issue-1996-07-10•Federal Register final rules — 1996-07-10
Federal Register final rules — 1996-07-10
issue-1996-07-10Federal Register final rules — 1996-07-10Regulation
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. 96-17594 Revision of Class E Airspace; La Porte, IN
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Page 36284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17594]
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DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 96-AGL-6]
Revision of Class E Airspace; La Porte, IN
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
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SUMMARY: This action revises Class E airspace at La Porte Municipal
Airport, La Porte, IN, to accommodate a localizer (LOC) Instrument
Approach Procedure to Runway 2. Controlled airspace extending upward
from 700 to 1200 feet above ground level (AGL) is needed to contain
aircraft executing the approach. The intended affect of this action is
to provide segregation of aircraft using instrument approach procedures
in instrument conditions from other aircraft operating in visual
weather conditions.
EFFECTIVE DATE: 0901 UTC, October 10, 1996.
FOR FURTHER INFORMATION CONTACT: John A. Clayborn, Air Traffic
Division, Operations Branch, AGL-530, Federal Aviation Administration,
2300 East Devon Avenue, Des Plaines, Illinois 60018, telephone (847)
294-7568.
SUPPLEMENTARY INFORMATION:
History
On Thursday, May 2, 1996, the FAA proposed to amend part 71 of the
Federal Aviation Regulations (14 CFR part 71) to accommodate a
localizer (LOC) Instrument Approach Procedure to Runway 2, La Porte
Municipal Airport, La Porte, IN (61 FR 19591). The proposal was to add
controlled airspace extending upward from 700 to 1200 feet AGL to
contain Instrument Flight Rules (IFR) operations in controlled airspace
during portions of the terminal operation and while transiting between
the enroute and terminal environments.
Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments objecting to the proposal were received. Class E airspace
designations for areas extending upward from 700 feet or more above the
surface of the earth 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
the Order.
The Rule
This amendment to part 71 of the Federal Aviation Regulations (14
CFR part 71) revises Class E airspace at La Porte Municipal Airport, La
Porte, IN, to accommodate a localizer (LOC) Instrument Approach
Procedure to Runway 2. Controlled airspace extending upward from 700 to
1200 feet AGL is needed to contain aircraft executing the approach. The
area will be depicted on appropriate aeronautical charts thereby
enabling pilots to circumnavigate the area or otherwise comply with IFR
procedures.
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 regulating
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) 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 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.
* * * * *
AGL IN E5 La Porte, IN [Revised]
La Port Municipal Airport, IN
(lat. 41 deg.34'22'' N., long. 86 deg.44'03''W.)
La Porte NDB
(lat. 41 deg.29'56''N., long. 86 deg.46'17''W.)
That airspace extending upward from 700 feet above the surface
within a 7.3-mile radius of the La Porte Municipal Airport and
within 2.5 miles each side of the 201 deg. bearing from the La Porte
NDB extending from the 7.3-mile radius to 11.4 miles south of the
airport, excluding that airspace within the Michigan City, IN,
Valparaiso, IN, and Knox, IN Class E airspace area.
* * * * *
Issued in Des Plaines, Illinois on June 20, 1996.
Maureen Woods,
Manager, Air Traffic Division.
[FR Doc. 96-17594 Filed 7-9-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-17592 Establishment of Class E Airspace; Menomonie, WI
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36284-36285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17592]
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[[Page 36285]]
DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 96-AGL-4]
Establishment of Class E Airspace; Menomonie, WI
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
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SUMMARY: This action establishes Class E airspace at Score Field,
Menomonie, WI, to accommodate a Very High Frequency Omnidirectional
Range/Distance Measuring Equipment (VOR/DME) for Runway 27. Controlled
airspace extending upward from 700 to 1200 feet above ground level
(AGL) is needed to contain aircraft executing the approach. The
intended effect of this action is to provide segregation of aircraft
using instrument approach procedures in instrument conditions from
other aircraft operating in visual weather conditions.
EFFECTIVE DATE: 0901 UTC, August 24, 1996.
FOR FURTHER INFORMATION CONTACT:
John A. Clayborn, Air Traffic Division, Operations Branch, AGL-530,
Federal Aviation Administration, 2300 East Devon Avenue, Des Plaines,
Illinois 60018, telephone (847) 294-7568.
SUPPLEMENTARY INFORMATION:
History
On May 2, 1996, the FAA proposed to amend part 71 of the Federal
Aviation Regulations (14 CFR part 71) to establish Class E5 at Score
Field, Menomonie, WI (61 FR 19592). The proposal was to add controlled
airspace extending upward from 700 to 1200 feet AGL to contain
Instrument Flight Rules (IFR) operations in controlled airspace during
portions of the terminal operation and while transiting between the
enroute and terminal environments.
Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments objecting to the proposal were received. Class E5 airspace
designations for airspace areas extending upward from 700 feet or more
above the surface of the earth 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 E5
airspace designation listed in this document will be published
subsequently in the Order.
The Rule
This amendment to part 71 of the Federal Aviation Regulations (14
CFR part 71) establishes Class E5 airspace at Score Field, Menomonie,
WI, to accommodate a Very High Frequency Omnidirectional Range/Distance
Measuring Equipment (VOR/DME) for Runway 27. Controlled airspace
extending upward from 700 to 1200 feet AGL is needed to contain
aircraft executing the approach. The area will be depicted on
appropriate aeronautical charts thereby enabling pilots to
circumnavigate the area or otherwise comply with IFR procedures.
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 11034; 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.
* * * * *
AGL WI E5 Menomonie, WI [New]
Menomonie, Score Field, WI
(lat. 44 deg.53'29''N, long. 91 deg.52'00''W)
That airspace extending upward from 700 feet above the surface
within a 6.4 mile radius of Score Field.
* * * * *
Issued in Des Plaines, Illinois on June 24, 1996.
Maureen Woods,
Manager, Air Traffic Division.
[FR Doc. 96-17592 Filed 7-9-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-17591 Establishment of Class E Airspace; Sturgis, SD
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36285-36286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17591]
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DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 92-AGL-5]
Establishment of Class E Airspace; Sturgis, SD
AGENCY: Federal Aviation Administration; Sturgis, SD.
ACTION: Final rule.
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SUMMARY: This action establishes Class E airspace at Sturgis, SD. A
Global Positioning System (GPS) standard instrument approach procedure
(SIAP) to Runway 29 has been developed for the Sturgis Municipal
Airport. Controlled airspace extending upward from 700 feet above
ground level (AGL) is needed to contain aircraft executing the
approach. The intended effect of this action is to provide segregation
of aircraft using instrument approach procedures in instrument
conditions from other aircraft operating in visual weather conditions.
EFFECTIVE DATE: 0901 UTC, October 10, 1996.
FOR FURTHER INFORMATION CONTACT:
John A. Clayborn, Air Traffic Division, Operations Branch, AGL-530,
Federal Aviation Administration, 2300 East Devon Avenue, Des Plaines,
Illinois 60018, telephone (847) 294-7568.
SUPPLEMENTARY INFORMATION:
History
On May 2, 1996, the FAA proposed to amend part 71 of the Federal
Aviation Regulations (14 CFR part 71) to establish Class E airspace at
Sturgis, SD (61 FR 19590). The proposal was to add controlled airspace
extending upward from 700 feet AGL to contain Instrument Flight Rules
(IFR) operations in controlled airspace during portions of the terminal
operation and while transiting between the enroute and terminal
environments.
Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments objecting to the proposal were received. Class E airspace
designations for areas extending upward from 700 feet or more above the
surface
[[Page 36286]]
of the earth 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
the Order.
The Rule
This amendment to part 71 of the Federal Aviation Regulations (14
CFR part 71) establishes Class E airspace at Sturgis, SD to accommodate
aircraft executing the GPS Runway 29 SIAP at Sturgis Municipal Airport.
Controlled airspace extending upward from 700 feet AGL is needed to
contain aircraft executing the approach. The area will be depicted on
appropriate aeronautical charts thereby enabling pilots to
circumnavigate the area or otherwise comply with IFR procedures.
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 11034; 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 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.
* * * * *
AGL SD E5 Sturgis, SD [New]
Sturgis Municipal Airport, SD
(lat. 44 deg.26'06'' N, long. 103 deg.22'38'' W)
That airspace extending upward from 700 feet above the surface
within a 7-mile radius of the Sturgis Municipal Airport.
* * * * *
Issued in Des Plaines, Illinois on June 20, 1986.
Maureen Woods,
Manager, Air Traffic Division.
[FR Doc. 96-17591 Filed 7-9-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-17588 Delegation of Authority
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36286-36287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17588]
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DEPARTMENT OF TRANSPORTATION
14 CFR Part 91
Delegation of Authority
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notice of delegation of authority.
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SUMMARY: The Administrator of the FAA is delegating the authority to
administer certain provisions of Special Aviation Regulation (SFAR) No.
74--Airspace and Flight Operations Requirements for the 1996 Summer
Olympic Games, Atlanta, GA, to the Regional Administrator for the
Southern Region. This delegation will enable the FAA to respond to the
immediate needs of the Olympic Committee, local and Federal law
enforcement officials and other safety personnel during the Olympic
Games.
EFFECTIVE DATE: July 10, 1996.
FOR FURTHER INFORMATION CONTACT:
Steve Alogna, Olympic Project Manager, Federal Aviation Administration,
1701 Columbia Ave., College Park, Georgia 30337; (404) 305-5051.
SUPPLEMENTARY INFORMATION: On February 12, 1996, the FAA published SFAR
No. 74 in the Federal Register (61 FR 5492), which establishes airspace
and flight operations requirements for the XXVI Olympic Games. This
regulation is to provide for security of the venues, safe operations,
and efficient management of air traffic to, within, and from these
areas, and to prevent an unsafe congestion of sightseeing and other
aircraft over the various games sites. Paragraph A.3 of SFAR No. 74
contains provisions to provide flexible and efficient management and
control of air traffic, such as the authority to give priority to or
exclude from certain requirements of
[[Page 36287]]
the SFAR flight operations dealing with essential military, medical and
rescue, essential public health and welfare, Presidential and Vice
Presidential delegations, visiting heads of state, the Olympic
Committee and media whose planned activities have been coordinated with
and accredited by the Atlanta Committee for the Olympic Games and law
enforcement and security officials.
As circumstances may warrant, it may be necessary for the
appropriate Regional Administrator to exercise the authority as stated
above and provided for in paragraph A.3 of SFAR No. 74. This delegation
will enable the Regional Administrator for the Southern Region to
administer the provisions of paragraph A.3. of SFAR No. 74.
Delegation
Accordingly, I hereby delegate my authority to administer paragraph
A.3. of SFAR No. 74 to the Regional Administrator of the Southern
Region.
Issued in Washington, DC on June 3, 1996.
David R. Hinson,
Administrator.
[FR Doc. 96-17588 Filed 7-9-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-17585 Fisheries of the Exclusive Economic Zone off Alaska; Atka Mackerel in the Eastern Aleutian District and Bering Sea Subarea
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Page 36306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17585]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 679
[Docket No. 960129019-6019-01; I.D. 070596A]
Fisheries of the Exclusive Economic Zone off Alaska; Atka
Mackerel in the Eastern Aleutian District and Bering Sea Subarea
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Closure.
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SUMMARY: NMFS is closing the directed fishery for Atka mackerel in the
Eastern Aleutian District and Bering Sea subarea of the Bering Sea and
Aleutian Islands management area (BSAI). This action is necessary to
prevent exceeding the total allowable catch of Atka mackerel in this
area.
EFFECTIVE DATE: 1200 hrs, Alaska local time (A.l.t.), July 8, 1996,
until 2400 hrs, A.l.t., December 31, 1996.
FOR FURTHER INFORMATION CONTACT: Mary Furuness, 907-586-7228.
SUPPLEMENTARY INFORMATION: The groundfish fishery in the BSAI exclusive
economic zone is managed by NMFS according to the Fishery Management
Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands
Area (FMP) prepared by the North Pacific Fishery Management Council
under authority of the Magnuson Fishery Conservation and Management
Act. Fishing by U.S. vessels is governed by regulations implementing
the FMP at 50 CFR part 679 and at subpart H of 50 CFR part 600.
The total allowable catch of Atka mackerel for the Eastern Aleutian
District and Bering Sea subarea was established by the Final 1996
Harvest Specifications of Groundfish (61 FR 4311, February 5, 1996) for
the BSAI and subsequent reserve apportionment (61 FR 16085, April 11,
1996) as 26,700 metric tons (mt). (See Sec. 679.20(c)(3)(iii).) As of
June 8, 1996, 6,014 mt remain. The directed fishery for Atka mackerel
in the Eastern Aleutian District and Bering Sea subarea was closed
under Sec. 679.20(d)(iii) on February 14, 1996, (61 FR 6323, February
20, 1996); see also Sec. 679.20(d)(1) and opened on July 1, 1996 (61 FR
33046, June 26, 1996; see also Sec. 679.25(a).)
The Director, Alaska Region, NMFS (Regional Director), has
determined, in accordance with Sec. 679.20(d)(1)(iii), that the Atka
mackerel total allowable catch in the Eastern Aleutian District and
Bering Sea subarea soon will be reached. Therefore, the Regional
Director has established a directed fishing allowance of 26,200 mt
after determining that 500 mt will be taken as incidental catch in
directed fishing for other species in the Eastern Aleutian District and
Bering Sea subarea. Consequently, NMFS is prohibiting directed fishing
for Atka mackerel in the Eastern Aleutian District and Bering Sea
subarea.
Maximum retainable bycatch amounts for applicable gear types may be
found in the regulations at Sec. 679.20(e).
Classification
This action is taken under Sec. 679.20 and is exempt from review
under E.O. 12866.
Authority: 16 U.S.C. 1801 et seq.
Dated: July 5, 1996.
Donald J. Leedy,
Acting Office Director, Office of Fisheries Conservation and
Management, National Marine Fisheries Service.
[FR Doc. 96-17585 Filed 7-5-96; 4:19 pm]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-17576 Pesticide Tolerance for 1-[[2-(2,4-Dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl]-1H-1,2,4-triazole
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36299-36302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17576]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4321/R2251; FRL-5381-7]
RIN 2070-AB78
Pesticide Tolerance for 1-[[2-(2,4-Dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a tolerance for combined residues of the
fungicide 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound in or on the raw
agricultural commodity stonefruit group at 1.0 part per million (ppm).
The regulation to establish a maximum permissible level for residues of
the fungicide was requested in a petition submitted by the Ciba-Geigy
Corp.
EFFECTIVE DATE: This regulation becomes effective July 10, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4321/R2251], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. A copy of any objections and hearing
requests filed with the Hearing Clerk should be identified by the
document control number and submitted to: Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring copy of objections and hearing
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202. Fees accompanying objections shall be labeled ``Tolerance
Petition Fees'' and forwarded to: EPA Headquarters Accounting
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh,
PA 15251.
An electronic copy of objections and hearing requests filed with
the Hearing Clerk may be submitted to OPP by sending electronic mail
(e-mail) to: [email protected]
Copies of electronic objections and hearing requests must be
submitted as an ASCII file avoiding the use of special characters and
any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 5.1 file format
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the
[[Page 36300]]
docket number [PP 4F4321/R2251] . No ``Confidential Business
Information'' (CBI) should be submitted through e-mail. Copies of
electronic objections and hearing requests on this rule may be filed
online at many Federal Depository Libraries. Additional information on
electronic submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Connie B. Welch, Product
Manager (PM) 21, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 227, CM #2, 1921
Jefferson Davis Highway, Arlington, VA 22202 (703) 305-6226; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA issued a notice (FRL-4971-5), published
in the Federal Register of November 15, 1995 (60 FR 57421), which
announced that Ciba-Geigy Corp., P.O. Box 18300, Greensboro, NC 27419
had submitted pesticide petition (PP) 4F4321 to EPA requesting that the
Administrator, pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d ), establish a tolerance for
combined residues of the fungicide 1-[[2-(2,4-dichlorophenyl)-4-propyl-
1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole in or on the raw
agricultural commodity stonefruit group at 1.0 ppm part per million
(ppm). There were no comments received in response to the notice of
filing.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the tolerance include:
1. Plant and animal metabolism studies.
2. Residue data for crop and livestock commodities.
3. Two enforcement methods and multiresidue method testing data.
4. A 90-day rat feeding study with a no-observable-effect level
(NOEL) of 12 mg/kg/day.
5. A 90-day dog feeding study with a NOEL of 1.25 mg/kg/day.
6. A rabbit developmental toxicity study with a maternal NOEL of
100 mg/kg/day and a developmental toxicity NOEL of greater than 400 mg/
kg/day (highest dose tested) (HDT)).
7. A rat teratology study with a maternal NOEL of 30 mg/kg/day and
a developmental toxicity NOEL of 30 mg/kg/day.
8. A two-generation rat reproduction study with a reproductive NOEL
of 125 mg/kg/day (HDT) and a developmental toxicity NOEL of 25 mg/kg/
day.
9. A 1-year dog feeding study with a NOEL of 1.25 mg/kg/day.
10. A 2-year rat chronic feeding/carcinogenicity study with a NOEL
of 5 mg/kg/day with no carcinogenic potential under the conditions of
the study up to and including approximately 125 mg/kg/day, the highest
dose tested.
11. A 2-year mouse chronic feeding/carcinogenicity study with a
NOEL of 15 mg/kg/day and with a statistically significant increase in
combined adenomas and carcinomas of the liver in male mice at
approximately 375 mg/kg/day, the highest dose tested.
12. Ames test with and without activation, negative.
13. A mouse dominant-lethal assay, negative.
14. Chinese hamster nucleus anomaly, negative.
15. Cell transformation assay, negative.
Ciba-Geigy submitted information which resolved the previously
outstanding concerns about the nature of the residue in ruminants, an
explanation of recovery calculations, and an explanation of the crop
field trial protocol. Data gaps exist concerning dosing in the mouse
carcinogenicity study. These data requirements were required under
reregistration, pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq.
As part of EPA's evaluation of potential human health risks, 1-[[2-
(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-
triazole has been the subject of five Peer Reviews and one Scientific
Advisory Panel (SAP) meeting. 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole was originally evaluated by the
Peer Review Committee on January 15, 1987, and classified as a Group C
(possible human) carcinogen with a recommendation made for the
quantification of estimated potential human risk using a linearized
low-dose extrapolation. The method resulted in the establishment of a
Q* of 7.9 x 10-2 (mg/kg/day)-1.
The Peer Review Committee's decision was presented to the FIFRA
Scientific Advisory Panel on March 2, 1988. The Panel did not concur
with the committee's overall assessment of the weight-of-evidence on
the carcinogenicity of 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole. The Panel recommended placing
the chemical in Group D, indicating that the Group C classification was
based on minimal evidence. The Panel's determination that EPA's Group C
classification was based on minimal evidence was due to the fact that
the incidence of liver tumors in male mice only occurred when the mice
were given an excessive chemical dose.
As part of a fifth Peer Review, EPA considered additional
information provided by the registrant in support of the registrant's
argument that the high dose was excessively toxic in the mouse
carcinogenicity study. It further argued that the data from the high
dose (2,500 ppm) should not be included in the evaluation of
carcinogenic potential of 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole. In support of these arguments,
the registrant provided two subchronic oral toxicity studies in mice.
Ciba-Geigy also provided a reread of the pathology slides from a mouse
oncogenicity study which it felt indicated sufficient concurrent liver
toxicity at 2,500 ppm to document that this dose was excessive. These
findings were not present in the original pathology report. Owing to
the inconsistency in Ciba-Geigy's report and the original report, the
Agency requested that an independent (third) evaluation of the
pathology slides be made to determine if the pathology reported could
be confirmed. The results of this (third) pathology evaluation were
used in the fifth Peer Review in place of data resulting from the
earlier evaluations provided by Ciba-Geigy.
The Peer Review Committee considered the following facts regarding
the toxicology data on 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole in a weight-of-evidence
determination of carcinogenic potential:
1. Increased numbers of adenomas (increased trend and pairwise
comparison) were found in the livers of male CD1 mice given 2,500 ppm
of 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-
1,2,4-triazole in their diet.
2. The treated animals had earlier fatalities than the controls.
3. The numbers of carcinomas were increased (trend only) in male
mice only at the 2,500 ppm dose level. Tumors were not significantly
increased at the 500 ppm dose level. Adenomas observed in the treated
animals were larger and more numerous than those in controls; however,
the tumor type (adenoma) was the same.
4. No excessive number of tumors was found in female mice.
5. In a rat study conducted with acceptable doses of 1-[[2-(2,4-
dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole,
no
[[Page 36301]]
excessive numbers of tumors were found.
The Peer Review Committee determined, based on the additional
information submitted by Ciba-Geigy from two 90-day subchronic studies
in mice that the 2,500 ppm dose used in the 2-year chronic study
exceeded the maximum tolerated dose (MTD) based on the endpoint of
hepatic necrosis, and the 500 ppm dose used in the chronic study was
inadequate to assess the carcinogenicity of 1-[[2-(2,4-dichlorophenyl)-
4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole. Based on the
third pathology evaluation of the chronic study, the Peer Review
Committee disagreed with Ciba-Geigy's argument that the study showed
excessive toxicity at the 2,500 ppm dose. However, the Peer Review
Committee concluded that the 90-day subchronic studies are a better
measure of what would be an MTD.
Based upon these findings, the Peer Review Committee agreed that
the classification for 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole should remain a Group C
(possible human) carcinogen and recommended against the previously used
Q* (viz. 0.079) for risk assessment purposes. For the purpose of
risk characterization the Peer Review Committee recommended that the
reference dose (RfD) approach should be used for quantification of
human risk. This decision was based on the disqualification of the high
dose (2,500 ppm), making the data inappropriate for the calculation of
Q*. Because the middle dose (500 ppm) was not considered
sufficiently high enough for assessing the carcinogenic potential of 1-
[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-
triazole, EPA has requested an additional mouse study at intermediate
dose levels in male mice only. EPA does not expect that these data will
significantly change the above cancer assessment that 1-[[2-(2,4-
dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole
poses a negligible risk to humans.
The reference dose for 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole is 0.013 mg/kg/day, and based
on a NOEL of 1.25 mg/kg/day and an uncertainty factor of 100. The NOEL
is taken from a 1-year dog feeding study that demonstrated irritation
of the stomach in males as an endpoint effect. The Anticipated Residue
Contribution (ARC) from the current action is estimated at 0.000673 mg/
kg/day and utilizes 5 percent of the RfD of the general population of
the 48 states. The ARC for the most highly exposed subgroup, non-
nursing infants < 1 year is 0.002203 mg/kg/day (17 percent of the RfD).
The nature of the residue in plants and animals is adequately
understood and adequate analytical methods (gas chromatography) are
available for enforcement purposes. Adequate animal tissue, milk, and
egg tolerances exist to cover secondary residues incurred in those
commodities from the proposed uses.
The enforcement methodology has been submitted to the Food and Drug
Administration for publication in the Pesticide Analytical Manual,
Volume II (PAM II). Because of the long lead time for publication of
the method in PAM II, the analytical methodology is being made
available in the interim to anyone interested in pesticide enforcement
when requested from: Calvin Furlow, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 1132,
CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202 (703) 305-
5232.
There are presently no actions pending against the continued
registration of this chemical. The pesticide is considered useful for
the purpose for which the tolerance is sought.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
will protect the public health. Therefore, the tolerance is established
as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections to the regulation and may also request a hearing on
those objections. Objections and hearing requests must be filed with
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy
of the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issue(s) on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the objector (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issue(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32).
A record has been established for this rulemaking under the docket
number [PP 4F4321/R2251] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rule-making record
which will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Viginia address in ``ADDRESSES'' at the beginning of this document.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines
``significant'' as those actions likely to lead to a rule (1) having an
annual effect on the economy of 100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local or tribal governments or communities (also known as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3)
[[Page 36302]]
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
Pursuant to the requirements of the Regulatory Flexibility Act (5
U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing
exemptions from tolerance requirements do not have a significant
economic impact on a substantial number of small entities. A
certification statement to this effect was published in the Federal
Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 2, 1996.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.434, the table in paragraph (a) is amended by adding
alphabetically an entry for stonefruit group to read a follows:
Sec. 180.434 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole; tolerances for residues.
* * * * *
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Stonefruit group........................................... 1.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 96-17576 Filed 7-9-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-17571 Triphenyltin Hydroxide; Tolerance Revision
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36298-36299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17571]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300414A; FRL-5381-4]
RIN 2070-AB78
Triphenyltin Hydroxide; Tolerance Revision
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is issuing a final tolerance rule for triphenyltin
hydroxide. All domestic registrations of triphenyltin hydroxide for use
on carrots, peanuts and peanut hulls have been cancelled and EPA is
revoking these tolerances.
EFFECTIVE DATES: This regulation is effective August 9, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
docket number, [OPP-300414A], may be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. A copy of any objections and hearing requests
filed with the Hearing Clerk should be identified by the docket number
and submitted to: Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring copy of objections and hearing requests to Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees
accompanying objections shall be labeled ``Tolerance Petition Fees''
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
An electronic copy of objections and hearing requests filed with
the Hearing Clerk may be submitted to OPP by sending electronic mail
(e-mail) to:[email protected]. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1 file format or ASCII file format. All copies
of electronic objections and data in electronic form must be identified
by the docket number [OPP-300414A]. No Confidential Business
Information (CBI) should be submitted through e-mail. Copies of
electronic objections and hearing requests on this rule may be filed
online at many Federal Depository Libraries. Additional information on
electronic submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: Jude Andreasen, Special Review and
Reregistration Division (7508W), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Telephone: (703) 308-8016; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of March 6, 1996 (61
FR 8901)(FRL-5347-7), EPA issued a proposed rule that gave notice that
EPA intended to revoke tolerances for triphenyltin hydroxide on
carrots, peanuts and peanut hulls. There were no comments or requests
for referral to an advisory committee received in response to the
proposed rule. The data submitted with the proposal and other relevant
material have been evaluated and discussed in the proposed rule. Based
on the data and information considered, the Agency concludes that the
tolerances are not needed to protect the public health. Therefore, the
tolerances are being removed as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections to the regulation and may also request a hearing on
those objections. Objections and hearing requests must be filed with
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy
of the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issue(s) on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the objector (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issue(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32).
A record has been established for this rulemaking under docket
number OPP-300414A (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
[[Page 36299]]
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines
``significant'' as those actions likely to lead to a rule (1) having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local or tribal governments or communities (also known as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement,
grants, user fees, or loan programs; or (4) raising novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
Pursuant to the requirements of the Regulatory Flexibility Act (5
U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing
exemptions from tolerance requirements do not have a significant
economic impact on a substantial number of small entities. A
certification statement explaining the factual basis for this
determination was published in the Federal Register of May 4, 1981 (46
FR 24950).
This final rule does not impose any enforceable duty, or contain
any ``unfunded mandates'' as described in Title II of the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior
consultation as specified by Executive Order 12875 (58 FR 58093,
October 28, 1993), entitled Enhancing the Intergovernmental
Partnership, or special consideration as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 24, 1996.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.236 is revised to read as follows:
Sec. 180.236 Triphenyltin hydroxide; tolerances for residues.
Tolerances are established for residues of the fungicide
triphenyltin hydroxide in or on raw agricultural commodities as
follows:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, goats, hogs, horses and sheep, kidney and liver... 0.05
Pecans.................................................... 0.05
Potatoes.................................................. 0.05
Sugar beet, roots......................................... 0.1
------------------------------------------------------------------------
[FR Doc. 96-17571 Filed 7-9-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-17565 Regattas and Marine Parades; Correction
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Page 36292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17565]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Coast Guard
33 CFR Part 100
[CGD 95-054]
RIN 2115-AF17
Regattas and Marine Parades; Correction
AGENCY: Coast Guard, DOT.
ACTION: Correction to interim rule.
-----------------------------------------------------------------------
SUMMARY: This notice contains corrections to the interim rule (CGD 95-
054) revising Coast Guard marine event regulations that was published
Wednesday, June 26, 1996, (61 FR 33027).
EFFECTIVE DATE: July 10, 1996.
FOR FURTHER INFORMATION CONTACT: Mr. Carlton Perry, Office of Boating
Safety, (202) 267-0979.
SUPPLEMENTARY INFORMATION: In Sec. 100.19, Chief, Operations, is
incorrectly referred to as ``the Chief, Office of Operations.''
Accordingly, the publication on June 26, 1996, of the interim rule
(CGD 95-054) that is the subject of FR Doc. 96-16319 is corrected as
follows:
Sec. 100.19 [Corrected]
1. On page 33033, in the second and third columns, remove the words
``the Chief, Office of Operations'' wherever they appear and add, in
their place, the words ``Chief, Operations,''.
J. A. Creech,
Captain, U.S. Coast Guard, Director, Operations Policy.
[FR Doc. 96-17565 Filed 7-9-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-17562 Digital Data Transmission Within the Video Portion of TV Broadcast Station Transmissions
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36302-36305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17562]
=======================================================================
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR PART 73
[MM Docket No. 95-42; FCC 96-274]
Digital Data Transmission Within the Video Portion of TV
Broadcast Station Transmissions
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This Order amends the Commission's Rules to allow broadcast
television licensees to use approved methods of ancillary data
transmission without prior Commission authorization. The methods
approved in this Report and Order are two ``overscan'' systems, as
proposed by Yes! Entertainment Corporation and A.C. Nielsen Company,
and two ``sub-video'' systems, as proposed by Digideck, Incorporated
and WavePhore, Inc. The intended effect of this rule is to permit the
transmission of data streams in the NTSC television signal for a
variety of uses, such as software and business data downloading,
activation of interactive toys, and program identifying and tracking.
EFFECTIVE DATE: July 10, 1996.
FOR FURTHER INFORMATION CONTACT:
Jim McNally, Gordon Godfrey, or Paul Gordon, Mass Media Bureau, Policy
and Rules Division, (202) 418-2120.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report
and Order, FCC 96-274, adopted June 21, 1996 and released June 28,
1996. The full text of this Commission decision is available for
inspection and copying during normal business hours in the FCC Dockets
Branch (Room 239), 1919 M Street, N.W., Washington, D.C. The complete
text of this decision may also be purchased from the Commission's copy
contractor, International Transcription Services, (202) 857-3800, 2100
M Street, N.W., Suite 140, Washington, DC 20037.
Synopsis of Order
1. This Report and Order amends the Commission's Rules to allow
broadcast television licensees to use approved methods of ancillary
data transmission without prior Commission authorization. Examination
of this issue was raised in the Notice of Proposed Rule Making in this
proceeding.1 Two of the newly approved types of systems involve
``overscan'' methods, and the other two use a ``sub-video'' method.
These methods, as well as a ``signal substitution'' method proposed by
En Technology Corporation (En), will be further described below. We do
not have a basis for imposing a government-imposed standard for digital
data at this time.
---------------------------------------------------------------------------
\1\ 60 FR 24606, May 9, 1995.
---------------------------------------------------------------------------
Background
2. 47 CFR 73.646 allows the transmission, without prior Commission
consent, of ancillary telecommunications services within the Vertical
Blanking Interval (VBI) (Line 1 through Line 21) of television
broadcast signals. The VBI precedes the active video portion of the
standard NTSC television signal. In contrast, data transmission systems
operating within the active video portion of the television picture
have been authorized only on a case-by-case basis, in order to protect
the public's ability to receive high-quality over-the-air video
broadcast transmissions. Various parties have now asked the Commission
to permit broadcasters to employ new data transmission systems
utilizing the active video portion of the television picture.
3. Overscan. Ancillary data transmitting systems using the
``overscan'' method function by replacing the transmitted video signal
with digitally encoded information in an area on the perimeter of the
picture, not normally seen by viewers because it is masked off by the
television cabinet. Line 22, the first line of active video, has
traditionally been used for this purpose and Yes! proposes to use the
extreme left edge of the picture
[[Page 36303]]
similarly. Nielsen has been using line 22 since 1989, under temporary,
conditional authority, to transmit the Nielsen Automated Measurement of
Lineup (AMOL) system signal identification codes, and is seeking
permanent authority for this use.
4. Sub-video. Sub-video systems distribute the ancillary signals
throughout the visible picture. The amplitudes of these signals are
kept sufficiently low (or are confined to such a limited part of the
normally emitted video spectrum bandwidth) that they are supposed to be
imperceptible to the viewer. WavePhore and Digideck have developed
different sub-video systems. Both systems continue to be examined by
the National Data Broadcasting Committee (the Committee), an entity
formed in 1993 by the National Association of Broadcasters and the
Consumer Electronics Group of the Electronic Industries Association.
Authorizing Ancillary Services
5. The Commission approves the use of the Yes!, Nielsen, Digideck
and WavePhore signal transmission systems, as presented in this
proceeding, by all television broadcast stations, including low power
TV stations. It retains the authority to direct licensees to take
corrective action should the ancillary transmissions unacceptably harm
picture quality or cause interference to other stations. According to
the Commission, this action is not inconsistent with others' ongoing
efforts to develop a coherent national standard recommendation for
certain data services.
Authorization of Specific Systems
6. The problem-free operation of previous overscan systems verifies
the inherently innocuous nature of their use and prompts the Commission
to approve the use of the Yes! system and to grant permanent authority
to Nielsen for its AMOL system to be used on line 22 on a non-exclusive
basis. Further, the Commission does not set a technical standard or
sharing criteria for Line 22 overscan systems, as had been requested by
Airtrax in a related petition.
7. The Commission found that sub-video systems, apparently also can
operate as proposed without causing material picture degradation or
increasing the host station's potential for causing interference.
Approval of the use of these systems is based on the favorable results
of the National Data Broadcasting Committee's laboratory testing and on
the Commission reliance that broadcasters will continue to exercise
full technical control over their signals and will be responsible for
operating in a manner that does not increase their stations' potential
for causing interference or degrade picture quality.
8. The Commission decided not to delay the deployment of these
systems in order to set a mandatory standard or standards, given that
they will be directed, at least initially, either to subscribers of a
particular service or to viewers who have purchased special equipment
to receive the signals. Should more general-consumer oriented services
be developed in the future, it can reexamine the issue of standards in
that context.
9. Data insertion systems must protect the integrity of closed
captioning signals on line 21. Any data insertion must be accomplished
in a manner that leaves the licensee with the capability to modify,
reduce, or eliminate the data insertion if necessary to terminate any
interference caused, or to restore the quality of a degraded picture.
Licensees' Rights and Obligations
10. Ancillary signals may be analog or digital, and they can be
used to provide broadcast, point-to-point, or point-to-multipoint
services. Services that are common carrier in nature are subject to
common carrier regulation. Licensees that desire to operate in a common
carrier mode must apply to the Commission for the appropriate
authorization and comply with all policies and rules applicable to the
particular service. Each licensee must retain ultimate control over the
content of any inserted data and retain the ability to remove ancillary
information from the signal when it deems necessary, unless the
ancillary services are common carrier in nature.
11. Signals that are intended for an audience needing special
equipment or who must subscribe to the service do not constitute
``broadcasting.'' For example, the rule addressing the lowest unit
charge for political candidates does not apply to these transmissions.
At the same time, however, if significant public interest uses of this
ancillary transmission technology suggest themselves, the Commission
may consider means by which to advance or ensure such usage of the
broadcast spectrum.
Miscellaneous Issues
12. Comsat expressed concern about sub-video data insertion causing
problems where analog video is converted to digital video for program
distribution, which may also be a concern for possible future consumer
digital VCRs. Because industry participants have sufficient interest
and the greatest expertise to resolve these issues, the Commission does
not see a specific role for it to play at this point.
13. A proposal by Radio Telecom and Technology, Inc. to include its
``reverse VBI'' technology in this proceeding is beyond the proper
scope of this proceeding and is not included in the instant
consideration.
14. One commenting party, En Technology, submitted information
regarding its ``Malachi'' system. The Malachi system would typically
replace many lines, or portions of lines, and thus be quite perceptible
to the viewer. Such a system raises additional issues regarding
spectrum allocation and use that have not been addressed in this
proceeding, and it would appear to go beyond the scope of the
operational flexibility proposed in the NPRM. Accordingly, the
Commission does not authorize use of the En system in this Report and
Order.
Ordering Clause
15. Therefore, it is ordered that, pursuant to Sections 4(i) and
303(r) of the Communications Act of 1934, as amended, that Part 73 of
the Commission' Rules and Regulations IS AMENDED as set forth below.
16. It is further ordere that the requests of A.C. Nielsen Company
and Yes! Entertainment Corporation for the Commission to allow
television broadcast licensees to use their respective overscan
ancillary data transmission systems without prior Commission
authorization ARE GRANTED to the extent indicated above, and in all
other aspects ARE DENIED.
17. It is further ordered that the requests of WavePhore, Inc. and
Digideck, Inc. for the Commission to allow television broadcast
licensees to use their respective sub-video ancillary data transmission
systems without prior Commission authorization ARE GRANTED to the
extent indicated above, and in all other aspects ARE DENIED.
18. It is further ordered that the petition for Rule Making filed
by Airtrax is dismissed.
Final Regulatory Flexibility Act Analysis
I. Reason for Action
In recent years, several new methods of embedding data within
television video signals have been developed. These methods degrade
television video by varying degrees, but only one of the methods is by
design intended to be perceived by viewers. The Commission is acting to
provide for such services
[[Page 36304]]
that do not significantly degrade the television picture because it
believes its broadcast licensees have the qualifications and experience
to determine which of the new systems are maximally compatible with
their primary broadcast obligations and may yet be used to provide
additional information services to segments of the public.
II. Objectives
The action taken herein provides an interim standard for the use of
the above-described data transmission technologies and is intended to
benefit broadcasters and the generally small entities which are
believed to be the most likely providers of ancillary data services.
III. Legal Basis
The action taken is authorized by Sections 4 (i) and (j), 302, 303
and 403 of the Communications Act of 1934, as amended.
IV. Description, Potential Impact and Number of Small Entities Affected
Many broadcasters are considered to be small business entities.
Thus, several thousand licensees of television broadcast facilities of
all types (commercial and educational VHF and UHF stations,
translators, boosters and Low Power TV stations) could benefit from the
rule amendments herein adopted. Most providers of the data services
envisioned herein are also expected to fall within the classification
of a ``small business entity,'' at least initially. Their number is
unknown, but may amount to several hundred over the next few years.
V. Recording, Record Keeping and Other Compliance Requirements
No comments specifically addressed the Initial Regulatory
Flexibility Analysis. No new record-keeping or compliance requirements
are imposed by the new rules.
VI. Federal Rules which Overlap, Duplicate or Conflict With this Rule
None.
VII. Any Significant Alternative Minimizing Impact on Small Entities
and Consistent With the Stated Objectives
None.
List of Subjects in 47 CFR Part 73
Television broadcasting.
Federal Communications Commission.
William F. Caton,
Acting Secretary.
Rule Changes
Title 47 of the Code of Federal Regulations Part 73 is amended as
follows:
PART 73--RADIO BROADCAST SERVICES
1. The authority citation for Part 73 continues to read as follows:
Authority: 47 U.S.C. 154, 303, 334.
2. Section 73.621 is amended by revising paragraph (f) to read as
follows:
Sec. 73.621 Noncommercial educational TV stations.
* * * * *
(f) Telecommunications Service on the Vertical Blanking Interval
and in the Visual Signal. The provisions governing VBI and visual
signal telecommunications service in Sec. 73.646 are applicable to
noncommercial educational TV stations.
* * * * *
3. Section 73.646 is amended by revising the section heading and
paragraphs (a), (b), (d), (e) and (f) to read as follows:
Sec. 73.646 Telecommunications Service on the Vertical Blanking
Interval and in the Visual Signal.
(a) Telecommunications services permitted on the vertical blanking
interval (VBI) and in the visual signal include the transmission of
data, processed information, or any other communication in either a
digital or analog mode.
(b) Telecommunications service on the VBI and in the visual signal
is of an ancillary nature and as such is an elective, subsidiary
activity. No service guidelines, limitations, or performance standards
are applied to it. The kinds of service that may be provided include,
but are not limited to, teletext, paging, computer software and bulk
data distribution, and aural messages. Such services may be provided on
a broadcast, point-to-point, or point to multipoint basis.
* * * * *
(d) Television licensees are authorized to lease their VBI and
visual signal telecommunications facilities to outside parties. In all
arrangements entered into with outside parties affecting
telecommunications service operation, the licensee or permittee must
retain control over all material transmitted in a broadcast mode via
the station's facilities, with the right to reject any material that it
deems inappropriate or undesirable. The licensee or permittee is also
responsible for all aspects of technical operation involving such
telecommunications services.
(e) The grant or renewal of a TV station license or permit will not
be furthered or promoted by proposed or past VBI or visual signal
telecommunications service operation; the licensee must establish that
its broadcast operation serves the public interest wholly apart from
such telecommunications service activities. (Violation of rules
applicable to VBI and visual signal telecommunications services could,
of course, reflect on a licensee's qualifications to hold its license
or permit.)
(f) TV broadcast stations are authorized to transmit VBI and visual
telecommunications service signals during any time period, including
portions of the day when normal programming is not broadcast. Such
transmissions must be in accordance with the technical provisions of
Sec. 73.682.
4. Section 73.682 is amended by adding paragraph (a)(24) to read as
follows:
Sec. 73.682 TV transmission standards.
(a) * * *
(24) Licensees and permittees of TV broadcast and low power TV
stations may insert non-video data into the active video portion of
their TV transmission, subject to certain conditions:
(i) The active video portion of the visual signal begins with line
22 and continues through the end of each field, except it does not
include that portion of each line devoted to horizontal blanking.
Figures 6 and 7 of Sec. 73.699 identify the numbered line referred to
in this paragraph;
(ii) Inserted non-video data may be used for the purpose of
transmitting a telecommunications service in accordance with
Sec. 73.646. In addition to a telecommunications service, non-video
data can be used to enhance the station's broadcast program service or
for purposes related to station operations. Signals relating to the
operation of TV stations include, but are not limited to program or
source identification, relay of broadcast materials to other stations,
remote cueing and order messages, and control and telemetry signals for
the transmitting system; and
(iii) A station may only use systems for inserting non-video
information that have been approved in advance by the Commission. The
criteria for advance approval of systems are as follows:
[[Page 36305]]
(A) The use of such signals shall not result in significant
degradation to any portion of the visual, aural, or program-related
data (closed captioning) signals of the television broadcast station;
(B) No increase in width of the television broadcast channel (6
MHz) is permitted. Emissions outside the authorized television channel
must not exceed the limitations given in Sec. 73.687(e). Interference
to reception of television service either of co-channel or adjacent
channel stations must not increase over that resulting from the
transmission of programming without inserted data; and
(C) Where required, system receiving or decoding devices must meet
the TV interface device provisions of Part 15, Subpart H of this
chapter.
(iv) No protection from interference of any kind will be afforded
to reception of inserted non-video data.
(v) Upon request by an authorized representative of the Commission,
the licensee of a TV station transmitting encoded programming must make
available a receiving decoder to the Commission to carry out its
regulatory responsibilities.
* * * * *
5. Section 73.1207 is amended by revising paragraph (b)(2) to read
as follows:
Sec. 73.1207 Rebroadcasts.
* * * * *
(b) * * *
(2) Permission must be obtained from the originating station to
rebroadcast any subsidiary communications transmitted by means of a
multiplex subcarrier or telecommunications service on the vertical
blanking interval or in the visual signal of a television signal.
* * * * *
6. Section 73.3613 is amended by revising paragraph (e) to read as
follows:
Sec. 73.3613 Filing of contracts.
* * * * *
(e) The following contracts, agreements or understandings need not
be filed but shall be kept at the station and made available for
inspection upon request by the FCC: contracts relating to the sale of
television broadcast time to ``time brokers'' for resale; subchannel
leasing agreements for Subsidiary Communications Authorization
operation; franchise/leasing agreements for operation of
telecommunications services on the TV vertical blanking interval and in
the visual signal; time sales contracts with the same sponsor for 4 or
more hours per day, except where the length of the events (such as
athletic contests, musical programs and special events) broadcast
pursuant to the contract is not under control of the station; and
contracts with chief operators.
[FR Doc. 96-17562 Filed 7-9-96; 8:45 am]
BILLING CODE 6712-01-P
Complete official Federal Register PDF
FR Doc. 96-17559 Office of the Assistant Secretary for HousingFederal Housing Commissioner; Streamlining Mortgagee Requirements
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36452-36453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17559]
[[Page 36451]]
_______________________________________________________________________
Part III
Department of Housing and Urban Development
_______________________________________________________________________
24 CFR Part 202, et al.
Office of the Assistant Secretary for Housing--Federal Housing
Commissioner; Streamlining Mortgagee Requirements; Final Rule
Federal Register / Vol. 61, No. 133 / Wednesday, July 10, 1996 /
Rules and Regulations
[[Page 36452]]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
24 CFR Parts 202, 203, 221, and 234
[Docket No. FR-3957-F-02]
RIN 2502-AG57
Office of the Assistant Secretary for Housing--Federal Housing
Commissioner; Streamlining Mortgagee Requirements
AGENCY: Office of the Assistant Secretary for Housing--Federal Housing
Commissioner, HUD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule makes final the January 26, 1996 interim rule which
revised FHA's mortgagee requirements to streamline and make the FHA
process more flexible for mortgagees and FHA's customers and clients.
EFFECTIVE DATE: August 9, 1996.
FOR FURTHER INFORMATION CONTACT: William M. Heyman, Director, Office of
Lender Activities and Land Sales Registration, Room 9156, Department of
Housing and Urban Development, 451 Seventh Street, SW, Washington, DC
20410, telephone (voice) (202) 708-1515, (TTY) (202) 708-4594. (These
are not toll-free numbers.)
SUPPLEMENTARY INFORMATION:
Background
Early in 1995 the FHA Single Family Business Practices Working
Group was established to develop recommendations to streamline the FHA
process, reduce or eliminate unnecessary requirements, promote greater
opportunities for first-time homebuyers and minorities, and maintain a
responsible risk management program. The Working Group was comprised of
representatives of mortgage lenders, State and local governments, trade
associations, realtors, government-sponsored enterprises, and other
interested parties.
On January 26, 1996, at 61 FR 2650, the Department published an
interim rule on Streamlining Mortgagee Requirements. The revisions made
by the interim rule resulted from the efforts and recommendations made
by the Working Group. They were designed to make the FHA process more
flexible for mortgagees, and for State and local governments and
nonprofit associations, and also to expand homeownership opportunities.
They were also intended to assist in making the FHA a more effective
organization to serve the needs of our customers and clients. In
addition, the revisions were intended to minimize the differences
between FHA and conventional loan processing and to place greater
reliance and accountability on mortgagees.
The interim rule made the following changes:
--Section 202.11(a)(5) was revised to establish uniform requirements on
the use of authorized agents by supervised and nonsupervised
mortgagees. For conforming reasons, Secs. 202.13(e) and 202.17(d) were
removed.
--Section 202.12(m) was revised to eliminate the requirement that a
branch office of a mortgagee must be approved by FHA to originate FHA
mortgages. A branch registry process is permitted. However, a
nonsupervised loan correspondent is required to provide evidence that
it complies with the net worth requirements for itself and all of its
branches, as set forth in Sec. 202.12(n)(3).
--Section 202.15(c)(1) was revised to eliminate the requirement that
loans must be closed in the name of the Loan Correspondent, and to
permit such mortgages to be closed in either the name of the Loan
Correspondent or its Sponsor(s).
--Section 202.15(c)(5) was revised to eliminate the compliance report
and the report on internal control from Loan Correspondents' annual
audited financial statements.
--Section 203.3(b)(2) was revised to eliminate the requirement that FHA
individually approve mortgagees' Direct Endorsement underwriters and to
establish a registry process for the underwriter. Also, the requirement
that the technical staff utilized by the mortgagee be approved by the
Secretary was removed. For conforming reasons, Secs. 203.3(b)(3) and
(c) were eliminated.
Public Comments
The public was afforded a 60-day comment period on the January 26,
1996 interim rule. Two commenters responded: one certified public
accountant firm and one national association of certified public
accountants. Below is a listing of the comments presented, and the
Department's response follows each comment.
Comment: The commenter questions (1) Whether the auditor needs to
meet GAO Yellow Book general requirements for education, etc., given
the lower level of scope, and (2) is the auditor required to
communicate indications of illegal acts to HUD if such indications are
present?
Response: (1) Unless engaged in other GAO Yellow Book audits, the
auditor of a loan correspondent mortgagee would no longer have to meet
the GAO Yellow Book education requirements. The Department notes,
however, that Professional Standards provide that an auditor should
obtain a level of knowledge of the auditee's business that will enable
the auditor to plan and perform the audit in accordance with Generally
Accepted Auditing Standards. (2) The auditor will still be required to
report illegal acts as set forth in Handbook 2000.04 REV-1,
Consolidated Audit Guide for Audits of HUD Programs.
Comment: The commenter urges the issuance by the Office of the
Inspector General of a supplement to Handbook 2000.04 REV-1,
Consolidated Audit Guide for Audits of HUD Programs. Otherwise, the
commenter believes there will be confusion among both loan
correspondents and their auditors since the Consolidated Audit Guide is
in conflict with the interim rule.
Response: The Department is revising the Consolidated Audit Guide
to reflect this and other changes. In the meantime, loan correspondent
mortgagees and auditors may refer to Mortgagee Letter 96-12 for
guidance.
Comment: Another commenter requests that the final rule state
whether the financial statement audits of Loan Correspondents should be
performed in accordance with Government Auditing Standards or in
accordance with Generally Accepted Auditing Standards (GAAS).
Response: The Department will no longer require that financial
statement audits of loan correspondent mortgagees be performed in
accordance with Government Auditing Standards. Such audits, however,
must be performed according to Generally Accepted Auditing Standards.
Although this will not be incorporated into the final rule, it will be
specified in the Consolidated Audit Guide and in Mortgagee Approval
Handbook 4060.1 REV-1, both of which are being revised by the
Department.
This Rule
No changes are needed to the regulatory text as a result of the
public comments received on the January 26, 1996 interim rule.
Therefore, this final rule adopts the interim rule without substantive
change. In addition, this final rule makes conforming changes to parts
202, 203, 221, and 234.
Other Matters
Environmental Finding
A Finding of No Significant Impact with respect to the environment
was
[[Page 36453]]
made in accordance with HUD regulations at 24 CFR Part 50, which
implement section 102(2)(C) of the National Environmental Policy Act of
1969, for the January 26, 1996 interim rule. Since this final rule
makes no changes to the interim rule, the Finding of No Significant
Impact for the interim rule shall serve as the finding for the final
rule. The Finding of No Significant Impact is available for public
inspection between 7:30 a.m. and 5:30 p.m. weekdays in the Office of
the Rules Docket Clerk, Office of the General Counsel, Department of
Housing and Urban Development, Room 10276, 451 Seventh Street, S.W.,
Washington, D.C. 20410.
Executive Order 12612, Federalism
The General Counsel, as the Designated Official under section 6(a)
of Executive Order 12612, Federalism, has determined that the policies
contained in this rule do not have substantial direct effects on States
or their political subdivisions, or the relationship between the
Federal government and the States, or on the distribution of power and
responsibilities among the various levels of government. As a result,
the rule is not subject to review under the Order. Specifically, the
requirements of this rule are directed to insuring mortgages and do not
impinge upon the relationship between the Federal government and State
and local governments.
Executive Order 12606, The Family
The General Counsel, as the Designated Official under Executive
Order 12606, The Family, has determined that this rule does not have
potential for significant impact on family formation, maintenance, and
general well-being, and, thus, is not subject to review under the Order
because it revises mortgagee requirements.
The Regulatory Flexibility Act
In accordance with 5 U.S.C. 605(b) (the Regulatory Flexibility
Act), the Secretary by his approval of this rule hereby certifies that
this rule does not have a significant economic impact on a substantial
number of small entities because the changes made by this rule are
primarily procedural and will not have a significant economic impact.
List of Subjects
24 CFR Part 202
Administrative practice and procedure, Home improvement,
Manufactured homes, Mortgage insurance, Reporting and recordkeeping
requirements.
24 CFR Part 203
Hawaiian Natives, Home improvement, Indians--lands, Loan programs--
housing and community development, Mortgage insurance, Reporting and
recordkeeping requirements, Solar energy.
24 CFR Part 221
Low and moderate income housing, Mortgage insurance, Reporting and
recordkeeping requirements.
24 CFR Part 234
Condominiums, Mortgage insurance, Reporting and recordkeeping
requirements.
Accordingly, under the authority of 42 U.S.C. 3535(d), chapter II
of title 24 of the Code of Federal Regulations is amended by adopting
as final, without change, the interim rule for ``Parts 202 and 203,
Streamling Mortgagee Requirements'', published in the Federal Register
on January 26, 1996 (61 FR 2650). Chapter II is also amended by further
amending part 203, and by amending parts 221 and 234 as follows:
PART 203--SINGLE FAMILY MORTGAGE INSURANCE
1. The authority citation for part 203 continues to read as
follows:
Authority: 12 U.S.C. 1709, 1710, 1715b, and 1715u; 42 U.S.C.
3535(d).
Secs. 203.51, 203.258, 203.259a, 203.359, 203.363, 203.366, 203.368,
203.369, 203.378, 203.379, 203.380, 203.402, and 203.423 [Amended]
2. Part 203 is amended by removing the word ``approved'' wherever
it appears before the word ``underwriter'' in the following sections:
Secs. 203.51(2), 203.258(c)(2), 203.259a(a)(2)(ii)(B), 203.359(b)
introductory text, 203.363(b) paragraph heading, 203.366(b)(1),
203.368(a)(1)(ii), 203.369(a)(1), 203.369(b), 203.378(c)(3),
203.379(b), 203.380(a)(1)(iii), 203.402(g)(1) paragraph heading,
203.402(g)(2) paragraph heading, and 203.423(a)(1).
PART 221--LOW COST AND MODERATE INCOME MORTGAGE INSURANCE
3. The authority citation for part 221 continues to read as
follows:
Authority: 12 U.S.C. 1707(a), 1715b, and 1715l; 42 U.S.C.
3535(d).
Sec. 221.70 [Amended]
7. In Sec. 221.70(a)(2), the reference to ``approved underwriter''
is revised to read ``underwriter''.
PART 234--CONDOMINIUM OWNERSHIP MORTGAGE INSURANCE
8. The authority for part 234 continues to read as follows:
Authority: 12 U.S.C. 1715b and 1715y; 42 U.S.C. 3535(d). Section
234.520(a)(2)(ii) is also issued under 12 U.S.C. 1707(a).
234.85 [Amended]
9. In Sec. 234.85(a)(2), the reference to ``approved underwriter''
is revised to read ``underwriter''.
Dated: July 2, 1996.
Nicolas P. Retsinas,
Assistant Secretary for Housing--Federal Housing Commissioner.
[FR Doc. 96-17559 Filed 7-9-96; 8:45 am]
BILLING CODE 4210-27-P
Complete official Federal Register PDF
FR Doc. 96-17558 Office of the Assistant Secretary for Policy Development and Research; Community Development Work Study Program; Amendments; Final Rule
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36456-36460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17558]
[[Page 36455]]
_______________________________________________________________________
Part IV
Department of Housing and Urban Development
_______________________________________________________________________
24 CFR Part 570
Office of the Assistant Secretary for Policy Development and Research;
Community Development Work Study Program; Amendments; Final Rule
Federal Register / Vol. 61, No. 133 / Wednesday, July 10, 1996 /
Rules and Regulations
[[Page 36456]]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
24 CFR Part 570
[Docket No. FR-3902-F-02]
RIN 2528-AA05
Office of the Assistant Secretary for Policy Development and
Research; Community Development Work Study Program; Amendments; Final
Rule
AGENCY: Office of the Assistant Secretary for Policy Development and
Research, HUD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On November 6, 1995 (60 FR 56104), HUD published for public
comment a rule proposing to revise HUD's regulations governing the
Community Development Work Study Program (CDWSP). Under the CDWSP, HUD
awards grants to institutions of higher education, either directly or
through areawide planning organizations (APOS), or States, for the
purpose of providing assistance to economically disadvantaged and
minority full-time students who participate in a community development
work-study program. The November 6, 1995 rule proposed to make several
revisions to the CDWSP so that it would more effectively and
efficiently meet its program objectives. This rule finalizes the
policies and procedures of the November 6, 1995 proposed rule and
considers the public comments submitted on the proposed rule.
EFFECTIVE DATE: August 9, 1996.
FOR FURTHER INFORMATION CONTACT: John Hartung, Office of University
Partnerships, Department of Housing and Urban Development, Room 8130,
425 Seventh Street, SW., Washington, D.C. 20410, telephone (202) 708-
1537. (This telephone number is not toll-free.) Hearing- or speech-
impaired individuals may access this number via TTY by calling the
toll-free Federal Information Relay Service at 1-800-877-8339.
SUPPLEMENTARY INFORMATION:
I. Paperwork Reduction Act Statement
The information collection requirements contained in this final
rule have been approved by the Office of Management and Budget (OMB) in
accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520), and assigned OMB control number 2528-0175. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless the collection displays a valid
control number.
II. The November 6, 1995 Proposed Rule
On November 6, 1995 (60 FR 56104), HUD published for public comment
a rule proposing to revise its regulations at 24 CFR 570.415, which
govern the Community Development Work Study Program (CDWSP). Section
501(b)(2) of the Housing and Community Development Act of 1987 (Pub.L.
100-242, approved February 5, 1988), added a new section 107(c) to the
Housing and Community Development Act of 1974 (42 U.S.C. 5301 et seq.)
creating the CDWSP. Under the CDWSP, HUD is authorized to award grants
to institutions of higher education, either directly, or through
areawide planning organizations (APOs) or States, for the purpose of
providing assistance to economically disadvantaged and minority
students who participate in a community development work study program
while enrolled in a full-time community development academic program.
The November 6, 1995 rule proposed to make several revisions to
Sec. 570.415 so that it would more effectively and efficiently meet the
objectives of the CDWSP. HUD has determined that these changes are
necessary as a result of its experience in administering the CDWSP.
Among other revisions, the November 6, 1995 rule proposed to: (1) limit
the number of students assisted under the CDWSP to five students per
participating institution of higher education; (2) limit the CDWSP to
graduate level programs; and (3) permit institutions of higher learning
to apply individually or through APOs. The November 6, 1995 proposed
rule described in detail the amendments to 24 CFR 570.415.
III. Changes to the November 6, 1995 Proposed Rule
This rule clarifies the definition of ``areawide planning
organization (APO)'' set forth in the November 6, 1995 proposed rule.
Language in the current definition referencing the ``nonmetropolitan
area'' served by an APO is confusing since no specific
``nonmetropolitan'' areas are delineated for census purposes. The
November 6, 1995 rule proposed to establish a revised definition,
clarifying the relevant geographic area for purposes of an APO. Upon
further consideration, HUD has determined that this proposed definition
did not adequately address the ambiguity present in the current
definition. This final rule clarifies that in order for an organization
operating in a nonmetropolitan area to be considered an APO, its
jurisdiction must cover at least one county.
This final rule also makes one revision to the November 6, 1995
proposed rule as a result of public comment. Specifically, HUD has
decided to amend 24 CFR 570.415 by combining the per-student limit on
CDWSP tuition assistance with the per-student limit on ``additional
support.'' The public comment period on the November 6, 1995 proposed
rule expired on January 5, 1996. Ten public comments were received. The
following section of the preamble presents a summary of the significant
issues raised by the public commenters on the proposed rule, and HUD's
responses to these comments.
IV. Discussion of Public Comments on the November 6, 1996 Proposed
Rule
1. Support for the CDWSP and the Elimination of the Repayment
Requirements.
Comment. Several commenters expressed their strong support for the
CDWSP. These commenters believe the CDWSP is a valuable resource for
providing assistance to qualified minority and disadvantaged students
pursuing graduate level studies in the field of community planning.
Further, the majority of commenters applauded the proposed rule's
elimination of the repayment requirements currently found at 24 CFR
570.415(g)(3)(i) and (k)(3)(ii). As one of the commenters, a
university, wrote:
[W]e are delighted with the proposed amendments to 24 CFR
570.415(g) and 24 CFR 570.415(k), which eliminate the program's
repayment requirements. The university agrees that this requirement
is both unnecessary as an incentive to highly motivated students and
onerous to the recipient institution.
2. CDWSP Should Not be Limited to Graduate Programs
Comment. Four of the commenters opposed the proposed amendment to
paragraph (a) of Sec. 570.415, which would have limited the CDWSP to
graduate-level programs. These commenters believed the proposed
amendment would unfairly restrict CDWSP participation, and deny the
community the valuable contributions made by certain undergraduate
students. One commenter felt that this would especially be true for
``nontraditional'' undergraduate students, such as older, working, and
minority students. The commenter noted that these students often
possess valuable work and life experiences that they bring to their
work study assignments, greatly benefiting
[[Page 36457]]
the community organizations for whom they work.
HUD Response. HUD does not agree with these commenters. While HUD
appreciates the value of undergraduate participation in the CDWSP, the
program has long emphasized a curriculum that leads directly and
immediately to careers in community and economic development or a
related field. The masters degree has in recent years become the
accepted credential for professional positions in these fields.
Moreover, although CDWSP funding addresses a critical need for highly
qualified professionals, it is insufficient to fully meet that need in
an era when the community and economic development field is
increasingly complex. Accordingly, HUD finds it prudent to concentrate
the funding in graduate programs, where it can be of the greatest and
most immediate overall benefit to communities.
3. Five Student Limit Would Adversely Impact Minority Students
Four commenters were concerned about the potential negative impact
of proposed 24 CFR 570.415(c)(2), which would have limited CDWSP
assistance to five students per participating institution of higher
education. These commenters believed that the proposed amendment would
discourage the recruitment of minority students. The commenters wrote
that the proposed amendment would increase competition for the small
pool of minority students. This increased competition might lead many
colleges and universities to conclude that the available funding does
not warrant the extensive expenditures of time and resources
traditionally needed to identify and recruit qualified minority
students.
HUD Response. HUD disagrees. HUD's practice in recent years has
been to fund five or fewer students per college or university, despite
the authority to fund up to ten students per institution of higher
learning. Although the proposed amendment may reduce HUD's discretion,
it is not a divergence from existing practice. Moreover, HUD believes
the amendment will improve opportunities for qualifying minorities to
participate in the CDWSP. The amendment allows more institutions to
participate in the program and thus more interested students to apply.
4. Participation Through APOs Should be Encouraged
Proposed 24 CFR 570.415(d)(1)(iii) would have permitted
institutions of higher education to apply for participation in the
CDWSP independently of an APO. One commenter wrote that partnerships
between universities and APOs are essential to the success of the
CDWSP. This commenter noted that APOs have strong ties with many area
local governments and nonprofit organizations that serve as excellent
placement agencies. These strong relations enable APOs to provide a
variety of diverse internship opportunities.
The commenter also believed that it is more cost effective if APOs
administer CDWSP participation. The commenter noted that without APO
coordination, HUD staff must handle the administrative costs and
paperwork for each individual participating college or university. This
commenter believed that APO participation in the CDWSP dramatically
decreases the administrative burden for HUD staff and assists in
preserving limited Federal resources. The commenter suggested that HUD
revise the November 6, 1995 proposed rule to include language strongly
encouraging work partnerships between APOs and universities, especially
in metropolitan areas.
HUD Response. HUD has not adopted the suggestion made by the
commenter. HUD agrees that in some circumstances the participation of
an APO may lead to a stronger application, but this is not necessarily
always the case. HUD believes the matter is best left to the discretion
of the institutions of higher education and the APOS. Further HUD
believes that institutions of higher education should not be penalized
for choosing to submit an individual application. While the
administrative burden for either HUD or the institutions of higher
education may be less when an APO is involved, this is not necessarily
always the case. The comparative advantage of an APO on these matters
depends on how effectively it communicates with HUD and monitors the
activities of the institutions of higher education involved.
5. HUD Should Consolidate Tuition and ``Additional Support'' Cost
Categories
Comment. One commenter suggested that HUD combine the per-student
limit on CDWSP tuition assistance with the per-student limit on
``additional support,'' a category that includes books and travel. The
commenter, director of the CDWSP at a private institution of higher
education, indicated that the institution would likely utilize this
greater flexibility to provide the entire combined amount to the
students as tuition assistance.
HUD Response. HUD agrees with the suggestion made by the commenter.
Tuition at private institutions now generally exceeds by far the
existing $3,500 annual per-student limit on CDWSP tuition assistance.
The additional flexibility would help economically disadvantaged and
minority students better afford to complete their degree. In
particular, students may find that they can minimize travel expense by
attending locally sponsored conferences, rather than travelling to
distant locations, and thus direct additional funds to meeting their
tuition obligations. Likewise, some students may be able to purchase
books at less than $500 per year, leaving more funds for meeting
tuition requirements.
Although this amendment was not part of the November 6, 1995
proposed rule, it falls squarely within the spirit of that rule. The
November 6, 1995 rule proposed an across-the-board streamlining of the
CDWSP in order to increase program efficiency, eliminate unnecessary
procedures, and clarify the existing regulations. The change suggested
by the commenter will increase the flexibility provided to CDWSP
participants, thus permitting the program to more effectively meet its
objective of assisting qualified minority and disadvantaged students.
Accordingly, this final rule adopts the commenter's recommendation and
amends 24 CFR 570.415 to consolidate the per-student limit on tuition
assistance with the per-student limit on additional support.
V. Other Matters
Environmental Impact. A Finding of No Significant Impact with
respect to the environment was made at the proposed rule stage in
accordance with HUD regulations at 24 CFR part 50, which implements
section 102(2)(C) of the National Environmental Policy Act of 1969
(NEPA). This Finding of No Significant Impact remains applicable to
this final rule and is available for public inspection between 7:30
a.m. and 5:30 p.m. weekdays in the Office of the Rules Docket Clerk,
Office of the General Counsel, Department of Housing and Urban
Development, Room 10276, 451 Seventh Street, SW., Washington, DC 20410-
0500.
Regulatory Flexibility. The Secretary, in accordance with the
Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed and approved
this final rule, and in so doing certifies that this final rule will
not have a significant economic impact on a substantial number of small
entities. This rule makes several streamlining changes to the CDWSP.
The amendments made by this rule are designed to clarify the existing
regulations, increase program
[[Page 36458]]
efficiency, and eliminate unnecessary procedures. This final rule only
affects applicants and participants in the CDWSP, and will not have any
meaningful economic impact on any entity.
Federalism Impact. The General Counsel, as the Designated Official
under section 6(a) of Executive Order 12612, Federalism, has determined
that the policies contained in this final rule will not have
substantial direct effects on States or their political subdivisions,
or the relationship between the Federal government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Specifically, the requirements of this final rule
are directed toward applicants and participants in HUD's Community
Development Work Study Program (CDWSP). It effects no changes in the
current relationships between the Federal government, the States and
their political subdivisions in connection with CDWSP.
Family Impact. The General Counsel, as the Designated Official
under Executive Order 12606, The Family, has determined that this final
rule does not have the potential for significant impact on family
formation, maintenance and general well-being, and, thus, is not
subject to review under the Order. No significant changes in existing
HUD policies or programs will result from promulgation of this final
rule, as those policies and programs relate to family concerns.
List of Subjects in 24 CFR Part 570
Administrative practice and procedure, American Samoa, Community
development block grants, Grant programs--education, Grant programs--
housing and community development, Guam, Indians, Lead poisoning, Loan
programs--housing and community development, Low and moderate income
housing, New communities, Northern Mariana Islands, Pacific Islands
Trust Territory, Pockets of poverty, Puerto Rico, Reporting and
recordkeeping requirements, Small cities, Student aid, Virgin Islands.
(The catalog of Federal domestic assistance program number is
14.234)
Accordingly, 24 CFR part 570 is amended as follows:
PART 570--COMMUNITY DEVELOPMENT BLOCK GRANTS
1. The authority citation for 24 CFR part 570 continues to read as
follows:
Authority: 42 U.S.C. 3535(d) and 5300-5320.
Subpart E--Special Purpose Grants
2. Section 570.415 is amended by:
a. Revising paragraph (a);
b. Revising paragraph (b);
c. Revising paragraphs (c)(1)(i) (A) and (B),
d. Removing paragraph (c)(1)(i)(C);
e. Revising paragraph (c)(2);
f. Revising paragraphs (d)(1)(i) (A) and (B), (d)(1)(ii), and
(d)(1)(iii);
g. Revising paragraph (d)(2)(i)(A);
h. Removing paragraph (d)(2)(i)(D) and redesignating paragraphs
(d)(2)(i) (E) through (I) as paragraphs (d)(2)(i) (D) through (H),
respectively;
i. Revising newly designated (d)(2)(i)(E);
j. Revising paragraphs (f)(1) and (f)(2)(i);
k. Revising paragraphs (g)(1) (ii) and (iii), (g)(2)(ii), and
(g)(3) (i) and (ii);
l. Revising paragraphs (i)(1)(iii) and (i)(2);
m. Revising paragraph (k)(3)(ii); and
n. Removing paragraph (k)(3)(iii) and redesignating paragraph
(k)(3)(iv) as paragraph (k)(3)(iii), to read as follows:
Sec. 570.415 Community Development Work Study Program.
(a) Applicability and objectives. HUD makes grants under CDWSP to
institutions of higher education, either directly or through areawide
planning organizations or States, for the purpose of providing
assistance to economically disadvantaged and minority students who
participate in a work study program while enrolled in full-time
graduate programs in community and economic development, community
planning, and community management. The primary objectives of the
program are to attract economically disadvantaged and minority students
to careers in community and economic development, community planning,
and community management, and to provide a cadre of well-qualified
professionals to plan, implement and administer local community
development programs.
(b) Definitions. The following definitions apply to CDWSP:
Applicant means an institution of higher education, a State, or an
areawide planning organization that submits an application for
assistance under CDWSP.
Areawide planning organization (APO) means an organization
authorized by law or by interlocal agreement to undertake planning and
other activities for a metropolitan or nonmetropolitan area. For an
organization operating in a nonmetropolitan area to be considered an
APO, its jurisdiction must cover at least one county.
CDWSP means the Community Development Work Study Program.
Community building means community and economic development,
community planning, community management, land use and housing
activities.
Community building academic program or academic program means a
graduate degree program whose purpose and focus is to educate students
in community building. ``Community building academic program'' or
``academic program'' includes but is not limited to graduate degree
programs in community and economic development, community planning,
community management, public administration, public policy, urban
economics, urban management, and urban planning. ``Community building
academic program'' or ``academic program'' excludes social and
humanistic fields such as law, economics (except for urban economics),
education and history. ``Community building academic program'' or
``academic program'' excludes joint degree programs except where both
joint degree fields have the purpose and focus of educating students in
community building.
Economically disadvantaged and minority students means students who
satisfy all applicable guidelines established at the participating
institution of higher education to measure financial need for academic
scholarship or loan assistance, including, but not limited to, students
who are Black, American Indian/Alaskan Native, Hispanic, or Asian/
Pacific Island, and including students with disabilities.
Institution of higher education means a public or private
educational institution that offers a community building academic
program and that is accredited by an accrediting agency or association
recognized by the Secretary of Education under 34 CFR part 602.
Recipient means an approved applicant that executes a grant
agreement with HUD.
Student means a student enrolled in an eligible full-time academic
program. He/she must be a first-year student in a two-year graduate
program. Students enrolled in Ph.D. programs are ineligible.
Student with disabilities means a student who meets the definition
of ``person with disabilities'' in the Americans with Disabilities Act
of 1990.
(c) * * *
(1) * * *
(i) * * *
(A) Student stipend. The amount of the student stipend is based
upon the prevailing hourly rate for initial entry positions in
community building and the number of hours worked by the student at the
work placement assignment, except that the hourly rate used should be
sufficiently high to allow a student to earn the full stipend without
working over 20 hours per week
[[Page 36459]]
during the school year and 40 hours per week during the summer. The
amount of the stipend the student receives may not exceed the actual
amount earned, up to $9,000 per year.
(B) Tuition support and additional support. The amount of support
for tuition, fees, books, and travel related to the academic program,
workplace assignment or conferences may not exceed actual costs
incurred or $5,000 per year, whichever is higher. The conferences are
limited to those dealing with community building, sponsored by
professional organizations.
* * * * *
(2) Number of students assisted. The minimum number of students
that may be assisted is three students per participating institution of
higher education. If an APO or State receives assistance for a program
that is conducted by two or more institutions of higher education, each
participating institution must have a minimum of three students in the
program. The maximum number of students that may be assisted under
CDWSP is five students per participating institution of higher
education.
(d) * * *
(1) * * *
(i) * * *
(A) Institutions of higher education. Institutions of higher
education offering a community building academic program are eligible
for assistance under CDWSP.
(B) Areawide planning organizations and States. An APO or a State
may apply for assistance for a program to be conducted by two or more
institutions of higher education. Institutions participating in an APO
program must be located within the particular area that is served by
the APO and is identified by the State law or interlocal agreement
creating the APO. Institutions of higher education participating in a
State program must be located within the State.
(ii) To be eligible in future funding competitions for CDWSP,
recipients are required to maintain a 50-percent rate of graduation
from a CDWSP-funded academic program.
(iii) If an institution of higher education that submits an
individual application is also included in the application of an APO or
State, then the separate individual application of the institution of
higher education will be disregarded. Additionally, if an institution
of higher education is included in the application of both an APO and a
State, then the references to the institution in the application of the
State will be stricken. The State's application will then be ineligible
if fewer than two institutions of higher education remain as
participants in the State's application.
(2) * * *
(i) * * *
(A) Recruit and select students for participation in CDWSP. The
recipient shall establish recruitment procedures that identify
economically disadvantaged and minority students pursuing careers in
community building, and make such students aware of the availability of
assistance opportunities. Students must be selected before the
beginning of the semester for which funding has been provided.
* * * * *
(E) Encourage participating students to obtain employment for a
minimum of two years after graduation with a unit of State or local
government, Indian tribe or nonprofit organization engaged in community
building.
* * * * *
(f) Work placement agencies eligibility and responsibilities. (1)
Eligibility. To be eligible to participate in the CDWSP, the work
placement agencies must be involved in community building and must be
an agency of a State or unit of local government, an APO, an Indian
tribe, or a nonprofit organization.
(2) * * *
(i) Provide practical experience and training in community
building.
* * * * *
(g) * * *
(1) * * *
(ii) Must be a full-time student enrolled in the first year of
graduate study in a community building academic program at the
participating institution of higher education. Individuals enrolled in
doctoral programs are ineligible.
(iii) Must demonstrate an ability to maintain a satisfactory level
of performance in the community building academic program and in work
placement assignments, and to comply with the professional standards
set by the recipient and the work placement agencies.
* * * * *
(2) * * *
(ii) An interest in, and commitment to, a professional career in
community building.
* * * * *
(3) * * *
(i) Enroll in a two-year program. A student's academic and work
placement responsibilities include: Full-time enrollment in an approved
academic program; maintenance of a satisfactory level of performance in
the community building academic program and in work placement
assignments; and compliance with the professional conduct standards set
by the recipient and the work placement agency. A satisfactory level of
academic performance consists of maintaining a B average. A student's
participation in CDWSP shall be terminated for failure to meet these
responsibilities and standards. If a student's participation is
terminated, the student is ineligible for further CDWSP assistance.
(ii) Agree to make a good-faith effort to obtain employment in
community building with a unit of State or local government, an Indian
tribe, or a nonprofit organization. The term of employment should be
for at least two consecutive years following graduation from the
academic program. If the student does not obtain such employment, the
student is not required to repay the assistance received.
* * * * *
(i) * * *
(1) * * *
(iii) The applicant must demonstrate that each institution of
higher education participating in the program as a recipient has the
required academic programs and faculty to carry out its activities
under CDWSP. Each work placement agency must have the required staff
and community building work study program to carry out its activities
under CDWSP.
(2) Rating. All applications that meet the threshold requirements
for applicant eligibility will be rated based on the following
selection criteria:
(i) Quality of academic program. The quality of the academic
program offered by the institution of higher education, including
without limitation the:
(A) Quality of course offerings;
(B) Appropriateness of course offerings for preparing students for
careers in community building; and
(C) Qualifications of faculty and percentage of their time devoted
to teaching and research in community building.
(ii) Rates of graduation. The rates of graduation of students
previously enrolled in a community building academic program at the
institution of higher education, specifically including (where
applicable) graduation rates from any previously funded CDWSP academic
programs or similar programs.
(iii) Extent of financial commitment. The commitment and ability of
the institution of higher education to assure that CDWSP students will
receive sufficient financial assistance (including loans, where
necessary) above and beyond the CDWSP funding to complete
[[Page 36460]]
their academic program in a timely manner and without working in excess
of 20 hours per week during the school year.
(iv) Quality of work placement assignments. The extent to which the
participating students will receive a sufficient number and variety of
work placement assignments, the assignments will provide practical and
useful experience to students participating in the program, and the
assignments will further the participating students' preparation for
professional careers in community building.
(v) Likelihood of fostering students' permanent employment in
community building. The extent to which the proposed program will lead
participating students directly and immediately to permanent employment
in community building, as indicated by, without limitation:
(A) The past success of the institution of higher education in
placing its graduates (particularly CDWSP-funded and similar program
graduates where applicable) in permanent employment in community
building; and
(B) The amount of faculty and staff time and institutional
resources devoted to assisting students (particularly students in
CDWSP-funded and similar programs where applicable) in finding
permanent employment in community building.
(vi) Effectiveness of program administration. The degree to which
an applicant will be able effectively to coordinate and administer the
program. HUD will allocate the maximum points available under this
criterion equally among the following considerations set forth in
paragraphs (i)(2)(vi) (A), (B), and (C) of this section, except that
the maximum points available under this criterion will be allocated
equally between the considerations set forth in paragraphs (i)(2)(vi)
(A) and (B) of this section only where the applicant has not previously
administered a CDWSP-funded program.
(A) The strength and clarity of the applicant's plan for placing
CDWSP students on rotating work placement assignments and monitoring
CDWSP students' progress both academically and in their work placement
assignments;
(B) The degree to which the individual who will coordinate and
administer the program has clear responsibility, ample available time,
and sufficient authority to do so; and
(C) The effectiveness of the applicant's prior coordination and
administration of a CDWSP-funded program, where applicable (including
the timeliness and completeness of the applicant's compliance with
CDWSP reporting requirements).
(vii) Commitment to meeting economically disadvantaged and minority
students' needs. The applicant's commitment to meeting the needs of
economically disadvantaged and minority students as demonstrated by
policies and plans regarding, and past effort and success in,
recruiting, enrolling and financially assisting economically
disadvantaged and minority students. If the applicant is an APO or
State, then HUD will consider the demonstrated commitment of each
institution of higher education on whose behalf the APO or State is
applying; HUD will then also consider the demonstrated commitment of
the APO or State to recruit and hire economically disadvantaged and
minority students.
* * * * *
(k) * * *
(3) * * *
(ii) If a student's participation in CDWSP is terminated before the
completion of the two-year term of the student's program, the recipient
may substitute another student to complete the two-year term of a
student whose participation has terminated. The substituted student
must have a sufficient number of academic credits to complete the
degree program within the remaining portion of the terminated student's
two-year term.
* * * * *
Dated: June 28, 1996.
Michael A. Stegman,
Assistant Secretary for Policy Development and Research.
[FR Doc. 96-17558 Filed 7-9-96; 8:45 am]
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Complete official Federal Register PDF
FR Doc. 96-17557 Office of the Secretary; Streamlining of HUD Regulations Governing the Protection of Human Subjects
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36462-36463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17557]
[[Page 36461]]
_______________________________________________________________________
Part V
Department of Housing and Urban Development
_______________________________________________________________________
24 CFR Part 60
Office of the Secretary: Streamlining of HUD Regulations Governing the
Protection of Human Subjects; Final Rule
Federal Register / Vol. 61, No. 133 / Wednesday, July 10, 1996 /
Rules and Regulations
[[Page 36462]]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
24 CFR Part 60
[Docket No. FR-4069-F-01]
RIN 2501-AC26
Office of the Secretary; Streamlining of HUD Regulations
Governing the Protection of Human Subjects
AGENCY: Office of the Secretary, HUD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: HUD's regulations at 24 CFR part 60 govern the protection of
human subjects involved in research conducted or sponsored by HUD.
These regulations are identical to those set forth by the Department of
Health and Human Services (HHS). This final rule, which is part of
HUD's continuing efforts to implement the President's regulatory reform
initiative, amends part 60 to simply cross-reference to the HHS
regulations, rather than repeating these identical provisions.
EFFECTIVE DATE: August 9, 1996.
FOR FURTHER INFORMATION CONTACT: Camille E. Acevedo, Assistant General
Counsel for Regulations, Office of General Counsel, Room 10276,
Department of Housing and Urban Development, 451 Seventh Street, SW.,
Washington, DC 20410, telephone (202) 708-3055. (This is not a toll-
free number.) Hearing- or speech-impaired individuals may access this
number via TTY by calling the toll-free Federal Information Relay
Service at 1-800-877-8339.
SUPPLEMENTARY INFORMATION:
I. Background
On June 18, 1991 (56 FR 28003), HUD and fifteen other Federal
Departments and Agencies published a common rule establishing
guidelines for the protection of human subjects involved in research
conducted or funded by these Departments and Agencies. Adoption of
these common requirements implemented a recommendation made by the
President's Commission for the Study of Ethical Problems in Medicine
and Biomedical and Behavioral Research (the President's Commission),
which was established by 42 U.S.C. 300v. HUD has codified these
requirements at 24 CFR part 60.
The President's Commission is directed by 42 U.S.C. 300v-1(c) to
report biennially to the President, the Congress, and appropriate
Federal Departments and Agencies on the protection of human research
subjects involved in biomedical or behavioral research. In carrying out
that charge, the President's Commission must conduct a review of ``the
rules, policies, guidelines, and regulations of all Federal agencies
regarding the protection of human subjects of biomedical or behavioral
research which such agencies conduct or sponsor.'' Further, the review
``may include such recommendations for legislation and administrative
action as the [President's] Commission deems appropriate.'' (See 42
U.S.C. 300v-1(c).)
In December 1981, the President's Commission issued its first
biennial report. Each Department or Agency receiving recommendations
from the President's Commission with respect to its rules, policies,
guidelines or regulations, is required by 42 U.S.C. 300v-1(b)(1) to
publish the recommendations for public comment. On March 29, 1982 (47
FR 13272), the Department of Health and Human Services (HHS) published
the recommendations on behalf of all affected Departments and Agencies.
Among other suggestions, the President's Commission recommended that:
The President should, through appropriate action, require that
all federal departments and agencies adopt as a common core the
regulations governing research with human subjects issued by the
Department of Health and Human Services (codified at 45 CFR part
46), as periodically amended or revised, while permitting additions
needed by any department or agency that are not inconsistent with
these core provisions. (47 FR 13272, 13294)
In May 1982, the affected Federal Departments and Agencies formed a
committee, chaired by an HHS representative, to consider the
recommendations made by the President's Commission and the public
comments submitted on these recommendations. On June 3, 1986 (51 FR
20204), the committee published for public comment a proposed model
policy for the protection of human subjects. In accordance with the
recommendation made by the President's Commission, the proposed model
policy was based on subpart A of the HHS regulations at 45 CFR part 46.
The June 18, 1991 rule finalized the requirements set forth in the June
3, 1986 proposed model policy and considered the public comments
submitted on the proposed policy.
HUD's regulations at 24 CFR part 60, which implement the model
policy, are identical to the HHS regulations at 45 CFR part 46, subpart
A. One of the goals of President's Clinton's regulatory reform
initiative is the elimination of repetitious regulatory provisions.
Accordingly, this final rule amends 24 CFR part 60 to simply cross-
reference to the HHS requirements, rather than repeating these
identical provisions. Elimination of these redundant provisions will
assist in HUD's goal of streamlining the content of title 24.
II. Justification for Final Rulemaking
HUD generally publishes a rule for public comment before issuing a
rule for effect, in accordance with its own regulations on rulemaking
in 24 CFR part 10. However, part 10 provides for exceptions to the
general rule if the agency finds good cause to omit advance notice and
public participation. The good cause requirement is satisfied when
prior public procedure is ``impracticable, unnecessary, or contrary to
the public interest'' (24 CFR 10.1). HUD finds that good cause exists
to publish this rule for effect without first soliciting public
comment. This rule merely eliminates unnecessary repetition by reducing
HUD's regulations at 24 CFR part 60 to a single section which cross-
references the identical HHS requirements at 45 CFR part 46, subpart A.
It does not establish or affect substantive policy. Therefore, prior
public comment is unnecessary.
III. Other Matters
Environmental Impact
A Finding of No Significant Impact with respect to the environment
has been made in accordance with HUD regulations at 24 CFR part 50,
which implements section 102(2)(C) of the National Environmental Policy
Act of 1969. The Finding of No Significant Impact is available for
public inspection between 7:30 a.m. and 5:30 p.m. weekdays in the
Office of the Rules Docket Clerk. Office of General Counsel, Department
of Housing and Urban Development, Room 10276, 451 Seventh Street, SW,
Washington, DC 20410.
Executive Order 12612, Federalism
The General Counsel has determined, as the Designated Official for
HUD under section 6(a) of Executive Order 12612, Federalism, that the
policies contained in this final rule will not have federalism
implications and, thus, are not subject to review under that Order.
This final rule eliminates unnecessary repetition by amending 24 CFR
part 60 to merely cross-reference to the identical HHS regulatory
provisions. The final rule will not impinge upon the relationship
between the Federal Government and State and local governments.
[[Page 36463]]
Executive Order 12606, The Family
The General Counsel, as the Designated Official under Executive
Order 12606, The Family, has determined that this final rule does not
have a potential for significant impact on family formation,
maintenance, and general well-being. This rule, as part of HUD's
continuing efforts to implement the President's regulatory reform
initiative, eliminates redundant regulatory provisions from title 24 of
the CFR. No substantial change in existing HUD policies or programs
will result from promulgation of this rule.
Regulatory Flexibility Act.
The Secretary, in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)) has reviewed and approved this final rule, and in so
doing certifies that this final rule will not have a significant
economic impact on a substantial number of small entities. This final
rule eliminates unnecessary repetition from title 24 of the CFR. The
rule reduces HUD's regulations at 24 CFR part 60 to a single section
which simply cross-references to the identical HHS requirements at 45
CFR part 46, subpart A. Elimination of these redundant provisions will
assist in HUD's continuing efforts to implement the President's
regulatory reform initiative. This rule does not establish or affect
substantive policy, and will not have any meaningful economic impact on
any entity.
List of Subjects in 24 CFR Part 60
Human research subjects, Reporting and recordkeeping requirements.
Accordingly, 24 CFR part 60 is amended as follows:
PART 60--PROTECTION OF HUMAN SUBJECTS
1. The authority citation for 24 CFR part 60 is revised to read as
follows:
Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b) and 3535(d).
2. Section 60.101 is revised to read as follows:
Sec. 60.101 Cross-reference.
The provisions set forth at 45 CFR part 46, subpart A, concerning
the protection of human research subjects, apply to all research
conducted, supported, or otherwise subject to regulation by HUD.
Secs. 60.102 through 60.124 [Removed]
3. Sections 60.102 through 60.124 are removed.
Dated: June 28, 1996.
Henry G. Cisneros,
Secretary.
[FR Doc. 96-17557 Filed 7-9-96; 8:45 am]
BILLING CODE 4210-32-P
Complete official Federal Register PDF
FR Doc. 96-17545 Final Rule Making Findings of Failure To Submit Required State Implementation Plans for Nonattainment Areas for Ozone
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36292-36295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17545]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[FRL-5536-1]
Final Rule Making Findings of Failure To Submit Required State
Implementation Plans for Nonattainment Areas for Ozone
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The EPA is taking final action in making findings, under the
Clean Air Act (CAA or Act), that 10 states and the District of Columbia
failed to make complete ozone nonattainment state implementation plans
(SIP) submittals required for 9 nonattainment areas under the Act.
Under certain provisions of the Act, as implemented consistent with a
memorandum issued by EPA Assistant Administrator Mary D. Nichols, on
March 2, 1995, these states are required to submit SIP measures
providing for certain percentage reductions in emissions of ozone
precursors, termed ``rate of progress'' reductions; as well as SIP
commitments to submit SIP measures providing for the remaining required
rate-of-progress reductions as well as any additional emissions
reductions needed for attainment of the ozone ambient air quality
standards in the affected nonattainment areas.
This action triggers the 18-month time clock for mandatory
application of sanctions in theses states under the Act. This action is
consistent with the CAA mechanism for assuring SIP submission.
EFFECTIVE DATE: This action is effective as of July 3, 1996.
FOR FURTHER INFORMATION CONTACT:
General questions concerning this notice should be addressed to Kimber
Scavo, Office of Air Quality Planning and Standards, Air Quality
Strategies and Standards Division, MD-15, Research Triangle Park, NC
27711; tel. (919) 541-5534. For questions related to a specific area,
please contact the appropriate regional office:
Dave Conroy, Manager, Air Quality Planning Unit, EPA Region I (CAQ),
JFK Federal Building, Boston, Massachusetts 02203-2211, tel. (617) 565-
3255 (Connecticut, New Hampshire)
William S. Baker, Chief, Air Programs Branch, EPA Region II (2AWM-AP);
290 Broadway, New York, New York 10007-1866, tel. (212) 637-4249 (New
York, New Jersey)
Marcia Spink, Associate Director, Air, Toxics and Radiation Division,
EPA Region III (3AT00), 841 Chestnut Building, Philadelphia,
Pennsylvania, 19107, tel. (215) 566-2104 (Delaware, Maryland, Virginia,
District of Columbia)
Steven Rothblatt, Branch Chief, Air Programs Branch, EPA Region V (AR-
18J); 77 West Jackson Blvd., Chicago, IL 60604-3590, tel. (312) 353-
2211 (Illinois, Indiana, Wisconsin)
SUPPLEMENTARY INFORMATION:
I. Background
In 1990, Congress amended the Clean Air Act to address, among other
things, continued nonattainment of the ozone national ambient air
quality standard (NAAQS). Pub. L. 101-549, 104 Stat. 2399, codified at
42 U.S.C., 7401-7671q (1991). The Amendments divide ozone nonattainment
areas into, in general, five classifications based on air quality
[[Page 36293]]
design value; and establish specific requirements, including new
attainment dates, for each classification. CAA Secs. 107(d)(1)(C) and
181.
The 1990 Amendments required states containing the highest
classified ozone nonattainment areas--those classified as serious,
severe, or extreme--to submit SIPs providing for periodic reductions in
ozone precursors of a rate of 9% averaged over every three-year period,
beginning after 1996 and ending with the area's attainment date. CAA
Sec. 182(c)(2)(B). This SIP submission may be referred to as the Rate-
of-Progress, or ROP, SIP. The 1990 Amendments further required these
states to submit a demonstration of attainment (including air quality
modeling) for the nonattainment area, as well as SIP measures
containing any additional reductions that may be necessary to attain by
the attainment date. CAA Sec. 182(c)(2)(A). This SIP submission may be
referred to as the Attainment Demonstration. These CAA provisions
established November 15, 1994, as the required date for these SIP
submittals.
Notwithstanding significant efforts, the states generally were not
able to meet this November 15, 1994 deadline for the required SIP
submissions.
On March 2, 1995, EPA Assistant Administrator Mary D. Nichols sent
a memorandum to EPA Regional Administrators (the March 2, 1995
Memorandum, or Memorandum) recognizing the efforts made by states and
the remaining difficulties in making the ROP and Attainment
Demonstration SIP submittals. The March 2, 1995 Memorandum recognized
that in general, many States have been unable to complete these SIP
requirements within the deadlines prescribed by the Act due to
circumstances beyond their control. These states were hampered by
unavoidable delays in developing the underlying technical information
needed for the required SIP submittals. The Memorandum recognized that
development of the necessary technical information, as well as the
control measures necessary to achieve the large level of reductions
likely to be required, is particularly difficult for the many states
affected by ozone transport.
Accordingly, as an administrative remedial matter, the March 2,
1995 Memorandum indicated that EPA would establish new time-frames for
SIP submittals. The Memorandum called for States seeking to avail
themselves of the new policy to submit, by May 1995, a letter
committing to the new time-frames.
The Memorandum further indicated that EPA would divide the required
SIP submittals into two phases. The Phase I submittals generally
consisted of (i) SIP measures providing for ROP reductions due by the
end of 1999 (the first 9% of ROP reductions); (ii) a SIP commitment
(sometimes referred to as an enforceable commitment) to submit any
remaining required ROP reductions on a specified schedule after 1996
(with submission no later than the end of 1999); and (iii) a SIP
commitment to submit the Attainment Demonstration by mid-1997 (with
submission by no later than the end of 1999 of any additional rules
needed to attain).\1\ The Memorandum indicated that EPA would establish
the end of 1995 as the due date for the Phase I submittals. States
could have proposed a schedule for making the submissions in 1996 if
necessary due to administrative scheduling imperatives (such as the
schedule for legislative sessions).
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\1\ The March 2, 1995 Memorandum established other requirements,
and somewhat different requirements for states other than the
Northeast states. These are described in greater detail in the
enclosures to the findings letters, discussed below, which are
included in the docket to this rulemaking.
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The Phase II submittals were due at specified times after 1996, and
primarily consisted of the remaining ROP SIP measures, the Attainment
Demonstration and required additional rules, and any regional controls
necessary for attainment by all areas in the region.
In addition, the March 2, 1995 Memorandum called for a
collaborative process among the States in the eastern half of the
country to evaluate and address transport of ozone and its precursors.
The Memorandum lead to the formation of the Ozone Transport Assessment
Group (OTAG), which includes representatives of those states; EPA
officials; and interested members of the public, including
environmental groups and industry. As indicated in the Memorandum, EPA
has envisioned that OTAG would complete its work by the end of 1996.
The March 2, 1995 Memorandum was widely circulated, and by June
1995, states opting for the time-frames it described had submitted
letters to EPA generally committing to submit the SIP measures called
for under the Memorandum.
OTAG's first meetings were on May 18, 1995, in Reston, Virginia,
and June 19, 1995, in Washington, D.C. OTAG has continued to meet
regularly since then.
By the first few months of 1996, some states appeared to be lagging
in their compliance efforts with the Phase I deadlines. By memorandum
dated April 19, 1996, Assistant Administrator Nichols directed the
Regional Administrators to determine the status of the state planning
efforts to allow EPA to determine which states were or were not in
substantial compliance with the Phase I deadlines. By letters dated in
May 1996, EPA Regional Administrators informed the states that it was
important that they complete the Phase I submittals as soon as
possible, and requested that they provide EPA with a schedule for
completing these submittals. These letters cautioned that EPA would,
within the near future, evaluate the states' schedule; and that if EPA
considered the schedule insufficiently expeditious, EPA would consider
beginning the process under CAA section 179(a)(1), described below, of
sanctioning states that fail to make required submittals.
The EPA regional offices and state officials discussed the states'
progress, and the states generally developed schedules for completing
the Phase I requirements.
Although EPA recognizes the continued progress states are making in
developing the required SIPs, EPA believes that in most cases, the
schedules presented by the states are not sufficiently expeditious for
the states to be considered in substantial compliance with the Phase I
deadlines.
The 1990 Amendments establish specific consequences if EPA finds
that a State has failed to meet certain requirements of the CAA. Of
particular relevance here is CAA section 179(a)(1), the mandatory
sanctions provision. Section 179(a) sets forth four findings that form
the basis for application of a sanction. The first finding, that a
State has failed to submit a plan or one or more elements of a plan
required under the CAA, is the finding relevant to this rulemaking.
Today, EPA is finding that 10 States and the District of Columbia
have failed to make required SIP submissions for 9 nonattainment areas.
If these States have not made the required complete submittals
within 18 months of the effective date of today's rulemaking, pursuant
to CAA section 179(a) and 40 CFR 52.31, the offset sanction identified
in CAA section 179(b) will be applied in the affected areas. If the
States have still not made a complete submission 6 months after the
offset sanction is imposed, then the highway funding sanction will
apply in the affected areas, in accordance with 40 CFR 52.31. In
addition, CAA section 110(c) provides that EPA promulgate a federal
implementation plan (FIP) no later than 2 years after a finding under
section 179(a).
[[Page 36294]]
The 18-month clock will stop and the sanctions will not take effect
if, within 18 months after the date of the finding, EPA finds that the
State has made a complete submittal as to each of the SIP elements for
which these findings are made. In addition, EPA will not promulgate a
FIP if the State makes the required SIP submittal and EPA takes final
action to approve the submittal within 2 years of EPA's finding.
At approximately the same time as the signing of this notice, EPA
Regional Administrators are sending letters to the 11 States describing
the status of the states' effort and these findings in more detail.
These letters, and the enclosures that they include, are included in
the docket to this rulemaking.
I. Final Action
A. Rule
Today, EPA is making findings of failure to submit for 9
nonattainment areas in 10 states and the District of Columbia, due to
failure to submit complete SIP revisions consisting of the following
three items: (i) A SIP provision requiring emission reductions of 9% in
ozone precursors from the end of 1996 to 1999; (ii) SIP commitments to
adopt an Attainment Demonstration; and (iii) SIP commitments to adopt
any additional rules needed to complete the requirements for ROP
reductions after 1999, and until the attainment date.
The states, nonattainment areas (and classification of the
nonattainment areas) that are receiving these findings are listed
below. Each state is receiving all three findings for each of its
areas, except that states with areas classified as serious are
receiving only the first two findings. Serious areas have an attainment
date of 1999, and thus are not required to submit ROP SIPs after 1999.
Connecticut: Greater CT Area (serious); New York-Northern New Jersey-
Long Island, NY-NJ-CT, Area (severe).
New Hampshire: Boston-Lawrence-Worcester, MA-NH, Area (serious);
Portsmouth-Dover-Rochester, NH, Area (serious).
New Jersey: New York-Northern New Jersey-Long Island, NY-NJ-CT, Area
(severe); Philadelphia-Wilmington-Trenton, PA-NJ-DE-MD, Area (severe).
New York: New York-Northern New Jersey-Long Island, NY-NJ-CT, Area
(severe).
Delaware: Philadelphia-Wilmington-Trenton, PA-NJ-DE-MD, Area (severe).
Maryland: Baltimore Area (severe); Philadelphia-Wilmington-Trenton, PA-
NJ-DE-MD, Area (severe); Washington, DC-MD-VA, Area (serious).
Virginia: Washington, DC-MD-VA, Area (serious).
District of Columbia: Washington, DC-MD-VA, Area (serious).
Illinois: Chicago-Gary-Lake County, IL-IN, Area (severe).
Indiana: Chicago-Gary-Lake County, IL-IN, Area (severe).
Wisconsin: Milwaukee-Racine, Area (severe).
B. Effective Date Under the Administrative Procedures Act
EPA has issued this action as a rulemaking because EPA has treated
this type of action as rulemaking in the past. However, EPA believes
that it would have the authority to issue this action in as an informal
adjudication, and is considering which administrative process--
rulemaking or informal adjudication--is appropriate for future actions
of this kind.
Because EPA is issuing this action as a rulemaking, the
Administrative Procedures Act (APA) applies.
Today's action will be effective on July 3, 1996. Under the APA, 5
U.S.C. 553(d)(3), agency rulemaking may take effect before 30 days
after the date of publication in the Federal Register if the agency has
good cause to mandate an earlier effective date. Today's action
concerns SIP submissions that are already overdue; and EPA previously
cautioned the affected states that the SIP submissions were overdue and
that EPA was considering the action it is taking today. In addition,
today's action simply starts a ``clock'' that will not result in
sanctions against the states for 18 months, and that the states may
``turn off'' through the submission of complete SIP submittals. These
reasons support an effective date prior to 30 days after the date of
publication.
C. Notice-and-Comment Under the Administrative Procedures Act
This notice is a final agency action, but is not subject to the
notice-and-comment requirements of the APA, 5 U.S.C. 553(b). EPA
believes that because of the limited time provided to make findings of
failure to submit and findings of incompleteness regarding SIP
submissions or elements of SIP submission requirements, Congress did
not intend such findings to be subject to notice-and-comment
rulemaking. However, to the extent such findings are subject to notice-
and-comment rulemaking, EPA invokes the good cause exception pursuant
to the APA, 5 U.S.C. 553(b)(3)(B). Notice and comment are unnecessary
because no EPA judgment is involved in making a nonsubstantive finding
of failure to submit elements of SIP submissions required by the Clean
Air Act. Furthermore, providing notice and comment would be
impracticable because of the limited time provided under the statute
for making such determinations. Finally, notice and comment would be
contrary to the public interest because it would divert agency
resources from the critical substantive review of complete SIPs. See 58
FR 51270, 51272, n.17 (Oct. 1, 1993); 59 FR 39832, 39853 (Aug. 4,
1994).
D. Executive Order 12866
The Office of Management and Budget (OMB) has exempted this
regulatory action from Executive Order 12866 review.
E. Unfunded Mandates
Under sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (Unfunded Mandates Act), signed into law on March 22, 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.
In addition, under the Unfunded Mandates Act, before EPA
establishes any regulatory requirements that may significantly or
uniquely affect small governments, including tribal governments, EPA
must have developed, under section 203 of the UMRA, a small government
agency plan.
EPA has determined that today's action is not a Federal mandate.
The various CAA provisions discussed in this notice require the states
to submit SIPs. This notice merely provides a finding that the states
have not met those requirements. This notice does not, by itself,
require any particular action by any State, local, or tribal
government; or by the private sector.
For the same reasons, EPA has determined that this rule contains no
regulatory requirements that might significantly or uniquely affect
small governments.
F. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 600 et seq.,
EPA must prepare a regulatory flexibility analysis assessing the impact
on small entities of any rule subject to the notice-and-comment
rulemaking requirements. Because this action is exempt from such
requirements, as described above, it is not subject to the RFA.
[[Page 36295]]
G. Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the APA, as amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), EPA
submitted, by the effective date of this rule, a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives and the Comptroller General of the General
Accounting Office. This rule is not a ``major rule'' as defined by APA
Sec. 804(2), as amended.
As noted above, EPA is issuing this action as rulemaking. There is
a question as to whether this action is a rule of ``particular
applicability'', under section 804(3)(A) of APA as amended by SBREFA--
and thus exempt from the congressional submission requirements--because
this rule applies only to named states. In this case, EPA has decided
to err on the side of submitting this rule to Congress, but will
continue to consider this issue of the scope of the exemption for rules
of ``particular applicability''.
H. Paperwork Reduction Act
This rule does not contain any information collection requirements
which require OMB approval under the Paperwork Reduction Act (44 U.S.C.
3501 et seq.).
I. Judicial Review
Under CAA Section 307(b)(1), a petition to review today's action
may be filed in the Court of Appeals for the District of Columbia
within 60 days of July 10, 1996.
Dated: July 3, 1996.
Mary D. Nichols,
Assistant Administrator.
[FR Doc. 96-17545 Filed 7-9-96; 8:45 am]
BILLING CODE 6560-50-M
Complete official Federal Register PDF
FR Doc. 96-17542 Direct Food Substances Affirmed as Generally Recognized as Safe; Cocoa Butter Substitute Derived From High-Oleic Safflower or Sunflower Oil
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36287-36290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17542]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 184
[Docket No. 88G-0388]
Direct Food Substances Affirmed as Generally Recognized as Safe;
Cocoa Butter Substitute Derived From High-Oleic Safflower or Sunflower
Oil
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to affirm that cocoa butter substitute manufactured from
high-oleic safflower or sunflower oil is generally recognized as safe
(GRAS). This action is in response to a petition filed by Fuji Oil Co.,
Ltd. (Fuji).
DATES: Effective July 10, 1996.
FOR FURTHER INFORMATION CONTACT: Nega Beru, Center for Food Safety and
Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St.
SW.,-Washington, DC 20204, 202-418-3097.
SUPPLEMENTARY INFORMATION:
I. Background-
In accordance with the procedures described in Sec. 170.35 (21 CFR
170.35), Fuji Oil Co., Ltd., 6-1, Hachiman-cho, Minami-ku, Osaka 542,
Japan, submitted a petition (GRASP 8G0348) requesting that
Sec. 184.1259 (21 CFR 184.1259) be amended to affirm that the use of
safflower or sunflower oil in the manufacture of cocoa butter
substitute is GRAS.
In the Federal Register of January 26, 1989 (54 FR 3853), FDA
published a notice of filing of Fuji's petition and gave interested
parties an opportunity to submit comments to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857. FDA received three comments in response to
that notice. These comments are discussed below.
In the filing notice, the agency gave notice that the petition had
requested that Sec. 184.1259 be amended to permit the use of safflower
or sunflower oil in the manufacture of cocoa butter substitute.
However, the petition requested, and the agency evaluated, the use of
high-oleic safflower or sunflower oil in the manufacture of cocoa
butter substitute. Therefore, because the filing notice did not make
clear that the proposed starting materials for the manufacture of the
petitioner's cocoa butter substitute are high-oleic rather than the
typical high-linoleic safflower and sunflower oils, the agency
published an amended filing notice in the Federal Register of April 28,
1995 (60 FR 20998), to give interested persons an opportunity to
comment with respect to the above-mentioned change. No comments were
received in response to the amended filing notice.
II. Standards for GRAS Affirmation
Pursuant to Sec. 170.30 (21 CFR 170.30), general recognition of
safety may be based only on the views of experts qualified by
scientific training and experience to evaluate the safety of substances
added to food. The basis of such views may be either: (1) Scientific
procedures, or (2) in the case of a substance used in food prior to
January 1, 1958, experience based on common use in food
(Sec. 170.30(a)). General recognition of safety based upon scientific
procedures requires the same quantity and quality of scientific
evidence as is required to obtain approval of a food additive and
ordinarily is to be based upon published studies, which may be
corroborated by unpublished studies and other data and information
(Sec. 170.30(b)). General recognition of safety through experience
based on common use in food prior to January 1, 1958, may be determined
without the quantity or quality of scientific procedures required for
approval of a food additive, and ordinarily is to be based upon
generally available data and information concerning the pre-1958
history of use of the substance in food (Sec. 170.30(c)(1)).
Cocoa butter substitute from high-oleic safflower or sunflower oil
was not used in food prior to 1958, and therefore cannot qualify for
GRAS status based on a history of common use in food (Sec. 170.30(c)).
Accordingly, FDA has evaluated the ingredient on the basis of
scientific procedures (Sec. 170.30(b)).
In evaluating this petition, the agency reviewed data and
information concerning: (1) The chemical composition of the cocoa
butter substitute; (2) the process used to manufacture it; (3) the
functional equivalence of the cocoa butter substitute to cocoa butter
substitute made from palm oil; (4) use of the cocoa butter substitute
in food; and (5) information regarding the safety of the cocoa butter
substitute.
III. Identity, Specifications, and Manufacturing Process
The common or usual name of the petitioned substance is ``cocoa
butter substitute primarily from high-oleic safflower or sunflower
oil.'' Its chemical name is 1,3-distearoyl-2-olein (CAS Reg. No. 2846-
04-0). The petitioner provided evidence to demonstrate that the
specifications for cocoa butter substitute primarily from high-oleic
safflower or sunflower oil conform to those for cocoa butter substitute
primarily from palm oil, 1-palmitoyl-2-oleoyl-3-stearin, which are set
forth in Sec. 184.1259(b)(1) through (b)(9).
Traditional safflower and sunflower oils typically contain high
levels of linoleic acid and low levels of oleic acid. However, in the
manufacture of its cocoa butter substitute, Fuji uses high-oleic acid-
containing safflower or sunflower oil. The high-oleic acid varieties of
safflower and sunflower were obtained through common breeding
techniques and are the subjects of several published articles (Refs. 1
through 7).
According to Fuji, its cocoa butter substitute is manufactured by
reacting ethyl stearate (obtained from food-grade stearic acid) with
high-oleic safflower oil or sunflower oil under nitrogen gas in the
presence of a catalyst (lipase enzyme preparation adsorbed onto
granular celite (diatomaceous earth)) at 37 to 47 deg.C for 48 hours.
After completion of the reaction, the catalyst
[[Page 36288]]
is removed by filtration. The remaining free fatty acids and ethyl
esters of fatty acids are distilled off at high temperature under
vacuum. The reaction product is fractionated with hexane to remove
high- and low-melting point fractions and refined by the ordinary
refining process for edible fats and oils (deacidification, bleaching,
deodorization).
IV. Functional Equivalence to Cocoa Butter Substitute Primarily
from Palm Oil
Cocoa butter substitutes have been described as nonhydrogenated
vegetable oils that contain a monounsaturated fatty acid at the 2
position and saturated fatty acids at the 1 and 3 positions (Ref. 8).
Cocoa butter substitute derived from palm oil is a mixture of
triglycerides containing oleic acid at the 2 position and saturated
fatty acids (mostly palmitic and stearic acids) at the 1 and 3
positions. Cocoa butter substitute from high-oleic safflower or
sunflower oil is a mixture of triglycerides containing oleic acid at
the 2 position and mostly stearic acid at the 1 and 3 positions.
Although the fatty acid composition of cocoa butter substitute
from high-oleic safflower or sunflower oil is different from that of
cocoa butter substitute derived from palm oil (higher in stearic acid
and lower in palmitic acid content), this difference in composition
does not affect the function of this cocoa butter substitute in food
(Ref. 9). The petitioner provided a published study by Feuge, et al.
(Ref. 10), who tested three mixtures (one consisting essentially of
oleopalmitostearin, another consisting essentially of oleostearin, and
a third consisting mostly of oleopalmitin) for their ability to
function as cocoa butter substitutes. The results showed that all three
products, when mixed with cocoa butter, had melting properties closely
resembling those of cocoa butter and therefore could be satisfactory
cocoa butter substitutes. Further, the petitioner stated that although
cocoa butter substitute from high-oleic safflower or sunflower oil by
itself can be used to make chocolate, it can also be blended with other
approved triglycerides to produce a cocoa butter substitute that is
similar in chemical composition to natural cocoa butter and to cocoa
butter substitute primarily from palm oil.
V. Use in Food
The petitioned use of the ingredient is in the following food
categories: confections and frostings as defined in Sec. 170.3(n)(9)
(21 CFR 170.3(n)(9)); in coatings of soft candy as defined in
Sec. 170.3(n)(38); and in sweet sauces and toppings as defined in
Sec. 170.3(n)(43). The petition proposes that use of the ingredient in
food be limited to levels consistent with current good manufacturing
practice (CGMP).
VI. Safety Information
The petition relies in part on the data developed to establish the
safety of cocoa butter substitute derived from palm oil. Section
184.1259 provides for the interesterification of partially saturated
1,2,3-triglycerides (derived from palm oil) with ethyl stearate in the
presence of a suitable lipase enzyme preparation. This is also used in
the manufacture of the cocoa butter substitute derived from high-oleic
safflower or sunflower oil.
Cocoa butter substitute made from high-oleic safflower or
sunflower oil consists predominantly of the triglyceride 1,3-
distearoyl-2-oleine. The components of this cocoa butter substitute are
glycerol and oleic and stearic acids. These components are naturally
found as part of glycerides, lipids, lipoproteins, and membranes of
both plants and animals. Moreover, they are the same fatty acids and
glycerol components as are found in a broad range of edible fats and
oils that are GRAS. The synthesis and metabolism of these substances
are well understood and are documented in biochemistry textbooks (for
example, Ref. 11).
The only difference between cocoa butter substitute derived from
high-oleic safflower or sunflower oil, on the one hand, and cocoa
butter substitute derived from palm oil, on the other hand, is a
difference in fatty acid composition, specifically, the ratio of
stearic acid to palmitic acid. The agency finds that this difference
does not pose a safety concern. Both of these fatty acids have been
safely consumed as common, naturally-occurring compounds in foods (Ref.
12), and the proposed use will not change dietary consumption
significantly. Therefore, the agency concludes that cocoa butter
substitute prepared from high-oleic safflower or sunflower oil is
equivalent to cocoa butter substitute prepared from palm oil with
respect to safety, provided it meets the specifications for the similar
palm oil-derived product.
Further, the petitioner submitted three published studies to
support its contention that cocoa butter substitute made from high-
oleic safflower or sunflower oil is safe (Refs. 13 through 15). The
studies included an acute oral toxicity study in rats, a subchronic
(90-day) oral toxicity study in rats, and a study to assess
mutagenicity in bacteria. The bacterial study showed that cocoa butter
substitute derived from high-oleic safflower or sunflower oil is not
mutagenic; no significant effects from consumption of the cocoa butter
substitute were found in the acute and subchronic toxicity studies.
VII. Response to Comments
FDA received three comments in response to the notice announcing
the filing of the petition. All of the comments supported the proposed
GRAS affirmation of cocoa butter substitute derived from high-oleic
safflower or sunflower oil.
Two comments stated that the GRAS affirmation regulation should
provide for the use of food-grade stearic acid as an alternative to
ethyl stearate as a starting material in manufacturing the petitioned
cocoa butter substitute. The comments asserted that it was common
industry practice to use both ethyl stearate and stearic acid in
interesterification reactions. In addition, the comments pointed out
that not only is stearic acid a natural metabolite, but food-grade
stearic acid is affirmed as GRAS (21 CFR 184.1090), and FDA permits the
use of stearic acid as a raw material to produce various substances
approved as food additives, including polysorbate 60, polysorbate 65,
sorbitan monostearate, and calcium stearoyl-2-lactylate (21 CFR
172.836, 172.838, 172.842, and 172.844, respectively). Moreover, the
comments asserted that stearic acid is a more desirable starting
material than ethyl stearate because an end product cocoa butter
substitute devoid of residual fatty acid ethyl esters can be produced.
The agency finds that, although the petitioner stated that ethyl
stearate would be used as a starting material in the
interesterification reaction during the manufacturing of its cocoa
butter substitute, it is also common industry practice to use stearic
acid in the manufacturing process (Ref. 16). Further, the agency notes
that ethyl stearate is itself made from the GRAS substance stearic
acid. In essence, direct use of stearic acid in the interesterification
reaction bypasses the intermediate step of first converting stearic
acid to ethyl stearate. The resulting cocoa butter substitute is the
same regardless of whether ethyl stearate or stearic acid is used in
the manufacturing process. Therefore, the agency agrees that the direct
use of stearic acid as a starting material, without first converting it
to ethyl stearate, does not affect the GRAS status of the petitioned
cocoa butter substitute. Moreover, the agency concludes that an
opportunity for public comment on the
[[Page 36289]]
direct use of stearic acid as a starting material is not necessary
because the two substances are so closely related. Therefore, in
amending Sec. 184.1259, the agency is including stearic acid as an
alternative raw material in the manufacture of cocoa butter substitute
from high-oleic safflower or sunflower oil.
One of the comments also stated that acetone should be allowed as
a solvent in the fractional crystallization of the petitioned cocoa
butter substitute during the manufacturing process and suggested a
residual acetone specification of not more than 5 parts per million.
The comment stated that acetone is a well-recognized solvent in the
edible oils industry and cited a number of FDA regulations that permit
its use as a solvent. Indeed, acetone is approved as an extractant for
annatto extract (21 CFR 73.30(a)(1)(ii)), as a diluent for color
additive mixtures made with D&C Red No. 39 (21 CFR 74.1339(a)(2)), as
an optional bleaching ingredient with flour (21 CFR 137.105(a)(6)), as
a processing solvent in the manufacture of the food additive N-acetyl-
L-methionine (21 CFR 172.372(a)(4)) and in the extraction of spice (21
CFR 173.210). The agency notes that the safety of the use of acetone as
a solvent is well recognized in the food oil industry. However, the
agency has no basis to set a specification for residual acetone because
it did not evaluate the use of acetone as a solvent in manufacturing
cocoa butter substitute. The agency also notes that, as always, any
residual solvent that becomes or may reasonably be expected to become a
functional component of food must be an approved food additive or GRAS
for use in that food.
The third comment consisted of a report by a panel of scientific
experts who evaluated evening primrose oil as a dietary supplement and
concluded that it was safe. The comment stated that the report on the
safety of evening primrose oil should aid FDA in determining the GRAS
status of Fuji's product because evening primrose oil is chemically
related to both safflower and sunflower oils in that the primary
constituent of all these oils is the GRAS substance linoleic acid. The
comment stated that it was submitted because FDA must consider
chemically and pharmacologically related substances in the diet when
considering the GRAS status of any substance (Sec. 170.3(i)(2)).
The safflower and sunflower oils the petitioner proposed to use as
raw material for the production of cocoa butter substitute are derived
from high-oleic variant seeds containing approximately 75 percent oleic
acid in their triglycerides instead of linoleic acid, which is the
major fatty acid in evening primrose oil and in oils derived from
traditional safflower and sunflower. Thus, the assertion that evening
primrose oil is similar to high-oleic safflower and sunflower oils
based on fatty acid content is erroneous.
More importantly, the petition does not seek to affirm the GRAS
status of safflower oil and sunflower oil, both of which are common
food items, but rather cocoa butter substitute derived by chemical
processes from high-oleic safflower or sunflower oil. For these
reasons, the agency finds this comment not relevant to the question of
whether cocoa butter substitute derived from high-oleic safflower or
sunflower oil is GRAS.
VIII. Conclusions
Based on the published literature about the petitioned cocoa
butter substitute and the data supporting the safety of cocoa butter
substitute from palm oil, corroborated by widely available information
about the safe consumption of glycerol and of oleic and stearic acids,
the agency concludes that cocoa butter substitute from high-oleic
safflower or sunflower oil is GRAS when used in accordance with CGMP
(21 CFR 184.1(b)(1)).
IX. Environmental Effects
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
X. Analysis of Impacts
FDA has examined the impacts of this 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 impacts; and equity). According to Executive
Order 12866, a regulatory action is significant if it meets any one of
a number of specific conditions, including having an annual effect on
the economy of $100 million; adversely affecting in a material way a
sector of the economy, competition, or jobs; or raising novel legal or
policy issues. The Regulatory Flexibility Act requires agencies to
minimize the economic impact of their regulations on small businesses.
FDA finds that this final rule is not a significant regulatory
action as defined by Executive Order 12866. The rule does not raise
novel legal or policy issues. The compliance cost to firms currently in
the industry is zero because the rule prohibits no current activity.
Potential benefits of the rule include the wider use of this cocoa
butter substitute because of reduced uncertainty concerning its
regulatory status, and any resources saved by eliminating the need to
prepare further petitions to affirm the GRAS status of the use of this
cocoa butter substitute.
Finally, in compliance with the Regulatory Flexibility Act, FDA
certifies that the final rule will not have a significant economic
impact on a substantial number of small businesses. Therefore, under
the Regulatory Flexibility Act, no further analysis is required.
XI. Effective Date
As this rule recognizes an exemption from the food additive
definition in the Federal Food, Drug, and Cosmetic Act, and from the
approval requirements applicable to food additives, no delay in
effective date is required by the Administrative Procedure Act (5 U.S.C
553(d)). The rule will therefore be effective immediately (5 U.S.C.
553(d)(1)).
XII. References
The following references have been placed on display in the
Dockets Management Branch (address above) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Winter, G., ``A New Safflower Oil with a Low Iodine Value,''
Nature, 179:582-583, 1957.
2. Knowles, P. F., A. B. Hill, and J. E. Ruckman, ``High Oleic
Acid Content in New Safflower, UC-1,'' California Agriculture, p.
15, 1965.
3. Fick, G. N., ``Genetics and Breeding of Sunflower,'' Journal
of the American Oil Chemists' Society, 60:1252-1253, 1983.
4. Purdy, R. H., ``Oxidative Stability of High Oleic Sunflower
and Safflower Oils,'' Journal of the American Oil Chemists' Society,
62:523-525, 1985.-
5. Smith, J. R., ``Safflower: Due for a Rebound,'' Journal of
the American Oil Chemists' Society, 62:1286-1291, 1985.
6. Purdy, R. H., ``High Oleic Sunflower: Physical and Chemical
Characteristics,'' Journal of the American Oil Chemists' Society,
63:1062-1066, 1986.
[[Page 36290]]
7. Anonymous, ``U. S. Sun Crop: Potential Still not Realized,''
Journal of the American Oil Chemists' Society, 63:1218-1224, 1986.
8. Faulkner, R. W., ``Cocoa Butter Equivalents are Truly
Specialty Vegetable Fats,'' The Manufacturing Confectioner, pp. 56-
61, 1981.
9. Memorandum from M. DiNovi, FDA to L. Lin, FDA, November 2,
1988.
10. Feuge, R. O. et al., ``Cocoa Butter-Like Fats from Domestic
Oils,'' Journal of the American Oil Chemists' Society, 35:194-199,
1958.
11. Lehninger, A. L., Principles of Biochemistry, Worth
Publishers, Inc., New York, NY, 1982.
12. Memorandum from J. C. Griffiths, FDA to L. Lin, FDA, July
14, 1989.
13. Shimoda, T. et al., ``Safety Studies of a Transesterified
Fat Produced by an Immobilized Lipase: I. Acute Oral Toxicity Study
in Rats,'' Journal of the American College of Toxicology, 13 (Suppl.
1):10-18, 1994.
14. Shimoda, T. et al., ``Safety Studies of a Transesterified
Fat Produced by an Immobilized Lipase: II. Subchronic Oral Toxicity
and Recovery Studies in Rats,'' Journal of the American College of
Toxicology, 13 (Suppl. 1):19-37, 1994.
15. Shimoda, T. et al., ``Safety Studies of a Transesterified
Fat Produced by an Immobilized Lipase: III. Bacterial Reversion
Test,'' Journal of the American College of Toxicology, 13 (Suppl.
1):38-45, 1994.
16. MacRae, A. R., ``Lipase-Catalysed Interesterification of
Oils and Fats,'' Journal of the American Oil Chemists' Society,
60:291-294, 1983.
List of Subjects in 21 CFR Part 184
Food ingredients.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 184 is amended as follows:
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
1. The authority citation for 21 CFR part 184 continues to read as
follows:
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
2. Section 184.1259 is amended by revising the section heading and
paragraph (a) to read as follows:
Sec. 184.1259 Cocoa butter substitute.
(a) The common or usual name for the triglyceride 1-palmitoyl-2-
oleoyl-3-stearin is ``cocoa butter substitute primarily from palm
oil.'' The common or usual name for the triglyceride 1-3-distearoyl-2-
olein is ``cocoa butter substitute primarily from high-oleic safflower
or sunflower oil.''
(1) The ingredient 1-palmitoyl-2-oleoyl-3-stearin is manufactured
by:
(i) Directed esterification of fully saturated 1,3-diglycerides
(derived from palm oil) with the anhydride of food-grade oleic acid in
the presence of the catalyst trifluoromethane sulfonic acid
(Sec. 173.395 of this chapter), or
(ii) By interesterification of partially saturated 1,2,3-
triglycerides (derived from palm oil) with ethyl stearate in the
presence of a suitable lipase enzyme preparation that is either
generally recognized as safe (GRAS) or has food additive approval for
such use.
(2) The ingredient 1-3-distearoyl-2-olein is manufactured by
interesterification of partially unsaturated 1,2,3-triglycerides
(derived from high-oleic safflower or sunflower oil) with ethyl
stearate or stearic acid in the presence of a suitable lipase enzyme
preparation that is either GRAS or has food additive approval for such
use.
* * * * *
Dated: June 13, 1996.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 96-17542 Filed 7-9-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-17541 Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36290-36291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17541]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Oxytetracycline Injection
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental abbreviated new
animal drug application (ANADA) filed by Boehringer Ingelheim Animal
Health, Inc. The supplemental ANADA provides for the subcutaneous use
of oxytetracycline injection in cattle for treatment of diseases caused
by oxytetracycline susceptible organisms.
EFFECTIVE DATE: July 10, 1996.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Animal Health, Inc.,
2621 North Belt Hwy., St. Joseph, MO 64506, has filed supplemental
ANADA 200-008, which provides for subcutaneous use of oxytetracycline
injection in addition to the approved intravenous and intramuscular use
in beef and nonlactating dairy cattle for the treatment of pneumonia
and shipping fever associated with Pasteurella spp. and Hemophilus
spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by
Moraxella bovis; foot rot and diphtheria caused by Fusobacterium
necrophorum; bacterial enteritis (scours) caused by Escherichia coli;
wooden tongue caused by Actinobacillus lignieresi; leptospirosis caused
by Leptospira pomona; and wound infections and acute metritis caused by
strains of staphylococci and streptococci organisms sensitive to
oxytetracycline. The product is also approved for intramuscular use in
swine.
Boehringer Ingelheim's supplemental ANADA 200-008 for subcutaneous
use of oxytetracycline injection (OXY-TET 200/BIO-MYCIN 200) in cattle
is approved as of May 22, 1996, and the regulations are amended in 21
CFR 522.1660 (c)(1)(iii) to reflect the approval. The basis for
approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a
summary of safety and effectiveness data and information submitted to
support approval of this application may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has determined under 21 CFR 25.24(d)(1)(i) 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 in 21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
[[Page 36291]]
Sec. 522.1660 [Amended]
2. Section 522.1660 Oxytetracycline injection is amended in
paragraph (c)(1)(iii) by revising the first sentence to read
``Administer intramuscularly, intravenously, or subcutaneously at 3 to
5 milligrams level, intramuscularly or subcutaneously at 9 milligrams
level.'' * * *
Dated: June 25, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-17541 Filed 7-9-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-17498 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972; Amendment
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36291-36292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17498]
=======================================================================
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DEPARTMENT OF DEFENSE
Department of the Navy
32 CFR Part 706
Certifications and Exemptions Under the International Regulations
for Preventing Collisions at Sea, 1972; Amendment
AGENCY: Department of the Navy, DOD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of the Navy is amending its certifications and
exemptions under the International Regulations for Preventing
Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy
Assistant Judge Advocate General (Admiralty) of the Navy has determined
that USS KINGFISHER (MHC 56) is a vessel of the Navy which, due to its
special construction and purpose, cannot fully comply with certain
provisions of the 72 COLREGS without interfering with its special
functions as a naval ship. The intended effect of this rule is to warn
mariners in waters where 72 COLREGS apply.
EFFECTIVE DATE: June 25, 1996.
FOR FURTHER INFORMATION CONTACT: Captain R.R. Pixa, JAGC, U.S. Navy
Admiralty Counsel, Office of the Judge Advocate General, Navy
Department, 200 Stovall Street, Alexandria, Virginia, 22332-2400,
Telephone Number: (703) 325-9744.
SUPPLEMENTARY INFORMATION: Pursuant to the authority granted in 33
U.S.C. 1605, the Department of the Navy amends 32 CFR Part 706. This
amendment provides notice that the Deputy Assistant Judge Advocate
General (Admiralty) of the Navy, under
[[Page 36292]]
authority delegated by the Secretary of the Navy, has certified that
USS KINGFISHER (MHC 56) is a vessel of the Navy which, due to its
special construction and purpose, cannot fully comply with the
following specific provisions of 72 COLREGS without interfering with
its special function as a naval ship: Rule 27(f), pertaining to the
display of all-round lights by a vessel engaged in mineclearance
operations; and Annex I, paragraph 9(b), prescribing that all-round
lights be located as not to be obscured by masts, topmasts or
structures within angular sectors of more than six degrees. The Deputy
Assistant Judge Advocate General (Admiralty) of the Navy has also
certified that the lights involved are located in closest possible
compliance with the applicable 72 COLREGS requirements.
Moreover, it has been determined, in accordance with 32 CFR Parts
296 and 701, that publication of this amendment for public comment
prior to adoption is impracticable, unnecessary, and contrary to public
interest since it is based on technical findings that the placement of
lights on this vessel in a manner differently from that prescribed
herein will adversely affect the vessel's ability to perform its
military functions.
List of Subjects in 32 CFR Part 706
Marine safety, Navigation (water), and Vessels.
PART 706--[AMENDED]
Accordingly, 32 CFR Part 706 is amended as follows:
1. The authority citation for 32 CFR Part 706 continues to read:
Authority: 33 U.S.C. 1605.
2. Section 706.2 is amended by adding the following ship to Table
Four, paragraph 18:
Sec. 706.2 Certifications of the Secretary of the Navy under Executive
Order 11964 and 33 U.S.C. 1605.
* * * * *
------------------------------------------------------------------------
Obscured angles relative
to ship's heading
Vessel Number ---------------------------
Port STBD
------------------------------------------------------------------------
Kingfisher................... MHC 56....... 59.5 deg. to 281.7 deg.
78.3 deg.. to 300.5
deg..
------------------------------------------------------------------------
Dated: June 25, 1996.
Approved.
R.R. Pixa,
Captain, JAGC, U.S. Navy, Deputy Assistant Judge Advocate General
(Admiralty).
[FR Doc. 96-17498 Filed 7-9-96; 8:45 am]
BILLING CODE 3810-FF-P
Complete official Federal Register PDF
FR Doc. 96-17469 Defense Federal Acquisition Regulation Supplement; Individual Compensation
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36305-36306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17469]
=======================================================================
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DEPARTMENT OF DEFENSE
48 CFR Part 231
[DFARS Case 96-D314]
Defense Federal Acquisition Regulation Supplement; Individual
Compensation
AGENCY: Department of Defense (DoD).
ACTION: Interim rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: The Director of Defense Procurement has issued an interim rule
amending the Defense Federal Acquisition Regulation Supplement (DFARS)
to implement Section 8086 of Public Law 104-61 by placing a ceiling on
allowable individual compensation under DoD contracts that are awarded
after July 1, 1996, when payments are from funds appropriated in fiscal
year 1996.
DATES: Effective date: July 10, 1996.
Comment date: Comments on the interim rule should be submitted in
writing to the address shown below on or before September 9, 1996, to
be considered in the formulation of the final rule.
ADDRESSES: Interested parties should submit written comments to:
Defense Acquisition Regulations Council, Attn: Ms. Sandra G. Haberlin,
PDUSD (A&T) DP (DAR), IMD 3D139, 3062 Defense Pentagon, Washington, DC
20301-3062. Telefax number (703) 602-0350. Please cite DFARS Case 96-
D314 in all correspondence related to this issue.
FOR FURTHER INFORMATION CONTACT: Ms. Sandra G. Haberlin, (703) 602-
0131.
SUPPLEMENTARY INFORMATION:
A. Background
Section 8086 of the National Defense Appropriations Act for Fiscal
Year 1996 (Pub. L. 104-61) limits allowable costs for individual
compensation to $200,000 per year unless the Office of Federal
Procurement Policy (OFPP) establishes in the Federal Acquisition
Regulations guidance governing the allowability of individual
compensation. On June 10, 1996, OFPP advised that it has determined
that it will not alter the $200,000 ceiling on allowable individual
compensation costs contained in the Public Law. This restriction
applies to DoD contracts awarded after July 1, 1996, when payments are
from funds appropriated in fiscal year 1996.
The interim DFARS rule amends DFARS Subpart 231.2, Contracts with
Commercial Organizations; Subpart 231.3, Contracts with Educational
Institutions; Subpart 231.6, Contracts with State, Local, and Federally
Recognized Indian Tribal Governments; and Subpart 231.7, Contracts with
Nonprofit Organizations, to implement the statutory ceiling on
allowable individual compensation costs. In supplementing the cost
principle at FAR 31.205-6, this DFARS rule relies upon the definition
of compensation found in the FAR cost principle.
B. Determination To Issue an Interim Rule
A determination has been made under the authority of the Secretary
of Defense to issue this rule as an interim rule. Compelling reasons
exist to promulgate this rule without prior opportunity for public
comment. This rule implements Section 8086 of the National Defense
Appropriations Act for Fiscal Year 1996 (Pub. L. 104-61) and applies to
all DoD contracts issued after July 1, 1996. An interim rule is
necessary to ensure that DoD contracting activities become aware of the
statutory ceiling on allowable individual compensation costs when
forward pricing contracts which will be awarded after July 1, 1996,
using fiscal year 1996 funds. However, comments received in response to
the publication of this interim rule will be considered in formulating
the final rule.
C. Regulatory Flexibility Act
The interim rule is not expected to have a significant economic
impact on a substantial number of small entities within the meaning of
the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because most
contracts awarded to small entities use simplified acquisition
procedures or are awarded on a competitive, fixed-price basis, and
therefore the cost principles do not apply. In addition, this interim
DFARS rule applies only to DoD contractors who incur individual
compensation costs in excess of $200,000 per year in performing new
contracts awarded after July 1, 1996, using funds appropriated in
fiscal year 1996. An initial regulatory flexibility analysis has
therefore not been performed. Comments are invited from small
businesses and other interested parties. Comments from small entities
concerning the affected DFARS subparts will also be considered in
accordance with Section 610 of the Act. Such comments must be submitted
[[Page 36306]]
separately and cite 5 U.S.C. 601, et seq. (DFARS Case 96-D314), in
correspondence.
D. Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (Pub. L. 104-13) does not apply
because the interim rule does not impose any additional reporting or
recordkeeping requirements which require the approval of the Office of
Management and Budget under 44 U.S.C. 3501, et seq.
List of Subjects in 48 CFR Part 231
Government procurement.
Michele P. Peterson,
Executive Editor, Defense Acquisition Regulations Council.
Therefore, 48 CFR Part 231 is amended as follows:
1. The authority citation for 48 CFR Part 231 continues to read as
follows:
Authority: 41 U.S.C. 421 and 48 CFR Chapter 1.
PART 231--CONTRACT COST PRINCIPLES AND PROCEDURES
2. Section 231.205-6 is amended by revising paragraph (a)(2) to
read as follows:
231.205-6 Compensation for personal services.
(a)(2)(i) Costs for individual compensation in excess of $250,000
per year are unallowable under DOD contracts that are awarded after
April 15, 1995, and are funded by fiscal year 1995 appropriations
(Section 8117 of Pub. L. 103-335).
(ii) Costs for individual compensation in excess of $200,000 per
year are unallowable under DOD contracts that are awarded after July 1,
1996, and are funded by fiscal year 1996 appropriations (Section 8086
of Pub. L. 104-61).
* * * * *
3. Section 231.303 is amended by revising paragraph (3) to read as
follows:
231.303 Requirements.
* * * * *
(3) The limitations on allowable individual compensation at
231.205-6(a)(2) (i) and (ii) also apply to this subpart.
4. Section 231.603 is revised to read as follows:
231.603 Requirements.
The limitations on allowable individual compensation at 231.205-
6(a)(2) (i) and (ii) also apply to this subpart.
5. Section 201.703 is revised to read as follows:
231.703 Requirements.
The limitations on allowable individual compensation at 231.205-
6(a)(2) (i) and (ii) also apply to this subpart.
[FR Doc. 96-17469 Filed 7-9-96; 8:45 am]
BILLING CODE 5000-04-M
Complete official Federal Register PDF
FR Doc. 96-17417 Amendment to Class E Airspace; Pittsfield, MA
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36283-36284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17417]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Airspace Docket No. 96-ANE-12]
Amendment to Class E Airspace; Pittsfield, MA
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: This action confirms the effective date of a rule, published
on
[[Page 36284]]
May 29, 1996, which revised the Class E airspace area at Pittsfield, MA
(PSF) to provide for adequate controlled airspace for those aircraft
using the GPS RWY 8 Instrument Approach Procedure to Pittsfield
Municipal Airport.
EFFECTIVE DATE: The rule published at 61 FR 26781 is effective on 0901
UTC, August 15, 1996.
FOR FURTHER INFORMATION CONTACT:
Joseph A. Bellabona, Operations Branch, ANE-530.6, Federal Aviation
Administration, 12 New England Executive Park, Burlington, MA 01803-
5299; telephone: (617) 238-7536; fax (617) 238-7596.
The FAA published a direct final rule with a request for comments
in the Federal Register on May 29, 1996 (61 FR 26781), The FAA uses the
direct final rulemaking procedure for a non-controversial rule where
the FAA believes that there will be no adverse public comment. The
direct final rule advised the public that no adverse comments were
anticipated, and that unless a written adverse comment, or a written
notice of intent to submit such an adverse comment, were received
within the comment period, the regulation would become effective on
August 15, 1996. No adverse comments were received, and thus this
document confirms that the final rule will become effective on that
date.
Issued in Burlington, MA, on July 1, 1996.
David J. Hurley,
Manager, Air Traffic Division, New England Region.
[FR Doc. 96-17417 7-9-96; 8:45 am]
BILLING CODE 4910-13-m
Complete official Federal Register PDF
FR Doc. 96-17359 Regulations and Statements of General Policy Issued Under the Packers and Stockyards Act
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36279-36283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17359]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
9 CFR Part 201
RIN 0580-AA44
Regulations and Statements of General Policy Issued Under the
Packers and Stockyards Act
AGENCY: Grain Inspection, Packers and Stockyards Administration
(GIPSA), USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: As part of GIPSA's efforts to review and streamline its
regulations, proposed amendments to rules issued under the Packers and
Stockyards Act (7 U.S.C. 181 et seq.) were published in the Federal
Register (60 FR 29506) on June 5, 1995, and identified as Group II.
This document adopts proposed changes which modify six trade practice
regulations and retains seven regulations and seven statements of
general policy in their present form.
EFFECTIVE DATE: August 9, 1996.
FOR FURTHER INFORMATION CONTACT: Daniel Van Ackeren, Director,
Livestock Marketing Division, 202-720-6951, or Tommy Morris, Director,
Packer and Poultry Division, 202-720-7363.
SUPPLEMENTARY INFORMATION: In response to the proposed rule published
in the Federal Register (60 FR 29506), the Agency received comments
from four organizations and two companies.
Although the Agency did not propose any changes to Sec. 201.43, a
poultry growers association suggested that a new paragraph be added to
Sec. 201.43 to require live poultry dealers to maintain certain records
for flock placements. After considering the comment, the Agency has
concluded that this regulation will be retained in its present form.
The Agency believes that Sec. 401 of the P&S Act adequately addresses
the issue of record maintenance.
The Agency received three comments regarding Sec. 201.49. A
livestock trade association agrees with the proposed amendment. A major
hog slaughterer suggests that records be retained for lot summaries
instead of individual
[[Page 36280]]
weights. They feel that the volume of the records for the individual
weights would be too impractical to maintain. A cattle producers
association stated that this regulation is consistent with its policy.
As proposed, Sec. 201.49 (a) will be amended to specifically state
that all scales used to purchase livestock on a dressed weight basis be
equipped with printing devices. The Agency will amend subsection (b) of
Sec. 201.49 to require weighmaster identification on executed poultry
scale tickets that is uniform with identification required by livestock
weighers.
The cattle producers association suggested that the Agency closely
monitor Sec. 201.53 and help to ensure that information released to the
beef industry is accurate and timely. After considering the comment,
the Agency has concluded that this regulation will be retained in its
present form. The Agency believes this regulation adequately addresses
the importance of accurate information.
No comments were received regarding the proposed amendment to
Sec. 201.55 to include the purchase, sale, acquisition and settlement
of live poultry.
The Agency received two comments regarding Sec. 201.71. One
livestock trade association and a livestock producers association
agreed with the proposed amendment. As proposed, Sec. 201.71(a) will be
amended to incorporate by reference the 1996 edition of the National
Institute of Standards and Technology (NIST) Handbook 44. Section
201.71(b) will be amended to require that scales used to purchase
livestock on a carcass weight basis be equipped with printing devices.
The Agency received a comment regarding Sec. 201.73-1 from a
livestock trade association agreeing with the technical change to this
section. The Agency will change Sec. 201.73-1 to more accurately
reflect where forms are available and where they are to be filed.
One hog slaughterer suggested that Sec. 201.76 be clarified to
state that any reweighing of livestock be requested immediately. They
also pointed out that the reweighing of dressed livestock would be
impossible after carcasses have cleared the hot scale and entered the
cooler. After considering the comment, the Agency has concluded that
this regulation will be retained in its present form. The Agency
believes immediate reweighing can be accomplished using other packer-
owned monorail scales installed before, after or in rail-around areas
near the kill floor scale. Where other scales are not available,
reweighing can be accomplished by using an Agency-owned portable
monorail scale.
The Agency received a comment from a livestock trade association
regarding Sec. 201.98 agreeing with the proposed amendment. As
proposed, Sec. 201.98 will be amended by adding the wording, ``unless
the charge is for services mandated by law or statute.''
The Agency received two comments regarding Sec. 201.100. A poultry
growers association suggested that paragraph (d) be amended by adding a
clause prohibiting persons who are employees and raise poultry under a
poultry growing arrangement for the same live poultry dealer that
employs them from being included in a grouping or ranking of non-
employee growers. A farm association commented that this section is
badly needed to make contract growing fair for all growers. After
considering the comments, the Agency concluded that this regulation
will be retained in its present form. Inclusion of employee growers in
a grouping or ranking of all growers is not a violation of the P&S Act
unless they are treated favorably over non-employee growers. The Agency
has authority to address preferential or discriminatory treatment under
section 202 of the P&S Act.
No comments were received regarding the proposed amendment to
Sec. 201.108-1. As proposed, Sec. 201.108-1 will be amended by
incorporating instructions for weighing live poultry on electronic
scales with digital readouts.
As proposed, each of the following regulations and statements of
general policy will be retained in its present form:
Sec.
201.53 Persons subject to the Act not to circulate misleading
reports about market conditions or prices.
201.69 Furishing information to competitor buyers.
201.70 Restriction or limitation of competition between packers and
dealers prohibited.
201.73 Scale operators to be qualified.
201.76 Reweighing.
201.100 Records to be furnished poultry growers and sellers.
201.200 Sale of livestock to a packer on credit.
203.2 Statement of general policy with respect to the giving by
meat packers of meat and other gifts to Government employees.
203.4 Statement with respect to the disposition of records by
packers, live poultry dealers, stockyard owners, market agencies and
dealers.
203.7 Statement with respect to meat packer sales and purchase
contracts.
203.15 Trust benefits under sections 206 and 207 of the Act.
203.16 Mailing of checks in payment for livestock purchased for
slaughter, for cash and not on credit.
203.18 Statement with respect to packers engaging in the business
of custom feeding livestock.
203.19 Statement with respect to packers engaging in the business
of livestock dealers or buying agencies.
In the process of reviewing these regulations, it was determined
that they were necessary for the efficient and effective enforcement of
the P&S Act and for the orderly conduct of the marketing system. The
absence of any of the regulations would be detrimental to the industry
and could result in increased litigation.
The Agency received a comment from a farm association regarding
Sec. 203.4. This policy statement notifies persons subject to the P&S
Act that certain records may be disposed of after a specific period of
time. It also states that the Deputy Administrator may require that
records be retained for a longer period pending completion of an
investigation. The policy statement advises that if records are
disposed of before the specified periods, the Agency will consider
taking formal action. The farm association suggested that records be
retained for three (3) years or more. After considering the comment,
the Agency has concluded that this policy will be retained in its
present form. The two year retention schedule provided in this section
has not caused problems in administering the provisions of the P&S Act.
Further, the Agency has the authority to require that records be
retained for longer periods when deemed necessary.
The Agency received a comment from a cattle producers association
regarding Sec. 203.18. This policy statement notifies packers that
ownership or operation of custom feedlots may, under certain
circumstances, result in a conflict of interest or anticompetitive
violations. It suggests packers consult with the Agency before
commencing such activity. The association urges the Agency to closely
scrutinize this policy statement. Current authority under the P&S Act
is sufficient to allow the Agency to review any arrangement that may
result in an unfair practice or advantage. A per se prohibition of
these type of arrangements can only be achieved by legislative action
to amend the P&S Act. For these reasons, no changes are being made in
Sec. 203.18. The Agency will continue to evaluate these types of
arrangements on a case-by-case basis.
The Agency received a comment regarding Sec. 203.19 from a
livestock trade association. The association proposed
[[Page 36281]]
that this section be amended to prohibit packers and their employees or
agents engaged in the business of a buying agency from purchasing and
reselling classes or species of livestock which are not part of their
main business activity as a packer. The Agency will not make changes to
Sec. 203.19 at this time, but will continue to evaluate each such
arrangement on a case-by-case basis. As a practical matter, most
packers consult with the Agency before entering into such arrangements.
Amending this rule to require such consultation does not appear
necessary. Attempting to shift the burden of proof that the arrangement
does not restrain trade would not relieve the Agency of the
responsibility to investigate and make a factual determination.
The changes in Secs. 201.49, 201.55, 201.71, 201.73-1, 201.98, and
201.108-1 do not impose or change any recordkeeping or information
collection requirements. Existing requirements in these regulations
have been previously approved by OMB under Control No. 0590-0001.
As provided by the Regulatory Flexibility Act, it is hereby
certified that these amended rules will not have a significant economic
impact on a substantial number of small entities and a statement
explaining the reasons for the certification is set forth in the
following paragraph and is being provided to the Chief Counsel for
Advocacy of the Small Business Administration.
While these amended rules impact small entities, they will not have
a significant economic impact on any entity, large or small. The
primary effect of the changes in Secs. 201.49 and 201.71 is to require
that when livestock is purchased on the basis of carcass weight, the
scale used on such purchases be equipped with a printer. The primary
effect of the change in Sec. 201.55 is to require that when poultry is
bought, sold, acquired, or settled on a weight basis, the actual weight
on the scale ticket be used for such purposes, as is currently required
for livestock. The primary effect of the change in Sec. 201.73-1 is to
make a technical change in the name of the Agency pursuant to Public
Law 103-354, the Federal Crop Insurance Reform and the Department of
Agriculture's Reorganization Act of 1994. The primary effect of the
change in Sec. 201.98 is to allow packers and dealers to charge for
services that are mandated by law or statute. The primary effect of the
change in Sec. 201.108-1 is to update the regulation.
This rule has been determined to be not significant for purposes of
Executive Order 12866 and, therefore, has not been reviewed by OMB.
These amendments do not impose any new paperwork requirements and do
not have implications of Federalism under the criteria of E.O. 12612.
These amendments have been reviewed under E.O. 12778, Civil Justice
Reform, and are not intended to have retroactive effect. These
amendments will not pre-empt State or local laws, regulations, or
policies unless they present an irreconcilable conflict with this
amendment. Prior to judicial challenge of the amendment to rule, a
party must first be found by the Secretary to be in violation of the
P&S Act and in violation of the accompanying regulations. Second, the
party must appeal that finding and the validity of the regulation to
the Secretary in the course of the administrative proceeding. Only
after taking these steps, may the party challenge the regulation in a
court of competent jurisdiction.
List of Subjects in 9 CFR Part 201
Reporting and recordkeeping requirements, Stockyards, Trade
practices, Incorporation by reference.
Done at Washington, D.C., this 1st day of July 1996.
James R. Baker,
Administrator, Grain Inspection, Packers and Stockyards Administration.
For the reasons set forth in the preamble, 9 CFR Part 201 is
amended to read as follows:
1. The authority citation for Part 201 continues to read as
follows:
Authority: 7 U.S.C. 204, 228; 7 CFR 2.17(e), 2.56.
2. Section 201.49 is revised to read as follows:
Sec. 201.49 Requirements regarding scale tickets evidencing weighing
of livestock and live poultry.
(a) Livestock. When livestock is weighed for the purpose of
purchase or sale, a scale ticket shall be issued which shall be
serially numbered and used in numerical sequence. Sufficient copies
shall be executed to provide a copy to all parties to the transaction.
In instances where the weight values are automatically recorded
directly on the account of purchase, account of sale or other basic
record, this record may serve in lieu of a scale ticket. When livestock
is purchased on a carcass weight or carcass grade and weight basis, the
hot carcass weights shall be recorded using a scale equipped with a
printing device, and such printed weights shall be retained as part of
the person or firm's business records to substantiate settlement on
each transaction. Scale tickets issued under this section shall show:
(1) The names and location of the agency performing the weighing
service,
(2) The date of the weighing;
(3) The name of the buyer and seller or consignor, or a designation
by which they may be readily identified;
(4) The number of head;
(5) Kind of livestock;
(6) Actual weight of each draft of livestock; and
(7) The name, initials, or number of the person who weighed the
livestock, or if required by State law, the signature of the weigher.
(b) Poultry. When live poultry is weighed for the purpose of
purchase, sale, acquisition, or settlement by a live poultry dealer, a
scale ticket shall be issued which shall show:
(1) The name of the agency performing the weighing service;
(2) The name of the live poultry dealer;
(3) The name and address of the grower, purchaser, or seller;
(4) The name or initials or number of the person who weighed the
poultry, or if required by State law, the signature of the weigher;
(5) The location of the scale;
(6) The gross weight, tare weight, and net weight;
(7) The date and time gross weight and tare weight are determined;
(8) The number of poultry weighed;
(9) The weather conditions;
(10) Whether the driver was on or off the truck at the time of
weighing; and
(11) The license number of the truck or the truck number; provided,
that when live poultry is weighed on a scale other than a vehicle
scale, the scale ticket need not show the information specified in
paragraphs (b)(9)-(11) of this section. Scale tickets issued under this
paragraph shall be at least in duplicate form and shall be serially
numbered and used in numerical sequence. One copy shall be furnished to
the grower, purchaser, or seller, and one copy shall be furnished to or
retained by the live poultry dealer.
(Approved by the Office of Management and Budget under control
number 0590-0001.)
3. Section 201.55 is revised to read as follows:
Sec. 201.55 Purchases, sales, acquisitions, and settlements to be made
on actual weights.
When livestock or live poultry is bought, sold, acquired, or
settled on a weight basis, settlement therefor shall be on the basis of
the actual weight on the scale ticket. If the actual weight used is not
obtained on the date and at the
[[Page 36282]]
place of transfer of possession, this information shall be disclosed
with the date and location of the weighing on the accountings, bills,
or statement issued. Any adjustment to the actual weights shall be
fully and accurately explained on the accountings, bills, or statements
issued and records shall be maintained to support such adjustment.
(Approved by the Office of Management and Budget under control
number 0590-0001.)
4. Section Sec. 201.71 (a) and (b) is revised to read as follows:
Sec. 201.71 Scales, accurate weights, repairs, adjustments or
replacements after inspection.
(a) All scales used by stockyard owners, market agencies, dealers,
packers, and live poultry dealers to weigh livestock, livestock
carcasses, or live poultry for the purpose of purchase, sale,
acquisition, or settlement shall be installed, maintained, and operated
to insure accurate weights. Such scales shall meet applicable
requirements contained in the General Code, Scale Code, and Weights
Code of the 1996 edition of National Institute of Standards and
Technology Handbook 44, ``Specifications, Tolerances, and Other
Technical Requirements for Weighing and Measuring Devices,'' which is
hereby incorporated by reference. This incorporation by reference was
approved by the Director of the Federal Register on January 11, 1989.
These materials are incorporated as they exist on the date of approval
and a notice of any change in these materials will be published in the
Federal Register. This handbook is for sale by the Superintendent of
Documents, U.S. Government Printing Office, Washington, D.C. 20402. It
is also available for inspection at the Office of the Federal Register
Information Center, 800 North Capitol Street, N.W., suite 700,
Washington, D.C. 20408.
(b) All scales used by stockyard owners, market agencies dealers,
packers, and live poultry dealers to weigh livestock or live poultry
for the purpose of purchase, sale, acquisition, or settlement and all
scales used for the purchase, sale, acquisition, or settlement of
livestock on a carcass weight basis shall be equipped with a printing
device which shall be used for recording weight values on a scale
ticket or other document used for this purpose.
5. Section Sec. 201.73-1 introductory text is revised to read as
follows:
Sec. 201.73-1 Instructions for weighing livestock.
Stockyard operators, market agencies, dealers, and packers who
operate scales on which livestock is weighed in purchase or sales
transactions are responsible for the accurate weighing of such
livestock. They shall supply copies of the instructions in this section
to all persons who perform weighing operations for them and direct such
person to familiarize themselves with the instructions and to comply
with them at all times. This section shall also apply to any additional
weighers who are employed at any time. Weighers must acknowledge their
receipt of these instructions and agree to comply with them, by signing
in duplicate, P&SA Form 215 provided by the Packers and Stockyards
Programs. One copy of the form is to be filed with a regional office of
the Packers and Stockyards Programs and the other retained by the
agency employing the weighers.
6. Section Sec. 201.98 is revised to read as follows:
Sec. 201.98 Packers and dealers not to charge, demand, or collect
commission, yardage, or other service charges.
No packer or dealer shall, in connection with the purchase of
livestock in commerce, charge, demand, or collect from the seller of
the livestock any compensation in the form of commission, yardage, or
other service charge unless the charge is for services mandated by law
or statute and is not inconsistent with the provisions of the Act.
7. Section Sec. 201.108-1 introductory paragraph and paragraphs,
(a) and (c)-(f) are revised to read as follows:
Sec. 201.108-1 Instructions for weighing live poultry.
Live poultry dealers who operate scales on which live poultry is
weighed for purposes of purchase, sale, acquisition, or settlement are
responsible for the accurate weighing of such poultry. They shall
supply copies of the instructions in this section to all persons who
perform weighing operations for them and direct such persons to
familiarize themselves with the instructions and to comply with them at
all times. This section shall also apply to any additional weighers who
are employed at any time. Weighers must acknowledge their receipt of
these instructions and agree to comply with them by signing in
duplicate, a form provided by the Packers and Stockyards Programs,
Grain Inspection, Packers and Stockyards Administration. One copy of
this form is to be filed with a regional office of the Packers and
Stockyards Programs, Grain Inspection, Packers and Stockyards
Administration and the other copy retained by the Agency employing the
weighers. The following instructions shall be applicable to the
weighing of live poultry on all scales, except that paragraph (c)(1) of
this section is only applicable to the weighing of live poultry on
vehicle scales.
(a) Balancing the empty scale. (1) The scale shall be maintained in
zero balance at all times. The empty scale shall be balanced each day
before weighing begins and thereafter its zero balance shall be
verified before any poultry is weighed. In addition, the zero balance
of the scale shall be verified whenever a weigher resumes weighing
duties after an absence from the scale.
(2) Before balancing the empty scale, the weigher shall notify
parties outside the scale house of his/her intention and shall be
assured that no persons or vehicles are in contact with the platform.
When the empty scale is balanced and ready for weighing, the weigher
shall so indicate by appropriate signal.
(3) Weighbeam scales shall be balanced by first seating each poise
securely in its zero notch and then moving the balance ball to such
position that a correct zero balance is obtained. A scale equipped with
a balance indicator is correctly balanced when the indicator comes to
rest in the center of the target area. A scale not equipped with a
balance indicator is correctly balanced if the weighbeam, when released
at the top or bottom of the trig loop, swings freely in the trig loop
in such manner that it will come to rest at the center of the trig
loop.
(4) Dial scales shall be balanced by releasing all drop weights and
operating the balance ball or other balancing device to obtain a
correct zero balance. The indicator must visibly indicate zero on the
dial reading face and the ticket printer must record a correct zero
balance. ``Balance tickets'' shall be filed with other scale tickets
issued on that date.
(5) Electronic digital scales should be properly warmed up before
use. In most cases it is advisable to leave the electric power on
continuously. The zero balance shall be verified by recording the zero
balance on a scale ticket. The main indicating element and the remote
visual weight display shall indicate zero when the balance is verified.
The proper procedure for balancing this type of scale will vary
according to the manufacturer. Refer to the operator's manual for
specific instructions.
(6) A balance ball or other balancing device shall be operated only
when balancing the empty scale and shall not be operated at any time or
for any other purpose.
[[Page 36283]]
(7) The time at which the empty scale is balanced or its zero
balance verified shall be marked on scale tickets or other permanent
records.
* * * * *
(c) Weighing the load. (1) Vehicle scales used to weigh live
poultry shall be of sufficient length and capacity to weigh an entire
vehicle as a unit; provided, that a trailer may be uncoupled from a
tractor and weighed as a single unit. Before weighing a vehicle, either
coupled or uncoupled, the weigher shall be assured that the entire
vehicle is on the scale platform and that no persons are on the scale
platform.
(i) On a weighbeam scale with a balance indicator the weight of a
vehicle shall be determined by moving the poises to such positions that
the indicator will come to rest within the central target area.
(ii) On a weighbeam scale without a balance indicator the weight
shall be determined by moving the poises to such positions that the
weighbeam, when released from the top or bottom of the trig loop, will
swing freely in the trig loop and come to rest at the approximate
center of the trig loop.
(iii) On a dial scale the weight of a vehicle is indicated
automatically when the indicator revolves around the dial face and
comes to rest.
(iv) On an electronic digital scale the weight of a vehicle is
indicated automatically when the weight value indicated is stable.
(2) The correct weight is the value in pounds indicated by a
weighbeam, dial or digital scale when a stable load balance is
obtained. In any case, the weigher should concentrate on the beam tip,
balance indicator, dial or digital indicator while weighing and not be
concerned with reading the visible weight indications until a stable
load balance is obtained. On electronic digital scales, the weigher
should concentrate on the pulsing or flickering of weight values to
assure that the unit indicates a stable weight before activating the
print button.
(d) Recording the weight. (1) The gross or tare weight shall be
recorded immediately after the load balance is obtained and before any
poises are moved or load removed from the scale platform. The weigher
shall make certain that the printed weight record agrees with the
weight value visibly indicated on the weighbeam, dial or digital
indicator when correct load balance is obtained. The weigher shall also
assure that the printed weight value is sufficiently distinct and
legible.
(2) The weight printing device on a scale shall be operated only to
produce a printed or impressed record of the weight while the load is
on the scale and correctly balanced. If the weight is not printed
clearly and correctly, the ticket shall be marked void and a new one
printed before the load is removed from the scale.
(e) Weigher's responsibilities. (1) The primary responsibility of a
weigher is to determine and record the true weight of live poultry
without prejudice or favor to any person or agency and without regard
for poultry ownership, price, condition, shrink, or other
considerations. A weigher shall not permit the representations or
attitudes of any persons or agencies to influence their judgment or
action in performing his/her duties.
(2) Scale tickets issued shall be serially numbered and used in
numerical sequence. Sufficient copies shall be executed to provide a
copy to all parties to the transaction. Unused scale tickets or those
which are partially executed shall not be left exposed or accessible to
other parties. All such tickets shall be kept under lock when the
weigher is not at his duty station.
(3) Accurate weighing and weight recording require that a weigher
shall not permit operations to be hurried to the extent that inaccurate
weights or incorrect weight records may result. The gross, tare and net
weights must be determined accurately to the nearest minimum
graduation. Manual operations connected with balancing, weighing, and
recording shall be performed with the care necessary to prevent damage
to the accurately machined and adjusted parts of weighbeams, poises,
and printing devices. Rough handling of these parts shall be avoided.
(4) Poultry growers, live poultry dealers, sellers, or others
having legitimate interest in a load of poultry are entitled to observe
the balancing, weighing, and recording procedures. A weigher shall not
deny such persons that right or withhold from them any information
pertaining to the weight. The weigher shall check the zero balance of
the scale or reweigh a load of poultry when requested by such parties
or duly authorized representatives of the administrator.
(f) General precautions. (1) The poises of weighbeam scales are
carefully adjusted and sealed to a definite weight at the factory and
any change in that weight seriously affects weighing accuracy. A
weigher, therefore, shall observe if poise parts are broken, loose or
lost or if material is added to a poise and shall report any such
condition to his/her superior or employer. Balancing or weighing shall
not be performed while a scale ticket is in the slot of a weighbeam
poise.
(2) Stops are provided on scale weighbeams to prevent movement of
poises back of the zero graduation when balancing or weighing. When the
stops become worn or broken and allow a poise to be set behind the zero
position, this condition must be reported by the weigher to their
superior or employer and corrected without delay.
(3) Motion detection circuits are a part of electronic scales. They
are designed to prevent the printing of weight values if the load has
not stabilized within prescribed limits. The weighmaster's duty is to
print the actual weight of the load within these limits. This requires
printing the actual weight of the load, not one of the other weights
that may be within the motion detection limits.
(4) Foreign objects or loose material in the form of nuts, bolts,
washers, or other material on any part of the weighbeam assembly,
including the counter-balance hanger or counter-balance weights, are
potential sources of weighing error. Loose balancing material must be
enclosed in the shot cup of the counter-balance hanger and counter-
balance weights must not be of the slotted type which can readily be
removed.
(5) Whenever, for any reason, a weigher has reason to believe that
a scale is not functioning properly or not yielding correct weight
values, the weigher shall discontinue weighing, report the facts to the
parties responsible for scale maintenance and request inspection, test
or repair of the scale.
(6) When a scale has been adjusted, modified, or repaired in any
manner which can affect the accuracy of weighing or weight recording,
the weigher shall not use the scale until it has been tested and
inspected and found to be accurate.
[FR Doc. 96-17359 Filed 7-9-96; 8:45 am]
BILLING CODE 3410-EN-P
Complete official Federal Register PDF
FR Doc. 96-17358 Regulations Issued Under the Packers and Stockyards Act
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36277-36279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17358]
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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.
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Federal Register / Vol. 61, No. 133 / Wednesday, July 10, 1996 /
Rules and Regulations
[[Page 36277]]
DEPARTMENT OF AGRICULTURE
Grain Inspection, Packers and Stockyards Administration
9 CFR Part 201
RIN 0580-AA45
Regulations Issued Under the Packers and Stockyards Act
AGENCY: Grain Inspection, Packers and Stockyards Administration
(GIPSA), USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: As part of GIPSA's efforts to review and streamline its
regulations, proposed amendments to rules issued under the Packers and
Stockyards (P&S) Act were published in the Federal Register on August
21, 1995, and identified as Group III. This document adopts proposed
changes which modify two regulations, to provide uniform termination
procedures for all bonds and bond equivalents and to change the
requirement that funds pledged to secure bond equivalents be maintained
in FDIC-insured accounts to permit their deposit in any Federally-
insured account, and retains seven regulations in their present form.
EFFECTIVE DATE: August 9, 1996.
FOR FURTHER INFORMATION CONTACT: Dan Van Ackeren, Director, Livestock
Marketing Division, 202-720-6951, or Tommy Morris, Director, Packer and
Poultry Division, 202-720-7363.
SUPPLEMENTARY INFORMATION: In response to the proposed rule published
in the Federal Register (60 FR 43411), the Agency received comments
from two marketing associations, one livestock selling agency, a State
department of agriculture, and a law firm representing livestock
marketing interests.
Two comments were received regarding the modification of
Sec. 201.27. This regulation provides for approved sureties, authorizes
bond equivalents, and requires bond or bond equivalents to be on forms
approved by the Administrator. Both comments generally supported the
proposed modification of Sec. 201.27(b)(1) and (b)(2), but urged the
Agency to assure that funds pledged under bond equivalents be provided
the same degree of protection as those insured by the Federal Deposit
Insurance Corporation (FDIC). As long as funds are actually deposited
or invested in fully negotiable obligations of the United States,
deposited in Federally-insured accounts, or letters of credit are
issued by Federally-insured institutions, then bond equivalents will
continue to have the same degree of protection as those insured by the
FDIC.
As proposed, Sec. 201.27(b)(1) and (b)(2) will be modified to
broaden these subsections to permit funds pledged under bond
equivalents to be on deposit or in accounts that are Federally-insured
and not limited to only deposits or accounts insured by the FDIC. This
modification would also permit all Federally-insured banks or other
institutions to issue letters of credit, not just those banks or
institutions insured by FDIC. The primary benefit accrues to persons
choosing to meet bonding requirements with bond equivalents by
permitting all Federally-insured deposits and letters of credit (not
just FDIC) and would expand the number of banks or other institutions
available to those seeking bond equivalents without increasing the risk
to livestock sellers.
No comments were received concerning Sec. 201.34. This regulation
sets forth procedures for termination of market agency, dealer, and
packer bonds and trust fund agreements. As proposed, the Agency will
amend Sec. 201.34(c) to include termination procedures for trust
agreements. This will provide uniform termination for all bonds and
bond equivalents.
As proposed, each of the following regulations will be retained in
its present form:
Sec. 201.10 Requirements and procedures for registration.
Sec. 201.28 Duplicates of bonds or equivalents to be filed with
regional supervisor.
Sec. 201.29 Market agencies, packers and dealers required to file
and maintain bonds.
Sec. 201.30 Amount of market agency, dealer and packer bonds.
Sec. 201.31 Conditions in market agency, dealer and packer bonds.
Sec. 201.32 Trustee in market agency, dealer and packer bonds.
Sec. 201.33 Persons damaged may maintain suit; filing and
notification of claims; time limitation; legal expenses.
In the process of reviewing these regulations, it was determined
that they were necessary to the efficient and effective enforcement of
the P&S Act and to the orderly conduct of the marketing system. The
absence of any of the regulations would result in increased litigation.
Three comments were received concerning Sec. 201.10, which
specifies the requirements and procedures for registration for those
persons desiring to operate as market agencies or dealers as defined in
Sec. 301 of the P&S Act. One comment suggested modifying Sec. 201.10 by
prohibiting market agencies, dealers, and packers from operating
subject to the P&S Act, under their bond or anyone else's bond, until
all debts owed approved livestock auction markets had been paid,
regardless of whether such debt had been dismissed in bankruptcy. The
Agency believes that such a modification would not be in the best
interest of all livestock sellers since the comment referred to only
debts owed to approved livestock auction markets. The Agency could also
be in conflict with Federal bankruptcy statutes if a registration was
denied based on a debt dismissed in bankruptcy. Under the provisions of
the P&S Act, all market agencies and dealers are required, as a
condition for registration, to be solvent. That is, current assets must
be equal to or exceed current liabilities.
Two other comments received regarding Sec. 201.10 suggested the
regulation lacks specificity as to what circumstances or past
activities are deemed actionable in denying the registration of an
applicant. They also suggested serious violations of the Act, such as
fraud, theft, and embezzlement, should warrant denial of registration
unless the applicant can show just cause why registration should not be
denied. The Agency believes this concern is sufficiently addressed in
Sec. 201.10(b) which specifies that if the Administrator has reason to
believe the applicant is unfit to engage in the activity for which
application has been made, the applicant will be afforded an
opportunity for a full hearing for the
[[Page 36278]]
purpose of showing cause why the application should not be denied. This
paragraph gives the Agency authority to review each application and to
deny registration to those believed unfit to engage in the business of
a market agency or dealer. It is believed Sec. 201.10(b) can be
enforced more effectively if this regulation is not narrowed to
specified violations of the P&S Act. After considering the comments,
the Agency has concluded this regulation should be retained in its
present form.
One comment was received regarding Sec. 201.29, which requires
market agencies, packers and dealers to file and maintain bonds. The
comment indicated no particular concern regarding the language in
Sec. 201.29, but suggested the P&S Act should be changed to insure that
all major buyers of livestock, including feedlots, be required to
maintain a reasonable bond. Those feedlots operating as dealers or
market agencies as defined under the P&S Act, are subject to the
registration and bonding provisions. Broader coverage to all major
buyers would require a change in the statute. Therefore, the Agency has
concluded this regulation should be retained in its present form.
All five comments to the proposal addressed Sec. 201.30. This
regulation sets forth the formulae for computing bonds for market
agencies, dealers, and packers. It also provides the Administrator the
authority to adjust the level of bond required whenever he/she
determines a bond is not adequate to secure the obligations of the
person or firm.
Two comments generally supported the Agency's proposal to retain
Sec. 201.30 in its present form and believed that even a modest
increase in bond levels would not appreciably improve the financial
protection afforded livestock sellers and may exclude smaller reputable
businesses from operating altogether. The Agency was also urged to give
serious consideration to establishing alternatives to the current bonds
and bond equivalents such as the financial security funds used in
several Canadian provinces.
One comment suggested changing the formulae for determining bond
size for market agencies buying on commission and dealers (Clause 2
bond) to one half of an average week's gross purchases from the prior
year (52 weeks). Another comment suggested the Agency eliminate the 10
percent threshold on dealer bonds over $75,000 because the threshold is
unfair to smaller dealers and the default of a larger dealer could have
a greater impact on the livestock industry than a smaller dealer. One
comment recommended increasing the minimum requirement for dealers and
market agencies buying on commission from the current $10,000 to
$25,000. The comment also stated that an increase in the minimum bond
from $10,000 to $25,000 may discourage potential dealers, who may not
be financially secure or responsible, from becoming a livestock dealer.
After considering these comments, the Agency has concluded
Sec. 201.30 will be retained in its present form. The Agency does not
believe it is necessary to increase the minimum bond level of Clause 2
bonds or to remove the threshold on bonds over $75,000 at this time.
The cost to the industry of increasing minimum bond levels would far
outweigh the increased protection that would be gained by such an
increase. Small dealers and market agencies buying on commission, which
include 48 percent of all dealers or market agencies, would be hardest
hit by an increase in bond levels and may find it difficult to remain
in business. The Agency also believes that the cost to the industry of
removing the 10 percent threshold on Clause 2 bonds over $75,000 would
far outweigh the benefit to livestock sellers and cause an undue
hardship on larger dealers and market agencies buying on commission
since many would likely be unable to obtain the required bond coverage.
However, the Agency will continue to review the levels of bonds and to
study alternative methods of providing financial protection to
livestock sellers. In addition, the Department is supporting proposed
legislation to amend the P&S Act to establish a dealer trust for the
benefit of sellers of livestock to dealers and market agencies buying
on commission. If the proposed legislation is passed, livestock sellers
will benefit from additional protection under the Act.
Two comments were received regarding Sec. 201.32 which refers to
trustees named in market agency, dealer, and packer bonds. Both
comments suggested Sec. 201.32 be amended to show that whenever
multiple trustees are listed on a bond, the Agency should designate a
``lead'' trustee to represent those who filed claims against the bond.
Both comments further suggested that whenever trust agreements or trust
fund agreements (bond equivalents) are used in lieu of a bond, the bank
issuing collateral for a trust fund agreement or an irrevocable letter
of credit should not be permitted to act as trustee. They believe an
inherent conflict of interest exists whenever the bank holding the
collateral for a bond equivalent (or issued a letter of credit) is also
named as trustee.
After reviewing these comments, the Agency has decided to retain
Sec. 201.32 in its present form. The Agency does not accept bonds or
bond equivalents with multiple trustees listed, therefore, does not
believe it is necessary to amend the regulation to designate a ``lead''
trustee. Trustees on bond equivalents have a fiduciary responsibility
to carry out their duty as trustee when bond claims are filed. Whenever
a trustee fails to carry out their fiduciary responsibility on behalf
of the claimants, the Agency has the authority to appoint a new trustee
to carry out the trustee's responsibility.
Three comments were received concerning Sec. 201.33, which pertains
to filing and notification of bond claims, time limitations, and the
filing of civil suit to recover on the bond or bond equivalent.
One comment suggested the number of days to file a claim stay at 60
days, but to pay only those claims that are filed within 21 days of the
first unpaid debt. The comment further stated that this is sufficient
time for those following the prompt pay laws and they should not be
penalized by dividing bond proceeds with those who have given buyers
credit. The Agency believes this suggestion would give livestock
sellers insufficient time to file the bond claims. Some sellers of
livestock may not have specifically extended credit to the buyer, yet
may be classified as a credit seller if a bond claim is not filed
within 21 days of the date of the transaction and therefore, not
included in the payout of bond proceeds. We believe there is
insufficient basis to warrant this change in the bond requirements at
this time.
Two other comments suggested two changes to this regulation. They
suggested that the Agency clarify the term ``date of transaction.''
They state that it has been assumed for years that the term ``date of
transaction'' meant the date of the sale or, at most, the date payment
was due after the sale. The comment also accurately states that
Sec. 201.33(d) requires that a claim must be filed within 60 days from
the date of the transaction on which the claim is based and, if for
some reason the claim is not paid or acknowledged as a valid claim, the
claimant can then file suit on that claim alleging as a cause of action
that the claimant has a valid claim but the surety has denied liability
or failed to pay the claim. In other words, filing a claim within 60
days from the date of the transaction is a condition precedent which
must be met in order to file suit. They believe this paragraph should
be
[[Page 36279]]
clarified to avoid confusion and keep persons from filing suit against
a surety company 15 or 18 months after a transaction when no claim was
ever filed against the bond.
The Agency believes that the language in Sec. 201.33 is
sufficiently clear and does not believe it is necessary to define
``date of transaction'' or to modify paragraph (d). In addition,
Sec. 409 of the P&S Act provides a basis for when payment is due in
subject transactions. Under Sec. 409, payment must be made by the close
of the next business day following the purchase of livestock and
transfer of possession thereof. After considering these comments, the
Agency has decided to retain Sec. 201.33 in its present form.
The proposed changes in Sec. 201.27(b)(1) and (b)(2) and in
Sec. 201.34(c) do not impose or change any recordkeeping or information
collection requirements. Existing requirements in these regulations
have been previously approved by OMB under control No. 0590-0001.
As provided by the Regulatory Flexibility Act, it is hereby
certified that these amended rules will not have significant economic
impact on a substantial number of small entities and a statement
explaining the reasons for the certification is set forth in the
following paragraph and is being provided to the Chief Counsel for
Advocacy of the Small Business Administration.
While these proposed amended rules impact small entities, they will
not have a significant economic impact on any entity, large or small.
The primary effect of the changes in rules Sec. 201.27(b)(1) and (b)(2)
is to permit funds pledged under bond equivalents to be on deposit or
in accounts that are Federally insured and to permit Federally-insured
banks and other institutions to issue letters of credit. Eligible
institutions would no longer be restricted to those banks or
institutions insured by FDIC. The primary effect of the rule change in
Sec. 201.34(c) is to include the termination of trust agreements.
These rules have been determined to be not significant for purposes
of Executive Order 12866 and, therefore, have not been reviewed by OMB.
These amendments do not impose any new paperwork requirements and do
not have implications for Federalism under the criteria for E.O. 12612.
This final rule has been reviewed under E.O. 12778, Civil Justice
Reform. This action is not intended to have retroactive effect. This
rule does not preempt any State or local laws, regulations, or
policies, unless they present an irreconcilable conflict with this
rule. There are no administrative procedures which must be exhausted
prior to any judicial challenge to the provisions of this rule.
List of Subjects in 9 CFR Part 201
Bonding, Dealer, Market Agency, Packer, Registration.
Done at Washington, D.C., on this 1st day of July 1996.
James R. Baker,
Administrator, Grain Inspection, Packers and Stockyards Administration.
For the reasons set forth in the preamble, the Grain Inspection,
Packers and Stockyards Administration will amend 9 CFR part 201 as
follows:
PART 201--[AMENDED]
1. The authority citation for part 201 continues to read as
follows:
Authority: 7 U.S.C. 204, 228: 7 CFR 2.17(e), 2.56.
2. Revise Sec. 201.27(b) to read as follows:
Sec. 201.27 Underwriter: equivalent in lieu of bonds; standard forms.
* * * * *
(b) Any packer, market agency, or dealer required to maintain a
surety bond under these regulations may elect to maintain, in whole or
partial substitution for such surety bond, a bond equivalent, or
combination thereof, must be the total amount of the surety bond
otherwise required under these regulations. Any such bond equivalent
must be in the form of:
(1) A trust fund agreement governing funds actually deposited or
invested in fully negotiable obligations of the United States or
Federally-insured deposits or accounts in the name of and readily
convertible to currency by a trustee as provided in Sec. 201.32, or
(2) A trust agreement governing funds which may be drawn by a
trustee as provided in Sec. 201.32, under one or more irrevocable,
transferrable, standby letters of credit, issued by a Federally-insured
bank or institution and physically received and retained by such
trustee.
* * * * *
3. Revise Sec. 201.34(c) as follows:
Sec. 201.34 Termination of market agency, dealer and packer bonds.
* * * * *
(c) Each trust fund agreement and trust agreement shall contain a
provision requiring that, prior to terminating such agreement, at least
30 days notice in writing shall be given to the Administrator, Grain
Inspection, Packers and Stockyards Administration, U.S. Department of
Agriculture, Washington, D.C. 20250, by the party terminating the
agreement. Such provision shall state that in the event the principal
named therein files an acceptable bond or bond equivalent to replace
the agreement, the 30-day notice requirement may be waived and the
agreement will be terminated as of the effective date of the
replacement bond or bond equivalent.
* * * * *
[FR Doc. 96-17358 Filed 7-9-96; 8:45 am]
BILLING CODE 3410-EN-P
Complete official Federal Register PDF
FR Doc. 96-17323 Approval of State Programs and Delegation of Federal Authorities
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36295-36298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17323]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[AD-FRL-5531-3]
Approval of State Programs and Delegation of Federal Authorities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: This action revises the ``Approval of State Programs and
Delegation of Federal Authorities'' (subpart E). The amendments are
being made to clarify regulatory text, reduce administrative burden and
provide more flexibility to States using this rulemaking. Additionally,
today's action does not have any environmental impact. As a result, the
Agency does not anticipate receiving adverse comments. Consequently,
the amendments are being issued as a direct final rule.
DATES: The direct final rule will be effective August 19, 1996 unless
significant, adverse comments are received by August 9, 1996. If
significant, timely adverse comments are received on the direct final
rule, the direct final rule will be withdrawn.
ADDRESSES: Comments. Comments should be submitted (in duplicate, if
possible) to: Air and Radiation Docket and Information Center (6102),
Attention Docket Number A-96-09, Room M-1500, U.S. EPA, 401 M Street,
SW., Washington, DC 20460. The EPA requests that a separate copy also
be sent to the contact person listed below.
FOR FURTHER INFORMATION CONTACT: Mr. Gilbert Wood at (919) 541-5272 or
Ms. Sheila Q. Milliken at (919) 541-2625, Integrated Implementation
Group, Information Transfer and Program Integration Division (MD-12),
U.S. Environmental Protection Agency, Research Triangle Park, North
Carolina 27711.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities potentially affected by this action are State, local, or
tribal governments that voluntarily implement Clean Air Act (Act)
section 112 rules, emission standards, or requirements. This action
does not regulate emission sources directly. Regulated categories and
entities include:
------------------------------------------------------------------------
Category Examples of regulated entities
------------------------------------------------------------------------
State, local, tribal governments.... State, local, or tribal
governments that voluntarily
request approval of rules or
programs to be implemented in
place of Act section 112 rules,
emission standards or
requirements or voluntarily
request delegation of unchanged
section 112 rules.
------------------------------------------------------------------------
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. The existing procedures
and criteria for requesting and receiving approval of these State,
local, or tribal government rules or programs or voluntarily requesting
delegation of unchanged section 112 rules are in sections 63.90 through
63.95 of this subpart.
On November 26, 1993 (58 FR 62262), the EPA promulgated in the
Federal Register guidance relating to the approval of State programs
and delegation of Federal authorities under the authority of section
112(l) of the Act. Section 112(l)(2) of the Act requires the EPA to
publish guidance useful to States in developing programs for
implementing and enforcing emission standards and other requirements
for hazardous air pollutants (HAP). The use of delegation under section
112(l) is voluntary on the part of the States. The regulations were
promulgated as subpart E in 40 CFR part 63.
Today's action modifies the subpart E final regulation to improve
clarity of administrative procedures and eliminate unnecessary and, in
some cases, impractical requirements imposed on the States. Today's
changes do not significantly modify the requirements of the regulation.
The revisions are discussed in the order in which they appear in the
subpart E regulation. If timely significant adverse comments are
received on any amendment of this direct final rule, that amendment of
the direct final rule will be withdrawn and all such comments will be
addressed in a subsequent final rule based on the proposed rule
contained in the proposed rules section of this Federal Register that
addresses issues in this direct final rule. If no timely significant
adverse comments are received on this direct final rule, then the
direct final rule will become effective August 19, 1996 and no further
action is contemplated on the parallel proposal published today.
Preamble Outline
The following outline is provided to aid in locating information in
this preamble.
I. Description of Changes
A. Approval of State Mechanism to Receive Delegation of Existing
and Future Unchanged Federal Section 112 Standards and Requirements
B. Deletion of 6-month Reporting Requirement
C. Additional Language Regarding Implementation of Chemical
Safety Hazard Investigation Board Requirement
D. Approval of State Rules and Programs Designed to Limit
Potential to Emit (PTE)
II. Unfunded Mandates Reform Act
III. Administrative
A. Paperwork Reduction Act
B. Executive Order 12866 Review
C. Regulatory Flexibility Act
D. Submission to Congress and the General Accounting Office
[[Page 36296]]
I. Description of Changes
A. Approval of State Mechanism to Receive Delegation of Existing and
Future Unchanged Federal Section 112 Standards and Requirements
Section 63.91 of the subpart E rule establishes a process for
straight delegation of individual maximum achievable control technology
(MACT) standards after they are promulgated, but it does not include a
process for approving a program for delegation of all future MACT
standards through a single, advance program approval. State and local
agencies have asked for a more streamlined method for taking delegation
of future and existing unchanged Federal section 112 standards and
requirements.
The EPA agrees with the merit of a program that will allow State
and local agencies to receive upfront approval of the mechanism with
which they would take delegation of existing and future unchanged
Federal section 112 standards. Such a program would eliminate the need
for State and local agencies to submit individual requests for
delegation of unchanged Federal section 112 standards on a rule-by-rule
basis. Regional Offices would benefit by receiving early identification
of States' intentions for receiving delegation. State and local
agencies would have minimal administrative burden in submitting their
requests for approval.
The EPA established policy for such a process for sources subject
to part 70 permitting through a memorandum entitled, ``Straight
Delegations Issues Concerning Sections 111 and 112 Requirements and
Title V,'' dated December 10, 1993, from John Seitz, Director, Office
of Air Quality Planning and Standards, U.S. EPA. A similar program for
sources not subject to part 70 is detailed in the revised enabling
guidance for subpart E (``Interim Enabling Guidance for the
Implementation of 40 CFR part 63, subpart E,'' dated November 1993,
EPA-453/R-93-040). The EPA intends to codify the policy described in
the memorandum and guidance in this direct final rulemaking. Therefore,
EPA is making the necessary revisions to the subpart E rule to include
a process of approving State mechanisms for receiving delegation of
existing and future unchanged Federal section 112 standards and
requirements consistent with its current policy. Submittals previously
approved before today's action will not be affected. Revisions are
being made to sections 63.90 and 63.91 which specifically indicate that
States can request upfront EPA approval of the State's mechanism for
taking delegation of future unchanged Federal section 112 standards and
requirements.
B. Deletion of 6-Month Reporting Requirement
The subpart E rule currently contains a provision which requires 6-
month reporting by sources of all required monitoring or testing for
the State rule which replaces a Federal rule (Sec. 63.93(b)(4)(iv)).
This requirement was originally placed in the subpart E rule to be
consistent with requirements in the part 70 operating permit rule at 40
CFR part 70, Sec. 70.6(a)(3)(iii)(A).
State and local agencies believe that the 6-month reporting
requirement for regulated sources is duplicative of reporting
requirements already included in individual MACT standards and the
title V permit program regulations. They feel that this requirement is
unnecessary and creates paperwork with little or no benefit.
An example of where this requirement could adversely affect a
source is in the case where the MACT rule only requires yearly
reporting. If a State wanted to substitute their rule for the Federal
MACT rule, the source would be required to report every 6 months due to
the existing subpart E requirement. Area sources do not trigger the 6-
month reporting requirement of title V, and thus, should only be
required to report yearly. Nonetheless, subpart E currently mandates 6-
month reporting. Consequently, it imposes, an unnecessary additional
burden on sources in States with delegated air toxics programs.
In this scenario, the EPA feels that there would be no value added
in increasing the reporting requirement to a mandatory minimum of 6-
months because EPA has already determined the frequency of reporting
necessary to assure compliance in each MACT standard or in the General
Provisions. In addition, since section 112(l) is voluntary, the 6-month
reporting provision imposes an increased burden on sources whose States
submit equivalent State rules or programs for EPA approval, and
discourages States from accepting delegation of the Federal rule.
The EPA agrees that this requirement is not necessary as a general
requirement and is revising section 63.93 by deleting
Sec. 63.93(b)(4)(iv).
C. Additional Language Regarding Implementation of Chemical Safety and
Hazard Investigation Board Requirement
Section 112(r)(7)(B)(iii) requires coordination with the Chemical
Safety and Hazard Investigation Board (CSHIB) on accident
investigations. For consistency, the subpart E rule (section 63.95
(b)(4)(i)) reiterates this requirement. State and local agencies
believe this language should be deleted because the CSHIB has not yet
been established. Continued inclusion of this provision imposes a
meaningless requirement. It should be noted, however, that the CSHIB
may be convened at some later date. The EPA agrees that it is
appropriate that the requirement not take effect until the CSHIB is
convened. Consequently, section 63.95(b)(4)(i) is being revised to add
the sentence, ``This requirement will not take effect until the
Chemical Safety and Hazard Investigation Board is convened.''
D. Approval of State Rules and Programs Designed to Limit Potential to
Emit (PTE)
Currently, a number of States are submitting, for EPA approval into
the State Implementation Plan, rules and programs such as prohibitory
rules and federally enforceable State operating permit programs
(FESOP). There are a few hazardous air pollutants (for example
methylene chloride) which are not regulated by the criteria pollutant
program. Accordingly, when a State seeks Federal approval of these
rules and programs, as they relate to such pollutants, the EPA approval
will be given pursuant to section 112(l) of the Act.
The current subpart E rule does not expressly provide for approval
of programs designed to limit sources' potential to emit hazardous air
pollutants. As explained in various recent notices approving PTE
programs for section 112 purposes, EPA believes the authority exists
under section 112(l) of the statute to approve PTE programs.
Promulgation of a rule expressly providing for such approvals is
consistent with this statutory authority. Thus, the EPA is today
revising subpart E to clarify that it may be used to approve State PTE
programs for section 112 purposes, in order to ensure that an
unintended ``gap'' does not exist for pollutants such as methylene
chloride.
The EPA notes that it is currently reexamining its policy on PTE
for the section 112, title V, and new source review programs. One
possible outcome of this reexamination is that PTE limits will no
longer have to be federally enforceable. However, EPA believes that
today's revision to subpart E is neutral with respect to this issue.
The revision to subpart E merely clarifies that the rule may be used as
a pathway for approval of State PTE programs. It does not in and of
itself establish a
[[Page 36297]]
requirement that limits on PTE must be issued pursuant to a program
approved by EPA. In other words, today's revision clarifies that
subpart E may be used to approve a PTE program that a State chooses to
submit, without addressing whether or why a State would make this
choice.
II. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
1 year.
Today's rule contains no Federal mandates (under the regulatory
provisions of title II of the UMRA) for State, local, or tribal
governments or the private sector. The UMRA generally excludes from the
definition of ``Federal intergovernmental mandate'' duties that arise
from participation in a voluntary Federal program. The EPA has also
determined that this rule does not contain a Federal mandate that may
result in expenditures of $100 million or more for State, local, and
tribal governments, in the aggregate, or the private sector in any 1
year. Thus, today's rule is not subject to the requirements of sections
202 and 205 of the UMRA.
III. Administrative
A. Paperwork Reduction Act
The information collection requirements of the previously
promulgated subpart E rulemaking were submitted to and approved by the
Office of Management and Budget (OMB). A copy of this Information
Collection Request (ICR) document (with an OMB approval control number
2060-0264) may be obtained from the Regulatory Information Division
(2136), U.S. Environmental Protection Agency, 401 M Street, SW,
Washington, D.C. 20460, or by calling (202) 260-2740.
Today's changes to the rulemaking may slightly reduce the
information collection burden estimates made previously. Since the
expected reduction will not be significant, the ICR has not been
revised.
B. Executive Order 12866 Review
The subpart E rulemaking, promulgated on November 26, 1993 was
considered a ``significant regulatory action'' under Executive Order
12866 (58 FR 5173, dated October 4, 1993) and submitted to OMB for
review. According to the Executive Order, a ``significant regulatory
action is 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, of 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 of entitlements, grants,
user fees, or loan programs, or the rights and obligations of
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.
Today's action is not considered a ``significant regulatory
action'' within the meaning of this Executive Order. The amendments
issued today clarify the rule and change certain administrative
requirements to increase the flexibility to States in terms of gaining
approval of their respective State programs. Therefore, the EPA
concludes these amendments do not need to undergo OMB review.
C. Regulatory Flexibility Act
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this final rule. This rule will
not increase, and is likely to reduce, regulatory burdens on small
businesses. EPA has determined that this rule will have no adverse
effect on small businesses.
D. Submission to Congress and the General Accounting Office
Under section 801(a)(1)(A) of the Administrative Procedures Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to publication of the rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
List of Subjects in 40 CFR Part 63
Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.
Dated: June 26, 1996.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, title 40, chapter I, of
the Code of Federal Regulations is amended as follows:
PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart E--Approval of State Programs and Delegation of Federal
Authorities
2. Section 63.90 is amended by adding a sentence after the third
sentence and a sentence at the end of the introductory text to read as
follows:
Sec. 63.90 Program overview.
* * * In this process, States may seek approval of a State
mechanism for receiving delegation of existing and future unchanged
Federal section 112 standards. * * * This subpart also establishes
procedures for the approval of State rules or programs to establish
limitations on the potential to emit pollutants listed in or pursuant
to section 112(b) of the Act.
* * * * *
2. Section 63.91 is amended by revising paragraph (a) introductory
text to read as follows:
Sec. 63.91 Criteria common to all approval options.
(a) Approval process. To obtain approval under this subpart of a
rule or program that is different from the Federal rule, the criteria
of this section and the criteria of either Sec. 63.92, Sec. 63.93 or
Sec. 63.94 must be met. For approval of State programs to implement and
enforce Federal section 112 rules as promulgated without changes
(except for accidental release programs), only the criteria of this
section must be met. This includes State requests for upfront approval
of their mechanism for taking delegation of future unchanged Federal
section 112 standards and requirements as well as approval to implement
and enforce unchanged Federal section 112 standards and requirements on
a rule-by rule basis. For approval of State rules or programs to
implement and enforce the Federal accidental release prevention program
as promulgated without
[[Page 36298]]
changes, the requirements of this section and section Sec. 63.95 must
be met. In the case of accidental release prevention programs which
differ from the Federal accidental release prevention program, the
requirements of this section, Sec. 63.95, and either Sec. 63.92 or
Sec. 63.93 must be met. The Administrator may, under the authority of
Section 112(l) and this subpart, also approve a State program designed
to establish limits on the potential to emit of pollutants listed
pursuant to Section 112(b) of the Clean Air Act. For a State's initial
request for approval of any rule or program under this subpart, and
except as otherwise specified under Sec. 63.92, Sec. 63.93, or
Sec. 63.94 for a State's subsequent requests for approval, the approval
process will be the following:
* * * * *
Sec. 63.93 [Amended]
3. Section 63.93 is amended by removing paragraph (b)(4)(iv).
4. Section 63.95 is amended by revising paragraph (b)(4)(i) to read
as follows:
Sec. 63.95 Additional approval criteria for accidental release
prevention programs.
* * * * *
(b) * * *
(4) * * *
(i) The Chemical Safety and Hazard Investigation Board,
particularly during accident investigation. This requirement will not
take effect until the Chemical Safety and Hazard Investigation Board is
convened; and
* * * * *
[FR Doc. 96-17323 Filed 7-9-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-17315 New Animal Drugs for Use in Animal Feeds; Chlortetracycline
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Page 36291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17315]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Chlortetracycline
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Hoffmann-La Roche, Inc. The supplemental
NADA provides for use of a free-choice, mineral, Type C cattle feed
containing chlortetracycline (CTC) for grazing beef cattle weighing
over 700 pounds (lb) for control of active anaplasmosis infections.
EFFECTIVE DATE: July 10, 1996.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0217.
SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland St.,
Nutley, NJ 07110, filed a supplement to NADA 48-761,
Aureomycin (chlortetracycline) mineral, Type C cattle feed
containing 4 grams CTC per lb. The supplement provides for free-choice
feeding to grazing beef cattle weighing over 700 lb at 0.0125 to 0.05
lb of Type C feed per 100 lb of body weight per day (0.5 to 2.0
milligrams (mg) CTC per lb of body weight per day) for control of
active infections of anaplasmosis caused by Anaplasma marginale
susceptible to chlortetracycline. The supplement is approved as of July
10, 1996, and the regulations are amended in 21 CFR 558.128(c)(4) to
reflect the approval. The basis of approval is discussed in the freedom
of information summary.
With approval of this supplement, cattle may be fed 0.5 to 2.0 mg
CTC per head per day. To provide for safe use at the upper limit, a
withdrawal time of 4 days prior to slaughter is provided.
Use of Type A medicated articles to make free-choice CTC Type C
medicated feeds requires an approved Form FDA 1900 as in 21 CFR
510.455.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a
summary of safety and effectiveness data and information submitted to
support approval of this application may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning July 10, 1996,
because the supplemental application contains reports of new clinical
or field investigations (other than bioequivalence or residue studies)
or human food safety studies (other than bioequivalence or residue
studies) essential to the approval and conducted or sponsored by the
applicant. The 3 years of marketing exclusivity applies only to the new
claim for which the supplement was approved.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.128 [Amended]
2. Section 558.128 Chlortetracycline is amended in paragraph (c)(4)
by removing the phrase ``daily minimum intake of 0.5 milligram of
chlortetracycline per pound of body weight to aid in the prevention of
anaplasmosis'' and adding in its place ``daily intake of 0.5 to 2.0
milligrams of chlortetracycline per pound of body weight to aid in the
control of active infection of anaplasmosis caused by Anaplasma
marginale susceptible to chlortetracycline; discontinue use 4 days
prior to slaughter''.
Dated: May 31, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-17315 Filed 7-9-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-17230 Alteration of Jet Routes J-86 and J-92; Correction
[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Page 36286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17230]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 93-AWP-4]
Alteration of Jet Routes J-86 and J-92; Correction
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This action corrects a final rule published in the Federal
Register on June 13, 1996 (Airspace Docket No. 93-AWP-4). In the
airspace designation of Jet Route 86 (J-86), effective August 15, 1996,
erroneously showed ``Miami, FL'' as the ending point for J-86. This
action corrects the definition of J-86 by changing the ending point to
read ``Dolphin, FL.''
EFFECTIVE DATE: 0901 UTC, August 15, 1996.
FOR FURTHER INFORMATION CONTACT: Bill Nelson, Airspace and Rules
Division, ATA-400, Office of Air Traffic Airspace Management, Federal
Aviation Administration, 800 Independence Avenue, SW., Washington, DC
20591; telephone: (202) 267-8783.
SUPPLEMENTARY INFORMATION: Federal Register Document 96-15062, Airspace
Docket No. 93-AWP-4, published on June 13, 1996 (61 FR 29938), extended
J-86 and realigned J-92 to enhance traffic flows and reduce controller
workload. However, in the June 13 publication the description for J-86
erroneously indicated Miami, FL as the ending point for J-86. This
action corrects that error.
Correction of Final Rule
Sec. 71.1 [Corrected]
Accordingly, pursuant to the authority delegated to me, the
airspace designation for J-86, published in the Federal Register on
June 13, 1996 (61 FR 29939); Federal Register Document 96-15062, Column
1) is corrected to read as follows:
* * * * *
J-86 [Revised]
From Beatty, NV; INT Beatty 131 deg. and Boulder City, NV,
284 deg. radials; Boulder City; Peach Springs, AZ; Winslow, AZ; El
Paso, TX; Fort Stockton, TX; Junction, TX; Austin, TX; Humble, TX;
Leeville, LA; INT Leeville 104 deg. and Sarasota, FL, 286 deg.
radials; Sarasota; INT Sarasota 103 deg. and La Belle, FL, 313 deg.
radials; La Belle; to Dolphin, FL.
* * * * *
Issued in Washington, DC, on June 28, 1996.
Nancy B. Kalinowski,
Acting Program Director for Air Traffic Airspace Management.
[FR Doc. 96-17230 Filed 7-9-96; 8:45 am]
BILLING CODE 4910-13-P
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