
(f) This amendment becomes effective May 29, 1996.
Issued in Fort Worth, Texas, on May 2, 1996.
Eric Bries,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 96-11959 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-11958 Airworthiness Directives; Bell Helicopter Textron, Inc. Model 47B, 47B-3, 47D, 47D-1, 47G, 47G-2, 47G-2A, 47G-2A-1, 47G-3, 47G-3B, 47G-3B-1, 47G-3B-2, 47G-3B-2A, 47G-4, 47G-4A, 47G-5, 47G-5A, 47H-1, 47J, 47J-2, 47J-2A, and 47-K Helicopters
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24218-24220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11958]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 96-SW-01-AD; Amendment 39-9616; AD 96-06-12]
RIN 2120-AA64
Airworthiness Directives; Bell Helicopter Textron, Inc. Model
47B, 47B-3, 47D, 47D-1, 47G, 47G-2, 47G-2A, 47G-2A-1, 47G-3, 47G-3B,
47G-3B-1, 47G-3B-2, 47G-3B-2A, 47G-4, 47G-4A, 47G-5, 47G-5A, 47H-1,
47J, 47J-2, 47J-2A, and 47-K Helicopters
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: This document publishes in the Federal Register an amendment
adopting Airworthiness Directive (AD) 96-06-12 which was sent
previously to all known U.S. owners and operators of Bell Helicopter
Textron, Inc. (Bell) Model 47B, 47B-3, 47D, 47D-1, 47G, 47G-2, 47G-2A,
47G-2A-1, 47G-3, 47G-3B, 47G-3B-1, 47G-3B-2, 47G-3B-2A, 47G-4, 47G-4A,
47G-5, 47G-5A, 47H-1, 47J, 47J-2, 47J-2A, and 47-K helicopters by
individual letters. This AD requires a visual inspection of each tail
rotor blade (blade) tip, abrasion strip, blade skin, and blade butt for
corrosion or delamination. This amendment is prompted by reports that a
number of Model 47 helicopter blades were manufactured using a clad
aluminum alloy material instead of a bare aluminum alloy material. The
actions specified by this AD are intended to prevent premature
delamination or separation of the blade tip block or the abrasion
strip, which could lead to failure of the blade and subsequent loss of
control of the helicopter.
[[Page 24219]]
DATES: Effective May 29, 1996, to all persons except those persons to
whom it was made immediately effective by priority letter AD 96-06-12,
issued on March 13, 1996, which contained the requirements of this
amendment.
Comments for inclusion in the Rules Docket must be received on or
before July 15, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Office of the Assistant Chief Counsel, Attention:
Rules Docket No. 96-SW-01-AD, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.
FOR FURTHER INFORMATION CONTACT: Mr. Tony Nguyen, Aerospace Engineer,
Rotorcraft Certification Office, Rotorcraft Directorate, FAA, 2601
Meacham Blvd., Fort Worth, Texas 76137, telephone (817) 222-5177; fax
(817) 222-5960.
SUPPLEMENTARY INFORMATION: On March 13, 1996, the FAA issued priority
letter AD 96-06-12, applicable to Bell Model 47B, 47B-3, 47D, 47D-1,
47G, 47G-2, 47G-2A, 47G-2A-1, 47G-3, 47G-3B, 47G-3B-1, 47G-3B-2, 47G-
3B-2A, 47G-4, 47G-4A, 47G-5, 47G-5A, 47H-1, 47J, 47J-2, 47J-2A, and 47-
K helicopters, which requires, prior to the first flight of each day,
and at intervals not to exceed 10 hours time-in-service (TIS) if the
helicopter is operated for more than 10 hours in any one day, a visual
inspection of each blade tip, abrasion strip, blade skin, and blade
butt for corrosion or delamination. That action was prompted by reports
that a number of Model 47 helicopter blades were manufactured using a
clad aluminum alloy material instead of a bare aluminum alloy material.
The shear and peel strength of bonded clad aluminum alloy is less than
the shear and peel strength of bonded bare aluminum alloy. This
condition, if not corrected, could result in premature delamination or
separation of the blade tip block or the abrasion strip, which could
lead to failure of the blade and subsequent loss of control of the
helicopter.
Since the unsafe condition described is likely to exist or develop
on other Bell Model 47B, 47B-3, 47D, 47D-1, 47G, 47G-2, 47G-2A, 47G-2A-
1, 47G-3, 47G-3B, 47G-3B-1, 47G-3B-2, 47G-3B-2A, 47G-4, 47G-4A, 47G-5,
47G-5A, 47H-1, 47J, 47J-2, 47J-2A, and 47-K helicopters of the same
type design, the FAA issued priority letter AD 96-06-12 to prevent
premature delamination or separation of the blade tip block or the
abrasion strip, which could lead to failure of the blade and subsequent
loss of control of the helicopter. The AD requires, prior to the first
flight of each day, and at intervals not to exceed 10 hours TIS, if the
helicopter is operated for more than 10 hours in any one day, a visual
inspection of each blade tip, abrasion strip, blade skin, and blade
butt for corrosion or delamination. If any of the inspections reveal
corrosion or delamination, removal of the blades and replacement with
airworthy blades is required.
Since it was found that immediate corrective action was required,
notice and opportunity for prior public comment thereon were
impracticable and contrary to the public interest, and good cause
existed to make the AD effective immediately by individual letters
issued on March 13, 1996 to all known U.S. owners and operators of Bell
Model 47B, 47B-3, 47D, 47D-1, 47G, 47G-2, 47G-2A, 47G-2A-1, 47G-3, 47G-
3B, 47G-3B-1, 47G-3B-2, 47G-3B-2A, 47G-4, 47G-4A, 47G-5, 47G-5A, 47H-1,
47J, 47J-2, 47J-2A, and 47-K helicopters. These conditions still exist,
and the AD is hereby published in the Federal Register as an amendment
to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to
make it effective to all persons.
Comments Invited
Although this action is in the form of a final rule that involves
requirements affecting flight safety and, thus, was not preceded by
notice and an opportunity for public comment, comments are invited on
this rule. Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments as they may desire.
Communications should identify the Rules Docket number and be submitted
in triplicate to the address specified under the caption ADDRESSES. All
communications received on or before the closing date for comments will
be considered, and this rule may be amended in light of the comments
received. Factual information that supports the commenter's ideas and
suggestions is extremely helpful in evaluating the effectiveness of the
AD action and determining whether additional rulemaking action would be
needed.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. All comments submitted will be
available, both before and after the closing date for comments, in the
Rules Docket for examination by interested persons. A report that
summarizes each FAA-public contact concerned with the substance of this
AD will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this rule must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket No. 96-SW-01-AD.'' The postcard will be date stamped and
returned to the commenter.
The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
The FAA has determined that this regulation is an emergency
regulation that must be issued immediately to correct an unsafe
condition in aircraft, and that it is not a ``significant regulatory
action'' under Executive Order 12866. It has been determined further
that this action involves an emergency regulation under DOT Regulatory
Policies and Procedures (44 FR 11034, February 26, 1979). If it is
determined that this emergency regulation otherwise would be
significant under DOT Regulatory Policies and Procedures, a final
regulatory evaluation will be prepared and placed in the Rules Docket.
A copy of it, if filed, may be obtained from the Rules Docket at the
location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Safety.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
[[Page 24220]]
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding a new airworthiness directive
to read as follows:
AD 96-06-12 Bell Helicopter Textron, Inc.: Amendment 39-9616.
Docket No. 96-SW-01-AD.
Applicability: Model 47B, 47B-3, 47D, 47D-1, 47G, 47G-2, 47G-2A,
47G-2A-1, 47G-3, 47G-3B, 47G-3B-1, 47G-3B-2, 47G-3B-2A, 47G-4, 47G-
4A, 47G-5, 47G-5A, 47H-1, 47J, 47J-2, 47J-2A, and 47-K helicopters,
with tail rotor blade assembly, part number (P/N) 047-642-117-105,
serial numbers (S/N) A-1943 through A-2068, installed, certificated
in any category.
Note 1: This AD applies to each helicopter identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For helicopters that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must use the authority
provided in paragraph (f) to request approval from the FAA. This
approval may address either no action, if the current configuration
eliminates the unsafe condition, or different actions necessary to
address the unsafe condition described in this AD. Such a request
should include an assessment of the effect of the changed
configuration on the unsafe condition addressed by this AD. In no
case does the presence of any modification, alteration, or repair
remove any helicopter from the applicability of this AD.
Compliance: Required as indicated, unless accomplished
previously.
To prevent premature delamination or separation of the tail
rotor blade (blade) tip block or the abrasion strip, which could
lead to failure of the blade and subsequent loss of control of the
helicopter, accomplish the following:
(a) Prior to the first flight of each day, visually inspect each
blade tip, abrasion strip, blade skin and blade butt as follows:
(1) Inspect each blade tip for corrosion or delamination
adjacent to the abrasion strip and tip block.
(2) Inspect each abrasion strip for corrosion or delamination,
paying particular attention to the abrasion strip leading edge.
(3) Inspect each blade skin for corrosion, paying particular
attention to any areas of paint cracking or damage. Inspect all
bonded joints for corrosion or delamination.
(4) Inspect each blade butt around the bearings for corrosion or
delamination.
(b) Thereafter, conduct the visual inspections specified in
paragraph (a) of this AD at intervals not to exceed 10 hours time-
in-service.
(c) If the inspections required by paragraphs (a) and (b) of
this AD reveal any corrosion or delamination, replace the blade with
an airworthy blade before further flight.
(d) Installation of any airworthy tail rotor blade assembly
which has been FAA-approved for the particular Model 47 helicopter,
except for P/N 047-642-117-105 with S/N A-1943 through A-2068,
constitutes a terminating action for the requirements of this AD.
(e) Installation of tail rotor blade assembly, P/N 047-642-117-
105M, including those with S/N A-1943 through A-2068, constitutes a
terminating action for the requirements of this AD.
Note 2: Bell Helicopter Textron Alert Service Bulletin No. 47-
96-21, dated January 29, 1996, pertains to this AD.
(f) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Rotorcraft Certification Office,
Rotorcraft Directorate. Operators shall submit their requests
through an FAA Principal Maintenance Inspector, who may concur or
comment and then send it to the Manager, Rotorcraft Certification
Office.
Note 3: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Rotorcraft Certification Office.
(g) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the helicopter to a location where
the requirements of this AD can be accomplished.
(h) This amendment becomes effective on May 29, 1996, to all
persons except those persons to whom it was made immediately
effective by Priority Letter AD 96-06-12, issued March 13, 1996,
which contained the requirements of this amendment.
Issued in Fort Worth, Texas, on May 3, 1996.
Eric Bries,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 96-11958 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-11945 Technical Amendment to Attainment Status Designation for PM-10; South Dakota
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Page 24242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11945]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 81
[SD001-0001; FRL-5502-1]
Technical Amendment to Attainment Status Designation for PM-10;
South Dakota
AGENCY: Environmental Protection Agency (EPA).
ACTION: Technical amendment.
-----------------------------------------------------------------------
SUMMARY: On February 6, 1996, EPA published a direct final rule
amending the attainment status designation for the ``Rest of State''
area in South Dakota (excluding Rapid City) from unclassifiable to
attainment for PM-10 (see 61 FR 4357). As stated in that Federal
Register document, if adverse or critical comments were received by
March 7, 1996, the effective date would be delayed and notice would be
published in the Federal Register. EPA subsequently received adverse
comments on that direct final rule. However, EPA mistakenly did not
withdraw the direct final rule in time before it became effective on
April 8, 1996. Therefore, EPA is amending the South Dakota's PM-10
attainment status designation table to reflect the unclassifiable PM-10
designation for the ``Rest of State'' area which existed previous to
the direct final rulemaking published on February 6, 1996. EPA will
address the comments received in a subsequent final action in the near
future. EPA will not institute a second comment period on this
document.
EFFECTIVE DATE: This amendment becomes effective on May 14, 1996.
FOR FURTHER INFORMATION CONTACT: Vicki Stamper, 8P2-A, U.S.
Environmental Protection Agency, Region VIII, 999 18th Street, Suite
500, Denver, Colorado 80202-2466, (303) 312-6445.
SUPPLEMENTARY INFORMATION: See the information provided in the direct
final rule located in the final rules section of the February 6, 1996
Federal Register, and in the short informational document located in
the proposed rule section of the February 6, 1996 Federal Register.
List of Subjects in 40 CFR Part 81
Air pollution control, National parks, Wilderness areas.
Dated: April 26, 1996.
Jack W. McGraw,
Acting Regional Administrator.
40 CFR part 81, subpart B, is amended as follows:
PART 81--[AMENDED]
1. The authority citation for Part 81 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
2. Section 81.342 is amended by revising the table for ``South
Dakota--PM-10'' to read as follows:
Sec. 81.342 South Dakota.
* * * * *
South Dakota--PM-10
----------------------------------------------------------------------------------------------------------------
Designation Classification
Designated area ----------------------------------------------------------------------------------
Date Type Date Type
----------------------------------------------------------------------------------------------------------------
Rapid City Area.............. 11/15/90 Unclassifiable ..........................
Rest of State\1\............. 11/15/90 Unclassifiable ..........................
----------------------------------------------------------------------------------------------------------------
\1\ Denotes a single area designation for PSD baseline area purposes.
[FR Doc. 96-11945 Filed 5-13-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-11895 Drawbridge Operation Regulations; Saginaw River, MI
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24235-24236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11895]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Coast Guard
33 CFR Part 117
[CGD09-96-003]
RIN 2115-AE47
Drawbridge Operation Regulations; Saginaw River, MI
AGENCY: Coast Guard, DOT.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: By this direct final rule, the Coast Guard is revising the
regulations governing the operations of the CSX (formerly the Chessie
System) railroad bridge at mile 18.0 over the Saginaw River in Saginaw,
Michigan. The owners have made a request to the Coast Guard to maintain
the bridge as a fixed structure with the stipulation and understanding
that the bridge may be placed back into operation within six months
upon notification of the Coast Guard.
DATES: This rule is effective on August 12, 1996, unless the Coast
Guard receives written adverse comments or written notice of intent to
submit adverse comments on or before July 15, 1996. If such comments or
notice are received, the Coast Guard will withdraw this direct final
rule, and a timely notice of withdrawal will be published in the
Federal Register.
ADDRESSES: Comments may be mailed to Commander (obr), Ninth Coast Guard
District, 1240 E. Ninth St., Cleveland, OH 44199-2060, or may be
delivered to room 2083 at the same address between 7 a.m. and 3 p.m.,
Monday through Friday, except Federal holidays. The telephone number is
(216) 522-3993.
The District Commander maintains the public docket for this
rulemaking. Comments will become part of this docket and will be
available for inspection or copying at the above address during the
same time.
FOR FURTHER INFORMATION CONTACT:
Mr. Scott M. Striffler, Project Manager, at (216) 522-3993.
SUPPLEMENTARY INFORMATION:
Request for Comments
Any comments must identify the name and address of the person
submitting the comment, specify the rulemaking docket (CGD09-96-003)
and the specific section of this rule to which each comment applies,
and give the reason for each specific comment. Please submit two copies
of all comments and attachments in an unbound format, no larger than
8\1/2\ by 11 inches, suitable for copying and electronic filing.
Persons wanting acknowledgment of receipt of comments should enclose
stamped, self-addressed postcards or envelopes.
Regulatory Information
The Coast Guard is publishing a direct final rule, the procedures
of which are outlined in 33 CFR 1.05-55, because no adverse comments
are anticipated. If no adverse comments or any written notices of
intent to submit adverse comment are received within the specified
comment period, this rule will become effective as stated in the DATES
section. In that case, approximately 30 days prior to the effective
date, the Coast Guard will publish a notice in the Federal Register
stating that no adverse comment was received and confirming that this
rule will become effective as scheduled. However, if the Coast Guard
receives written adverse comment or written notice of intent to submit
adverse comment, the Coast Guard will publish a notice in the final
rule section of the Federal Register to announce withdrawal of all or
part of this direct final rule. If adverse comments apply to only part
of this rule, and it is possible to remove that part without defeating
the purpose of this rule, the Coast Guard may adopt as final those
parts of this rule on which no adverse comments were received. The part
of this rule that was the subject of adverse comment will be withdrawn.
If the Coast Guard decides to proceed with a rulemaking following
receipt of adverse comments, a separate Notice of Proposed Rulemaking
(NPRM) will be published and a new opportunity for comment provided.
A comment is considered ``adverse'' if the comment explains why
this rule would be inappropriate, including a challenge to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change.
Background and Purpose
The placement of a movable bridge in a ``fixed status'' means that
the bridge is essentially locked in the closed position and all the
operating gear removed. This rule will allow the owners (CSX Railroad
Corp.) of the CSX (formerly the Chessie System) railroad bridge, at
mile 18.0 over the Saginaw River in Saginaw, Michigan, to maintain the
bascule bridge in a ``fixed status''. The owners initiated this action
due to the absence of any requests to open the bridge for commercial
traffic since 1988. Furthermore, the bridge is unattended and subject
to high maintenance costs from recurring vandalism. As part of the
background for this rulemaking, the Coast Guard requested bridgetender
logs for the previous five years, but CSX stated that it did not
maintain records for this bridge during the period because no requests
for openings were made. The Coast Guard asked for confirmation of the
owner's claims from the local Coast Guard Station in Saginaw, Michigan.
The Station verified that the bridge had not opened within the
experience of the personnel assigned there. The Station also noted that
they are not aware of any commercial traffic that has, or will have, a
need to pass
[[Page 24236]]
through the bridge. Additionally, there are currently no loading or
unloading facilities for commercial vessels above the bridge. The Coast
Guard queried the Lake Carriers Association (LCA), representatives of
Great Lakes commercial shipping companies, to determine what the impact
of allowing the bridge to be maintained as a fixed structure may have
on current and anticipated commercial marine traffic. The LCA indicated
that their members would not be adversely impacted by the conversion of
the bridge from a bascule to a fixed span. The owners pointed out that
the Grand Trunk and Western railroad bridge, further upriver at mile
19.2, was converted from a movable to a fixed span in previous years
and does not impact marine traffic in this area of the river. The CSX
bridge has a vertical clearance of 13 feet, which is one foot higher
than the Grand Trunk and Western bridge. The Coast Guard has
stipulated, and the owners have agreed, to restore this bridge to an
operable status within six months of notification by the Coast Guard if
there is future commercial marine activity in the area. The Coast Guard
concludes that the placement of this bridge in a fixed status would not
impact commercial marine interests and does not anticipate any adverse
comments to this Direct Final Rule.
Regulatory Evaluation
This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866 and does not require an assessment of
potential costs and benefits under section 6(a)(3) of that order. It
has not been reviewed by the Office of Management and Budget under that
order. It is not significant under the regulatory policies and
procedures of the Department of Transportation (DOT) (44 FR 11040;
February 26, 1979). The Coast Guard expects the economic impact of this
rule to be so minimal that a full Regulatory Evaluation under paragraph
10e of the regulatory policies and procedures of DOT is unnecessary.
This conclusion is based on the fact that there has been no active
commerce upriver from this bridge for many years and this situation is
not expected to change in the future. Additionally, no vessel has
requested that the bridge be opened since 1988. While there is some
recreational marine traffic active above this bridge, the placement of
a similar railroad bridge in a fixed status 1.2 miles further upriver
has not caused any adverse effects for any business, recreational, or
commercial vessel.
Small Entities
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Coast Guard must consider the economic impact on small entities of a
rule for which a general notice of proposed rulemaking is required.
``Small entities'' may include (1) Small businesses and not-for-profit
organizations that are independently owned and operated and are not
dominant in their fields and (2) governmental jurisdictions with
populations of less than 50,000.
Therefore, for the reasons discussed above, the Coast Guard finds
that this rule will not have a significant economic impact on a
substantial number of small entities. Any comments submitted in
response to this finding will be evaluated under the criteria described
earlier in the preamble for comments.
Collection of Information
This rule contains no collection-of-information requirements under
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Federalism
The Coast Guard has analyzed this rule under the principles and
criteria contained in Executive Order 12612 and has determined that
this rule does not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
Environment
The Coast Guard considered the environmental impact of this rule
and concluded that, under paragraph 2.B.2 of Commandant Instruction
M16475.1B, (as revised by 59 FR 38654, July 29, 1994), this rule is
categorically excluded from further environmental documentation. A
``Categorical Exclusion Determination'' is available in the docket for
inspection or copying where indicated under ADDRESSES.
List of Subjects in 33 CFR Part 117
Bridges.
For reasons set out in the preamble, 33 CFR part 117 is revised as
follows:
PART 117--DRAWBRIDGE OPERATION REGULATIONS
1. The authority citation for Part 117 continues to read as
follows:
Authority: 33 U.S.C. 499; 49 CFR 1.46; 33 CFR 1.05(g); section
117.255 also issued under the authority of Pub. L. 102-587, 106
Stat. 5039.
2. Section Sec. 117.647 is amended by revising paragraphs (a) and
(d) to read as follows:
Sec. 117.647 Saginaw River.
(a) The draws of the Detroit and Mackinac railroad bridge, mile 2.5
at Bay City, and the Conrail railroad bridge, mile 4.4 at Bay City,
shall open on signal; except that, from December 16 through March 15,
the draws shall open on signal if at least 12 hours notice is given.
* * * * *
(d) The draw of the CSX railroad bridge, mile 18.0, need not be
opened for the passage of vessels. The owner shall return the draw to
an operable condition within a reasonable time when directed by the
District Commander to do so.
* * * * *
Dated: April 26, 1996.
G.F. Woolever,
Rear Admiral, U.S. Coast Guard Commander, Ninth Coast Guard District.
[FR Doc. 96-11895 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-11886 Petroleum Products and Low-Stress Pipelines
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24244-24246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11886]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Part 195
Petroleum Products and Low-Stress Pipelines
AGENCY: Research and Special Programs Administration, (RSPA), DOT.
ACTION: Interpretation and partial stay of enforcement of regulation.
-----------------------------------------------------------------------
SUMMARY: This document interprets the definition of ``petroleum
product'' under RSPA's safety regulations for hazardous liquid 1
pipelines. The definition has been applied to petrochemical products
that the regulations were not intended to cover. The interpretation
should reduce confusion in deciding which low-stress pipelines 2
are subject to the regulations.
---------------------------------------------------------------------------
1 ``Hazardous liquid'' means petroleum, petroleum
products, or anhydrous ammonia. (Sec. 195.2)
2 Low-stress pipeline means a hazardous liquid pipeline
that is operated in its entirety at a stress level of 20 percent or
less of the specified minimum yield strength of the line pipe.
(Sec. 195.2)
---------------------------------------------------------------------------
In addition, this document stays enforcement of the regulations
against low-stress pipelines regulated by the U.S. Coast Guard, and
against certain short low-stress pipelines that serve plants and
transportation terminals. Application of the regulations to these lines
would cause undue burdens for industry and government. The stay should
ease difficulties in applying the regulations to low-stress pipelines.
EFFECTIVE DATE: May 14, 1996.
FOR FURTHER INFORMATION CONTACT:
L. M. Furrow, (202) 366-4559.
SUPPLEMENTARY INFORMATION:
Background
In response to a Congressional directive,3 RSPA extended its
hazardous liquid pipeline safety regulations (49 CFR Part 195) to cover
certain low-stress pipelines other than rural gathering lines and
gravity-powered lines (59 FR 35465; July 12, 1994). That rulemaking
action affected low-stress pipelines that transport highly volatile
liquids, low-stress pipelines that are located onshore in non-rural
areas, and low-stress pipelines that are located offshore or in
waterways that are navigable in fact and currently used for commercial
navigation (Sec. 195.1(b)(3)).
---------------------------------------------------------------------------
3 The Secretary of Transportation may not provide an
exception from regulation for a hazardous liquid pipeline facility
only because the facility operates at low internal stress. (49
U.S.C. Sec. 60102(k))
---------------------------------------------------------------------------
Transfer lines comprised the largest proportion of low-stress
pipelines brought under Part 195 (about two-thirds of the pipelines and
one-third of the mileage). The remainder included trunk lines and non-
rural gathering lines. Transfer lines are used to transport hazardous
liquid locally between facilities such as transportation terminals,
manufacturing plants, petrochemical plants, and oil refineries, or to
connect these facilities to associated storage or long-distance
pipeline transportation. Because the rulemaking action affected the
current operating practices of many companies unfamiliar with Part 195,
we allowed operators to delay compliance of
[[Page 24245]]
existing low-stress pipelines until July 12, 1996 (Sec. 195.1(c)).
Meaning of Petroleum Product
The impact of the rulemaking action intensified last fall,
particularly for petrochemical companies, when RSPA interpreted the
definition of ``petroleum product.'' Part 195 defines ``petroleum
product'' as ``flammable, toxic, or corrosive products obtained from
distilling and processing of crude oil, unfinished oils, natural gas
liquids, blend stocks and other miscellaneous hydrocarbon
compounds''4 (Sec. 195.2). The Hoechst Celanese Corporation had
asked us whether two of its products come under this definition.
Focusing on the ``miscellaneous hydrocarbon compounds'' aspect of the
definition, we said the products, ethylene glycol and formic acid, were
petroleum products because they are, respectively, flammable and toxic,
and are produced by processing hydrocarbon compounds. Upon further
consideration, however, we now believe that interpretation was too
broad in light of the historical context of Part 195.
---------------------------------------------------------------------------
\4\ Hydrocarbon compounds are chemical compounds composed solely
of hydrogen and carbon.
---------------------------------------------------------------------------
Since its inception, Part 195 has applied to petroleum products
transported in liquid form by pipeline (34 FR 15473; Oct. 4, 1969).
Only recently, while trying to clarify Part 195 requirements and reduce
the burden of government regulation, did we adopt the present
definition of petroleum product (59 FR 33395; June 28, 1994).
Previously, both RSPA and the hazardous liquid pipeline transportation
industry identified petroleum products as hydrocarbon compounds derived
from processing natural gas or petroleum. This processing typically
occurs at oil refineries, gas processing plants, and gasoline
plants.5
---------------------------------------------------------------------------
5 Part 195 was based largely on voluntary standards contained
in the 1966 edition of ``Code for Pressure Piping, Liquid Petroleum
Transportation Piping Systems,'' (designated USAS B31.4-1966)
prepared and published by the American Society of Mechanical
Engineers. A diagram on page 2 of the code shows that the code
applies to pipelines that run between production facilities,
refineries, gasoline plants, gas processing plants, terminals, and
bulk plants.
---------------------------------------------------------------------------
Petroleum products include butane, propane, gasoline, heating oil,
aviation fuel, kerosine, and diesel fuel. Also included are hydrocarbon
feedstocks, such as ethylene and propylene, that are the basis of
hundreds of petrochemical products, including paints, plastics,
synthetic fibers, and fertilizers. Prior to the definition, we did not
consider the intermediate and finished products manufactured at
petrochemical plants by further processing hydrocarbon feedstocks to be
petroleum products. These petrochemical products are characterized by
the addition of chemicals, such as chlorine, nitrogen, or oxygen, to
the hydrocarbon feedstocks.
In adopting the definition of petroleum product, we did not seek to
expand this prior understanding of the term, only to clarify it.6
For this reason, the definition of petroleum product must be applied
consistent with its regulatory background. Thus, petrochemical products
that are made by chemical means using petroleum products as a raw
material do not come under the definition. Ethylene glycol, which is
used in car antifreeze and other finished products, is an example of a
petrochemical product that does not come under the Part 195
regulations.
---------------------------------------------------------------------------
6 In the Federal Register document concerning petroleum
product and other terms that RSPA proposed to define, RSPA said
``[t]he proposed new definitions and definition change would not
compromise pipeline safety because they would not alter the intended
application of the existing part 195 regulations.'' (57 FR 56306;
Nov. 27, 1992)
---------------------------------------------------------------------------
Stay of Enforcement of 49 CFR Part 195 Against Certain Low-stress
Pipelines
As mentioned above, Part 195 applies to certain low-stress
pipelines used to transfer hazardous liquids locally. These transfer
lines link long-distance pipelines and truck, rail, and vessel
transportation terminals with various industrial plants, including
manufacturing plants, petrochemical plants, and oil refineries. Many of
the lines interconnect the plants themselves. These local transfer
lines are generally short, averaging about a mile in length. They are
usually operated in association with transfer piping on the grounds of
the plants and terminals. Some transfer lines that serve industrial
plants or terminals may be operated by long-distance pipeline
operators.
Transfer lines or segments of lines on the grounds of industrial
plants and transportation terminals generally are excepted from Part
195 (Sec. 195.1(b) (6) and (7)).7 However, this excepted piping is
subject to Occupational Safety and Health Administration (OSHA) safety
standards, including, when 10,000 pounds or more of flammable liquid
are involved, the Process Safety Management regulations (29 CFR
1910.119) issued under the Clean Air Act Amendments of 1990. These
regulations are designed to reduce the risk of fires and explosions
caused by the escape of hazardous chemicals from facility processes. In
addition, transfer lines between vessels and marine transportation-
related facilities are subject to safety requirements of the U.S. Coast
Guard (33 CFR Parts 154 and 156). These requirements apply to transfer
lines from the dock loading arm or manifold up to the first valve after
the line enters the Spill Prevention Control and Countermeasure (SPCC)
containment or secondary containment if the facilities are not
protected by SPCC plans.
---------------------------------------------------------------------------
7 Part 195 applies to transfer piping on facility grounds
if the piping is necessary to control the operating pressure of off-
grounds lines covered by Part 195, or if the on-grounds piping
serves a breakout storage tank.
---------------------------------------------------------------------------
RSPA is concerned that the impending imposition of the Part 195
regime on a multitude of short hazardous liquid transfer lines
throughout the U.S. and Puerto Rico may create difficulties for both
industry and government that are not counterbalanced by a reduction in
risk. A significant difficulty for many operators of transfer lines is
that the lines may be designed and operated according to standards and
specifications that differ from Part 195 requirements. Some time and
expense would be necessary for operating personnel to become familiar
with Part 195 and the companion drug and alcohol rules in 49 CFR Part
199.
Another difficulty for industry is the separate federal regulatory
regimes over transfer piping. Part 195 generally does not displace OSHA
regulations over on-grounds transfer piping. So most plants and
terminals would have to comply with OSHA's Process Safety Management
regulations for some transfers and Part 195 for others.8 For
transfers between vessels and marine transportation-related facilities,
the Coast Guard safety regulations would apply as well. Application of
Part 195 to these marine terminal transfer lines duplicates agency
efforts within DOT and creates uncertainty in the industry as to which
DOT regulations apply to particular facilities. The upshot of these
separate regulatory regimes of RSPA, OSHA, and the Coast Guard is that
differing safety rules and enforcement policies could confuse operating
personnel and increase administrative costs through separate operating
plans and recordkeeping.
---------------------------------------------------------------------------
\8\ However, where Part 195 applies to facility transfer piping,
OSHA regulations may be preempted, because OSHA is precluded from
enforcing its regulations against employee working conditions over
which another federal agency prescribes or enforces safety
regulations. (29 U.S.C. Sec. 653(b)(1)).
---------------------------------------------------------------------------
Carrying out adequate government inspections presents a further
difficulty. The task of finding and educating the many new operators
coming under Part 195 because of low-stress pipelines is
[[Page 24246]]
likely to be a major, protracted effort that could swamp current
inspection resources.
At the same time, the risk to the public from short low-stress
transfer lines off plant or terminal grounds is generally low. A low
operating stress is itself a safety factor against several accident
causes. And the short length means the potential spill volume would be
limited should an accident occur. Also, typically there is limited
public exposure in the industrial areas where low-stress transfer lines
are located. The risk of marine transfer lines is reduced even more by
the U.S. Coast Guard regulations and inspection force.
Therefore, we are considering amending Part 195 to except short,
low-stress transfer lines that traverse areas outside plant and
terminal grounds. We are also considering excepting low-stress transfer
lines of any length that are regulated by the U.S. Coast Guard. We
intend to publish a notice of proposed rulemaking (NPRM) in the Federal
Register to seek public comment on these proposals.
Meanwhile, effective May 14, 1996, I am staying enforcement of Part
195 against two categories of low-stress pipelines: (1) low-stress
pipelines regulated by the U.S Coast Guard; and (2) low-stress
pipelines that are less than 1 mile in length (measured outside plant
or terminal grounds), except if the pipeline crosses offshore or any
waterway currently used for commercial navigation. This stay will
remain in effect until modified through another Federal Register
document or until Part 195 is amended as a result of the NPRM,
whichever happens first. RSPA will continue to enforce Part 195 over
short lines that cross offshore or commercially navigable waterways but
do not come under U.S. Coast Guard regulations because of the need to
reduce the threat of environmental damage.
Authority: (49 U.S.C. Sec. 60102 et seq.; 49 CFR 1.53)
Issued in Washington, DC on May 7, 1996.
Richard B. Felder,
Associate Administrator for Pipeline Safety.
[FR Doc. 96-11886 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-60-P
Complete official Federal Register PDF
FR Doc. 96-11882 Airworthiness Directives; Jetstream Model 4101 Airplanes
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24216-24218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11882]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 95-NM-95-AD; Amendment 39-9617; AD 96-10-10]
RIN 2120-AA64
Airworthiness Directives; Jetstream Model 4101 Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This amendment adopts a new airworthiness directive (AD),
applicable to certain Jetstream Model 4101 airplanes, that requires
inspections of the handrail assembly at the main entrance door to
detect loose or missing rivets, abnormal movement between the handrail
pivot-tube and the spigot that attaches to the bearing assembly, and
[[Page 24217]]
cracks on the handrail pivot-tube. It also requires repair or
replacement of the assembly, if necessary, and provides for two
optional terminating actions. This amendment is prompted by a report
indicating that fatigue cracks and loose rivets were found on the
handrail assembly of the main passenger entrance door on an in-service
airplane. The actions specified by this AD are intended to prevent
these conditions, which can lead to the failure of the door handrail
assembly; such failure could allow the door to fall free and
subsequently cause injury to people on the airplane or on the ground.
DATES: Effective June 18, 1996.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of June 13, 1996.
ADDRESSES: The service information referenced in this AD may be
obtained from Jetstream Aircraft, Inc., P.O. Box 16029, Dulles
International Airport, Washington, DC 20041-6029. This information may
be examined at the Federal Aviation Administration (FAA), Transport
Airplane Directorate, Rules Docket, 1601 Lind Avenue SW., Renton,
Washington; or at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: William Schroeder, Aerospace Engineer,
Standardization Branch, ANM-113, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (206)
227-2148; fax (206) 227-1149.
SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal
Aviation Regulations (14 CFR part 39) to include an airworthiness
directive (AD) that is applicable to certain Jetstream Model 4101
airplanes was published in the Federal Register on November 24, 1995
(60 FR 58023). That action proposed to require inspections of the
handrail assembly at the main entrance door to detect loose or missing
rivets, abnormal movement between the handrail pivot-tube and the
spigot that attaches to the bearing assembly, and cracks on the
handrail pivot-tube. It also proposed to require repair or replacement
of the assembly, if necessary. The proposal also provided for two
optional terminating actions.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. Due consideration has been given to
the comments received.
Support for the Proposal
Two commenters support the proposal.
Request to Withdraw the Proposal as Unnecessary
One commenter requests that the proposal be withdrawn. This
commenter, the only U.S. operator affected by the requirements of the
proposed rule, states that it is currently in the process of
accomplishing the terminating actions on all of its affected airplanes.
Its schedule calls for the terminating action to be accomplished on all
of these airplanes by the time the final rule would become effective.
In light of this, the commenter maintains that an AD is unnecessary and
the proposal should be withdrawn.
The FAA does not concur. While the operator's fleet may be the only
airplanes currently on the U.S. Register that would be affected by the
AD, there is the possibility that other airplanes of this same type
design may be imported in the future and placed on the Register.
Without this AD, there would be no assurance that the unsafe condition
was addressed on those airplanes. For this reason, the FAA finds that
the issuance of the final rule is both necessary and warranted.
Conclusion
After careful review of the available data, including the comments
noted above, the FAA has determined that air safety and the public
interest require the adoption of the rule as proposed.
Cost Impact
The FAA estimates that 4 airplanes of U.S. registry will be
affected by this AD. To accomplish the inspections, it would take
approximately 1 work hour per airplane, at an average labor rate of $60
per work hour. Based on these figures, the cost impact of the proposed
AD on U.S. operators is estimated to be $240, or $60 per airplane, per
inspection.
This cost impact figure is based on assumptions that no operator
has yet accomplished any of the requirements of this AD action, and
that no operator would accomplish those actions in the future if this
AD were not adopted. However, the FAA has been advised that the
terminating actions provided by this rule have been accomplished on all
4 affected U.S.-registered airplanes. Therefore, the promulgation of
this AD will impose no new additional costs on U.S. operators.
Should an operator elect to accomplish one of the two terminating
actions provided by this AD, the following costs would apply:
Installation of the interim reinforcement of the handrail assembly
takes approximately 4.5 work hours to accomplish, at an average labor
charge of $60 per work hour. Based on these figures, the cost impact of
this optional action is $270 per airplane, plus the cost of necessary
parts.
Installation of the structural improvements of the door and door
support, and the completely redesigned door handrail assembly, takes
approximately10 work hours to accomplish, at an average labor charge of
$60 per work hour. Based on these figures, the cost impact of this
optional action is $600 per airplane, plus the cost of necessary parts.
Regulatory Impact
The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this action (1) is
not a ``significant regulatory action'' under Executive Order 12866;
(2) is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and (3) will not have a
significant economic impact, positive or negative, on a substantial
number of small entities under the criteria of the Regulatory
Flexibility Act. A final evaluation has been prepared for this action
and it is contained in the Rules Docket. A copy of it may be obtained
from the Rules Docket at the location provided under the caption
ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 USC 106(g), 40113, 44701.
[[Page 24218]]
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
96-10-10 Jetstream: Amendment 39-9617. Docket 95-NM-95-AD.
Applicability: Model 4101 airplanes; equipped with handrail
assembly, Part No. 6020203 Issue C, with Modification No. JM41179
(reference Jetstream Alert Service Bulletin J41-A52-009);
certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
otherwise modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (f) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent failure of the entrance door handrail assembly, which
subsequently could result in injury to passengers, flightcrew, or
groundcrew, accomplish the following:
(a) Within 50 landings after the effective date of this AD,
conduct a detailed visual inspection of the handrail assembly at the
main entrance door to detect loose or missing rivets, abnormal
movement between the handrail pivot-tube and the spigot that
attaches to the bearing assembly, and cracks on the handrail pivot-
tube, in accordance with Jetstream Alert Service Bulletin J41-A52-
036, dated June 13, 1994.
(b) If no cracks or other discrepancies are detected during the
inspection required by paragraph (a) of this AD, repeat the
inspection thereafter at intervals not to exceed 300 hours time-in-
service.
(c) If evidence of any loose or missing rivet is revealed, or if
abnormal movement between the handrail pivot-tube and the spigot
that attaches to the bearing assembly is detected, as a result of
any of the inspections required by this AD, prior to further flight,
accomplish the procedures specified in paragraph 2.B.(4) of
Jetstream Alert Service Bulletin J41-A52-036, dated June 13, 1994.
Thereafter, repeat the inspection required by paragraph (a) of this
AD at intervals not to exceed 300 hours time-in-service.
(d) If evidence of cracking is revealed as a result of any of
the inspections required by this AD, prior to further flight,
accomplish the requirements of either paragraph (d)(1), (d)(2), or
(d)(3) of this AD:
(1) Install a new handrail assembly, Part No. 6020203 Issue C
standard, as specified in paragraph 2.B.(5)(d) of Jetstream Alert
Service Bulletin J41-A52-036, dated June 13, 1994. After
installation, repeat the inspection required by paragraph (a) of
this AD at intervals not to exceed 300 hours time-in-service. Or
(2) Install the interim reinforcement of the handrail assembly
(Customer Option Kit. No. Jk42619) in accordance with Jetstream
Service Bulletin J41-52-041-42619, dated June 13, 1994. Such
installation constitutes terminating action for the inspections
required by this AD. Or
Note 2: Jetstream Service Bulletin J41-52-041-42619 refers to
Flight Refuelling Service Bulletin 6020303-52-1 for additional
installation information.
(3) Install the structural improvements of the door and door
support, and the completely redesigned door handrail assembly, in
accordance with Jetstream Service Bulletin J41-52-025, dated
February 11, 1994. Such installation constitutes terminating action
for the inspections required by this AD.
Note 3: Jetstream Service Bulletin J41-52-025 refers to Flight
Refuelling Service Bulletin 6020303-52-2 for additional installation
information.
(e) Terminating action for the inspections required by this AD
consists of installation of the item(s) specified in either
paragraph (e)(1) or (e)(2) of this AD:
(1) Installation of the interim reinforcement of the handrail
assembly (Customer Option Kit. No. Jk42619) in accordance with
Jetstream Service Bulletin J41-52-041-42619, dated June 13, 1994. Or
(2) Installation of the structural improvements of the door and
door support, and the completely redesigned door handrail assembly,
in accordance with Jetstream Service Bulletin J41-52-025, dated
February 11, 1994.
(f) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Standardization Branch, ANM-113,
FAA, Transport Airplane Directorate. Operators shall submit their
requests through an appropriate FAA Principal Maintenance Inspector,
who may add comments and then send it to the Manager,
Standardization Branch, ANM-113.
Note 4: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Standardization Branch, ANM-113.
(g) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
(h) The inspections shall be done in accordance with Jetstream
Alert Service Bulletin J41-A52-036, dated June 13, 1994. The interim
reinforcement of the handrail assembly shall be done in accordance
with Jetstream Service Bulletin J41-52-041-42619, dated June 13,
1994. The installation of the structural improvements of the door
and door support, and the completely redesigned door handrail
assembly, shall be done in accordance with Jetstream Service
Bulletin J41-52-025, dated February 11, 1994. This incorporation by
reference was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
obtained from Jetstream Aircraft, Inc., P.O. Box 16029, Dulles
International Airport, Washington, DC 20041-6029. Copies may be
inspected at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue, SW., Renton, Washington; or at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(i) This amendment becomes effective on June 18, 1996.
Issued in Renton, Washington, on May 7, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-11882 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-11855 Approval and Promulgation of Air Quality Implementation Plans; Delaware: Amendment of Final Rule Pertaining to Regulation 24Control of Volatile Organic Compound Emissions, Section 47Offset Lithographic Printing; Correction
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Page 24239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11855]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[DE26-1-6940; FRL-5503-6]
Approval and Promulgation of Air Quality Implementation Plans;
Delaware: Amendment of Final Rule Pertaining to Regulation 24--Control
of Volatile Organic Compound Emissions, Section 47--Offset Lithographic
Printing; Correction
AGENCY: Environmental Protection Agency (EPA).
ACTION: Correction to Amendment of direct final rule.
-----------------------------------------------------------------------
SUMMARY: This document contains corrections to an amendment of a direct
final rule, which was published on Tuesday, March 26, 1996 (61 FR
13101) (96-7063). This amendment pertains to Delaware Regulation 24,
Control of Volatile Organic Compound Emissions, section 47, Offset
Lithographic Printing.
EFFECTIVE DATE: March 26, 1996.
FOR FURTHER INFORMATION CONTACT: Rose Quinto, (215) 597-3164.
SUPPLEMENTARY INFORMATION:
Background
On January 26, 1996, EPA published a Direct Final Rule approving a
State Implementation Plan (SIP) revision submitted by Delaware (61 FR
2419) pertaining to Delaware Regulation 24, Control of Volatile Organic
Compound Emissions, sections 10, 11, 12, 44, 45, 47, 48, and 49, and
Appendices I, K, L, and M, effective November 29, 1994. These sections
of Regulation 24 establish additional emission standards that represent
the application of reasonably available control technology (RACT) to
categories of stationary sources of volatile organic compounds (VOCs).
Because EPA received adverse comments on section 47, Offset
Lithographic Printing, EPA published an amendment of the direct final
rule on March 26, 1996 (61 FR 13101), withdrawing section 47 only.
Need for Correction
As published, the amendment of the direct final rule contains
errors which may prove to be misleading and are in need of
clarification.
Correction of Publication
Accordingly, at 61 FR 13101, Mar. 26, 1996 the publication of the
amendment, is corrected to read as follows: The heading ``Sec. 54.420
[Amended]'' is corrected to read ``Sec. 52.420 [Amended]''. In
amendatory instruction 2 the reference to ``Sec. 54.420(c)(54)(i)(B)''
is corrected to read ``Sec. 52.420(c)(54)(i)(B)''.
Dated: May 1, 1996.
W. Michael McCabe,
Regional Administrator, Region III.
[FR Doc. 96-11855 Filed 5-13-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-11824 Airworthiness Directives; Boeing Model 737-300, -400, and -500 Series Airplanes
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24206-24208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11824]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 95-NM-117-AD; Amendment 39-9613; AD 96-10-08]
RIN 2120-AA64
Airworthiness Directives; Boeing Model 737-300, -400, and -500
Series Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule.
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SUMMARY: This amendment adopts a new airworthiness directive (AD),
applicable to certain Boeing Model 737-300, -400, and -500 series
airplanes, that requires inspection to detect damage of a wire bundle
and clamp that are located in the electronic/electrical (E/E) equipment
bay, and repair of the damaged wire bundle. That action also requires
replacement of the existing steel clamp with a nylon clamp, and
rearrangement of the clamp installation. This amendment is prompted by
a report of fire in the E/E equipment bay due to electrical arcing
caused by chafing of a wire bundle. The actions specified by this AD
are intended to prevent chafing of a wire bundle that could cause short
circuiting of the wire bundle, and could result in smoke and fire in
the E/E equipment bay.
DATES: Effective June 13, 1996.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of June 13, 1996.
ADDRESSES: The service information referenced in this AD may be
obtained from Boeing Commercial Airplane Group, P.O. Box 3707, Seattle,
Washington 98124-2207. This information may be examined at the Federal
Aviation Administration (FAA), Transport Airplane Directorate, Rules
Docket 95-NM-117-AD, 1601 Lind Avenue, SW., Renton, Washington; or at
the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Stephen Oshiro, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue, SW., Renton, Washington;
telephone (206) 227-2793; fax (206) 227-1181.
SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal
Aviation Regulations (14 CFR part 39) to include an airworthiness
directive (AD) that is applicable to certain Boeing Model 737-300, -
400, and -500 series airplanes was published in the Federal Register on
October 13, 1995 (60 FR 53307). That action proposed to require a
visual inspection to detect damage of the wire bundle and clamp in the
electronic/electrical (E/E) equipment bay, and repair, if necessary.
Additionally, that action proposed to require replacement of the rubber
cushioned steel clamp with a nylon clamp, and the installation of
additional clamps to prevent contact between wire bundle W2132 (or
W0132) and power feeder wire bundle W0142.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. Due consideration has been given to
the comments received.
Support for the Proposal
One commenter supports the proposed rule.
Request to Withdraw the Rule: Basis May be an Isolated Incident
One commenter requests that the FAA first review the findings on
airplanes inspected thus far and, if no incorrect routing exists on
other airplanes, the proposed rule should be withdrawn. This commenter
states that the Supplementary Information section of the preamble to
the proposal only states that an unsafe condition is ``likely to
exist'' on other airplanes, and asks that further explanation be given
as to why the FAA believes other airplanes may be affected. This
commenter has received no reports of similar conditions on other
airplanes.
The FAA agrees that fleetwide corrective actions should not be
mandated in response to incidents determined to be truly ``isolated.''
In this case, however, AD action is warranted since the FAA has
confirmed that the incident described in the notice was the result of a
manufacturing error, and that this error was repeated on numerous
airplanes. As part of its investigation, the FAA conducted inspections
of 10 airplanes in the manufacturer's production facility. These
inspections revealed that incorrect wire bundle clamps were installed
in each of these airplanes. Furthermore, a review of manufacturing
records indicates that this condition exists in approximately 620
previously delivered airplanes. In light of this evidence, the FAA has
determined that the condition addressed by this AD is not the result of
a single isolated incident, as the commenter suggests.
Request to Withdraw the Rule: No Essential Flight Circuits are Involved
-
One commenter requests that the AD be withdrawn because of the fact
that no essential flight circuits were affected as a result of the
damage to the wiring. The wire bundle involved in the damage is not
associated with flight-critical systems.
The FAA agrees that loss of the systems associated with the damaged
wire bundle would not significantly affect safe flight and landing of
the airplane. The FAA's primary concern, however, is not the loss of
system function, but the possibility of chafing of a wire bundle that
could cause short circuiting of the wire bundles. Such short circuiting
of the wire bundles could result in an undetected in-flight fire, since
Electrical Equipment (E/E) bays of Model 737 airplanes are not equipped
with fire detection systems.
Request to Withdraw the Proposal: No ``Formal'' Service Document Exists
One commenter contends that the FAA should not issue an AD that
cites an ``informal'' service letter (Boeing Service Letter 737-SL-24-
106, dated March 10, 1995) as the appropriate
[[Page 24207]]
source of instructions for accomplishing the proposed actions. The
commenter maintains that a ``formal'' service bulletin should be issued
if the manufacturer finds the chafing problem to be more than an
isolated incident.
The FAA does not concur with the commenter. The fact that the
manufacturer chose to publish the service information in a form other
than a ``formal'' service bulletin, is not a justifiable reason to
withdraw the proposed AD. It is appropriate for the FAA to reference in
AD's any document that is available to affected operators and contains
procedural instructions necessary for conducting required actions.
Further, the decision to mandate corrective actions via the AD process
is based on the FAA's assessment of the potential hazardous condition,
not the assessment by the manufacturer.
Request to Withdraw the Rule: Service Information Incomplete
Two commenters state that the service letter, cited in the proposed
rule as the appropriate service information, contains an incomplete
list of parts. The commenters assert that the service letter only
indicates a ``family'' of hardware, and leaves the determination of the
appropriate clamp diameters and screw lengths up to the operators. The
commenters request that an AD not be issued unless the manufacturer
finds it advisable to publish a formal service bulletin containing a
complete and accurate list of parts.
The FAA acknowledges the commenters' observation that the service
letter contains an incomplete list of parts; however, that list is not
incomplete to the extent that the AD should be withdrawn. The FAA finds
that clarification of these parts is necessary so that operators will
have no difficulty performing the requirements of this AD. In those
situations where part numbers are incomplete, the undefined parameters
are limited to non-critical part dimensions or, in the case of the
NAS42DD-6 spacer, a dimension and finish. The function of the subject
parts is to establish a reasonable amount of separation from
surrounding structure by providing positive mechanical support for the
wire bundles. In these applications, a high degree of precision in the
unspecified dimensions is not essential. It also is reasonable to
assume that the modification will be accomplished by trained personnel,
whose discretion in the selection of part sizes is appropriate. Such
discretion will give operators the flexibility needed to deal with
slight manufacturing variations in the wire bundle installation of the
affected area. The FAA agrees that some guidance may prove useful to
operators unfamiliar with the parts identified in the service letter;
therefore, the FAA has revised paragraph (a) of the final rule to
include descriptions for the installation of the screw size, spacer
clearance, and specific finish requirements for the spacers.
Request to Extend Compliance Time
Two commenters request that the compliance time of the proposed
rule be increased from the proposed 12 months to 18 months. The
commenters state that extending the compliance period will allow
operators to accomplish the inspection during a scheduled ``C'' check,
when airplanes are brought to the main maintenance base for an extended
hold. Adoption of a 12-month compliance time would require affected
operators to special schedule airplanes so that the requirements of the
rule can be accomplished; this would entail additional expenses over
what the FAA estimated in its cost impact information.
The FAA concurs that the compliance time can be extended somewhat.
The FAA's intent was that the inspections be conducted during a
regularly scheduled maintenance visit for the majority of the affected
fleet. The FAA now recognizes that 15 months corresponds more closely
to the interval representative of the majority of affected operators'
normal maintenance schedules. Extending the compliance time by three
additional months will not adversely affect safety, and will allow the
modification to be performed at a base during regularly scheduled
maintenance. Paragraph (a) of the final rule has been revised to
reflect a compliance time of 15 months.
Request to Revise Cost Impact Information
One commenter requests that the FAA's cost impact estimation be
revised to specify that two work hours are required to accomplish the
proposed modification, instead of one work hour. The commenter explains
that the access to the work area is from under the cabin floor, and the
personnel performing the modification are in an awkward position and
are unable to fully view the work area. Because of these factors, the
modification would take a longer time that the FAA's estimated one work
hour.
The FAA does not concur. The cost impact information, below,
describes only the ``direct'' costs of the specific actions required by
this AD. The FAA's estimate of 1 work hours necessary to accomplish the
required actions is based on the best data available to date, and
represents the time necessary to perform only the actions actually
required by this AD. The FAA recognizes, that in accomplishing the
requirements of any AD, operators may incur ``incidental'' costs in
addition to the ``direct'' costs. The cost analysis in AD rulemaking
actions, however, typically does not include incidental costs, such as
the time required to gain access and close up, planning time, or time
necessitated by other administrative actions. Because incidental costs
may vary significantly from operator to operator, they are almost
impossible to calculate.
Conclusion
After careful review of the available data, including the comments
noted above, the FAA has determined that air safety and the public
interest require the adoption of the rule with the changes previously
described. The FAA has determined that these changes will neither
increase the economic burden on any operator nor increase the scope of
the AD.
Cost Impact
There are approximately 620 Model 737-300, -400, and -500 series
airplanes of the affected design in the worldwide fleet. The FAA
estimates that 195 airplanes of U.S. registry will be affected by this
AD, that it will take approximately 1 work hour per airplane to
accomplish the required actions, and that the average labor rate is $60
per work hour. Required parts will cost approximately $25 per airplane.
Based on these figures, the cost impact of the AD on U.S. operators is
estimated to be $16,575, or $85 per airplane.
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of the requirements of this AD
action, and that no operator would accomplish those actions in the
future if this AD were not adopted.
Regulatory Impact
The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this action (1) is
not a ``significant regulatory action'' under Executive Order 12866;
(2) is not a ``significant rule'' under DOT
[[Page 24208]]
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act. A final evaluation has been prepared
for this action and it is contained in the Rules Docket. A copy of it
may be obtained from the Rules Docket at the location provided under
the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
96-10-08 Boeing: Amendment 39-9613. Docket 95-NM-117-AD.
Applicability: Model 737-300, -400, and -500 series airplanes,
as listed in Boeing Service Letter 737-SL-24-106, dated March 10,
1995; certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
otherwise modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (c) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent short circuiting of a wire bundle located in the
electrical/electronics (E/E) equipment bay, which could result in
smoke and fire, accomplish the following:
(a) Within 15 months after the effective date of this AD,
accomplish the requirements of paragraphs (a)(1), (a)(2), and
(a)(3), of this AD in accordance with Boeing Service Letter 737-SL-
24-106, dated March 10, 1995.
Note 2: Screws having part number (P/N) NAS1801-3-( ) and
spacers having P/N NAS42DD-6-( ), used to install the clamps as
specified by this service letter, should be selected to provide a
minimum of 0.25 inch clearance between wire bundles and surrounding
structure and objects. Additionally, the spacers should have a part
number having a chemical film finish code of ``FC'' or a gray
anodize finish code of ``N.''
(1) Perform a visual inspection to detect damage of the wire
bundle and clamps in the E/E compartment. If any damage is detected,
prior to further flight, repair in accordance with the service
letter.
(2) Reclamp wire bundle W2132 (or W0132) by removing the steel
cushioned clamp and installing a nylon clamp on the aft side of the
existing nut and bolt hole at body station (BS) 360, water line (WL)
203, left buttock line (LBL) 57, in accordance with the service
letter.
(3) Install additional clamps to wire bundles W2132 (or W0132)
and power feeder wire bundle WO142, in accordance with the service
letter.
(b) Within 10 days after detecting any damage to the wire bundle
or clamp as a result of the inspection required by paragraph (a) of
this AD, submit a report of the damage findings to the FAA,
Transport Airplane Directorate, Seattle Manufacturing Inspection
District Office (MIDO), Attention: George Carter, 1601 Lind Avenue
SW., Renton, Washington 98055-4056; telephone (206) 237-6229; fax
(206) 965-0264. Information collection requirements contained in
this regulation have been approved by the Office of Management and
Budget (OMB) under the provisions of the Paperwork Reduction Act of
1980 (44 U.S.C. 3501 et seq.) and have been assigned OMB Control
Number 2120-0056.
(c) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Seattle Aircraft Certification
Office (ACO), FAA, Transport Airplane Directorate. Operators shall
submit their requests through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Seattle ACO.
Note 3: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Seattle ACO.
(d) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
(e) The actions shall be done in accordance with Boeing Service
Letter 737-SL-24-106, dated March 10, 1995, including Attachments I
and II. This incorporation by reference was approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from Boeing Commercial Airplane
Group, P.O. Box 3707, Seattle, Washington 98124-2207. Copies may be
inspected at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue, SW., Renton, Washington; or at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(f) This amendment becomes effective on June 13, 1996.
Issued in Renton, Washington, on May 6, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-11824 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-11823 Airworthiness Directives; McDonnell Douglas Model DC-9-80 Series Airplanes and Model MD-88 Airplanes
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24214-24216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11823]
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DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 95-NM-127-AD; Amendment 39-9614; AD 92-10-13 R1]
RIN 2120-AA64
Airworthiness Directives; McDonnell Douglas Model DC-9-80 Series
Airplanes and Model MD-88 Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule.
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SUMMARY: This amendment revises an existing airworthiness directive
(AD), applicable to certain McDonnell Douglas Model DC-9-80 series
airplanes and Model MD-88 airplanes, that currently requires a revision
to the FAA-approved Airplane Flight Manual (AFM) to specify that the
autothrottles must be disconnected if engine surge (stall) is detected
during takeoff. That AD was prompted by results of an accident
investigation, which revealed that the digital flight guidance computer
(DFGC) on these airplanes can incorrectly identify an engine surge or
stall as being an engine failure. This can cause the autothrottles to
unclamp and automatically advance the thrust levers during takeoff. The
actions specified by that AD are intended to prevent automatic advance
of the thrust lever on a surging engine during takeoff, which could
cause engine failure. This amendment provides for an optional
terminating action for the AFM revision.
DATES: Effective June 13, 1996.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of June 13, 1996.
ADDRESSES: The service information referenced in this AD may be
obtained from McDonnell Douglas Corporation, 3855 Lakewood Boulevard,
Long Beach, California 90846, Attention: Technical Publications
Business Administration, Department C1-L51 (2-60). This information may
be examined at the Federal Aviation Administration (FAA), Transport
Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton,
Washington; or at the FAA, Transport Airplane Directorate, Los Angeles
Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood,
California; or at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Robert Baitoo, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Transport Airplane Directorate, Los
Angeles Aircraft Certification Office, 3960 Paramount Boulevard,
Lakewood,
[[Page 24215]]
California; telephone (310) 627-5245; fax (310) 627-5210.
SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal
Aviation Regulations (14 CFR part 39) by superseding AD 92-10-13,
amendment 39-8247 (57 FR 19249, May 5, 1992), which is applicable to
certain McDonnell Douglas Model DC-9-80 series airplanes and Model MD-
88 airplanes, was published in the Federal Register on October 18, 1995
(60 FR 53888). That action proposed to require the installation of a
modified digital flight guidance computer (DFGC), which, when
accomplished, would terminate the requirement for the AFM revision.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. Due consideration has been given to
the comments received.
Support for the Proposal
Three commenters support the proposed rule.
Requests To Withdraw the Proposal
Several commenters request that the FAA withdraw the proposed rule
or retain the proposed installation as an optional terminating action
for the AFM revision. The commenters contend that the requirements of
the proposed AD provide no additional safety over existing AD 92-10-13;
the safety of the affected airplanes is ensured by the currently
installed hardware and the procedural changes that are required by the
existing AD. One commenter, Honeywell, states that both AD 92-10-13 and
the proposed AD achieve the same goal of preventing forward throttle
movement in the event of an engine surge or stall. AD 92-10-13 achieves
this goal by requiring the pilot to recognize the surge condition and
to manually disconnect the autothrottles. The proposed AD accomplishes
this in a different manner--by forcing the DFGC autothrottles to remain
in the clamp mode. Because the engine surge condition is easily and
unambiguously recognized in the cockpit and the resultant action
required by AD 92-10-13 (disconnecting the autothrottle) is likewise
clear and easily accomplished, the correct execution for the subject
condition is assured. The commenters also state that accomplishment of
the requirements of the proposed AD would pose an immense cost to some
operators. The commenters contend that such expense is unnecessary when
an equivalent, alternative means is available.
The FAA does not concur with the requests to withdraw the final
rule. However, the FAA has determined that, based on the information
provided by the commenters, the currently installed hardware and the
procedural changes required by the existing AD do provide a long term
and adequate level of safety. While the manufacturer has advised the
FAA that the new DFGC (part number 4034241-972) was incorporated on all
production Model DC-9-80 series airplanes as of July 1995, the FAA has
determined that the installation should be provided in this AD as an
optional terminating action for the AFM revision. Therefore, this
action revises AD 92-10-13 to add a new paragraph (c) that provides for
installation of the new DFGC's as an optional terminating action for
the AFM revision.
Other Changes to the Final Rule
The FAA also has clarified the applicability of this rule to
specify that only airplanes equipped with digital flight guidance
computers (DFGC) having part numbers prior to 4034241-972 are subject
to the requirements of the AD. This change will exclude airplanes on
which the terminating installation has been accomplished previously or
in production.
Conclusion
After careful review of the available data, including the comments
noted above, the FAA has determined that air safety and the public
interest require the adoption of the rule with the changes previously
described. The FAA has determined that these changes will neither
increase the economic burden on any operator nor increase the scope of
the AD.
Cost Impact
There are approximately 1,117 McDonnell Douglas Model DC-9-80
series airplanes and Model MD-88 airplanes of the affected design in
the worldwide fleet. The FAA estimates that 643 airplanes of U.S.
registry will be affected by this AD.
The AFM revision that is currently required by AD 92-10-13 takes
approximately 1 work hour per airplane to accomplish, at an average
labor rate of $60 per work hour. Based on these figures, the cost
impact on U.S. operators of this current requirement is estimated to be
$38,580, or $60 per airplane.
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of the requirements of this AD
action, and that no operator would accomplish those actions in the
future if this AD were not adopted.
Should an operator elect to accomplish the optional terminating
action that is provided by this AD action (the removal of DFGC's having
part number 4034241-971 and installation of DFGC's having part number
4034241-972), it would take approximately 1 work hour per airplane to
accomplish, at an average labor rate of $60 per work hour. Required
parts will cost approximately $2,000 per airplane (that is, $1,000 per
DFGC, and 2 DFGC's per airplane). Based on these figures, the cost
impact of the optional terminating action is estimated to be $2,060 per
airplane.
Should an operator have an airplane equipped with DFGC's having
part numbers other than (lower than) 4034241-971, additional actions
may be necessary prior to accomplishing the optional terminating
action. Those additional actions involve modification(s) of the DFGC's
to bring them to the level of configuration of DFGC's having part
number 4034241-971. Depending on the current configuration of the
DFGC's installed on the airplane, the highest costs associated with
modifying a DFGC to a part number 4034241-971 configuration (excluding
subsequent modification to the part number 4034241-972 configuration)
could be as much as $92,000 per airplane (that is, $46,000 per DFGC,
and 2 DFGC's per airplane).
Regulatory Impact
The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this action (1) is
not a ``significant regulatory action'' under Executive Order 12866;
(2) is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and (3) will not have a
significant economic impact, positive or negative, on a substantial
number of small entities under the criteria of the Regulatory
Flexibility Act. A final evaluation has been prepared for this action
and it is contained in the Rules Docket. A copy of it may be obtained
from the Rules Docket at the location provided under the caption
ADDRESSES.
[[Page 24216]]
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 USC 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by removing amendment 39-8247 (57 FR
19249, May 5, 1992), and by adding a new airworthiness directive (AD),
amendment 39-9614, to read as follows:
92-10-13 R1 McDonnell Douglas: Amendment 39-9614. Docket 95-NM-127-
AD. Revises AD 92-10-13, Amendment 39-8247.
Applicability: Model DC-9-80 series airplanes and Model MD-88
airplanes equipped with digital flight guidance computers (DFGC)
having part numbers prior to 4034241-972; certificated in any
category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (d) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously. -
To prevent automatic thrust lever advance on a surging engine
during takeoff, which could cause engine failure, accomplish the
following:
(a) Within 30 days after May 20, 1992 (the effective date of AD
92-10-13, amendment 39-8247), revise the Limitations Section of the
FAA-approved Airplane Flight Manual (AFM) to include the following
statement. This may be accomplished by inserting a copy of this AD
in the AFM.
``LIMITATIONS SECTION
Autothrottles must be disconnected if engine surge (stall) is
detected during takeoff.''
(b) Within 30 days after May 20, 1992 (the effective date of AD
92-10-13, amendment 39-8247), revise the Procedures Section of the
FAA-approved AFM to include the following statement. This may be
accomplished by inserting a copy of this AD in the AFM.
``PROCEDURES SECTION
CAUTION
During takeoff, the Digital Flight Guidance Computer (DFGC)
engine failure logic is armed if (1) the flight director pitch axis
is in takeoff mode, (2) the aircraft is above 400 feet radio
altitude, and (3) both engine pressure ratios (EPRs) are below the
go-around EPR limit. If the DFGC detects an EPR drop greater than or
equal to 0.25 EPR and 7% N1 from the same engine, as compared
to the other engine, the engine failure logic is satisfied and the
DFGC will change the Thrust Rating Panel (or indicator) thrust limit
to Go-Around (GA). This will cause the autothrottle system to
unclamp and enter normal EPR limit (EPR LIM) mode where the
throttles will maintain the higher engine EPR at the selected go-
around thrust rating EPR LIM. Such an EPR and N1 drop may also
result from an engine surge (stall). Advancing thrust levers on a
surging engine will hinder surge recovery and may result in eventual
engine failure.
If an engine surge (stall) is detected during takeoff:
(1) Disconnect autothrottles.
(2) Reduce thrust on affected engine (idle if necessary).
(3) Shut down the affected engine if surging and popping continues.
(4) If affected engine surging or popping stops, accomplish the
following:
A. Place ignition switch to GRD START & CONTIN.
B. Place ENG anti-ice switches to ON.
C. Place PNEU X-FEED VALVE lever OPEN on affected side.
D. Place AIR FOIL anti-ice switches ON.
E. Advance affected throttle slowly.
(5)- If engine surging or popping returns, turn the ENG anti-ice
switch OFF.
(6)- After normal operation has been established, the autothrottles
may be re-engaged.
Note: A NO MODE light may be annunciated due to abnormal bleed
configuration.''
(c) Replacement of both DFGC's having a part number prior to
4034241-972, with DFGC's having part number 4034241-972, in
accordance with McDonnell Douglas Service Bulletin MD80-22-111,
dated May 23, 1995, constitutes terminating action for the
requirements of this AD. Once the replacements are accomplished, the
AFM revisions required by paragraphs (a) and (b) of this AD may be
removed.
Note 2: McDonnell Douglas Service Bulletin MD80-22-111, dated
May 23, 1995, references Honeywell Service Bulletin 4034241-22-44,
dated May 22, 1995, as an additional source of service information.
Note 3: Paragraph 1.B of McDonnell Douglas Service Bulletin
MD80-22-111, dated May 23, 1995, specifies certain concurrent
actions that affect airplanes equipped with DFGC's having part
numbers prior to 4034241-971.
(d) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Los Angeles Aircraft Certification
Office (ACO), FAA, Transport Airplane Directorate. Operators shall
submit their requests through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Los Angeles ACO.
Note 4: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Los Angeles ACO.
(e) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
(f) The replacement shall be done in accordance with McDonnell
Douglas Service Bulletin MD80-22-111, dated May 23, 1995. This
incorporation by reference was approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. Copies may be obtained from McDonnell Douglas Corporation, 3855
Lakewood Boulevard, Long Beach, California 90846, Attention:
Technical Publications Business Administration, Department C1-L51
(2-60). Copies may be inspected at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
FAA, Los Angeles Aircraft Certification Office, Transport Airplane
Directorate, 3960 Paramount Boulevard, Lakewood, California; or at
the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.
(g) This amendment becomes effective on June 13, 1996.
Issued in Renton, Washington, on May 6, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-11823 Filed 5-13-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-11814 Radio Broadcasting Services; Chester, Shasta Lake City, Alturas, McCloud, Weaverville and Central Valley, CA
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24242-24243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11814]
=======================================================================
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 94-76; 94-77; RM-8470; RM-8477; RM-8523; RM-8524]
Radio Broadcasting Services; Chester, Shasta Lake City, Alturas,
McCloud, Weaverville and Central Valley, CA
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document grants allotment proposals in the above-
captioned, interrelated proceedings at Chester, Shasta Lake City,
Alturas, McCloud and Weaverville, CA, in response to petitions for rule
making filed by m. JAYNE sawyer (``sawyer'') (MM Docket No. 94-76; RM-
8477), and Mark C. Allen (``Allen'') (MM Docket No. 94-77; RM-8470), as
well as mutually-exclusive counterproposals filed by Goldrush
Broadcasting (``Goldrush'') and by Corey J. McCaslin (``McCaslin''), as
set forth infra (see Supplementary Information). See 59 FR 36735, and
59 FR 36736, published July 19, 1994. With this action, the proceeding
is terminated.
[[Page 24243]]
DATES: Effective June 17, 1996. The window period for filing
applications will open on June 17, 1996, and close on July 18, 1996.
FOR FURTHER INFORMATION CONTACT: Nancy Joyner, Mass Media Bureau, (202)
418-2180. Questions related to the window application filing process
should be addressed to the Audio Services Division, FM Branch, (202)
418-2700.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Report and Order, involving two consolidated, interrelated proceedings
consisting of MM Docket No. 94-76 and MM Docket No. 94-77, adopted
April 23, 1996, and released May 3, 1996. The full text of this
Commission decision is available for inspection and copying during
normal business hours in the FCC's Reference Center (Room 239), 1919 M
Street, NW., Washington, DC. The complete text of this decision may
also be purchased from the Commission's copy contractors, International
Transcription Service, Inc., (202) 857-3800, located at 1919 M Street,
NW., Room 246, or 2100 M Street, NW., Suite 140, Washington, DC 20037.
The Commission, at the request of Goldrush allots Channel 259A to
Chester, California, in lieu of Channel 296A, as requested by sawyer,
as that community's second local FM service (MM Docket No. 94-76; RM-
8477; RM-8523). In response to Goldrush's request, Channel 296C3 is
allotted to Shasta Lake City, California, in lieu of Channel 276A, as
requested by Allen. Also, in response to Goldrush's request, Channel
297C is allotted to Alturas, California, as that community's third
local FM service, and Channel 238C3 is allotted to McCloud, California,
as that community's first local commercial FM service (MM Docket No.
94-77; RM-8470; RM-8523). Additionally, in response to the
counterproposal filed by Corey J. McCaslin, Channel 276C2 is allotted
to Weaverville, California, as that community's first local FM service
(MM Docket No. 94-77; RM-8470; RM-8524). Coordinates for Channel 259A
at Chester, California, are 40-20-00 and 121-15-13; coordinates for
Channel 296C3 at Shasta Lake City, California, are 40-43-58 and 122-21-
59; coordinates for Channel 297C at Alturas, California, are 41-29-34
and 120-31-37; coordinates for Channel 238C3 at McCloud, California,
are 41-15-18 and 122-08-24; and coordinates for Channel 276C2 at
Weaverville, California, are 40-49-32 and 122-55-21. Additionally, as
indicated in the Notice in MM Docket No. 94-77, 9 FCC Rcd 3318 (1994),
we are also making an editorial amendment herein to the FM Table of
Allotments to reflect that Channel 257C3 is deleted at Central Valley,
California, and allotted at Shasta Lake City as a result of the former
community's dissolution and incorporation into Shasta Lake City,
pursuant to Resolution No. 93-02 of the Shasta County Local Agency
Formation Commission.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Part 73 of title 47 of the Code of Federal Regulations is amended
as follows:
PART 73--[AMENDED]
1. The authority citation for part 73 continues to read as follows:
Authority: Secs. 303, 48 Stat., as amended, 1082; 47 U.S.C. 154,
as amended.
Sec. 73.202 [Amended]
2. Section 73.202(b), the Table of FM Allotments under California,
is amended by adding Channel 297C at Alturas;
3. Section 73.202(b), the Table of FM Allotments under California,
is amended by adding Channel 259A at Chester;
4. Section 73.202(b), the Table of FM Allotments under California,
is amended by removing Central Valley, Channel 257C3;
5. Section 73.202(b), the Table of FM Allotments under California,
is amended by adding McCloud, Channel 238C3;
6. Section 73.202(b), the Table of FM Allotments under California,
is amended by adding Shasta Lake City, Channel 257C3;
7. Section 73.202(b), the Table of FM Allotments under California,
is amended by adding Channel 296C3 at Shasta Lake City;
8. Section 73.202(b), the Table of FM Allotments under California,
is amended by adding Weaverville, Channel 276C2.
Federal Communications Commission.
Andrew J. Rhodes,
Acting Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-11814 Filed 5-13-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-11808 The State Vocational Rehabilitation Services Program
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24390-24403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11808]
[[Page 24389]]
_______________________________________________________________________
Part III
Department of Education
_______________________________________________________________________
34 CFR Part 361
The State Vocational Rehabilitation Services Program; Final Rule
Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Rules
and Regulations
[[Page 24390]]
DEPARTMENT OF EDUCATION
34 CFR Part 361
RIN 1820-AB13
The State Vocational Rehabilitation Services Program
AGENCY: Department of Education.
ACTION: Final regulations.
-----------------------------------------------------------------------
SUMMARY: The Secretary amends the regulations governing The State
Vocational Rehabilitation Services Program. These regulations are
needed to implement section 12(d) of the Rehabilitation Act of 1973
(Act), as amended by the Rehabilitation Act Amendments of 1992 (1992
Amendments) and the Rehabilitation Act Amendments of 1993. Section
12(d) of the Act requires that the Secretary promulgate regulations
establishing requirements for the implementation of an order of
selection for the receipt of vocational rehabilitation services. An
order of selection is required under section 101(a)(5)(A) of the Act if
a designated State unit (DSU) determines that it is unable to provide
services to all eligible individuals who apply for services. If a DSU
establishes an order of selection, it must first provide services to
individuals with the most severe disabilities before serving other
eligible individuals. The regulations are necessary to ensure the
proper administration of the order of selection requirements by DSUs.
EFFECTIVE DATE: These regulations take effect on June 13, 1996.
FOR FURTHER INFORMATION CONTACT: Suzanne Tillman, U.S. Department of
Education, 600 Independence Avenue, S.W., Room 3220, Mary E. Switzer
Building, Washington, D.C. 20202-2735. Telephone: (202) 205-8303.
Individuals who use a telecommunications device for the deaf (TDD) may
call the Federal Information Relay Service (FIRS) at 1-800-877-8339
between 8 a.m. and 8 p.m., Eastern time, Monday through Friday.
SUPPLEMENTARY INFORMATION: The State Vocational Rehabilitation Services
Program is a State-administered program that provides individualized
vocational rehabilitation (VR) services to eligible individuals with
disabilities. The purpose of the program is to assist States in
operating a comprehensive, coordinated, effective, efficient, and
accountable program for vocational rehabilitation designed to assess,
plan, develop, and provide VR services for individuals with
disabilities so that they may prepare for and engage in gainful
employment.
The program supports the National Education Goal that, by the year
2000, every adult American, including individuals with disabilities,
will possess the knowledge and skills necessary to compete in a global
economy and exercise the rights and responsibilities of citizenship.
On July 16, 1993, the Secretary published a notice of proposed
rulemaking (NPRM) in the Federal Register (58 FR 38482) to implement
section 12(d) of the Act, as amended by the 1992 Amendments (Pub. L.
102-569) and the Rehabilitation Act Amendments of 1993 (Pub. L. 103-
73), which requires that the Secretary issue regulations on the
requirements for implementing an order of selection by a DSU.
Analysis of Comments and Changes
In response to the Secretary's invitation in the NPRM, 45 parties
submitted comments on the proposed regulations. An analysis of the
comments and of the changes in the regulations since publication of the
NPRM follows.
Major issues are grouped according to subject under appropriate
sections of the regulations. Technical and other minor changes--and
suggested changes the Secretary is not legally authorized to make under
the applicable statutory authority--are not addressed. The Secretary
also has not addressed comments that relate to issues that are more
appropriately dealt with in other program regulations being developed
to implement the 1992 Amendments.
In addition, the proposed regulations have been reviewed and
revised in accordance with the Department's principles for regulating,
which were developed as part of the Administration's regulatory
reinvention initiative under the National Performance Review II. The
principles are designed to ensure that the Department regulates in the
most flexible, most equitable, and least burdensome way possible. As a
result of that review, several non-statutory paperwork requirements in
the proposed regulations have been eliminated or modified. These
changes are discussed in the following paragraphs and in the section-
by-section summary.
Section 101(a)(5)(A) of the Act requires a DSU to explain how it
will provide VR services to all eligible individuals or, if it cannot
provide services to all these individuals, to describe and justify the
order of selection the DSU will follow in serving eligible individuals,
with first priority being given to individuals with the most severe
disabilities. Accordingly, Sec. 361.36(a)(1) of the final regulations
requires DSUs that do not establish an order of selection to explain
how, on the basis of its projected fiscal and personnel resources and
its assessment of the rehabilitation needs of individuals with severe
disabilities within the State, the DSU will continue to serve all
individuals currently receiving services, provide assessment services
to all applicants and VR services to all individuals determined to be
eligible in the next fiscal year, and meet all other program
requirements.
The proposed regulations would have required each DSU that does not
establish an order of selection to provide detailed information to
support that decision, including its projected number of applicants,
eligible individuals, and qualified personnel, projected costs of
services and administration, and projected revenues. The Secretary
believes that requiring all DSUs to submit these projections is overly
burdensome and unnecessary for those States that have not experienced
problems in serving all eligible individuals in recent years. Thus, the
requirements in the final regulations are more narrowly tailored to
address the underlying problem of ensuring that DSUs do not improperly
avoid establishing an order of selection.
The final regulations establish two different information
requirements for DSUs that do not plan to establish an order of
selection: one for DSUs that have demonstrated the ability to serve all
eligible individuals and meet all program requirements and one for DSUs
that have not demonstrated this ability. The first information
requirement (Sec. 361.36(a)(2)) applies to DSUs whose past practice
demonstrates their ability to serve all eligible individuals without an
order of selection. DSUs will be subject to this requirement if they
have provided assessment services to all applicants, provided the full
range of services to all eligible individuals, made referral forms
widely available, conducted outreach efforts to identify and serve
those underserved in the past, and have not delayed the development of
individualized written rehabilitation programs (IWRPs) or the provision
of services for eligible individuals. This provision permits these DSUs
to submit a narrative explanation of their ability in the next year to
continue to serve everyone and meet all program requirements.
The second information requirement (Sec. 361.36(a)(3)) applies to
DSUs that have not demonstrated their ability to serve all eligible
individuals and meet all program requirements without an
[[Page 24391]]
order of selection. This more detailed information requirement would
apply to DSUs that--(1) Said in their State plans for the current or
past year that they could serve everyone, but, in fact, did not do so;
(2) Served all eligible individuals in the current or past year by not
meeting the requirements in Sec. 361.36(a)(2); or (3) Provided services
under an order of selection in the current or preceding fiscal year,
but believe that they can serve all eligible individuals in the next
fiscal year. These DSUs will be required to provide information,
including projections, similar to the information that would have been
required of all DSUs under the NPRM. Specifically, these DSUs must
describe the changed circumstances that will enable them to serve all
eligible individuals in the forthcoming fiscal year and must submit the
projections required under Sec. 361.36(a)(3) to support this
determination, including projected numbers of applicants, eligible
individuals, and qualified personnel, projected costs of services and
administration, and projected revenues. In addition, Sec. 361.36(a)(3)
requires these DSUs to provide, as relevant, comparable data for the
current or preceding fiscal year, or both years, of these projected
costs and resources.
These changes in the final regulations are intended to reduce
paperwork burdens on DSUs that have a demonstrated capacity to serve
all eligible individuals and, at the same time, to ensure that if a DSU
decides not to implement an order of selection, even though it has not
been able to serve all eligible persons in the past, that the decision
is supported in the State plan by sufficient data showing the DSU's
projected costs and resources.
Section 361.36(a)--General Provisions
Assurance of ability to serve all eligible individuals.
--Range of Services
Comments: Several commenters on Sec. 361.36(a)(1)(i) of the
proposed regulations requested that this provision specify that a DSU
is able to provide the full range of services listed in section 103(a)
of the Act. These commenters were concerned that a DSU could interpret
the wording ``able to provide services'' to mean that it may avoid
establishing an order of selection if it is able to provide some, but
not all, of the services listed in section 103(a) of the Act.
Discussion: The Secretary agrees with these commenters. A DSU that
assures that it is able to provide services to all eligible individuals
must be able to provide all of the services listed in section 103(a) of
the Act.
Changes: The Secretary has revised Sec. 361.36(a)(1)(i) to provide
that the State plan must contain an assurance that the DSU is able to
provide the full range of services listed in section 103(a) of the Act,
as appropriate, to all eligible individuals.
--Monitoring and review of assurances
Comments: Several commenters were concerned that the Secretary
would not adequately monitor compliance with the assurances provided by
a DSU. Several commenters recommended that the Secretary thoroughly
examine a DSU's decision not to implement an order of selection and
approve or disapprove that decision, as appropriate.
One commenter feared that, in order to avoid implementing an order
of selection, DSUs may expand counselor caseload sizes beyond the
capacity of counselors to serve eligible individuals in a meaningful
way. Caseload sizes could continue to grow but might not trigger an
order of selection.
One commenter suggested adding factors to measure a DSU's
compliance with these regulations. This commenter also suggested that
if a DSU is found in substantial noncompliance and fails to take
corrective action, it should be subject to financial sanctions.
Several commenters stated that a DSU should be required to evaluate
the impact of its order of selection to determine if there are any
unintended consequences or exclusions of specific groups of individuals
with disabilities.
Discussion: The Secretary ensures that a DSU is complying with its
assurances through annual reviews and periodic on-site monitoring of
State vocational rehabilitation programs required by sections
107(a)(3)(A) and 107(a)(4)(B) of the Act. Section 107(a)(3)(A) of the
Act requires the Secretary, as part of the monitoring process, to
conduct on-site visits, including on-site reviews of records, to verify
that a DSU is following requirements regarding order of selection.
Section 107(a)(4)(B) requires the Secretary to examine, in conducting
the review and monitoring, a DSU's provision of services, including, if
applicable, order of selection requirements.
Section 101(a)(7) of the Act requires a DSU to ensure, as part of
its comprehensive system of personnel development, that it has an
adequate supply of qualified personnel to provide vocational
rehabilitation services. The regulations require DSUs that do not
establish an order of selection to satisfy all VR program requirements,
including those relating to the comprehensive system of personnel
development. The Secretary also reviews and monitors compliance with
section 101(a)(7) of the Act.
The Secretary does not believe it is necessary to add factors to
measure a DSU's compliance with the order of selection requirements of
the State plan. A DSU's compliance with the order of selection
requirements will be monitored like any other State plan requirement,
and a DSU's noncompliance with these requirements will be dealt with
like any other finding of noncompliance with the State plan
requirements.
The Secretary believes that a DSU (along with the State
Rehabilitation Advisory Council (Council), if the DSU has a Council),
should evaluate the impact of its order of selection as part of its
administration of the program and would expect a discussion of this
impact in its annual evaluation of the program.
Changes: None.
Explanation of how a DSU will serve all eligible
individuals.
--Detailed nature of explanation
Comments: Several commenters opposed the proposed requirement that
a DSU provide a detailed explanation of the methods by which it will
provide services to all eligible individuals because they believe it is
overly burdensome. One commenter believed that the required projections
in Sec. 361.36(a)(1)(ii) of the proposed regulations might prevent
closer cooperation between consumer groups and DSUs because consumer
groups might believe that the incidence and prevalence of their
disability is greater than indicated in the statistical data used by
the DSU.
Several commenters believed that there is no practical way for a
DSU to make the required projections because of the uncertainty of
future funding levels and of the effect of the revised eligibility
requirements under the Act.
One commenter stated that if projections are required, the
Secretary should keep documentation to a minimum. This commenter
requested that a DSU be able to use existing data, e.g., Federal census
and population data, to make its projections.
Discussion: The legislative history accompanying the 1992
Amendments to the order of selection requirement indicates an
expectation on the part of the Congress that the Secretary will
promulgate regulations that will obligate States wishing to avoid
establishing an order of selection to prove that they are indeed able
to serve all eligible individuals. Nevertheless, the data
[[Page 24392]]
projections required in the proposed regulations have been
significantly reduced in accordance with the Department's principles
for regulating. Application of the remaining documentation requirements
is limited to--(1) Those DSUs that were unable to serve all eligible
individuals (including DSUs that established an order of selection) in
the current or preceding fiscal year, but contend they will be able to
do so in the next fiscal year; and (2) Those DSUs that were able to
serve all eligible individuals in the current or preceding fiscal year
only by not meeting the requirements in Sec. 361.36(a)(2). The
Secretary believes that the documentation requirements remaining in the
regulations to support a DSU's conclusion that it is able to serve all
eligible individuals, even though it has been unable to serve all
eligible persons in the past, is fully consistent with congressional
intent.
The Secretary believes that the required explanation will not
impose any additional data collection burdens on a DSU. The Secretary
believes that existing information in a DSU's required statewide
studies and annual evaluations, comprehensive statewide assessments of
the rehabilitation needs of individuals with severe disabilities,
comprehensive system of personnel development, and budget data would
enable a DSU to provide the required explanation without any need for
additional data collection.
The Secretary believes that a DSU should be able to predict funding
levels for the program during the upcoming fiscal year through use of
State and Federal budget data.
The Secretary believes that Federal census and population data
alone are not sufficient for a DSU to make the required projections.
These data are not updated often enough for a DSU to rely solely on
these sources in making its projections, but may be useful in
conjunction with information from a DSU's statewide studies,
comprehensive statewide assessments, comprehensive system of personnel
development, and budget data.
Changes: The Secretary has revised Sec. 361.36(a)(1)(ii) of the
proposed regulations to reduce the data projections that a DSU must
provide as part of its explanation of how it is able to serve all
eligible individuals. This provision has been relocated to
Sec. 361.36(a)(3) of the final regulations and applies only to--(1)
DSUs that were unable to serve all eligible individuals during the
current or preceding fiscal year; and (2) DSUs that contend that they
served all eligible individuals in the preceding and current fiscal
years, but cannot attest to meeting the program requirements listed in
Sec. 361.36(a)(2) for both those years.
--Projections for serving all eligible individuals with disabilities
Comments: Several commenters suggested that the Secretary require a
DSU to provide separate projections for serving individuals with non-
severe, severe, and the most severe disabilities in providing the data
in Sec. 361.36(a)(1)(ii) (A) and (B) of the proposed regulations. These
commenters believed that the approach taken in the proposed regulations
would allow a DSU to average the costs of serving all populations, and
the commenters recommended that a DSU be required to break out the
costs of serving individuals with severe and the most severe
disabilities. Commenters contended that the average projected cost of
serving all individuals is substantially less than the cost of serving
the subgroup of individuals with the most severe disabilities because
of the variety of services and supports that individuals in this
category require. One of these commenters also believed that providing
specific data on each of these populations would help to determine the
extent to which a DSU has engaged in aggressive outreach efforts to
serve a greater number of individuals with the most severe
disabilities.
One commenter requested that, in making its projections, a DSU be
required to take into consideration the likelihood that more
individuals will be applying for services as a result of the revised
eligibility requirements established under the 1992 Amendments and that
more of these individuals will be individuals with the most severe
disabilities because of the expanded requirements to provide personal
assistance and rehabilitation technology services.
Discussion: As discussed previously, the Secretary has
significantly revised the proposed regulations to require DSUs to
submit projections as part of their State plan only in limited
circumstances. Specifically, Sec. 361.36(a)(3) requires DSUs that were
unable to serve all eligible individuals during the current or previous
fiscal year, but believe that they do not need to establish an order of
selection in the next fiscal year, to include in their State plans the
projected numbers of eligible individuals, the projected costs of
serving those individuals, the projected revenues, and the projected
number of qualified personnel. (These State plan requirements also
apply to DSUs that do not establish an order of selection but cannot
provide the assurances in Sec. 361.36(a)(2).) However, any DSU that
does not establish an order of selection must still consider the
rehabilitation needs of individuals with severe disabilities as part of
its explanation under Sec. 361.36(a)(1)(i), even though the final
regulations do not require separate projections for individuals with
non-severe, severe, and most severe disabilities under
Sec. 361.36(a)(3).
The Secretary agrees that averaging the costs of serving all
eligible individuals would not provide an accurate estimate of the
costs of serving individuals with severe and the most severe
disabilities if a State relied solely on cost data for years prior to
the enactment of the 1992 Amendments in making its projections. The
Secretary believes that in making projections with respect to the cost
of serving all eligible individuals, a DSU must consider the costs of
serving individuals with severe disabilities.
The Secretary agrees that more individuals with severe disabilities
and individuals with the most severe disabilities have become eligible
to receive services under the revised eligibility requirements in the
1992 Amendments. However, the Secretary believes that any significant
expansion in the number of eligible individuals that is attributable to
the revised eligibility criteria has already taken place. Consequently,
the Secretary believes there is no need to require DSUs under
Sec. 361.36(a)(3) to provide separate projections for serving
individuals with non-severe, severe, and most severe disabilities as
long as the projected number of all eligible individuals and the
projected costs of serving those individuals is provided.
Changes: The Secretary has revised Sec. 361.36(a)(1)(ii) of the
proposed regulations to reduce the amount of data and related
explanations that must be submitted as part of the State plan. In
addition, the regulations require that this data be included as part of
the State plan only if--(1) The DSU was unable to serve all eligible
individuals in the current or preceding fiscal year; or (2) The DSUs
did not meet the requirements in Sec. 361.36(a)(2) in serving all
eligible individuals in the current and preceding fiscal years. This
provision has been relocated to Sec. 361.36(a)(3) in the final
regulations.
--Cost-containment
Comments: Several commenters suggested that a DSU be required to
control costs before implementing an order of selection. One commenter
suggested adding a new requirement to the regulations that a DSU, prior
to
[[Page 24393]]
implementing an order of selection, implement methods to control costs,
including, but not limited to, rigorous administrative controls and
oversight, aggressively pursuing comparable services and benefits,
paying vendors based on performance outcomes, developing equitable
financial need policies, and establishing collaborative program funding
through interagency agreements that will enable the DSU to provide
services to all eligible persons.
Another commenter requested that a DSU that is unable to secure its
full Federal allotment for the program due to insufficient State match
be required to demonstrate efforts to obtain the full match in order to
be able to implement an order of selection. This commenter also
requested that the Secretary question or not approve a DSU's decision
to implement an order of selection if it is unable to fill vacant
counselor positions due to a statewide freeze on hiring, since
counselor salaries are primarily funded by Federal funds.
On the other hand, several commenters requested that a DSU be
prohibited from establishing inappropriate, arbitrary, or groundless
policy restrictions on the provision of services that are intended to
avoid implementation of an order of selection. Some of these commenters
recommended that the Secretary establish an appeal process to the
Rehabilitation Services Administration (RSA) Regional Offices so that
parties may challenge these types of restrictions.
Discussion: The Secretary agrees that a DSU should undertake all
efforts to control costs before it opts to establish an order of
selection. Some of the means suggested by commenters for controlling
costs are already Federal requirements (e.g., program costs must be
reasonable and necessary and DSUs must pursue comparable services and
benefits before providing most services), while others are State
options (e.g., paying vendors based on performance outcomes, developing
equitable financial need policies, and establishing collaborative
program funding through interagency agreements). The Secretary
encourages DSUs to use these State options whenever possible to contain
costs.
In conjunction with a DSU's determination of whether it needs to
establish an order of selection, a DSU should consider whether the
adoption of certain cost containment measures would enable the DSU to
serve all eligible individuals. Adoption of cost containment measures,
therefore, should be considered both at the time the DSU develops its
State plan submission on order of selection prior to the beginning of
the fiscal year and whenever changed circumstances during the fiscal
year warrant reevaluation of the need to establish an order of
selection in accordance with Sec. 361.36(b). If a DSU undertakes cost
containment strategies and is still unable to serve all eligible
individuals, it is required to establish an order of selection for
services.
The Secretary does not believe there is authority to establish a
link between a DSU's ability to meet its full matching requirement--and
therefore earn its entire allotment--and its right to implement an
order of selection. In fact, the inability of a DSU to obtain its full
matching contribution may be a factor in its need to establish an order
of selection, since a DSU would have fewer program funds available
because of insufficient State dollars and the loss of some Federal
funds.
As previously noted, the Secretary agrees that DSUs need to proceed
carefully in establishing an order of selection. Therefore, the
Secretary requires, under Sec. 361.36(e)(1), that a DSU consult with
and seriously consider the advice of the Council regarding the need to
establish an order of selection. The Secretary does not believe it is
necessary or advisable to establish an appeal process that is
specifically for order of selection compliance issues. Section 107(c)
of the Act provides a general appeals process for substantial
noncompliance with any State plan requirement under this program.
Changes: None.
--Assessment of rehabilitation needs of individuals with severe
disabilities
Comments: One commenter requested that the provision in
Sec. 361.36(a)(1)(ii)(B)(1) of the proposed regulations requiring a DSU
to assess the rehabilitation needs of ``individuals with severe
disabilities'' within the State be changed to require a DSU to assess
the needs of ``individuals with the most severe disabilities.'' The
commenter believed that this change would be consistent with section
101(a)(5)(A) of the Act.
Discussion: Section 101(a)(5)(A) of the Act provides that the State
plan shall contain the plans, policies, and methods to be followed in
carrying out the State plan and in its administration and supervision,
including the results of a comprehensive, statewide assessment of the
rehabilitation needs of ``individuals with severe disabilities''
residing within the State. Therefore, Sec. 361.36(a)(1)(i) of the final
regulations correctly tracks the language in section 101(a)(5)(A) of
the Act. The Secretary notes, however, that the broad category of
``individuals with severe disabilities'' would include as a subcategory
``individuals with the most severe disabilities.''
Changes: None.
--Interagency cooperative agreements
Comments: One commenter requested that the provision in
Sec. 361.36(a)(1)(ii)(B)(4) of the proposed regulations, which
highlighted or emphasized the consideration of cooperative agreements
serving certain groups of individuals with disabilities, be changed to
read ``including individuals served by the Individuals with
Disabilities Education Act, * * * and any other cooperative
agreements'' in order to ensure that equal weight is given to all
cooperative arrangements.
One commenter recommended that the Secretary require a DSU to
include in its projections estimates of the number of individuals with
severe disabilities that will be provided services under the
interagency cooperative arrangement with programs that rely on Javits-
Wagner-O'Day Act (JWOD Act) set-asides.
Discussion: The Secretary believes that requiring in the State plan
separate estimates of the number of individuals with disabilities to be
served under interagency cooperative arrangements is overly burdensome.
As long as the DSU considers these agreements when ascertaining the
projected numbers of eligible individuals and the projected costs of
administering its program, there is no need to provide a separate
breakdown of the number of applicants or eligible individuals receiving
services under each type of agreement.
Changes: In accordance with the Department's principles for
regulating, the Secretary has revised the proposed regulations to
eliminate the requirement that the DSU include estimates of the number
of individuals to be served under interagency cooperative agreements as
part of its projected costs of administering the program.
--Development of order of selection as a contingency plan
Comments: Several commenters requested that a DSU be required to
develop an order of selection regardless of whether it needs to be
implemented in the current fiscal year. These commenters believed it is
important for each DSU to have an order of selection available as a
contingency measure.
Discussion: There is no statutory authority to require a DSU to
develop an order of selection if a DSU determines it is presently able
to serve all eligible individuals and will be able to do so throughout
the fiscal year. Section 101(a)(5)(A) of the Act requires a DSU
[[Page 24394]]
to establish an order of selection only if it is unable to serve all
eligible individuals.
A DSU could, however, choose to develop the priority categories in
an order of selection in anticipation of possible future need, but
would still be required at the time of implementation of the order of
selection to meet the public participation requirements of section
101(a)(23) of the Act, including consultation with the Council.
Changes: None.
Order of selection.
--Applicability of order of selection to funds not included in State
match or Federal allotment
Comments: One commenter requested that the order of selection
requirement not apply to service funds that are not included in the
State match or Federal allotment.
Discussion: The order of selection requirement applies to all
expenditures under the State plan, including expenditures made with
Federal funds and DSU expenditures made with non-Federal funds that are
necessary to meet a DSU's matching and maintenance-of-effort
requirements.
Changes: None.
--Outcome and service goals
Comments: One commenter suggested adding a paragraph to
Sec. 361.36(a)(2) of the proposed regulations requiring a DSU to show
the outcome and service goals and the time in which they may be
achieved for individuals. The commenter believed that this reporting
requirement should be added to ensure that the Secretary will know with
specificity the types of services and service outcomes being provided,
either if a DSU elects to establish and implement an order of selection
or if a DSU assures that it is able to serve all eligible individuals.
According to the commenter, if a DSU establishes an order of selection
for services, it will be very important for evaluation purposes to
define the mix of services, goals, and timelines for providing services
to individuals with the most severe disabilities.
Discussion: The Secretary agrees with the change suggested by the
commenter. Section 101(a)(5)(A) of the Act requires a DSU to show the
outcomes and service goals, and the time within which they may be
achieved, for individuals provided services under an order of selection
established by a DSU. Section 101(a)(10)(A) of the Act requires a DSU
to include in its State plan the outcomes, service goals, and service
costs for individuals under each priority category in a DSU's order of
selection.
Changes: The Secretary has revised Sec. 361.36(a)(2) of the
proposed regulations to provide that a DSU's order of selection must
include the order to be followed in selecting eligible individuals to
be provided services, a justification of that order of selection, and a
description of the outcome and service goals and service costs for
individuals with disabilities in each priority category within the
order and the time within which these goals may be achieved. This
provision has been relocated to Sec. 361.36(a)(1)(ii) of the final
regulations.
Section 361.36(b)--Time for Determining Need for and Implementation of
an Order of Selection
--Implementation of an order of selection and opening and closing of
priority categories during the fiscal year
Comments: One commenter recommended requiring a DSU to periodically
review whether it needs to establish an order of selection. This
commenter also recommended requiring a DSU to periodically update its
projections under Sec. 361.36(a)(1) of the proposed regulations so that
the DSU, with advice and input from the Council (if the DSU has a
Council), can make decisions with current information.
One commenter recommended that the regulations require a DSU to
reevaluate its decision not to establish an order of selection at some
regular interval identified in the regulations, rather than permit the
DSU to determine the timing of its reevaluation. Otherwise, the
commenter feared that many DSUs would delay reevaluation and likely be
forced to implement an order of selection on an emergency basis.
One commenter suggested that a DSU submit reports to the Secretary
and to the Council comparing the actual costs and numbers of
individuals served with its projections under Sec. 361.36(a)(1) of the
proposed regulations and any adjustments to the projections.
Other commenters suggested that a DSU be required, no later than 45
days after the end of each quarter, to submit a report on how service
and expenditure levels for that quarter and cumulatively for the fiscal
year compare to the projections made by the DSU under Sec. 361.36(a)(1)
of the proposed regulations. These commenters believed that this type
of reporting would allow the Secretary to track the accuracy of a DSU's
projections. Other commenters recommended requiring a DSU to submit
quarterly reports to the Secretary on the accuracy of a DSU's
projections and the need to establish an order of selection.
One commenter inquired whether a DSU may implement an order of
selection during the fiscal year, rather than at the beginning of the
fiscal year. This commenter believed that requiring a DSU to establish
an order of selection at the beginning of each fiscal year might cause
a DSU to be overly conservative and to close more priority categories
than is necessary.
One commenter inquired whether a DSU may adjust, during the fiscal
year, which priority categories are open and closed.
Discussion: The Secretary considers DSU reevaluation of the need to
establish an order of selection necessary to the proper management of
the program. However, the Secretary does not believe that requiring
reevaluation at regular intervals during the course of each fiscal year
is necessary. A requirement of this type would be overly burdensome and
would apply an inflexible standard to determinations that are best
governed by a DSU's individual circumstances. The regulations,
therefore, require a DSU to reevaluate its decision not to implement an
order of selection for services, in consultation with the Council,
whenever changed circumstances, such as a decrease in its fiscal or
personnel resources or an increase in program costs, indicate that it
may no longer be able to provide the full range of services to all
eligible individuals. In addition, documentation related to
reevaluations is to be provided to the Council, as well as to the
Department during RSA's monitoring and review of the order of selection
requirement under sections 107(a)(3)(A) and 107(a)(4)(B) of the Act.
A DSU is required to determine the need for an order of selection
prior to the beginning of the fiscal year and to reevaluate that need
during the year under Sec. 361.36(b) if circumstances change after the
beginning of the fiscal year. If changed circumstances warrant
establishing an order of selection during the fiscal year, a DSU may
implement an order of selection at that time. The Secretary prefers,
however, for a DSU to implement an order of selection at the beginning
of the fiscal year if it foresees any circumstances that may affect its
ability to serve all eligible individuals throughout the year. The
preparations needed to establish and implement an order of selection
take time. During this time, resources may be further strained. Thus,
the Secretary believes that a conservative approach toward implementing
an order of selection and opening priority categories is preferable so
that sufficient resources are available
[[Page 24395]]
throughout the year to serve all individuals with severe disabilities,
including individuals with the most severe disabilities.
If a DSU implements an order of selection during the fiscal year,
rather than at the outset, and thereafter cannot serve all individuals
with severe and the most severe disabilities, it would be out of
compliance with the order of selection requirement.
The Secretary believes that a DSU may use its discretion as to the
timing for opening and closing priority categories as long as the order
of categories is maintained. When considering whether to open a
category, a DSU should evaluate not only current resources but also the
impact that continuing to serve these eligible individuals under this
category will have on resources expected to be available in the next
fiscal year, or possibly beyond.
Changes: The Secretary has revised Sec. 361.36(e)(1) to provide
that the DSU shall consult with and seriously consider the advice of
the Council regarding the need to establish an order of selection,
including any reevaluation of the need to establish an order of
selection under Sec. 361.36(b)(2).
Section 361.36(c)--Establishing an Order of Selection.
--Further guidance on factors to be considered in establishing an order
of selection
Comments: Several commenters recommended that the Secretary provide
further guidance on what factors a DSU should use in establishing an
order of selection. One of these commenters suggested adding five
factors that a DSU should consider in establishing an order of
selection: Lower levels of educational achievement; longer lengths of
unemployment, under-employment, or lower level jobs; lower levels of
self-esteem and self-worth; need for two or more services; and need for
services for a longer length of time.
One commenter requested that a statement be added to Sec. 361.36(c)
indicating that the criteria for determining which individuals are
individuals with the most severe disabilities must be equally
applicable to, and not lead to the exclusion of, transitioning
students. This commenter was concerned that a DSU may define an
``individual with the most severe disability'' by using factors, such
as an employment history of repeated failures, that may exclude youth
with severe disabilities.
Discussion: In establishing an order of selection a DSU can only
consider severity of disability. The Secretary believes that an order
of selection must be based on the factors or criteria contained in the
definition of an ``individual with a severe disability'' in section
7(15)(A) of the Act. An ``individual with a severe disability'' is
defined as an individual with a disability (1) who has a severe
physical or mental impairment that seriously limits one or more
functional capacities (such as mobility, communication, self-care,
self-direction, interpersonal skills, work tolerance, or work skills)
in terms of employment outcome; (2) whose vocational rehabilitation can
be expected to require multiple vocational rehabilitation services over
an extended period of time; and (3) who has one or more physical or
mental disabilities, as identified in section 7(15)(A) of the Act, or
any other disability or disabilities that cause comparable substantial
functional limitation.
In determining which individuals with severe disabilities are
individuals with the most severe disabilities, for purposes of
providing them with the highest priority in an order of selection, a
DSU cannot merely apply the criteria in this definition. Because
individuals with the most severe disabilities are a subgroup of
individuals with severe disabilities, the Secretary believes that a DSU
must refine these criteria to identify this subgroup.
A DSU may refine these factors, for example, by basing its order of
selection on the number and degree of functional limitations, the
amount of time vocational rehabilitation services would be needed, and
the number of vocational rehabilitation services needed. When refining
these factors, a DSU may choose to refine one factor or a combination
of factors. The purpose of refining these factors is to link the nature
and depth of the individual's functional limitations with the need for
multiple and complex services that require an extended period of time
for completion.
A DSU could refine the first criterion by requiring that an
individual demonstrate limitations in three or more functional
capacities, such as mobility, communication, self-care, self-direction,
interpersonal skills, work tolerance, or work skills. Alternatively, a
DSU could specify the degree of functional limitations within one or
more functional capacities by requiring that an individual demonstrate
a minimum number of specific functional limitations, such as five
specific functional limitations, within one or more functional
capacities.
Possible examples of specific functional limitations within the
functional capacity of self-direction include--(1) Purposeless shifting
from one activity to another; (2) Inability to follow through with and
complete assignments; (3) Problems related to time management; (4)
Making decisions impulsively without consideration for previous plans
or experience; (5) Limitations in gathering, organizing, and analyzing
information; (6) Difficulties in adapting to changing work
requirements; and (7) Inability to monitor work performance and to
adjust behaviors and activities if the current performance is not
adequate.
A DSU could refine the second criterion by specifying the minimum
number of vocational rehabilitation services required by the individual
or by specifying the extended period of time required for the provision
of services. For example, in order to link the complexity or
substantiality of the services provided to the severity of functional
limitations, a DSU could establish a criterion that an individual
require 2 or more major services that will be at least 12 months in
duration. Major services could be defined as those services described
in section 103(a) of the Act, excluding diagnostic services; supportive
services, such as maintenance and transportation, that complement the
provision of major services; and the counseling, guidance, and service
coordination provided to every eligible individual.
A DSU could base the minimum time period required for the provision
of multiple vocational rehabilitation services on a DSU's experience
with the length of time necessary for individuals with severe
disabilities to achieve an employment outcome. This extended period of
time could be defined as the period of time at the upper end of the
range required for individuals with severe disabilities to achieve an
employment outcome, after eliminating any exceptional cases.
Socioeconomic factors, such as levels of educational achievement or
length of unemployment or underemployment, and personal traits, such as
levels of self-esteem, however, cannot be used in establishing an order
of selection because these factors are not measures of severity of
disability or even measures of disability. For example, using a factor
such as low level of educational achievement would tend to include
individuals whose disabilities were acquired at birth or during the
developmental years while excluding individuals whose disabilities were
acquired after having completed high levels of education, even though
both groups of individuals might demonstrate equal substantial
[[Page 24396]]
functional limitations and have an equal need for multiple services
over an extended period of time. Using a factor such as an employment
history of repeated failures would have the effect of excluding youth
who may have little or no employment history.
Changes: The Secretary has revised Sec. 361.36(c) by adding a new
paragraph (1) that states that an order of selection must be based on a
refinement of the three criteria in the definition of ``individual with
a severe disability'' in section 7(15)(A) of the Act.
Priority for individuals with the most severe
disabilities.
--Federal criteria for defining individuals with the most severe
disabilities
Comments: Several commenters expressed concern about the potential
for an individual to be denied services if the individual moves to a
State in which the DSU uses different criteria for determining which
individuals have the most severe disabilities. One commenter inquired
as to whether there will be a consistent procedure for determining
severity of disability, and other commenters requested that the
regulations include appropriate criteria for defining ``most severe.''
Discussion: There is no statutory authority for the Secretary to
establish Federal criteria to determine which individuals are
individuals with the most severe disabilities. Section 101(a)(5) of the
Act mandates that each DSU has the responsibility to develop its own
criteria in this regard.
Changes: None.
--Functional limitations
Comments: One commenter requested that the Secretary clarify that a
DSU may base an order of selection on limitations of functional
capacities in addition to those listed in the statutory definition of
``individual with a severe disability'' in section 7(15)(A)(i) of the
Act.
Another commenter suggested that the Secretary encourage DSUs to
determine which individuals are the most severely disabled based on the
types of functional limitations specified in the definition of
``developmental disability'' in section 6001(5) of the Developmental
Disabilities and Bill of Rights Act (DD Act). ``Developmental
disability'' is defined, in part, as a severe, chronic disability that
results in substantial functional limitations in three or more of the
following areas of major life activity: (1) Self-care. (2) Receptive
and expressive language. (3) Learning. (4) Mobility. (5) Self-
direction. (6) Capacity for independent living. (7) Economic self-
sufficiency.
Discussion: A DSU may base an order of selection on limitations of
functional capacities in addition to those functional capacities listed
in section 7(15)(A)(i) of the Act. This listing is not all-inclusive
because it is preceded by the words ``such as.'' However, functional
limitations under this program must affect the achievement of an
employment outcome. The DD Act definition specifies functional
limitations that affect major life activities. Under The State
Vocational Rehabilitation Services Program, some of the functional
areas specified in the DD Act, such as economic self-sufficiency and
capacity for independent living, would not necessarily be considered a
functional limitation that impedes the achievement of an employment
outcome, but rather would be considered a potential outcome or benefit
of the VR program. Therefore, they could not be used as a factor in
determining severity of disability under the VR program. As part of a
review of a DSU's criteria for identifying individuals with the most
severe disabilities, the Secretary would assess the appropriateness of
using particular different functional capacities.
Changes: None.
Factors that cannot be used in determining order of
selection of eligible individuals.
--Applying eligibility restrictions to order of selection decisions
Comments: Several commenters opposed applying eligibility
restrictions to order of selection decisions. These commenters stated
that the eligibility and order of selection requirements are intended
to stand alone under the Act.
Discussion: The Secretary agrees that the eligibility requirements
and the order of selection requirements are separate requirements.
Eligibility determinations can be based only on the statutory
eligibility criteria in section 102(a)(1) of the Act. Determinations of
the order of serving eligible individuals can be based only on severity
of disability in accordance with section 101(a)(5)(A) of the Act.
Neither determination can be based on any of the factors in
Sec. 361.36(c)(2).
Changes: None.
--Residency prohibition
Comments: One commenter believed that the residency prohibition
needed to be clarified because, as worded in the NPRM, it would
encourage individuals who live in one State to apply for services in
another State.
Discussion: The Secretary's intention was to prohibit an order of
selection from being based on any particular durational residency
requirement as long as the individual is present in the State and can
complete a program of services. The Secretary did not intend to address
the issue of the ability of residents of one State to receive VR
services in another State.
Changes: The Secretary has revised Sec. 361.36(c)(1)(i) of the
proposed regulations to prohibit an order of selection from being based
on any duration of residency requirement, provided the individual is
present in the State. This provision has been relocated to
Sec. 361.36(c)(2)(i) of the final regulations.
--Type of disability prohibition
--Individuals who are blind or visually-impaired
Comments: One commenter urged the Secretary to ensure that State
rehabilitation agencies that serve only individuals who are blind or
visually impaired be permitted to continue to serve these individuals
if those agencies are operating under an order of selection. In
addition, this commenter recommended that State rehabilitation agencies
that serve all individuals with disabilities be required to recognize
blindness as a severe disability for purposes of order of selection.
Discussion: If a DSU that serves only individuals who are blind or
visually impaired is unable to serve all eligible individuals, it must
prioritize according to severity of disability.
An individual who is blind or visually impaired must be assessed
like all other eligible individuals with disabilities according to the
three criteria in the definition of an ``individual with a severe
disability'' in section 7(15)(A) of the Act. A DSU may not determine
that an individual who is blind or visually impaired automatically
meets this definition, i.e., that every individual who is blind or
visually impaired is an individual with a severe disability or an
individual with a most severe disability. An individual who is blind,
however, would automatically satisfy the third element in the
definition because ``blindness'' is included among the listing of
physical or mental disabilities that the Act recognizes as causing
substantial functional limitation.
In addition, if an individual is determined blind pursuant to Title
II or Title XVI of the Social Security Act, section 102(a)(2) of the
Rehabilitation Act considers that individual to have a severe physical
or mental impairment that seriously limits one or more functional
capacities in terms of an employment outcome, thus satisfying the first
criterion in the definition of an
[[Page 24397]]
``individual with a severe disability.'' There is no basis in the Act,
however, for automatically determining that an individual who is blind
or visually impaired would require multiple vocational rehabilitation
services over an extended period of time.
Changes: None.
--Individuals with disabilities of alcoholism and other drug abuse
Comments: One commenter was concerned that individuals with
disabilities of alcoholism and other drug abuse would not receive fair
consideration under an order of selection. In order to ensure fair
consideration for these individuals, the commenter requested that
criteria be added that require a DSU to include among individuals with
the most severe disabilities those individuals with chronic relapsing
conditions.
Discussion: Section 105(a)(5)(A) requires a DSU, not the Secretary,
to establish criteria for determining which individuals with severe
disabilities are individuals with the most severe disabilities. Any
criteria established by a DSU for identifying individuals with the most
severe disabilities should apply equally to individuals with chronic
and individuals with acute disabling conditions. Many individuals with
chronic relapsing conditions, such as alcohol or drug abuse, may
experience substantial functional limitations and require multiple
vocational rehabilitation services over an extended period of time.
However, an assessment of whether a particular individual with a
disability meets these criteria, including an assessment of an
individual who is disabled because of alcohol or drug abuse, must be
done on a case-by-case basis.
Changes: None.
--Source of referral prohibition
Comments: One commenter inquired whether the emphasis on
interagency cooperative arrangements in the Act allows a DSU to
establish a priority under an order of selection for eligible
individuals referred by school systems under the Individuals with
Disabilities Education Act (IDEA) or the Carl D. Perkins Vocational and
Applied Education Act (Perkins Act).
Discussion: A DSU may not establish a priority under an order of
selection for eligible individuals referred by school systems under
IDEA or the Perkins Act because the source of referral is not
necessarily an indicator of severity of disability. While some of these
individuals might be individuals with severe or the most severe
disabilities, all individuals referred by schools under these programs
may not necessarily meet these criteria. This determination must be
made on an individual basis.
Changes: None.
--Prohibition against using type of expected employment outcome
Comments: Several commenters opposed this prohibition. Several
commenters contended that the purpose of the Title I program is to
assist individuals with disabilities to enter into gainful employment,
and, therefore, the type of expected employment outcome should be used
as a factor in establishing an order of selection. One commenter
contended that one of the evaluation standards for the program to be
developed by the Secretary under section 106(a)(2) of the Act may
relate to the achievement of competitive employment outcomes and an
increase in post-placement earnings. The commenter believed it is
unfair to evaluate a DSU on the level of earnings of the individuals it
places in employment if it cannot use type of employment and amount of
earnings as a factor in establishing an order of selection.
Finally, one commenter inquired whether, given the increased
emphasis in the Act on supported employment, a DSU should be permitted
to establish a priority in its order of selection for eligible
individuals whose employment outcome is in a supported employment
setting.
Discussion: Individuals with multiple functional limitations and a
need for multiple services over an extended period of time will have
varying expected employment outcomes, including competitive employment,
supported employment, and other types of employment. Thus, type of
expected employment outcome and level of post-placement earnings are
not indicative of severity of disability and cannot be used as criteria
for determining the level of severity of disability.
Although an individual whose employment outcome is in a supported
employment setting would be included in the group of individuals with
the most severe disabilities because supported employment services
under the Act can only be provided to individuals with the most severe
disabilities, a DSU cannot give individuals whose employment outcome is
in a supported employment setting priority over other individuals with
the most severe disabilities who have different employment outcome
goals.
Changes: None.
--Prohibition against considering the particular service needs of an
individual or anticipated cost of services required by an individual
Comments: Several commenters opposed these prohibitions. Several
commenters questioned the logic of prohibiting consideration of service
needs when establishing an order of selection because the need for
multiple services is part of the definition of ``individual with a
severe disability.'' One commenter also pointed out that this
restriction is contrary to previous RSA sub-regulatory guidance that
has allowed DSUs to use service needs and costs in establishing
priority categories for individuals with non-severe disabilities.
Finally, one commenter inquired whether it is consistent with the Act
for a DSU to establish a priority in its order of selection for
eligible individuals who require rehabilitation technology devices and
services.
Several commenters believed that the Secretary should revise the
regulations to allow a DSU to develop an IWRP for only non-purchased
services if resources are not available to also provide purchased
services. These commenters requested that a DSU that has established an
order of selection for services be allowed to provide a priority to
persons who do not have a severe or most severe disability and who need
only non-purchased services as long as adequate resources are available
to serve first those individuals who are the most severely disabled.
Discussion: The Secretary agrees that clarification is needed. This
provision is intended to prohibit a DSU from giving priority to an
individual who has one or more specific service needs over another
individual who has different service needs. For example, a DSU is
prohibited from giving priority to individuals who require physical
restoration services over individuals who require vocational training.
A DSU is also prohibited from giving priority to individuals who
require rehabilitation technology devices and services, as raised by
one commenter, over any other individual who requires a different
service.
One of the examples provided in the preamble to the proposed
regulations to illustrate this provision may have caused confusion. The
example stated that a DSU is prohibited from establishing an order of
selection that gives priority to individuals who require short-term
services over individuals who require long-term services. Since a DSU
is required to consider, in establishing its order of selection, an
individual's need for vocational rehabilitation services over an
extended period of time under the second factor of the definition of
``individual with a
[[Page 24398]]
severe disability,'' the use of the words ``short-term'' and ``long-
term'' was inappropriate. The example was intended to illustrate the
principle that the cost of services cannot be a factor in an order of
selection and that DSUs cannot give priority to individuals who need
short-term, less costly services over individuals who need longer term
and more costly services.
The Secretary believes that there is no basis under the Act for
exempting from the order of selection requirement the provision of non-
purchased services. The Act does not draw any distinction between the
provision of purchased and non-purchased vocational rehabilitation
services with respect to a DSU's determination of the order in which it
will provide services to eligible individuals if it cannot serve all
eligible individuals. The order must be predicated, as section
101(a)(5)(A) requires, on severity of disability: Individuals with the
most severe disabilities must be served first.
This means, for example, that if a DSU has established three
service categories for serving eligible individuals (i.e., individuals
with the most severe disabilities, individuals with severe
disabilities, and individuals with non-severe disabilities), then it
must be able to provide all needed services, whether purchased or not,
to all individuals with the most severe disabilities before serving any
individuals with severe disabilities. In addition, it must be able to
provide all needed services to all individuals with severe disabilities
before serving any individuals in the last category who have less than
severe disabilities. An individual's need for only non-purchased
services cannot override this order.
Thus, the Secretary believes that a DSU cannot establish a priority
category anywhere in its order of selection that provides solely for
the provision of non-purchased services, even among individuals with
non-severe disabilities. This interpretation represents a policy
reversal by RSA of its position in subregulatory guidance (RSA-MT-92-
17, March 20, 1992), which permitted a DSU to give a service priority
to non-severely disabled individuals whose rehabilitation needs do not
require the expenditure of case service funds (i.e., individuals who
need only counseling, guidance, and placement services that can be
provided by DSU staff) over other non-severely disabled individuals.
To address the concern of some DSUs on this issue, the Secretary
has proposed regulations for this program in 34 CFR 361.37(c) that were
published in the Federal Register on December 15, 1995 (60 FR 64476)
and that would provide a limited exception to this prohibition. These
proposed regulations would authorize any DSU that has implemented an
order of selection to establish an expanded information and referral
program that includes the provision of job referral services to
eligible individuals who are not being served under a DSU's order of
selection, provided that certain State plan requirements are met. These
requirements include a description in the State plan of the level of
commitment of staff and other resources for this purpose and an
assurance that funds to carry out this program will supplement and not
supplant funds available for providing VR services to eligible
individuals who are able to be served under the DSU's order of
selection.
Changes: The Secretary has clarified Sec. 361.36(c)(1)(vi) of the
proposed regulations by providing that the need for specific services
by an individual cannot be the basis for an order of selection. This
provision has been relocated to Sec. 361.36(c)(2)(vi) of the final
regulations.
--Income level of the individual or the individual's family
Comments: Several commenters recommended that a DSU be permitted to
give priority to persons on public assistance in its order of selection
because these individuals have a greater need for services than those
who have larger incomes.
Discussion: A DSU may not give priority to persons on public
assistance under its order of selection because use of public
assistance is a socioeconomic factor that may not necessarily be
related to the presence of a disability or to the severity of that
disability. Individuals who are on public assistance and who are
included in a priority category currently being served by a DSU can
receive services. As noted in the preamble to the NPRM, however, the
income level of an individual or the individual's family can be a
factor only in determining whether an individual is required by a DSU
to pay part of the cost of a service. This is a State option permitted
under current regulations in 34 CFR 361.47(a).
Changes: None.
--Transitioning students
Comments: One commenter believed the intent of section
101(a)(24)(A) (i), (ii), and (iii) of the Act is to ensure that all
eligible students receive services in a timely manner and to ensure
that there is no gap in services between the school system and the
vocational rehabilitation system.
One commenter inquired how a DSU will handle transitioning special
education students if an order of selection is implemented.
Specifically, the commenter inquired whether a student who is receiving
vocational rehabilitation services would continue to receive services
if the student falls outside of the priority categories being served
under an order of selection established by a DSU.
Another commenter was concerned that transitioning students would
be placed on waiting lists for services. This commenter recommended
requiring a DSU operating under an order of selection to include in its
State plan the plans, policies, and procedures to identify how the DSU
will work with education officials and others to meet the needs of
transitioning youth and to otherwise fulfill their obligations under
the Act concerning the provision of transition services.
Discussion: Even though section 101(a)(24)(A) (i), (ii), and (iii)
of the Act strengthen the provisions for transition services to
students with disabilities, a student who is determined eligible for
services after a DSU implements an order of selection will be served
only if the student is among those individuals included in a priority
category that is currently being served under the DSU's order of
selection.
Section 361.36(d)(3), however, provides that a DSU must ensure that
it will continue to provide all needed services under an IWRP to any
eligible individual who has begun to receive services prior to the
effective date of the order of selection, irrespective of the severity
of the individual's disability. Thus, for example, if a transitioning
student with severe disabilities is receiving vocational rehabilitation
services under an IWRP prior to the effective date of the order of
selection, the student will continue to receive all needed services
even if the DSU is able under its order of selection to initiate
services only to individuals with the most severe disabilities.
Transitioning students who are not included in a priority category
that is currently being served under a DSU's order of selection will be
placed on a waiting list unless services were begun prior to the
implementation of the order of selection.
Changes: None.
--Individuals with less severe disabilities
Comments: One commenter inquired whether individuals with less
severe disabilities will be systematically left out of the process in
those DSUs that implement an order of selection. This
[[Page 24399]]
commenter feared that the proposed regulations permit a DSU to refuse
services to an individual because his or her disability is not severe
enough.
One commenter inquired whether a DSU may limit the number of
individuals with non-severe disabilities who may be served under an
order of selection so that there will be funds available to serve
individuals with a severe disability who may apply for services.
Discussion: The order of selection requirement mandates that
services be provided first to individuals with the most severe
disabilities before serving other eligible individuals. This means that
individuals with the most severe disabilities are served before
individuals with severe disabilities and individuals with non-severe
disabilities. A DSU that implements an order of selection may be unable
to serve eligible individuals with non-severe disabilities.
The Secretary urges DSUs operating under an order of selection to
be conservative in assessing their ability to serve individuals other
than those with the most severe disabilities before opening additional
priority categories. This approach is needed to ensure that sufficient
resources are available throughout the year to serve individuals under
higher priority categories (i.e., individuals with most severe
disabilities and individuals with severe disabilities) who apply for
services and become eligible after the beginning of the fiscal year. As
stated previously, the Secretary prefers this conservative approach
since a potential increase in the number of applicants with severe
disabilities might affect the DSU's ability to comply with the order of
selection requirements throughout the year.
Changes: None.
Section 361.36(d)--Administrative Requirements
--Identify the order of selection as a State-imposed requirement
Comments: One commenter recommended deleting this requirement. The
commenter stated that the only legally permissible reason for
implementing an order of selection policy is resource limitations.
Since funding for the program is a shared responsibility of State and
Federal governments, the commenter believed there was no reason to
attribute resource shortfalls exclusively to a State.
Discussion: The Secretary believes that the commenter
misinterpreted this provision of the proposed regulations. The intent
of the provision was for a DSU to identify its particular order of
selection policy as a State-imposed requirement (not the order of
selection requirement itself, which is a Federal requirement) since
this policy is a State rule or policy relating to the administration or
operation of the program under section 17 of the Act. Nevertheless, the
Secretary believes that there is no reason to particularly highlight
this one State-imposed requirement in the regulations over other State-
imposed requirements, such as a State's financial needs test. The
Secretary intends to address State-imposed requirements in general in
other regulations for this program.
Changes: The Secretary has deleted the requirement in
Sec. 361.36(d)(2) of the proposed regulations that a DSU identify its
order of selection policy as a State-imposed requirement.
--Written policies
Comments: Several commenters suggested that written policies for an
order of selection include requirements that the policies must provide
that affected individuals are notified of the State's particular order
of selection, the priority category to which they have been assigned,
and their right to appeal assignment to a particular priority category.
One commenter suggested revising Sec. 361.36(d)(3) of the proposed
regulations to provide that a DSU must establish written policies
related to the development, establishment, and administration of the
order of selection that should include, but not be limited to, the
following: (1) Consultation with the Council. (2) Staff orientation and
training. (3) Notification to individuals applying for services, or in
an appropriate case, the parent, family member, guardian, advocate, or
authorized representative of such an individual. (4) Monitoring
procedures. (5) Caseload management. (6) Evaluation of effectiveness of
the order of selection. The commenter believed that these policies
should be required since they include important accountability
elements.
Discussion: The Secretary agrees that a DSU must ensure that each
eligible individual is informed of the priority categories that have
been established in a DSU's order of selection, of the particular
priority category to which he or she has been assigned, and of his or
her right to appeal assignment to a particular priority category under
the State's procedures for reviewing rehabilitation counselor or
coordinator determinations. The Secretary believes these are basic
procedural rights that eligible individuals have under this program.
These notification requirements are specified in Sec. 361.36(d)(2).
In accordance with the Department's principles for regulating,
however, the Secretary has eliminated the requirement in the proposed
regulations that DSUs establish written policies related to the
development, establishment, and administration of its order of
selection. The Secretary believes that requiring DSUs to establish
written policies covering all aspects of the implementation of an order
of selection is overly burdensome. Nevertheless, the Secretary
encourages a DSU to develop policies, as needed, to ensure proper
administration of its order of selection, including policies in areas
such as staff orientation and training, monitoring procedures, caseload
management, and evaluation and management of the order of selection.
Changes: The Secretary has revised Sec. 361.36(d)(3) of the
proposed regulations to require a DSU to notify all eligible
individuals of the priority categories in a DSU's order of selection,
their assignment to a particular category, and their right to appeal
assignment to a particular priority category. This provision has been
relocated to Sec. 361.36(d)(2) of the final regulations.
--Continuity of services
Comments: One commenter requested clarification of this provision.
The commenter noted that a person could have a completed and signed
IWRP, but not yet have begun to receive services under the IWRP. This
commenter requested that the regulations be revised to provide that
anyone with a completed and signed IWRP must continue to receive
services in accordance with their approved IWRP, irrespective of the
severity of their disability. Another com
FR Doc. 96-11808 The State Vocational Rehabilitation Services Program
menter inquired whether the
continuity of services requirement entitles an individual who is
receiving services under one DSU's order of selection to receive
services from a DSU in another State if that individual moves and falls
outside of the priority categories being served by the DSU in the
second State.
Discussion: The continuity of services requirement ensures that an
eligible individual who has begun to receive services under an IWRP
prior to the effective date of a DSU's order of selection will continue
to receive all needed services, including services that may be
necessary because of amendments to the IWRP, irrespective of the
severity of that individual's disability.
An eligible individual who has a completed IWRP, but who has not
begun to receive services under that
[[Page 24400]]
IWRP, would not be covered by this requirement. This means that the
continuity of services requirement does not apply to any services
provided in developing an eligible individual's IWRP. This requirement
takes effect at the point in the rehabilitation process when services
leading to an employment outcome have been initiated under an IWRP.
Finally, the continuity of services requirement is DSU-specific and
does not entitle an individual who is receiving services under one
DSU's order of selection to receive services under another DSU's order
of selection if the individual is not included among the individuals
being served under the second DSU's order of selection.
Changes: The Secretary has revised Sec. 361.36(d)(4) of the
proposed regulations to ensure that a DSU continues to provide all
services needed by any eligible individual who has begun to receive
services ``under an IWRP'' prior to the effective date of the order of
selection, irrespective of the severity of the individual's disability.
This change is necessary to clarify that it is the receipt of services
under an IWRP that triggers the continuity of services requirement.
This provision has been relocated to Sec. 361.36(d)(3) of the final
regulations.
--Third-party funding arrangements
Comments: One commenter recommended that the Secretary permit
third-party funding arrangements that conflict with a DSU's order of
selection if these arrangements reflect priorities in national or State
policy. Another commenter feared that requiring DSUs to renegotiate
third-party arrangements will result in a considerable reduction in
resources to serve individuals with disabilities.
One commenter recommended that the Secretary provide a further
explanation of how a DSU can ensure that its third-party arrangements
are ``consistent'' with its order of selection for services. This
commenter also requested that the Secretary take into consideration the
practical difficulties for a provider of renegotiating a contract
midstream. Another commenter inquired whether cooperative arrangements,
like third-party arrangements, must be consistent with a DSU's order of
selection.
One commenter questioned whether a DSU may select a category of
individuals for priority under its order of selection because that
category is funded by targeted funds from another agency.
Discussion: The Secretary believes that a DSU's funding
arrangements for providing services, such as third-party arrangements
and cooperative arrangements, cannot override its order of selection if
those funds are used under the State plan. For example, a DSU that
receives third-party funding to serve individuals with mental illness
may not serve individuals with mental illness who fall outside of the
priority categories being served under the order of selection. This is
necessary to ensure that an order of selection is applied fairly and
evenly to all individuals regardless of whether funding arrangements
are in place to serve individuals from particular disability groups. If
a funding arrangement is inconsistent with a DSU's order of selection,
a DSU must renegotiate these arrangements so that individuals are
served in a manner consistent with the DSU's order of selection.
Changes: The phrase ``under the State plan'' has been added to
Sec. 361.36(d)(4) to clarify that any funding arrangements that are
used by a DSU to provide services under the State plan must be
consistent with a DSU's order of selection.
--Other requirements
Comments: Several commenters were concerned that there is an
inadequate number of counselors qualified to properly evaluate severity
of disability. These commenters suggested that the Secretary ensure
that qualified counselors are available to evaluate individuals to
determine whether they will receive services under an order of
selection.
Discussion: Section 101(a)(7) of the Act requires a DSU to develop
a comprehensive system of personnel development to ensure that an
adequate supply of qualified State rehabilitation professional and
paraprofessionals is available in the State. The Secretary believes
that this provision mandates that staff in sufficient numbers be
qualified to properly evaluate functional limitations for purposes of
determining severity of disability. The Secretary believes that all
DSUs operating under an order of selection must provide staff with
appropriate training to be able to make these determinations.
Changes: None.
Section 361.36(e)--State Rehabilitation Advisory Council
Comments: One commenter recommended that the Secretary highlight
the responsibility of the DSU to seek and seriously consider the advice
of the Council on DSU criteria for determining which individuals are
individuals with the most severe disabilities.
Several commenters suggested that a DSU that has implemented an
order of selection be required to consult other advisory boards,
service providers, advocacy organizations, consumers, family members,
and rehabilitation vendors, in addition to the Council, regarding the
content of the order of selection. One of these commenters stated that
this consultation is necessary because the composition of the Council
may not ensure sufficient or equal representation by persons of
different disabilities, such as persons with mental illness.
Several commenters recommended that the Secretary add a new
Sec. 361.36(f) stating that the client assistance program and other
parties must be consulted, under section 101(a)(23)(C) of the Act,
before revisions are made to a DSU's order of selection.
Discussion: The Secretary does not believe that it is necessary to
further highlight the responsibility of a DSU to seek and seriously
consider the advice of the Council when developing the criteria for
determining which individuals are the most severely disabled. The
Secretary believes that Sec. 361.36(e)(3) sufficiently highlights this
responsibility.
The Secretary agrees with the commenters who suggest that advisory
boards, other than the Council, service providers, advocacy
organizations, consumers, family members, rehabilitation vendors, and
the director of the client assistance program (CAP) are valuable
sources of information and should be consulted by a DSU in determining
the content of its order of selection. The Secretary believes that
consultation with these and other groups as to the content of the DSU's
order of selection is sufficiently addressed under sections 101(a)(18),
101(a)(23), and 105(b)(1) of the Act. These statutory provisions
provide for broad public participation in the development of the State
plan and of policies governing the provision of vocational
rehabilitation services under the plan.
Changes: None.
Additional comment
--Development of IWRP
Comments: Several commenters requested that a DSU not be required
to develop an IWRP for all individuals eligible for vocational
rehabilitation services under the Act if the DSU cannot serve all
eligible individuals and is providing services under an order of
selection. These commenters stated that requiring a DSU that has
implemented an order of selection to develop IWRPs for all eligible
individuals, regardless of
[[Page 24401]]
whether the individual could currently be served, would result in
unnecessary work for vocational rehabilitation counselors and would
give false hope to individuals who fall outside of the categories being
served.
Discussion: The Secretary understands the concern expressed by
these commenters and is addressing this issue in other vocational
rehabilitation program regulations. The proposed regulations concerning
development of an IWRP for this program published in the Federal
Register on December 15, 1995 (60 FR 64476, proposed Sec. 361.45(a))
would require a DSU that has implemented an order of selection to
develop an IWRP only for each eligible individual that it is able to
serve.
Changes: None.
Executive Order 12866
Assessment of Costs and Benefits
These final regulations have been reviewed in accordance with
Executive Order 12866. Under the terms of the order the Secretary has
assessed the potential costs and benefits of this regulatory action.
The potential costs associated with the final regulations are those
resulting from statutory requirements and those determined by the
Secretary to be necessary for administering this program effectively
and efficiently.
In assessing the potential costs and benefits--both quantitative
and qualitative--of these regulations, the Secretary has determined
that the benefits of the regulations justify the costs.
The Secretary has also determined that this regulatory action does
not unduly interfere with State, local, and tribal governments in the
exercise of their governmental functions.
Summary of Potential Benefits Relative to Potential Costs of the
Regulatory Provisions Discussed Previously in This Preamble
The Secretary believes that the final regulations represent the
least burdensome way to implement the statutory requirement that a DSU
explain the methods by which it will serve all eligible individuals for
VR services or, in the alternative, establish and justify the order of
selection it shall follow in serving first those individuals with the
most severe disabilities. In addition, the Secretary believes that the
regulations present the most effective means of ensuring that DSUs do
not improperly avoid establishing an order of selection (i.e., failing
to establish an order of selection even though the DSU cannot serve all
eligible individuals). Reduction of burden on DSUs and other benefits
resulting from the final regulations are discussed in the following
paragraphs of this section and throughout the analysis of comments and
changes section of the preamble.
Reduction of Paperwork Burden on Grantees
As stated previously in this preamble, review of the final
regulations in accordance with the Department's principles for
regulating resulted in two major, burden-reducing changes from the
proposed regulations. First, under the final regulations, DSUs that
have successfully served all eligible individuals in the past are not
required to include detailed projections (e.g., projected number of
eligible individuals, projected program costs and revenues) as part of
their explanation of how they will continue to serve everyone and meet
all other program requirements in the next year. As long as a DSU can
provide the assurances required in the regulations to confirm its past
ability to serve all eligible individuals, the DSU's explanation under
Sec. 361.36(a)(1) is not subject to minimum content requirements.
Second, the regulations reduce the number of data projections and
related demonstrations that must be included as part of the explanation
for DSUs that have been unable to serve all eligible individuals in the
past. The remaining projections are needed to indicate whether a DSU
that has been unable to serve all eligible individuals previously can
serve everyone in the next year.
Evaluation of Need to Establish an Order of Selection
Once a DSU decides, prior to the beginning of the fiscal year, that
it does not need to establish an order of selection, the final
regulations require the DSU to reevaluate this decision whenever
changed circumstances indicate that it may no longer be able to serve
all eligible individuals. DSUs, therefore, are responsible for
determining whether they need to implement an order of selection after
the start of the year. The Secretary prefers this flexible approach
rather than imposing in the regulations a specific time when all DSUs
must reevaluate the need to establish an order of selection, as some
commenters on the proposed regulations suggested.
Instructions for Establishing an Order of Selection
Section 361.36(c) provides, for DSUs unable to serve all eligible
individuals, clear directives on how to establish an order of selection
for providing services. In addition, this section includes specific
factors that cannot be used in developing an order of selection. Many
commenters on the proposed regulations had requested clarification as
to whether these factors could be considered in formulating specific
priority categories under an order of selection.
Additional Benefits
The final regulations include provisions intended to enhance the
protection of individuals with disabilities by DSUs operating under an
order of selection. For example, the regulations require DSUs to notify
all eligible individuals of the priority categories in the State's
order of selection, as well as their assignment to a particular
category. Additionally, the regulations require DSUs to continue to
serve any eligible individual who has begun to receive services under
an IWRP prior to the effective date of the order of selection,
irrespective of the severity of the individual's disability.
Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995, no persons are required
to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number assigned to the
collection of information in these final regulations is displayed at
the end of the affected section of the regulations.
Intergovernmental Review
This program is subject to the requirements of Executive Order
12372 and the regulations in 34 CFR Part 79. The objective of the
Executive order is to foster an intergovernmental partnership and a
strengthened federalism by relying on processes developed by State and
local governments for coordination and review of proposed Federal
financial assistance.
In accordance with the order, this document is intended to provide
early notification of the Secretary's specific plans and actions for
this program.
Assessment of Educational Impact
In the notice of proposed rulemaking, the Secretary requested
comments on whether the proposed regulations would require transmission
of information that is being gathered by or is available from any other
agency or authority of the United States.
Based on the response to the proposed regulations and on its own
review, the Department has determined that the
[[Page 24402]]
regulations in this document do not require transmission of information
that is being gathered by or is available from any other agency or
authority of the United States.
List of Subjects in 34 CFR Part 361
Administrative practice and procedures, Grant programs--education,
Grant programs--social programs, Reporting and recordkeeping
requirements, Vocational rehabilitation.
(Catalog of Federal Domestic Assistance Number 84.126--The State
Vocational Rehabilitation Services Program)
Dated: March 4, 1996.
Richard W. Riley,
Secretary of Education.
The Secretary amends Part 361 of Title 34 of the Code of Federal
Regulations as follows:
PART 361--THE STATE VOCATIONAL REHABILITATION SERVICES PROGRAM
1. The authority citation for Part 361 continues to read as
follows:
Authority: 29 U.S.C. 711(c), unless otherwise noted.
2. Section 361.36 is revised to read as follows:
Sec. 361.36 Ability to serve all eligible individuals; order of
selection for services.
(a) General provisions.
(1) The State plan must contain--
(i) An assurance that the designated State unit is able to provide
the full range of services listed in section 103(a) of the Act, as
appropriate, to all eligible individuals. The assurance must be
supported by an explanation that satisfies the requirements of
paragraph (a)(2) or (a)(3) of this section and describes how, on the
basis of the designated State unit's projected fiscal and personnel
resources and its assessment of the rehabilitation needs of individuals
with severe disabilities within the State, it will--
(A) Continue to provide services to all individuals currently
receiving services;
(B) Provide assessment services to all individuals expected to
apply for services in the next fiscal year;
(C) Provide services to all individuals who are expected to be
determined eligible in the next fiscal year; and
(D) Meet all program requirements; or
(ii) The order to be followed in selecting eligible individuals to
be provided services, a justification of that order of selection, and a
description of the outcome and service goals and service costs to be
achieved for individuals with disabilities in each category within the
order and the time within which these goals may be achieved.
(2) For those designated State units that provided assurances in
their State plans for the current fiscal year and the preceding fiscal
year that they are able to provide the full range of services, as
appropriate, to all eligible individuals, the explanation required by
paragraph (a)(1)(i) of this section must include a statement that,
during the current fiscal year and the preceding fiscal year, the DSU
has in fact--
(i) Provided assessment services to all applicants and the full
range of services, as appropriate, to all eligible individuals;
(ii) Made referral forms widely available throughout the State;
(iii) Conducted outreach efforts to identify and serve individuals
with disabilities who have been unserved or underserved by the
vocational rehabilitation system; and
(iv) Not delayed, through waiting lists or other means,
determinations of eligibility, the development of individualized
written rehabilitation programs (IWRPs) for individuals determined
eligible, or the provision of services for eligible individuals for
whom IWRPs have been developed.
(3) For those designated State units unable to provide the full
range of services to all eligible individuals during the current or
preceding fiscal year, or unable to provide the statement required in
paragraph (a)(2) of this section, the explanation required by paragraph
(a)(1)(i) of this section must include--
(i) A description of the circumstances that have changed that will
allow the DSU to meet the requirements of paragraph (a)(1)(i) of this
section in the next fiscal year, including a description of--
(A) The estimated number of and projected costs of serving, in the
next fiscal year, individuals with existing IWRPs;
(B) The projected number of individuals with disabilities who will
apply for services and will be determined eligible in the next fiscal
year and the projected costs of serving those individuals;
(C) The projected costs of administering the program in the next
fiscal year, including, but not limited to, costs of staff salaries and
benefits, outreach activities, and required statewide studies; and
(D) The projected revenues and projected number of qualified
personnel for the program in the next fiscal year;
(ii) Comparable data, as relevant, for the current or preceding
fiscal year, or for both years, of the costs listed in paragraphs
(a)(3)(i) (A) through (C) of this section and the resources identified
in paragraph (a)(3)(i)(D) of this section and an explanation of any
projected increases or decreases in these costs and resources; and
(iii) A demonstration that the projected revenues and the projected
number of qualified personnel for the program in the next fiscal year
are adequate to cover the costs identified in paragraphs (a)(3)(i) (A)
through (C) of this section so as to ensure the provision of the full
range of services, as appropriate, to all eligible individuals.
(b) Time for determining need for an order of selection.
(1) The designated State unit shall determine, prior to the
beginning of each fiscal year, whether to establish and implement an
order of selection.
(2) If the designated State unit determines that it does not need
to establish an order of selection, it shall reevaluate this
determination whenever changed circumstances during the course of a
fiscal year, such as a decrease in its fiscal or personnel resources or
an increase in its program costs, indicate that it may no longer be
able to provide the full range of services, as appropriate, to all
eligible individuals.
(c) Establishing an order of selection.
(1) Basis for order of selection. An order of selection must be
based on a refinement of the three criteria in the definition of
``individual with a severe disability'' in section 7(15)(A) of the Act.
(2) Factors that cannot be used in determining order of selection
of eligible individuals. An order of selection may not be based on any
other factors, including--
(i) Any duration of residency requirement, provided the individual
is present in the State;
(ii) Type of disability;
(iii) Age, gender, race, color, creed, or national origin;
(iv) Source of referral;
(v) Type of expected employment outcome;
(vi) The need for specific services or anticipated cost of services
required by an individual; or
(vii) The income level of an individual or an individual's family.
(3) Priority for individuals with the most severe disabilities. The
State plan must assure that those individuals with the most severe
disabilities are selected for service before other individuals with
disabilities. The designated State unit shall establish criteria for
determining which individuals are individuals with the most severe
disabilities. The criteria must be consistent with the definition of
[[Page 24403]]
``individual with a severe disability'' in section 7(15)(A) of the Act
and the requirements in paragraphs (c)(1) and (2) of this section.
(d) Administrative requirements. In administering the order of
selection, the designated State unit shall--
(1) Implement the order of selection on a statewide basis;
(2) Notify all eligible individuals of the priority categories in a
State's order of selection, their assignment to a particular category,
and their right to appeal their category assignment;
(3) Continue to provide all needed services to any eligible
individual who has begun to receive services under an IWRP prior to the
effective date of the order of selection, irrespective of the severity
of the individual's disability;
(4) Ensure that its funding arrangements for providing services
under the State plan, including third-party arrangements and awards
under the establishment authority, are consistent with the order of
selection. If any funding arrangements are inconsistent with the order
of selection, the designated State unit shall renegotiate these funding
arrangements so that they are consistent with the order of selection.
(e) State Rehabilitation Advisory Council. The designated State
unit shall consult with and seriously consider the advice of the State
Rehabilitation Advisory Council regarding the--
(1) Need to establish an order of selection, including any
reevaluation of the need under paragraph (b)(2) of this section;
(2) Priority categories of the particular order of selection;
(3) Criteria for determining individuals with the most severe
disabilities; and
(4) Administration of the order of selection.
(Approved by the Office of Management and Budget under control
number 1820-0500.)
(Authority: Secs. 7(15)(A); 12(d); 17; 101(a)(4); 101(a)(5)(A);
101(a)(7); 101(a)(11)(A); 101(a)(15)(D); 101(a)(24); 101(a)(30);
101(a)(36)(A)(ii); 107(a)(4)(B); and 504(a) of the Act; 29 U.S.C.
706(15)(A), 711(d), 716, 721(a)(4), 721(a)(5)(A), 721(a)(7),
721(a)(11)(A), 721(a)(15)(D), 721(a)(24), 721(a)(30),
721(a)(36)(A)(ii), 727(a)(4)(B), and 794(a))
[FR Doc. 96-11808 Filed 5-13-96; 8:45 am]
BILLING CODE 4000-01-P
Complete official Federal Register PDF
FR Doc. 96-11370 National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies: Cryptosporidium, Giardia, Viruses, Disinfection Byproducts, Water Treatment Plant Data and Other Information Requirements
[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Rules and Regulations]
[Pages 24354-24388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11370]
[[Page 24353]]
_______________________________________________________________________
Part II
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 141
National Primary Drinking Water Regulations: Monitoring Requirements
for Public Drinking Water Supplies; Final Rule
Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Rules
and Regulations
[[Page 24354]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 141
[WH-FRL-5501-1]
RIN 2040-AC24
National Primary Drinking Water Regulations: Monitoring
Requirements for Public Drinking Water Supplies: Cryptosporidium,
Giardia, Viruses, Disinfection Byproducts, Water Treatment Plant Data
and Other Information Requirements
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: Today, EPA is promulgating an information collection rule
(ICR) which establishes monitoring and data reporting requirements for
large public water systems (PWSs). This rule is intended to provide EPA
with information on the occurrence in drinking water of (1) chemical
byproducts that form when disinfectants used for microbial control
react with chemicals already present in source water (disinfection
byproducts (DBPs)) and (2) disease-causing microorganisms (pathogens),
including Cryptosporidium. Also, EPA will collect engineering data on
how PWSs currently control such contaminants. All data collected
pursuant to this rule will be available to the public via the Internet.
This information is being collected because a Regulatory
Negotiation on disinfectants and DBPs concluded that additional
information is needed to assess the potential health problem created by
the presence of DBPs and pathogens in drinking water and to assess the
extent and severity of risk in order to make sound regulatory and
public health decisions. These contaminants may have adverse human
health effects, including cancer, liver and kidney damage, and may
cause microbial disease such as cryptosporidiosis and hepatitis.
EPA will use information generated by this rule, along with
concurrent research, to determine whether revisions need to be made to
EPA's current drinking water filtration and disinfection rule and to
determine the need for new regulations for disinfectants and DBPs.
EPA has determined that the rule's objectives can be satisfied, and
sufficient information collected, by requiring only large PWSs to
collect the data. Surface water systems serving at least 100,000 people
and ground water systems serving at least 50,000 must monitor. EPA will
supplement this information with EPA-funded surveys that target smaller
PWSs. The specific information required is based on the number of
people served, the source of water (i.e., surface water or ground
water), and the type(s) of treatment used.
Although Cryptosporidium is an important drinking water pathogen,
it poses difficult measurement challenges. To ensure quality of data,
EPA has and will continue to take extraordinary steps. The first is to
continue an extensive method analysis and possible improvements. The
second is to establish stringent laboratory approval criteria to
increase Cryptosporidium data quality for developing a national
occurrence data base and conducting a national cost assessment of
possible future rules. Finally, EPA will supplement the collection of
Cryptosporidium data in this rule with a separate, EPA-funded survey.
EPA believes this combination of data collection activities will
produce the best data possible.
DATES: The effective date for this final rule is June 18, 1996. The
incorporation by reference of certain publications listed in the rule
is approved by the Director of the Federal Register as of June 18,
1996. This rule shall remain effective until December 31, 2000.
The information collection requirements contained in subpart M of
part 141 have not been approved by the Office of Management and Budget
(OMB) and are not effective until OMB has approved them. EPA will
publish a final rule announcing the effective date when OMB approves
the information collection requirements.
ADDRESSES: Copies of the public comments received, EPA responses, and
all other supporting documents (including references included in this
notice) are available for review at the U.S. Environmental Protection
Agency (EPA) Drinking Water Docket (MC-4101), 401 M Street SW,
Washington, DC 20460. For access to Docket materials, call (202) 260-
3027 between 9 am and 3:30 pm (Eastern) for an appointment. Copies of
major supporting documents cited in the reference section of this
notice are available for inspection at EPA's regional offices, listed
below. Copies of ``ICR Sampling Manual'', ``DBP/ICR Analytical Methods
Manual'', ``ICR Manual for Bench- and Pilot-scale Studies'', ``ICR
Microbial Laboratory Manual'', ``Reprints of EPA Methods for Chemical
Analyses under the Information Collection Rule'', and ``ICR Water
Utility Database System Users' Guide'' are available for a fee from the
National Technical Information Service (NTIS), U.S. Department of
Commerce, 5285 Port Royal Road, Springfield, VA 22161. The toll-free
number is 800-336-4700, local 703-487-4650. Copies of ``Standard
Methods for the Examination of Water and Wastewater'', 19th Ed., 1995,
are available from the American Public Health Association, 1015
Fifteenth Street, NW, Washington, DC 20005. Copies of ``Guidance Manual
for Compliance with the Filtration and Disinfection Requirements for
Public Water Systems using Surface Water Sources'', Appendices C and O,
1991, are available from American Water Works Association, 6666 West
Quincy Avenue, Denver, CO 80235.
FOR FURTHER INFORMATION CONTACT: The Safe Drinking Water Hotline,
Telephone (800) 426-4791. The Safe Drinking Water Hotline is open
Monday through Friday, excluding Federal holidays, from 9:00 am to 5:30
pm Eastern Time. Since this rule will be directly implemented by EPA
rather than States, EPA recommends that inquiries be directed to EPA.
For technical inquiries, contact Tom Grubbs or Paul S. Berger, Ph.D.,
Office of Ground Water and Drinking Water (4603), U.S. Environmental
Protection Agency, 401 M Street SW, Washington, DC 20460, telephone
(202) 260-7270 (Grubbs) or (202) 260-3039 (Berger). For implementation
inquiries, contact Barbara Wysock, Technical Support Division, U.S.
Environmental Protection Agency, 26 West Martin Luther King Drive,
Cincinnati, OH 45268, telephone (513) 569-7906, or your EPA regional
office.
SUPPLEMENTARY INFORMATION:
EPA Regional Office Points of Contact for the Information Collection
Rule
I. Kevin Reilly, Water Supply Section, JFK Federal Bldg., Room 203,
Boston, MA 02203, (617) 565-3619
II. Michael Lowy, Water Supply Section, 290 Broadway, 24th Floor,
New York, NY 10007-1866, (212) 637-3830
III. Ghassan Khaled, Drinking Water Section (3WM41), 841 Chestnut
Building ,Philadelphia, PA 19107, (215) 597-8992
IV. David Parker, Water Supply Section, 345 Courtland Street,
Atlanta, GA 30365, (404) 347-2913 ext. 6493
V. Kimberly Harris, Water Supply Section, 77 W. Jackson Blvd.,
Chicago, IL 60604, (312) 353-2650
VI. Blake L. Atkins, Team Leader, Water Supply Section, 1445 Ross
Avenue, Dallas, TX 75202, (214) 665-2297
VII. Stan Calow, State Programs Section, 726 Minnesota Ave., Kansas
City, KS 66101, (913) 551-7410
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VIII. Bob Benson or Bob Clement, Public Water Supply Section (8WM-
DW), 999 18th Street, Suite 500, Denver, CO 80202-2466, (303) 312-
6243 (Benson), (303) 312-6079 (Clement)
IX. Barry Pollock, Water Supply Section, 75 Hawthorne Street, San
Francisco, CA 94105, (415) 744-1913
X. Wendy Marshall, Drinking Water Unit, 1200 Sixth Avenue (OW-136),
Seattle, WA 98101, (206) 553-1890
Regulated Entities
Entities potentially regulated by this action are public water
systems that treat surface water and serve at least 100,000 people and
public water systems that treat ground water and serve at least 50,000
people. Regulated categories and entities include:
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Category Example of regulated entities
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Public water systems......... Public water systems that treat surface
water and serve at least 100,000 people.
Public water systems that treat ground
water and serve at least 50,000 people.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in this table could also be regulated. To determine whether
your public water system is regulated by this action, you should
carefully examine the applicability criteria in Sec. 141.141 of the
rule. If you have questions regarding the applicability of this action
to a particular entity, contact the person listed in the preceding FOR
FURTHER INFORMATION CONTACT section.
Table of Contents
I. Summary of Regulation
II. Statutory Authority
III. Regulatory Background
IV. Description of Today's Action
A. New Terms
B. General Applicability
C. Applicability of ICR Requirements to Specific Classes of PWSs
D. Disinfection Byproducts and Related Monitoring
E. Microbiological Monitoring Requirements
F. Disinfection Byproduct Precursor Removal Studies
G. Dates, Schedules, and Reporting Requirements
H. Summary
V. Significant Changes to the Proposed Rule
VI. State Implementation
VII. Cost of Rule
VIII. Other Statutory Requirements
A. Executive Order 12866
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Enhancing the Intergovernmental Partnership
E. Unfunded Mandates Reform Act
IX. References
Abbreviations Used in This Notice
deg.C--degrees Celsius
CFR--Code of Federal Regulations
CT--product of disinfectant residual concentration (C (mg/l)) and
contact time (T (minutes))
DBP--disinfection byproduct
D/DBPR--Disinfectants/Disinfection Byproducts Rule
DSE--distribution system equivalent
EPA--Environmental Protection Agency
ESWTR--Enhanced Surface Water Treatment Rule
equ--equivalents
ft--foot or feet
ft \2\--square feet
ft \3\--cubic feet
FR--Federal Register
GAC--granular activated carbon
gpd--gallons per day
GWUDI--ground water under the direct influence of surface water
HAA5--haloacetic acids (five)
HAA6--haloacetic acids (six)
HAN--haloacetonitriles
HK--haloketones
ICR--Information Collection Rule
MGD--million gallons per day
mg/l--milligrams per liter
nm--nanometers
OMB--Office of Management and Budget
PE--performance evaluation
psi--pounds per square inch
PWS--public water system
PWSID--public water system identification
RSSCT--rapid small-scale column test
SCFM--standard cubic feet per minute
SDS--simulated distribution system
THM4--trihalomethanes (four)
TOC--total organic carbon
TOX--total organic halides
TTHM--total trihalomethanes
m--micrometers
UFCTOX--Uniform formation conditions for total organic halides
U.S.C.--United States Code
WIDB--Water Industry Data Base
I. Summary of Regulation
Acting under the requirement of the Safe Drinking Water Act to
regulate additional contaminants that may cause adverse health effects,
EPA convened a regulatory negotiation in 1992 due to concerns over the
health effects of chemical byproducts (known as disinfection byproducts
(DBPs)). DBPs form in drinking water when disinfectants used for
microbial control react with organic and inorganic chemicals already
present in source water. The regulatory negotiation was convened to
determine how the risk-risk issue of controlling the level of DBPs in
drinking water on the one hand while controlling exposure to disease-
causing microbes (pathogens) on the other hand is best addressed.
The Negotiating Committee, consisting of representatives of State
and local regulatory and public health agencies, local elected
officials, consumer groups, public water systems (PWSs), environmental
groups, and EPA, met for more than six months to develop a plan to
concurrently control DBPs and microorganisms. The Committee determined
that an important component of their plan would be to develop
additional information to better define the problem and better identify
possible solutions. To develop this information, the Committee agreed
that PWSs should be required to collect occurrence and treatment data
to characterize disinfectants, DBPs, and microorganisms in drinking
water. The Committee also decided that some PWSs should conduct
treatment studies to evaluate the use of granular activated carbon or
membranes to remove DBP precursors. The information collected, in
addition to concurrently conducted health effects and technology
research, will be used to evaluate the need for possible changes to the
current Surface Water Treatment Rule (SWTR) and to evaluate the need
for future regulations for disinfectants and DBPs. All data collected
pursuant to this rule will be available to the public via the Internet.
(See Section III below and the preamble to the proposed Information
Collection Rule (ICR) [59 FR 6332, February 10, 1994] for a more
detailed discussion of the regulatory negotiation process).
Today, EPA is promulgating an information collection rule (ICR)
which requires large PWSs to generate and provide the Agency with
specific monitoring data and other information characterizing their
water systems. There are three classes of PWSs affected, each somewhat
differently, by this rule. The three general classes are: (1) PWSs that
serve at least 100,000 people and use surface water; (2) PWSs that
serve at least 100,000 people, and use only ground water as the source;
and (3) PWSs that serve at least 50,000, but less than 100,000, people
and use ground water as the source. Throughout this rule and preamble,
requirements for
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PWSs or treatment plants that use ground water under the direct
influence of surface water as a source are the same as those for
surface water.
Table I-1 contains a summary of today's rule, which will appear in
subpart M to 40 CFR Part 141.
Table I-1.--General Subpart M Requirements \1\
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Treatment Studies
Type of PWS \2\ DBP and related monitoring \3\ Microbial Monitoring \4\ \5\
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PWS using surface water \6\ Yes--monthly for 18 months...................... Yes--monthly for 18 months...................... Yes.
serving 100,000.
PWS using ground water serving Yes--monthly for 18 months...................... NA.............................................. Yes.
100,000.
PWS using ground water serving NA.............................................. NA.............................................. Yes.
50,000 to <100,000.
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\1\ These are general requirements and do not include regulatory allowances for reduced monitoring and other specific provisions provided in the rule.
\2\ Population served will include both retail and wholesale populations. Specific instructions for calculating population served are included in the
rule.
\3\ DBP and related monitoring includes monitoring for DBPs and other parameters at specified locations throughout the treatment plant. Also, PWSs will
be required to characterize treatment processes in the treatment plant. Monitoring includes disinfectant residuals, trihalomethanes, haloacetic acids,
haloacetonitriles, haloketones, chloral hydrate, chlorite, chlorate, bromide, bromate, total organic halides (TOX), total organic carbon (TOC), and
general water quality parameters.
\4\ Microbiological monitoring includes monitoring for specific pathogens and microbial indicators: total culturable viruses, total coliforms, fecal
coliforms or E. coli, Giardia, and Cryptosporidium.
\5\ PWSs must conduct treatment study applicability monitoring and, unless avoidance criteria are met, bench- or pilot-scale treatment studies to
determine the effectiveness of granular activated carbon (GAC) or membranes in reducing the levels of precursors to the formation of disinfection
byproducts.
\6\ Includes PWSs using ground water under the direct influence of surface water.
A major issue with this rule is the adequacy of the protozoa
analytical method to generate meaningful occurrence information for
Cryptosporidium. The analytical method is relatively new and difficult
to conduct. Even experienced laboratories have had widely varying
results. EPA has worked over the last couple of years to improve the
method and evaluate its performance under field conditions. The most
recent round of testing showed laboratories recovering between 5% and
21% of the Cryptosporidium known to be present. However, despite its
generally acknowledged limitations, this method is the best method
either currently available or anticipated to be available in the near
future and EPA is confident that data produced by approved laboratories
will enable the Agency to develop a reliable national occurrence data
base and national cost impact estimates for various scenarios of
regulations.
In making its determination whether the protozoa analytical method
is adequate to yield meaningful results, EPA focussed on how the data
were to be used. Specifically, the data generated under this rule will
be used to develop a national occurrence data base and national cost
impact estimates for various scenarios of regulations which could be
promulgated to reduce microbiological risk. Also, these data may be
used in conjunction with results of dose-response health effects
research to develop benefit estimates for regulatory options. ICR data
would not be used, except at the option of the PWS, to make compliance
determinations with future rules. At the national level, EPA will
aggregate data from PWS samples analyzed at different laboratories so
that the range of relative error is much smaller, nationally, than it
would be for a single PWS. EPA developed statistically based data
quality objectives which indicated that, even if Cryptosporidium
recovery averaged only 8%, the range of uncertainty in cost estimates
would be no greater than with previously issued drinking water rules.
The reason the recovery rate can be this low is because of the large
number of PWSs (over 300) which would be generating data. With a much
smaller sample size, a higher range of recovery would be needed. With
such a large data base, EPA's independently evaluated statistical
analysis shows that an 8% recovery rate can provide a reliable
adjustment factor from which to estimate national occurrence. EPA
believes that, with the stringent laboratory approval requirements
contained in this rule, recovery rates will meet this minimum
requirement. As added insurance that the data will be useful, EPA
intends to conduct a companion survey of 50 PWSs where the data are
analyzed by a single laboratory meeting even more stringent
requirements than those imposed in this rule. The results from this
survey will augment the ICR-generated data and improve their
statistical reliability.
II. Statutory Authority
The Safe Drinking Water Act (SDWA, or the Act), as amended in 1986,
requires EPA to publish maximum contaminant level goals (MCLGs) for
contaminants which may have an adverse effect on human health and are
known or anticipated to occur in PWSs. For such contaminants, EPA must
also promulgate national primary drinking water regulations (NPDWRs)
which specify either maximum contaminant levels (MCLs) or treatment
techniques (42 U.S.C. 300g-1). An MCL must be set as close to the MCLG
as feasible.
Under the Act, PWSs can be required to ``establish and maintain
such records, make such reports, conduct such monitoring, and provide
such information as the Administrator may reasonably require by
regulation to assist him in establishing regulations, [or] * * * in
evaluating the health risks of unregulated contaminants''. 40 U.S.C.
300j-4. This provision authorizes EPA to require systems to monitor and
provide the Agency with these data as well as other data characterizing
the systems, including source and treated water quality.
In addition, the Act defines NPDWRs to include ``criteria and
procedures to assure a supply of drinking water which dependably
complies with such maximum contaminant levels; including quality
control and testing procedures * * *''. 40 U.S.C. 300f(1)(D). This
provision authorizes EPA to require systems and laboratories to use
Agency-approved methods and quality assurance criteria for collecting
and analyzing water samples. EPA is using these information collection
authorities as the basis for promulgating the ICR.
III. Regulatory Background
EPA has issued two regulations intended to control pathogens in
public water supplies--the Total Coliform Rule (54 FR 27544, June 29,
1989) and the Surface Water Treatment Requirements (SWTR) (54 FR 27486,
June 29, 1989). A
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third regulation, the Groundwater Disinfection Rule, is currently under
development and will add further protection for systems using ground
water.
In addition to these regulations, EPA concluded that it was
necessary to address disinfectants and chemical byproducts that form
when disinfectants used for microbial control in drinking water react
with various organic and inorganic chemicals in the source water.
Chronic exposure to various DBPs may cause cancer, liver and kidney
damage, heart and neurological effects, and effects to unborn children.
In 1992, EPA instituted a formal regulatory negotiation (reg-neg)
process to develop the Disinfectants/Disinfection Byproducts Rule (D/
DBPR) (57 FR 53866, November 13, 1992). This negotiation was discussed
in the proposed rule.
In the course of the discussions, the Negotiating Committee
determined that insufficient data were available on DBPs to make
appropriate regulatory decisions. The Committee was concerned about the
risk from DBPs, on one hand, and microbial risk on the other. As
disinfectant use is decreased to decrease the formation of DBPs, the
risk of microbial illness increases. Microbes cause many diseases,
including giardiasis, cryptosporidiosis, dysentery, and hepatitis. For
individuals with weakened immune systems, these diseases can be fatal.
The Committee recommended that additional data be developed on
health effects, occurrence of and exposure to these contaminants, and
on the capabilities of treatment technologies to reduce levels of these
contaminants. Committee members were also concerned about limited data
available on microbial contaminants in water. (See preamble of proposed
ICR for a more detailed discussion of the need for additional data and
rationale for the proposed monitoring and reporting requirements. 59 FR
6332 (February 10, 1994).) The Committee agreed to proceed with the
proposal of regulatory actions but at the same time to initiate a
process for developing additional data for future regulatory decisions.
Accordingly, the Committee developed three proposed rules: (a) the
Information Collection Rule (ICR) (59 FR 6332, February 10, 1994), (b)
the ``interim'' Enhanced Surface Water Treatment Rule (ESWTR) (59 FR
38832, July 29, 1994), and (c) the D/DBPR (59 FR 38668, July 29, 1994).
It is the ICR that is the subject of this final rulemaking.
The Negotiating Committee's development of the three proposed rules
was based on: (1) the need to take prudent immediate steps by proposing
a Stage 1 D/DBP rule and an interim ESWTR and (2) the need to develop
additional data through monitoring and research for future regulatory
decisions that would support refinements to the proposed interim ESWTR,
and development of the long-term ESWTR and Stage 2 D/DBP rule.
The information collected under this rule will be used to determine
the most effective regulatory option(s) to reduce exposure to
pathogens, disinfectants, and DBPs. All can have adverse effects on
human health. Over 200 million people will benefit from these rules
once they are fully effective. Preliminary estimates of the annual
benefits of the rules could be the avoidance of many cases of disease,
including as many as several thousand cancer cases and 500,000 cases of
giardiasis, and control of the parasite Cryptosporidium. Accordingly,
today's final rule, which requires this additional information, meets
the direction and objectives of the Negotiating Committee.
The ICR is designed to obtain both microbial and DBP occurrence,
exposure, and treatment data for input into the ESWTR and Stage 2 D/DBP
rule, as outlined below, and is expected to require the expenditure of
an estimated $130 million over three years by a segment of PWSs. The
commitment by the public water supply community to support this
collection of additional data is linked to EPA's commitment to provide
(1) adequate quality control procedures for collecting and managing the
information obtained under the ICR and (2) additional funding,
especially on health effects research, for properly interpreting ICR
data.
The Negotiating Committee also agreed that more data, especially
monitoring data, should be collected under the ICR to assess possible
shortcomings of the SWTR and to develop appropriate remedies, if
needed, to prevent increased risk from microbial disease as systems
begin complying with the Stage 1 D/DBP Rule. It was also agreed that
EPA would propose an interim ESWTR for systems serving at least 10,000
people that included a wide range of regulatory alternatives. Data
gathered under the ICR will form the basis for developing the most
appropriate criteria among the options presented in the proposed
interim ESWTR. Eventually a long-term ESWTR would include possible
refinements to the interim ESWTR and be applicable to all system sizes.
The interim and long-term ESWTR rules would become effective
concurrently with the requirements of the Stage 1 D/DBP rule for the
respective different system sizes.
The Negotiating Committee also agreed that additional data on the
occurrence of disinfectants, DBPs, and potential surrogates for DBPs;
source water and within-treatment plant conditions affecting the
formation of DBPs; and bench- and pilot-scale information on the
removal of DBP precursors would be useful for developing Stage 2 D/DBP
regulatory criteria beyond those currently being considered for
proposal in Stage 1. Additional data will be developed on potential
consumer exposures, acute short-term health effects, and chronic health
effects through a concurrent EPA-sponsored research program. These data
will support important decisionmaking that will be required when
promulgating the Stage 2 D/DBPR.
IV. Description of Today's Action
This preamble briefly summarizes the background of the ICR, the
major elements of the regulations, and the major changes from the
proposal. The proposed ICR (59 FR 6332, February 10, 1994) includes a
detailed discussion of the lengthy regulatory negotiation process that
led to the development of the ICR and is an essential part of the
record for the decisions made in this final action. While the
discussions from the proposed ICR are not generally repeated here, this
preamble occasionally cites the proposed rule where such references are
useful.
The purpose of the ICR is to establish specific data collection
requirements for PWSs and to identify the exact manner in which the
data are to be collected and transmitted to the Agency. Most of the
requirements are presented in the rule in tabular format, because of
the diverse characteristics of the PWSs subject to the ICR. EPA also
concluded that technical manuals would be the most efficient way of
communicating the detailed requirements of the ICR to those who are
actually responsible for implementing the regulations. These technical
manuals are incorporated by reference into the ICR. These manuals will
be sent by EPA to those PWSs subject to the requirements of the rule.
These technical manuals can also be obtained through the National
Technical Information Service.
A. New Terms (Sec. 141.140)
EPA has developed new definitions to address specific issues raised
by the ICR and to respond to commenters' questions concerning
applicability and monitoring requirements. The definitions in
Sec. 141.140 apply only to
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the regulatory requirements of this rule (i.e., 40 CFR Part 141,
subpart M).
B. General Applicability
1. Notice of Applicability (Secs. 141.142(c)(2)(i) and
141.143(c)(3)(i))
In Appendix B of the proposed ICR, EPA included lists of PWSs that
it expected would have to comply with at least some of the proposed ICR
requirements, based on the Agency's own data system, on the Water
Industry Data Base (WIDB), or both. EPA requested comment on the
accuracy of these lists. Based on public comments and input from EPA
regions and States, the Agency developed an updated list of PWSs that
are expected to comply with subpart M requirements. Each of these PWSs
will receive a Notice of Applicability. Upon receiving a Notice of
Applicability, a PWS must reply within 35 days, specifically
identifying the subpart M requirements that apply to each treatment
plant operated by the PWS. A PWS that believes that it does not meet
applicability criteria must so indicate in its response to EPA's Notice
of Applicability.
Although EPA has expended considerable effort to identify all of
the PWSs subject to subpart M, it is possible that an affected PWS may
not have been identified. Failure to receive a Notice of Applicability
does not relieve a PWS of its responsibility for compliance. A PWS that
meets the applicability requirements, but does not receive an EPA
Notice of Applicability, must contact the ICR Utilities Coordinator,
TSD, USEPA, 26 West Martin Luther King Drive, Cincinnati, OH 45268, so
the Agency can send the necessary materials.
2. Applicability Determinations
In order to account for both retail and wholesale populations
served by treated water produced by a PWS, and to determine specific
monitoring requirements for each treatment plant operated by the PWS,
each PWS subject to this regulation must calculate the population
served by its entire system and by each of its plants. To make these
calculations, the PWS must complete Appendix A to Sec. 141.141(a). A
PWS that serves no retail population is required to use an EPA-
developed equation to calculate the wholesale population that it serves
and determine applicability (Cummins, 1987). This equation, included in
Appendix A, was developed from hundreds of data points showing the
relationship between flow and population served.
For the ICR, a treatment plant includes any site where a
disinfectant or oxidant is added to the water prior to the water
entering the distribution system (e.g., a chlorinator at a well). A PWS
that uses multiple wells drawing from the same aquifer and has no
central treatment plant is considered to have one treatment plant for
those wells and must monitor accordingly.
C. Applicability of ICR Requirements to Specific Classes of PWSs
The following discussion identifies the ICR requirements that are
applicable to each class of PWSs covered by this final rule. Sections
D-G explain each of these requirements in greater detail.
1. PWSs Serving at Least 100,000 People and Using Surface Water, or
Ground Water Under the Direct Influence of Surface Water, as a Source
a. Monitoring for DBPs and Related Parameters
All PWSs in this class must monitor for DBPs, DBP precursors, and
other chemical parameters at specific locations throughout each
treatment plant operated by the PWS on a monthly basis for a period of
18 months. Such PWSs also must characterize treatment processes (e.g.,
filtration or sedimentation) monthly for the 18 month period. The only
exception to this requirement is that PWSs receiving all of their water
from a supplier and not further disinfecting that water at the entrance
to their distribution system are not required to conduct such
monitoring.
In addition, for each treatment plant that uses chloramines,
hypochlorite solution, ozone, or chlorine dioxide for treatment or
disinfection residual maintenance, a PWS must conduct an analysis of
parameters related to those disinfectants, such as cyanogen chloride
for PWSs that use chloramines. This additional monitoring must also be
conducted by PWSs that disinfect finished water at the entrance to
their distribution system and receive that water from a PWS that
treated the water with chloramines, hypochlorite solution, ozone, or
chlorine dioxide.
b. Monitoring for Disease-causing Microorganisms and Microbial
Indicators
Unless a PWS meets the requirements for reduced monitoring (as
described in section E), all PWSs in this class must: (1) monitor their
source water at the intake of each treatment plant that treats surface
water for Cryptosporidium, Giardia, total culturable viruses, total
coliforms, and fecal coliforms or Escherichia coli (E. coli); and (2)
monitor their finished water for these microorganisms when
Cryptosporidium and Giardia exceed 10 per liter in the source water, or
when total culturable virus levels exceed one per liter in the source
water.
c. Treatment Studies
i. Treatment Study Applicability (Total Organic Carbon (TOC))
Monitoring
All PWSs must monitor for TOC to determine at which treatment
plants they must conduct treatment studies. PWSs must conduct TOC
monitoring at the following locations:
--At the influent of each treatment plant that treats surface water and
serves a population of 100,000 people or more.
--On finished water at each treatment plant serving a population of
100,000 people or more and using ground water as the source.
--For PWSs that serve at least 100,000 people but have no individual
treatment plant serving 100,000 or more, PWSs must conduct TOC
monitoring at the treatment plant serving the largest population. PWSs
must monitor for TOC at the influent of the treatment plant if it
treats surface water and must monitor finished water if it treats
ground water.
ii. Bench- and Pilot-scale Treatment Studies
Unless a PWS qualifies for one of the exceptions discussed in
section F of this preamble, PWSs in this class must conduct bench- and/
or pilot-scale treatment studies to determine the effectiveness of
granular activated carbon (GAC) or membranes in reducing the levels of
DBP precursors.
2. PWSs Serving at Least 100,000 People, Using Only Ground Water as a
Source
a. Monitoring for DBPs and Related Parameters
All PWSs in this class must monitor for DBPs, DBP precursors, and
other chemical parameters at specific locations throughout each
treatment plant operated by the PWS on a monthly basis for a period of
18 months. Such PWSs also must characterize treatment processes (e.g.,
aeration or ion exchange) monthly for the 18 month period. The only
exception to this requirement is that PWSs receiving all of their water
from a supplier and not further disinfecting that water at the entrance
to their distribution system are not required to conduct such
monitoring.
In addition, for each treatment plant that uses chloramines,
hypochlorite solution, ozone, or chlorine dioxide for treatment or
disinfection residual
[[Page 24359]]
maintenance, a PWS must conduct an analysis of parameters related to
those disinfectants. This additional monitoring must also be conducted
by PWSs that disinfect finished water at the entrance to their
distribution system and receive that water from a PWS that treated the
water with chloramines, hypochlorite solution, ozone, or chlorine
dioxide.
b. Treatment Studies
i. Treatment Study Applicability (TOC) Monitoring
All PWSs must monitor for TOC to determine at which treatment
plants they must conduct treatment studies. PWSs must conduct TOC
monitoring at the following locations:
--On finished water at each treatment plant serving a population of
100,000 people or more and using ground water as the only source.
--For PWSs that serve at least 100,000 people but have no individual
treatment plant serving 100,000 or more, PWSs must conduct TOC
monitoring on finished water at the treatment plant serving the largest
population.
ii. Bench- and Pilot-scale Treatment Studies
Unless a PWS qualifies for one of the exceptions provided in
section F of this preamble, PWSs in this class must conduct bench- and/
or pilot-scale treatment studies to determine the effectiveness of
granular activated carbon (GAC) or membranes in reducing the levels of
DBP precursors.
3. PWSs Serving at Least 50,000 People, But Less Than 100,000, and
Using Ground Water as a Source
PWSs serving at least 50,000, but less than 100,000, (with at least
50,000 served by ground water) are required to monitor for TOC in the
finished water at the treatment plant serving the largest population.
Subsequently, unless a PWS qualifies for one of the exceptions provided
in section F, PWSs in this class must conduct bench- and/or pilot-scale
treatment studies to determine the effectiveness of granular activated
carbon (GAC) or membranes in reducing the levels of DBP precursors.
D. Disinfection Byproducts (DBPs) and Related Monitoring Requirements
1. General Monitoring (Secs. 141.141(c) and 141.142(a))
PWSs affected by this requirement must conduct monthly monitoring
for DBPs, DBP precursors, and other chemical parameters at each
treatment plant and in the distribution system. These PWSs will also be
required to characterize treatment processes (e.g., filtration and
sedimentation) in the treatment plant on a monthly basis for 18 months.
PWSs receiving all of their water from a supplier and not further
disinfecting that water at the entrance to the distribution system are
not required to conduct any monitoring under this rule.
2. Additional Monitoring Requirements for PWSs Using Chloramines,
Hypochlorite Solution, Ozone, or Chlorine Dioxide (Secs. 141.142(a)
(2)-(5))
For each treatment plant that uses chloramines, hypochlorite
solution, ozone, or chlorine dioxide for treatment or disinfection
residual maintenance, a PWS must also conduct an analysis of such
parameters as cyanogen chloride, chlorate, pH, temperature, free
residual chlorine, bromide, bromate, ammonia, and aldehydes. For
consecutive systems (i.e., PWSs receiving finished water from another
PWS), the receiving PWS must consult with the provider to ensure that
all such additional analyses are completed. For example, the rule
requires a PWS covered by the ICR that receives finished water that has
been treated with chlorine dioxide to conduct additional monitoring of
parameters such as chlorite, chlorate, chlorine dioxide residual, and
aldehydes. A PWS receiving finished water has the obligation to
determine whether the water it receives has been treated with
chloramines, chlorine dioxide, ozone, or hypochlorite solution and what
additional monitoring, if any, is required, and to conduct the
necessary monitoring.
3. Analytical Methods (Sec. 141.142(b))
For conducting the required analyses, PWSs are required to use the
methods specifically approved for subpart M. With the exception of
optional analyses for assimilable organic carbon (AOC) and
biodegradable organic carbon (BDOC), only results from laboratories
that have been approved by EPA to perform sample analyses for DBPs will
be acceptable. Laboratories may apply for approval under the provisions
of Sec. 141.142(b)(2).
E. Microbiological Monitoring Requirements
1. Monitoring (Secs. 141.141(d) and 141.143(a))
a. Source Water Monitoring
Microbiological monitoring requirements include monitoring for
disease-causing microorganisms, such as Cryptosporidium and Giardia,
total culturable viruses, and indicator organisms. To be eligible for
reduced monitoring, a PWS must notify EPA in its response to the EPA
Notice of Applicability of its plans to reduce monitoring, which is
available under the following provisions:
--A PWS may avoid the requirement to conduct finished water monitoring
of Cryptosporidium and Giardia (Sec. 141.143(a)(2)(iii)) by complying
instead with alternative monitoring requirements, including particle
counting at several locations within the treatment plant.
--A PWS may avoid virus monitoring (Sec. 141.143(a)(2)(iv)), if the PWS
has monitored for total coliforms, fecal coliforms, or E. coli in the
treatment plant influent for at least five days/week for any
consecutive six month period beginning January 1, 1994, and 90 percent
of all samples taken in that six-month period contain no greater than
100 total coliforms/100 milliliters (ml), or 20 fecal coliforms/100 ml,
or 20 E. coli/100 ml. For purposes of making this determination, PWSs
may use source water coliform data collected under the SWTR. EPA and
the Negotiating Committee agreed that raw waters that contained
densities of total coliforms, fecal coliforms, or E. coli lower than
the specified density value were unlikely to contain measurable levels
of viruses.
b. Finished Water Monitoring
PWSs must conduct finished water monitoring at any treatment plant
at which it detects, during the first 12 months of monitoring, 10 or
more Giardia cysts, or 10 or more Cryptosporidium oocysts, or one or
more total culturable viruses, per liter of water. The PWS must analyze
finished water samples for the same organisms analyzed for in source
water until 18 months of source water microbial monitoring are
completed.
c. Archiving
If either i or ii below occurs, PWSs must arrange to submit samples
of treatment plant influent and finished water to EPA for virus
archiving each month until the 18 months of microbial monitoring are
complete.
i. After the PWS learns that viruses were detected in any previous
sample of finished water.
ii. After the PWS learns that a density of at least 10 viruses per
liter was detected in any previous treatment plant influent sample.
2. Analytical Methods (Sec. 141.143(b))
PWSs are required to use the analytical methods approved for
subpart
[[Page 24360]]
M for pathogens and indicator organisms. In addition, systems are
required to use EPA-approved laboratories for analysis of Giardia,
Cryptosporidium, and total culturable viruses. As proposed, a PWS must
use laboratories certified for microbiology analyses under the EPA or
State drinking water program for the analysis of total coliforms, fecal
coliforms, and E. coli. Laboratory approval criteria for Giardia,
Cryptosporidium, and total culturable viruses are found in the ``ICR
Microbial Laboratory Manual'', EPA 600/R-95/178, April 1996.
Periodically, the Agency will update the list of EPA-approved
laboratories under this rule.
F. Disinfection Byproduct Precursor Removal Studies: Bench- and Pilot-
Scale Treatment Studies and Treatment Study Applicability Monitoring
1. Determination of Treatment Study Requirements: Treatment Study
Applicability (TOC) Monitoring (Sec. 141.141(e) (2)-(3)
To determine which treatment plants will be required to conduct
bench- and/or pilot-scale testing, PWSs are required to conduct
treatment study applicability monitoring. Treatment study applicability
monitoring requires monitoring for TOC for 12 consecutive months. PWSs
must monitor for TOC in the influent of each treatment plant that
treats surface water and serves a population of 100,000 people or more.
For treatment plants serving a population of 100,000 people or more and
using ground water as the source, TOC monitoring must be conducted on
finished water. For PWSs that serve at least 100,000 people but have no
individual treatment plant serving 100,000 or more, TOC monitoring must
be conducted at the treatment plant serving the largest population.
PWSs serving at least 50,000, but fewer than 100,000 (with at least
50,000 served by ground water), are required to monitor finished water
TOC at the treatment plant serving the largest population. A PWS
operating multiple treatment plants using the same source is only
required to conduct one treatment study for those treatment plants.
2. Treatment Study Requirements (Sec. 141.144(b))
Treatment studies will consist of bench- and/or pilot-scale testing
systems for at least one of the two appropriate candidate technologies
(granular activated carbon (GAC) or membrane processes) for the
reduction of organic DBP precursors. The treatment studies must be
designed to yield representative performance data and to allow the
development of treatment cost estimates for different levels of organic
DBP control. To simulate the most likely treatment scenario, treatment
studies will need to be conducted with the effluent from the treatment
processes that are already in place to remove DBP precursors and TOC.
PWSs are required to conduct pilot-scale studies at treatment plants
serving 500,000 people or more and may conduct either bench- or pilot-
scale studies at those serving fewer than 500,000.
a. Bench-scale Testing (Sec. 141.144(b)(1))
Bench-scale tests are continuous flow tests using the rapid small
scale column test (RSSCT) for GAC and either flat sheet or single-
element bench test apparatus for membranes. Water to be used in bench-
scale tests must be representative of water which would be applied to
the advanced treatment full-scale technology. The testing will include
the information specified in this rule and in the ``Manual for Bench-
and Pilot-scale Treatment Studies'', EPA 814-B-96-003, April 1996. EPA
has provided utilities flexibility to select a bench-scale protocol
appropriate for its circumstances.
b. Pilot-scale Testing (Sec. 141.144(b)(2))
PWSs must conduct pilot-scale tests as continuous flow tests. For
GAC, the PWS must use GAC of a particle size representative of that
used in full-scale practice, a pilot GAC column with a minimum inner
diameter of 2.0 inches, and hydraulic loading rate (volumetric flow
rate/column cross-sectional area) representative of that used in full-
scale practice. For membranes, the PWS must use a staged array to
achieve a recovery of at least 75%. Pilot-scale testing must include
the information specified in this rule and in the ``Manual for Bench-
and Pilot-scale Treatment Studies'', EPA 814-B-96-003, April 1996.
3. Treatment Study Exceptions (Secs. 141.141(e)(3) and
141.141(e)(7)(i))
PWSs that would otherwise be required to conduct a bench- and/or
pilot-scale treatment study are exempt from treatment study
requirements if they operate treatment plants that:
--Use chlorine as both the primary and residual disinfectant and have,
as an annual average, levels less than 40 micrograms per liter
(g/l) for THM4 and less than 30 g/l for HAA5. The
quarterly average is calculated by averaging results from all
individual distribution system samples taken during the quarter. The
annual average is calculated by averaging the four quarterly averages.
--Use surface water that does not exceed a TOC level of 4.0 milligrams
per liter (mg/l) in the treatment plant influent, when calculated by
averaging the 12 monthly TOC samples.
--Use ground water not under the direct influence of surface water that
does not exceed a TOC level of 2.0 mg/l in the finished water, when
calculated by averaging the 12 monthly TOC samples.
--Already use full-scale GAC or membrane technology. These PWSs must
submit full-scale plant data and data that show that the technology
effectively removes DBP precursors and must monitor the full-scale
process to comply with DBP and related monitoring requirements.
4. Joint Studies (Secs. 141.141(e)(4) and 141.141(e)(7)(ii))
PWSs that use common water resources and similar treatment trains
(e.g., conventional filtration treatment or softening) may conduct
joint treatment studies with other PWSs. A PWS operating more than one
treatment plant using similar treatment trains on the same source is
not required to conduct multiple studies. PWSs wishing to conduct joint
studies must submit a letter of intent to EPA signed by all PWSs
planning to participate in the study, as well as the additional
information specified in Sec. 141.141(e)(7)(ii) of the rule. Once all
applicability monitoring is complete, each PWS must formally apply for
EPA approval of a joint study. The minimum number and type of treatment
studies to be conducted in a joint study are specified in
Sec. 141.141(e)(4) of the rule.
5. Alternatives to Treatment Studies (Secs. 141.141(e)(5) and
141.141(e)(7)(iii))
In lieu of conducting a treatment study, a PWS may apply to EPA to
contribute funds to a cooperative research effort. The PWS must show in
its application to EPA that the treatment plant for which the waiver of
the treatment study is sought uses a common water resource which is
being studied by another PWS or a cooperative of PWSs. If EPA approves
the application, the PWS shall contribute funds for use in a dedicated
cooperative research program related to disinfectants, DBPs, and
enhanced surface water treatment. The mandatory contributions that must
be made under this option are as follows: $300,000 for a treatment
plant serving a population of 500,000 or more, and $100,000 for a
treatment plant serving a population of fewer than 500,000.
[[Page 24361]]
6. Grandfathered Studies (Secs. 141.141(e)(6) and 141.141(e)(7)(iv))
PWSs that have conducted studies of precursor removal using GAC or
membrane technology and which meet specified criteria may use the
results of those studies, if approved by EPA, in lieu of conducting
another treatment study. PWSs using grandfathered studies must submit
appropriate information on the earlier studies, such as data, study
description, equipment used, protocol, analytical methods, and
information to develop a full-scale cost estimate, and obtain EPA
approval.
G. Dates, Schedules and Reporting Requirements
EPA intends to notify PWSs that they are subject to this rule. PWSs
receiving a Notice of Applicability from EPA must respond within 35
days of receipt.
1. Sampling Plans (Sec. 141.141(f))
PWSs required to comply with subpart M requirements must submit
sampling plans to EPA for review and approval no later than eight weeks
after receiving sampling software and requirements from EPA. Once EPA
notifies the PWS that the plan has been approved, the PWS must begin
monitoring the following month.
2. Monitoring
PWSs must begin treatment study applicability monitoring (i.e., TOC
monitoring) no later than three months from the date the rule is
published in the Federal Register, regardless of whether the sampling
plan has been approved. For other applicable monitoring requirements, a
PWS must begin monitoring the month after receiving notice that the
PWS's sampling plan has been approved by EPA. If the PWS must conduct
both DBP and microbiological monitoring, the PWS must begin monitoring
for both in the same month.
3. Data Reporting (Secs. 141.142(c) and 141.143(c))
PWSs must submit monthly monitoring reports electronically on
diskettes in the format that EPA has prescribed and will be providing
to affected PWSs. This electronic reporting is necessary because of the
need for EPA to evaluate and manipulate the data.
4. Treatment Studies (Sec. 141.141(f)(4))
A PWS must begin treatment studies not later than 23 months from
the date that the ICR is published in the Federal Register. PWSs must
submit a report of each completed treatment study not later than 38
months after the final rule appears in the Federal Register.
H. Summary
Table IV-1 below provides a listing of the requirements contained
in today's rule cross-referenced to the section of the rule where each
requirement appears.
Table IV-1.--Summary of Subpart M Regulatory References
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subject DBP and related monitoring Microbiological monitoring Treatment studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Definitions...................... Sec. 141.140......................... Sec. 141.140......................... Sec. 141.140
PWS applicability................ Sec. 141.141(b)...................... Sec. 141.141(b)...................... Sec. 141.141(b)
Treatment plant applicability.... Sec. 141.141 (b), (c)................ Sec. 141.141 (b), (d)................ Sec. 141.141 (b), (e)
Schedule......................... Sec. 141.141(f)(2)................... Sec. 141.141(f)(3)................... Sec. 141.141(f)(4)
Monitoring requirements.......... Sec. 141.142(a)...................... Sec. 141.143(a)...................... Sec. 141.144 (a), (b)
Analytical methods............... Sec. 141.142(b)...................... Sec. 141.143(b)...................... Sec. 141.144(c)
Reporting requirements........... Sec. 141.142(c)...................... Sec. 141.143(c)...................... Sec. 141.144(d)
--------------------------------------------------------------------------------------------------------------------------------------------------------
V. Significant Changes to the Proposed Rule
In response to comments received during the public comment period,
EPA made many changes to the rule. All comments were evaluated, and EPA
has prepared a comment-response document that contains EPA's responses
to those public comments. That document, along with other documents
that support the rule, is available in the Drinking Water Docket. The
following sections provide a discussion of the most significant
comments considered.
A. Rule Applicability
The most far-reaching change in rule applicability was removing
PWSs serving 10,000 to 99,999 that use surface water from any ICR
requirements. EPA decided to take this action because the analytical
method for protozoan measurement had proven to be very complex and
difficult, and EPA was concerned about whether an adequate number of
laboratories would be able to meet the approval criteria, which include
passing a performance evaluation sample.
Many commenters noted that the DBP and related monitoring and
reporting required in the proposed rule were not applicable to their
PWS. These commenters believed that many of the proposed requirements
would not make sense based on the configuration or operational
practices of their PWS. During development of the ICR data system, EPA
held a number of public meetings with representatives of PWSs and
others to evaluate the applicability of the proposed requirements for
the universe of treatment plants. These meetings helped EPA to: (1)
Clarify the categories of PWSs that would appropriately be required to
meet the different requirements of the ICR and (2) clarify treatment
plant monitoring and data collection requirements. For example, the
Agency modified proposed rule language to include PWSs that sell or buy
large amounts of water in the appropriate applicability category. Also,
EPA has reorganized the rule to make it easier to find applicability
and monitoring requirements.
EPA has coordinated with the American Water Works Association
(AWWA) to form a group of technical experts that will be available to
PWSs to answer questions about this rule concerning applicability,
sampling plans, and monitoring. PWSs may contact these experts at 800-
200-0984 or on the Internet at [email protected].
B. Data Quality Objectives
Several commenters noted that EPA did not clearly identify data
quality objectives for the large amount of data to be generated by this
rule. In response, EPA participated in several public workshops that
addressed this issue. During the workshops, statisticians, data
managers, scientists, and engineers reviewed the proposed requirements
to ensure that the data reporting is necessary and adequate to achieve
the goals of the rule. Also, EPA has developed a quality control
program to ensure that data used in modeling are appropriate for
regulatory development.
C. Data System
Commenters noted that EPA's data system for PWSs at the time of
proposal,
[[Page 24362]]
the Federal Reporting Data System (FRDS), was inadequate to handle and
manipulate the large amount of data that will be reported under this
rule. Commenters stated that the Agency needed to develop a new data
system that is able to receive, store, retrieve, manipulate, and
analyze data submitted by PWSs. Additionally, commenters noted that
once such a data system became available, EPA would have to test the
data system to ensure its smooth operation.
EPA used a contractor as the primary data systems developer for
this project. The contractor worked closely with EPA personnel and a
broad array of technical experts from drinking water suppliers and
other interested parties to understand the regulatory requirements,
develop data manipulation procedures and report capability, produce
adequate user instructions, and ensure the data system could perform
necessary data handling and manipulation.
The utility data system has undergone alpha, beta, and gamma
testing and revision and has been found to meet EPA's needs. Other data
systems, for laboratory quality assurance data and mainframe data
storage and manipulation, are undergoing similar testing and revision.
Testing and revision will be completed before data entry begins under
the rule.
D. Data Base Development
Many commenters stated that EPA, not PWSs, should fund the
development of a data base adequate to meet the objectives of the ICR
(i.e., determine what regulatory requirements are necessary for the
control of disinfectants, DBPs, and pathogens). Under section
1445(a)(1) of the Act, however, EPA is authorized to require PWSs to
conduct monitoring and provide information necessary to establish
drinking water regulations, including evaluating the health risks of
unregulated contaminants.
The information collected under this rule will enable EPA to
determine current occurrence levels and patterns for unregulated
contaminants. Because the ICR will provide EPA with detailed
information on what treatment PWSs already have in place and how well
such treatment processes work, the rule will also allow the Agency to
develop predictive models to evaluate the effect that various changes
in treatment will cause. Participants in the regulatory negotiation
process understood the importance of the data collection effort as it
relates to the objectives of the SDWA and agreed, as part of the
negotiation, to participate in the effort.
E. Protozoan Analytical Method
Many commenters expressed concern that EPA lacks an analytical
method to provide adequate quality data for Cryptosporidium. Also, some
commenters believed that the method that the Agency proposed was too
complex and difficult for reliable use by most laboratories. EPA has
taken several steps to address these concerns. The first was to
establish stringent laboratory approval criteria to assure adequate
quality analyses and ensure that data quality objectives are met. EPA
developed data quality objectives after consultation with outside
parties, including statisticians and microbiologists, to determine
minimum percentage recoveries and precision to meet data analytical
objectives (i.e., to characterize national occurrence of
Cryptosporidium for the purpose of conducting a regulatory impact
analysis). Based on performance evaluation testing of microbiological
laboratories, EPA believes that only laboratories that maintain high
standards will be able to comply with the EPA criteria.
In the ICR proposal, any PWS that treated surface water and served
a population of at least 10,000 would have been required to sample at
each treatment plant, with more sampling required for PWSs serving at
least 100,000. However, because only a small number of laboratories
would be available to analyze samples, EPA reduced the universe of PWSs
that must collect and analyze Cryptosporidium samples. In the final
rule, only PWSs that treat surface water and serve a population of at
least 100,000 are required to sample for Cryptosporidium. A PWS serving
fewer than 100,000 is not required to take any microbiological samples.
By reducing both the number of PWSs that are required to sample and the
number of samples that some of the remaining PWSs are required to take,
EPA expects that the number of laboratories who will qualify to conduct
testing will be able to handle the workload.
Since PWSs serving fewer than 100,000 people are no longer required
to conduct microbiological monitoring, EPA intends to conduct two
sample surveys to collect microbiological occurrence data at smaller
PWSs to determine the correlation with the data collected at PWSs
serving at least 100,000 people. These sample surveys will be conducted
at PWSs using surface water serving (1) 10,000 to 100,000 people and
(2) fewer than 10,000 people. A secondary purpose of these sample
surveys will be to collect occurrence data for areas where no PWSs will
be collecting microbiological occurrence data because there are no PWSs
serving at least 100,000 people that use surface water (e.g., the upper
Great Plains and Rocky Mountain area).
EPA has determined that the purposes of the ICR will not be
adversely affected by reducing the number of PWSs required to provide
data. In conjunction with requiring fewer samples, EPA has continued to
refine the analytical method and validate its accuracy and precision in
non-EPA laboratories. Results of field testing that used various source
waters in multiple laboratories indicate that a well-operated
laboratory will be able to exceed EPA's minimum recoveries. The field
testing results also indicate that well-operated laboratories will be
able to provide adequate data for deriving national occurrence data
that will be used in national cost estimates for evaluating different
ESWTR regulatory options. Depending on the criteria developed for the
interim ESWTR, data collected under the ICR may also be useful for
implementing the interim ESWTR. EPA further believes that analysis of
these data may aid in the identification of target indicators that
smaller PWSs using surface water can utilize for determining the level
of treatment needed for compliance with the ESWTR.
EPA believes that meaningful national occurrence data and
regulatory impact analyses for different ESWTR regulatory options can
be derived from ICR data if laboratories achieve, on average, greater
than an 8% recovery for protozoan cysts. EPA simulation studies
indicated that if this laboratory performance is achieved, PWSs should
be able to detect and enumerate protozoa at least twice (among 18
monthly ICR raw water samples) at most sites where protozoa are
actually present. This level of occurrence, with use of a
statistically-derived adjustment factor for estimating true protozoan
concentrations from measured values, would enable EPA to estimate the
number of systems, nationally, that require different levels of
treatment to achieve a desired finished water concentration, as might
be prescribed under the ESWTR. Such an analysis, together with
treatment cost and performance information for various technologies,
would allow EPA to estimate national costs for different ESWTR
regulatory options. Also, samples in which Cryptosporidium are not
detected will help EPA evaluate the extent to which analyzable sample
volume and percent recovery affect the ability to quantify source water
protozoan concentrations. Such information will help EPA evaluate the
[[Page 24363]]
extent to which the protozoan method may need to be improved, or
special monitoring provisions adopted, to enable appropriate treatment
requirements to be prescribed for all systems under the ESWTR. For
example, depending upon the extent which better methods can be
developed for implementation of the ESWTR, utilities may be able to
increase the number of raw water samples collected (beyond the minimum
that may be required) to enable more sensitive quantification of source
water concentrations, and more accurate level of treatment requirement
estimates.
To provide for higher quality data to estimate national occurrence
and conduct a national regulatory impact analysis, EPA is prescribing
stringent laboratory approval criteria specific to the ICR. For a
laboratory to qualify for conducting protozoan analysis, it must (a)
conduct a comprehensive inventory to ensure the extensive equipment and
personnel requirements are met, (b) employ at least one principal
analyst (with previous experience of having analyzed at least 100
samples using the IFA procedure) to verify all microscopic counts, (c)
pass an on-site inspection that includes observation of the analysis
being performed by the laboratory, and (d) achieve sufficient recovery
and precision on PE samples provided by EPA. EPA does not normally
undertake the actions noted in (a) through (c) as part of laboratory
approval and will require more frequent PE samples (in d)) than usual.
EPA intends to provide technical assistance to laboratories during the
laboratory approval process to enhance laboratory performance.
While performance by ICR approved laboratories should be adequate
for conducting national regulatory impact analysis, EPA believes that
better method performance, and knowledge of how that performance varies
for specific water qualities, will be needed for individual PWSs to
comply with future rules. To address this issue, EPA is conducting
research to improve method performance. In the short term, EPA is
evaluating the extent to which the IFA method can be improved, focusing
mainly on the effects of different filters and smaller raw water sample
volumes. In the long term, as part of its five year research plan, EPA
is attempting to develop new methods that can achieve better recovery
and precision, and distinguish whether the oocysts that are detected
are alive or infectious to humans. Many researchers outside of EPA are
also involved with these efforts.
One shortcoming of PE samples is that they do not reproduce the
full range of sampling or water quality conditions of ICR monitoring.
To augment the ICR, EPA will conduct a sample survey of 50 PWSs serving
100,000 to measure Cryptosporidium under tightly controlled laboratory
conditions. Only those Cryptosporidium data from the ICR which meet
data quality objectives will be used, with EPA survey data, in a cost
analysis. EPA believes it appropriate to require Cryptosporidium data
under the ICR because: (1) the incremental cost of its inclusion is low
(since the same method and sample is used for Giardia), (2) a
sufficient number of laboratories are expected to meet the data quality
objectives, (3) the more experience laboratories have with the method,
the better their performance should be, and (4) through subsequent
testing, an adjustment factor can be generated to improve the utility
of ICR-generated protozoan data.
F. Other Changes
Other changes to the rule include requiring all systems taking
samples for microorganisms to also collect a full 18 months of virus
samples (with no provisions for reduced monitoring), unless a system
meets certain source water quality criteria. EPA is concerned about the
possibly significant variability in the virus density over time.
Therefore, the final rule eliminates the provision that allowed a PWS
to avoid further virus sampling if no viruses were found during the
first 12 months of sampling.
EPA decided not to include Clostridium perfringens and coliphage in
the list of microbial parameters to evaluate their potential use as
indicators. EPA was not confident that a valid laboratory approval and
performance evaluation process could be implemented and believes that
evaluation of indicators could be better accomplished under a separate
research project. EPA will allow particle counting in lieu of finished
water Cryptosporidium and Giardia monitoring, in order to develop data
to evaluate the usefulness of particle counting as a surrogate for
Cryptosporidium and Giardia removal.
The ICR also will require PWSs to submit treatment plant influent
and finished water samples for virus archiving under certain
conditions. EPA will use these samples to conduct research on
occurrence and treatment for specific viruses.
EPA has also added an additional analytical method (Standard Method
4500-Cl B) for determining free chlorine concentration in hypochlorite
stock solutions. A commenter pointed out that this method is able to
determine concentrations at much higher levels than the proposed
methods, reducing the need for large dilutions and their associated
potential for error. Because this method is not sensitive at
concentrations typically found in drinking water, its use is restricted
to analyses of hypochlorite solutions. Other approved analytical
methods may be used for any required free chlorine analyses, including
hypochlorite solutions.
G. Other Changes Considered
EPA also received comments on several other requirements that,
after evaluation, were not changed in the final ICR. One such comment
addressed the provision in the proposed rule to limit analyses of
cyanogen chloride and aldehyde to the EPA laboratory. Some commenters
disagreed with EPA's decision to limit cyanogen chloride and aldehyde
analyses to the EPA laboratory. Since EPA did not believe that it could
have developed performance evaluation samples and implemented a
laboratory approval program in the period of time that the Agency
believed it had available between proposal and promulgation, EPA's
laboratory will continue to be the only laboratory to analyze these
samples under the final rule. EPA believed that the following issues
could not be resolved in time: (1) the standard for cyanogen chloride
may not be stable for more than a few weeks and (2) the methods are not
simple (both require highly skilled analysts and must be analyzed
within 48 hours; aldehyde analysis is subject to contamination). The
EPA laboratory will provide sample containers and will not charge PWSs
for these analyses.
VI. State Implementation
The February 10, 1994, notice proposed that EPA, rather than
States, administer this rule. Many commenters believed that States
should be involved in the ICR and should be given primary enforcement
responsibility (primacy). Among their reasons were: States have more
experience with local conditions; administration of drinking water
rules by more than one party will cause confusion and contradictions
and would be cumbersome; it sends a message that the public water
system supervision program is not fully delegated; it would increase
noncompliance; it would not allow systems to use State waivers; State
administration would allow for local support and training and
facilitate corrective action; and EPA is not authorized to confer
partial primacy under the SDWA.
The rationale for proposing that EPA administer the ICR was that
this rule,
[[Page 24364]]
unlike other drinking water rules, is an information-gathering effort
of a limited duration, and the time constraints for implementing this
rule would strain State resources. The Negotiating Committee, including
the member representing State drinking water agencies, concurred on
this point during the regulatory negotiation. Some commenters agreed,
indicating that States should not administer the program. At least one
commenter remarked that States do not have the time or
FR Doc. 96-11370 National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies: Cryptosporidium, Giardia, Viruses, Disinfection Byproducts, Water Treatment Plant Data and Other Information Requirements
resources to
meet the ambitious ICR schedule.
EPA continues to believe that the short times involved with this
rule make it imperative that the Agency administer the rule. While some
States might be able to put all necessary mechanisms for rule
implementation (including regulatory authority and laboratory approval)
into place in the short-term (three months after promulgation), most
would not. EPA also believes that data such as these, which are to be
used for regulatory development (rather than for compliance) needs
national standardization to maximize the data's usefulness. To ensure
coordination with other implementation activities, EPA will be sharing
data with the States and will inform the States about any enforcement
actions the Agency intends to take to implement this rule.
VII. Cost of Rule
The ICR is estimated to result in national costs of $129 million,
with a range of $117 to $148 million, to be expended over a three year
period. Since this cost does not exceed $100 million per year, it does
not qualify as a ``major rule'' for purposes of Executive Order 12866,
or for the purposes of the Unfunded Mandate Reform Act of 1995. EPA has
prepared an economic impact analysis which establishes that this action
would not be a major rule within the meaning of the Executive Order. A
copy of this analysis is available in the docket. This analysis has
been submitted to the Office of Management and Budget for review. The
following is a summary of the cost estimates for implementation of this
rule.
A. Cost Estimates for Final ICR as Compared to the Proposed ICR
The range of the final total ICR cost estimates are exactly the
same as the range of cost estimates in the proposed rule. Comparisons
between the costs of the proposed rule and the costs of the final rule
are not straightforward, however, due to a number of factors. Some of
these factors resulted in higher cost estimates for some components of
the final rule, while other factors resulted in lower cost estimates
for various components of the final rule. The major factors which
resulted in changes to the final cost analysis include the following
items.
1. Decreases in the Final ICR Cost Estimates
The original cost estimates for DBP monitoring were found to have
been over-estimated in the proposed ICR due to a flawed assumption
regarding the number of treatment sites that systems using ground water
would be required to monitor. The proposed rule assumed that DBP
monitoring would be conducted at every treatment site within a ground
water system. The cost estimate in the final rule, however, more
realistically assumes that ground water systems will be required to
conduct DBP sampling at two treatment sites representing different
aquifers. This revised assumption reduced costs by $30 million. The
cost estimate for the final ICR also reflects the elimination of
microbial monitoring requirements for PWSs that serve fewer than
100,000 people.
2. Increases in the Final ICR Cost Estimates
The final rule cost estimates for DBP monitoring for surface water
systems show an increase of $11 million. This increase reflects a
number of revised assumptions including: changes regarding the number
of samples actually required by the monitoring requirements; a deeper
appreciation of the complexity of some treatment trains (an issue which
was brought to light during the development of the ICR data management
system); and the inclusion of some purchased water systems that re-
disinfect.
In addition, numerous unit cost assumptions within the analysis
were revised upwards to reflect public comments. Most notably, the
startup costs, microbial monitoring costs, and data reporting costs
were increased, taking into account information received from
commenters on the analysis accompanying the proposed rule.
3. Uncertainty
These national cost estimates have an inescapable range of
uncertainty associated with them. A sensitivity analysis performed in
response to public comments as part of the revised economic impact
analysis indicates that the greatest source of uncertainty is the cost
of the pilot- and bench-scale treatment studies. These studies were
estimated to cost $57 million in the proposed rule, with high and low
bounds of $76 and $45 million. In the final rule, EPA has retained the
original cost estimates and accompanying ranges for the cost of bench-
and pilot-scale treatment studies. EPA has also finalized an option for
utilities to contribute to a research fund in lieu of conducting pilot-
and bench-scale testing to reduce any possible duplication of effort
and possibly reduce costs to the PWS. The net effect of this option on
total costs is unpredictable. It is clear, however, that the pilot- and
bench-scale testing will remain the largest and most uncertain element
of the total cost.
B. Total Cost and Burden Estimates for the Final ICR
The total estimated cost of $129 million for the final ICR is
indicated in the third column of Table VII-1. The following five
elements contribute to the total cost:
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1. Start-up Activities (Sec. 141.141)
Start-up activities are estimated to cost a total of $7.6 million.
This estimate has been revised upward from the original cost estimate
of $515,000 in the proposed ICR to reflect public comments. Start-up
activities consist of reading and understanding the requirements of the
rule, determining applicability and evaluating treatment plants to
determine specific sampling requirements for each treatment plant,
preparing sampling plans, and installing and learning to operate
computer software to report monitoring results. Start-up costs will be
spread across an estimated 422 community water systems, resulting in an
average cost of $18,000 per system.
2. Microbiological Monitoring (Sec. 141.143)
Microbial monitoring, which is estimated to apply to 440 plants in
233 community surface water systems serving at least 100,000 people, is
estimated to cost $17.2 million. The average cost per plant is
estimated to be $39,000.
3. DBP and Related Monitoring (Sec. 141.142)
DBP monitoring is estimated to apply to 292 surface and ground
water community water systems that purchase none, or only a portion, of
their water and serve at least 100,000 people. DBP monitoring is also
estimated to apply to an additional 24 community water systems that
purchase all their finished water and disinfect that water prior to
distribution, and serve at least 100,000 people. DBP monitoring is
estimated to cost $37.5 million nationally, resulting in average costs
of $50,000 per treatment site for ground water systems and $69,000 per
treatment site for surface water systems.
This estimate is approximately $20 million less than the estimate
presented in the preamble to the proposed rule due to a flawed
assumption (discussed above) regarding the number of treatment sites
that PWSs using ground water would be required to monitor. The analysis
accompanying the proposed rule assumed that DBP monitoring would be
conducted at every treatment site within a ground water system (a total
of 1,295 sites in 59 ground water systems). The present analysis,
however, more realistically assumes DBP sampling at two treatment sites
per system (a total of 118).
4. Electronic Data Reporting (Secs. 141.143 and 141.142)
The ICR requires monthly electronic reporting of microbial
monitoring results and DBP monitoring results along with various
process parameters of water treatment processes related to microbial
treatment and DBP formation. The total cost is estimated to be $9.4
million nationally, with an average cost of $14,000 per treatment
plant. This estimate compares to $3.9 million estimated in the proposed
rule.
5. TOC Monitoring and Bench- and Pilot-Scale Treatment Studies
(Sec. 141.144)
Required TOC monitoring and bench- and pilot-scale treatment
studies are estimated to have a total national cost of $57 million,
with a range of $45 million to $75 million. For each treatment study,
costs are estimated to range from $150,000 to $750,000. This
requirement applies, with some exceptions, to all surface water
treatment plants serving at least 100,000 persons (or the largest
treatment plant in the PWS if no single treatment plant serves at least
100,000) that have an influent TOC concentration greater than 4 mg/l.
It also applies to all ground water treatment plants serving at least
100,000 persons (or the largest treatment plant in the PWS if no single
treatment plant serves at least 100,000) that have a finished water TOC
concentration greater than 2 mg/l, or to the largest ground water
treatment plant in PWSs serving 50,000 to 99,999 (with at least 50,000
served by ground water), if that treatment plant has a finished water
TOC concentration greater than 2 mg/l.
VIII. Other Statutory Requirements
A. Executive order 12866
Under Executive Order 12866, (58 FR 51735, October 4, 1993) the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact or entitlements, grants,
user fees, or loan programs or the rights and obligations of the
recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is a ``significant regulatory action'' within
the meaning of the Executive Order. As such, this action was submitted
to OMB for review. Changes made in response to OMB suggestions or
recommendations are documented in the public record.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act requires EPA to explicitly consider
the effect of proposed regulations on small entities. The Act requires
EPA to consider regulatory alternatives if a rule has a significant
economic impact on a substantial number of small entities. The Small
Business Administration defines a small water utility as one which
serves fewer than 3,300 people.
This Final Rule is consistent with the objectives of the Regulatory
Flexibility Act because it will not have any economic impact on any
small entities. The rule only applies to PWSs serving more than 50,000
people; thus, PWSs serving fewer than 50,000 people would not be
affected. Therefore, pursuant to section 605(b) of the Regulatory
Flexibility Act, 5 U.S.C. 605(b), the Administrator certifies that this
rule will not have a significant economic impact on a substantial
number of small entities.
C. Paperwork Reduction Act
The information collection requirements in this rule have been
submitted for approval to the Office of Management and Budget (OMB)
under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An
Information Collection Request document has been prepared by EPA (ICR
No. 270.35) and a copy may be obtained from Sandy Farmer, OPPE
Regulatory Information Division, U.S. Environmental Protection Agency
(2136), 401 M Street SW., Washington, DC 20460 or by calling (202) 260-
2740. The information requirements are not effective until OMB approves
them.
Public burden for this collection of information is estimated to
total 1,344,146 hours, about 200,794 more than estimated in the
proposed rule, reflecting public comments on the previous analysis.
There are five elements contributing to the total burden estimate, as
detailed in Table VII-1. The total burden associated with start-up
activities is estimated to be 188,700 hours. The total burden
associated with microbial monitoring is estimated to be 175,923 hours
(Sec. 141.143). Total burden for DBP monitoring is estimated to be
291,209
[[Page 24367]]
hours (Sec. 141.142). Total burden for the process data reporting
requirement is estimated to be 308,677 hours (Secs. 141.142 and
141.143). Total burden associated with the bench- and pilot-scale
treatment study requirement is estimated to be 379,636 hours
(Sec. 141.144).
The annual public reporting and recordkeeping burden for this
collection of information is estimated to average 1.42 hours per
response and 1,062 hours per respondent. This estimate includes the
time needed to review instructions; develop, acquire, install, and
utilize technology and systems for the purposes of collecting,
validating, and verifying information, processing and maintaining
information, and disclosing and providing information; adjust the
existing ways to comply with any previously applicable instructions and
requirements; train personnel to respond to a collection of
information; search existing data sources; complete and review the
collection of information; and transmit or otherwise disclose the
information.
No person is required to respond to a collection of information
unless it displays a currently valid OMB control number. The OMB
control numbers for EPA's regulations are displayed in 40 CFR Part 9.
Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this
burden to Director, OPPE Regulatory Information Division, U.S.
Environmental Protection Agency (2136), 401 M Street SW., Washington,
DC 20460; and to the Office of Information and Regulatory Affairs,
Office of Management and Budget, 725 17th Street NW., Washington, DC
20503, marked ``Attention: Desk Officer for EPA.'' Include the ICR
number in any correspondence.
D. Enhancing the Intergovernmental Partnership
As described in greater detail in the preamble to the proposed ICR,
EPA used a negotiated rulemaking process to develop the regulatory
approach to the problems associated with disinfection. The Negotiating
Committee included representatives of:
--Local public health, drinking water supply, and elected officials;
and
--State public health, regulated utilities commissioners, and drinking
water program officials.
Committee members were supported by other program and financial
officials and Washington-based association directors (e.g., Association
of State Drinking Water Administrators, National League of Cities) both
during meetings and between meetings of the Committee. Also, EPA made
documents publicly available and associations distributed them to
interested members.
During evaluation of public comments and development of the final
requirements, EPA held several public meetings to discuss monitoring
requirements, the data management system, applicability, and data
quality objectives.
E. Unfunded Mandates Reform Act
Section 201 of the Unfunded Mandates Reform Act of 1995 (``Unfunded
Mandates Act''), signed into law on March 22, 1995, requires each
agency, unless prohibited by law, to assess the effects of federal
regulations on State, local, and tribal governments and the private
sector. Under Section 202 of the Unfunded Mandates Act, EPA must
prepare an unfunded mandate statement to accompany any proposed rule
where the estimated costs to State, local, or tribal governments, or to
the private sector, will be $100 million or more in any one year. Under
Section 205, EPA must select the most cost-effective or least
burdensome alternative that achieves the requirements for actions
covered by Section 202, or explain why this was not possible. Section
203 requires EPA to establish a plan for informing and advising any
small governments that may be significantly affected by the rule.
The unfunded mandate statement under Section 202 must include: (1)
A citation of the statutory authority under which the rule is proposed,
(2) an assessment of the costs and benefits of the rule and the federal
resources available to defray the costs, (3) where feasible, estimates
of future compliance costs and disproportionate impacts upon particular
geographic or social segments of the nation or industry, (4) where
relevant, an estimate of the effect on the national economy, and (5) a
description of EPA's prior consultation with State, local, and tribal
officials.
Since this rule is not estimated to impose annual costs of $100
million or more on either State, local, or tribal governments, or on
the private sector, EPA is not required to prepare an unfunded mandate
statement. Because the rule only applies to PWSs serving at least
50,000 persons, no small governments are affected.
F. Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA)
For the purposes of Congressional review, OMB has determined that
this rule is not major under SBREFA. Therefore, this rule is effective
35 days after publication.
IX. References
APHA. 1995. American Public Health Association. ``Standard methods for
the examination of water and wastewater'' (19th ed.). Washington, DC.
AWWA. 1991. ``Guidance manual for compliance with the filtration and
disinfection requirements for public water systems using surface water
sources.'' American Water Works Association, Denver, CO.
Cummins, Michael D. Memorandum to Stephen Clark titled ``Average Flow
and Design Capacity for Technologies and Cost Documents.'' October 5,
1987.
EPA. U.S. Environmental Protection Agency. April 1996. ``ICR Comment
Response Document'', EPA 811-R-96-001.
EPA. U.S. Environmental Protection Agency. April 1996. ``ICR Sampling
Manual'', EPA 814-B-96-001.
EPA. U.S. Environmental Protection Agency. April 1996. ``DBP/ICR
Analytical Methods Manual'', EPA 814-B-96-002.
EPA. U.S. Environmental Protection Agency. April 1996. ``ICR Microbial
Laboratory Manual'', EPA 600/R-95/178.
EPA. U.S. Environmental Protection Agency. April 1996. ``ICR Manual for
Bench- and Pilot-scale Treatment Studies'', EPA 814-B-96-003.
EPA. U.S. Environmental Protection Agency. April 1996. ``Reprints of
EPA Methods for Chemical Analyses under the Information Collection
Rule'', EPA 814-B-96-006.
EPA. U.S. Environmental Protection Agency. April 1996. ``ICR Water
Utility Database System Users' Guide'', EPA 814-B-96-004.
List of Subjects in 40 CFR Part 141
Administrative practice and procedure, Analytical methods,
Chemicals, Incorporation by reference, Intergovernmental relations,
Microorganisms, Monitoring, National Primary Drinking Water
Regulations, Reporting and recordkeeping requirements, Water supply.
Dated: May 1, 1996.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, part 141 of title 40 of
the Code of Federal Regulations is amended as follows:
[[Page 24368]]
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
1. The authority citation for part 141 continues to read as
follows:
Authority: 42 U.S.C. 300f, 300g-1, 300g-2 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9.
2. Section 141.2 is amended by adding ``or PWS'' to the definition
for ``Public water System'' to read as follows:
Sec. 141.2 Definitions.
* * * * *
Public water system or PWS * * *
* * * * *
3. Section 141.6 is amended in paragraph (a) by revising the
reference ``(a) through (h)'' to read ``(a) through (i)'' and by adding
paragraph (i) to read as follows:
Sec. 141.6 Effective dates.
* * * * *
(i) Regulations for information collection requirements listed in
Subpart M are effective August 14, 1996, and shall remain effective
until December 31, 2000.
4. A new Subpart M is added consisting of Secs. 141.140 through
141.144 to read as follows:
Subpart M--Information Collection Requirements (ICR) for Public
Water Systems
Sec.
141.140 Definitions specific to subpart M.
141.141 General requirements, applicability, and schedule for
information collection.
141.142 Disinfection byproduct and related monitoring.
141.143 Microbial monitoring.
141.144 Disinfection byproduct precursor removal studies.
Subpart M--Information Collection Requriements (ICR) for Public
Water Systems
Sec. 141.140 Definitions specific to subpart M.
The following definitions apply only to the requirements of subpart
M of this part and are arranged alphabetically.
Distribution system means the components of a PWS that are under
the control of that PWS located after the point where the finished
water sample is taken and that provide distribution, storage, and/or
booster disinfection of finished water.
Distribution System Equivalent (DSE) sample means a sample
collected from the distribution system for the purpose of comparing it
with the ``simulated distribution system (SDS) sample''. The DSE sample
shall be selected using the following criteria:
(1) No additional disinfectant added between the treatment plant
and the site where the DSE sample is collected;
(2) Approximate detention time of water is available; and
(3) There is no blending with finished water from other treatment
plants.
Entry point to distribution system means a location following one
or more finished water sample points but prior to the beginning of the
distribution system.
Finished water means water that does not undergo further treatment
by a treatment plant other than maintenance of a disinfection residual.
Haloacetic acids (five) (HAA5) means the sum of the concentration
in micrograms per liter of the haloacetic acids mono-, di-, and
trichloroacetic acid; mono-, and di-, bromoacetic acid, rounded to two
significant figures.
Haloacetic acids (six) (HAA6) means the concentration in micrograms
per liter of the haloacetic acids mono-, di-, and trichloroacetic
acid; mono-, and di- bromoacetic acid; and bromochloroacetic acid,
rounded to two significant figures.
Haloacetonitriles (HAN) means the concentration in micrograms per
liter of the haloacetonitriles dichloro-, trichloro-, bromochloro-, and
dibromo- acetonitrile, rounded to two significant figures.
Haloketones (HK) means the concentration in micrograms per liter of
the haloketones 1,1-dichloropropanone and 1,1,1- trichloropropanone,
rounded to two significant figures.
Intake means the physical location at which the PWS takes water
from a water resource. Thereafter, the water is under the control of
that PWS.
Notice of applicability means a notice sent by EPA to a PWS that
indicates that EPA believes that the PWS must comply with some or all
requirements of subpart M. The PWS is required to reply to this notice
by providing information specified in the notice (e.g., retail and
wholesale population served, types of water sources used, volume of
water treated) by the date provided in subpart M.
Process train means some number of unit processes connected in
series starting from the treatment plant influent and ending with
finished water. A particular unit process may be in more than one
process train.
Purchased finished water means finished water purchased by one PWS
from another PWS (the wholesaler). Purchased finished water includes
both purchased finished water that is redisinfected and purchased
finished water that is not.
Simulated distribution system (SDS) sample means a finished water
sample incubated at the temperature and detention time of a ``DSE
sample'' collected from the distribution system. Analytical results of
the SDS sample will be compared with the DSE sample to determine how
well the SDS sample predicts disinfection byproduct formation in the
actual distribution system sample.
Total finished water means the flow (volume per unit of time) of
finished water obtained from all treatment plants operated by a PWS and
includes purchased finished water. This flow includes water entering
the distribution system and water sold to another PWS.
Treatment plant means the PWS components that have as their
exclusive source of water a shared treatment plant influent and that
deliver finished water to a common point which is located prior to the
point at which finished water enters a distribution system or is
diverted for sale to another PWS. For these components of the PWS to be
considered part of one treatment plant, the PWS must be able to collect
one representative treatment plant influent sample, either at a single
sample point or by a composite of multiple influent samples, and there
must exist a single sampling point where a representative sample of
finished water can be collected. For the purpose of subpart M, a
treatment plant is considered to include any site where a disinfectant
or oxidant is added to water prior to the water entering the
distribution system. Facilities in which ground water is disinfected
prior to entering a distribution system, and facilities in which
purchased finished water has a disinfectant added prior to entering a
distribution system, are considered treatment plants.
Treatment plant influent means water that represents the water
quality challenge to a particular plant.
Treatment system means all treatment plants operated by one PWS.
Trihalomethanes (four) (THM4) means the sum of the concentration in
micrograms per liter of the trihalomethanes chloroform,
bromodichloromethane, dibromochloromethane, and bromoform, rounded to
two significant figures.
Unit process means a component of a treatment process train which
serves any treatment purpose such as mixing or sedimentation for which
design and operating information is requested in Sec. 141.142(a), Table
6c, of this subpart.
Water resource means a body of water before it passes through an
intake structure. Examples of a water resource
[[Page 24369]]
include a river, lake, or aquifer. For a PWS which purchases finished
water, the water resource is the wholesale PWS which supplies the
purchased finished water. Generally water resources are not under the
direct control of a PWS.
Watershed control practice means protection of a water resource
from microbiological contamination prior to the water entering an
intake. These protective measures might include, but are not limited
to, a watershed control program approved under Sec. 141.71(b)(2) of
this part, or land use restrictions.
Sec. 141.141 General requirements, applicability, and schedule for
information collection.
(a) General requirements. (1) The purpose of subpart M is to
collect specified information from certain PWSs for a limited period of
time. Accordingly, subpart M is of limited duration and is effective
for a defined period (see Sec. 141.6 (i) and Sec. 141.141(e) of this
part). Since subpart M does not establish continuing obligations, a PWS
that has completed all of its requirements at the required duration and
frequency may discontinue its information collection efforts even if
subpart M is still in effect.
(2) For the purpose of this subpart, a PWS shall make applicability
determinations based on completion of data gathering, calculations, and
treatment plant categorization specified in Appendix A to paragraph (a)
of this section.
(3) For the purpose of this subpart, a PWS that uses multiple wells
drawing from the same aquifer and has no central treatment plant is
considered to have one treatment plant for those wells and shall
conduct required monitoring under this specification. A PWS with
multiple wells in one or more aquifers that are treated in the same
treatment plant is considered to have one treatment plant for those
wells and shall conduct required monitoring under this specification.
(i) To the extent possible, the PWS should sample at the well with
the largest flow and at the same well each month for the duration of
required monitoring.
(ii) A PWS must report information from Sec. 141.142(a) Tables 6a
through 6e of this subpart for each well that the PWS sampled.
(4) For the purpose of this subpart, a PWS shall treat ground water
sources that have been classified by the State as under the direct
influence of surface water by May 14, 1996, as surface water sources. A
PWS shall treat ground water sources that either have not been
classified by the State (as under the direct influence of surface water
or not) or have been classified by the State as ground water, by May
14, 1996, as ground water sources.
Appendix A to 40 CFR 141.141(a)
Purpose. The purpose of this appendix is to enable the PWS to
assign proportional amounts of its retail and wholesale population
served to specific treatment plants. The PWS shall then use these
values to determine which specific requirements in subpart M that it
must comply with and on what schedule.
Period of applicability determination. For the purpose of this
appendix, a PWS shall make applicability determinations based on
population calculated as annual averages based on PWS records of
treatment system or treatment plant operation during calendar year
1995.
--If a natural disaster made a treatment system or treatment plant
inoperable for one or more calendar months in 1995, the
applicability determination will be based on those months in 1995
during which the treatment system or treatment plant was in
operation, plus the calendar months from 1994 that are
representative of those months of 1995 during which the treatment
system or treatment plant was inoperable. The total time period
shall be 12 months.
--If the treatment system or treatment plant was not in operation
during one or more calendar months during 1995 due to a seasonal
reduction in demand for finished water, the months that the
treatment system or treatment plant was not in operation are to be
included in the 12 months of applicability determination with zero
flow indicating no operation.
--If the treatment system or treatment plant was not in operation
for one or more calendar months in 1995 due to construction and/or
maintenance, the applicability determination will be based on those
months in 1995 during which the treatment system or treatment plant
was in operation, plus the calendar months from 1994 that correspond
to those months of 1995 during which the treatment system or
treatment plant was inoperable. The total time period shall be 12
months.
--Treatment systems or treatment plants whose total operational
lifetime is fewer than 12 calendar months as of December 1995 are
not required to comply with subpart M requirements.
--PWSs that purchase all their water from one or more other PWSs and
do not further treat any of their water are not required to comply
with subpart M requirements.
Applicability determination. To determine applicability, the PWS
is required to collect certain operational data and perform
specified mathematical operations. All operational data and
calculated values will be expressed as either ``F'' (for flow) or
``P'' (for population), with a one or two character subscript. Table
A-1 contains a more detailed explanation.
Table A-1.--: Appendix A Subscript Identification Protocol
General.
1. ``F'' indicates a flow value. The PWS must use million gallons per
day (MGD) to express the flow throughout its calculations.
2. ``P'' indicates a population value, expressed as a number of people.
Subscripts.
1. ``PR'' is retail population, ``FW'' is wholesale flow, and ``FN'' is
purchased finished water that is not further treated.
2. Each ``F'' value (in Table A-2) or ``P'' value (in Table A-4) will
have a two character designator.
a. The first character in the subscript indicates the source type.
Possible entries are ``S'' (for surface water or ground water under
the direct influence of surface water), ``G'' (for ground water not
under the direct influence of surface water), ``P'' (for finished
water purchased from another PWS and further treated at the
entrance to the distribution system, such as by redisinfection),
and ``C'' (for combined, or the sum of all water treated by the
PWS, including purchased water that is further treated at the
entrance to the distribution system).
b. The second character in the subscript indicates the specific
identification of the treatment plant. This will be a number (e.g.,
1, 2, 3, * * *, with # being a non-specific designator) and ``T''
(for a Total).
[[Page 24370]]
Data from operational records. The PWS shall determine the
following information based on operational records.
--PR=Retail population served by the PWS
=________ (number of people)
--FN=treated water bought from one or more other PWSs and not
further treated at the entry point to the distribution system
=________ (MGD)
--FW= finished water sold to one or more other PWSs, regardless
of whether buying PWSs further treat the finished water
=________ (MGD)
--Flows from specific water resources to specific treatment plants.
For each treatment plant operated by the PWS, the PWS must determine
the flow from each water resource that provides water to the
treatment plant. In the following table, the PWS must enter flow
from each type of water resource into the appropriate block, using
the subscript identification protocol in Table A-1.
--FS#=surface water treated at treatment plant ``#''
=________ (MGD) (enter into Table A-2)
--FG#=ground water treated at treatment plant ``#''
=________ (MGD) (enter into Table A-2)
--FP#=treated water bought from one or more other PWSs and
further treated at treatment plant ``#'' prior to the entry point to
the distribution system
=________ (MGD) (enter into Table A-2)
Table A-2.--Treated Flow Values
----------------------------------------------------------------------------------------------------------------
Sources of treated water (FLOW)
------------------------------------------------------------------------------
Water resources (by type source) Treatment plants
------------------------------------------------------------------------------
#1 #2 #3 #4
----------------------------------------------------------------------------------------------------------------
Surface water (S)................ (FS1) (FS2) (FS3) (FS4)
Ground water (G)................. (FG1) (FG2) (FG3) (FG4)
Purchased finished water that is (FP1) (FP2) (FP3) (FP4)
further treated (P).
Combined (C)..................... (FC1) (FC2) (FC3) (FC4)
----------------------------------------------------------------------------------------------------------------
Note: The FC# value is calculated by adding the FS#, FG#, and FP# values in the column above.
--FCT=finished water produced in all of the PWS's treatment
plants (calculated by adding the combined flows from each treatment
plant ( (FC#)).
=________ (MGD)
Calculated values. The PWS must calculate the following values.
--Population equivalents. Divide the flow values in Table A-2 by the
conversion factor K below (a PWS-specific per capita finished water
usage rate) and enter in the corresponding box in Table A-3 below.
For each treatment plant operated by the PWS, the PWS must determine
the population served by each type of water resource that provides
water to the treatment plant.
Conversion factor=K=(FCT+FN-FW)/PR=________
For Table A-3, P=F/K, using F values from Table A-2 (e.g.,
PS1=FS1/K).
Table A-3: Population Served Values
----------------------------------------------------------------------------------------------------------------
Population served by treated water (number of people)
------------------------------------------------------------------------------
Water resources (by type source) Treatment plants
------------------------------------------------------------------------------
#1 #2 #3 #4
----------------------------------------------------------------------------------------------------------------
Surface water (S)................ (PS1) (PS2) (PS3) (PS4)
Ground water (G)................. (PG1) (PG2) (PG3) (PG4)
Purchased finished water that is (PP1) (PP2) (PP3) (PP4)
further treated (P).
Combined (C)..................... (PC1) (PC2) (PC3) (PC4)
----------------------------------------------------------------------------------------------------------------
Note: The PC# value is calculated by adding the PS#, PG#, and PP# values in the column above.
--PCT=number of people served by finished water produced in all
of the PWS's treatment plants (calculated by adding the combined
populations served by each treatment plant ( (PC#)))
=________ (people)
Note: A PWS that sells all its finished water and thus has no
retail population must calculate the population served by the PWS by
raising the PWS's average treated flow (in MGD) to the 0.95 power
and multiplying the result by 7,700. As an equation, this would
appear as:
PWS population served=7,700 (PWS's average treated flow in
MGD)0.95
The PWS may then calculate the population served by each of its
treatment plants by multiplying the PWS population served times the
average treated flow from the treatment plant divided by the average
treated flow for the PWS. As an equation, this would appear as:
[GRAPHIC] [TIFF OMITTED] TR14MY96.001
Treatment plant categorization. A PWS must categorize its
treatment plants to determine its specific compliance requirements
by reviewing Table A-4 below.
[[Page 24371]]
Table A-4.--Treatment Plant Categories
----------------------------------------------------------------------------------------------------------------
Treatment plant category PCT PC# PS# PG#
----------------------------------------------------------------------------------------------------------------
A.............................. 100,00 100,000.... 1..... NA.
0.
B.............................. 100,00 100,000.... Zero............. NA.
0.
C.............................. 100,00 PC# is <100,000 and is 1..... NA.
0. largest PC# in PWS.
D.............................. 100,00 PC# is <100,000 and is Zero............. NA.
0. largest PC# in PWS.
E.............................. 100,00 <100,000 and is not 1..... NA.
0. largest PC# in PWS.
F.............................. 100,00 <100,000 and is not Zero............. NA.
0. largest PC# in PWS.
G.............................. 50,000-99,999 and NA.................... NA............... Largest PG#.
PGT
50,000.
----------------------------------------------------------------------------------------------------------------
NA--not applicable.
(b) Applicability.
(1) Table 1 of this paragraph is a summary of treatment plant
categorization under the provisions of Appendix A to paragraph (a)
of this section.
Table 1.--Treatment Plant Categories
----------------------------------------------------------------------------------------------------------------
Treatment plant Treatment plant Treatment plant
Treatment plant category PWS combined combined population surface water ground water
population served served population served population served
----------------------------------------------------------------------------------------------------------------
A.............................. 100,00 100,000.... 1..... NA.
0.
B.............................. 100,00 100,000.... zero............. NA.
0.
C.............................. 100,00 Plant serves <100,000 1..... NA.
0. and is largest plant.
D.............................. 100,00 Plant serves <100,000 zero............. <100,000.
0. and is largest plant.
E.............................. 100,00 Plant serves <100,000 1..... NA.
0. and is not largest
plant in PWS.
F.............................. 100,00 Plant serves <100,000 zero............. <100,000.
0. and is not largest
plant in PWS.
G.............................. 50,000-99,999 and NA.................... NA............... Largest ground
water plant.
50,000 served by
ground water.
----------------------------------------------------------------------------------------------------------------
NA-not applicable.
(2) Table 2 of this paragraph specifies applicability for
requirements contained in Secs. 141.142, 141.143, and 141.144 of
this part, based on treatment plant categorization determined under
the provisions of Appendix A to paragraph (a) of this section.
Table 2--Subpart M Applicability
--------------------------------------------------------------------------------------------------------------------------------------------------------
Categories of treatment plants1
Subpart M Requirements -------------------------------------------------------------------------------------------------
A B C D E F G
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 141.142.--DBP and Related Monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 1a and 1b....................................... X X X X X X ............
Table 22.............................................. X X X X X X ............
Table 32.............................................. X X X X X X ............
Table 4a and 4b2...................................... X X X X X X ............
Table 5a and 5b2...................................... X X X X X X ............
Table 6............................................... X X X X X X ............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 141.143--Microbiological Monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
Treatment plant influent monitoring................... X ............ X ............ X ............ ............
Finished water monitoring3............................ X ............ X ............ X ............ ............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 141.144--Applicability Monitoring and Treatment Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Treatment study applicability monitoring.............. X X X X ............ ............ X
Pilot-scale treatment studies4........................ X X ............ ............ ............ ............ ............
Bench- or pilot-scale treatment studies4.............. X X X X ............ ............ X
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 As determined by Appendix A to paragraph (a) of this section.
2 Table 2 required only for treatment plants using chloramines. Table 3 required only for treatment plants using hypochlorite solution. Table 4a and 4b
required only for treatment plants using ozone. Table 5a and 5b required only for treatment plants using chlorine dio xide.
[[Page 24372]]
3 Only required for a PWS that, during any of the first twelve months of monitoring at the treatment plant influent, detects 10 or more Giardia cysts,
or 10 or more Cryptosporidium oocysts, or one or more total culturable viruses in one liter of water; or calculates a numerical value of the Giardia
or Cryptosporidium concentration equal to or greater than 1000 per 100 liters or virus concentration equal to or greater than 100 per 100 liters; or
detects no pathogens in the sample and calculates a numerical value of the detection limit for Giardia or Cryptosporidium concentration equal to or
greater than 1000 per 100 liters or virus concentration equal to or greater than 100 per 100 liters.
4 Pilot-scale treatment studies are required for treatment plants that serve a population of 500,000 or greater. Bench- or pilot-scale treatment studies
are required for treatment plants that serve a population of fewer than 500,000.
(c) Disinfection Byproduct and Related Monitoring. A PWS must
comply with the monitoring requirements in Sec. 141.142 of this
subpart for treatment plants in treatment plant categories A, B, C,
D, and E listed in Table 1 in paragraph (b)(1) of this section. The
PWS shall monitor monthly for 18 consecutive months at each
treatment plant, even if a treatment plant was not used for one or
more calendar months. When the treatment plant is not operating, the
PWS shall file the report required under Sec. 141.142(c) of this
subpart to indicate zero flow, and need only conduct treatment plant
influent monitoring under the provisions of Sec. 141.142 of this
subpart. A PWS must comply with the monitoring requirements in
Sec. 141.142 of this subpart for treatment plants in treatment plant
categories F listed in Table 1 in paragraph (b)(1) of this section
monthly for 18 consecutive months at each treatment plant, except if
a treatment plant was not used for one or more calendar months. When
the treatment plant is not operating, the PWS shall file the report
required under Sec. 141.142(c) of this subpart to indicate zero
flow, and is not required to conduct treatment plant influent
monitoring under the provisions of Sec. 141.142 of this subpart.
(d) Microbiological Monitoring. A PWS must comply with the
monitoring requirements in Sec. 141.143 of this subpart for
treatment plants in treatment plant categories A, C, and E listed in
Table 1 in paragraph (b)(1) of this section and Table 3 of this
paragraph. The PWS shall conduct 18 consecutive months of
microbiological monitoring at each treatment plant, even if it is
not operated each calendar month.
Table 3.--Microbiological Monitoring Requirements for Subpart M
------------------------------------------------------------------------
Treatment plant category
---------------------------------------
A, C and E
Microbial sample ---------------------------------------
Treatment plant
influent Finished water \1\
------------------------------------------------------------------------
Total culturable viruses........ 1/month \2\....... 1/month.
Total coliforms................. 1/month........... 1/month.
Fecal coliforms or E. coli...... 1/month........... 1/month.
Giardia......................... 1/month........... 1/month.\3\
Cryptosporidium................. 1/month........... 1/month.\3\
------------------------------------------------------------------------
\1\ Only required for a PWS that, during any of the first twelve months
of monitoring at the treatment plant influent, detects 10 or more
Giardia cysts, or 10 or more Cryptosporidium oocysts, or one or more
total culturable viruses in one liter of water; or calculates a
numerical value of the Giardia or Cryptosporidium concentration equal
to or greater than 1000 per 100 liters or virus concentration equal to
or greater than 100 per 100 liters; or detects no pathogens in the
sample and calculates a numerical value of the detection limit for
Giardia or Cryptosporidium concentration equal to or greater than 1000
per 100 liters or virus concentration equal to or greater than 100 per
100 liters. The PWS shall collect one sample of finished water during
each month that the treatment plant is operated at each such treatment
plant beginning in the first calendar month after the PWS learns of
such a result. A PWS shall continue finished water monitoring monthly
until 18 months of treatment plant influent monitoring has been
completed.
\2\ A PWS may avoid virus monitoring if the PWS has monitored total
coliforms, fecal coliforms, or E. coli in the source water for at
least five days/week for any period of six consecutive months
beginning after January 1, 1994, and 90% of all samples taken in that
six-month period contained no greater than 100 total coliforms/100 ml,
or 20 fecal coliforms/100 ml, or 20 E. coli/100 ml.
\3\ A PWS may avoid the requirement for finished water monitoring of
Giardia and Cryptosporidium if the PWS notifies EPA that it will
comply with the alternative monitoring requirements in Sec.
141.143(a)(2)(iii). The PWS must still conduct finished water
monitoring for all other microorganisms, except that Giardia and
Cryptosporidium monitoring in the finished water is not required.
(e) Disinfection Byproduct Precursor Removal Studies (Treatment
Studies).
(1) A PWS shall comply with treatment study applicability
monitoring in paragraph (e)(2) of this section at each treatment
plant in treatment plant categories A, B, C, D, and G listed in
Table 1 in paragraph (b)(1) of this section. A PWS shall comply with
the treatment study requirements in Sec. 141.144 of this subpart at
each such treatment plant, except for those treatment plants:
(i) Meeting the source water quality, disinfection practice, or
disinfection byproduct precursor removal practice criteria in
paragraph (e)(3) of this section, for which no treatment study is
required; or
(ii) Meeting the common water resource criteria in paragraph
(e)(4) of this section, for which several PWSs may conduct treatment
studies jointly, in lieu of separately; or
(iii) Meeting the common water resource criteria in paragraph
(e)(5) of this section, for which a PWS may contribute funds towards
research, in lieu of conducting a treatment study; or
(iv) At which a previous treatment study that meets the criteria
in paragraph (e)(6) of this section has already been conducted, for
which a PWS may use the results of this previous treatment study, in
lieu of conducting another treatment study; or
(v) Operated by the PWS that use the same water resource, as
classified by the procedure in paragraph (e)(4) of this section. The
PWS is not required to conduct more than one treatment study for
those treatment plants. If both pilot-scale and bench-scale
treatment studies would otherwise be required for treatment plants
on the same water resource, the PWS shall conduct a pilot-scale
study. A PWS with multiple water resources shall conduct treatment
studies for each treatment plant that uses different water
resources.
(2) Treatment study applicability monitoring.
(i) PWSs shall monitor total organic carbon (TOC) monthly for 12
months. Treatment plants using surface water shall monitor treatment
plant influent. Treatment plants using ground water shall monitor
finished water.
(ii) Treatment study applicability monitoring for THM4 and HAA5
is only required by a PWS that intends to qualify for avoiding a
treatment study under the provisions of paragraph (e)(3)(i) of this
section.
(iii) Total organic halides formed under the uniform formation
conditions (UFCTOX) monitoring is only required by a PWS that
intends to qualify for a joint treatment study under the provisions
of paragraph (e)(4)(i)(A)(2) of this section or for the alternative
to conducting a treatment study under the provisions of paragraph
(e)(5) of this section.
(3) Criteria under which no treatment study is required. A PWS
identified in paragraph (e)(1) of this section is not required to
conduct a treatment study at any treatment plant that satisfies any
criteria in paragraphs (e)(3) (i) through (iv) of this section,
provided that the PWS has also complied with the requirements in
paragraph (e)(7)(i) of this
[[Page 24373]]
section and EPA has approved the PWS's request to avoid the
treatment study.
(i) Treatment plants that use chlorine as both the primary and
residual disinfectant and have, as an annual average of four
quarterly averages, levels of less than 40
g/l for THM4 and less than 30 g/l for HAA5. Quarterly
averages are the arithmetic average of the four distribution system
samples collected under the requirements of Sec. 141.142(a)(1) of this
subpart.
(ii) Treatment plants using surface water that do not exceed a
TOC annual average of 4.0 mg/l in the treatment plant influent,
measured in accordance with Secs. 141.141(f)(4) and 141.144(a) of
this subpart and calculated by averaging the initial 12 monthly TOC
samples.
(iii) Treatment plants using only ground water not under the
direct influence of surface water that do not exceed a TOC annual
average of 2.0 mg/l in the finished water, measured in accordance
with Secs. 141.141(f)(4) and 141.144(a) of this subpart and
calculated by averaging the initial 12 monthly TOC samples.
(iv) Treatment plants that already use full scale membrane or
GAC technology. For a treatment plant that already uses full-scale
GAC or membrane technology capable of achieving precursor removal, a
PWS shall conduct monitoring and submit full-scale plant data
required for disinfection byproduct and related monitoring by
Sec. 141.142(a) of this subpart, ensuring that the GAC or membrane
processes are included in the process train being monitored. For a
treatment plant to be considered to have membrane technology to
achieve precursor removal, the PWS shall have used nanofiltration or
reverse osmosis membranes. GAC capable of removing precursors is
defined as GAC with an empty bed contact time (EBCT) of 15 minutes
or greater, with a time between carbon reactivation or replacement
of no more than nine months. PWSs that operate treatment plants that
use GAC with either an EBCT of less than 15 minutes or a replacement
or reactivation frequency for GAC longer than nine months may submit
a request to avoid treatment studies under the provisions of
paragraph (e)(7)(i) of this section by including data demonstrating
effective DBP precursor removal.
(4) Criteria under which joint treatment studies are allowed.
(i) PWSs that use common water resources and have similar treatment
trains may conduct joint treatment studies. A common water resource
for all types of surface water resources requires the mean treatment
plant influent TOC or UFCTOX of each of the cooperating treatment
plants to be within 10% of the average of the mean treatment plant
influent TOCs or UFCTOX of all the cooperating treatment plants. A
common water resource for all types of ground water resources
requires the mean treatment plant finished water TOC or UFCTOX of
each of the cooperating treatment plants to be within 10% of the
average of the mean treatment plant finished water TOCs or UFCTOX of
all the cooperating treatment plants. The mean is calculated from
the monthly TOC or UFCTOX monitoring data for the initial twelve
months of monitoring under Sec. 141.144(a) of this subpart. Similar
treatment trains means that, for example, softening plants may not
conduct joint studies with conventional treatment plants. In
addition, the applicable requirements in paragraphs (e)(4)(i) (A)
through (C) of this section shall be met for the water resource to
be considered a common water resource. If otherwise eligible, a PWS
may choose to either perform a joint treatment study with other
eligible systems or contribute funds to a cooperative research
program, as described in paragraph (e)(5) of this section, as an
alternative to conducting a treatment study.
(A) River sources. Treatment plants with river intakes are
considered to have a common water resource if the PWS meets either
criteria in paragraphs (e)(4)(i)(A) (1) or (2) of this section.
(1) The intakes are no more than 20 river miles apart and TOC at
each treatment plant influent is within 10% of the mean TOC of all
the treatment plant influents.
(2) The intakes are at least 20, but no more than 200, river
miles apart and the PWS demonstrates that the mean water resource
UFCTOX is within 10% of the mean UFCTOX of all the treatment plant
influents, based on UFCTOX analytical results of the same 12
consecutive months for all cooperating treatment plants.
(B) Lake/reservoir. Treatment plants with lake or reservoir
intakes are considered to have a common water resource if the same
lake or reservoir serves all the cooperating treatment plants and
TOC at each treatment plant influent is within 10% of the mean TOC
of all the treatment plant influents.
(C) Ground water not under the direct influence of surface
water. Treatment plants with intakes from a single aquifer are
considered to have a common water resource if treatment plant
finished water TOC at each treatment plant is within 10% of the mean
finished water TOC of all the treatment plants.
(ii) PWSs that meet the requirements of paragraph (e)(4)(i) of
this section shall conduct at least the number and type of joint
studies noted in the following tables. Joint studies shall only be
conducted among treatment plants in the same size category, i.e. a
population served of either 500,000 or of <500,000. The
maximum number of treatment plants with a population served
500,000 persons allowed to join together to conduct a
study is three. The maximum number of treatment plants with a
population served <500,000 persons allowed to join together to
conduct a study is six.
Joint Studies Requirement for Treatment Plants With a Population Served
of <500,000
------------------------------------------------------------------------
Number of plants Minimum studies to be conducted
------------------------------------------------------------------------
2............................. 1 pilot (GAC or membrane).
3............................. 1 pilot and 1 bench (GAC or membrane).
4............................. 2 pilots (GAC and/or membrane).
5............................. 2 pilots (GAC and/or membrane), 1 bench
(GAC or membrane).
6............................. 2 pilots and 2 bench (GAC and/or
membrane).
------------------------------------------------------------------------
Joint Studies Requirement For Treatment Plants With a Population Served
of 500,000
------------------------------------------------------------------------
Number of plants Minimum studies to be conducted
------------------------------------------------------------------------
2............................. 1 pilot (GAC or membrane), 2 bench (GAC
and/or membrane).
3............................. 2 pilots (GAC and/or membrane).
------------------------------------------------------------------------
(5) Criteria under which an alternative to conducting a
treatment study is allowed. In lieu of conducting the required
treatment study, a PWS may apply to EPA to contribute funds to a
cooperative research effort. The PWS shall submit an application to
EPA Technical Support Division, ICR Precursor Removal Studies
Coordinator, 26 W. Martin Luther King Drive, Cincinnati, OH 45268.
The application shall show that the treatment plant for which the
waiver of the treatment study is sought uses a common water
resource, as described in paragraph (e)(4) of this section, that is
being studied by another PWS or cooperative of PWSs operating
treatment plants in the same size category. A PWS operating
treatment plants serving a population of fewer than 500,000 may also
contribute to this fund if there is a common water resource (as
defined in paragraph (e)(4) of this section) treatment plant serving
500,000 or more conducting a treatment study. If EPA approves the
application, the PWS shall contribute funds in the amount specified
in paragraph (e)(5)(i) of this section to the Disinfection
Byproducts/Microbial Research Fund, to be administered by the
American Water Works Association Research Foundation (AWWARF) under
the direction of an independent research council, for use in a
dedicated cooperative research program related to disinfectants,
disinfection byproducts, and enhanced surface water treatment.
(i) The PWS shall contribute $300,000 for a treatment plant with
a population served of 500,000 or more. The PWS shall contribute
$100,000 for a treatment plant with a population served of fewer
than 500,000.
(ii) The PWS shall send the contribution to the address
specified in EPA's approval letter not later than 90 days after EPA
approves the PWS application for waiver of the treatment study.
(6) Criteria under which a previous treatment study is
acceptable (grandfathered studies). A PWS that has conducted studies
of precursor removal that meet all the criteria in paragraphs
(e)(6)(i) and (ii) of this section may use the results of that study
in lieu of conducting another treatment study.
[[Page 24374]]
(i) The PWS used analytical methods specified in Table 7 of
Sec. 141.142(b)(1) of this subpart and used the analytical and
quality control procedures described in ``DBP/ICR Analytical Methods
Manual'', EPA 814-B-96-002.
(ii) The PWS followed a protocol similar to that specified and
supplies the data specified in ``ICR Bench- and Pilot-scale
Treatment Study Manual'' (EPA 814-B-96-003, April 1996).
(7) Process for a PWS to obtain EPA approval of criteria
applicability. A PWS wanting to avoid the requirements for a
treatment study under the provisions of paragraphs (e)(3) through
(6) of this section shall submit the applicable information in
paragraphs (e)(7)(i) through (iv) of this section and in ``ICR
Bench- and Pilot-scale Treatment Study Manual'' (EPA 814-B-96-003,
April 1996) and all monitoring data required under Secs. 141.142(a)
and 141.143(a) of this subpart to EPA, Technical Support Division,
ICR Precursor Removal Studies Coordinator, 26 W. Martin Luther King
Drive, Cincinnati, OH 45268.
(i) Approval of request to avoid treatment studies. A PWS that
believes it qualifies to avoid the requirements for a treatment
study under the provisions of paragraph (e)(3)(i) through (iii) of
this section shall submit the information showing the applicable
criterion for not conducting the study has been met not later than
November 14, 1997. A PWS wanting to avoid the requirements for a
treatment study under the provisions of paragraph (e)(3)(iv) of this
section shall submit the supporting information, including any
pilot- or full-scale data showing effective precursor removal, not
later than November 14, 1997. A PWS that applies to avoid a
treatment study under the provisions of paragraph (e)(4) through (6)
of this section and subsequently qualifies to avoid a treatment
study under the provisions of paragraph (e)(3)(i) through (iii) of
this section may elect to avoid a treatment study under the
provisions of paragraph (e)(3)(i) through (iii) of this section. If
the PWS elects to avoid a treatment study under the provisions of
paragraph (e)(3)(i) through (iii) of this section, the PWS shall
notify all PWSs that were associated with the application to avoid a
treatment study under the provisions of paragraph (e)(4) through (6)
of this section.
(ii) Approval of request to conduct joint studies. A PWS that
believes it qualifies to avoid the requirements for a treatment
study under the joint study provisions of paragraph (e)(4) of this
section shall submit a letter of intent to EPA with the information
in paragraphs (e)(7)(ii)(A) through (F) of this section for all
treatment plants to be included in the joint study not later than
May 14, 1997. The letter shall be signed by all PWSs planning to
participate in the joint study. All PWSs shall submit a combined
application for joint studies approval to EPA (including 12 months
of treatment plant influent TOC or finished water TOC results or
UFCTOX results, as appropriate, for each treatment plant to be
included in the joint study) not later than November 14, 1997.
(A) Data to support their common water resource designation.
(B) Information to demonstrate that treatment plants have
similar treatment trains.
(C) Information that treatment plants are in the same size
category.
(D) The treatment plant influent TOC or finished water TOC
results, or UFCTOX results, as appropriate, from the first six
months of monitoring.
(E) What studies will be conducted (i.e., combination of bench/
pilot and GAC/membrane).
(F) Any additional supporting data.
(iii) Approval of request for alternative to treatment studies.
A PWS that believes it qualifies to avoid the requirements for a
treatment study under the provisions for an alternative in paragraph
(e)(5) of this section shall submit a letter of intent expressing
its intention to contribute funds to the cooperative research effort
not later than May 14, 1997. The letter shall identify the other
treatment plants using the same water resource which will be
conducting studies. Each PWS shall submit an application for
approval of alternative to treatment studies to EPA (including 12
months of treatment plant influent TOC or finished water TOC results
or UFCTOX results, as appropriate) not later than November 14, 1997.
EPA shall notify the PWS whether a treatment study is required
(because there is no other appropriately sized treatment plant using
the same water resource conducting a treatment study) or if the PWS
can avoid the study by contributing funds to the cooperative
research effort specified in paragraph (e)(5) of this section.
(iv) Approval of request to use grandfathered studies. A PWS
that believes it qualifies to avoid the requirements for a treatment
study under the grandfathered study provisions of paragraph (e)(6)
of this section shall submit the following information not later
than February 14, 1997: a description of the study, the equipment
used, the experimental protocol, the analytical methods, the quality
assurance plan, and any reports resulting from the study. EPA shall
review the information and inform the PWS whether or not the prior
study meets the ICR requirements. Not later than November 14, 1997,
the PWS must submit study data in the format specified in ``ICR
Manual for Bench- and Pilot-scale Treatment Studies'', EPA 814-B-96-
003, April 1996. An approved grandfathered study can be
justification for common water resource PWSs contributing to the
cooperative research effort under the provisions of paragraph (e)(5)
of this section, but may not be used as joint treatment studies
unless it incorporates the requirements listed in Sec. 141.141(e)(4)
of this section and the PWS submits written concurrence of the PWS
which conducted the study.
(f) Effective dates. (1) A PWS shall respond to the Notice of
Applicability sent by EPA within 35 calendar days of receipt of that
notice. The PWS's response to the Notice shall indicate what
requirements in subpart M apply to each treatment plant operated by
the PWS. If a PWS meets the applicability criteria in paragraph (b)
of this section and has not received a Notice of Applicability from
EPA by June 28, 1996, that PWS must request a Notice of
Applicability from EPA by contacting the ICR Utilities Coordinator,
TSD, USEPA, 26 West Martin Luther King Drive, Cincinnati, OH 45268,
not later than July 15, 1996.
(2) A PWS required to monitor under both paragraphs (c) and (d)
FR Doc. 96-11370 National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies: Cryptosporidium, Giardia, Viruses, Disinfection Byproducts, Water Treatment Plant Data and Other Information Requirements
of this section shall begin monitoring to comply with the provisions
of Sec. 141.142 (Disinfection Byproduct and Related Monitoring) and
Sec. 141.143 (Microbiological Monitoring) of this subpart in the
same month. The PWS must submit the sampling plans required by
Secs. 141.142(c)(2)(ii) and 141.143(c)(3)(ii) of this subpart at the
same time.
(3) Disinfection Byproduct and Related Monitoring. A PWS
operating a treatment plant required to comply with Sec. 141.142 of
this subpart shall begin monitoring in the calendar month following
approval of the DBP and related monitoring sampling plan submitted
under the provisions of Sec. 141.142(c)(2)(ii) of this subpart. Once
a PWS has begun monitoring, it shall continue to monitor for 18
consecutive months.
(4) Microbiological Monitoring. A PWS operating a treatment
plant identified in paragraph (d) of this section shall begin
monitoring under the provisions of Sec. 141.143 of this subpart in
the calendar month following approval of the sampling plan submitted
under the provisions of Sec. 141.143(c)(3)(ii) of this subpart. Once
a PWS has begun monitoring, it shall continue to monitor for 18
consecutive months.
(5) DBP precursor removal studies. (i) TOC, UFCTOX, THM4, and
HAA5 monitoring. A PWS required to comply with Sec. 141.144 of this
subpart shall begin TOC, UFCTOX, THM4, and HAA5 monitoring specified
in paragraph (e)(2) of this section not later than August 14, 1996
and continue this monitoring for 12 consecutive months for TOC and
UFCTOX and four consecutive quarters for THM4 and HAA5.
(ii) A PWS required to conduct a disinfection byproduct
precursor removal study (treatment study) under the provisions of
paragraph (e)(1) of this section shall begin conducting such
treatment studies not later than April 14, 1998 and submit the
report(s) of the completed study to EPA not later than July 14,
1999.
Sec. 141.142 Disinfection byproduct and related monitoring.
(a) Monitoring requirements. Samples taken under the provisions of
this section shall be taken according to the procedures described in
the ``ICR Sampling Manual,'' EPA 814-B-96-001, April 1996. If a
treatment plant configuration results in two required sampling points
from any table in this section when in fact it is a single location,
duplicate analyses are not required for the same location and time. A
PWS that uses purchased finished water shall determine whether any
monitoring of treatment plant influent is required under paragraphs
(a)(2) through (5) of this section because of certain treatment (e.g.,
use of hypochlorite or chlorine dioxide) of the water provided by the
selling PWS.
[[Page 24375]]
(1) A PWS shall obtain a complete set of samples at the frequency
and location noted in Tables 1a and 1b of this section for treatment
plants required to test under Sec. 141.141(b) of this subpart. Samples
shall be taken according to the sampling plan approved under the
provisions of paragraph (c)(2)(ii) of this section.
(i) Samples of finished water shall be collected at a point after
which all treatment processes for a particular treatment plant are
complete (including the clearwell and final point of chlorination) and
before the distribution system begins. A PWS that purchases finished
water shall collect a sample before additional disinfectant is added to
the purchased finished water. A PWS shall collect a sample of purchased
finished water only if the PWS redisinfects the purchased finished
water. A sample of finished water is a sample representing the final
product water from a particular treatment plant.
(ii) A sample of treatment plant influent for a PWS that treats
untreated water shall be taken at a location at the upstream end of a
treatment plant where waters from all intakes are blended prior to any
treatment or chemical addition. For treatment plants that have multiple
intakes and add chemicals at the intake, the sample of treatment plant
influent shall be a flow proportional composite of intake samples
collected before chemical addition and before pretreatment. If the
intakes are expected to have the same source water quality, one
representative intake sample may be taken. If a disinfectant is added
at or before the intake (e.g., for zebra mussel control), the sample
shall be taken in the vicinity of the intake so that the sample is not
contaminated by the disinfectant. A sample of treatment plant influent
for a PWS that treats purchased finished water is taken at a location
just before the purchased finished water is treated. An intake sample
is collected after the intake but before blending with waters from
other intakes and before addition of chemicals or any treatment.
Table 1a.--Monthly Monitoring Requirements for Treatment Plants
------------------------------------------------------------------------
Sampling point Monthly analyses 1
------------------------------------------------------------------------
Treatment plant influent for pH, Alkalinity, Turbidity, Temperature,
non-finished water. Calcium and Total Hardness, TOC, UV 254,
Bromide, Ammonia.
Treatment plant influent for pH, Alkalinity, Turbidity, Temperature,
purchased finished water 2. Calcium and Total Hardness, TOC, UV 254,
Disinfectant residual 3.
Before first point of oxidant Chlorine demand test.
addition.
Washwater return between pH, Alkalinity, Turbidity, Temperature,
washwater treatment plant Calcium and Total hardness, TOC, UV 254,
and point of addition to Bromide, Ammonia, Disinfectant residual
process train 4. 3 if disinfectant is used.
Additional water sources pH, Alkalinity, Turbidity, Temperature,
added to process train after Calcium and Total hardness, TOC, UV 254,
treatment plant influent. Bromide, Ammonia, Disinfectant residual
The sample point is before 3 if disinfectant is used.
additional water is blended
with the process train.
Before Filtration............ pH, Alkalinity, Turbidity, Temperature,
Calcium and Total Hardness, TOC, and UV
254.
After Filtration............. pH, Alkalinity, Turbidity, Temperature,
Calcium and Total Hardness, TOC, and UV
254.
Before each Point of pH, Alkalinity, Turbidity, Temperature,
Disinfection 5. Calcium and Total Hardness, TOC, and UV
254.
After every unit process that Disinfectant Residual 3.
is downstream from the
addition of chlorine or
chloramines.
Finished water sample point pH, Alkalinity, Turbidity, Temperature,
(Plant effluent). Calcium and Total Hardness, TOC, UV 254,
Disinfectant Residual 3.
Entry point to distribution pH, Alkalinity, Turbidity, Temperature,
system 6. Calcium and Total Hardness, TOC, UV 254,
Disinfectant Residual 3.
------------------------------------------------------------------------
\1\ TOC: total organic carbon. UV 254: absorbance of ultraviolet light
at 254 nanometers.
\2\ Samples of purchased finished water shall be taken prior to addition
of any more disinfectant.
\3\ Free chlorine residual and total chlorine residual shall be measured
in treatment systems using free chlorine. Total chlorine residual, but
not free chlorine residual, shall be measured in treatment systems
using chloramines as the residual disinfectant.
\4\ Washwater return shall be sampled prior to blending with the process
train.
\5\ For utilities using ozone or chlorine dioxide, Tables 4 and 5,
respectively, of this section, show additional monitoring requirements
at this sampling point. Addition of ammonia for the purpose of
converting free chlorine to chloramines is considered a point of
disinfectant addition. PWSs that disinfect just before filtration may
use the ``before filtration'' sampling point analytical results to
meet the monitoring requirement for this point.
\6\ Entry point to distribution system only required for treatment
plants that blend finished water with finished water from other
treatment plant(s) prior to entry point of distribution system. For
most treatment plants, the finished water sample point and the entry
point to the distribution system are the same.
Table 1b.--Quarterly Monitoring Requirements for Treatment Plants
------------------------------------------------------------------------
Sampling point Quarterly analyses1
------------------------------------------------------------------------
Treatment plant influent for TOX.
non-finished water.
Treatment plant influent for THM4, HAA67, HAN, CP, HK, CH, TOX.
purchased finished water.
Washwater Return between TOX.
washwater treatment plant
and point of addition to
process train.
After filtration if THM4, HAA67, HAN, CP, HK, CH, TOX.
disinfectant is applied at
any point in the treatment
plant prior to filtration.
Finished water sample point THM4, HAA67, HAN, CP, HK, CH, TOX.
(Plant Effluent).
Entry point to distribution THM4, HAA67, HAN, CP, HK, CH, TOX.
system2.
SDS3......................... THM4, HAA67, HAN, CP, HK, CH, TOX, pH,
Alkalinity, Turbidity, Temperature,
Calcium and Total Hardness, Disinfectant
Residual5.
[[Page 24376]]
Four monitoring points in THM4, HAA67, HAN, CP, HK, CH, TOX, pH,
distribution system4,6. Alkalinity, Turbidity, Temperature,
Calcium and Total Hardness, Disinfectant
Residual5.
------------------------------------------------------------------------
\1\ TOC: total organic carbon. THM4: trihalomethane (four). HAA6:
haloacetic acids (six). HAN: Haloacetonitriles. CP: chloropicrin. HK:
haloketones. CH: chloral hydrate. TOX: total organic halide. For THM4,
HAA6, HAN, and HK, analytical results for individual analytes shall be
reported.
\2\ Entry point to distribution system only required for treatment
plants that blend finished water with finished water from other
treatment plant(s) prior to entry point of distribution system. For
most treatment plants, the finished water sample point and the entry
point to the distribution system are the same.
\3\ Simulated Distribution System (SDS) sample shall be collected at the
finished water sampling point (or entry point to distribution system
if finished water from two or more plants are blended prior to
entering the distribution system) and analyzed using the method
specified in Sec. 141.142. PWSs using purchased finished water are
not required to take an SDS sample at treatment plants that use only
purchased finished water.
\4\ For each treatment plant, one distribution system equivalent sample
location (known as DSE) shall be chosen to correspond to the SDS
sample, one sample location shall be chosen to be representative of
maximum residence time for the treatment plant, and the remaining two
sample locations shall be representative of the average residence time
in the distribution system for the treatment plant. PWSs using
purchased finished water shall take three samples representing the
average residence time in the distribution system for the treatment
plant and one representing the maximum residence time for the
treatment plant (no DSE sample required).
\5\ Free chlorine residual and total chlorine residual shall be measured
in treatment systems using free chlorine. Total chlorine residual, but
not free chlorine residual, shall be measured in treatment systems
using chloramines as the residual disinfectant.
\6\ A PWS may use TTHM compliance monitoring locations and analytical
results under Sec. 141.30 of this part to the extent that such
locations and analytical results are consistent with the requirements
of this section.
\7\ PWSs are encouraged to also analyze for the additional haloacetic
acids bromodichloro-, chlorodibromo-, and tribromo-acetic acid, and
report the results as part of the reports specified in paragraph
(c)(1) of this section.
(2) Additional requirements for PWSs using chloramines. For each
treatment plant that uses chloramines for treatment or disinfection
residual maintenance, a PWS shall also conduct the additional sampling
identified in Table 2 of this section. A PWS shall send samples of
cyanogen chloride taken under the provisions of this paragraph for
analysis to EPA, following the procedures contained in the ``ICR
Sampling Manual,'' EPA 814-B-96-001, April 1996.
Table 2.--Additional Quarterly Monitoring for Treatment Plants Using
Chloramines
------------------------------------------------------------------------
Sampling point Quarterly analyses
------------------------------------------------------------------------
Treatment plant influent for purchased Cyanogen Chloride\2\.
finished water \1\.
Finished water sample point (plant Cyanogen Chloride\2\.
effluent).
Distribution system sample point Cyanogen Chloride\2\.
representing a maximum residence time
in distribution system relative to the
treatment plant.
------------------------------------------------------------------------
\1\ Applicable only when wholesale water provider is using chloramines.
\2\ EPA shall provide all analytical results to the PWS. The PWS shall
report all results in its monthly report.
(3) Additional requirements for PWSs using hypochlorite solutions.
For each treatment plant that uses hypochlorite solutions for treatment
or disinfection residual maintenance, a PWS shall also conduct the
additional sampling identified in Table 3 of this section.
Table 3.--Additional Quarterly Monitoring for Treatment Plants Using
Hypochlorite Solutions
------------------------------------------------------------------------
Sampling point Quarterly analyses
------------------------------------------------------------------------
Treatment plant influent for non- Chlorate.
finished water.
Treatment plant influent for purchased Chlorate.
finished water \1\.
Hypochlorite Stock Solution............ pH, Temperature, Free Residual
Chlorine, Chlorate.
Finished Water Sample Point (Plant Chlorate.
Effluent).
------------------------------------------------------------------------
\1\ Applicable only when wholesale water provider is using hypochlorite
solutions.
(4) Additional requirements for PWSs using ozone. For each
treatment plant that uses ozone for treatment, a PWS shall also conduct
the additional sampling identified in Tables 4a and 4b of this section.
A PWS shall collect samples for bromate taken under the provisions of
this paragraph in duplicate, with the PWS analyzing one aliquot and
submitting the other aliquot for analysis to EPA, following the
procedures contained in the ``ICR Sampling Manual,'' EPA 814-B-96-001,
April 1996. A PWS shall submit samples for aldehydes taken under the
provisions of this paragraph for analysis to EPA, following the
procedures contained in the ``ICR Sampling Manual,'' EPA 814-B-96-001,
April 1996.
Table 4a.--Additional Monthly Monitoring for Treatment Plants Using
Ozone
------------------------------------------------------------------------
Sampling point Monthly analyses
------------------------------------------------------------------------
Ozone Contactor Influent............... Bromide, bromate 2,3, and
ammonia.
[[Page 24377]]
Each Ozone Contact Chamber Effluent \1\ Ozone residual.
Ozone Contactor Effluent............... Bromate\2\.
Finished Water Sample Point (Plant Bromate\2\.
Effluent).
------------------------------------------------------------------------
\1\ Each ozone contactor can be subdivided into its contact chambers.
Measure ozone residual in effluent of all contact chambers until <0.05
mg/l is measured in two consecutive chambers.
\2\ EPA shall provide all analytical results to the PWS. The PWS shall
report all results in its monthly report.
\3\PWSs are not required to analyze a bromate sample at this location.
However, PWSs are still required to submit a sample to EPA for
analysis.
Table 4b.--Additional Quarterly Monitoring for Treatment Plants Using
Ozone
------------------------------------------------------------------------
Sampling point Quarterly analyses
------------------------------------------------------------------------
Ozone Contactor Influent............... Aldehydes \1\ and AOC/BDOC \2\.
Ozone Contactor Effluent............... Aldehydes \1\ and AOC/BDOC \2\.
Finished Water Sample Point (Plant Aldehydes \1\ and AOC/BDOC \2\.
Effluent).
------------------------------------------------------------------------
\1\ EPA shall measure the following aldehydes: formaldehyde,
acetaldehyde, propanal, butanal, pentanal, glyoxal, and methyl
glyoxal. EPA may analyze for other aldehydes. EPA shall provide all
analytical results to the PWS. The PWS shall report all results in its
monthly report.
\2\ Analysis and submission of data for both assimilable organic carbon
(AOC) and biodegradable organic carbon (BDOC) are optional. Analytical
methods for AOC and BDOC are listed in ``DBP/ICR Analytical Methods
Manual,'' EPA 814-B-96-002, April 1996.
(5) Additional sampling requirements for PWSs using chlorine
dioxide. For each treatment plant that uses chlorine dioxide for
treatment or disinfection residual maintenance, a PWS shall also
conduct the additional sampling identified in Tables 5a and 5b of this
section. A PWS shall collect samples for bromate taken under the
provisions of this paragraph in duplicate, with the PWS analyzing one
aliquot and submitting the other aliquot for analysis to EPA, following
the procedures contained in the ``ICR Sampling Manual,'' EPA 814-B-96-
001, April 1996. A PWS shall submit samples for aldehydes taken under
the provisions of this paragraph for analysis to EPA, following the
procedures contained in the ``ICR Sampling Manual,'' EPA 814-B-96-001,
April 1996.
Table 5a.--Additional Monthly Monitoring for Treatment Plants Using
Chlorine Dioxide
------------------------------------------------------------------------
Sampling point Monthly analyses
------------------------------------------------------------------------
Treatment plant influent for purchased Chlorine Dioxide Residual,
finished water \1\. Chlorite, Chlorate.
Before first chlorine dioxide Chlorate, bromate 2,3.
application.
Before application of ferrous salts, Chlorine Dioxide Residual,
sulfur reducing agents, or GAC. Chlorite, Chlorate, pH.
Finished water sample point (plant Chlorine Dioxide Residual,
effluent). Chlorite, Chlorate, Bromate
\2\.
Three distribution system sampling Chlorine Dioxide Residual,
points (1 near first customer, 1 in Chlorite, Chlorate, pH, and
middle of distribution system, and 1 Temperature.
representative of maximum residence
time in the distribution system).
------------------------------------------------------------------------
\1\ Applicable only when wholesale water provider is using chlorine
dioxide.
\2\ EPA shall provide all analytical results to the PWS. The PWS shall
report all results in its monthly report.
\3\ PWSs are not required to analyze a bromate sample at this location.
However, PWSs are still required to submit a sample to EPA for
analysis.
Table 5b.--Additional Quarterly Monitoring for Treatment Plants Using
Chlorine Dioxide
------------------------------------------------------------------------
Sampling point Quarterly analyses
------------------------------------------------------------------------
Before First Chlorine Dioxide Aldehydes \1\ and AOC/BDOC \2\.
Application.
Before First Point of Downstream Aldehydes \1\ and AOC/BDOC \2\.
Chlorine/Chloramine Application After
Chlorine Dioxide Addition.
Finished Water Sample Point (Plant Aldehydes \1\ and AOC/BDOC \2\.
Effluent).
------------------------------------------------------------------------
\1\EPA shall measure the following aldehydes: formaldehyde,
acetaldehyde, propanal, butanal, pentanal, glyoxal, and methyl
glyoxal. EPA may analyze for other aldehydes. EPA shall provide all
analytical results to the PWS. The PWS shall report all results in its
monthly report.
\2\ Analysis and submission of data for both assimilable organic carbon
(AOC) and biodegradable organic carbon (BDOC) are optional. Analytical
methods for AOC and BDOC are listed in ``DBP/ICR Analytical Methods
Manual,'' EPA 814-B-96-002, April 1996.
(6) Additional requirements. A PWS shall also report the applicable
information in Tables 6a through 6e of this section. A PWS is required
to provide the information in paragraphs (a)(6)(i) through (iii) of
this section for each unit process listed in Table 6c. The PWS may
provide the information in paragraphs (a)(6)(iv) and (v) of this
section for each unit process listed in Table 6c. T10 and T50
tracer studies shall be conducted as specified in ``Guidance Manual for
Compliance with the Filtration and Disinfection Requirements for Public
Water Systems using Surface Water Sources'', Appendix C.
(i) Unit process flow (MGD) at time of sampling.
(ii) T10 (minutes). A PWS shall determine T10 based on a
one-time tracer study in the clearwell of all treatment plants required
to conduct
[[Page 24378]]
microbiological monitoring under the provisions of Sec. 141.141(d) of
this subpart. The PWS may use results of a tracer study conducted to
meet the requirements of subpart H (Filtration and Disinfection) of
this part to meet this requirement. For subsequent T10
determinations, the PWS shall use a flow-proportional interpolation of
the clearwell tracer study. For unit processes other than a clearwell,
a PWS shall either estimate T10 or use an interpolation of tracer
study T10 using multiple flows for each unit process in which a
disinfectant residual exists.
(iii) Chemicals in use at time of sampling. Report chemical name,
chemical dose at time of sampling, and measurement formula. Measurement
formulas (e.g., mg/l as Aluminum) shall be provided to determine the
correct amount of the chemical compound being added.
(iv) Short circuiting factor (optional). The short circuiting
factor is an assumed value for the ratio of T10 to nominal contact
time (volume divided by flow).
(v) T50 (minutes) (optional). T50 should be reported only
if based on a tracer study.
Table 6a.--Public Water System Information
----------------------------------------------------------------------------------------------------------------
Permanent data Design data Monthly data
----------------------------------------------------------------------------------------------------------------
Public Water System:
Utility Name .......................................... Sampling Dates: From
Public Water Supply Identification Number (date) To (date).
(PWSID) Retail population on day
Water Industry Data Base (WIDB) Number of sampling.
[Optional] Wholesale population on
Official Contact Person: day of sampling.
Name Monthly average Retail
Mailing Address flow (MGD).
Phone Number [optional] Monthly average
FAX Number [optional] Wholesale flow (MGD).
ICR Contact Person:
Name
Mailing Address
Phone Number [optional]
FAX Number [optional]
E-Mail Address [optional]
Treatment Plant: \1\
Plant name Plant type (e.g., Conventional Filtration, Hours of operation
ICR plant number assigned by EPA \2\ Direct Filtration, In-Line Filtration, (hours per day)
PWSID number of treatment plant \3\ Two Stage Softening, Disinfection Only/ Sludge solids production
State approved (permitted) plant capacity Groundwater, Other Groundwater treatment) (lb/day)
(MGD) Percent solids in sludge
Historical minimum water temperature ( (%)
deg.C)
Installed sludge handling capacity (lb/
day)
Process Train:
Name Process Train Type (e.g., Conventional
Filtration, Direct Filtration, In-Line
Filtration, Two Stage Softening,
Disinfection Only/Groundwater, Other
Groundwater treatment)
----------------------------------------------------------------------------------------------------------------
\1\ A PWS that operates more than one treatment plant shall report treatment plant information in this table for
each treatment plant.
\2\ EPA shall assign ICR plant number after the PWS submits sampling plan.
\3\ PWSID of treatment plant if different from the PWSID reported in ``Public Water System''.
Table 6b.--Plant Influent Information
----------------------------------------------------------------------------------------------------------------
Permanent data Monthly data
----------------------------------------------------------------------------------------------------------------
Water Resource \1\
----------------------------------------------------------------------------------------------------------------
Name of resource: If Reservoir/Lake: Mean Residence Time (days).
Type of resource (One of the
following):
1 Flowing stream
2 Reservoir/Lake
3 Ground water classified as
under the direct influence of
surface water (GWUDI)
4 Ground water
5 Purchased finished water
6 Non-Fresh (such as salt water)
----------------------------------------------------------------------------------------------------------------
Intake-Surface Water \2\
----------------------------------------------------------------------------------------------------------------
Location of intake: \3\ Flow on day of sampling (MGD).
Latitude (deg/min/sec)
Longitude (deg/min/sec)
Hydrologic unit code (8 digit), if
known \4\
Stream Reach Code (3 digit) (if known)
River mile number (mile) (if known)
Is watershed control practiced? (yes/no)
----------------------------------------------------------------------------------------------------------------
[[Page 24379]]
Intake-Ground Water \5\ 6
----------------------------------------------------------------------------------------------------------------
Location of intake: Flow on day of sampling (MGD).
Latitude (deg/min/sec)
Longitude (deg/min/sec)
Hydrological unit code (8 digit), if
known \4\
Is wellhead protection practiced? (yes/no)
----------------------------------------------------------------------------------------------------------------
Intake-Purchased Finished Water \7\
----------------------------------------------------------------------------------------------------------------
Name of supplying utility................. Flow on day of sampling (MGD).
PWSID of supplying utility
----------------------------------------------------------------------------------------------------------------
Plant Influent \8\
----------------------------------------------------------------------------------------------------------------
Monthly average flow (MGD).
Flow at time of sampling (MGD).
----------------------------------------------------------------------------------------------------------------
\1\ Each treatment plant shall have at least one water resource. Each water resource shall have at least one
intake. A treatment plant that uses more than one water resource shall report water resource information in
this table for each water resource.
\2\ Intake-Surface Water describes the physical location of an intake structure located in a river, lake, or
other surface water resource or, for ground water under the direct influence of surface water, the physical
location of a well.
\3\ The location of the intake will allow cross referencing into other data bases containing information on
possible contamination threats to the intake.
\4\ The hydrologic unit code will allow cross referencing into other data bases containing information on
possible contamination threats to the intake.
\5\ An Intake-Ground Water describes the physical location of a well or well field (if multiple wells draw from
a common aquifer.
\6\ A PWS is not required to report information for ground water that is not treated.
\7\ A PWS is required to report information for purchased finished water only if that water is further treated.
\8\ Multiple ``Intakes'' combine into one ``Plant Influent.'' Each treatment plant has only one treatment plant
influent. The treatment plant influent shall mark the point in the treatment plant where the ``Plant
Influent'' sample shall be collected as described in Tables 1, 2, 3 and 5 of this section.
Table 6c.--Unit Process Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Design data Monthly data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Presedimentation Basin \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tube Settler Brand Name Liquid volume (gallons).
Plate Settler Brand Name Surface area (ft2).
Baffling type\2\ Projected Tube Settler Surface Area (ft\2\).
Projected Plate Settler Surface Area (ft2).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ozone Contact Basin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information for the complete ozone contact basin: Information for the complete ozone contact basin:
Type of Ozone Contactor (One of the following) Ozone CT (mg min/l).10
1 Bubble Diffusion Ozone Giardia Inactivation (logs).
2 Turbine Ozone Virus Inactivation (logs).
Number of Chambers Ozone concentration in feed gas (% by weight).
Information for each ozone contact chamber: Total Ozone Gas Flow Rate to Contactor (SCFM).3
Chamber sequence number Type of feed gas used to generate ozone (one of the following).
Liquid volume (ft3) 1 Air.
Surface area (ft2) 2 Oxygen.
Water/Ozone flow regime (one of the following) Total Ozone Applied Dose (mg/l).
1 Counter-current Information for each ozone contact chamber:
2 Co-current Percent ozone gas flow split to this chamber (%).
Hydrogen peroxide dose (mg/l).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Washwater Return Point 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indicate which washwater treatment processes are being used on day of Flow of returned washwater at time of sampling (MGD).
sampling 24 hr average flow prior to sampling (MGD).
Is there treatment (yes/no):
[[Page 24380]]
If yes:
Plain sedimentation (yes/no)
Coagulation/sedimentation (yes/no)
Filtration (yes/no)
Disinfection (yes/no)
Other Treatment (Text)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rapid Mix
--------------------------------------------------------------------------------------------------------------------------------------------------------
Type of mixer (one of the following): Mean velocity gradient ``G'' (sec-1).4
Liquid volume (gallons).
1 Mechanical
2 Hydraulic
3 Static
4 Other
Baffling type 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Flocculation Basin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Type of mixer (one of the following): Mean velocity gradient ``G'' (sec-1) in each stage.4
Liquid volume of each stage (gallons).
1 Mechanical
2 Hydraulic
Number of stages
Baffling type 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sedimentation Basin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tube settler brand name Liquid volume (gallons).
Plate settler brand name Surface area (ft2).
Baffling type 2 Projected tube settler surface area (ft2).
Projected plate settler surface area (ft2).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Solids Contact Clarifier
--------------------------------------------------------------------------------------------------------------------------------------------------------
Brand name: Liquid volume (gallons).
Surface area of settling zone (ft2).
Projected tube settler surface area (ft2).
Projected plate settler surface area (ft2).
Type (check all that apply):
Rectangular basin
Upflow
Reactor-clarifier
Sludge blanket
Tube settler brand name
Plate settler brand name
Baffling type 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adsorption Clarifier
--------------------------------------------------------------------------------------------------------------------------------------------------------
Brand Name Liquid volume (gallons).
Baffling type 2 Surface area (ft2).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dissolved Air Flotation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baffling type 2 Liquid volume (gallons).
Surface area (ft2).
Percent recycle rate (%).
Recycle stream pressure (psi).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recarbonation Basin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baffling type 2 Liquid volume (gallons).
Surface area (ft2).
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 24381]]
Filtration
--------------------------------------------------------------------------------------------------------------------------------------------------------
Media Type (one of the following): Liquid volume (gallons).
Surface area (ft2).
Average filter run time (hr).
1 Dual media (Anthracite/Sand)
2 GAC over sand
3 Tri media (Anthracite/Sand/Garnet)
4 Sand
5 Deep bed monomedia anthracite
6 Deep bed monomedia GAC
7 Greensand
8 Other
Design depth of GAC (inch)
Type and manufacturer of activated carbon
Design media depth (inch)
Minimum water depth to top of media (ft)
Depth from top of media to top of backwash trough (ft)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Slow Sand Filtration
--------------------------------------------------------------------------------------------------------------------------------------------------------
Media type Surface area (ft2).
Media depth Average filter run length.
Media size Cleaning method.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diatomaceous Earth Filter
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effective DE filter surface (ft2).
Precoat (lb/ft2).
Bodyfeed (mg/l).
Run length (hours).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Granular Activated Carbon--Post-Filter Adsorber
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturer of activated carbon Liquid volume (gallons).
Type of activated carbon Surface area (ft2).
Carbon volume (ft3).
Empty bed contact time (minutes).
Operating reactivation frequency (days).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Membranes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Model name: Surface area (ft\2\).
Type (one of the following): Percent recovery (%).
1 Reverse osmosis Operating pressure (psi).
2 Nanofiltration Operating flux (gpd/ft2).
3 Ultrafiltration Cleaning method (one of the following)
4 Microfiltration Hydraulic.
5 Electrodialysis Chemical.
Number of stages Cleaning frequency (days).
Molecular weight cutoff (daltons)
Design flux (gpd/ft2)
Design pressure (psi)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Air Stripping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Packing height (ft) Horizontal cross-section area (ft2).
Design air to water ratio (volume/volume) Air flow (SCFM).3
Type of packing (Name)
Nominal size of packing (inch)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ion Exchange
--------------------------------------------------------------------------------------------------------------------------------------------------------
Resin (Name) Liquid volume (gallons).
Resin manufacturer Surface area (ft2).
Design exchange capacity (equ/ft3) 3
Bed depth (ft)
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[[Page 24382]]
Disinfection Contact Basin 5 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baffling type 2 Liquid volume (gallons).
Surface area (ft2).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clearwell 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baffling type 2 Liquid volume (gallons).
Minimum liquid volume (gallons) Surface area (ft2).
Covered or Open
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additional Water Sources 9
--------------------------------------------------------------------------------------------------------------------------------------------------------
Type of water source: Flow of additional source (MGD).6
Purchased Finished water
Untreated ground water
Treated ground water
Untreated surface water
Treated surface water
Other
FR Doc. 96-11370 National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies: Cryptosporidium, Giardia, Viruses, Disinfection Byproducts, Water Treatment Plant Data and Other Information Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Purpose Surface area (ft2) [optional].
Liquid Volume (gallons) [optional].
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 A reservoir to which oxidants, disinfectants, or coagulants are added is considered a presedimentation basin.
2 Baffling type classified as one of the following: 1 (Unbaffled (mixed tank)), 2 (Poor (inlet/outlet only)), 3 (Average (Inlet/Outlet and
intermediate)), 4 (Superior (Serpentine)), or 5 (Perfect (Plug flow)). Information on classifying baffling types can be found in ``Guidance Manual for
Compliance with the Filtration and Disinfection Requirements for Public Water Systems using Surface Water Sources'', Appendix C.
3 ``SCFM'' is standard cubic feet per minute. ``Equ/ft\3\'' is equivalents per cubic foot.
4 The mean velocity gradient is typically computed as G=square root of (P/uV) where P=power expended, u=viscosity, and V=liquid volume.
5 The disinfection contact basin shall have a stable liquid level.
6 Disinfection Contact Basin can be used to represent a pipe with a long contact time.
7 A clear well may have a variable liquid level.
8 The ``Washwater Return'' shall mark the point in the process train where washwater joins the main flow.
9 Additional water sources includes water that is added to the process train after the influent.
10 Ozone CT calculated using the procedure contained in ``Guidance Manual for Compliance with the Filtration and Disinfection Requirements for Public
Water Systems using Surface Water Sources'', Appendix O, 1991.
Table 6d.--Additional Process Train Information
----------------------------------------------------------------------------------------------------------------
Design data Monthly data
----------------------------------------------------------------------------------------------------------------
Disinfectant Addition
----------------------------------------------------------------------------------------------------------------
Disinfectants in use at time of sampling.
Dose (mg/l).
Chemical formula (e.g., mg/l as chlorine).
----------------------------------------------------------------------------------------------------------------
Finished Water Sample Point (Plant Effluent) \1\ \2\
----------------------------------------------------------------------------------------------------------------
Monthly average flow (MGD).
Flow at time of sampling (MGD).
----------------------------------------------------------------------------------------------------------------
\1\ This shall mark the end of a treatment plant.
\2\ Unless the finished water of this treatment plant is blended with finished water from another treatment
plant, this point is also the entry point to the distribution system.
Table 6e.--Finished Water Distribution Information
----------------------------------------------------------------------------------------------------------------
Design data Monthly data
----------------------------------------------------------------------------------------------------------------
Entry Point to Distribution System \1\
----------------------------------------------------------------------------------------------------------------
Monthly average flow (MGD).
Flow at time of sampling (MGD).
----------------------------------------------------------------------------------------------------------------
[[Page 24383]]
Wholesale Information \2\
----------------------------------------------------------------------------------------------------------------
Name of purchaser...................................... Flow at time of sampling (MGD).
PWSID of purchaser
----------------------------------------------------------------------------------------------------------------
Distribution System
----------------------------------------------------------------------------------------------------------------
Typical maximum residence time (days) Maximum residence time (days).
Average residence time (days) Average residence time (days).
Design volume of distribution system storage (million Number of disinfection booster stations in operation at
gallon) time of sampling:
Total surface area of open reservoirs in distribution Chlorine.
system storage (ft\2\) Chloramine.
Chlorine dioxide.
Range of distribution system disinfectant dosages.
Chlorine: High (mg/l) Low (mg/l).
Chloramine: High (mg/l) Low (mg/l).
Chlorine dioxide: High (mg/l) Low (mg/l).
----------------------------------------------------------------------------------------------------------------
\1\ Multiple treatment plants can feed into one entry point to the distribution system. If there is only one
treatment plant then ``Finished Water Sample Point (Plant Effluent)'' and ``Entry Point to Distribution
System'' are the same.
\2\ The supplying public water system shall report ``Wholesale Information'' for each public water system which
purchases finished water.
(b) Analytical methods. (1) A PWS shall use the methods identified
in Table 7 of this section for conducting analyses required by this
subpart.
Table 7.--Analytical Methods Approved for Subpart M
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methodology \1\
Analyte --------------------------------------------------------------------------------------------------------------------
40 CFR reference \2\ EPA method Standard method \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
pH, alkalinity, calcium hardness, Sec. 141.23(k)(1)
temperature.
Turbidity.......................... Sec. 141.74(a)(1)
Disinfectant residuals: free Sec. 141.74(a)(2) ................................ 4500-Cl B \9\
chlorine, total chlorine, chlorine
dioxide, ozone.
Trihalomethanes: chloroform, bro... Sec. 141.24(e) 551.1 \4\
modichloromethane, dibro...........
mochloromethane, bromoform.........
Haloacetic acids: mono-, di-, and ........................................ 552.1, \5\ 552.2 \4\ 6251 B
trichloroacetic acids; mono- and
dibromoacetic acid;
bromochloroacetic acid.
Chloral hydrate.................... ........................................ 551.1 \4\
Haloacetonitriles: di- and ........................................ 551.1 \4\
trichloroacetonitrile;
bromochloroacetonitrile;
dibromoacetonitrile.
Haloketones: 1,1-Dichloropropanone; ........................................ 551.1 \4\
1,1,1-trichloropropanone.
Chloropicrin....................... ........................................ 551.1 \4\
Chlorite........................... ........................................ 300.0 \6\
Chlorate........................... ........................................ 300.0 \6\
Bromide............................ ........................................ 300.0 \6\
Bromate............................ ........................................ 300.0 \6\
Total Organic Halide (TOX)......... ........................................ ................................ 5320 B
Total Organic Carbon............... ........................................ ................................ 5310 B, 5310 C, 5310 D
UV absorbance at 254 nm............ ........................................ ................................ 5910
Simulated Distribution System Test ........................................ ................................ 5710 C
(SDS).
Total Hardness..................... ........................................ ................................ 2340 B,\7\ 2340 C
Ammonia............................ Sec. 136.3, Table 1b \8\ 350.1 \6\ 4500-NH3 D, 4500-NH3 G
Chlorine Demand Test............... ........................................ ................................ 2350 B
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Analyses shall be conducted by using mandatory analytical and quality control procedures contained in ``DBP/ICR Analytical Methods Manual'', EPA 814-
B-96-002.
\2\ Currently approved methodology for drinking water compliance monitoring is listed in Title 40 of the Code of Federal Regulations in the sections
referenced in this column. The 18th and 19th editions of Standard Methods for the Examination of Water and Wastewater, American Public Health
Association, 1015 Fifteenth Street NW, Washington, D.C. 20005, are equivalent for the methods cited in these sections. Therefore, either edition may
be used.
[[Page 24384]]
\3\ Except where noted, all methods refer to the 19th edition of Standard Methods for the Examination of Water and Wastewater, American Public Health
Association, 1015 Fifteenth Street NW, Washington, D.C. 20005.
\4\ Analytical method reprinted in ``Reprints of EPA Methods for Chemical Analyses Under the Information Collection Rule'', EPA 814-B-96-006. Originally
published in ``Methods for the Determination of Organic Compounds in Drinking Water--Supplement III,'' EPA/600/R-95/131, August 1995, PB95-261616.
\5\ Analytical method reprinted in ``Reprints of EPA Methods for Chemical Analyses Under the Information Collection Rule'', EPA 814-B-96-006. Originally
published in ``Methods for the Determination of Organic Compounds in Drinking Water--Supplement II,'' EPA/600/R-92/129, August 1992, PB92-207703.
\6\ Analytical method reprinted in ``Reprints of EPA Methods for Chemical Analyses Under the Information Collection Rule'', EPA 814-B-96-006. Originally
published in ``Methods for the Determination of Inorganic Substances in Environmental Samples,'' EPA/600/R-93/100, August 1993, PB94-121811.
\7\ The following methods, cited at Sec. 141.23(k)(1) of this part, can be used to determine calcium and magnesium concentrations for use in
conjunction with Standard Method 2340 B: EPA Method 200.7, Standard Method 3111 B, Standard Method 3120 B, or ASTM Method D511-93 B.
\8\ PWSs may use only the automated electrode method from Sec. 136.3, Table 1b.
\9\ Standard Method 4500-Cl B is approved only for determining free chlorine residual concentrations in hypochlorite stock solutions. This method may
not be used for any other disinfectant residual analyses.
(2) Analyses under this section shall be conducted by laboratories
that have received approval from EPA to perform sample analysis for
compliance with this rule. Laboratories that wish to become approved
shall contact EPA in writing at USEPA, Technical Support Division, ICR
Laboratory Coordinator, 26 W. Martin Luther King Drive, Cincinnati, OH
45268 not later than November 14, 1996. Requirements for approval are
included in ``DBP/ICR Analytical Methods Manual'', EPA 814-B-96-002.
(c) Reporting. (1) A PWS shall report required data and information
collected under the provisions of paragraph (a) of this section to EPA,
using an EPA-specified computer readable format. A PWS shall submit a
monthly report that indicates the analytical results of all samples
collected, including quarterly samples taken in that same month, and
all process train data. These reports shall be submitted on a diskette
no later than the fourth month following sampling. In addition to the
information in Tables 1 through 6 in paragraph (a) of this section,
reports shall include PWSID, ICR plant identification, sample date,
analysis date, laboratory identification numbers, analytical methods
used, sample identification numbers, quality assurance code, internal
standards, surrogate standards, and preserved sample pH, if
appropriate.
(2) Additional Requirements. A PWS shall submit a DBP and related
monitoring sampling plan for EPA approval, using software provided by
EPA, for each treatment plant specified in Sec. 141.141(b)(2) of this
subpart that indicates sampling point locations and monitoring to be
conducted at each point, and process treatment train information. This
sampling plan shall be submitted to EPA at the same time and on the
same diskette as the microbiological sampling plan required by
Sec. 141.143(c)(3) and no later than eight weeks after the PWS receives
the Notice of ICR Final Applicability Determination from EPA, using the
procedure specified in ``ICR Sampling Manual'', EPA 814-B-96-001, April
1996.
(3) All reports required by this section shall be submitted to
USEPA (ICR4600), ICR Data Center, Room 1111 East Tower, 401 M Street
SW., Washington, DC 20460.
(4) The PWS shall keep all data for at least three years following
data submission to EPA.
(d) Incorporation by reference. The documents and methods listed in
paragraphs (d) (1) and (2) of this section are incorporated by
reference for purposes specified in this section. This incorporation by
reference was approved by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. Copies may be
inspected at USEPA, Drinking Water Docket (4101), 401 M Street SW.,
Washington, DC 20460, or at Office of the Federal Register, 800 North
Capitol Street, NW., Suite 700, Washington, DC.
(1) ``Standard Methods for the Examination of Water and
Wastewater,'' 19th edition, 1995. Available from the American Public
Health Association, 1015 Fifteenth Street, NW., Washington, DC 20005.
(2) ``Guidance Manual for Compliance with the Filtration and
Disinfection Requirements for Public Water Systems using Surface Water
Sources'', Appendices C and O, 1991. Available from American Water
Works Association, 6666 West Quincy Avenue, Denver, CO 80235.
Sec. 141.143 Microbial monitoring.
(a) Monitoring requirements. (1) Parameters. A PWS shall sample for
the following parameters for the period specified in Sec. 141.141(d) of
this subpart and at the location specified and using the analytical
methods specified in paragraphs (a)(2) and (b), respectively, of this
section. For each sample, a PWS shall determine the densities of total
coliforms, fecal coliforms or Escherichia coli, Giardia,
Cryptosporidium, and total culturable viruses for each treatment plant
required to monitor under the provisions of Sec. 141.141(b) of this
subpart.
(2) Monitoring locations. (i) A PWS shall collect one sample of the
treatment plant influent at the frequency specified in Sec. 141.141(d)
of this subpart.
(A) A sample of treatment plant influent shall be taken at a
location at the upstream end of a treatment plant where waters from all
intakes are blended prior to any treatment or chemical addition.
(B) For treatment plants that have multiple intakes and add
chemicals at the intake, the PWS shall take an intake sample of the
water resource with the poorest microbiological quality (or, if that
cannot be determined, the water resource with the highest flow)
collected before chemical addition and before pretreatment. If the
intakes are expected to have the same source water quality, one
representative intake sample may be taken. If a disinfectant is added
at or before the intake (e.g., for zebra mussel control), the sample
shall be taken in the vicinity of the intake in such manner that the
sample is not contaminated by the disinfectant.
(ii) A PWS that, during any of the first twelve months of
monitoring at the treatment plant influent, detects 10 or more Giardia
cysts, or 10 or more Cryptosporidium oocysts, or one or more total
culturable viruses, in one liter of water; or calculates a numerical
value of the Giardia or Cryptosporidium concentration equal to or
greater than 1000 per 100 liters or virus concentration equal to or
greater than 100 per 100 liters; or detects no pathogens in the sample
and calculates a numerical value of the detection limit for Giardia or
Cryptosporidium concentration equal to or greater than 1000 per 100
liters or virus concentration equal to or greater than 100 per 100
liters; shall also collect one sample of finished water per month at
each such treatment plant, beginning in the first calendar month after
the PWS learns of such a result. The sample of finished water shall be
collected at a point after which all treatment
[[Page 24385]]
processes for a particular treatment plant are complete (including the
clearwell and final point of disinfection) and before the distribution
system begins. For each sample of finished water, PWSs shall determine
the density of total coliforms, fecal coliforms or E. coli, Giardia,
Cryptosporidium, and total culturable viruses. A PWS shall continue
finished water monitoring monthly until 18 months of treatment plant
influent monitoring has been completed.
(iii) In lieu of conducting finished water monitoring of Giardia
and Cryptosporidium specified in paragraph (a)(2)(ii) of this section,
a PWS may notify EPA in its response to the notice of applicability
required by paragraph (c)(3)(i) of this section that the PWS will
comply with the alternative monitoring requirements in paragraphs
(a)(2)(iii) (A) and (B) of this section. The PWS shall still conduct
finished water monitoring for all other microorganisms, except for
Giardia and Cryptosporidium monitoring in the finished water.
(A) The PWS measures the particle counts in the treatment plant
influent, at points immediately prior to filtration and after
filtration (but before the addition of post-filtration chemicals).
Particle counting shall be conducted on the same treatment train as is
sampled for monitoring conducted under the provisions of
Sec. 141.142(a) of this subpart. Such samples shall be collected
monthly during the entire 18-month monitoring period, using the
procedures contained in the ``ICR Sampling Manual'', EPA 814-B-96-001,
April 1996. The PWS may use either grab or continuous particle
counting. Particle counting shall be conducted during the same time as
protozoa monitoring required by paragraph (a)(2)(iii)(B) of this
section.
(1) If grab sampling is conducted, the PWS shall collect 12 samples
per location at the treatment plant influent, filter influent, and
filter effluent, over either a 24-hour period or the duration of the
filter run, whichever is shorter.
(2) If continuous particle counting is conducted, the PWS shall
collect 12 instrument readings per location, evenly spaced in time, at
the treatment plant influent, filter influent, and filter effluent,
over either a 24-hour period or the duration of the filter run,
whichever is shorter.
(3) For each sample, the PWS shall measure particle counts per
milliliter in the size ranges of 3m-5m, 5m-
7m, 7m-10m, 10m-15m, and
>15m, and shall report to EPA the mean value in each size
range of the 12 values collected over the sampling period.
(B) The PWS collects and analyzes at least four consecutive months
of Giardia and Cryptosporidium samples at the same locations specified
in paragraph (a)(2)(iii)(A) of this section, within the first 12 months
of the 18 months of sampling. The PWS shall collect Giardia and
Cryptosporidium samples during the same time period as it is conducting
particle counting. The minimum sample volume for Giardia and
Cryptosporidium analyses shall be 100 liters for treatment plant
influent and 1,000 liters for water that has undergone any treatment.
The PWS may use results of monitoring for Giardia and Cryptosporidium
in the treatment plant influent specified in paragraph (a)(2) of this
section to meet the requirements of this paragraph as long as such
monitoring meets the requirements of both this paragraph and paragraph
(a)(2) of this section.
(iv) If a PWS has monitored total coliforms, fecal coliforms, or E.
coli in the treatment plant influent for at least five days/week for
any period of six consecutive months beginning after January 1, 1994
and 90% of all samples taken in that six-month period contained no
greater than 100 total coliforms/100 ml, or 20 fecal coliforms/100 ml,
or 20 E. coli/100 ml, the PWS may request to not conduct virus
monitoring for that treatment plant, for the duration of the
requirement. Even if approved, the PWS may subsequently be required to
monitor under the criteria in paragraph (a)(2)(iv)(A) of this section.
This request shall be submitted as part of the response to the notice
of applicability required by paragraph (c)(3)(i) of this section.
(A) If the PWS is subsequently required to monitor the finished
water under the provisions of paragraph (a)(2)(ii) of this section, the
PWS shall monitor, along with the other specified organisms, total
culturable viruses, as specified in paragraph (a)(2)(i) of this section
for treatment plant influent and as specified in paragraph (a)(2)(ii)
of this section for finished water, until 18 months of microbial
monitoring is completed.
(B) A PWS may use coliform data collected under Sec. 141.71(a)(1)
of this part for this purpose but, if this is done, the PWS shall
submit two separate monitoring reports. One report, to meet the
requirements of Sec. 141.71(a)(1) of this part, shall continue to be
submitted as required by subpart H of this part. The other report shall
be submitted to meet the requirements of paragraph (c)(3) of this
section.
(C) If a PWS does not provide EPA with six months of suitable
coliform results as part of its response to the notice of
applicability, the PWS shall begin virus monitoring. If a PWS begins
virus monitoring and subsequently provides EPA with six months of
coliform results that are at or below the indicated density limit, and
EPA approves the request to not conduct virus monitoring, the PWS may
avoid subsequent treatment plant virus monitoring.
(b) Analytical Methods. (1) A PWS shall use the methods listed in
paragraphs (b)(1)(i) through (v) of this section for monitoring under
this subpart.
(i) Fecal coliforms--specified at Sec. 141.74(a)(1) of this part,
except that whenever paired source water samples and finished water
samples are to be collected, only the fecal coliform procedure
(Standard Method 9221E), as specified in Sec. 141.74(a)(1) of this
part, using EC Medium, can be used. The time between sample collection
and initiation of sample analysis shall not exceed eight hours. Samples
shall be chilled, but not frozen, and shipped at a temperature of less
than 10 deg.C. Samples not processed immediately at the laboratory
shall be refrigerated. The laboratory must invalidate samples that
arrive frozen or at a temperature greater than 10 deg.C.
(ii) Total coliforms--specified at Sec. 141.74(a)(2) of this part.
The time between sample collection and initiation of sample analysis
shall not exceed eight hours. Samples shall be chilled, but not frozen,
and shipped at a temperature of less than 10 deg.C. Samples not
processed immediately at the laboratory shall be refrigerated. The
laboratory must invalidate samples that arrive frozen or at a
temperature greater than 10 deg.C.
(iii) E. coli--as specified by Sec. 141.21(f)(6)(i) through (iii)
of this part, except that the density shall be reported. PWSs using the
EC+MUG and ONPG-MUG tests shall use either a 5-tube or 10-tube 10-ml
configuration, with serial dilutions of the original sample as needed,
and report the Most Probable Number. PWSs may also use a commercial
multi-test system for E. coli enumeration, as long as they use M-Endo
medium for the initial isolation of the organisms, pick every colony on
the plate with the appearance of a total coliform, and streak it for
purification before subjecting the colony to a multi-test system. The
time between sample collection and initiation of sample analysis,
regardless of method used, shall not exceed eight hours. Samples shall
be chilled, but not frozen, and shipped at a temperature of less than
10 deg.C. Samples not processed immediately at the laboratory shall be
[[Page 24386]]
refrigerated. The laboratory must invalidate samples that arrive frozen
or at a temperature greater than 10 deg.C.
(iv) Giardia and Cryptosporidium--ICR Protozoan Method, as
described in ``ICR Microbial Laboratory Manual'', EPA 600/R-95/178,
April 1996.
(v) Total culturable viruses--Virus Monitoring Protocol, as
described in ``ICR Microbial Laboratory Manual'', EPA 600/R-95/178,
April 1996.
(2) Laboratories. A PWS shall use EPA-approved laboratories to
analyze for Giardia, Cryptosporidium, and total culturable viruses. A
PWS shall use laboratories certified for microbiology analyses by
either EPA or a State under the EPA or State drinking water program for
the analysis of total coliforms, fecal coliforms, and E. coli.
Laboratories that wish to become approved shall contact EPA in writing
at USEPA, Technical Support Division, ICR Laboratory Coordinator, 26 W.
Martin Luther King Drive, Cincinnati, OH 45268 not later than August
14, 1996. Laboratory approval criteria for Giardia, Cryptosporidium,
and total culturable viruses are found in the ``ICR Microbial
Laboratory Manual'', EPA 600/R-95/178, April 1996.
(3) A PWS shall send EPA a virus archive sample prepared as
described in Chapter VIII of ``ICR Microbial Laboratory Manual'', EPA
600/R-95/178, April 1996, for each water sample identified in paragraph
(b)(3)(i) or (ii) of this section.
(i) Samples of treatment plant influent and finished water, for
every month after the PWS learns that viruses were detected in any
previous sample of finished water.
(ii) Samples of treatment plant influent and finished water,
regardless of whether viruses are detected in the finished water, for
every month after the PWS learns that a density of at least 10 viruses/
L was detected in any previous treatment plant influent water sample.
(iii) A PWS may arrange to have virus samples shipped directly to
EPA by its virus laboratory for archiving.
(iv) Samples shall be sent on dry ice to ICR Virus Archiving
Coordinator following the procedures specified in ``ICR Microbial
Laboratory Manual'', EPA 600/R-95/178, April 1996.
(c) Reporting. (1) A PWS shall report data and information required
under paragraphs (a) and (b) of this section using an EPA-specified
computer readable format. A PWS shall submit a monthly report on a
diskette, no later than the fourth month following sampling, that
indicates the analytical results of all samples collected. Reports
shall include PWSID, ICR plant identification, sample date, analysis
date, laboratory identification numbers, analytical methods used,
sample identification numbers, analytical batch numbers, quality
assurance code, and processing batch numbers, if appropriate.
(2)(i) For a PWS using the alternative to Giardia and
Cryptosporidium monitoring in paragraph (a)(2)(iii) of this section,
the PWS shall report to EPA the mean value in each size range of the 12
particle counting values collected over the sampling period. In
addition, during the four consecutive months when the PWS collects
Giardia and Cryptosporidium samples specified in paragraph
(a)(2)(iii)(B) of this section, the PWS shall report to EPA, for each
measured site, the densities of Giardia and Cryptosporidium at each
measured site. This information shall be submitted at the same time as
the report required by paragraph (c)(1) of this section.
(ii) A PWS that is not required to monitor for total culturable
viruses under the provisions of paragraph (a)(2)(iv) of this section
shall report to EPA the dates and results of all total coliform, fecal
coliform, or E. coli monitoring used by the PWS to determine that
additional virus monitoring is unnecessary. The report shall indicate
all data collected during the six-month time period, and how the data
were used to calculate compliance with this requirement.
(3) Additional Requirements. A PWS shall submit a microbiological
sampling plan for EPA approval, using software provided by EPA, for
each treatment plant specified in Sec. 141.141(b) of this subpart that
indicates sampling point locations and monitoring to be conducted at
each point. This sampling plan shall be submitted to EPA at the same
time and on the same diskette as the DBP and related monitoring
sampling plan required by Sec. 141.142(c)(2) and no later than eight
weeks after the PWS receives the Notice of ICR Final Applicability
Determination from EPA, using the procedure specified in ``ICR Sampling
Manual'', EPA 814-B-96-001, April 1996.
(4) All reports required by this section shall be submitted to
USEPA (ICR4600), ICR Data Center, Room 1111 East Tower, 401 M Street
SW., Washington, DC 20460.
(5) The PWS shall keep all data for at least three years following
data submission to EPA.
Sec. 141.144 Disinfection byproduct precursor removal studies.
(a) TOC, UFCTOX, THM4, and HAA5 applicability monitoring. A PWS
required to comply with this section shall conduct TOC, UFCTOX, THM4,
and HAA5 monitoring specified in Sec. 141.141(e)(2) of this subpart. A
PWS may use monitoring results from samples required by Sec. 141.142(a)
of this subpart to meet this requirement to the extent that all
requirements in each section are met.
(b) Treatment study requirements. A PWS identified in
Sec. 141.141(b) of this subpart shall conduct disinfection byproduct
precursor removal studies (treatment studies). The treatment study
shall use bench-and/or pilot-scale systems for at least one of the two
appropriate candidate technologies (GAC or membrane processes) for the
reduction of organic DBP precursors. The treatment studies shall be
designed to yield representative performance data and allow the
development of national treatment cost estimates for different levels
of organic disinfection byproduct control. The treatment objective of
the studies is the achievement of levels of byproducts less than 40
g/L TTHM and 30 g/L HAA5, as an annual average. The
treatment study shall be conducted with the effluent from treatment
processes already in place that remove disinfection byproduct
precursors and TOC, to simulate the most likely treatment scenario.
PWSs are permitted to optimize these processes or pilot additional
processes appropriate for pretreatment for treatment studies. In order
to minimize the formation of DBPs, the test water for both the bench-
and pilot-scale tests shall be obtained from a location before the
first point at which oxidants or disinfectants that form halogenated
disinfection byproducts are added. If the use of these oxidants or
disinfectants precedes any full-scale treatment process that removes
disinfection byproduct precursors, then bench- and pilot-scale
treatment processes that represent these full-scale treatment processes
are required prior to the GAC or membrane process. A PWS should
exercise sound judgement in its selection of treatment process to study
and the point at which to obtain water for study. Depending upon the
type of treatment study, the study shall be conducted in accordance
with the following criteria.
(1) Bench-scale tests are continuous flow tests using rapid small
scale column test (RSSCT) for GAC and small scale membrane test
apparatus as specified in ``ICR Manual for Bench- and Pilot-scale
Treatment Studies'' (EPA 814-B-96-003, April 1996).
(i) GAC bench-scale testing shall include information on the
experimental conditions and results necessary to adequately determine
the scaled-up breakthrough curves under
[[Page 24387]]
the conditions of each RSSCT. At least two empty bed contact times
(EBCTs) shall be tested using the RSSCT. These RSSCT EBCTs shall be
designed to represent a full-scale EBCT of 10 min and a full-scale EBCT
of 20 min. Additional EBCTs may be tested. The RSSCT testing is
described in the ``ICR Bench- and Pilot-scale Treatment Study Manual''
(EPA 814-B-96-003, April 1996). The RSSCT tests at each EBCT shall be
run quarterly to ascertain the impact of seasonal variation. Thus a
total of four RSSCTs at each EBCT should be run. When seasonal
variation is not significant, as is the case in most ground waters, the
quarterly tests should be run to investigate other variables, as
described in the ``ICR Bench- and Pilot-scale Treatment Study Manual''
(EPA 814-B-96-003, April 1996). The RSSCT shall be run until the
effluent TOC concentration is at least 70% of the average influent TOC
concentration or the effluent TOC reaches a plateau at greater than 50%
of the influent TOC (i.e., the effluent TOC does not increase over a
two-month full-scale-equivalent time period by more than 10% of the
average influent TOC concentration) or a RSSCT operation time that
represents the equivalent of one year of full-scale operation,
whichever is shorter. The average influent TOC is defined as the
running average of the influent TOC at the time of effluent sampling.
If, after completion of the first quarter RSSCTs, the PWS finds that
the effluent TOC reaches 70% of the average influent TOC within 20
full-scale equivalent days on the EBCT=10 min test and within 30 full-
scale equivalent days on the EBCT=20 min test, the last three quarterly
tests shall be conducted using membrane bench-scale testing with only
one membrane, as described in paragraph (b)(1)(ii) of this section.
(ii) Membrane bench-scale testing shall include information on the
experimental conditions and results necessary to determine the water
quality produced by the membrane treatment and a preliminary estimate
of productivity. The testing procedures and monitoring and reporting
requirements are described in the ``ICR Bench- and Pilot-scale
Treatment Study Manual'' (EPA 814-B-96-003, April 1996). A minimum of
two different membrane types with nominal molecular weight cutoffs of
less than 1000 shall be investigated. Membrane tests shall be conducted
quarterly over one year to determine the seasonal variation. Thus, a
total of four bench-scale tests with each membrane shall be run. If
seasonal variation is not significant, as is the case of most ground
waters, the quarterly tests should be run to evaluate the impact of
other variables, such as pretreatment, or additional membranes could be
tested. Alternatively, a PWS may choose to conduct a long-term, single
element study using a single membrane type in lieu of evaluating two
membranes in four quarterly short-term tests, using the protocol in the
``ICR Bench- and Pilot-scale Treatment Study Manual'' (EPA 814-B-96-
003, April 1996).
(2) A PWS shall conduct pilot-scale testing as continuous flow
tests. For GAC, the PWS shall use GAC of particle size representative
of that used in full-scale practice, a pilot GAC column with a minimum
inner diameter of 2.0 inches, and hydraulic loading rate (volumetric
flow rate/column cross-sectional area) representative of that used in
full-scale practice. The PWS shall design a pilot-scale membrane system
as a staged array of elements as described in ``ICR Manual for Bench-
and Pilot-scale Treatment Studies'', EPA 814-B-96-003, April 1996.
(i) GAC pilot-scale testing. (A) The pilot testing procedures and
monitoring and reporting requirements are prescribed in the ``ICR
Bench- and Pilot-scale Treatment Study Manual'' (EPA 814-B-96-003,
April 1996).
(B) At least two EBCTs shall be tested, EBCT=10 min and EBCT=20
min, using the pilot-scale plant. Additional EBCTs may be tested.
(C) The pilot tests at each EBCT shall continue until the effluent
TOC concentration is at least 70% of the average influent TOC
concentration on two consecutive TOC sample dates that are at least two
weeks apart or the effluent TOC reaches a plateau at greater than 50%
of the influent TOC (i.e., the effluent TOC does not increase over a
two-month period by more than 10% of the average influent TOC
concentration). If either of these criteria is met for the 20-minute
EBCT prior to six months run time, a second pilot test at each EBCT
shall be conducted following the same sampling requirements. In all
cases the maximum length of the pilot study (one or two tests) is one
year. The average influent TOC is defined as the running average of the
influent TOC at the time of sampling. The pilot-scale testing shall be
timed to capture seasonal variation. If seasonal variation is not
significant, as is the case with most ground waters, the pilot-scale
test runs shall be designed to evaluate the impact of other variables,
such as pretreatment.
(ii) Membrane pilot-scale testing.
(A) The membrane pilot testing procedures and monitoring and
reporting requirements are prescribed in the ``ICR Bench- and Pilot-
scale Treatment Study Manual'' (EPA 814-B-96-003, April 1996).
(B) The membrane test system shall be designed to yield information
on loss of productivity (fouling), pretreatment requirements, cleaning
requirements, and permeate quality and operated at a recovery
representative of full-scale operation.
(C) The pilot-scale testing shall be run for one year.
(3) Chlorination under simulated distribution system (SDS)
conditions shall be used prior to the measurement of THM4, HAA6, TOX,
and chlorine demand. These conditions are described in ``ICR Manual for
Bench- and Pilot-scale Treatment Studies'' (EPA 814-B-96-003, April
1996) and represent the average conditions in the distribution system
at that time with regard to holding time, temperature, pH, and chlorine
residual. If chlorine is not used as the final disinfectant in
practice, then a chlorine dose shall be set to yield a free chlorine
residual of 1.0 to 0.5 mg/l after a holding time, temperature, and pH
equal to those representative of the distribution system averages.
(c) Analytical Methods. All analyses required by paragraphs (a) and
(b) of this section shall be conducted using the methods and the
mandatory analytical and quality control procedures contained in either
``DBP/ICR Analytical Methods Manual'' (EPA 814-B-96-002, April 1996) or
``ICR Manual for Bench- and Pilot-scale Treatment Studies'' (EPA 814-B-
96-003, April 1996). In addition, TOC analyses required by paragraph
(a) of this section shall be conducted by a laboratory approved under
the provisions of Sec. 141.142(b)(2) of this subpart.
(d) Reporting. (1) TOC and UFCTOX reporting. A PWS shall submit the
monthly results of 12 months of TOC or UFCTOX monitoring required by
paragraph (a)(1) of this section and the annual average of those
monthly results not later than October 14, 1997. This report is not
required to be submitted electronically. Although a PWS may use
monitoring results from samples required by Sec. 141.142(a) of this
subpart to meet this requirement, it shall submit separate reports to
meet this reporting requirement and the reporting requirement in
Sec. 141.142(c)(1) of this subpart.
(2) A PWS shall report all data collected under the provisions of
paragraph (b) of this section. In addition, a PWS shall report the
information for water resource and full-scale and pilot- or bench-scale
[[Page 24388]]
pretreatment processes that precede the bench/pilot systems. These data
and information shall be reported in the format specified in ``ICR
Manual for Bench- and Pilot-scale Treatment Studies'' (EPA 814-B-96-
003, April 1996) not later than July 14, 1999.
(3) All reports required by this section shall be submitted to
USEPA, Technical Support Division, ICR Precursor Removal Studies
Coordinator, 26 West Martin Luther King Drive, Cincinnati, OH 45268.
[FR Doc. 96-11370 Filed 5-13-96; 8:45 am]
BILLING CODE 6560-50-P
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