issue-1996-09-09•Federal Register final rules — 1996-09-09
Federal Register final rules — 1996-09-09
issue-1996-09-09Federal Register final rules — 1996-09-09Regulation
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. 96-22958 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Shrimp Fishery Off the Southern Atlantic States; Amendment 1
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47446-47449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22958]
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 622
[Docket No. 960409106-6207-02; I.D. 031196A]
RIN 0648-AG26
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic;
Shrimp Fishery Off the Southern Atlantic States; Amendment 1
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Final rule.
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SUMMARY: NMFS issues this final rule to implement Amendment 1 to the
Fishery Management Plan for the Shrimp Fishery of the South Atlantic
Region (FMP). This rule prohibits trawling for rock shrimp in an area
off the Florida east coast; requires permits for dealers and vessels in
the rock shrimp fishery off the southern Atlantic states; requires
dealers to report information needed to monitor the fishery; and
requires that the initial sale, trade, barter, or transfer of rock
shrimp harvested from the exclusive economic zone (EEZ) off the
southern Atlantic states occur only between permitted dealers and
permitted vessels. In addition, NMFS informs the public of the approval
by the Office of Management and Budget (OMB) of the collection-of-
information requirements contained in this rule. The intended effect is
to protect critical habitat and conserve and manage the rock shrimp
fishery.
EFFECTIVE DATES: October 9, 1996; except that the amendments to
Secs. 622.4, 622.5, and 622.45 are effective November 1, 1996.
ADDRESSES: Requests for copies of the final regulatory flexibility
analysis (FRFA) should be sent to Peter J. Eldridge, Southeast Regional
Office,
[[Page 47447]]
NMFS, 9721 Executive Center Drive N., St. Petersburg, FL 33702.
Comments regarding the collection-of-information requirements
contained in this rule should be sent to Edward E. Burgess, Southeast
Regional Office, NMFS, 9721 Executive Center Drive N., St. Petersburg,
FL 33702, and to the Office of Information and Regulatory Affairs, OMB,
Washington, DC 20503 (Attention: NOAA Desk Officer).
FOR FURTHER INFORMATION CONTACT: Peter J. Eldridge, 813-570-5305.
SUPPLEMENTARY INFORMATION: The FMP was prepared by the South Atlantic
Fishery Management Council (Council) under the authority of the
Magnuson Fishery Conservation and Management Act (Magnuson Act). The
background and rationale for the measures in Amendment 1, and the
rationale for NMFS's disapproval, based on a preliminary evaluation of
Amendment 1, of a measure that would have required vessel operator
permits, were contained in the preamble to the proposed rule (61 FR
17866, April 23, 1996) and are not repeated here.
Comments and Responses
Comment: One fisherman commented that the area being closed to
trawling is too large. He believes the outer or offshore edge of the
closed area should be moved shoreward from the proposed 100-fathom
(183-m) depth contour to the offshore edge of the Oculina Bank Habitat
Area of Particular Concern (HAPC). He states that this will allow
fishermen to continue their harvest of pink and rock shrimp in this
area. In addition, he recommends delaying implementation of Amendment 1
until after the 1996 rock shrimp season (July through October).
Response: Amendment 1 specifically addresses the need to minimize
impacts of the rock shrimp fishery on essential bottom habitat.
Amendment 1 will extend protection of the valuable Oculina coral
species and its existing habitat to the north and east of the existing
HAPC. Amendment 1 recognizes and analyzes the adverse economic impacts
of displacing fishermen from the area in which trawling would be
prohibited. The Council concluded that the potential long-term economic
benefits of the closed area would outweigh the short-term adverse
effects. NMFS concurs with that conclusion. Thus, NMFS does not support
moving the outer boundary of the proposed no-trawling area shoreward to
the edge of the HAPC. Also, because of documented damage to Oculina
habitat from trawling, to the detriment of the important species
dependent on that habitat, it is not wise or prudent to delay
implementation of approved Amendment 1.
Changes from the Proposed Rule
Since the proposed rule was published, NMFS has consolidated most
of its fishery regulations for the Southeast Region into one set of
regulations at 50 CFR part 622 (published on July 3, 1996, 61 FR
34930). Accordingly, the implementing regulations for Amendment 1 in
this final rule are amendments to part 622 in lieu of amendments to the
south Atlantic shrimp regulations, previously contained in part 659.
Part 622 contains general provisions common to all federally managed
fisheries (e.g., permit application procedures, vessel and gear
identification requirements, and prohibitions). Therefore, such general
provisions that appeared in the proposed rule are not included in this
final rule. Minor changes in language have been made to conform to the
standards in part 622. The proposed rule would have required the owner
or operator of a permitted vessel or a permitted dealer to notify the
Director, Southeast Region, NMFS (RD) within 15 days after any change
in the information previously submitted on the permit application. To
conform with the standard in other fisheries permitted by the RD, as it
exists in part 622, the time frame for that notification is changed to
30 days.
Effective Dates
To allow time to publicize the requirements for vessel and dealer
permits, distribute applications for such permits, receive and process
applications, and issue permits, NMFS makes the provisions of this
final rule that require permits, or that are dependent on the
possession of a permit, effective November 1, 1996.
Classification
The RD determined that Amendment 1 is necessary for the
conservation and management of the shrimp fishery off the southern
Atlantic states and that it is consistent with the Magnuson Act and
other applicable law, with the exception of the measure that was
previously disapproved. See the proposed rule for a discussion of the
disapproved measure.
This action has been determined to be not significant for purposes
of E.O. 12866.
NMFS prepared a final regulatory flexibility analysis (FRFA) that
indicates this final rule is necessary to minimize the impacts of rock
shrimp trawling on important coral and coral reef resources and on
live- and hard-bottom habitats within and adjacent to the HAPC off the
east coast of Florida. Minimizing habitat damage will enhance survival
of juvenile rock shrimp and snapper-grouper species dependent upon this
habitat. Also this rule will allow NMFS to collect fishery and
biological information necessary to improve the management program and
to ensure attainment of optimum yield over the long-term. The one
public comment received on the proposed rule indicated that the area
closed to shrimp trawling is too large and should be reduced to
minimize lost pink and rock shrimp harvest. The Council had already
assessed this option in the initial regulatory flexibility analysis
(IRFA) and related analyses of management options supporting its
preferred measures in Amendment 1; it concluded that a smaller closed
area would not offer sufficient habitat protection (see comments and
responses above). Accordingly, this comment did not result in changes
to the conclusions of the IRFA.
The FRFA indicates that this rule will result in significant
economic impacts on between 65 and 108 vessels and 12 dealers; all of
these vessels and dealers are considered small entities for purposes of
the Regulatory Flexibility Act. The magnitude of the impacts per small
entity were difficult to quantify because rock shrimp landings vary
considerably from year to year and rock shrimp exhibit considerable
geographic movement and could move from areas closed to trawling to
open areas and, thus, be harvested. The principal adverse impacts will
result from prohibiting shrimp trawling in the closed area. Assuming
that the affected vessels cannot redirect their fishing effort to other
areas, and assuming continuation of recent harvest rates, affected
vessels may lose approximately $41,000 each the first year. It is
likely, however, that most vessels will be able to shift their effort
to other areas or to other fisheries and these losses are not projected
for the long-term. The extent to which vessels are able to shift to
open areas or to other fisheries will determine how well they can
minimize reduced rock shrimp catches and revenues; this extent cannot
be estimated at this time. It is possible that some vessels may not
demonstrate reduced net revenues if, by switching to other fishing
areas, they can harvest larger sized shrimp that bring a significantly
higher price per pound.
This final rule contains new collection-of-information requirements
including: Vessel permit applications; dealer permit applications;
dealer
[[Page 47448]]
reports regarding rock shrimp receipts; and vessel identification
requirements. These requirements will affect vessel owners or operators
who choose to participate in the rock shrimp fishery and dealers who
intend to purchase rock shrimp from permitted vessels. The professional
skills necessary for complying with these information collection
requirements are the same as required by the vessel owners/operators
and dealers permitted in other federally managed fisheries of the south
Atlantic area; these skills include the ability to understand, fill
out, and submit to NMFS necessary application forms for vessel or
dealer permits and for reporting landings and ex-vessel prices.
In trying to minimize significant economic impacts on small
entities, the Council and NMFS considered numerous management
alternatives in selecting the preferred management measures regarding
addition of rock shrimp to the FMP management unit, habitat and shrimp
resource protection, and permitting and reporting requirements. In
general, some of the management options considered and rejected would
have had less of a short-term impact on rock shrimp fishermen but the
long-term damage to essential habitat and resource productivity would
have been greater. Regarding the management unit measure, the FRFA
indicates that a management unit with a smaller geographic range would
not provide management authority for future, timely regulatory actions
necessary to protect shrimp and habitat resources beyond the Oculina
HAPC. Regarding the extent of the area closed to shrimp trawling, the
area chosen was proposed by the industry as representing an acceptable
balance between protecting critical shrimp and habitat resources and
minimizing adverse, regulatory impacts. Rock shrimp fishing in the area
to be closed has occurred only in recent years and the catch has
consisted mainly of very small rock shrimp, which are intercepted
before they reach traditional fishing grounds. The trawling closure
area may result in higher fishery yields and revenues over the long-
term, in part because small shrimp, otherwise harvested, will be
allowed to reach a larger size and command a higher market price per
pound. Regarding permitting and reporting and recordkeeping
requirements, the Council deliberately chose an approach that would
minimize burdens on reporting entities while still providing the
information on actual landings and harvest locations necessary for
management. While permits are required for vessels and dealers, only
the dealers are required to submit reports on landings. The Council
decided that this approach would minimize burdens on the individual
fisherman (e.g., no mandatory log book system required). Also, the
Council encouraged NMFS to use information from state fisheries
agencies, particularly from Florida where most landings occur, to
minimize additional reporting burdens on dealers. Refer to the FRFA for
further details (see ADDRESSES). Notwithstanding any other provision of
law, no person is required to respond to nor shall a person be subject
to a penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act (PRA) unless
that collection of information displays a currently valid OMB control
number.
This rule contains new collection-of-information requirements
subject to the PRA for vessels and dealers in the rock shrimp fishery--
namely, vessel permit applications, dealer permit applications, dealer
reports regarding rock shrimp receipts, and vessel identification
requirements. The existing vessel identification requirements contained
in 50 CFR 622.6(a)(1)(i) and (a)(2) are made applicable to a vessel in
the rock shrimp fishery by requiring such vessel to obtain a permit--
each vessel for which a permit has been issued under 50 CFR 622.4 is
required to comply with those requirements. These collections of
information have been approved by OMB under OMB control numbers 0648-
0205, 0648-0205, 0648-0013, and 0648-0306, respectively. The public
reporting burdens for these collections are estimated to average 20, 5,
15, and 45 minutes per response, respectively, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collections of information. Send comments regarding any of these
reporting burden estimates, or any other aspect of the collections of
information, including suggestions for reducing the burdens, to NMFS
and OMB (see ADDRESSES).
List of Subjects in 50 CFR Part 622
Fisheries, Fishing, Puerto Rico, Reporting and recordkeeping
requirements, Virgin Islands.
Dated: September 3, 1996.
N. Foster,
Deputy Assistant Administrator for Fisheries, National Marine Fisheries
Service.
For the reasons set out in the preamble, 50 CFR Part 622 is amended
as follows:
PART 622--FISHERIES OF THE CARIBBEAN, GULF AND SOUTH ATLANTIC
1. The authority citation for part 622 continues to read as
follows:
Authority: 16 U.S.C. 1801 et seq.
2. In Sec. 622.2, the definition of ``Dealer'' is added, in
alphabetical order, to read as follows:
Sec. 622.2 Definitions and acronyms.
* * * * *
Dealer, in addition to the definition specified in Sec. 600.15 of
this chapter, means the person who first receives rock shrimp harvested
from the EEZ upon transfer ashore.
* * * * *
3. In Sec. 622.4, effective November 1, 1996, paragraph
(a)(2)(viii) is added and the first sentence of paragraph (a)(4) is
revised to read as follows:
Sec. 622.4 Permits and fees.
(a) * * *
(2) * * *
(viii) South Atlantic rock shrimp. For a person aboard a vessel to
fish for rock shrimp in the South Atlantic EEZ or possess rock shrimp
in or from the South Atlantic EEZ, a commercial vessel permit for rock
shrimp must be issued to the vessel and must be on board.
* * * * *
(4) * * * For a dealer to receive Gulf reef fish, golden crab
harvested from the South Atlantic EEZ, South Atlantic snapper-grouper,
rock shrimp harvested from the South Atlantic EEZ, or wreckfish, a
dealer permit for Gulf reef fish, golden crab, South Atlantic snapper-
grouper, rock shrimp, or wreckfish, respectively, must be issued to the
dealer. * * *
* * * * *
4. In Sec. 622.5, effective November 1, 1996, paragraph (c)(7) is
added to read as follows:
Sec. 622.5 Recordkeeping and reporting.
(c) * * *
(7) South Atlantic rock shrimp. (i) A dealer who has been issued a
permit for rock shrimp, as required under Sec. 622.4(a)(4), and who is
selected by the SRD must provide information on receipts of rock shrimp
and prices paid on forms available from the SRD. The required
information must be submitted to the SRD at monthly intervals
postmarked not later than 5 days after the end of each month. Reporting
frequencies and reporting deadlines may be modified upon notification
by the SRD.
(ii) On demand, a dealer who has been issued a dealer permit for
rock
[[Page 47449]]
shrimp, as required under Sec. 622.4(a)(4), must make available to an
authorized officer all records of offloadings, purchases, or sales of
rock shrimp.
* * * * *
5. In Sec. 622.35, paragraph (g) is added to read as follows:
Sec. 622.35 South Atlantic EEZ seasonal and/or area closures.
* * * * *
(g) Rock shrimp closed area. No person may trawl for rock shrimp in
the area east of 80 deg.00' W. long. between 27 deg.30' N. lat. and
28 deg.30' N. lat. shoreward of the 100-fathom (183-m) contour, as
shown on the latest edition of NOAA chart 11460; and no person may
possess rock shrimp in or from this area on board a fishing vessel.
6. In Sec. 622.45, effective November 1, 1996, paragraph (g) is
added to read as follows:
Sec. 622.45 Restrictions on sale/purchase.
* * * * *
(g) South Atlantic rock shrimp. (1) Rock shrimp harvested in the
South Atlantic EEZ on board a vessel that does not have a valid
commercial permit for rock shrimp, as required under
Sec. 622.4(a)(2)(viii), may not be transferred, received, sold, or
purchased.
(2) Rock shrimp harvested on board a vessel that has a valid
commercial permit for rock shrimp may be transferred or sold only to a
dealer who has a valid permit for rock shrimp, as required under
Sec. 622.4(a)(4).
(3) Rock shrimp harvested in the South Atlantic EEZ may be received
or purchased by a dealer who has a valid permit for rock shrimp, as
required under Sec. 622.4(a)(4), only from a vessel that has a valid
commercial permit for rock shrimp.
[FR Doc. 96-22958 Filed 9-6-96; 8:45 am]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-22945 Revision of Class E Airspace; Delta County Airport Escanaba, MI
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47411-47412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22945]
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DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 96-AGL-3]
Revision of Class E Airspace; Delta County Airport Escanaba, MI
AGENCY: Federal Aviation Administration (FAA) DOT.
ACTION: Final rule.
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SUMMARY: This action revises Class E airspace to accommodate the
addition of an Automatic Weather Observation System (AWOS-3) at Delta
County Airport, Escanaba, MI, to operate turbo-jet charter service on a
24 hour basis. 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, December 5, 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 29, 1996, the FAA proposed to amend part 71 of the Federal
Aviation Regulations (14 CFR part 71) to revise Class E airspace at
Delta County Airport, Escanaba, MI (61 FR 26856). 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 surface area are published in paragraph 6002 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 to accommodate the addition of an
Automatic Weather Observation System (AWOS-3) at Delta County Airport,
Escanaba, MI. 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 regulation for which frequent and routine
amendments are necessary to keep them operationally current. Therefore,
this regulation--(1)
[[Page 47412]]
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 incorporated 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 6002 The Class E airspace areas designated as a surface
area for an airport.
* * * * *
AGL MI E2 Escanaba, MI [Revised]
Escanaba, Delta County Airport, MI
(Lat. 45 deg.43'18''N., long. 87 deg.05'40''W.)
Escanaba VORTAC
(Lat. 45 deg.43'21''N., long. 87 deg.05'23''W.)
Within a 4.2-mile radius of the Escanaba VORTAC, and within 2.6
miles each side of the Escanaba VORTAC 007 radial, extending from
the 4.2-mile radius to 7.4 miles northeast, and within 2.6 miles
each side of the Escanaba VORTAC 101 radial, extending from the 4.2-
mile radius to 7.4 miles east, and within 2.6 miles each side of the
Escanaba VORTAC 266 radial extending from the 4.2-mile radius to 7
miles west of the VORTAC.
* * * * *
Issued in Des Plaines, Illinois on August 26, 1996.
Peter H. Salmon,
Acting Manager, Air Traffic Division.
[FR Doc. 96-22945 Filed 9-6-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-22939 Form BD Amendments
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47412-47413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22939]
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SECURITIES AND EXCHANGE COMMISSION
17 CFR Part 249
[Release No. 34-37632; File No. S7-2-95]
RIN 3235-AG25
Form BD Amendments
AGENCY: Securities and Exchange Commission.
ACTION: Final rule: Suspension of compliance date for Form BD
amendments.
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SUMMARY: The Securities and Exchange Commission is suspending the
compliance date for recent amendments to Form BD, the uniform broker-
dealer registration form under the Securities Exchange Act of 1934, as
it applies to filings made by all registered broker-dealers and broker-
dealer applicants.
EFFECTIVE DATE: The effective date for amendments to Form BD adopted by
the Securities and Exchange Commission on July 12, 1996 and published
on July 18,
[[Page 47413]]
1996 (61 FR 37357) remains August 19, 1996. Effective September 9,
1996, the compliance date with respect to these amendments to Form BD
is suspended. The Commission will publish in the Federal Register a
document notifying the public of a new compliance date.
FOR FURTHER INFORMATION CONTACT: Glenn J. Jessee, Special Counsel,
(202) 942-0073, Office of Chief Counsel, Division of Market Regulation,
Securities and Exchange Commission, 450 Fifth Street, N.W., Mail Stop
5-10, Washington, D.C. 20549.
SUPPLEMENTARY INFORMATION: On July 12, 1996, the Securities and
Exchange Commission (``Commission'') adopted amendments to Form
BD,1 the uniform application form for broker-dealer registration
under the Securities Exchange Act of 1934.2 As discussed in the
Adopting Release, the use of Form BD, as amended on July 12, 1996, is
intended to coincide with the implementation of the redesigned Central
Registration Depository (``CRD''), a computer system operated by the
National Association of Securities Dealers, Inc. (``NASD'') that
maintains registration information regarding broker-dealers and their
registered personnel. Among other things, the redesigned CRD system
will allow broker-dealers to file Form BD electronically.
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\1\ 17 CFR 240.15b1-1; 17 CFR 249.501.
\2\ Securities Exchange Act Release No. 37431 (Jul. 12, 1996),
61 FR 37357 (Jul. 18, 1996) (``Adopting Release'').
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The implementation of the redesigned CRD is being accomplished in
phases. On May 20, 1996, the NASD began a two-month test of the system
with the voluntary participation of several NASD member firms and one
service bureau. Following completion of the test, it was expected that
on July 29, 1996, broker-dealers participating in the test would begin
filing all of their registration and licensing information
electronically with the redesigned CRD on a pilot basis. Then, on
September 9, 1996, it was expected that the NASD would begin Phase I of
the implementation of the redesigned CRD system, at which time
registered broker-dealers and broker-dealer applicants would be
required to begin using Form BD, as amended on July 12, 1996. The test
of the redesigned CRD system that began on May 20, however, revealed
that additional changes are needed in the software that will be used by
broker-dealers to make electronic filings and that broker-dealers need
more time to prepare their internal operations and infrastructure to
support electronic filing. As a result, the NASD has determined to
delay further implementation of the redesigned CRD system until early
in 1997.
Because of this delay, the Commission is suspending the compliance
date for Form BD, as amended on July 12, 1996, for all registered
broker-dealers and broker-dealer applicants. Accordingly, broker-
dealers and broker-dealer applicants should continue to use Form BD, as
revised November 16, 1992. At such time as another date for the start
of Phase I is determined, the Commission expects that it will set
appropriate compliance dates for the amendments to Form BD and publish
a document in the Federal Register notifying the public of such
compliance dates.
Dated: September 4, 1996.
By the Commission.
Jonathan G. Katz,
Secretary.
[FR Doc. 96-22939 Filed 9-6-96; 8:45 am]
BILLING CODE 8010-01-P
Complete official Federal Register PDF
FR Doc. 96-22916 Rail General Exemption AuthorityExemption of Ferrous Recyclables
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Page 47446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22916]
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DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
49 CFR Part 1039
[Ex Parte No. 346 (Sub-No. 35)]
Rail General Exemption Authority--Exemption of Ferrous
Recyclables
AGENCY: Surface Transportation Board.
ACTION: Final rule.
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SUMMARY: Pursuant to its authority under 49 U.S.C. 10502, the Surface
Transportation Board is exempting from regulation the transportation by
rail of blast furnace, open hearth, rolling mill or coke oven products,
NEC (STCC Commodity Group No. 33-119). This commodity group is added to
the list of exempt commodities, as set forth below, and is intended to
eliminate unnecessary regulation.
EFFECTIVE DATE: October 9, 1996.
FOR FURTHER INFORMATION CONTACT: Beryl Gordon, (202) 927-5660. [TDD for
the hearing impaired: (202) 927-5721.]
SUPPLEMENTARY INFORMATION: Since the Interstate Commerce Commission's
1 decision of May 16, 1995 (60 FR 26839, May 19, 1995), in this
proceeding, which refrained from exempting commodities in STCC
Commodity Group No. 33-119 because it included certain recyclable
materials deemed to be nonferrous, Congress has passed the ICCTA. The
ICCTA repealed the special statutory protections for transportation of
nonferrous recyclable commodities. As a consequence, because regulation
of the rail transportation of commodities in STCC Commodity Group No.
33-119 is not necessary, rather than distinguishing between ferrous and
nonferrous commodities within the commodity group, we will exempt the
entire five-digit commodity group.
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\1\ The ICC Termination Act of 1995, Pub. L. No. 104-88, 109
Stat. 803 (ICCTA), which was enacted on December 29, 1995, and took
effect on January 1, 1996, abolished the Interstate Commerce
Commission (ICC) and transferred certain functions to the Surface
Transportation Board (Board). This decision relates to a proceeding
that was pending with the ICC prior to January 1, 1996, and to
functions that are subject to Board jurisdiction pursuant to 49
U.S.C. 10701 et seq. Citations are to the current sections of the
statute.
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Regulatory Flexibility Act
The Board certifies that this exemption will not have a significant
economic impact on a substantial number of small entities within the
meaning of the Regulatory Flexibility Act. This exemption will reduce
regulation; it imposes no new reporting or other requirements directly
or indirectly on small entities.
Environment and Energy
This action will not significantly affect either the quality of the
human environment or the conservation of energy resources.
List of Subjects in 49 CFR Part 1039
Intramodal transportation, Manufactured commodities, Railroads.
Decided: August 27, 1996.
By the Board, Chairman Morgan, Vice Chairman Simmons, and
Commissioner Owen.
Vernon A. Williams,
Secretary.
For the reasons set forth in the preamble, title 49, chapter X,
part 1039 of the Code of Federal Regulations is amended as follows:
PART 1039--EXEMPTIONS
1. The authority citation for part 1039 is revised to read as
follows:
Authority: 5 U.S.C. 553; 49 U.S.C. 10502 and 13301.
2. Section 1039.11, paragraph (a), is amended by adding the
following new entry to the end of table:
Sec. 1039.11 Miscellaneous commodities exemptions.
(a) * * *
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STCC No. STCC tariff Commodity
------------------------------------------------------------------------
* * * * *
33 119 6001-X, eff. 1-11-96 Blast furnace, open
hearth, rolling mill or
coke oven products, NEC.
------------------------------------------------------------------------
* * * * *
[FR Doc. 96-22916 Filed 9-6-96; 8:45 am]
BILLING CODE 4915-00-P
Complete official Federal Register PDF
FR Doc. 96-22851 Radio Broadcasting Services; Canton, MO and Canton, IL
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Page 47436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22851]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 96-32; RM-8719]
Radio Broadcasting Services; Canton, MO and Canton, IL
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document substitutes Channel 265C2 for Channel 265C3 at
Canton, Missouri, and modifies the license for Station KRRY to specify
operation on Channel 265C2, in response to a proposal filed by Bick
Broadcasting Co. See 61 FR 10300, March 13, 1996. The coordinates for
Channel 265C2 at Canton, Missouri, are 40-07-33 and 91-31-42. To
accommodate the upgrade at Canton, Missouri, we shall substitute
Channel 266A for Channel 265A at Canton, Illinois, and provide cut-off
protection to the applicant for Channel 266A (BPH-951011MA). The
coordinates for Channel 266A at Canton, Illinois, are 40-36-49 and 89-
56-22. With this action this proceeding is terminated.
EFFECTIVE DATE: October 7, 1996.
FOR FURTHER INFORMATION CONTACT: Kathleen Scheuerle, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report
and Order, MM Docket No. 96-32, adopted August 16, 1996, and released
August 23, 1996. The full text of this Commission decision is available
for inspection and copying during normal business hours in the
Commission's Reference Center (Room 239), 1919 M Street, NW.,
Washington, DC. The complete text of this decision may also be
purchased from the Commission's copy contractors, International
Transcription Services, Inc., 2100 M Street, NW., Suite 140,
Washington, DC 20037, (202) 857-3800.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Part 73 of title 47 of the Code of Federal Regulations is amended
as follows:
PART 73--[AMENDED]
1. The authority citation for part 73 continues to read as follows:
Authority: Secs. 303, 48 Stat., as amended, 1082; 47 U.S.C. 154,
as amended.
Sec. 73.202 [Amended]
2. Section 73.202(b), the Table of FM Allotments under Missouri, is
amended by removing Channel 265C3 and adding Channel 265C2 at Canton.
3. Section 73.202(b), the Table of FM Allotments under Illinois is
amended by removing Channel 265A and adding Channel 266A at Canton.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-22851 Filed 9-6-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-22850 Radio Broadcasting Services; Chama, NM
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Page 47436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22850]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 95-166; RM-8717]
Radio Broadcasting Services; Chama, NM
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Commission, at the request of KNXX, Inc., allots Channel
255A to Chama, New Mexico, as the community's first local aural
service. See 60 FR 56553, November 9, 1995. Channel 255A can be
allotted to Chama in compliance with the Commission's minimum distance
separation requirements without the imposition of a site restriction,
at coordinates 36-54-12 North Latitude and 106-34-42 West Longitude.
With this action, this proceeding is terminated.
DATES: Effective October 15, 1996. The window period for filing
applications will open on October 15, 1996, and close on November 5,
1996.
FOR FURTHER INFORMATION CONTACT: Leslie K. Shapiro, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Report and Order, MM Docket No. 95-166, adopted August 23, 1996, and
released August 30, 1996. The full text of this Commission decision is
available for inspection and copying during normal business hours in
the FCC Reference Center (Room 239), 1919 M Street, NW., Washington,
DC. The complete text of this decision may also be purchased from the
Commission's copy contractor, International Transcription Service,
Inc., (202) 857-3800, 2100 M Street, NW., Suite 140, Washington, DC
20037.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Part 73 of title 47 of the Code of Federal Regulations is amended
as follows:
PART 73--[AMENDED]
1. The authority citation for part 73 continues to read as follows:
Authority: Secs. 303, 48 Stat., as amended, 1082; 47 U.S.C. 154,
as amended.
Sec. 73.202 [Amended]
2. Section 73.202(b), the Table of FM Allotments under New Mexico,
is amended by adding Chama, Channel 255A.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-22850 Filed 9-6-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-22847 Radio Broadcasting Services; Hayden and Meeker, CO
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47435-47436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22847]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 95-106; RM-8655, RM-8698]
Radio Broadcasting Services; Hayden and Meeker, CO
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document allots Channel 297A to Hayden, Colorado, as that
community's second local FM transmission service, in response to a
petition for rule making filed on behalf of Thomas Broadcasting. See 60
FR 36772, July 18, 1995. Additionally, Channel 251C is allotted to
Meeker, Colorado, in response to a counterproposal filed on behalf of
1530, LLC (RM-8698). Coordinates used for Channel 297A at Hayden,
Colorado, are 40-29-42 and 107-15-30. Coordinates used for Channel 251C
at Meeker, Colorado, are 40-02-24 and 107-55-00. With this action, the
proceeding is terminated.
DATES: Effective October 15, 1996. The window period for filing
applications will open on October 15, 1996, and close on November 15,
1996.
FOR FURTHER INFORMATION CONTACT: Nancy Joyner, Mass Media Bureau, (202)
418-2180. Questions related to the window application filing process
for Channel 297A at Hayden, Colorado, and for Channel 251C at Meeker,
Colorado, should be addressed to the Audio Services Division, FM
Branch, (202) 418-2700.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Report and Order, MM Docket No. 95-106, adopted August 23, 1996, and
released August 30, 1996. The full text of this Commission decision is
available for inspection and copying during normal business hours in
the FCC's Reference Center (Room 239), 1919 M Street, NW., Washington,
DC. The complete text of this decision may also be purchased from the
Commission's copy
[[Page 47436]]
contractors, International Transcription Service, Inc., (202) 857-3800,
located at 1919 M Street, NW., Room 246, or 2100 M Street, NW., Suite
140, Washington, DC 20037.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Part 73 of title 47 of the Code of Federal Regulations is amended
as follows:
PART 73--[AMENDED]
1. The authority citation for part 73 continues to read as follows:
Authority: Secs. 303, 48 Stat., as amended, 1082; 47 U.S.C. 154,
as amended.
Sec. 73.202 [Amended]
2. Section 73.202(b), the Table of FM Allotments under Colorado, is
amended by adding Channel 297A at Hayden.
3. Section 73.202(b), the Table of FM Allotments under Colorado, is
amended by adding Meeker, Channel 251C.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-22847 Filed 9-6-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-22846 Radio Broadcasting Services; Lakeview, AR
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Page 47435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22846]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 95-96; RM-8645]
Radio Broadcasting Services; Lakeview, AR
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document allots FM Channel 228C3 to Lakeview, Arkansas,
as that community's first local aural transmission service, in response
to a petition for rule making filed by Dale Hendrix. See 60 FR 35372,
July 7, 1995. With this action, the proceeding is terminated.
DATES: Effective October 7, 1996. The window period for filing
applications will open on October 7, 1996, and close on November 7,
1996.
FOR FURTHER INFORMATION CONTACT: Nancy Joyner, Mass Media Bureau, (202)
418-2180. Questions related to the window application filing process
for Channel 228C3 at Lakeview, Arkansas, should be addressed to the
Audio Services Division, (202) 418-2700.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Report and Order, MM Docket No. 95-96, adopted August 16, 1996, and
released August 23, 1996. The full text of this Commission decision is
available for inspection and copying during normal business hours in
the FCC's Reference Center (Room 239), 1919 M Street, NW., Washington,
DC. The complete text of this decision may also be purchased from the
Commission's copy contractors, International Transcription Service,
Inc., (202) 857-3800, located at 1919 M Street, NW., Room 246, or 2100
M Street, NW., Suite 140, Washington, DC 20037.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Part 73 of title 47 of the Code of Federal Regulations is amended
as follows:
PART 73--[AMENDED]
1. The authority citation for part 73 continues to read as follows:
Authority: Secs. 303, 48 Stat., as amended, 1082; 47 U.S.C. 154,
as amended.
Sec. 73.202 [Amended]
2. Section 73.202(b), the Table of FM Allotments under Arkansas, is
amended by adding Lakeview, Channel 228C3.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-22846 Filed 9-6-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-22845 Radio Broadcasting Services; Leavenworth, Othello, and East Wenatchee, WA
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47434-47435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22845]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 95-14; RM-8552]
Radio Broadcasting Services; Leavenworth, Othello, and East
Wenatchee, WA
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Commission, at the request of Ronald A. Murray, d/b/a
Murray Broadcasting, substitutes Channel 266A for Channel 249A at
Leavenworth, Washington, and modifies Station KLVH(FM)'s construction
permit accordingly. To accommodate the substitution, we also downgrade
Channel 248C1 to Channel 248C3 at Othello, Washington, and modify
Station KZLN-FM's construction permit accordingly; and substitute
Channel 249A for Channel 266A at East Wenatchee, Washington, and modify
Station KYSN(FM)'s license accordingly. See 60 FR 6689, February 3,
1995. Channel 266A can be allotted at Leavenworth in compliance with
the Commission's minimum distance
[[Page 47435]]
separation requirements without the imposition of a site restriction at
petitioner's authorized site. The coordinates for Channel 266A at
Leavenworth are North Latitude 47-35-32 and West Longitude 120-38-35.
Channel 248C3 can be allotted to Othello without the imposition of a
site restriction at Station KZLN-FM's authorized site. The coordinates
for Channel 248C3 at Othello are North Latitude 46-45-55 and West
Longitude 119-16-49. See Supplementary Information, infra.
EFFECTIVE DATE: October 15, 1996.
FOR FURTHER INFORMATION CONTACT: Sharon P. McDonald, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Report and Order, MM Docket No. 95-14 adopted August 23, 1996, and
released August 30, 1996. The full text of this Commission decision is
available for inspection and copying during normal business hours in
the FCC Reference Center (Room 239), 1919 M Street, NW., Washington,
DC. The complete text of this decision may also be purchased from the
Commission's copy contractors, International Transcription Service,
Inc., (202) 857-3800, 2100 M Street, NW., Suite 140, Washington, DC
20037.
Channel 249A can be allotted to East Wenatchee without the
imposition of a site restriction at Station KYSN(FM)'s authorized site.
The coordinates for Channel 249A at East Wenatchee are North Latitude
47-22-52 and West Longitude 120-17-16. Since Leavenworth, Othello, and
East Wenatchee are located within 320 kilometers (200 miles) of the
U.S.-Canadian border, concurrence of the Canadian government has been
obtained. With this action, this proceeding is terminated.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Part 73 of title 47 of the Code of Federal Regulations is amended
as follows:
PART 73--[AMENDED]
1. The authority citation for Part 73 continues to read as follows:
Authority: Sections 303, 48 Stat., as amended, 1082; 47 U.S.C.
154, as amended.
Sec. 73.202 [Amended]
2. Section 73.202(b), the Table of FM Allotments under Washington,
is amended by removing Channel 249A and adding Channel 266A at
Leavenworth; removing Channel 248C1 and adding Channel 248C3 at
Othello; and by removing Channel 266A and adding Channel 249A at East
Wenatchee.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-22845 Filed 9-6-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-22843 Radio Broadcasting Services; Oxford, MS
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47436-47437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22843]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 96-93; RM-8788]
Radio Broadcasting Services; Oxford, MS
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Commission, at the request of Angel Broadcasting, allots
Channel 286A to Oxford, Mississippi, as the community's fourth local FM
service. See 61 FR 20207, May 6, 1996. Channel 286A can be allotted to
Oxford in compliance with the Commission's minimum distance separation
requirements with a site restriction of
[[Page 47437]]
11.2 kilometers (6.9 miles) north in order to avoid short-spacing
conflicts with the licensed site of Station WBKJ(FM), Channel 286C1,
Kosciusko, Mississippi, and with a construction permit for Station
WLPX(FM)[formerly WYCG(FM)], Channel 288A, Water Valley, Mississippi.
The coordinates for Channel 286A are at Oxford 34-28-06 and 89-30-33.
With this action, this proceeding is terminated.
DATES: Effective October 7, 1996. The window period for filing
applications will open on October 7, 1996, and close on November 7,
1996.
FOR FURTHER INFORMATION CONTACT: Pam Blumenthal, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Report and Order, MM Docket No. 96-93, adopted August 16, 1996, and
released August 23, 1996. The full text of this Commission decision is
available for inspection and copying during normal business hours in
the FCC Reference Center (Room 239), 1919 M Street, NW., Washington,
DC. The complete text of this decision may also be purchased from the
Commission's copy contractor, ITS, Inc., (202) 857-3800, 2100 M Street,
NW., Suite 140, Washington, DC 20037.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Part 73 of title 47 of the Code of Federal Regulations is amended
as follows:
PART 73--[AMENDED]
1. The authority citation for part 73 continues to read as follows:
Authority: Secs. 303, 48 Stat., as amended, 1082; 47 U.S.C. 154,
as amended.
Sec. 73.202 [Amended]
2. Section 73.202(b), the Table of FM Allotments under Mississippi,
is amended by adding Channel 286A at Oxford.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-22843 Filed 9-6-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-22815 Department Hearings and Appeals Procedures
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Page 47434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22815]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
Office of Hearings and Appeals
43 CFR Part 4
Department Hearings and Appeals Procedures
AGENCY: Office of Hearings and Appeals, Interior.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document eliminates redundant words in 43 CFR 4.1(a)
addressing authority of Administrative Law Judges to hold hearings
within the Department of the Interior.
EFFECTIVE DATE: September 9, 1996.
FOR FURTHER INFORMATION CONTACT:
James P. Terry, Deputy Director, Office of Hearings and Appeals, U.S.
Department of the Interior, 4015 Wilson Blvd., Arlington, VA 22203
Telephone: (703) 235-3810.
SUPPLEMENTARY INFORMATION: Because this action reflects agency
management in deleting non-substantive, redundant language relating to
scope of actions for which Administrative Law Judges within the
Department of the Interior have existing hearing responsibility, the
Department has determined that the provisions of the Administrative
Procedures Act, 5 U.S.C. 553 (b) and (d), allowing for public notice
and comment and a 30-day delay in the effective date of a rule, are
unnecessary and impracticable.
List of Subjects in 43 CFR Part 4
Administrative practice and procedure, Scope of authority,
Applicable regulations.
Therefore, under the authority of the Secretary of the Interior
contained in 5 U.S.C. 301, section 4.1(a) in Subpart A in Part 4 of
Title 43 of the Code of Federal Regulations, is amended as follows:
PART 4--[AMENDED]
Subpart A--General; Office of Hearings and Appeals
1. The authority citation for Part 4 continues to read:
Authority: R.S. 2478, as amended, 43 U.S.C. 1201, unless
otherwise noted.
2. Section 4.1(a) is revised to read as follows:
Sec. 4.1 [AMENDED]
* * * * *
(a) A Hearings Division comprised of administrative law judges who
are authorized to conduct hearings in cases required by law to be
conducted pursuant to 5 U.S.C. 554, and hearings in other cases arising
under statutes and regulations of the Department, including rule making
hearings, and
* * * * *
Dated: August 28, 1996.
Bonnie R. Cohen,
Assistant Secretary--Policy, Management and Budget.
[FR Doc. 96-22815 Filed 9-6-96; 8:45 am]
BILLING CODE 4310-79-M
Complete official Federal Register PDF
FR Doc. 96-22761 Consumer Information Regulations: Uniform Tire Quality Grading Standards
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47437-47446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22761]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
49 CFR Part 575
[Docket No. 94-30, Notice 06]
RIN 2127-AF17
Consumer Information Regulations: Uniform Tire Quality Grading
Standards
AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule amends the Uniform Tire Quality Grading
Standards to: Revise treadwear testing procedures to maintain the base
course wear rate of course monitoring tires at its current value of
1.34. This revision is expected to eliminate treadwear grade inflation,
reduce testing expenses, and reduce the environmental consequences of
operating test convoys for the purpose of calculating the base course
wear rate for each new batch of course monitoring tires; and add a top
end traction grading category of ``AA'' to the current traction grading
categories of A, B, and C. The new AA category will make possible the
differentiation of tires with the very highest traction characteristics
from those with lower traction characteristics.
DATES: This final rule is effective March 9, 1998.
Any petition for reconsideration of this rule must be received by
NHTSA not later than October 24, 1996.
ADDRESSES: Petitions for reconsideration should refer to the docket and
notice numbers noted above for this rule and be submitted to the Docket
Section, National Highway Traffic Safety Administration, 400 Seventh
Street SW, Room 5109, Washington, DC 20590; telephone (202) 366-4949.
Docket room hours are from 9:30 a.m. to 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: For technical issues: Mr. Orron Kee,
Chief, Consumer Programs Division, Office of Planning and Consumer
Programs, National Highway Traffic Safety Administration, 400 Seventh
Street SW, Room 5307, Washington, DC 20590; telephone (202) 366-0846;
FAX (202) 493-2739. For legal issues: Mr. Walter K. Myers, Office of
the Chief Counsel, National Highway Traffic Safety Administration, 400
Seventh Street SW, Room 5219, Washington, DC 20590; telephone (202)
366-2992; FAX (202) 366-3820.
SUPPLEMENTARY INFORMATION:
Preamble Table of Contents
I. Introduction
II. Background
(a) Current Provisions
(1) Treadwear
(2) Traction
(b) Request for Comments
(c) Notice of Proposed Rulemaking
(1) Treadwear
(2) Traction
(3) Fuel Economy
(4) Comments
(d) DOT Appropriations Act of 1996
(e) Public Comments on the NPRM
(1) Treadwear
(2) Traction
III. Agency Decision
(a) Treadwear
(b) Traction
IV. Cost/Benefit Analysis
(a) Treadwear
(b) Traction
V. Rulemaking Analyses and Notices
(a) EO 12866 and DOT Regulatory Policies and Procedures
(b) Regulatory Flexibility Act
(c) EO 12612--Federalism
(d) National Environmental Policy Act
(e) Paperwork Reduction Act
(f) Civil Justice Reform
I. Introduction
This final rule amends the Uniform Tire Quality Grading Standards
(49 CFR 575.104) to fix the base course wear rate of course monitoring
tires at a permanent value of 1.34, and establishes an AA traction
grade. A proposal in the agency's Notice of Proposed Rulemaking of May
24, 1995 (60 FR 27472) to rescind the temperature resistance grade and
substitute therefor a fuel economy grade based on low rolling
resistance characteristics of tires is not addressed in this notice
(see the discussion in paragraph II(d) below).
II. Background
(a) Current Provisions. Section 30123(e) of Title 49, United States
Code requires the Secretary of Transportation to prescribe a uniform
system for grading motor vehicle tires to assist consumers in making
informed choices when purchasing tires. Pursuant to that congressional
mandate, NHTSA promulgated the Uniform Tire Quality Grading Standards
(UTQGS) in 49 CFR 575.104. The UTQGS apply to new pneumatic tires for
use on passenger cars, except deep tread, winter-type snow tires,
space-saver or temporary-use spare tires, tires with nominal rim
diameters of 10 to 12 inches, and limited production tires as defined
in Sec. 575.104(c)(2).
The UTQGS require tire manufacturers and tire brand name owners to
grade their tires with respect to their relative treadwear, traction,
and
[[Page 47438]]
temperature resistance performance. Treadwear grades are shown by
numbers, such as 100, 150, and 200, while traction and temperature
resistance grades are indicated by the letters A, B, and C, with A
representing the best performance and C indicating the minimum level of
performance necessary to comply with Federal Motor Vehicle Safety
Standard No. 109, New pneumatic tires.
(1) Treadwear. Treadwear is graded by first running the tires being
graded, called ``candidate tires,'' over a selected 400-mile segment of
public highway near San Angelo, Texas. After an 800-mile ``break-in''
run, the candidate tires are driven over the test course for a total of
6,400 miles in test convoys composed of 4 passenger cars and/or light
truck vehicles. Each driver remains in the same position within the
convoy. The vehicles are rotated among the 4 positions in the convoy
regularly as are the positions of the tires on the test vehicles so
that the tires get equal time with each driver, each vehicle, and each
wheel position.
``Course monitoring tires'' (CMT) are used as the control standard
in grading candidate tires. CMTs are specially designed and built to
American Society for Testing and Materials (ASTM) standard E1136 to
have narrow limits of variability. When NHTSA procures a new batch, or
lot, of CMTs, the agency establishes a new base course wear rate (BCWR)
for that lot. The BCWR, measured in miles per thousand miles (MPTM), is
established by running tires from the new lot of CMTs over the 6,400-
mile test course, in the same manner as candidate tires, with tires
from the previous batch of CMTs. A course severity adjustment factor
(CSAF) for the CMTs is determined by dividing the BCWR for the old CMTs
by the average wear rate of the old CMTs in the test. The wear rate of
the new CMTs is then multiplied by the CSAF to determine the adjusted
wear rate (AWR) of the new CMTs, which then becomes the BCWR for the
new CMTs.
Once the BCWR for the new CMTs is established, these CMTs are used
to grade candidate tires. Upon completion of the 6,400-mile test, the
BCWR is divided by the average wear rate of the CMTs to determine the
CSAF for the candidate tires. That factor is then applied to the wear
rates of the candidate tires to obtain the AWR of the candidate tires.
That AWR is then extrapolated to the point of wearout (considered to be
1/16th inch of remaining tread depth), which is then converted to the
treadwear rating of the tire.
The BCWR is intended to provide a common baseline by which to grade
candidate tires by relating all new CMTs to the original lot of CMTs.
However, NHTSA has noted that the BCWRs of successive new lots of CMTs
have been steadily declining over the years. Specifically, the first
lot of CMTs procured from Goodyear Tire and Rubber Company (Goodyear)
in 1975 yielded a BCWR of 4.44. The latest batch, procured by the
agency in 1995, produced a BCWR of 1.34.
The significance of the decrease in the BCWR rate is that as the
BCWR decreases, the treadwear grade increases. Consequently, the newer
treadwear grades have increased to the point that they have become a
somewhat misleading indicator of actual tread life when compared to
tires tested with higher BCWRs.
(2) Traction. Traction grades are established by locked-wheel
braking tests of traction on wet asphalt and wet concrete surfaces at
the Uniform Tire Quality Grading Test Facility (UTQGTF), located at
Goodfellow Air Force Base near San Angelo, Texas. A test trailer is
equipped first with two control tires manufactured in accordance with
ASTM standard E501. The trailer is towed over the wet asphalt surface
at a speed of 40 miles per hour (mph) and one wheel equipped with a
control tire is locked. The traction coefficient of that tire is
recorded continuously and averaged for a period of 0.5 to 1.5 seconds
after lockup. The UTQGTF is arranged so that the test trailers traverse
both the asphalt and the concrete test surfaces in a loop. The test is
repeated for a total of 10 times on each surface for each tire and the
measurements taken on a surface are averaged to determine the control
tire's traction coefficient for that surface. The purpose of testing
the control tires is to monitor the friction properties of the asphalt
and concrete surfaces to account for daily fluctuation due to
environmental factors and the polishing effects of sustained use.
The same procedure is used to measure the locked-wheel braking
traction coefficients of candidate tires. The measured traction
coefficients of candidate tires are adjusted by the difference between
the nominal coefficients of the control tires on the test surfaces
(0.50 for the asphalt surface and 0.35 for the concrete surface) and
the actual coefficient of the control tire run simultaneously with the
candidate tire. Using this procedure, the measured coefficients of all
candidate tires are adjusted to a common pavement friction basis for
each of the test surfaces.
The grades of the candidate tires are currently designated as
``A'', ``B'', and ``C''. A tire achieving a high level of traction
performance on both the wet asphalt (above 0.47) and the wet
concrete (above 0.35) surfaces is graded ``A.'' A tire
achieving medium traction performance (above 0.38 on wet
asphalt and above 0.26 on wet concrete) is graded ``B.'' A
tire achieving a traction performance level of 0.38 or less on
the wet asphalt and 0.26 or less on wet concrete is graded
``C.''
(b) Request for Comments. As a result of the White House Conference
on Global Climate Change held on June 10 and 11, 1993, the White House
issued a report announcing nearly 50 initiatives to reduce greenhouse
gas emissions in the United States. The report, entitled ``Climate
Change Action Plan,'' was issued on October 19, 1993 and, among other
things, calls for reduction of greenhouse gas emissions to 1990 levels
by the year 2000. One such initiative called for DOT, through NHTSA, to
issue new rules and test procedures requiring tire manufacturers to
test and label tires relative to their fuel economy based on their
rolling resistance. 1
---------------------------------------------------------------------------
\1\ Action #22: ``DOT, through the National Highway Traffic
Safety Administration, will adopt test procedures and new DOT rules
requiring tire manufacturers to test and label (for fuel economy
based on rolling resistance). DOT will also create a consumer-
focused publicity program and a monitoring program in order to
realize maximum benefits. The Administration is proposing to
obligate $0.3 million in FY 1995 for this action and $2 million
through 2000.''
---------------------------------------------------------------------------
Pursuant to the Climate Change Action Plan, NHTSA published a
Request for Comments on April 25, 1994 (59 FR 19686) seeking responses
to a series of questions regarding available data on rolling resistance
and testing procedures. The notice also posed questions concerning
whether and how the treadwear testing procedures should be changed; and
whether a traction grade of ``AA'' should be created to identify those
tires with clearly superior traction characteristics. NHTSA also asked
whether the UTQGS should include peak traction, how it should be
measured and expressed, and the cost of measuring peak traction. 2
NHTSA noted that if peak traction performance of tires differed
substantially from sliding traction, an alternative traction grading
procedure might be necessary.
---------------------------------------------------------------------------
\2\ Peak traction is the primary traction force in anti-lock
braking systems in which maximum braking action is obtained while
the tire is still rolling.
---------------------------------------------------------------------------
(c) Notice of Proposed Rulemaking. After consideration of the 34
timely comments received in response to the Request for Comments, NHTSA
published a Notice of Proposed
[[Page 47439]]
Rulemaking (NPRM) on May 24, 1995 (60 FR 27472), with a comment closing
date of July 10, 1995.
(1) Treadwear. The agency proposed to freeze the BCWR of the CMTs
used in treadwear grading at its then-current value of 1.47 MPTM in an
attempt to reduce treadwear grade creep.
The agency explained in the NPRM that it had considered many
possible explanations for the consistent decrease in the BCWR of the
CMTs, such as differences in climatic variations, changes in course
severity, non-uniformity of wear rates among tires in the same lot,
effects of aging and storage of CMTs, and errors in the BCWR
calculation. To minimize the aging/storage factor, the agency now wraps
CMTs in polyethylene bags for storage in a facility in which, although
not temperature controlled, the temperature varies only between 50 deg.
and 90 deg. Fahrenheit throughout the year. The agency then proposed
fixing the BCWR at 1.47 MPTM to address the possibility of an error in
the BCWR calculation. The agency believed that in addition to reducing,
if not eliminating, the treadwear grade inflation, fixing the BCWR at a
single figure would eliminate the time and expenditure of scarce
resources required for operating test convoys for each new lot of CMTs,
as well as eliminating the environmental impacts of operating those
convoys.
(2) Traction. The agency further proposed to create a traction
grade of ``AA'' to distinguish those tires with superior traction
characteristics from those with lower traction performance
characteristics.
NHTSA noted in the NPRM that analysis of traction data since 1989
revealed that traction performance has improved to the extent that the
current grading system does not adequately differentiate between tires
with varying levels of traction performance, particularly the tires
showing the highest levels of traction performance. To address that
situation, the agency solicited comments in the Request for Comments on
whether the traction grading rules should be amended to differentiate
more clearly between the highest performing tires. After considering
the responses to the Request for Comments, NHTSA proposed to establish
a new traction grading category of ``AA'' for tires achieving traction
coefficients of more than 0.54 on wet asphalt and more than
0.41 on wet concrete 3. NHTSA stated that since the
``AA'' category would be optional, manufacturers would incur no
additional costs beyond modifying paper labels and sales brochures to
reflect 4 traction grades instead of three. On the other hand, an
``AA'' category might provide an incentive to manufacturers to improve
the traction performance of their tire lines.
---------------------------------------------------------------------------
\3\ The preamble in the NPRM erroneously discussed a traction
coefficient value of 0.41 for the wet concrete surface. The
correct value should have been 0.38.
---------------------------------------------------------------------------
With respect to the peak traction data solicited in the Request for
Comments, NHTSA decided, based on the comments received, not to propose
inclusion of peak traction in the traction ratings at this time. NHTSA
noted that the majority of vehicles currently on the road are not
equipped with ABS. The significance of that fact is that those vehicles
continue to depend on sliding traction rather than peak traction for
maximum stopping action. In addition, several tire manufacturers
commented that peak traction performance is highly correlated with
sliding traction performance.
(3) Fuel Economy. The agency proposed in the NPRM to rescind the
temperature resistance grade and substitute therefor a fuel economy
rating based on low rolling resistance characteristics of the tire.
(4) Comments. The NPRM generated 120 comments, all of which
addressed the fuel economy proposal, while 10 commented on the traction
proposal and 12 on the treadwear proposal. Commenters to the fuel
economy proposals included several members of the U.S. Congress; the
Secretary of Energy; tire manufacturers, wholesalers, and retail
dealers, including their foreign plants and subsidiaries;
environmental, safety, and consumer advocates; educators; and members
of the public. Except for a certain few tire manufacturers, the
majority of the tire industry and certain members of Congress strongly
opposed the fuel economy proposal. The Secretary of Energy, on the
other hand, along with most advocacy groups and most members of the
public, supported it.
In response to a number of requests, the agency extended the NPRM
comment period to August 14, 1995 (60 FR 34961, July 5, 1995) and
hosted a public meeting on the UTQGS proposals on July 28, 1995.
Twenty-five representatives of the groups enumerated above made oral
presentations at the meeting while a number of others, including
several members of Congress, filed written submissions. Nearly all the
statements presented at the meeting, whether oral or written, addressed
the fuel economy issue, expressing positions on both sides of the
issue. Thereafter, in response to further requests, the agency again
extended the NPRM comment period to September 1, 1995 to permit
participants at the public meeting an opportunity to file written
responses to matters presented at the public meeting (60 FR 42496,
August 16, 1995).
Although the comment period closed on September 1, 1995, NHTSA
continued to receive correspondence on both sides of the rolling
resistance issue, including letters from various members of the
Congress.
(d) DOT Appropriations Act of 1996. In early November, 1995, while
NHTSA was still evaluating the comments and data from the NPRM and the
public meeting, the Transportation Appropriations Act for Fiscal Year
1996 was enacted. Amendment number 66 to that Act prohibited the
obligation or expenditure of any funds
[T]o plan, finalize, or implement any rulemaking to add to section
575.104 of title 49 of the Code of Federal Regulations any
requirement pertaining to a grading standard that is different from
the three grading standards (treadwear, traction, and temperature
resistance) already in effect.
NHTSA discontinued rulemaking activity on the fuel economy issue, but
continued to assess the comments on the treadwear and traction
proposals. Accordingly, this final rule addresses only the latter two
proposals.
(e) Public Comments on the NPRM.
(1) Treadwear. Some commenters supported the proposal to fix the
BCWR at the current figure, others supported the proposal as better
than nothing, and still others opposed it. Regardless of their support
for fixing the BCWR at a single figure, all commented that the present
treadwear test procedure is inadequate and a new test procedure should
be devised.
Michelin, The Cooper Tire Company (Cooper), Continental General
Tire, Inc. (CGT), and the Rubber Manufacturers Association (RMA)
supported the proposal to fix the BCWR at its current value so that
further grade inflation will not occur. RMA and CGT agreed that the
BCWR should be fixed immediately at 1.34 to prevent any further
deterioration of the treadwear grades. Bridgestone/Firestone, Inc. (BF)
supported fixing the BCWR, although it regards the BCWR itself as
invalid in view of the consistency of the quality of modern tires.
Similarly, Hercules Tire and Rubber Company (Hercules) supported
freezing the BCWR at its current value ``or simply scrapping the system
and starting over.'' Goodyear commented that the treadwear grade itself
should be removed from the UTQGS because as manufacturers' treadwear
warranties continue to improve, the treadwear labels under the UTQGS
become less
[[Page 47440]]
significant for tire consumers. If the grade is not eliminated,
however, Goodyear supports freezing the BCWR at its current value.
Nevertheless, the company, like some other commenters, believes the
treadwear test to be unreliable, inaccurate, cumbersome, costly, and
environmentally unfriendly.
The Kelly Springfield Tire Company (Kelly) and Multinational
Business Services, Inc. (MBS) oppose fixing the BCWR at a single
figure. The European Tyre and Rim Technical Organisation (ETRTO) stated
that changing the BCWR would be misleading to consumers because too
many factors have an influence on the test results. Kelly stated that
the treadwear grade should be eliminated and that freezing the BCWR
would not make the treadwear rating any less confusing to consumers.
Advocates for Highway and Auto Safety (Advocates), MTS Systems
Corporation (MTS), and Herzlich Consulting, Inc. (Herzlich) expressed
no opinion on freezing the BCWR, but commented at length on the
inadequacy of the treadwear test. Advocates stated that using CMTs to
determine the treadlife of all candidate tires creates test conditions
that are arguably much less demanding than actual operating conditions
on the road. MTS stated that the treadwear test should be conducted in
an indoor test lab under controlled, repeatable conditions.
(2) Traction. Ten commenters, including 8 tire manufacturers,
submitted comments on the ``AA'' traction proposal. Two supported the
proposal, while the rest opposed it.
In support of the proposal, Michelin stated that creation of an
additional traction grade would provide more differentiation between
tires with superior traction characteristics without having to redefine
the current A, B, and C levels. ETRTO stated that the present traction
grades are generally acceptable and should be maintained, but if NHTSA
wants to add a grade to indicate higher traction characteristics, ETRTO
would prefer to maintain the present grades as they are and add an
``AA'' grade.
In opposing the addition of an ``AA'' grade to the traction
category, Goodyear, Cooper, Dunlop, and CGT all stated that the
traction test procedures were flawed and should be revised to reflect
more accurately the true traction characteristics of tires. Goodyear,
Dunlop and Kelly stated that the test procedure does not allow tires
designed for hydroplane resistance to demonstrate that feature.
Goodyear asserted that the average water depth of 0.02 inches used in
the UTQGS test procedure is less than half the industry standard depth
of 0.05 inches. Thus, the water depth used in traction grading favors
tires with less void area. Dunlop suggested that a hydroplaning test be
conducted in water depths of up to 15 millimeters (0.6 inches).
Finally, Goodyear repeated its assertion made in earlier comments that
the new test pads used at the UTQGTF caused traction grades to go down,
and adding an ``AA'' grade would only accentuate the flaws in the test
procedure.
Cooper asserted that the current test procedure is not repeatable
or sensitive enough to detect the real differences between tires. For
example, the ASTM ``standard'' tire is a straight-ribbed bias tire
designed to be specially sensitive to differences in road surfaces,
while candidate tires are commercial radial tires designed to yield
good traction performance over a wide range of road surfaces and
weather conditions.
Dunlop stated that the traction test is an insufficient basis for a
traction grade because it is only a straight-ahead test on a damp
surface. Dunlop and CGT suggested that, to be more accurate, the test
should include accelerating traction, cornering traction, and traction
testing under varying ambient conditions. Dunlop also suggested that if
the current traction test procedures were not eliminated, a wet lateral
braking test should be conducted over 2 different friction surfaces
where deceleration Gs are measured and stopping distances calculated.
Finally, Dunlop suggested adding the word ``wet'' to traction labels
because the current straight-ahead test renders the traction rating
``inconclusive'' as a benefit to consumers whose vehicles are equipped
with ABS.
MBS stated that the traction rating, based solely on sliding
traction, is not helpful because it indicates nothing about other
traction characteristics. MBS asserted that the traction rating should
include peak traction performance for consumers with vehicles equipped
with ABS. Kelly, however, stated that although there is a correlation
between peak and sliding traction and that both values can be
considered for grading purposes, the results are dependent on the
differences among the various types of ABS systems. Thus, since a
significant majority of vehicles in service are not equipped with ABS,
sliding traction values rather than peak traction values should be
retained for the traction ratings.
MBS and Dunlop argued that adding an AA grade could confuse
consumers and mislead them because straight-ahead, sliding traction may
not be best for ABS-equipped vehicles. Kelly stated that consumers
could be confused by the limited amount of differentiation within the
AA category. MBS and Cooper stated that the traction test should be
redesigned and improved to be repeatable, sensitive, and relevant, and
that research and testing should be conducted to ascertain the
correlations among the different tire traction characteristics.
Advocates strongly opposed adding an AA rating to the UTQGS.
Rather, Advocates favored increasing the minimum requirements for the
existing grades. Advocates argued that adding an AA grade would not be
as much of an incentive for tire manufacturers to improve the traction
characteristics of their tires as would increasing minimum grade
requirements. Advocates further asserted that adding an AA grade would
only give manufacturers an excuse to charge higher prices for more
highly-rated tires, thereby providing them larger profits.
Finally, Kelly stated that although the cost of tire mold reworking
would be minimal, the costs associated with the proposed change would
not be insignificant. Kelly stated that the 6,750 paper labels used in
the Kelly production scheme would have to be changed to reflect the 4-
grade traction rating system when only a very small number of higher
grade changes would occur. Kelly asserted that the cost of changing
those labels would be significant due to the necessity for new artwork,
production of new labels, and subsequent destruction or other disposal
of obsolete labels. CGT estimated that adding an AA grade would incur
costs of $48,000 for new labels and required point-of-sale information.
Like Kelly, Dean Tire & Rubber Company argued that adding an AA rating
to the UTQGS would increase costs with no commensurate benefit.
III. Agency Decision
(a) Treadwear. NHTSA does not disagree that the treadwear grading
procedure could be further improved. NHTSA does disagree, however, with
Goodyear and Kelly that the treadwear grade should be eliminated. As
the agency noted in the NPRM, 74 percent of consumers are familiar with
the treadwear rating and 29 percent consider it in purchasing tires.
Thus, the solution is not to eliminate the treadwear rating, but to
improve the grading procedure to make the rating as meaningful and
helpful as possible to the tire-buying public.
As stated above, when the NPRM was published on May 24, 1995, the
then-current BCWR was 1.47 MPTM. Since that time, a new lot of CMTs was
[[Page 47441]]
procured and calibrated with a BCWR of 1.34. Thus, the BCWR continues
its steady decline. To control that decline, this final rule announces
the freezing of the BCWR at 1.34. Nothing in the comments has dissuaded
NHTSA from believing that freezing the BCWR at 1.34 will significantly
reduce, if not eliminate altogether, any variation in the grading
results between lots. The agency also believes that the use of ASTM-
specification tires with strict quality control will also contribute to
controlling any lot-to-lot variations. NHTSA notes that the changes in
the BCWRs have been consistently in the downward direction. If tire
performance were changing appreciably due to production variables, the
BCWR could be expected to change randomly in either direction.
NHTSA also disagrees with the commenters that stated that
manufacturers' treadwear warranties have progressed to the point that
they can supplant the UTQGS treadwear ratings. One manufacturer
acknowledged that manufacturers' treadwear warranties are not always
based on test results. Further, not all tires carry manufacturers'
warranties and the terms of such warranties are not uniform.
Accordingly, NHTSA believes that the UTQGS treadwear ratings are more
accurate, consistent, and meaningful to consumers than manufacturers'
warranties because the UTQGS ratings are based on uniformly applicable
criteria.
The commenters' suggestions for changing the treadwear grading
procedure fall into 2 basic categories: Revising the road test and
developing a laboratory test. The commenters favoring the revised road
test stated that the San Angelo test course is too mild and that, with
the great improvement in treadwear in recent years, a test of only
6,400 miles does not provide sufficient tread wear on which to base
reliable projections to wearout. The commenters that favored the
laboratory test argued that a lab test would eliminate the need for
CMTs and test convoys and would provide consistent, repeatable test
results. In neither case did commenters suggest any specific test
procedures nor offer any data that could form the basis for development
of revised tests. NHTSA believes that adoption of either of these
alternatives could entail considerable expenditure of funds and
resources. Expansion of the road test to more closely approximate full-
life testing of treadwear would increase the test duration and
significantly increase costs and environmental impact. NHTSA's
experience has shown that laboratory test machines lose repeatability
because the abrasive surfaces of the test wheels tend to fill up with
rubber particles. Accordingly, NHTSA does not believe that either of
these alternatives is practicable at this time. The agency has,
however, requested the assistance of the ASTM F9 committee in devising
a better treadwear test. In addition, the agency intends to request
data on the effects of aging on treadwear performance and storage
procedures to reduce aging in a future Federal Register notice.
NHTSA believes, therefore, that until a better treadwear grading
procedure can be devised, the BCWR should be fixed at its present value
of 1.34 MPTM. The establishment of a BCWR for a new lot of CMTs does
not normally need to be promulgated by rulemaking action published in
the Federal Register. In this case, however, since the agency solicited
public comment on its proposal to change the procedure for calculating
the BCWR by fixing it at a permanent value, the agency deems it
appropriate to announce this decision in the Federal Register.
(b) Traction. As noted above, Goodyear again commented that the new
skid pads at the UTQGTF are more severe than the old pads in traction
rating. NHTSA notes that the skid pads were changed in December 1991,
and acknowledges that there may be a statistical difference in test
results between the new pads and the old pads. Since the old pads no
longer exist, however, the agency is not able to make a comparison for
the purpose of devising a possible correction factor. Nevertheless, the
agency believes that any differences in the test results do not
significantly affect the traction ratings of tire lines and in any
case, new tire lines should by now, after nearly 5 years, have replaced
those tested on the old skid pads. Thus, most tires should by now be
graded on a common basis.
Several commenters proposed other types of traction testing,
including the testing of hydroplaning, cornering, acceleration, and
peak traction characteristics, and testing in various water depths,
ambient conditions, and road surfaces. While the agency regards these
suggestions as worthy of consideration, they go beyond the scope of the
proposals in the NPRM. Those traction factors could, however, be the
subject of future agency research.
While Dunlop's suggestion that the traction grade be labeled ``wet
traction'' on the tire sidewall and on other required labels may be
somewhat more informative to the public, such a change would require
the modification of tire molds, tread labels, and point-of-sale
brochures. NHTSA believes that the costs associated with such a subtle
change could not be justified by any perceived benefit.
NHTSA does not agree with Advocates' suggestion for raising the
cutoff values for the existing traction grades rather than establishing
a new grading category. The agency believes that considerable public
confusion could be generated during the transition to the higher cutoff
values where tires bearing the same grade but with significantly
different traction characteristics are available side-by-side on store
shelves. Such a transition could be lengthy because changing tire molds
could take as long as 2 to 3 years and some tires may remain in
dealers' stocks for a year or more. Further, since the UTQGS are only
consumer information and do not establish minimum traction performance
levels, the agency believes that simply adding an ``AA'' grade to the
UTQGS traction ratings is the simplest, least confusing, least
burdensome, and most cost effective way of differentiating between
those few tire lines with the highest traction performance
characteristics and those tire lines with lower levels of performance.
Advocates expressed concern that manufacturers would increase their
prices for AA rated tires to the detriment of consumers. NHTSA
acknowledges that manufacturers may choose to increase the prices of
their AA traction-rated tires. However, the agency regards that as the
type of marketing decision that manufacturers, distributors, and
dealers are free to make in response to any product rating program.
NHTSA believes that a tire rated AA for traction identifies that tire
as one with superior traction performance and even if it costs slightly
more, the consumer is advised of the specific characteristics of the
tire from which he or she can make an informed purchasing decision.
NHTSA believes that while there may be some costs associated with
the preparation and printing of tread labels and point-of-sale
brochures, such costs can be minimized with adequate lead time.
Manufacturers typically revise their labels and brochures annually,
presumably not printing them in unlimited quantities. Thus, a lead time
of 18 months should permit new labels and brochures to be prepared and
printed in accordance with the normal business cycle, without undue
scrappage of obsolete material. With respect to changing tire molds,
the agency notes that since an AA rating is optional, tire
manufacturers have an unlimited time in which to change molds on
qualifying tire lines, if they decide to rate their tires with a
traction
[[Page 47442]]
grade of AA at all. Accordingly, NHTSA believes that the minor costs
associated with this rulemaking are well justified by the value of this
rulemaking to consumers (see detailed discussion of costs and benefits
in Section IV, below).
The agency proposed the AA rating criteria in the NPRM based on the
statistical distribution of traction test results of 254 tire lines
tested on the new skid pads at the UTQGTF. The distribution of the
traction coefficients of the tested tires showed a mean, or average,
value of 0.516 on wet asphalt and 0.364 on wet concrete, with a
standard deviation of 0.029 on the wet asphalt and 0.017 on the wet
concrete. Since those calculations were made, NHTSA has tested 40
additional tire lines. The mean plus one standard deviation for the
entire population of 294 tires is 0.548 for asphalt and 0.387 for
concrete. This compares to the values of the mean minus one standard
deviation of 0.484 for asphalt and 0.341 for concrete, which are close
to the current threshold values for the A grade. The agency believes
that the proposed AA traction grade threshold is statistically
compatible with the ranges for the A grade and the combined ranges of
the B and C grades since, of the 294 tires tested, only 34 (12 percent)
would qualify for the AA traction grade while 213 (72 percent) would
qualify for the A grade. Thus, there should be approximately the same
number of tire lines graded AA as are graded B and C.
IV. Cost/Benefit Analysis
(a) Treadwear. The fixing of the BCWR at a permanent value of 1.34
MPTM will not cause the Federal government or tire manufacturers to
incur any additional costs. Instead, it will substantially reduce the
cost of CMTs to tire testers and remove the necessity for the
government to contract for one test convoy each year.
Tire manufacturers routinely purchase CMTs from lots procured by
the government for testing of their tire lines. Prior to September 1,
1995, NHTSA charged $304.50 per tire. A DOT Inspector General audit,
however, concluded that NHTSA was not recovering the full cost of
purchasing, storing, and testing the CMTs. By final rule published on
August 2, 1995 (60 FR 39269) NHTSA started charging $379.00 per tire,
effective September 1, 1995. That charge included the government's
purchase price of $250.00, $45.00 in testing costs to establish the
BCWR, $34.00 for storage costs, and $50.00 for general facility costs
and related salaries.
NHTSA estimates that fixing the BCWR at a permanent value will
eliminate the need to calibrate new lots of CMTs, perhaps even
eliminating the need for the government to purchase and store CMTs for
resale. The savings to the government realized by not having to procure
and store CMTs for resale and by not having to operate at least one
test convoy per year is difficult to quantify. However, manufacturers
purchasing CMTs from the government, even though they would no longer
need to, could realize savings of from $45.00 to $95.00 per tire. At
least the $45.00 testing cost could be saved, as well as perhaps some
or all of the storage and/or facility costs.
Although the specific benefits of this change are also difficult to
quantify, it is expected to reduce or eliminate the treadwear grade
inflation experienced in the past, thereby relieving manufacturers of
the possible need to retest certain tire lines and providing consumers
more consistent and reliable treadwear grade information.
(b) Traction. The addition of an AA traction grade will not require
any additional testing by manufacturers. Further, as previously noted,
the assessing of an AA traction grade is optional for manufacturers.
Accordingly, any costs associated with changing tire molds to show an
AA grade can be phased in at the manufacturers' convenience and during
the regular course of reworking the molds for their tire lines. In any
case, only a very few tire lines will be affected. Accordingly, NHTSA
estimates that there should be no additional mold or testing costs to
manufacturers as a result of this change.
The only additional costs required by this change will be to
indicate the existence of a new traction grade on tread labels and
point-of-sale brochures. CGT estimated this cost to be $48,000. Pirelli
estimated the cost of new artwork for labels to be $12,000 and the cost
of brochures and dealer price books at $104,000. Kelly stated that
6,750 label designs would need to be changed, but gave no cost figure.
Goodyear estimated that it would cost $26,000 for new labels and
$120,000 for new point-of-sale brochures. MBS estimated that the costs
of new labels and brochures would be $15 million for the tire industry.
None of the commenters specified whether the costs they quoted were
additional annual costs or whether those were one-time costs associated
with adding a description of the AA grade for the first time. Tire
manufacturers update and reissue their labels and brochures
periodically, normally annually, to account for new tire lines and
improvements or changes in existing tire lines. It follows, therefore,
that once a description of the AA grade is printed on/in the labels and
brochures, that description can be repeated without change on
subsequent labels and brochures without adding any additional costs to
those printings. Accordingly, the agency assumes the figures quoted
above are one-time costs only.
The MBS estimate of $15 million appears to be very high, compared
to the figures estimated by the manufacturers themselves. Even so,
NHTSA regards $15 million as a maximum figure applicable to the entire
tire industry that, as previously pointed out, would be a one-time
expenditure only.
This change will substantially benefit consumers by allowing them
to identify those tire lines with the highest traction performance
characteristics, thereby providing them even greater tire selectivity
and allowing them to make even more-informed choices. In addition,
NHTSA believes that introduction of an AA traction rating will provide
an incentive to tire manufacturers to improve the traction performance
of new tire lines, thereby contributing to motor vehicle safety.
V. Rulemaking Analyses and Notices
(a) Executive Order No. 12866 and DOT Regulatory Policies and
Procedures
This document was reviewed under Executive Order No. 12866,
Regulatory Planning and Review. NHTSA has analyzed the impact of this
rulemaking action and has determined that it is ``significant'' under
the DOT's regulatory policies and procedures because the proposal which
preceded it contained an issue of substantial public and congressional
interest. That issue, the substitution of a fuel economy grade for the
existing temperature resistance grade, is not addressed in this final
rule.
The Preliminary Regulatory Evaluation prepared by this agency for
the 1995 NPRM remains valid as to the amendments adopted in this final
rule. See section IV, Cost/Benefit Analysis, above for a full
discussion of cost savings, additional costs, and proposed anticipated
benefits of this rulemaking.
(b) Regulatory Flexibility Act
NHTSA has considered the effects of this rulemaking action under
the Regulatory Flexibility Act. I hereby certify that the amendments
promulgated by this final rule will not have a significant impact on a
substantial number of small entities. Accordingly, a regulatory
flexibility analysis has not been prepared.
The agency believes that few, if any, tire manufacturers qualify as
small
[[Page 47443]]
businesses. Small businesses, small organizations, and small
governmental units may be affected by this rulemaking action only to
the extent that they could possibly pay slightly more for tires that
are graded AA for traction performance characteristics.
(c) Executive Order 12612, Federalism
NHTSA has analyzed this rulemaking action in accordance with the
principles and criteria of Executive Order 12612 and has determined
that this rule does not have sufficient federalism implications to
warrant the preparation of a Federalism Assessment.
(d) National Environmental Policy Act
NHTSA has analyzed this rulemaking action for the purposes of the
National Environmental Policy Act and has determined that
implementation of this rulemaking action will not have any significant
impact on the quality of the human environment.
(e) Paperwork Reduction Act
The provisions of this final rule requiring manufacturers to mold
certain information into or onto the sidewalls of tires and to affix
labels to tires explaining the tire quality grades for the benefit of
consumers are considered to be third-party information collection
requirements as defined by the Office of Management and Budget (OMB) in
5 CFR part 1320. The information collection requirements for 49 CFR
575.104 have been submitted to and approved by OMB pursuant to the
provisions of the Paperwork Reduction Act, 44 U.S.C. Sec. 3501, et seq.
This collection of information authority has been assigned OMB control
number 2127-0519, Uniform Tire Quality Grading Standards, 49 CFR Part
575.104, and has been approved for use through September 30, 1998.
(f) Civil Justice Reform
This final rule does not have any retroactive effect. Under 49
U.S.C. 30103(b), whenever a Federal motor vehicle safety standard is in
effect, a state or political subdivision thereof may prescribe or
continue in effect a standard applicable to the same aspect of
performance of a motor vehicle only if the standard is identical to the
Federal standard. However, a state may prescribe a standard for a motor
vehicle or equipment obtained for its own use that imposes a higher
performance requirement than the Federal standard. 49 U.S.C. Sec. 30161
sets forth a procedure for judicial review of final rules establishing,
amending or revoking Federal motor vehicle safety standards. A petition
for reconsideration or other administrative proceedings is not required
before parties may file suit in court.
List of Subjects in 49 CFR Part 575
Consumer protection, Motor vehicle safety, Reporting and
recordkeeping, Tires.
In consideration of the foregoing, 49 CFR part 575 is amended as
follows:
PART 575--CONSUMER INFORMATION REGULATIONS
1. The authority citation for Part 575 continues to read as
follows:
Authority: 49 U.S.C. Secs. 322, 30111, 30115, 30117, and 30166;
delegation of authority at 49 CFR 1.50.
2. Section 575.104 is amended by revising paragraph (d)(1)(i)(B);
(d)(1)(iii); (d)(2)(i); the introductory text of (d)(2)(ii);
(e)(2)(ix)(C); Figure 1; Part I and the introductory text of Part II of
Figure 2; and the paragraph entitled ``Traction'' in Part II of Figure
2; by adding paragaph (d)(2)(ii)(D); and by removing paragraphs (i),
(j), (k), and (1), to read as follows:
Sec. 575.104 Uniform Tire Quality Grading Standards.
* * * * *
(d) Requirements--(1) Information.
(i) * * *
(A) * * *
(B) Each tire manufactured on and after the effective date of these
amendments, other than a tire sold as original equipment on a new
vehicle, shall have affixed to its tread surface so as not to be easily
removable a label or labels containing its grades and other information
in the form illustrated in Figure 2, Parts I and II. The treadwear
grade attributed to the tire shall be either imprinted or indelibly
stamped on the label containing the material in Part I of Figure 2,
directly to the right of or below the word ``TREADWEAR.'' The traction
grade attributed to the tire shall be indelibly circled in an array of
the potential grade letters AA, A, B, or C, directly to the right of or
below the word ``TRACTION'' in Part I of Figure 2. The temperature
resistance grade attributed to the tire shall be indelibly circled in
an array of the potential grade letters A, B, or C, directly to the
right of or below the word ``TEMPERATURE'' in Part I of Figure 2. The
words ``TREADWEAR,'' ``TRACTION,'' AND ``TEMPERATURE,'' in that order,
may be laid out vertically or horizontally. The text of Part II of
Figure 2 may be printed in capital letters. The text of Part I and the
text of Part II of Figure 2 need not appear on the same label, but the
edges of the two texts must be positioned on the tire tread so as to be
separated by a distance of no more than one inch. If the text of Part I
and the text of Part II of Figure 2 are placed on separate labels, the
notation ``See EXPLANATION OF DOT QUALITY GRADES'' shall be added to
the bottom of the Part I text, and the words ``EXPLANATION OF DOT
QUALITY GRADES'' shall appear at the top of the Part II text. The text
of Figure 2 shall be oriented on the tire tread surface with lines of
type running perpendicular to the tread circumference. If a label
bearing a tire size designation is attached to the tire tread surface
and the tire size designation is oriented with lines type running
perpendicular to the tread circumference, the text of Figure 2 shall
read in the same direction as the tire size designation.
* * * * *
(iii) In the case of information required in accordance with
Sec. 575.6(a) to be furnished to the first purchaser of a new motor
vehicle, each manufacturer of motor vehicles shall, as part of the
required information, list all possible grades for traction and
temperature resistance and restate verbatim the explanation for each
performance area specified in Figure 2. The information need not be in
the format of Figure 2, but it must contain a statement referring the
reader to the tire sidewall for the specific tire grades for the tires
with which the vehicle is equipped.
(2) Performance.--(i) Treadwear. Each tire shall be graded for
treadwear performance with the word ``TREADWEAR'' followed by a number
of two or three digits representing the tire's grade for treadwear,
expressed as a percentage of the NHTSA nominal treadwear value, when
tested in accordance with the conditions and procedures specified in
paragraph (e) of this section. Treadwear grades shall be expressed in
multiples of 20 (for example, 80, 120, 160).
(ii) Traction. Each tire shall be graded for traction performance
with the word ``TRACTION,'' followed by the symbols AA, A, B, or C,
when the tire is tested in accordance with the conditions and
procedures specified in paragraph (f) of this section.
* * * * *
(D) The tire may be graded AA only when its adjusted traction
coefficient is both:
(1) More than 0.54 when tested in accordance with
paragraph (f)(2) of this section on the asphalt surface specified in
paragraph (f)(1)(i) of this section; and
(2) More than 0.38 when tested in accordance with
paragraph (f)(2) of this
[[Page 47444]]
section on the concrete surface specified in paragraph (f)(1)(i) of
this section.
* * * * *
(e) * * *
(2) * * *
(ix) * * *
(C) Determine the course severity adjustment factor by assigning a
base course wear rate of 1.34 to the course monitoring tires and
dividing that rate by the average wear rate for the four course
monitoring tires.
* * * * *
(i) Removed.
(j) Removed.
(k) Removed.
(l) Removed.
* * * * *
BILLING CODE 4910-53-P
[[Page 47445]]
[GRAPHIC] [TIFF OMITTED] TR09SE96.023
BILLING CODE 4910-59-C
[[Page 47446]]
Figure 2--[Part I]--DOT QUALITY GRADES
TREADWEAR
TRACTION AA A B C
TEMPERATURE A B C
(Part II) All Passenger Car Tires Must Conform to Federal Safety
Requirements In Addition To These Grades
* * * * *
TRACTION
The traction grades, from highest to lowest, are AA, A, B, and
C. Those grades represent the tire's ability to stop on wet pavement
as measured under controlled conditions on specified government test
surfaces of asphalt and concrete. A tire marked C may have poor
traction performance. Warning: The traction grade assigned to this
tire is based on straight-ahead braking traction tests, and does not
include acceleration, cornering, hydroplaning, or peak traction
characteristics.
* * * * *
Issued on August 30, 1996.
Ricardo Martinez,
Administrator.
[FR Doc. 96-22761 Filed 9-6-96; 8:45 am]
BILLING CODE 4910-59-P
Complete official Federal Register PDF
FR Doc. 96-22713 Standards for the Flammability of Children's Sleepwear: Sizes 0 Through 6X and 7 Through 14; Stay of Enforcement
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Page 47412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22713]
=======================================================================
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1615 and 1616
Standards for the Flammability of Children's Sleepwear: Sizes 0
Through 6X and 7 Through 14; Stay of Enforcement
AGENCY: Consumer Product Safety Commission.
ACTION: Extension of stay of enforcement.
-----------------------------------------------------------------------
SUMMARY: The Commission announces that it is extending the stay of
enforcement of the Standard for the Flammability of Children's
Sleepwear: Sizes 0 Through 6X and the Standard for the Flammability of
Children's Sleepwear: Sizes 7 Through 14 in all cases involving
garments currently used or likely to be used as sleepwear if those
garments are skin-tight or nearly skin-tight, similar in design,
material, and fit to underwear, and labeled as ``underwear.''
EFFECTIVE DATE: This stay of enforcement first published at 58 FR 4078,
January 13, 1993, which became effective January 13, 1993, and was
extended at 59 FR 53584, October 25, 1994, and will continue until
March 9, 1998.
FOR FURTHER INFORMATION CONTACT: Patricia A. Fairall, Office of
Compliance, Consumer Product Safety Commission, Washington D.C. 20207;
telephone: (301) 504-0400, extension 1369.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 13, 1993
(4078), the Commission published a notice to announce a stay of
enforcement of the flammability standards for children's sleepwear. In
that notice, the Commission announced that it would not enforce the
Standard for the Flammability of Children's Sleepwear: Sizes 0 Through
6X (16 CFR Part 1615) or the Standard for the Flammability of
Children's Sleepwear: Sizes 7 Through 14 (16 CFR Parts 1616) in cases
involving garments used by children for sleeping which are: (1) skin-
tight or nearly skin-tight; (2) manufactured from fabrics such as rib
knit, interlock knit, or waffle knit; (3) relatively free of
ornamentation; and (4) labeled and marketed as ``underwear.'' On the
same date, the Commission published an advance notice of proposed
rulemaking to begin a proceeding to consider whether the children's
sleepwear standards should be amended to exempt tight-fitting sleepwear
garments, and garments in infant sizes. See 58 FR 4111.
In the Federal Register of October 25, 1994 (59 FR 53584), the
Commission announced that it was extending the stay of enforcement of
the children's sleepwear flammability standards until further notice.
On the same date, the Commission published proposed amendments of the
sleepwear flammability standards to exempt tight-fitting sleepwear
garments and some infant garments from the requirements of those
standards. See 59 FR 53616.
Elsewhere in this issue of the Federal Register, the Commission has
issued final amendments to exempt certain tight-fitting garments and
garments sized for children nine months of age or younger from the
requirements of the children's sleepwear flammability standards. These
amendments become effective January 1, 1997.
By publication of this notice, the Commission is also extending
until March 9, 1998 the stay of enforcement issued on January 13, 1993,
and continued on October 25, 1994. Garments covered by this stay must
meet applicable requirements of the Standard for the Flammability of
Clothing Textiles (16 CFR part 1610) and the Standard for the
Flammability of Vinyl Plastic Film (16 CFR part 1611).
Dated: August 29, 1996.
Todd A. Stevenson,
Deputy Secretary, Consumer Product Safety Commission.
[FR Doc. 96-22713 Filed 9-6-96; 8:45 am]
BILLING CODE 6355-01-P
Complete official Federal Register PDF
FR Doc. 96-22709 Current Good Manufacturing Practices for Blood and Blood Components: Notification of Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV Infection
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47413-47423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22709]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 606 and 610
[Docket No. 91N-0152]
RIN 0910-AA05
Current Good Manufacturing Practices for Blood and Blood
Components: Notification of Consignees Receiving Blood and Blood
Components at Increased Risk for Transmitting HIV Infection
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
biologics regulations to require that blood establishments (including
plasma establishments) prepare and follow written procedures for
appropriate action when it is determined that Whole Blood, blood
components (including recovered plasma), Source Plasma and Source
Leukocytes at increased risk for transmitting human immunodeficiency
virus (HIV) infection have been collected. This final rule requires
that when a donor who previously donated blood is tested on a later
donation in accordance with the regulations, and tests repeatedly
reactive for antibody to HIV, the blood establishment shall perform
more specific testing using a licensed test, if available, and notify
consignees who received Whole Blood, blood components, Source Plasma or
Source Leukocytes from prior collections so that appropriate action is
taken. Blood establishments and consignees are required to quarantine
previously collected Whole Blood, blood components, Source Plasma and
Source Leukocytes from such donors, and if appropriate, notify
transfusion recipients.
The Health Care Financing Administration (HCFA) is also issuing a
final rule, published elsewhere in this Federal Register, which
requires all transfusion services subject to HCFA's conditions of
Medicare participation for hospitals to notify transfusion recipients
who have received Whole Blood or blood components from a donor whose
subsequent donation test results are positive for antibody to HIV
(hereinafter referred to as HCFA's final rule). FDA is requiring
transfusion services that do not participate in Medicare and are,
therefore, not subject to HCFA's final rule, to take steps to notify
transfusion recipients.
FDA is taking this action to help ensure the continued safety of
the blood supply, and to help ensure that information is provided to
consignees of Whole Blood, blood components, Source Plasma and Source
Leukocytes and to recipients of Whole Blood and blood components from a
donor whose subsequent donation tests positive for antibody to HIV.
DATES: This regulation is effective November 8, 1996. Written comments
on the information colelction requirements should be submitted by
February 7, 1997.
ADDRESSES: Submit written comments on the information collection
requirements to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Sharon Carayiannis, Center for Biologics Evaluation and Research (HFM-
630), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-594-3074.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA has implemented an extensive system of donor screening and
testing procedures performed by blood establishments before, during,
and after donation, to help prevent the transfusion of blood products
that are at increased risk for transmitting HIV. HIV is the virus that
causes acquired immune deficiency syndrome (AIDS), a
[[Page 47414]]
communicable disease that can be transmitted through transfusion.
As a result of the screening and testing procedures, the risk of
transmitting HIV infection through blood transfusion is very low.
Despite the best practices of blood establishments, however, a person
may donate blood early in infection, during the period when the
antibody to HIV is not detectable by a screening test, but HIV is
present in the donor's blood (a so-called ``window'' period). If the
donor attempts to donate blood at a later date, the test for antibody
to HIV may, at that time, be repeatedly reactive. Therefore, FDA
believes such circumstances require clarification of the donor's status
through testing with a more specific antibody test and procedures to
``lookback'' at prior collections. Previously collected Whole Blood and
blood components would be at increased risk for transmitting HIV and a
recipient of a transfusion of Whole Blood and blood components
collected during the ``window'' period would not know that he or she
may have become infected with HIV through the transfusion unless
notified.
In the Federal Register of June 30, 1993 (58 FR 34962), FDA issued
a proposed rule to require appropriate action when it is later
determined that blood and blood components might have been collected
during the ``window'' period. FDA has reviewed comments submitted on
the proposed rule and is now issuing this final rule to require
facilities involved in the collection, processing, and administration
of blood to quarantine Whole Blood, blood components, Source Plasma and
Source Leukocytes which were collected from a donor who tested negative
at the time of previous donations but subsequently tests repeatedly
reactive for antibody to HIV. The final rule requires blood
establishments to inform consignees (e.g., hospital transfusion
services and manufacturers of plasma derivatives) of the collection and
distribution of such previously donated Whole Blood, blood components,
Source Plasma and Source Leukocytes.
In the Federal Register of June 30, 1993 (58 FR 34977), HCFA also
issued a proposed rule which would require certain transfusion services
to notify recipients of transfusions determined to be from a donor
whose subsequent donation tests positive for antibody to HIV
(hereinafter referred to as HCFA's proposed rule). The final rules
issued by both FDA and HCFA require transfusion services to perform
such notifications.
In a memorandum of understanding (MOU), FDA and HCFA agreed to
coordinate the inspections of transfusion services in medicare
participating hospitals to minimize duplication of effort and to reduce
the burden on affected facilities. Blood establishments, including
those hospital transfusion services not subject to HCFA's regulations
on the conditions of Medicare participation for hospitals, such as
Indian Health Service and Veteran's Administration Hospitals, are
subject to FDA's final rule. Thus, all transfusion services are subject
to the requirements for quarantine and transfusion recipient
notification under either the FDA or HCFA rule.
II. Highlights of the Final Rule
Under the biologics licensing and quarantine provisions of the
Public Health Service Act (42 U.S.C. 262-264) and the drug, device, and
the general administrative provisions of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 351-353, 355-360, and 371-374), FDA
has the authority to promulgate regulations designed to protect the
public from unsafe or ineffective biological products and to issue
regulations necessary to prevent the transmission of communicable
diseases into the United States or from one State to another.
Under these statutory authorities, FDA currently requires that each
donation be tested and found negative for antibody to HIV under
Sec. 610.45 (21 CFR 610.45). Existing regulations already restrict the
use, for transfusion or further manufacture, of a donation testing
repeatedly reactive for antibody to HIV. Even though current licensed
screening tests for antibody to HIV are very sensitive, testing may not
identify all units capable of transmitting HIV infection. For this
reason, many blood establishments have instituted special procedures
when blood or plasma has been collected from a donor testing positive
for antibody to HIV at a later date. These procedures, commonly
referred to as ``lookback'' procedures, involve determining the
suitability of prior collections of Whole Blood, blood components,
Source Plasma and Source Leukocytes from such a donor. These existing
procedures may also involve notifying consignees that have received
prior collections from the donor so consignees can quarantine such
products and, as appropriate, take steps to notify the transfusion
recipients of such Whole Blood and blood components.
While many blood establishments have voluntarily developed written
``lookback'' procedures, these existing procedures vary significantly
among blood establishments. As proposed in the Federal Register of June
30, 1993, FDA is amending the biologics regulations to require blood
establishments to prepare and follow written standard operating
procedures (SOP's), defining steps to be taken when ``lookback''
circumstances arise.
The final rule requires blood establishments to perform more
specific testing of the donor's blood using a licensed test, and to
notify consignees who received Whole Blood, blood components, Source
Plasma and Source Leukocytes from prior collections so that appropriate
action is taken. Blood establishments and consignees shall quarantine,
as described later in this document, previously collected Whole Blood,
blood components, Source Plasma and Source Leukocytes from such donors
until the donor's status is clarified through further testing. FDA is
requiring that other informative test results, if available, be
considered when determining the status of the donor and the suitability
of prior collections.
Upon completion of more specific testing, the final rule also
requires hospital transfusion services that do not participate in
Medicare and are, therefore, not subject to HCFA's final rule, to take
steps to notify transfusion recipients, as appropriate. Such
transfusion recipients shall receive notification for the purpose of
testing for evidence of HIV infection, early treatment, if indicated,
and counseling to take appropriate precautions to prevent the further
spread of the virus such as to sexual partners.
III. HCFA's Companion Rule
Under HCFA's proposed rule, transfusion services operated by
hospitals participating in Medicare and inspected by HCFA that receive
notification of previously collected Whole Blood and blood components
at increased risk for transmitting HIV, would be required to quarantine
such prior collections and notify the transfusion recipient's attending
physician, the transfusion recipient, or other authorized person, as
appropriate. HCFA's final rule requires the hospital transfusion
service to have a written agreement with each blood supplier
documenting these procedures.
As referenced in section I. of this document, FDA and HCFA
coordinate the inspections of transfusion services in medicare
participating hospitals to minimize duplication of effort and to reduce
the burden on affected facilities. In the MOU, it was estimated that
HCFA would be responsible for inspecting and surveying approximately
3,000 transfusion services. FDA continues to conduct the inspections of
[[Page 47415]]
establishments were activities include more than the performance of
compatibility testing. (See 49 FR 34448, August 31, 1984, and 21 CFR
607.65.)
IV. Other Sources of Information
As FDA recognized in the preamble to the proposed rule, blood
establishments may receive information from other sources which
indicate that a donor may be infected with HIV. FDA encourages blood
establishments to initiate ``lookback'' procedures whenever they have
information that a donor has become infected with HIV. FDA recognizes
the existence of diagnostic modalities for HIV infection, other than
antibody testing, such as virus culture or direct viral assays. FDA
encourages blood establishments to consider such test results, when
available and reliable, and to voluntarily initiate the ``lookback''
process as described in this final rule. Additionally, the final rule
requires that such results be considered prior to release of units
quarantined in a ``lookback'' procedure.
In particular, FDA recommends that blood establishments voluntarily
initiate ``lookback'' procedures based on HIV antigen testing, as
indicated in the August 8, 1995, Memorandum to All Registered Blood
Establishments, Regarding Recommendations for Donor Screening with a
Licensed Test for HIV-1 Antigen. In the August 8, 1995, memorandum FDA
provided recommendations for the implementation of donor screening
tests for HIV type 1 (HIV-1) antigen(s) within 3 months of the
commercial availability of the first test for HIV-1 antigen(s). The
August 8, 1995, memorandum stated that the average infectious
``window'' period, when HIV antibody is not detectable by the screening
test, is estimated to be approximately 22 to 25 days for screening with
combination assays for antibodies to HIV-1 and HIV-2. The memorandum
further stated that HIV antigen screening could reduce the ``window''
period by an estimated 6 days and could be expected to prevent up to 25
percent of the current ``window'' period donations or about 5 to 10
cases of transfusion associated HIV per year. Because HIV-1 antigen
screening will reduce but not eliminate the residual risk for HIV-1
from transfusion, FDA regards such screening as an interim measure
pending the availability of improved technology for this purpose. FDA
encourages continued development of new methods no further reduce the
risk of HIV transmission due to ``window'' period donations.
V. Responses to Letters of Comment
FDA provided interested individuals 60 days to submit written
comments on the proposed rule. FDA received a total of 25 letters of
comment, which included 10 from blood collection facilities or blood
banks, 8 from pathologists or pathology associations, 6 from blood
banking associations, and 1 from a parent of children with hemophilia.
Twenty-one comments agreed with the concept of ``lookback''. There
were differences of opinion as to how the ``lookback'' process should
be conducted and concerns regarding liability of various individuals
involved in the process. Three comments indicated support for the
strengthening of the ``lookback'' requirements, while eight comments
suggested that the proposed rule's cost to industry would pose a
significant burden with little benefit to public health.
After review and consideration of all comments, FDA continues to
believe that the new requirements for the handling of prior collections
of Whole Blood, blood components, Source Plasma and Source Leukocytes
later found to be at increased risk for transmitting HIV infection are
important public health measures. Below, FDA provides responses to the
comments received.
A. General Comments
1. Terminology Used by FDA and HCFA
Two comments expressed some confusion over specific terminology and
the differences in terminology used by FDA and HCFA. One comment
suggested the use of ``transfusion service'' instead of ``consignee.''
One comment suggested the use of a more specific term for
``recipient.''
FDA's use of the term consignee includes any facility to which the
Whole Blood, blood components, Source Plasma and Source Leukocytes have
been shipped (e.g., a transfusion service, a manufacturer of blood
products, or another blood banking establishment). As written, when the
rule uses the term consignee, it refers to more than a transfusion
service. The FDA and HCFA rules refer to ``transfusion services'' when
the rules are specific to transfusion services. To interchange these
terms would cause more confusion and would not achieve the goals
sought.
As suggested by one comment, FDA has amended the rule to use the
terms transfusion recipient or transfused patient in a number of places
to make it clear that FDA is referring to the recipient of the
transfusion. Where the term ``recipient'' is used alone, FDA believes
that the context makes it clear that the term refers to patients and
not to consignees.
FDA believes that the terminology used in the rules is appropriate
and understood by the entities subject to FDA regulation. FDA also
believes that the terminology used by HCFA is understood by the
entities regulated by HCFA.
2. Blood Donor Locator Service
Three comments stated an interest in using the Blood Donor Locator
Service (BDLS) as a part of the ``lookback'' process. One request was
to expand this service to locate recipients also.
The BDLS final rule which was published in the Federal Register of
December 24, 1991 (56 FR 66561), addressed similar comments calling for
the expanded use of the service. The statutory authority to conduct the
BDLS, as defined by section 8008 of the Technical and Miscellaneous
Revenue Act of 1988 (Pub. L. 100-647), only authorizes the Social
Security Administration to provide address information for blood donors
whose test results for antibody to HIV show that they are, or may be,
infected with HIV. The legislation authorizing the BDLS does not extend
to transfusion recipients or to any other individual. Participation in
the BDLS by State agencies and blood donation facilities is voluntary,
but participants must agree to comply with the provisions of the
statute and the regulations as defined in the BDLS final rule.
3. Organization of Information in the Final Rule
One comment suggested that the organization of information in the
regulations was confusing, and asked for clarification of the intent of
the regulations.
The rule is divided into subsections that provide specific
direction on each aspect of the ``lookback'' process. Each subsection
of the rule must be reviewed for a complete understanding of all
aspects of this important information. The following description serves
as a brief overview of the regulations. Section 606.100 (21 CFR
606.100) states the requirements for SOP's, and Sec. 606.160 (21 CFR
606.160) states the requirements for recordkeeping. Section 610.45(d)
identifies the circumstances under which the ``lookback'' process shall
be initiated. Section 610.46(a) (21 CFR 610.46(a)) states the
requirements for the initial steps of the ``lookback'' process. Section
610.46(a)(1) establishes the circumstances for quarantine and requires
notification of consignees to
[[Page 47416]]
quarantine such products. Section 610.46(a)(2) discusses quarantine of
products held by consignees.
Section 610.46(b) specifies the time limit for completion of the
licensed, more specific test and the notification of the consignee of
those test results. Section 610.46(c) addresses products that are
exempt from quarantine and Sec. 610.46(d) discusses requirements for
release from quarantine. Section 610.46(e) makes clear that these
actions are not considered to be product recalls. Section 610.47(a) (21
CFR 610.47(a)) covers those transfusion services not subject to HCFA's
regulations. Section 610.47(b) contains requirements for notification
of recipients and Sec. 610.47(c) addresses the notification of a legal
representative or relative acting on behalf of the recipient.
B. Comments on Sec. 606.100
Four comments requested more specific direction regarding the
content of SOP's.
It is intention of FDA to allow appropriate flexibility to blood
establishments in the development of their procedures. For example, as
mentioned in one comment, a blood establishment could identify by title
or name the individuals authorized to provide and receive consignee
notification in the ``lookback'' process. FDA further discusses the
content of SOP's in the responses to comments on specific subsections
of the rule.
C. Comments on Sec. 610.45(d)
1. Use of Information from Other Sources to Initiate ``Lookback''
Process
One comment stated that there will be additional circumstances when
a blood establishment can reliably and consistently receive information
that should result in the initiation of a ``lookback'' process. The
sources of this information may include the U.S. military, health
departments or physicians of former donors now found to be HIV-infected
or diagnosed as having AIDS.
FDA agrees that there will be circumstances when the initiation of
``lookback'' may be based on reliable information provided by the U.S.
military, health departments, and other sources and recommends
appropriate action in those instances. However, a blood establishment
generally has no control over whether they will be appropriately
contacted by these outside sources. In addition, the laws and
procedures governing such notifications will vary from State to State.
Therefore, FDA's final rule does not contain specific additional
circumstances under which ``lookback'' is required because the ability
for each establishment to meet the requirements will vary so widely,
based upon varying State laws, local practices, and confidentiality
issues.
2. Initiation of ``Lookback'' Process Based on Repeatedly Reactive
Screening Results
Three comments objected to the initiation of the ``lookback''
process based on the repeatedly reactive antibody screening test
results before the completion of the licensed, more specific test. One
comment stated that any ``lookback'' action, beyond the quarantine of
product, based on the antibody screening test results would be
inappropriate because those tests have a high rate of false positive
results and were not intended to be diagnostic without further
confirmatory testing.
One comment stated that there is a very high cost associated with
preventing the transfusion of very few infectious units based on: (1)
The estimate that of all donations made each year, most blood and blood
components will be transfused before a donor is permitted to donate
again 56 days later; (2) the estimate that only one half of donors will
return to donate again; and (3) the very low number of units expected
to be infectious despite proper testing.
One comment in support of the rule stated that the rule did not
place undue hardship on the blood banking industry. One comment
objected to the more stringent requirements for notification due to the
current burden of escalating demands and diminishing resources,
including increased workload due to more complicated patient illnesses,
vacant technical positions that cannot be filled due to the declining
numbers of skilled, qualified medical technologists, and hospital costs
rising faster than revenues. One comment stated concern that patient
needs would not be met because the increased regulation would force
hospital based donor centers to close as a result of economic
pressures.
One comment cited a threefold increase in the rate of repeatedly
reactive screening tests for antibody to HIV with none of those
confirmed by Western Blot in the past year, which would result in much
higher expected total annualized costs than projected by FDA. Two
comments stated that the actual costs would be twice that estimated by
FDA. Three comments stated that the goals of the proposed rule are
laudable but also estimated that most HIV infections are spread through
other modes of transmission and, therefore, our limited health care
dollars are better spent in other ways.
FDA is charged with the responsibility of protecting the public
from unsafe biological products and has the authority to promulgate
regulations to accomplish its public health mission. Comments on the
proposed rule indicate that SOP's for the ``lookback'' process are
already in place in a large percentage of blood establishments. Based
on comments received, FDA believes that the modification of existing
SOP's to meet the requirements of this rule would not impose an
unreasonable burden or expense to the large number of establishments
with an existing system for handling ``lookback'' circumstances.
FDA believes the prevention of a small number of transmissions of
HIV per year that will result from the initiation of the ``lookback''
process based on the repeatedly reactive antibody screening test
results or other informative test results is a clear benefit. FDA
believes that steps must be taken to avoid transfusion of potentially
unsuitable Whole Blood and blood components while waiting for the
completion of further testing, especially since the time limit for such
testing has been extended to 30 days, as described later in this
document. FDA recognizes that the requirement for the initiation of
this process at the time of the repeatedly reactive HIV antibody test
will result in some additional costs to blood establishments that
currently do not begin the process at this point. However, FDA believes
these steps are warranted to increase the safety of the nation's blood
supply.
D. Comments on Sec. 610.46(a)
1. Notification of Consignees
One comment stated concern regarding the notification of consignees
of the results of the licensed, more specific test and the potential
for confusion if the product in question had already been returned to
the blood donor center.
The final rule requires that blood establishments notify consignees
to quarantine Whole Blood, blood components, Source Plasma and Source
Leukocytes that are at increased risk for transmitting HIV infection.
Upon notification by the blood establishment, the consignee is to
promptly, within 72 hours, quarantine the affected products until
notified of the negative results of a licensed, more specific test.
Return of such products to the blood establishment is not a requirement
of this rule, and, therefore, should not create confusion. However, if
the
[[Page 47417]]
consignee does return the blood or blood components to the blood
establishment, no further consignee notification would be required. FDA
has amended the final rule to clarify the requirement to promptly
notify consignees, within 72 hours, for the purpose of identifying
those products that remain in inventory and require quarantine.
2. Products for Further Manufacture
One comment concerned Sec. 610.46(a)(2), which requires that
unpooled products held by the consignee shall be quarantined. The
comment stated that while it appears that the proposed rule is
structured to exclude large pools of plasma from some requirements, the
rule might be interpreted to have a different result when the
collecting facility and the manufacturing facility hold the same
license. The comment stated further that in this situation, both large
and small pools would be quarantined since the products were not
shipped to a consignee to be pooled.
The comment also asked that small pools of plasma intended for
further manufacture into noninjectable products also be exempt from
quarantine because they are sometimes pooled at the collection facility
and may include plasma considered to be in short supply. The comment
stated that small pools of plasma intended for the manufacture of
noninjectable products should be exempt from quarantine because they
are sufficiently safe as noninjectable products.
A collection facility would be required to quarantine all in-house
or ``on-site'' Whole Blood, blood components, Source Plasma and Source
Leukocytes. A manufacturing facility that shares an establishment
license with the collecting facility is not required to quarantine
pooled products. To avoid a shortage of injectable and noninjectable
products the final rule exempts from quarantine pooled Source Plasma
and Source Leukocytes intended for further manufacture into injectable
and noninjectable products, as described in Sec. 610.46(c). FDA
believes this requirement will better identify those affected products
to be quarantine while ensuring the availability of blood products for
further manufacture.
Additionally, FDA agrees that pools intended for further
manufacture into noninjectable products are sufficiently safe due to
their intended use as noninjectable products and are, therefore, exempt
from quarantine. The rule has been amended to clarify that Pooled
Source Plasma and Pooled Source Leukocytes are exempt from quarantine.
Appropriate safeguards must be used to prevent such products intended
for further manufacture into non-injectable products from being used
for further manufacture into injectable products.
E. Comments on Sec. 610.46(b)
1. Two Week Limit for Completion of Licensed, More Specific Test
One comment supported proposed Sec. 610.46(b) which requires the 2-
week time limit for completion of the licensed, more specific test and
consignee notification, while twenty-three comments expressed
disagreement with the time limit. The 2-week time limit was cited as
too short due to shipping of samples, batching of laboratory work, the
additional number of tests run when the sample is not negative,
dependence upon reference laboratories for this work, and unforeseen
circumstances that are beyond the control of the blood establishment.
The suggestions for a more appropriate timeframe ranged from 3 weeks to
8 weeks to ``as soon as possible''.
After consideration of the additional information provided in the
comment letters, FDA believes that it is appropriate and reasonable to
change the time limit for completion of the licensed, more specific
test and consignee notification of the test results. FDA is amending
Sec. 610.46(b) by allowing a maximum of 30 calendar days for completion
of the licensed, more specific test for antibody to HIV and consignee
notification of the test results.
FDA's concern for the prompt notification of the transfusion
recipient, without undue burden to industry, dictates that the time
limit for completion of testing not exceed 30 days. FDA's extension of
the time limit for the completion of these steps is intended to give
blood establishments a reasonable time period to comply with the
regulation. FDA expects that blood establishments will initiate and
complete such testing expeditiously, but take no longer than 30
calendar days.
The written SOP's of the establishment required under
Sec. 606.100(b)(19) should be adequate to ensure that the required
testing and consignee notification is routinely completed within 30
days. In rare circumstances, such as when there are testing problems,
testing and notification may take longer than 30 days. In such cases
the establishment should document in its records the reason for the
failure to meet the requirement. If the establishment frequently fails
to meet the required time limits, the establishment should review its
procedures to determine how testing and consignee notification can be
expedited.
2. Positive Test for Antibody to HIV-2
Two comments on Sec. 610.46(b) requested clarification on further
testing and notification of consignee and recipients when donors
subsequently test positive for antibody to HIV-2.
In the Memorandum to All Registered Blood Establishments, Revised
Recommendations for the Prevention of HIV Transmission by Blood and
Blood Products, dated April 23, 1992, FDA provided guidance
recommending that all blood establishments collecting Whole Blood,
blood components, Source Plasma, or Source Leukocytes implement a
licensed test for detection of antibody to HIV-2 by June 1, 1992. FDA
modified existing recommendations for prevention of HIV transmission by
blood and blood products to include HIV-2 testing at that time. The
revised recommendations for donor testing, deferral, and reentry are
found in section II. and the recommendations on ``lookback'' are found
in section IV. of the April 23, 1992, memorandum.
This final rule is similar to the FDA guidance on supplemental
tests recommended in the April 23, 1992, Memorandum. FDA has amended
Sec. 610.46(b) of the final rule to clarify requirements for HIV-2
testing. Currently, there is no ``licensed, more specific'' test for
antibody to HIV-2. Thus, the final rule requires the following:
(1) When a donor's screening test for antibody to HIV is repeatedly
reactive, a licensed, more specific test for antibody to HIV shall be
performed.
(2) When the repeatedly reactive screening test is performed using
a single virus test for antibody to HIV-2 or combination test for
antibody to HIV-1/HIV-2, a second screening test for HIV-2, which is
different from the original HIV-2 test, must also be performed. This
second, different enzyme immuno-assay (EIA) test must be a licensed
test and can be either a single virus test or a combination test.
Whole Blood, blood components, Source Plasma and Source Leukocytes
from prior collections may be released from quarantine only if the
donor is tested for antibody to HIV-1 by a licensed, more specific test
and the result is negative; and if the screening test is repeated using
a different EIA test for antibody to HIV-2, either single virus or
combination test, and the result is negative, absent other informative
test
[[Page 47418]]
results. Release from quarantine is not permitted under any other test
results. Transfusion recipient notification is required when the
licensed, more specific test for HIV-1 is positive or when the second,
different EIA test for antibody to HIV-2 is repeatedly reactive.
Whole Blood, blood components, Source Plasma and Source Leukocytes
are exempt from quarantine if the collection occurred more than 12
months prior to the donor's most recent negative screening test(s). If
the most recent negative screening test for antibody to HIV was
performed prior to the implementation of HIV-2 testing in June of 1992,
then the negative screening test for HIV-1 is sufficient to establish
the 12-month time period.
This final rule supersedes the existing recommendations for
``lookback'' procedures in section IV. of the April 23, 1992,
Memorandum, Exclusion/Retrieval of Potentially Contaminated Units From
Prior Collections and Notification of Consignees.
F. Comments on Sec. 610.46 (c) and (d)
1. Release From Quarantine and Western Blot Indeterminate Results
Two comments indicated confusion regarding the disposition of
components collected both greater than and less than the 12-month
period prior to the most recent nonreactive test result. Additionally,
two comments on the subject of Western blot indeterminate results asked
for clarification and for exemption from the ``lookback'' process due
to what the commentor believes is the unlikely occurrence that a unit
with an indeterminate Western blot test result would be infectious.
FDA is requiring prompt quarantine for Whole blood, blood
components, Source Plasma and Source Leukocytes collected from a donor
at increased risk for transmitting HIV infection. Quarantine is
required for units from such a donor collected within the 5years prior
to the repeatedly reactive test for antibody to HIV, if intended for
transfusion, or collected within 6 months prior to the repeatedly
reactive test result, if intended for further manufacture. Section
610.46(c) describes the situation in which Whole Blood, blood
components, Source Plasma and Source Leukocytes are exempt from
quarantine because there is serological evidence that the donation(s)
was not made during the ``window'' period.
In the preamble to the proposed rule, FDA stated that, based on
experience, current estimates predict with approximately 95 percent
confidence that in all cases of HIV infection, the person will test
positive for antibody to HIV by a licensed test within 6 months from
the date of infection. As stated in the preamble to the proposed rule,
to provide an additional margin of safety, FDA has extended the period
for quarantine to 12 months, to more closely approximate a 99 percent
confidence interval. Accordingly, FDA's requirement to quarantine all
Whole Blood, blood components, Source Plasma and Source Leukocytes
collected within 12 months prior to the most recent negative screening
test provides an added margin of safety during the months when an
infected donor may not yet test positive for antibody to HIV. All
donations made before this 12-month period would be outside the
``window'' period and would be exempt from quarantine.
The final rule is amended to clarify the requirements when other
informative test results are available. Section 610.46(d) of the final
rule states that a product may be released from quarantine if the
donor's blood is tested for antibody to HIV by a licensed, more
specific test and the test result is negative, absent other informative
test results. FDA believes that release from quarantine is possible
only if the more specific test is negative and there are no other
informative test results that show evidence of HIV infection. This
regulation does not allow the release from quarantine following and
indeterminate Western blot test result.
Blood establishments may voluntarily perform other FDA approved
informative tests for HIV and must consider those test results when
determining the status of the donor and the suitability of prior
collections. For example, FDA has recently recommended donor screening
for HIV-1 antigen(s) using approved tests. Testing for HIV-1 antigen(s)
using seroconversion samples has shown that donors with recent HIV
infection test repeatedly reactive for antibody to HIV, yet test as
negative or indeterminate by a more specific antibody test but positive
for HIV-1 antigen(s). Prior collections from such a donor would not be
exempt from quarantine unless collected more than 12 months prior to
the donor's most recent negative screening test for HIV antibody.
Disposition of prior collections at increased risk for transmitting
HIV infection should follow the establishment's SOP for appropriate
disposal of blood products that are unsuitable for transfusion, in
accordance with Sec. 606.40. The Memorandum to All Registered Blood
Establishments from the Director, Center for Biologics Evaluation and
Research, Control of Unsuitable Blood and Blood Components, dated April
6, 1988, provides additional guidance for quarantine and disposition of
products unsuitable for transfusion.
In situations where an establishment fails to comply within the 30-
day limit for completion of further testing, and subsequently the test
result is negative, the Whole Blood, blood components, Source Plasma
and Source Leukocytes may be released from quarantine and consignees
must be notified promptly upon availability of the test results.
Destruction of quarantined units is not required merely because further
testing was completed after the 30-day deadline. No release of
quarantined Whole Blood, blood components, Source Plasma and Source
Leukocytes is permitted before the results of the further testing are
available.
2. Use of Test Results From Other Laboratories
Two comments asked that blood establishments be allowed to use the
laboratory test results from other laboratories as evidence of the most
recent negative screening test for antibody to HIV, thus allowing the
quarantine and notification to be limited to units collected within 12
months prior to that negative result. One comment stated that evidence
of such negative screening results could be provided by independent
clinical laboratories, State health departments, military laboratories,
other blood banks, etc.
FDA agrees that test results from the Clinical Laboratories
Improvement Amendments of 1988 (42 U.S.C. 263a) certified laboratories
or licensed blood establishments may be accepted as evidence of the
most recent negative screening test for antibody to HIV, provided that
the blood establishment has assurance that the laboratory is certified
and is using a licensed test kit. The blood establishment should
receive and retain testing records documenting the test results.
G. Comments on Sec. 610.47(a)
1. Notification of Transfusion Recipient Prior to Completion of
Licensed, More Specific Test
Two comments disagreed with the proposed requirement to notify
recipients of potentially infectious units based upon screening results
if the licensed, more specific test results are not available within 2
weeks. One comment stated that upon notification, the transfusion
recipient would experience unnecessary worry since
[[Page 47419]]
more than 90 percent of repeatedly reactive screening results are not
confirmed by Western Blot testing.
As previously discussed in this final rule, the time limit for the
completion of the licensed, more specific test for HIV and the
consignee notification of those test results has been extended from 2
weeks to a maximum of 30-calendar days. This change makes it highly
unlikely that complete results will not be available prior to the
deadline for notification. If a situation of noncompliance occurs,
however, FDA has amended Sec. 610.47(a) so that recipient notification
prior to completion of the licensed, more specific test for HIV is not
required. This change is consistent with FDA's proposal to notify
recipients only if there are positive test results but not when the
test results are indeterminate.
FDA agrees that notification of transfusion recipients that the
transfused blood or blood component was at increased risk for
transmitting HIV is very likely to cause the recipient, and possibly
others, extreme anxiety and concern. Based on the rate of repeatedly
reactive screening tests that are not confirmed by further testing, a
significant percentage of recipients would be subjected to a tentative
notification which would prove to be alarming, confusing, and
unnecessary. Such recipients would be notified when the increased risk
for transmitting HIV has been confirmed by further testing.
2. Establishments Subject to ``Lookback'' Regulations
One comment asked for clarification on Sec. 610.47(a) which
addresses those establishments subject to FDA's rule and those
hospitals subject to HCFA's rule. Two comments asked if these
regulations apply to all regulated blood establishments, including
small, hospital-based transfusion services that also draw blood donors.
Section 610.47(a) specifically states that transfusion services that
are not subject to HCFA's regulations on the conditions of Medicare
participation for hospitals (42 CFR part 482) are subject to this rule.
FDA inspects establishments where activities include more than the
performance of compatibility testing, e.g., blood collection, washing
or freezing of red blood cells, and irradiating of blood components.
Therefore, small, hospital-based transfusion services that also draw
blood donors would be subject to this rule and inspection by FDA.
Certain establishments that do not participate in Medicare, such as
Indian Health Services and Veteran's Administration hospitals, are also
subject to FDA regulations.
HCFA's regulations apply to hospital transfusion services where
activities do not include more than the performance of compatibility
testing and that participate in Medicare. Section III. of this document
describes the division of responsibilities between FDA and HCFA for
inspections of blood establishments. HCFA's final rule is published
elsewhere in this issue of the Federal Register. This division of
responsibilities between FDA and HCFA, consistent with the MOU,
eliminates duplication of effort and reduces the burden on blood
establishments and hospitals.
H. Comments on Sec. 610.47(b)
1. Clarification of Responsibility for Transfusion Recipient
Notification
Two comments asked for clarification as to which entity is
responsible for notification of the transfusion recipient or his or her
physician in situations where the transfusion services are provided to
hospitals by community blood centers. One comment suggested more
consistent requirements between FDA and HCFA because it appeared that
the HCFA proposal makes the hospital responsible for the notification
of the recipient's physician rather than the transfusion service, as is
the case in the FDA proposed rule.
It is not the intention of FDA to designate the individual or the
department that will contact the recipient but rather to designate that
the transfusion service that issues the Whole blood or blood component
for transfusion will be ultimately responsible for ensuring that the
notification takes place. In a similar manner, HCFA holds the hospital
responsible for ensuring the notification is completed.
2. Process and Documentation for Transfusion Recipient Notification
Twenty-five comments expressed concern over the process and
timeframe for notification of the transfusion recipient. There were
some questions as to where the ultimate responsibility falls for
transfusion recipient notification and as to the documentation that is
required. Three comments asked that attending physicians be required to
comply with these regulations and asked for guidance in situations
where the recipient's physician declines to notify the recipient due to
conditions such as terminal illness, celibacy, or when the harmful
effects may exceed the benefits of notification. Additionally, two
comments expressed concern over respect for the doctor-patient
relationship and the authority to interfere with that relationship.
As stated previously, FDA intends that each establishment have the
flexibility to develop SOP's that describe the steps in this process
and all appropriate documentation. The SOP should address documentation
of person(s) contacted, by whom, when and whether the physician agreed
to notify the recipient, and any additional, pertinent information.
Some institutions may choose to designate a specific department or
person within the hospital to conduct the notification and counseling
for the recipient.
The SOP should be consistent with applicable local and State laws
and shall specify both a well designed system for accomplishing
notification and the required documentation of the outcome of these
efforts.
FDA believes that because the attending physician has developed as
relationship with the patient and is most familiar with that patient's
history, the patient's interests are best served when the attending
physician takes the responsibility for contact and counseling. In those
instances when this does not prove to be appropriate or possible, the
transfusion service is ultimately responsible for ensuring that the
notification takes place. If the patient is competent, but the
physician believes the information should not be given to the patient
and State law permits a legal representative or relative to receive
information on the patient's behalf, then the transfusion service or
physician should notify the patient's legal representative or relative.
Further, FDA believes that transfusion services should, upon learning
of the death of the transfusion recipient, continue the notification
process to inform the patient's family. Public health concerns would
warrant the notification process continue and include the deceased
patient's legal representative or relative. It would not be appropriate
for a physician or transfusion service to determine that the patient or
someone acting on his or her behalf need not be informed. The final
rule has been amended to clarify the notification requirements in
Secs. 610.46(c) and 610.47(b).
FDA has no regulatory authority over physicians in their role as
attending physicians, and for that reason, the agency is not able to
require their participation. Upon accepting responsibility for
recipient notification and counseling, it is reasonable to expect that
the physician would, in good faith, determine the appropriate
[[Page 47420]]
content and completeness of information provided to the recipient.
FDA is relying on HCFA's expertise in the area of hospital practice
in setting time limits for transfusion recipient notification.
Consistent with HCFA's final rule, published elsewhere in this issue of
the Federal Register, FDA believes that the hospital's notification
effort should consist of, at the minimum, three attempts by telephone
or in writing to reach the recipient, the recipient's legal
representative or relative. The final rule has been amended to clarify
that the transfusion service's notification effort should begin
immediately after receiving results of further testing for HIV and
should be completed 8 weeks later. The rule has also been amended to
clarify that the transfusion service should notify the patient, the
patient's legal representative or relative, as appropriate.
VI. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation in necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order, and has determined that
this is not a significant regulatory action.
The purpose of the ``lockback'' requirement is to reduce the risk
of transfusion transmitted HIV infection through the quarantine of
blood and blood components that might have been collected during the
``window'' period, when the antibody to HIV is not yet detectable by a
screening test. Notification of consignees to quarantine the affected
products, until a more specific test for antibody to HIV is completed,
will prevent any further transmission of the virus. Upon completion of
more specific testing, all recipients of prior collections from a donor
that subsequently tests positive for antibody to HIV will be notified
by their attending physician, when possible, or by the transfusion
service. Such transfusion recipients shall receive notification for the
purpose of testing for evidence of HIV infection, early treatment, if
indicated, and counseling to take appropriate precautions to prevent
the further spread of the virus such as to sexual partners.
Most blood establishments already participate in a ``lookback''
program. Ninety-five percent of blood establishments, collecting 98
percent of the nation's blood supply, already participate in a
``lookback'' notification of their customers to quarantine previously
shipped blood later determined to be at increased risk for transmitting
HIV. Thus, requirements for written procedures, records of consignee
notification, and records that relate the prior collections to the
donor, later found to be repeatedly reactive for antibody to HIV, would
affect at most about 5 percent of blood establishments; the remaining
establishments may need to make minor changes to their existing
procedures. Therefore, FDA believes this final rule should have a
minimal impact. FDA expects the total annualized cost of the final rule
to blood establishments to be $3,248,354. FDA anticipates only a small
number of cases per year that will involve transfusion recipient
notification. In conclusion, FDA has determined that the final rule is
not a significant regulatory action as defined in Executive Order
12866.
At the time of the proposed rule, the agency certified that the
proposed requirements would not have a significant impact on a
substantial number of small entities. However, in response to industry
comments and in light of amended requirements for analyzing impact on
small entities (as enacted by Pub. L. 104-121), it was determined that
a final regulatory flexibility analysis would be useful. Accordingly,
the agency has assessed this final rule in accordance with the
Regulatory Flexibility Act, with the following results:
Need for, and objective of, the rule. As described elsewhere in
this preamble, FDA is taking this action to help ensure the continued
safety of the blood supply, and to help ensure that information is
provided to consignees of Whole Blood, blood components, Source Plasma
and Source Leukocytes and to recipients of Whole Blood and blood
components from a donor whose subsequent donation test positive for
antibody to HIV.
Types and number of small entities affected. This rule will affect
all of the 3,015 registered U.S. blood establishments. Of these
registered establishments, approximately 400 are part of the American
Red Cross, which supplies approximately 45 percent of blood products
nationally. An additional 286 are Federal or State facilities. Many, or
most, of the remaining 2,204 establishments may be small entities as
defined by the Regulatory Flexibility Act.
The affect of this rule is greatest for those blood establishments
that have not already voluntarily implemented ``lookback'' procedures
similar to those required here. As stated in the proposed rule (58 FR
34962), FDA estimated that at least 95 percent of establishments,
supplying 98 percent of the nation's blood, have such voluntary
procedures and would need to make only minor changes to ensure that
they are in compliance with this rule. The remaining up to 150
establishments would require more substantial changes in their
procedures. FDA considers 150 to be an upper bound, since it is likely
that liability concerns and advances in automated data technology have
prompted most establishments that did not previously have ``lookback''
procedures to have them in place by now.
Projected reporting, recordkeeping, and other compliance
requirements. To comply with this rule, all blood establishments
subject to this rule, including small entities, must: (1) Review and,
if necessary, modify their SOP's; (2) maintain the necessary records to
carry out these procedures; and (3) notify consignees within 72 hours
of repeatedly reactive test results. Blood establishments that provide
transfusion services and that are not subject to HCFA regulations must
also notify physicians of prior donation recipients, or the recipients
themselves, of the need for HIV testing and counseling. The estimated
time needed for establishments to comply with the reporting,
disclosure, and recordkeeping requirements of this rule are described
in detail in the reporting and recordkeeping tables in section VII. of
this document.
FDA estimates that two types of skills will be necessary to meet
these reporting and recordkeeping requirements. The skills of a medical
technologist, or a person with equivalent training and experience, will
be necessary to record donor, quarantine, testing, and disposition
information, and to notify consignees of test results. Updating SOP's
and notifying physicians and recipients of test results will require a
person knowledgeable and experienced in medical laboratory practice.
Based on the reporting, disclosure, and recordkeeping burden
described in section VII. of this document, FDA estimates that
establishments that currently have ``lookback'' procedures will require
approximately 27 hours per year to bring their procedures into
compliance with this rule, while establishments without such procedures
will require approximately 40 hours
[[Page 47421]]
annually to complete the required tasks. Establishments whose
transfusion services are also covered by this rule will require an
additional 8 hours per year to comply. Based on an estimated average
hourly cost of $37.98 to perform the required tasks, FDA predicts that
the average annual cost of these requirements for establishments that
currently lack ``lookback'' procedures is $1,520 per facility for most
establishments and $1,820 for facilities that transfuse as well as
collect blood. Average annual costs for the great majority of
establishments that already have ``lookback'' procedures are expected
to be approximately $1,030 for most establishments and $1,340 for
covered establishments that also provide transfusions.
In addition to these reporting and recordkeeping costs, all
facilities will bear the additional cost of disposing of any affected
units; conducting licensed, more specific tests for HIV; and replacing
discarded units.
With the exception of the initial development of SOP's, all costs
related to implementing the requirements of this rule are related to
the number of units of blood collected from repeat donors who test
positive for HIV, which in turn is related to total blood collections.
The average number of units of blood drawn per establishment covered by
this rule is approximately 8,000 units per year. Smaller establishments
will have lower costs of compliance than the averages described above,
while larger blood facilities will have higher costs, in proportion to
the number of units of blood drawn per year.
Steps to minimize the economic impact on small entities. The
significant issues raised by public comments on the costs of putting in
place the required procedures, and the burdens imposed by the
timeframes in the proposed rule, are described elsewhere in this
preamble, FDA agrees with the numerous comments suggesting that 2 weeks
is too short a time period to allow for completion of the licensed,
more specific test and subsequent notification of consignees, and that
4 weeks is a more reasonable period. Accordingly, FDA has amended the
rule to allow 30 calendar days for the completion of these tasks. This
change should reduce the impact of the rule on small entities and
reduce the chance that blood transfusion recipients will fail to
receive notification that they had received blood or blood components
that are at increased risk of transmitting HIV infection and or fail to
receive appropriate counseling. In response to another comment, FDA
amended the proposed rule to specify that certain pooled blood products
intended for further manufacture into noninjectable products are exempt
from quarantine. This change should also reduce the burden of the rule
on some small entities. FDA rejected the option of excluding all small
entities from the rule, because to do so would exempt a substantial
proportion of establishments and defeat the objective of ensuring that
all establishments have appropriate procedures in place to ensure the
continued safety of the blood supply.
FDA's selection of the regulatory option described in this rule is
based on its legal authority under sections 351 and 361 of the Public
Health Service Act and section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351). The need for regulatory action results
from the fact that a small but significant number of new HIV infections
each year continue to be transmitted through blood transfusions; the
fact that a small minority of blood establishments still lack
appropriate procedures for identification of blood products at
increased risk for transmitting HIV infection and notification of
recipients of such products; and the need to ensure that those
establishments with voluntary ``lookback'' procedures in place have
procedures that are adequate and vigorously followed. The primary
policy consideration in the formulation of this rule is to protect the
public health.
VII. Paperwork Reduction Act of 1995
This final rule contains information collections which are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995. The title, description, and respondent
description of the information collection are shown below with an
estimate of the annual reporting and recordkeeping burden. Included in
the estimate is the time for reviewing procedures, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information.
Title: Current Good Manufacturing Practices for Blood and Blood
Components; Notification of Consignees Receiving Blood and Blood
Components at Increased Risk for Transmitting HIV Infection.
Description: The final rule requires that blood establishments
prepare and follow written procedures when the blood establishments
have collected Whole Blood, blood components, Source Plasma and Source
Leukocytes later determined to be at risk for transmitting HIV
infections. This final rule requires that when a donor who previously
donated blood is tested in accordance with Sec. 610.45 on a later
donation, and tests repeatedly reactive for antibody to HIV, the blood
establishment shall perform more specific testing using a licensed
test, and notify consignees who received Whole Blood, blood components,
Source Plasma or Source Leukocytes from prior collections so that
appropriate action is taken. Blood establishments and consignees are
required to quarantine previously collected Whole Blood, blood
components, Source Plasma and Source Leukocytes from such donors, and
if appropriate, notify transfusion recipients. The agency is issuing
this final rule to help ensure the continued safety of the blood
supply, to help ensure that information is provided to users of blood
and blood components, and to help ensure that transfusion recipients of
blood and blood components at risk for transmitting HIV will be
notified as appropriate.
Description of Respondents: Blood establishments (Business and Not-
for-Profit).
Individuals and organizations had an opportunity to comment on the
information collection requirements in the proposed rule. FDA has
revised these estimates based on current data. These estimates are an
approximation of the average time expected to be necessary for the
collection of information. They are based on such information as is
available to FDA. There are no capital costs, or operating and
maintenance costs associated with this information collection.
As required by the Paperwork Reduction Act of 1995, FDA will submit
a copy of this rule to OMB for review and approval of these information
requirements. Individuals and organizations may submit comments on the
information collection requirements by November 8, 1996. FDA
particularly invites comments on: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
collection of information, including the validity of the methodology
and assumption used; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) ways to minimize
the burden of the collection of information on respondents, including
through the use of automated collection techniques, when appropriate,
and other forms of information technology. Comments
[[Page 47422]]
should be directed to the Dockets Management Branch (address above).
At the close of the 60-day comment period, FDA will review the
comments received, make revisions as necessary to the information
collection requirements, and submit the requirements to OMB for review
and approval. Additional time will be allotted for public comment to
OMB on the requirements and OMB review. Prior to the effective date of
this final rule, FDA will publish a notice in the Federal Register of
OMB's decision to approve, modify, or disapprove the information
collection requirements. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.
Estimated Annual Reporting/Disclosure Burden
----------------------------------------------------------------------------------------------------------------
Annual
Number of frequency Total Hours per
21 CFR section respondents per annual response Total hours
response responses
----------------------------------------------------------------------------------------------------------------
610.46(a)..................................... 3,015 60 180,900 .17 30,753
610.46(b)..................................... 3,015 60 180,900 .17 30,753
610.47(b)..................................... 200 16 3,200 .5 1,600
-----------------------------------------------------------------
Total................................... ........... ........... ........... ............ 63,106
----------------------------------------------------------------------------------------------------------------
Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual Total
21 CFR section Number of frequency of annual Hours per Total hours
recordkeepers recordkeeping records recordkeeper
----------------------------------------------------------------------------------------------------------------
606.100(b)(19)............................ 3,015 1 3,015 2 6,300
606.160(b)(1)(vii)........................ 150 160 24,000 12.8 1,920
606.160(b)(1)(viii)....................... 3,015 60 180,900 4.8 14,472
---------------------------------------------------------------------
Total............................... ............. ............. ........... ............ 22,422
----------------------------------------------------------------------------------------------------------------
VIII. Environmental Impact
The agency has determined under 21 CFR 25.24(c)(10) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
List of Subjects
21 CFR Part 606
Blood, Labeling, Laboratories, Reporting and recordkeeping
requirements.
21 CFR Part 610
Biologics, Labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR parts 606 and 610 are amended as
follows:
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
COMPONENTS
1. The authority citation for 21 CFR part 606 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 505, 510, 520, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351,
352, 355, 360 360j, 371, 374); secs. 215, 351, 353, 361 of the
Public Health Service Act (42 U.S.C. 216, 262, 263a, 264).
2. Section 606.100 is amended by adding new paragraph (b)(19) to
read as follows:
Sec. 606.100 Standard operating procedures.
* * * * *
(b) * * *
(19) Procedures in accordance with Sec. 610.46 of this chapter to
look at prior donations of Whole Blood, blood components, Source Plasma
and Source Leukocytes from a donor who has donated blood and
subsequently tests repeatedly reactive for antibody to human
immunodeficiency virus (HIV) or otherwise is determined to be
unsuitable when tested in accordance with Sec. 610.45 of this chapter.
Procedures to quarantine in-house Whole Blood, blood components, Source
Plasma and Source Leukocytes intended for further manufacture into
injectable products that were obtained from such donors; procedures to
notify consignees regarding the need to quarantine such products;
procedures to determine the suitability for release of such products
from quarantine; procedures to notify consignees of Whole Blood, blood
components, Source Plasma and Source Leukocytes from such donors of the
results of the antibody testing of such donors; and procedures in
accordance with Sec. 610.47 of this chapter to notify attending
physicians so that transfusion recipients are informed that they may
have received Whole Blood and, blood components at increased risk for
transmitting human immunodeficiency virus.
* * * * *
3. Section 606.160 is amended by adding paragraphs (b)(1)(vii) and
(b)(1)(viii) to read as follows:
Sec. 606.160 Records.
* * * * *
(b) * * *
(1) * * *
(vii) Records to relate the donor with the unit number of each
previous donation from that donor.
(viii) Records of quarantine, notification, testing, and
disposition performed pursuant to Secs. 610.46 and 610.47 of this
chapter.
* * * * *
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
4. The authority citation for 21 CFR part 610 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,
355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health
Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
[[Page 47423]]
5. Section 610.45 is amended by adding a new paragraph (d) to read
as follows:
Sec. 610.45 Human immunodeficiency virus (HIV) requirements.
* * * * *
(d) For a donor whose test results for antibody to HIV are
repeatedly reactive or otherwise determined to be unsuitable when
tested in accordance with paragraph (a) of this section, the blood
establishment shall comply, as applicable, with Secs. 610.46 and
610.47.
6. New Secs. 610.46 and 610.47 are added to subpart E to read as
follows:
Sec. 610.46 ``Lookback'' requirements.
(a) Quarantine and notification. (1) All blood and plasma
establishments are required to take appropriate action when a donor of
Whole Blood, blood components, Source Plasma and Source Leukocytes
tests repeatedly reactive for antibody to human immunodeficiency virus
(HIV), or otherwise is determined to be unsuitable when tested in
accordance with Sec. 610.45. For Whole Blood, blood components, Source
Plasma and Source Leukocytes collected from that donor within the 5
years prior to the repeatedly reactive test, if intended for
transfusion, or collected within the 6 months prior to the repeatedly
reactive test, if intended for further manufacture into injectable
products, except those products exempt from quarantine in accordance
with Sec. 610.46(c), the blood establishment shall promptly, within 72
hours:
(i) Quarantine all such Whole Blood, blood components, Source
Plasma and Source Leukocytes from previous collections held at that
establishment; and
(ii) Notify consignees of the repeatedly reactive HIV screening
test results so that all Whole Blood, blood components, Source Plasma
and Source Leukocytes from previous collections they hold are
quarantined.
(2) Consignees notified in accordance with paragraph (a)(1)(ii) of
this section shall quarantine Whole Blood, blood components, Source
Plasma and Source Leukocytes held at that establishment except as
provided in paragraph (c) of this section.
(b) Further testing and notification of consignees of results.
Blood establishments that have collected Whole Blood, blood components,
Source Plasma or Source Leukocytes from a donor as described in
paragraph (a) of this section shall perform a licensed, more specific
test for HIV on the donor's blood, and in the case of distributed
products, further shall notify the consignee(s) of the results of this
test, within 30 calendar days after the donor's repeatedly reactive
test. Pending the availability of a licensed, more specific test for
HIV-2, a second, different screening test for antibody to HIV-2 shall
be used along with a licensed, more specific test for HIV-1.
(c) Exemption from quarantine. Products intended for transfusion
need not be held in quarantine if a determination has been made that
the Whole Blood, blood components, Source Plasma or Source Leukocytes
was collected more than 12 months prior to the donor's most recent
negative antibody screening test when tested in accordance with
Sec. 610.45. Pooled Source Plasma and Source Leukocytes are exempt from
quarantine.
(d) Release from quarantine. Whole Blood, blood components, Source
Plasma and Source Leukocytes intended for transfusion or further
manufacture which have been quarantined under paragraph (a) of this
section may be released if the donor is subsequently tested for
antibody to HIV as provided in paragraph (b) of this section and the
test result is negative, absent other informative test results.
(e) Actions under this section do not constitute a product recall
as defined in Sec. 7.3(g) of this chapter.
Sec. 610.47 ``Lookback'' notification requirements for transfusion
services.
(a) Transfusion services that are not subject to the Health Care
Financing Administration's regulations on conditions of Medicare
participation for hospitals (42 CFR part 482) are required to take
appropriate action in accordance with paragraphs (b) and (c) of this
section when a recipient has received Whole Blood or blood components
from a donor determined to be unsuitable when tested for human
immunodeficiency virus (HIV) infection in accordance with Sec. 610.45
and the results of the additional tests as provided for in
Sec. 610.46(b) are positive.
(b) Notification of recipients of prior transfusion. If the
transfusion service has administered Whole Blood or blood components as
described in paragraph (a) of this section, the transfusion service
shall notify the recipient's attending physician (physician of record)
and ask him or her to inform the recipient of the need for HIV testing
and counseling. If the physician is unavailable or declines to notify
the recipient, the transfusion service shall notify the recipient and
inform the recipient of the need for HIV testing and counseling. The
notification process shall include a minimum of three attempts to
notify the recipient and be completed within a maximum 8 weeks of
receipt of the result of the licensed, more specific test for HIV. The
transfusion service is responsible for notification, including basic
explanations to the recipient and referral for counseling, and shall
document the notification or attempts to notify the attending physician
or the recipient, pursuant to Sec. 606.160 of this chapter.
(c) Notification to legal representative or relative. If the
transfusion recipient has been adjudged incompetent by a State court,
the transfusion service or physician must notify a legal representative
designated in accordance with State law. If the transfusion recipient
is competent, but State law permits a legal representative or relative
to receive the information on the recipient's behalf, the transfusion
service or physician must notify the recipient or his or her legal
representative or relative. If the transfusion recipient is deceased,
the transfusion service or physician must continue the notification
process and inform the deceased recipient's legal representative or
relative. Reasons for notifying the recipient's relative or legal
representative on his or her behalf shall be documented pursuant to
Sec. 606.160 of this chapter.
Dated: July 11, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-22709 Filed 9-6-96; 8:45 am]
BILLING CODE 4160-01-M
Complete official Federal Register PDF
FR Doc. 96-22708 Medicare and Medicaid Programs; Hospital Standard for Potentially HIV Infectious Blood and Blood Products
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47423-47434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22708]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 482
[BPD-633-F]
RIN 0938-AE40
Medicare and Medicaid Programs; Hospital Standard for Potentially
HIV Infectious Blood and Blood Products
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule requires hospitals participating in the
Medicare and Medicaid programs to take appropriate action when the
hospitals learn that they have received whole blood, blood components
(including recovered plasma), source plasma, and source leukocytes
(hereafter referred to as blood or blood products) that are at
increased risk of transmitting Human Immunodeficiency Virus (HIV)
[[Page 47424]]
infection. If the hospital learns that it has received blood or blood
products collected from a donor recently exposed to HIV, before the
donor has a sufficient level of antibody to be detected by the
screening test for antibody to HIV, the hospital must quarantine any
blood or blood products remaining in inventory pending confirmatory
testing. If the presence of HIV is confirmed by more specific testing,
the hospital must notify patients who received the blood or blood
product.
This final rule is intended to ensure that proper health and safety
steps are taken to minimize further spread of HIV infection. A final
rule published elsewhere in this Federal Register by the Food and Drug
Administration applies the same requirements to entities furnishing
transfusion services that do not participate in the Medicare and
Medicaid programs and clarifies the responsibilities of blood
establishments to identify and notify the transfusion service that
received affected blood and blood products.
EFFECTIVE DATES: This rule is effective on November 8, 1996.
FOR FURTHER INFORMATION CONTACT: Janet Samen, (410) 786-9161.
SUPPLEMENTARY INFORMATION:
I. Background
Hospitals must meet certain conditions in order to participate in
the Medicare program. These conditions are intended to protect patient
health and safety and ensure that high-quality care is provided.
Hospitals receiving payment under Medicaid must meet the conditions for
participation in Medicare.
Regulations containing the Medicare conditions of participation for
hospitals are located in the Code of Federal Regulations at 42 CFR part
482, with the condition for hospital laboratory services at
Sec. 482.27. Section 482.27 contains general requirements for hospital
laboratories. The more detailed requirements for laboratories appear in
part 493, which sets forth requirements for all laboratories
participating in the Medicare, Medicaid, and Clinical Laboratories
Improvement Act (CLIA) programs.
In the Department of Health and Human Services, the Food and Drug
Administration (FDA) and HCFA are responsible for different aspects of
ensuring the safety of blood and blood products. Blood banks (referred
to as blood establishments in FDA regulations) are subject to the FDA
regulations for current good manufacturing practices and additional
standards for the manufacture of blood and blood components under 21
CFR parts 211 and 600, 601, 606, 610, and 640. Laboratories that
provide transfusion services are subject to CLIA requirements for
quality control and health and safety standards (42 CFR part 493,
subpart K) and laboratories in hospitals are also subject to the
hospital conditions of participation for adequacy of laboratory
services (Sec. 482.27). FDA and HCFA coordinate inspections of
hospital-based blood banks to minimize duplication of effort and reduce
the burden on affected facilities.
Human Immunodeficiency Virus (HIV) is a virus whose presence is
associated with Acquired Immune Deficiency Syndrome (AIDS). In response
to scientific data that show HIV is transmissible through infectious
blood and blood products, FDA has implemented an extensive system of
donor screening and testing procedures performed before, during, and
after a donation takes place to help prevent the transfusion of blood
and blood products that are infected with HIV.
Existing FDA regulations require each donation of blood to be
tested and found negative for the antibody to HIV and restrict the use,
for transfusion or further manufacture, of a donation testing
repeatedly reactive for the antibody to HIV. Repeatedly reactive means
that the initial HIV antibody screening test is reactive, retested in
duplicate, and one or both of the duplicate tests are reactive. As a
result of the FDA blood donor screening and testing procedures, the
risk of transmitting HIV infection through blood transfusion is very
low. However, despite the best practices of blood establishments, a
person may donate blood early in infection when the antibody to HIV is
not detectable by the screening test, but HIV is present in the donor's
blood (a so-called ``window'' period). If the donor attempts to donate
blood at a later date, the test for the antibody to HIV may at that
time be repeatedly reactive. Under such circumstances, previously
collected blood and blood products would be at increased risk for
transmitting HIV and a recipient of a blood product collected during
the ``window'' period would not know whether the donor was infected
with HIV at the time of the previous donation. Steps taken to identify
and quarantine remaining blood and blood products in storage and notify
recipients of the blood are known as ``lookback.''
As a result of advances in identifying the presence of HIV, the
``window'' period continues to shrink. The FDA final rule published
elsewhere in this Federal Register provides more information on the
length of the window period and discusses various diagnostic modalities
for HIV infection.
II. Proposed Regulations
FDA and HCFA published proposed regulations in the Federal Register
on June 30, 1993 (58 FR 34962 and 58 FR 34977, respectively) to require
lookback by blood establishments and transfusion services when it is
later determined that potentially HIV infectious blood or blood
products might have been collected and administered.
FDA proposed to require blood establishments (that is, facilities
involved in the manufacture of blood and blood components) to
quarantine previously collected blood and blood products collected from
a donor who tested negative at the time of a previous donation but
tests repeatedly reactive for the antibody to HIV on a later donation.
A donor would be considered to be infected by HIV if the results of the
FDA's licensed tests described at 21 CFR 610.45 show the presence of
the antibody to HIV and if the screening results are confirmed positive
by a licensed, more specific test. Blood establishments would be
required to promptly notify the hospital transfusion service of the
need to quarantine the potentially HIV infectious blood or blood
products that were distributed.
In the HCFA regulation, we proposed to add a new paragraph (c) to
Sec. 482.27 (``Conditions of participation: Laboratory services.'') to
set forth the standard for potentially HIV infectious blood and blood
products. Under the proposed rule, when the hospital learns that it has
administered blood that may have been collected during the ``window''
period, the hospital would be required to make several attempts to
notify the patient's attending physician (physician of record) and ask
the physician to inform the patient of the need for HIV testing and
counseling. If the physician is unavailable or declines to notify the
patient, the hospital must make several attempts to inform the patient
of the need for HIV testing and counseling. We proposed that the
notification include basic explanations to the patient and referral for
counseling and that the hospital document the notification or attempts
to notify the attending physician and the patient.
In addition, we proposed to require that, when services are
furnished to a hospital by an outside blood bank, there must be an
agreement governing the procurement, transfer, and availability of
blood and blood products specifying that the blood bank promptly notify
the hospital if potentially HIV infectious blood or blood products have
been made available to the hospital.
[[Page 47425]]
Notification would enable the hospital to take proper health and safety
steps to minimize further spread of HIV infection.
III. Analysis of and Responses to Public Comments
In response to the June 1993 HCFA proposed rule, we received 28
timely items of correspondence from national organizations, nurses,
hospital administrators, State offices, law firms, and various
organizations representing infection control officers and blood banks.
A summary of individual comments we received on the June 1993 proposed
rule, our responses, and the changes we have made are discussed below.
Coordination of FDA and HCFA Efforts
When HCFA and FDA published the June 1993 proposed rules, we
intended that all blood banks (that is, blood establishments involved
in the manufacture of blood and blood components) and transfusion
services (that is, consignees that receive blood and blood products
from blood banks/blood establishments and perform compatibility
testing) comply with the quarantine and patient notification
requirements. However, based on public comments received by both
agencies, it appears that there was public misunderstanding of the
mission of each agency and the scope of the rulemaking, as discussed
below.
Comment: One commenter indicated that terminology used by HCFA and
FDA is not consistent. In the FDA regulation, the terms ``consignees''
and ``transfusion services'' are used while the HCFA regulations refer
to ``hospitals'' and ``blood banks.'' The commenter requested more
consistent use of the terms. In addition, the commenter noted that the
term ``blood banks'' may refer to a transfusion service or a
freestanding community blood center. Finally, the commenter noted that
the term ``consignee'' may mean the facility providing the transfusion
service and that the term ``recipient'' may refer to the transfused
patient. The commenter asked that ``transfusion service'' and
``transfused patient'' be the preferred terms.
Response: While we agree that the use of different terms can be
confusing, we do not believe it would be appropriate to revise the
terminology used in the HCFA regulation because it is consistent with
that used elsewhere in title 42 of the Code of Federal Regulations,
including the hospital conditions of participation and the CLIA
regulations. Likewise, although the FDA terminology is different, it is
understood by the entities regulated by FDA and described by FDA as
follows.
A transfusion service is a facility that is part of either
a hospital or an independent clinical laboratory, that performs
compatibility tests, stores and distributes blood components, but is
not engaged in the routine collection or preparation of blood or plasma
except for therapeutic collections or separation of recovered plasma or
red blood cells.
A blood establishment is an FDA registered facility or
portion of a facility registered as such with FDA pursuant to 21 U.S.C.
section 510 and 21 CFR part 607 that manufactures blood or blood
products. These include hospital and non-hospital blood banks,
plasmapheresis centers, donor centers, and the laboratories performing
testing for these establishments.
To avoid confusion concerning whether FDA requirements regarding
lookback and quarantine apply to hospital transfusion services, we are
adding those requirements to the hospital conditions of participation.
We have added a paragraph (c)(3) to Sec. 482.27 to include the
following requirements:
Upon notification by the blood bank (blood establishment)
that certain blood and blood products are at increased risk for
transmitting HIV infection, the hospital (transfusion service) must
determine the disposition of the blood or blood product and if it is
holding any of the blood or blood product in inventory. If so, the
hospital must quarantine the blood or blood products until notified by
the blood bank of the results of an FDA-licensed, more specific test or
other followup testing recommended or required by FDA.
The hospital may release the blood or blood product from
quarantine only after notification by the blood bank that the
additional testing was negative for the HIV antibody, absent other
informative test results. If the testing confirms the presence of the
antibody for HIV, the hospital must dispose of the blood and blood
products in accordance with FDA regulations at 21 CFR 606.40 and notify
any patients who received the affected blood or blood products of the
need for HIV testing and counseling. (The FDA final regulation requires
the blood bank to complete the licensed, more specific test for the
antibody to HIV within 30 days and promptly notify the hospital
transfusion service of the test results.)
Comment: Several commenters suggested that any facility receiving
and administering blood or blood products be required to comply with
the same notification requirements as set forth in the proposed rule.
Two commenters also suggested this standard for ambulatory surgical
centers.
Response: When we published the proposed regulation, we
specifically requested public comment regarding the need to develop
similar requirements for other facilities that provide transfusion
services. Although we did not receive specific suggestions, we have
revised Sec. 482.27(c)(4) to clarify that when a hospital (transfusion
service) furnishes blood or blood products to another entity or
appropriate individual, the hospital retains responsibility for patient
notification.
We believe this approach is reasonable and consistent with the
usual path followed by blood from donation to transfusion. As clarified
in FDA regulations, blood establishments (defined in 21 CFR 607.3(c))
collect, screen, and test the blood, prepare blood components or
process blood for further manufacture, and label blood components for
distribution to a transfusion service. The transfusion service is the
entity responsible for determining compatibility with the patient's
sample and sending the blood to the patient's location (for example,
the hospital, clinic, nursing facility, or home setting). In order to
release the blood and blood products for transfusion, the hospital must
crossmatch the blood for compatibility with the patient's sample. In
doing so, the hospital would obtain enough information to enable them
to notify the patient. Thus, the hospital has patient information and a
notification system in place and is in the best position to perform
patient notification.
We note that FDA is adopting the patient notification requirements
for hospitals that do not participate in Medicare and Medicaid. Thus,
all hospitals that administer blood and blood products or release the
blood and blood products must comply with the same patient notification
requirements.
Timeframe for Completing Notification
In the proposed rule, we did not require a specific timeframe for
completion of the notification effort. Rather, we required the hospital
to make several attempts to notify the patient's attending physician
and, if the physician is unavailable or declines to notify, make
several attempts to notify the patient. We indicated in the preamble
that the hospital's notification effort should begin immediately after
receiving the information from the blood bank and be completed within 8
weeks. Although we specifically invited public comment on the
sufficiency of this level of effort, we did not receive enough
information to draw any
[[Page 47426]]
conclusions about existing patient notification activities. In
addition, the information we received indicated fundamental differences
in the viewpoints of the commenters as described below.
Comment: Two commenters agreed with the approach contained in the
proposed rule and did not want the hospital's search for the patient's
physician or the patient to be bound by a specific timeframe. One
commenter suggested that we only include the following requirements in
the final rule: (1) Require that hospitals have written procedures for
notifying patients; (2) provide for an appropriate, knowledgeable
person to talk with the patient if the physician cannot be reached or
chooses not to be involved; and (3) require that the notice be
expeditious and confidential and include recommendations to seek HIV
testing and counseling. Another commenter suggested that we require
only that the hospital exercise due diligence and document its
notification efforts.
Response: In order to respond to these commenters, we consulted
with FDA on the best approach to the notification timeframe. We have
decided to include a specific timeframe for completion of the
notification effort in order to prevent hospitals from making sporadic
efforts over a protracted period of time and to provide a reasonable
minimum standard (Sec. 482.27(c)(5)). We believe requiring at least
three attempts to notify the physician and, as necessary, three
attempts to notify the patient within 8 weeks is reasonable. Since
patient notification by the hospital rarely will be necessary, we do
not believe that requiring as many as six notification attempts will be
burdensome to hospitals.
Comment: One commenter asserted that the search could be performed
in less than 8 weeks depending on a hospital's ability to locate
records and contact the patient by mail. Still another commenter
questioned whether we had considered the possible delay in starting
treatment that may occur because of the 8-week period allowed for
notification and expressed concern that an 8-week delay could
contribute to individuals unknowingly transmitting HIV. One commenter
indicated that four or five attempts over a 3- to 5-day period would be
sufficient while another commenter suggested that we require a 12-week
timeframe based on their concern that the physician might decline at
the end of the 8 weeks and leave little time for the hospital to
perform the notification.
Response: We believe that most, if not all, notifications would be
accomplished with relatively little effort and that three attempts
should be sufficient in most cases. On the other hand, if a hospital
has made a good faith effort of at least three attempts but is not able
to locate the patient within 8 weeks, we do not expect the hospital to
continue its search. Of course, there is no limit on how much time a
hospital may choose to expend on this effort.
We do not intend for the hospital to use the entire 8 weeks to
attempt to locate a physician who, at the end of the 8-week period, may
be determined to be unavailable. Rather, we intend that the majority of
the 8 weeks be used to locate and notify the patient. We recommend that
the hospital promptly make three attempts within one week to notify the
physician. If the hospital is unable to locate the physician or the
physician does not agree to notify the patient, the hospital should
promptly start attempts to locate the patient.
In addition, it would be inappropriate for the physician to wait
until the end of the 8-week period to inform the hospital that he or
she is unwilling to notify the patient. In most cases, we believe that
the hospital will contact the physician by telephone and the physician
will make an immediate decision to agree or decline to notify the
patient. However, if the physician is not able to make an immediate
decision, the physician should indicate his or her decision within 1
week of the hospital's request. In this way, it is reasonable to expect
the hospital to locate and notify the patient in the remaining 7 weeks.
We are aware that there may be instances where the hospital's
notification efforts will extend beyond the 8-week period due to
circumstances beyond the hospital's control. For example, a physician
who agrees to notify the patient may later inform the hospital that he
or she was unable to notify the patient or the patient may not respond
timely to notification efforts because he or she is away from home. In
these cases, the hospital must document in the patient's medical record
the extenuating circumstances that prevented patient notification
within the 8-week timeframe (Sec. 482.27(c)(5)).
Comment: One commenter questioned whether patient notification is
necessary if several years have passed after receipt of a transfusion,
or whether the hospital can establish timeframes after which patient
notification need not be made.
Response: Section 610.46(a) of the FDA regulation published
elsewhere in this Federal Register defines the quarantine and
notification process to be followed by blood establishments supplying
blood to hospitals. Under this rule, when a blood establishment learns
of a change in the HIV status of a donor, the blood establishment must
determine if any prior donations meet the quarantine and notification
requirements set forth in 21 CFR 610.46(a) and, as appropriate, inform
the hospital(s) that received any prior donations from the donor. Once
the blood establishment notifies the hospital(s), we do not believe
that there is ever a time that patient notification need not be
attempted. It is only when the physician or the hospital cannot locate
the patient that the process may come to an end.
Role of the Physician in the Notification Process
Comment: One commenter suggested that we require any physician who
wishes to participate in the Medicare or Medicaid program to assume the
responsibility for notifying the patient and providing or making
available appropriate HIV counseling to the patient. Another commenter
requested that we indicate the consequences for physicians who fail to
notify the patient.
Response: Although we believe that it is appropriate for attending
physicians to notify their patients, we do not have authority under
current law to require that physicians do so. Thus, while it is true
that there are no Federal penalties imposed on physicians who decline
or do not take appropriate steps to notify the patient, we believe most
physicians will choose to notify the patient and voluntarily inform the
hospital whether notification occurred. Since we have an agreement with
each Medicare and Medicaid participating hospital and the law
authorizes us to include provisions such as these under the hospital
conditions of participation, we have determined that if the physician
does not agree to notify the patient, the hospital must assume
responsibility for patient notification.
Comment: Several commenters wanted clarification regarding when a
physician could decline to notify the patient. Many commenters
disagreed with permitting the physician the option to decline
notification. Four commenters stated that this policy contradicts
principles of continuity of care and sound medical practice. One
commenter asserted that no physician will notify patients if given the
option and that the requirement for hospitals to notify patients when
physicians decline removes any incentive for the physicians to
participate in the notification process.
Response: In the interest of continuity of care and sound medical
practice, we believe that most physicians will notify
[[Page 47427]]
their patients. However, we continue to believe there could be
legitimate reasons why a physician might refuse to notify the patient;
for example, the physician determines that the patient has moved to
another State and it would be difficult for the physician to identify
HIV counseling and testing programs in the patient's new location, or
the physician has had very limited or no contact with the patient in
several years.
Comment: Several commenters asked us to publish a definition of
``attending physician'' to clarify who should be responsible for
patient notification.
Response: In Sec. 482.27(c)(4), we have included the phrase
``physician of record'' in parentheses next to the term ``attending
physician.'' Although many physicians may have contact with a patient
in the course of a hospital stay, the admitting physician is identified
on the admission form. We believe that this physician is the
``physician of record'' and should be responsible for the notification.
However, if the physician who orders the transfusion is not the same
physician as the physician identified on the admitting form, the
hospital may ask either physician to perform the notification.
Comment: One commenter questioned the role the hospital plays in
determining whether a physician provided information and referred the
patient for counseling. One commenter asked that we specify whether the
hospital is obligated to complete any part of the notification that the
physician fails to carry out. Additionally, the commenter questioned
how the hospital would know what the physician had done.
Response: Under this regulation, when the physician accepts
responsibility for the notification, the hospital is not required to
follow up with the physician to determine whether patient notification
occurred. Since the hospital may not be aware of the information the
physician provides, we cannot require that the hospital complete the
notification. In light of physicians' professional relationship with
hospitals, we believe physicians will inform the hospital whether
notification occurred. If the physician informs the hospital that he or
she was unable to notify the patient, the hospital must proceed with
patient notification.
Comment: One commenter wanted to know at what point the hospital
resumes responsibility for notification if the physician is unable to
contact the patient. Two commenters questioned whether the physician is
required to inform the hospital of the results of notification, for
example, whether the physician was unable to locate the patient,
whether the patient was tested, and the results of the testing.
Response: Although we believe that the physician, as part of his or
her professional responsibility, will inform the hospital of the
results of notification, he or she is not required to do so. If the
physician accepts responsibility for notification, and later informs
the hospital that the patient was not notified, the hospital must
attempt notification, regardless of the time that elapsed after the
hospital first notified the physician.
Some State or local health groups may require further followup and
other epidemiological information but release of information is
dependent upon State and local laws, the medical practice, and the
patient-physician relationship. Finally, having the physician notify
the hospital of the results of testing of the referred patient is
outside the scope of the notification requirements of this regulation.
Comment: One commenter noted that the laws in his State require the
physician to provide information to the patient regarding blood
products in advance of any non-emergency transfusion and, when the
physician orders an HIV test, to obtain the patient's informed consent.
Response: While these precautions are indeed important to the risk
management of blood and blood products, they do not remove the need for
notification by the hospital or physician of possible contamination.
Comment: One commenter indicated that assigning patient
notification responsibility to the hospital means that a clinician must
be identified to handle the cases declined by the physician. Several
commenters questioned whether the appropriate individual to notify the
patient should be limited to someone with medical experience or whether
the hospital may designate any nonmedical personnel to perform these
notifications. One commenter indicated that the physician is the only
individual who should notify the patient, while another commenter noted
that the infection control representative in his facility is
responsible for notification. Another commenter requested that we
permit the hospital to bypass the doctor/patient relationship if the
physician resists the hospital's request to notify the patient. One
commenter suggested that when the physician declines to notify the
patient, the hospital should use the mail system, rather than have a
hospital employee unknown to the patient, to provide the notification.
Response: We continue to believe it is preferable that notification
be made by a physician with whom the patient has a professional
relationship, such as the attending physician who coordinated the care
during the patient's hospitalization or the physician who ordered the
blood or blood product. Nevertheless, the hospital may designate
another physician or an appropriate hospital representative to inform
the patient. We believe that the hospital in its policies and practices
will designate an appropriate, competent individual to perform this
type of notification such as an infection control officer, a nurse, a
clinical laboratory scientist, an individual with medical expertise who
is not a physician, or a social worker. We note that the hospital must
review any voluntary notification procedures to ensure that they
conform to the requirements of this regulation.
Comment: Several commenters indicated that hospitals should develop
policies to identify the appropriate physician to assist in
notification and counseling, in the event efforts to locate the
attending physician are unsuccessful.
Response: We have revised the regulation to require hospitals to
establish policies and procedures for notification (Sec. 482.27(c)(6)).
The final regulation does not require a hospital to provide HIV testing
or counseling, but merely to refer the patient for testing and
counseling. We expect that the referral for testing and counseling will
be made to a physician or organization that provides high quality HIV
testing and has extensive experience in providing HIV counseling.
Notification Requirements
Comment: We invited comment on whether our proposed rule should be
implemented as part of a Medicare hospital standard or as part of the
FDA requirements applicable to blood establishments. While most
commenters indicated that hospitals, not blood banks, should be
responsible for assuring that patients are properly notified of the
possibility that they have received infectious blood, some commenters
recommended that blood banks should be required to make notification.
Response: Based on the comments we received, we have determined
that the hospital could best perform the notifications since it has
access to medical records. Blood banks that are not departments of
hospitals do not routinely receive hospital patient information. If the
blood bank were a department within the hospital or performed
compatibility testing for the hospital, it would have access to patient
information and could perform the
[[Page 47428]]
notification as designated by hospital policy. Under this final
regulation, blood banks must notify the hospital of receipt of
potentially HIV infectious blood and blood products and hospitals are
responsible for patient notification.
Comment: Two commenters recommended that specific operational
issues should be developed at the hospital level within general
guidelines established by regulation. Another commenter suggested that
the regulation describe what hospitals are expected to accomplish and
let hospitals determine, based on their own experience and
circumstances, how best to notify patients. However, two others
requested that the mechanics of notification be spelled out for
standardization.
Response: As noted previously, we added Sec. 482.27 (c)(4) and
(c)(5) to require three attempts to notify the physician, and, as
necessary, three attempts to notify the patient with 8 weeks. We
believe that, within these parameters, the hospital retains flexibility
to develop its own policies and procedures in order to meet the
notification requirements.
Comment: One commenter indicated that the language of proposed
Sec. 482.27(c)(2) is inconsistent with the preamble because it implies
that the hospital is obligated to notify both the physician and the
patient.
Response: We are clarifying in this final rule that the hospital
must notify the patient only if the physician is unavailable, declines,
or later informs the hospital that he or she was unable to notify the
patient (Sec. 482.27(c)(4)).
Comment: One commenter indicated that a search should be terminated
only after a review is conducted by a hospital-sponsored ``lookback
advisory committee'' composed of relevant specialists and expert staff
members.
Response: While we support the use of an advisory committee to
determine when it is appropriate for patient notification efforts to
cease, we have decided not to adopt this suggestion in the regulation.
We would prefer to allow a hospital flexibility to develop responsible
policies and procedures. Of course, a hospital may choose to
incorporate the commenter's suggested approach into its policies and
procedures.
Comment: Four commenters indicated that there are no requirements
that identify the information to be released during patient
notification. The commenters suggested that we establish uniform and
standard minimum requirements for disclosing information to patients
during the notification process.
Response: We agree and have added Sec. 482.27(c)(6)(iii) to clarify
that when a physician or hospital notifies a patient about the need for
HIV testing and counseling, the patient will also be given the names of
several programs or places in the area where the patient resides that
provide these services. In addition, the patient will be told about any
requirements or restrictions the programs may impose such as whether
the program requires a fee, a physician request form, identification or
public assistance cards, or a residency requirement. In some
situations, the hospital, in conjunction with its advisory groups, will
provide the materials for the physician to use or identify programs
that provide the HIV testing and counseling. Some groups have developed
packages of materials, brochures, and information about the risks of
blood and blood products and how HIV infection is transmitted. The
Centers for Disease Control and Prevention (CDC) National AIDS Hotline
operates a toll-free number (1-800-342-2437) 24 hours a day that the
hospital or physician can give to the patient for more assistance. (The
Hotline offers anonymous, confidential AIDS information to the American
public. Trained information specialists answer questions about HIV
infection and AIDS. The physician or hospital can give the patient the
Hotline number (1-800-342-AIDS/2437 (English); 1-800-344-7432 (Spanish)
and 1-800-243-7889 (TDD/Deaf Access)). We encourage physicians and
hospitals to make available to the patient any additional information
that would be useful to the patient and consult with and obtain
resource materials from programs that are funded by the Ryan White
Comprehensive AIDS Resources Emergency Act, the CDC, county and State
health departments, and AIDS awareness groups.
Privacy and Recordkeeping
Comment: One commenter expressed concern that the proposed
regulation did not address the issue of privacy in recordkeeping,
including access to the information from the Blood Donor Locator
Service (BDLS) operated by the Social Security Administration (SSA),
and blood bank and hospital records. The commenter suggested that, even
though these issues may be addressed elsewhere, they needed to be
restated in this regulation.
Response: Hospital requirements for confidentiality in
recordkeeping are already in existing regulations at Sec. 482.24.
Documents related to notification become part of the patient's medical
record and are subject to the normal safeguards for access, information
release, patient consent, and other precautions for confidential
information, whether in hard copies, films, or computer records. If
there is any doubt about confidentiality or disclosure, a medical
record administrator can be consulted to provide adequate instructions.
In addition, the hospital must establish procedures that conform to all
Federal, State and local laws regarding confidentiality.
Comment: One commenter suggested that the hospital send the
physician a return postcard and ask that the postcard be sent back to
the hospital indicating whether the patient was notified, and, if so,
the date the physician notified the patient.
Response: As noted earlier, we have revised the regulation to
require hospitals to establish policies and procedures for
notification, including requirements for confidentiality
(Sec. 482.27(c)(7)). We have concerns about maintaining patient
confidentiality through use of postcards to convey information about
potentially HIV infectious blood and blood products. Although this
final rule affords the hospital the flexibility to establish policies
and procedures for the notification process, the policies and
procedures must protect patient confidentiality.
Comment: In addition to any State requirements or laws concerning
HIV confidentiality, many commenters recommended that all written
patient notifications be marked ``confidential'' and be sent only by
certified mail. Two commenters asked for a ``return receipt.''
Response: While we would support efforts by hospitals to use
certified mail when written patient notification is necessary, we have
decided not to incorporate this requirement in the regulation.
Similarly, although use of a return receipt would provide the hospital
with confirmation that the individual received the information,
incorporating this specific requirement may conflict with State laws
that require ``marking for confidentiality'' and would limit the
hospital's flexibility to develop a process based on its experience and
circumstances.
Comment: One commenter did not want all patients notified based on
a concern that once a patient's HIV status is known, the patient may be
subjected to ostracism and discrimination in receiving care. Since many
hospitals use universal precautions for infection control, the
commenter believed that there is no need to know the HIV status of
patients. However, information about
[[Page 47429]]
the HIV status could be retained by the patient's physician.
Response: We believe it is important for the patient to know of his
or her potential exposure to HIV so that he or she will be informed of
the need for testing and counseling in order to promote behavior
changes that will reduce the risk for transmission of HIV and to detect
HIV infection in persons so that their need for medical treatment and
other services can be assessed.
Comment: One commenter recommended that we clarify the
documentation needed to be filed by the attending physician and
materials to be developed and retained by the hospital. Another
commenter wanted to know which steps in the process should be
documented, that is, the attempts to notify patients, counseling,
patient referral, etc. One commenter questioned whether compliance can
be evaluated by Medicare, the FDA, or the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO) without specific
documentation requirements for notifying patients of potentially
infectious blood or blood products.
Response: We are not looking for lengthy documentation, but
sufficient recordkeeping that indicates when attempts were made to
notify the patient and the results of those attempts. We are not
prescribing forms that a hospital must use; however, a hospital may
develop its own record forms. We do not believe that additional files
or new systems of data should be kept on this matter. The surveyor, in
determining compliance, must be able to determine satisfactorily that
the manner in which the hospital performs notifications comports with
the regulation.
Comment: One commenter requested that we clarify the type of
information regarding the patient, for example, patient testing
results, that can be shared between physician and hospital.
Response: The hospital and the physician may determine if any
information should be shared. This rule does not require the sharing of
information between the physician and the hospital. Patient testing
results are outside the scope of this regulation.
Comment: One commenter asked for standardized recommendations for
record retention by blood banks and by institutions accepting and
administering blood and blood products. The commenter asserted that his
facility requires that employee health records be kept for 30 years
after terminating employment.
Response: Although a facility may require that employee health
records be kept for 30 years after the employee leaves employment, this
is not the current Federal standard for records involving blood and
blood products. The hospital conditions of participation require that
hospital medical records must be kept at least 5 years
(Sec. 482.24(b)(1)). The notification records and blood bank records
are subject to the same 5-year requirement. Additionally, the FDA
regulations at 21 CFR 606.160(d) require that blood and blood product
records be kept for at least 5 years after processing, or 6 months
after the latest expiration date, whichever is later. Under CLIA, the
laboratory regulations on quality control records for blood and blood
products (Sec. 493.1221) reflect the FDA regulation. Any longer
timeframe for retention of medical records is dependent upon hospital
policies, State laws, computerization, storage space, and
investigational studies.
Comment: Two commenters interpreted the proposed rule as requiring
notification by the hospital when the patient is terminally ill,
debilitated, or celibate, and is not (and has not been) an infection
risk to others. The commenters expressed concern that these patients
would be adversely affected by the notification. The commenter
interpreted the proposed rule to require the hospital to inform the
patient even if the physician caring for the patient, either alone or
in consultation with relatives, believes the harmful effects of
notification exceed the benefits of notification.
Response: We have revised the regulation at Sec. 482.27(c)(8) to
clarify that the physician or hospital may notify a legal
representative designated in accordance with State law. Further, if the
patient is competent, but the physician believes the information should
not be given to the patient and State law permits a legal
representative or relative to receive information on the patient's
behalf (for example, when the patient is under age 18), then the
physician must notify the patient's representative or relative. Upon
learning of the death of a transfusion patient, the hospital must
pursue the notification process to inform the patient's family. Public
health concerns would warrant that the notification process continue
and include the deceased patient's legal representative or relative. It
would not be appropriate for a physician or hospital to determine that
the patient or someone acting on his or her behalf need not be
informed.
Comment: Three commenters wanted epidemiologic information,
demographics, or other information to be provided to the State health
department or other appropriate entity for patient followup. Another
commenter requested that the blood bank notify the physician and the
regional health departments about potentially HIV infectious blood and
blood products being administered. The commenter referred to the health
department's ability to track various diseases and to provide pre- and
post- counseling of possible HIV-infected individuals.
Response: Disclosure of information to entities other than the
hospital, the patient, and, as appropriate, the patient's legal
representative or relative, is governed by State law and hospital
policies and is outside the scope of this rulemaking.
Comment: One commenter suggested that the notification about a
patient's HIV status be given to good samaritan bystanders. The
commenter stated that there are circumstances when an individual
injured in an accident or fire requires subsequent medical care. When
that care is given and the patient is found to be HIV positive, the
commenter stated that all those who have given the patient medical care
should be informed of the patient's status. The commenter wants State
and Federal regulations to protect health care workers, emergency
medical technicians, and public safety officials.
Response: The comment, while addressing an important public health
and safety issue, is beyond the scope of this regulation. However, the
CDC published a final rule on March 21, 1994 to address this issue (59
FR 13418).
Comment: One commenter wanted the hospital to be informed promptly
by outside blood sources if there is any doubt about its blood supplies
possibly being infected by the HIV virus.
Response: The issue raised by the commenter is addressed in the FDA
final regulation published elsewhere in this Federal Register.
Hospital Agreements With Blood Banks
Comment: One commenter indicated that government intrusion in
mandating agreements between hospitals and blood banks would not permit
the organizations to work out their own agreements. Another commenter
stated that if hospitals are required by regulation to have an
agreement for procurement, transfer, and availability of blood and
blood products, the blood banks would be in a position to impose
additional terms through the agreements that the hospital would not
otherwise wish to accept, for example, an agreement under which a
hospital would never seek indemnification from the blood bank for
infectious blood or
[[Page 47430]]
blood products. Another commenter suggested that his facility
occasionally obtains blood or blood products from a source other than
the blood bank that regularly supplies it. The commenter questioned
whether the hospital is required to have an agreement with all sources
supplying blood to the hospital.
Response: The laboratory requirements at Sec. 493.1277 already
require that in the case of services regularly furnished by an outside
blood bank, the hospital laboratory must have an agreement reviewed and
approved by the director that governs the procurement, transfer, and
availability of blood and blood products. We note that a blood bank
that is part of a hospital is not required to have an agreement with
the hospital administration, but the laboratory still would have
policies of proper practice that meet the FDA regulations and
requirements of other regulatory and accrediting bodies. We intend that
the details of the agreements or practice policies that are worked out
between the blood bank and the hospital be consistent with Federal,
State and local laws. Finally, we recognize that, under certain
circumstances, hospitals may receive blood from a source other than the
blood bank that has an agreement with the hospital. For example, during
a blood emergency, a hospital may receive blood from another blood bank
that may have a surplus of a special blood type that is needed by the
hospital's patient. In this situation, if the blood bank becomes aware
that the blood it furnished the hospital is potentially infected with
HIV, the FDA regulations require the blood bank to notify the hospital.
Comment: One commenter indicated that the blood bank obligations
are better achieved through regulations by the FDA. Further, the
commenter suggested that since requirements change from time to time,
all agreements would need to be changed every time. The commenter also
concluded that establishing requirements by regulation alone is more
flexible and efficient than regulations and contractual agreements.
Response: As noted previously, FDA and HCFA are responsible for
different aspects of ensuring the safety of blood and blood products.
Blood banks are subject to FDA regulations for current good
manufacturing practices and additional standards for the manufacture of
blood and blood components under 21 CFR parts 211 and 600, 601, 606,
610, and 640. HCFA regulations cover quality control, health and safety
issues, and adequacy of laboratory services. Since the hospital has
access to medical records and it is preferable that the notification is
made by an individual with whom the patient has a professional
relationship, such as the attending physician who coordinated the care
during the patient's hospitalization, we believe that the requirements
of this regulation should be addressed through the hospital conditions
of participation. Agreements can be written flexibly so that any
changes in FDA or HCFA requirements can be incorporated into operating
procedures rather than by constructing a new contractual agreement.
Comment: One commenter recommended that the SSA BDLS be expanded
and adapted to provide assistance in mandated lookback programs to
locate patients. Another commenter asked that the SSA BDLS program be
available for locating the last address of known sexual partners of
lookback patients if notifying them is determined to be necessary.
Response: The SSA BDLS was implemented to enable States and
authorized blood donation facilities to notify blood donors whose
donations indicate that they are or may be infected with HIV. Section
8008 of the Technical and Miscellaneous Revenue Act of 1988 (Pub. L.
100-647) provides for furnishing only to participating States and
authorized blood donation facilities at their request the last known
personal mailing address of blood donors whose blood donation shows
that they are or may be infected with HIV, if the State or authorized
blood donation facility has been unable to locate the donors. The SSA
BDLS cannot be used for any other purpose. To expand the program to
include obtaining information on the patient or known sexual partner
would require a legislative amendment.
Comment: One commenter stated that the rule did not address
requirements for hospitals that have their own blood banks.
Response: We have clarified in Sec. 482.27(c)(4) that if the
hospital has administered potentially HIV infectious blood and blood
products directly through its own blood bank or under an agreement with
an outside blood bank, the hospital must promptly notify the patient's
physician. We note that a hospital transfusion service that also
functions as a blood establishment, that is, collects and manufactures
blood and blood products, is subject to HCFA's final rule as a
transfusion service and FDA's final rule as a blood establishment.
Contracting for Notification
Comment: Four commenters recommended that we permit a hospital to
formally contract with a blood center to supervise the notification of
the patient, testing, and counseling procedures, if the physician is
unavailable or declines to do so. One commenter mentioned that the
departments of health in three States perform notification and tracing
of HIV/AIDS patients and contacts. Another commenter suggested public
health departments as an alternative for notification and counseling
because of the expertise and mechanisms that are already in place.
Response: There is no barrier to a hospital contracting with
another organization to perform the notification, testing, and
counseling. However, under this rule, the hospital is responsible for
the notification and referral. We are aware that a number of State
departments of health provide notification and tracing of HIV/AIDS
patients and contacts. Nonetheless, we continue to believe that the
hospital and the physician are in a better position to perform the
notification because of their prior involvement with the patient. A
hospital that delegates notification must ensure that the notification
and referral for counseling are performed in accordance with this
regulation. If the blood center or organization fails to comply with
the conditions of participation, the hospital would be subject to a
noncompliance action.
Counseling
Comment: Two commenters stated that some State laws require
specific counseling procedures and clinical information for those
undergoing counseling for HIV testing.
Response: We believe individual State laws should be followed to
provide information and counseling procedures following the
notification process. The notification and referral requirements in the
rule do not conflict with any such State laws.
Enforcement
Comment: One commenter urged us to recognize the Joint Commission
on Accreditation of Healthcare Organizations (JCAHO) and the American
Osteopathic Association (AOA) standards to avoid a second survey by
Medicare.
Response: We have been in contact with the JCAHO and AOA and have
evaluated their standards to ensure comparability with the requirements
in this final regulation. Both organizations plan to incorporate the
new requirements into the 1996 update to their accreditation standards.
Therefore, a hospital accredited by the JCAHO or the AOA would be
deemed to meet the Medicare requirement for the standards
[[Page 47431]]
on potentially HIV infectious blood and blood products. A second survey
by HCFA would not be routinely required. However, if a complaint was
filed regarding a look-back situation and HCFA decided the situation
warranted an investigation, HCFA may authorize a complaint
investigation.
Burden on Hospitals
Comment: One commenter disputed the estimate in the proposed rule
of 1 hour of public reporting burden (58 FR 34980) and suggested that
notification takes more than 1 hour to complete.
Response: We estimated the 1-hour timeframe based on several
assumptions: (1) The records on the patient had already been retrieved,
(2) the physician of record was noted on the admission sheet, and (3)
the hospital had the physician's correct phone number or address. We
anticipated that the phone conversation between the hospital
representative and physician would last approximately 10 minutes. We
inflated this figure to 1 hour because we wanted to include any time
necessary for recalls and wrong numbers. We also considered time
necessary for preparation of written notices and delivery of notices to
the mail room. We expect that a hospital will rarely need to notify a
patient directly, although we recognize that it would take additional
time. We did not receive any comments that cited examples of the time
involved to notify a patient. Some hospitals have computer linkup
between departments and can easily retrieve information. The time
involved for each case also may differ depending upon whether it was a
single unit of blood given to one patient versus a unit of blood that
was separated into several blood products and given to several
patients. If a single unit of blood is separated into several
components or blood products, each individual affected by the donor
represents a separate notification case.
Comment: Two commenters stated that the cost associated with an
additional standard would add an unnecessary regulatory burden.
Response: We disagree that the cost of this standard would be
burdensome. Although initial implementation of notification procedures
will require some expenditure of time and effort, we believe most
hospitals, blood banks, and physicians are currently voluntarily
complying with the requirements of this final regulation. We estimate
that the ongoing cost of complying with this regulation will be small
because the risk of a person being transfused with potentially HIV
infectious blood and blood products is small and declining.
IV. Provisions of the Final Regulations
After consideration of the public comments, we are adopting the
June 1993 proposed rule with the following changes.
We have clarified that when the blood bank notifies the
hospital that certain blood and blood products are at increased risk
for HIV infection, the hospital must determine if it is holding any of
the blood or blood product in inventory. If so, the hospital must
quarantine the blood or blood products until notified by the blood bank
of the results of a licensed, more specific test or other followup
testing recommended or required by FDA. The hospital may release the
blood or blood product from quarantine only after notification by the
blood bank that the licensed, more specific test was negative for HIV
antibody, absent other informative test results. (Sec. 482.27(c)(3))
We have clarified that when patient notification is
necessary, hospitals are required to make three attempts to notify the
patient's attending physician or the physician who ordered the blood or
blood product and ask the physician to notify the patient. If the
physician is unavailable, declines, or later informs the hospital that
he or she was unable to notify the patient, the hospital must make
three attempts to notify the patient. (Sec. 482.27(c)(4)
We have clarified that when a hospital releases blood and
blood products to another entity or appropriate individual for
transfusion, the hospital is responsible for the patient notification
process. (Sec. 482.27(c)(4))
We have specified that notification to a legal
representative or relative of the patient may be appropriate in those
instances permitted by State law or where the patient is deceased.
(Sec. 482.27(c)(8))
We have clarified that we are not requiring the physician
to make the actual counseling appointment for the patient and expanded
the description of the content of notification. (Sec. 482.27(c)(6)(ii)
and (iii))
We have clarified that a hospital's steps to notify must
be initiated promptly and completed within 8 weeks.
(Secs. 482.27(c)(4)(i) and (c)(5))
We have required that hospitals establish policies and
procedures for notification and documentation that conform to Federal,
State, and local laws, including requirements for confidentiality and
for medical records. (Sec. 482.27(c)(7))
We clarified that, if the hospital uses the services of an
outside blood bank, the agreement governing the procurement, transfer,
and availability of blood and blood products must require the blood
bank to promptly notify the hospital about potentially HIV infectious
blood and blood products. (Sec. 482.27(c)(2))
V. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.),
agencies are required to provide 60-day notice in the Federal Register
and solicit public comment before a collection of information
requirement is submitted to the Office of Management and Budget (OMB)
for review and approval. In order to fairly evaluate whether an
information collection should be approved by OMB, the Paperwork
Reduction Act of 1995 requires that we solicit comment on the following
issues:
Whether the information collection is necessary and useful
to carry out the proper functions of the agency;
The accuracy of the agency's estimate of the information
collection burden;
The quality, utility, and clarity of the information to be
collected; and
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Since this final rule contains information collections that are
subject to OMB review under the Paperwork Reduction Act of 1995, we are
soliciting public comment on these information collections as discussed
below.
As discussed in detail section III. of this preamble, we are
requiring in Sec. 482.27(c) that Medicare participating hospitals
undertake certain activities when they learn that they have received
blood or blood products that are at increased risk of transmitting HIV
infection. These activities include the identification and quarantine
of affected blood and blood products that remain in inventory pending
confirmatory testing. If the testing confirms that blood or blood
products the hospital received are potentially HIV infectious, the
hospital must promptly make at least three attempts to notify the
patient's attending physician and ask the physician to inform the
patient of the need for HIV testing and counseling. If the physician is
unavailable, declines, or later informs the hospital that he or she was
unable to notify the patient, the hospital must promptly make at least
three attempts to notify the patient, the patient's surviving relative,
or other person designated in accordance with State law. The hospital
must document in the patient's medical record the notification
[[Page 47432]]
or attempts to give the required notification. Hospitals must establish
policies and procedures for patient notification and documentation that
conform to Federal, State, and local laws, including requirements for
confidentiality. Finally, if the hospital uses the services of an
outside blood bank, the agreement governing procurement, transfer, and
availability of blood and blood products must be revised to require the
blood bank to promptly notify the hospital about potentially HIV-
infectious blood or blood products. We note that the burden associated
with these requirements involves the establishment of a system to
facilitate information collection (that is, the notification and
documentation of notification), but are not themselves information
collections.
These changes would not increase significantly the paperwork and
information collection burden on the approximately 6,400 Medicare-
participating hospitals. We estimate that development of policies and
procedures for handling potentially HIV-infectious blood and blood
products and revision of agreements between hospitals and their blood
banks will increase each hospital's recordkeeping burden by
approximately 2 hours. Since this 2 hour burden is a one-time
occurrence for each hospital, the total burden associated with this
particular requirement is 12,800 hours.
We further estimate that notifying patients and documenting
notification efforts in patients' medical records will take
approximately 1 hour per occurrence. As indicated in section III. of
this preamble, we based this estimate on several assumptions: (1) The
records on the patient had already been retrieved; (2) the physician of
record was noted on the admission sheet; and (3) the hospital had the
physician's correct telephone number or address. The time involved for
each lookback case also may differ depending upon whether it was a
single unit of blood given to one patient versus a unit of blood that
was separated into several blood products and given to several
patients. We considered each individual affected by the donor to be a
separate notification case. FDA has estimated that approximately 60
lookback cases occur annually, with 16 involving patient notification.
These cases are spread over approximately 6,600 hospitals, including
approximately 200 hospitals that do not participate in the Medicare
program. If we assume that all 16 cases involving patient notification
were to occur in Medicare-participating hospitals, this requirement
would increase the recordkeeping burden on these hospitals by a total
of 16 hours.
The total paperwork and reporting burden on Medicare participating
hospitals as a result of the information collection requirements in
this rule is, therefore, estimated to be 12,816 (12,800+16) hours.
Organizations and individuals were given an opportunity to comment
on these information collection requirements at the time the June 30,
1993 rule was published. However, because of the new estimate of the
two-hour recordkeeping burden on hospitals resulting from the need to
establish policies and procedures and to amend agreements with blood
banks, we are again soliciting public comment on these information
collection requirements and providing the 60-day notice. As also stated
in the June 30, 1993 rule, a document will be published in the Federal
Register after Office of Management and Budget approval is obtained.
Organizations and individuals desiring to submit comments on these
information collection and recordkeeping requirements should send them
to HCFA, OFHR, MPAS, C2-26-17, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
VI. Regulatory Impact Statement
Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612), we prepare a regulatory flexibility analysis unless we
certify that a rule will not have a significant economic impact on a
substantial number of small entities. For purposes of the RFA, we
consider hospitals, blood banks, and physicians to be small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 50 beds.
This final rule expands the scope of the notification requirements
to include hospitals that release blood and blood products to another
entity or appropriate individual. Physicians will be asked to inform
the recipient of a potentially HIV infectious blood or blood product of
the need for HIV testing and counseling. If the physician is
unavailable, declines, or informs the hospital that he or she was
unable to notify the patient, the hospital is responsible for
notification. It also requires hospitals to quarantine blood or blood
products collected during the ``window'' period pending completion of
more specific testing.
The most recent estimates of the current HIV risk per unit is 1 in
420,000. These estimates are a dramatic improvement over the 1 in 487
odds that prevailed before HIV testing of the blood supply began in
1985. Appropriate efforts to further reduce the risk have occurred by
public education, improved tests, donor questionnaires, and revised
criteria for donor self-referral. However, it remains possible, despite
the best practices of a blood bank, that a person might donate blood
and blood products early in infection during the ``window'' period, the
time it takes a recently infected person to develop the antibodies that
screening tests are designed to detect. That window period is estimated
to range from a few weeks to 6 months. Section 482.24 (``Condition of
participation: Medical record services.'') currently requires hospitals
to maintain records for a period of 5 years. We expect hospitals will
identify recipients of blood and blood products and meet the
requirements of this rule to the extent the hospitals have records that
permit them to do so.
As for ongoing activities, we anticipate that only a small number
of cases per year can be traced to potentially HIV infectious blood and
blood products, and thus, we do not expect these final regulations will
result in a substantial economic or resource burden on small entities.
In addition, since most hospitals, blood banks, and physicians are
currently voluntarily complying with the requirements of these final
regulations, the ramifications of these final regulations are not
expected to be substantial. Because of the small number of cases
detected, individual hospitals will be required to quarantine blood and
blood products and notify blood recipients in only a few, if any,
cases. Nevertheless, the policies and procedures must be written and
periodically updated to ensure that appropriate and timely quarantine
and patient notification take place. Though not significant, there will
be an additional burden of time and resources on hospitals not
currently involved in the notification process.
We believe the ongoing cost of notification after implementation of
this regulation will not be significant or burdensome because the risk
of a person being transfused with potentially HIV infectious blood and
blood products is declining. Even though this final rule will affect
few people per year, it is
[[Page 47433]]
important that we ensure that potentially infected people are notified
so they may seek appropriate medical care or consider behavior changes
so as not to infect others.
Therefore, we are not preparing analyses for either the RFA or
small rural hospitals since we have determined, and we certify, that
this final rule will not likely have a significant economic impact on a
substantial number of small entities or have a significant impact on
the operations of a substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, this
regulation was not reviewed by the Office of Management and Budget.
Under the provisions of Public Law 104-121, we have determined that
this final rule is not a major rule.
List of Subjects in 42 CFR Part 482
Grant programs--health, Hospitals, Medicaid, Medicare, Reporting
and recordkeeping requirements.
42 CFR part 482 is amended as follows:
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
1. The authority citation for part 482 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart C--Basic Hospital Functions
2. Section 482.27 is amended by adding a new paragraph (c) to read
as follows:
Sec. 482.27 Condition of participation: Laboratory services.
* * * * *
(c) Standard: Potentially infectious blood and blood products--(1)
Potentially HIV infectious blood and blood products are prior
collections from a donor who tested negative at the time of donation
but tests repeatedly reactive for the antibody to the human
immunodeficiency virus (HIV) on a later donation, and the FDA-licensed,
more specific test or other followup testing recommended or required by
FDA is positive and the timing of seroconversion cannot be precisely
estimated.
(2) Services furnished by an outside blood bank. If a hospital
regularly uses the services of an outside blood bank, it must have an
agreement with the blood bank that governs the procurement, transfer,
and availability of blood and blood products. The agreement must
require that the blood bank promptly notify the hospital of the
following:
(i) If it supplied blood and blood products collected from a donor
who tested negative at the time of donation but tests repeatedly
reactive for the antibody to HIV on a later donation; and
(ii) The results of the FDA-licensed, more specific test or other
followup testing recommended or required by FDA completed within 30
calendar days after the donor's repeatedly reactive screening test.
(FDA regulations concerning HIV testing and lookback procedures are set
forth at 21 CFR 610.45-et seq.)
(3) Quarantine of blood and blood products pending completion of
testing. If the blood bank notifies the hospital of the repeatedly
reactive HIV screening test results as required by paragraph (c)(2)(i)
of this section, the hospital must determine the disposition of the
blood or blood product and quarantine all blood and blood products from
previous donations in inventory.
(i) If the blood bank notifies the hospital that the result of the
FDA-licensed, more specific test or other followup testing recommended
or required by FDA is negative, absent other informative test results,
the hospital may release the blood and blood products from quarantine.
(ii) If the blood bank notifies the hospital that the result of the
FDA-licensed, more specific test or other followup testing recommended
or required by FDA is positive, the hospital must dispose of the blood
and blood products in accordance with 21 CFR 606.40 and notify patients
in accordance with paragraph (c)(4) of this section.
(4) Patient notification. If the hospital has administered
potentially HIV infectious blood or blood products (either directly
through its own blood bank or under an agreement described in paragraph
(c)(2) of this section) or released such blood or blood products to
another entity or appropriate individual, the hospital must take the
following actions:
(i) Promptly make at least three attempts to notify the patient's
attending physician (that is, the physician of record) or the physician
who ordered the blood or blood product that potentially HIV infectious
blood or blood products were transfused to the patient.
(ii) Ask the physician to immediately notify the patient, or other
individual as permitted under paragraph (c)(8) of this section, of the
need for HIV testing and counseling.
(iii) If the physician is unavailable, declines to make the
notification, or later informs the hospital that he or she was unable
to notify the patient, promptly make at least three attempts to notify
the patient, or other individual as permitted under paragraph (c)(8) of
this section, of the need for HIV testing and counseling.
(iv) Document in the patient's medical record the notification or
attempts to give the required notification.
(5) Timeframe for notification. The notification effort begins when
the blood bank notifies the hospital that it received potentially HIV
infectious blood and blood products and continues for 8 weeks unless--
(i) The patient is located and notified; or
(ii) The hospital is unable to locate the patient and documents in
the patient's medical record the extenuating circumstances beyond the
hospital's control that caused the notification timeframe to exceed 8
weeks.
(6) Content of notification. The notification given under
paragraphs (c)(4) (ii) and (iii) of this section must include the
following information:
(i) A basic explanation of the need for HIV testing and counseling.
(ii) Enough oral or written information so that the transfused
patient can make an informed decision about whether to obtain HIV
testing and counseling.
(iii) A list of programs or places where the patient can obtain HIV
testing and counseling, including any requirements or restrictions the
program may impose.
(7) Policies and procedures. The hospital must establish policies
and procedures for notification and documentation that conform to
Federal, State, and local laws, including requirements for
confidentiality and medical records.
(8) Notification to legal representative or relative. If the
patient has been adjudged incompetent by a State court, the physician
or hospital must notify a legal representative designated in accordance
with State law. If the patient is competent, but State law permits a
legal representative or relative to receive the information on the
patient's behalf, the physician or hospital must notify the patient or
his or her legal representative or relative. If the patient is
deceased, the physician or hospital must continue the notification
process and inform the deceased patient's legal representative or
relative.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; Program No. 93.774, Medicare--
Supplementary Medical Insurance; and Program No. 93.778, Medical
Assistance Program)
[[Page 47434]]
Dated: July 11, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: July 11, 1996.
Donna E. Shalala,
Secretary.
[FR Doc. 96-22708 Filed 9-6-96; 8:45 am]
BILLING CODE 4120-01-P
Complete official Federal Register PDF
FR Doc. 96-22701 Connection of Terminal Equipment to the Telephone Network
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Page 47434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22701]
=======================================================================
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 68
Connection of Terminal Equipment to the Telephone Network
AGENCY: Federal Communications Commission.
ACTION: Correcting amendments.
-----------------------------------------------------------------------
SUMMARY: This document contains corrections to the final regulations
which related to the connection of terminal equipment to the telephone
network.
EFFECTIVE DATE: September 9, 1996.
FOR FURTHER INFORMATION CONTACT: William von Alven, (202) 418-2342.
SUPPLEMENTARY INFORMATION:
Background
The final regulations that are the subject of these corrections
relate to the means of connection of data terminal equipment to the
telephone network and to the on-hook impedance limitations for all
types of terminal equipment.
Need for Correction
As published, the final regulations contain errors which may prove
to be misleading and are in need of clarification.
List of Subjects in 47 CFR Part 68
Communications equipment, Telephone.
PART 68--CONNECTION OF TERMINAL EQUIPMENT TO THE TELEPHONE NETWORK
Accordingly, 47 CFR Part 68 is corrected by making the following
correcting amendments:
1. The authority citation for Part 68 continues to read as follows:
Authority: Secs 4, 5, 201-5, 208, 15, 218, 226, 227, 303, 313,
314, 403, 410, 602 of the Communications Act of 1934, as amended, 47
U.S.C. 151, 154, 155, 201-5, 208, 215, 218, 226, 227, 303, 313, 314,
403, 404, 410, 602.
Sec. 68.104 [Corrected]
2. In Sec. 68.104, paragraph (b), in the first sentence, the
reference to ``Sec. 68.308(a)(4) (i) or (ii)'' is revised to read
``Sec. 68.308(b)(4) (i) or (ii)''.
Sec. 68.312 [Corrected]
3. In Sec. 68.312, paragraph (b)(2), the reference to ``paragraph
(a)(1)(v)'' is revised to read ``paragraph (b)(1)(v)''.
4. In Sec. 68.312, paragraph (c)(2), in the tenth sentence, the
reference to ``paragraph (a)(2)'' is revised to read ``paragraph
(b)(2)''.
5. In Sec. 68.312, paragraph (d)(1)(iv), the reference to
``paragraph (a)(1)(iv)'' is revised to read ``paragraph (b)(1)(iv)''.
Federal Communications Commission.
William F. Caton,
Acting Secretary.
[FR Doc. 96-22701 Filed 9-6-96; 8:45 am]
BILLING CODE 6712-01-U
Complete official Federal Register PDF
FR Doc. 96-22697 Standard for the Flammability of Children's Sleepwear: Sizes 0 Through 6X; Standard for the Flammability of Children's Sleepwear: Sizes 7 Through 14
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47634-47649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22697]
[[Page 47633]]
_______________________________________________________________________
Part III
Consumer Product Safety Commission
_______________________________________________________________________
16 CFR Parts 1615 and 1616
Flammable Fabrics Act: Children's Sleepwear (Sizes 0-6x, 7-14)
Flammability Standards; Final Rule
Federal Register / Vol. 61, No. 175 / Monday, September 9, 1996 /
Rules and Regulations
[[Page 47634]]
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1615 and 1616
Standard for the Flammability of Children's Sleepwear: Sizes 0
Through 6X; Standard for the Flammability of Children's Sleepwear:
Sizes 7 Through 14
AGENCY: Consumer Product Safety Commission.
ACTION: Final amendments.
-----------------------------------------------------------------------
SUMMARY: The Commission issues final amendments of the flammability
standards for children's sleepwear in sizes 0 through 6X and sizes 7
through 14. The amendments issued below revise the definition of
``children's sleepwear'' in the standard for sizes 0 through 6X to
exclude from the requirements of that standard: garments sized for
infants nine months of age or younger; and tight-fitting sleepwear
garments. The amendments also revise the definition of ``children's
sleepwear'' in the standard for sizes 7 through 14 to exclude tight-
fitting sleepwear garments.1 The amendments define the term
``tight-fitting garment'' in terms of maximum dimensions at specified
locations on garments in sizes for children older than 9 months through
children's size 14.
---------------------------------------------------------------------------
\1\ The Commission voted 2-1 to issue these amendments of the
children's sleepwear flammability standards, Chairman Ann Brown
dissenting.
---------------------------------------------------------------------------
The Commission issues these amendments because it finds that the
existing children's sleepwear standards are not limited to those
sleepwear garments which present an unreasonable risk of burn deaths
and injuries. The Commission concludes that the amendments will afford
consumers a wider selection of sleepwear garments for children without
diminishing the protection provided by the children's sleepwear
standards.
DATES: The amendments will become effective on January 1, 1997.
FOR FURTHER INFORMATION CONTACT: Patricia Fairall, Division of
Regulatory Management, Office of Compliance, Consumer Product Safety
Commission, Washington, DC 20207; telephone (301) 504-0400, extension
1369.
SUPPLEMENTARY INFORMATION:
A. Provisions of Final Amendments
By publication of this notice of final rulemaking, the Commission
amends the Standard for the Flammability of Children's Sleepwear: Sizes
0 through 6X (16 CFR part 1615) and the Standard for the Flammability
of Children's Sleepwear: Sizes 7 through 14 (16 CFR part 1616). The
amendments issued below exempt sleepwear garments sized for children
nine months of age and younger and ``tight-fitting'' sleepwear garments
sized for children older than nine months to children's size 14 from
all requirements of the children's sleepwear flammability standards.
The term ``tight-fitting garment'' is defined by specifying maximum
dimensions for the chest, waist, seat, upper arm, thigh, wrist, and
ankle of the garment for each size from 9-12 months through children's
size 14.
The amendments issued below are similar to proposed amendments
published in the Federal Register of October 25, 1994 (59 FR 53616).
The final amendments differ from the proposal by:
Increasing the size of infant garments exempted from the
current standard for sizes 0 through 6X;
Changing some of the maximum dimensions specified for
tight-fitting garments in children's sizes 6X through 14; and
Eliminating the requirement for a permanent label on
tight-fitting sleepwear garments to advise the purchaser that those
garments are not flame-resistant.
The differences between the proposed and final amendment are
discussed in detail under the heading G. Comments on the Proposed
Amendments.
The amendments issued below become effective on January 1, 1997.
The Commission's finding that this effective date is in the public
interest and the reasons for that finding are set forth under the
heading H. Effective Date. Elsewhere in this issue of the Federal
Register, the Commission has published a notice to continue through
March 9, 1998 a stay of enforcement for close-fitting garments which
are labeled and promoted as underwear.
B. Background
The Flammable Fabrics Act (FFA) (15 U.S.C. 1191 et seq.) authorizes
the issuance of flammability standards for products of wearing apparel
made from fabric to protect the public from unreasonable risks of the
occurrence of fire leading to death, injury, or significant property
damage.
In 1971, the Secretary of Commerce issued a flammability standard
for children's sleepwear in sizes 0 through 6X under the authority of
section 4 of the FFA (15 U.S.C. 1193). The standard was issued to
protect young children from death and serious burn injuries which had
been associated with ignition of sleepwear garments, such as nightgowns
and pajamas, by small open-flame sources. The standard for sleepwear in
sizes 0 through 6X became effective in 1972 and is now codified at 16
CFR part 1615.
In 1973, authority to issue flammability standards under provisions
of the FFA was transferred from the Department of Commerce to the
Consumer Product Safety Commission by section 30(b) of the Consumer
Product Safety Act (CPSA) (15 U.S.C. 2079(b)). In 1974, the Commission
issued a flammability standard for children's sleepwear in sizes 7
through 14. That standard became effective in 1975 and is now codified
at 16 CFR part 1616.
The safety requirements of the two standards are nearly identical.
They prescribe a test which requires that specimens of fabrics, seams,
and trim of children's sleepwear garments must self-extinguish after
exposure to a small open flame. Both standards require manufacturers of
children's sleepwear subject to their provisions to test prototypes of
sleepwear garments with acceptable results before beginning production.
Both standards also require manufacturers to sample and test garments
from regular production. Failure to comply with the sampling and
testing requirements of the standards is a violation of section 3 of
the FFA (15 U.S.C. 1192). The standards do not require or prohibit the
use of any particular type of fabric or garment design as long as the
manufacturer successfully completes the prescribed prototype and
production testing.
C. Garments Subject to the Sleepwear Standards
Both standards define the term ``children's sleepwear'' to mean
``any product of wearing apparel'' in the sizes covered by the standard
``such as nightgowns, pajamas, or similar or related items, such as
robes, intended to be worn primarily for sleeping or activities related
to sleeping.'' As originally issued and as amended below, both
standards exclude diapers and underwear from their coverage. See 16 CFR
1615.1(a) and 1616.2(a).
Under this definition, the coverage of the sleepwear standards is
not limited to children's pajamas, nightgowns, and robes, but also
includes other garments ``intended primarily for sleeping or activities
related to sleeping.'' 16 CFR 1615.1(a), 1616.2(a) During the time that
the standards have been in effect, the Commission staff has responded
to a large number of inquiries from manufacturers and importers of
children's garments about whether particular products are ``children's
[[Page 47635]]
sleepwear'' subject to the standards; or ``underwear,'' which is
specifically excluded from the standards; or ``daywear,'' ``playwear,''
or other categories of non-sleepwear garments, each of which is outside
the scope of the standards.
To provide guidance to the children's garment industry on the scope
of the sleepwear standards, in 1984 the Commission issued policy
statements which discuss the factors the Commission will consider when
determining whether a garment is intended to be worn primarily for
sleeping or related activities.(1) 2 These policy statements are
codified at 16 CFR 1615.64 and 1616.65. Additionally, the staff
developed a pamphlet describing and illustrating various styles of
sleepwear and non-sleepwear garments. This pamphlet was revised from
time to time, most recently in 1989.(2)
---------------------------------------------------------------------------
\2\ Numbers in parentheses identify reference documents in the
List of Relevant Documents at the end of this notice. Requests for
inspection of any of these documents should be made at the
Commission's Public Reading Room, 4330 East-West Highway, room 419,
Bethesda Maryland 20814, or by calling the Office of the Secretary
at (301) 504-0800.
---------------------------------------------------------------------------
During the past several years, many consumers have expressed a
desire to obtain children's garments made from 100 percent untreated
cotton fabric for use as sleepwear. Although the standards do not
prohibit any specific type of fabric in the production of children's
sleepwear, 100 per cent cotton fabric cannot pass the flammability
tests in the standards unless treated with a flame retardant. The
Commission also received information indicating that many parents were
dressing their children in underwear, large T-shirts, or other garments
made of 100 percent untreated cotton rather than traditional sleepwear
manufactured to comply with the sleepwear flammability standards.
These actions by manufacturers and consumers resulted in an
increasing number of children sleeping in garments which did not comply
with the children's sleepwear standards. In view of this trend, the
Commission decided in 1991 to re-examine the scope of the children's
sleepwear standards and to consider amending the definitions of the
term ``children's sleepwear'' in the two standards. The Commission
began this rulemaking proceeding in 1993.
D. Statutory Provisions
Section 4 of the FFA (15 U.S.C. 1193) authorizes the Commission to
issue or amend a flammability standard for a product of wearing apparel
if the Commission finds that a new or amended standard is needed to
protect the public against the unreasonable risk of the occurrence of
fire leading to death, injury, or significant property damage.
Section 4(g) of the FFA (15 U.S.C. 1193(g)) requires publication in
the Federal Register of an advance notice of proposed rulemaking (ANPR)
to begin a proceeding for the issuance or amendment of a flammability
standard. The ANPR must describe the product and the risk of injury
under consideration; summarize the regulatory alternatives being
considered; provide information about existing standards which may be
relevant; invite interested parties to submit an existing standard to
the Commission for publication as the proposed standard or a statement
of intention to develop or modify a voluntary standard to address the
risk of injury under consideration; and solicit written comments on the
risk of injury and regulatory alternatives under consideration.
If the Commission decides to continue the proceeding after
consideration of comments and submissions received in response to the
ANPR, section 4(i) of the FFA (15 U.S.C. 1193(i)) requires publication
in the Federal Register of a notice of proposed rulemaking (NPR). The
NPR must set forth the text of the proposed standard or amendment and a
preliminary regulatory analysis containing a discussion of the
anticipated benefits and costs of the proposed rule and other
regulatory alternatives considered by the Commission. Section 4(d) of
the FFA (15 U.S. C. 1193(d)) specifies that the NPR must provide
interested persons the opportunity to submit written comments and to
request a public hearing for oral presentation of data and opinions
concerning the proposal.
To issue a final standard or amendment, section 4(j) of the FFA (15
U.S.C. 1193(j)) requires the Commission to publish a notice of final
rulemaking setting forth the text of the final rule and the
Commission's final regulatory analysis of costs, benefits, and
regulatory alternatives. Additionally, section 4(b) of the FFA (15
U.S.C. 1193(b)) requires the notice of final rulemaking to contain
findings that the standard or amendment is needed to protect the public
from the unreasonable risk of death, injury, or significant property
damage from fires associated with the product under consideration; is
reasonable, technologically practicable, and appropriate; and is
limited to those fabrics or products which have been determined to
present an unreasonable risk of death, injury, or significant property
damage.
E. Publication of ANPR
The Commission began this proceeding by publication of an ANPR in
the Federal Register of January 13, 1993 (58 FR 4111).(4) The ANPR
identified the products under consideration as children's sleepwear
garments in sizes 0 through 14, and the risk of injury as death or
personal injury from fires resulting from ignition of children's
sleepwear by small open-flame sources.
The ANPR also described the regulatory alternatives being
considered by the Commission. Briefly summarized, the alternatives
were:
(1) Amend the children's sleepwear standards to exempt tight-
fitting sleepwear garments and sleepwear garments in infant sizes.
Children's sleepwear garments exempted from the requirements of the
sleepwear standard would be subject to the provisions of the Standard
for the Flammability of Clothing Textiles (16 CFR Part 1610). That
standard prohibits the manufacture, importation, or sale of garments
which are ``dangerously flammable because of rapid and intense
burning,'' but does not require garments to self-extinguish when
exposed to a small open-flame ignition source.
(2) Issue an enforcement policy statement to announce that the
Commission will not apply the requirements of the children's sleepwear
standards to tight-fitting sleepwear garments and garments in infant
sizes if those garments met the requirements of the clothing textiles
flammability standard.
The ANPR also contained information about other flammability
standards for children's sleepwear; solicited information about
relevant voluntary standards and statements of intention to develop or
modify a voluntary standard; and invited interested persons to submit
written comments on the ANPR.
On the same date the Commission published the ANPR, the Commission
announced that it would not enforce the children's sleepwear standards
in cases involving garments currently being used as sleepwear if those
garments are skin-tight or nearly skin-tight, relatively free of
ornamentation, made from fabrics such as rib knit, interlock knit, or
waffle knit, and labeled as ``underwear.'' 58 FR 4078(5)
In response to the ANPR, the Commission received more than 2,100
written comments from individuals, firms, and organizations. (More than
a third of the comments were identical form letters with space for the
[[Page 47636]]
commenter's name.) Comments were received from all 50 states, the
District of Columbia, Puerto Rico, the U.S. Virgin Islands, and from
United States citizens living abroad.(3), (6), (7) Almost all of these
comments favored modification of the standards to exempt some or all
children's sleepwear garments from their requirements.
In addition to the information provided by commenters, the
Commission also considered information developed or obtained by the
Commission staff. That information included injury data(10);
information about flammability characteristics of various fabrics and
garments(8), (11); and a review of children's sleepwear flammability
standards issued by Australia, Canada, New Zealand and the United
Kingdom.(9), (11)
From its review of burn injury data, the Commission estimates that
on average, about 1,150 children younger than 15 years of age were
treated each year in hospital emergency rooms for burn injuries
associated with clothing during the period from 1980 through 1993. Of
that total, the Commission estimates that each year, about 90 burn
injuries to children were associated with sleepwear, about 860 were
associated with day wear, and about 200 were associated with other
types of clothing or unspecified types of clothing.(10)
On average, each year about four children younger than fifteen
years of age died from fires associated with clothing of all types.(10)
Available information also shows that most thermal burn injuries
associated with sleepwear involved females, whereas most burn injuries
associated with day wear involved males. Thermal burn injuries from
nightwear were usually associated with nightgowns or pajamas that
probably were not tight-fitting.(10)
In 1978, the Commission staff reviewed information about deaths and
injuries associated with sleepwear to children younger than one year of
age. Ten cases involved injuries associated with sleepwear. However,
nine of these cases involved whole-house conflagrations, and the other
involved a home-made garment.(11) Thus, none of these cases involved
risks of injury which the sleepwear standards were intended to address.
F. Proposed Amendments
After consideration of comments received in response to the ANPR,
information compiled by the staff, and information presented at an oral
briefing by the staff, the Commission decided to propose amending the
children's sleepwear standards.
The Commission published a notice to propose amending the
children's sleepwear standards by exempting infant garments and tight-
fitting garments from their requirements on October 25, 1994. (59 FR
53616)(20)
Section 4 of the FFA (15 U.S.C. 1193) authorizes the agency to
issue or amend mandatory requirements for the flammability of wearing
apparel only when such requirements are ``needed to adequately protect
the public against unreasonable risk of the occurrence of fire leading
to death, injury, or significant property damage.'' (Emphasis added.)
Section 4 of the FFA also requires that in order to issue or amend a
standard, the Commission must find, among other things, that the
standard or amendment is ``limited'' to include only those garments
which have been determined to present an ``unreasonable risk'' of burn
deaths or injuries, or significant property damage. Consequently, the
Commission concluded that if the children's sleepwear standards
currently apply to garments which do not present an unreasonable risk
of fire leading to death, injury, or significant property damage, the
scope of the standards could be narrowed to remove those garments from
the coverage of the standards.
That notice proposed to amend the children's sleepwear flammability
standards by exempting:
(1) Garments intended for children six months of age and younger
from the standard for sizes 0 through 6X; and
(2) ``Tight-fitting'' sleepwear garments from the standard for
sizes 0 through 6X and the standard for sizes 7 through 14.
The proposed exemption for infant garments was stated in terms of
maximum dimensions for the chest and length of the garment. The maximum
dimensions specified were selected by considering body sizes of
children approximately six months old, as set forth in ASTM standard D
4910-89, ``Standard Tables of Body Measurements for Infants, Ages 0 to
18 months,'' published by ASTM (formerly the American Society for
Testing and Materials). (12)
The proposed amendments also required that an exempted infant
garment must be labeled to indicate that the garment is intended for
use by a child six months of age or younger.
In addition, the proposed amendments stated that garments in sizes
for infants six months of age or younger must meet the applicable
requirements of the flammability standards for clothing textiles and
vinyl plastic film (16 CFR parts 1610 and 1611).
The proposed amendments defined the term ``tight-fitting garment''
by specifying maximum dimensions for the following parts of the
garment: Chest, waist, seat, upper arm, thigh, wrist, and ankle. The
proposed amendments also required that an exempted tight-fitting
garment must be labeled to indicate its size. The maximum dimensions
specified by the proposed amendments for tight-fitting garments in
sizes for children six to 24 months old were selected by considering
body sizes of children approximately six months old set forth in a
proposed revision of ASTM standard D 4910. (12) The proposed maximum
dimensions for tight-fitting garments in sizes 2 through 6X were based
on dimensions specified in a draft ASTM standard tentatively designated
``Standard Table of Body Measurements for Pre-School Children Sizes 2--
6X/7.''(12) Maximum dimensions specified by the proposed amendments for
tight-fitting garments in sizes 7 through 14 were based on a report of
an anthropometric study of children ranging in age from infancy to the
age of 18 years, conducted in 1977 by the University of Michigan. (12)
To be eligible for the exemption from the requirements of the
children's sleepwear standards, the proposal specified that a tight-
fitting garment be labeled to indicate its size. The proposed
amendments also required that when offered for sale to consumers,
exempted garments in sizes for 6-to-9 months and larger must be clearly
and conspicuously labeled with a statement to advise consumers that the
garment is not flame-resistant and should be tight-fitting for the
safety of the child.
Finally, the proposed amendments required that sleepwear garments
exempted from the flammability requirements as ``tight-fitting''
garments must comply with applicable provisions of the flammability
standards for clothing textiles and vinyl plastic film (16 CFR parts
1610 and 1611).
In a separate notice also published on October 25, 1994 (59 FR
53584), the Commission extended until further notice the stay of
enforcement of the children's sleepwear standards published in 1993 for
cases involving skin-tight or nearly skin-tight garments similar in
design and manufacture to underwear, provided those garments were
labeled and marketed as underwear. (21)
G. Comments on the Proposed Amendments
In response to the proposal to amend the sleepwear standards, the
[[Page 47637]]
Commission received 39 written comments. Some commenters submitted more
than one comment.(22)-(61) Commenters included individual consumers,
students, a physician, a retired Federal employee, manufacturers and
importers of children's sleepwear and other children's garments, an
association of manufacturers of children's sleepwear, the American Burn
Association, the Coalition for American Trauma Care, Fire Prevention
Canada, the International Association of Fire Chiefs, the National
Cotton Council of America, and the Learn Not to Burn Foundation of the
National Fire Protection Association.
Additionally, on April 25, 1995, members of the Commission staff
conducted a public meeting with manufacturers and importers of
children's sleepwear and other children's garments, consumers, and
other interested persons to discuss the proposed amendments.(81)
The following is a summary of the principal issues raised by the
written comments and at the public meeting, and the Commission's
resolution of those issues.
1. Revocation of the Standards
A comment from one manufacturer of children's garments expresses
the view that available injury information does not establish that any
children's sleepwear garments present an unreasonable risk of burn
deaths or injuries to children. This comment urges the Commission to
revoke the standards in their entirety. (25)
When the Department of Commerce issued the flammability standard
for sizes 0 through 6X, it considered injury data collected by the
National Bureau of Standards (now the National Institute of Standards
and Technology) through the Flammable Fabrics Accident Case and Testing
System (FFACTS). From 1967 through January 1973, FFACTS obtained
information about 434 cases involving burn injuries associated with
sleepwear, 101 of which involved children younger than six years of
age. Although FFACTS incidents do not constitute a probability sample,
they document instances in which children were injured in fires
involving sleepwear before issuance of the standard for sizes 0 through
6X. (70)
Unlike FFACTS, the National Electronic Injury Surveillance System
(NEISS) gathers information about injuries by using a probability
sample. For that reason, NEISS data can be reliably projected into
national estimates of injuries associated with products. From burn
injuries to children associated with children's sleepwear during the
years 1980 through 1994 reported by NEISS, the Commission estimates
that during that time period, on average, about 90 children younger
than 15 years of age were treated in hospital emergency rooms each year
for burns associated with children's sleepwear. (70)
The estimated number of burn injuries associated with children's
sleepwear in the years following issuance of the sleepwear standards
has been relatively low. This indicates that the sleepwear standards
have been relatively successful. Therefore, the Commission does not
believe that available injury information supports revocation of the
children's sleepwear standards in their entirety.
A comment from one consumer questions whether use of children's
sleepwear manufactured from man-made fabrics to comply with the
sleepwear standards may increase the risk of sudden-infant-death
syndrome (SIDS). (22) The Commission has reviewed medical publications
concerning SIDS and has found no references which implicate a specific
type of fabric or clothing as a contributing factor to SIDS. (73)
2. Exemption for Infant Garments
The proposed amendments contained provisions to exempt garments for
infants six months of age and younger from the requirements of the
sleepwear standard for sizes 0 through 6X. The proposed amendments
limited the exemption for infant garments to those not exceeding
specified dimensions for the chest and overall length of the garment.
Those dimensions were selected using information about the body size of
children approximately six months old.
Before proposing that exemption, the Commission reviewed
information about burn deaths and injuries to children one year of age
and younger associated with sleepwear. That information included a
study completed in 1978 of 66 burn injuries to children younger than
one year old associated with clothing. In ten cases, the clothing
involved was specifically identified as sleepwear. Nine of those cases
involved whole-house fires; the other involved a home-made garment. The
Commission concluded that none of these cases involved risks of injury
which the sleepwear standard was intended to address. (11)
The Commission also considered information about children's
physical and mental development. That information shows that most
children are not capable of moving themselves until they are about
seven months old. For that reason, children six months of age and
younger are not likely to come within range of small open-flame
ignition sources when an adult is not present. (12)
A comment from the Children's Sleepwear Coalition (a group of
children's sleepwear manufacturers and suppliers) objects to the
proposal to exempt sleepwear garments for infants six months of age and
younger. This comment states that infants are unable to defend
themselves from risks of burn injury, and could be exposed to ignition
sources by adults. Such exposure could occur if adults smoke in their
presence, or place them near a kitchen range or other open flame
source. (30) Comments from two individual manufacturers of children's
sleepwear object to the proposed exemption for similar reasons. (45),
(54)
Comments from two manufacturers of children's sleepwear, an
importer of children's garments, and the National Cotton Council urge
the Commission to expand the scope of the exemption to include garments
for children one year of age and younger. (25), (28), (33), (47) In
support of this position, the comments cite the absence of injuries
associated with sleepwear to children younger than one year of age.
Comments from two manufacturers and one importer of children's
garments state that the proposed amendment to exempt infant sleepwear
garments was not consistent with industry practices for the sizing of
infant clothing. (23), (35), (53) Two of these comments state that the
maximum dimensions based on body measurements of children six months of
age would have the effect of exempting some, but not all, infant
garments. Garments in sizes 0 to three months (or infants ``small''
size) and three to six months (or infants ``medium'' size) would be
exempted by the proposal, but not garments in sizes six to nine months
(or infants ``large'' size). These comments recommend that the
exemption apply to garments intended for infants nine months of age and
younger, thereby exempting all sleepwear garments in infant sizes.
(35), (53)
A comment from one manufacturer of children's garments observed
that infants grow rapidly. This comment states that a garment having
the maximum dimensions for exemption as an ``infant garment'' in the
proposed amendment would fit a six-month-old child for only a short
period of time. This comment states that most parents purchase
children's garments with the expectation that their children will be
able to wear them for a reasonable period of time. (23)
[[Page 47638]]
At the Commission's public meeting on April 25, 1995, several
manufacturers of children's garments stated that parents typically buy
garments one size larger than the age of their children.(81)
After consideration of all of these comments, the Commission
concludes that the proposed exemption of ``infant garments'' should be
included in the final amendments, with some modification. The amendment
of the standard for sizes 0 through 6X issued below defines the term
``infant garment'' as one which is ``sized for a child nine months of
age or younger.''
The Commission proposed to exempt garments for children six-months
of age and younger because information about child development
indicates that until they reach the age of seven months, most infants
are not capable of moving by themselves.(12) Consequently, infants six
months of age and younger are at minimal risk of exposing their
clothing to an ignition source. And, available injury information
reveals an absence of burn injuries associated with sleepwear to
children younger than one year of age which might have been prevented
or reduced by the sleepwear standard.(10), (11)
The Commission recognizes that many parents and other adults
purchase infant garments one or two sizes larger than the age of the
intended wearer, due in part to the rapid rate at which infants grow.
By revising the definition of ``infant garment'' to include garments
sized for children nine months of age and younger, the amendment issued
below exempts garments in sizes frequently purchased for children
approximately six months of age and younger. Exemption of garments
sized for infants nine months of age and younger also makes allowance
for those infants who are slightly larger than the average six-month
old, and assures that a garment purchased for a six-month old will fit
the infant for a reasonable length of time. Additionally, this
modification of the proposed amendment makes the size of exempted
``infant garments'' more compatible with the range of sizes used by
manufacturers of infant garments.
The amendments issued below specify that the maximum length for a
one-piece infant garment shall not exceed 64.8 centimeters (25.75
inches). The maximum dimension for the length of either piece of a two-
piece infant garment is 40 centimeters (15.75 inches). These dimensions
were selected by considering body sizes of children approximately nine
months old set forth in ASTM standard D 4910-95 ``Standard Tables of
Body Measurements for Infants, Sizes 0 to 24 months,'' published by
ASTM (formerly the American Society for Testing and Materials). No
maximum dimension is specified for the chest of an infant garment
exempted by the final amendments because the safety of infant garments
is not dependent on a tight fit.
Exempted garments must comply with the flammability standards for
clothing textiles and vinyl plastic film (16 CFR parts 1610 and 1611),
and bear a label stating the size of the garment in terms of months of
age. If the label is not visible when the garment is offered for sale,
the size of the garment, in months, must appear legibly on the package.
3. Exemption for Tight-Fitting Garments
Comments from the National Cotton Council (33), (40), (48), five
firms which manufacture or import children's sleepwear or other
children's garments (28), (31), (34), (35), (42), (53), and a student
research group (29) generally support issuance of final amendments to
exempt tight-fitting children's sleepwear garments from the
requirements of the sleepwear flammability standards. (Some of these
comments recommend changes to specific provisions of the proposal,
which are discussed below.)
Comments supporting an exemption for tight-fitting garments made
from fabrics which are not flame-resistant state that those garments
provide protection to children from unreasonable risks of burn injuries
for the following reasons:
(1) Incident data do not show burn injuries associated with tight-
fitting sleepwear;
(2) If exposed to an ignition source, tight-fitting garments are
not easily ignited because the body absorbs some of the heat from the
ignition source;
(3) If these garments are ignited, the wearer becomes aware of
ignition almost immediately; and
(4) If ignited, these garments burn slowly because oxygen to
support combustion is available on only one side of the garment.
Comments supporting issuance of final amendments for tight-fitting
garments also observe that flammability standards for children's
sleepwear in effect in Canada, Australia, and New Zealand exempt tight-
fitting pajamas.(33), (40), (48)
In addition, a study cited in the proposal shows that no burn
deaths associated with children's sleepwear have been reported in
Canada since 1987.(33), (63)
Comments from the Children's Sleepwear Coalition (30), (58), five
individual manufacturers of children's sleepwear (45), (46), (54)-(56),
(59), a student research group (27), the Learn Not to Burn Foundation
of the National Fire Protection Association (32), (78), the
International Association of Fire Fighters (36), Fire Prevention Canada
(37), and the Coalition for American Trauma Care (60) assert that the
current low rate of children's deaths associated with ignition of
clothing is evidence that the children's sleepwear standards have been
effective. These comments express concern that exempting tight-fitting
sleepwear garments and thereby allowing them to be made from fabrics
which are not flame-retardant will expose children to an increased risk
of burn deaths and injuries.
Before proposing the amendments, the Commission considered
available data which show a measurable reduction in burn deaths
associated with all types of clothing, including children's sleepwear,
during the past 20 years. (10), (11). Additionally, information about
burn injuries associated with all types of children's clothing from
1980 through 1994 shows that children's sleepwear has been associated
with a relatively small proportion of those injuries. From its
evaluation of this injury information, the Commission concludes that
the children's sleepwear standards have contributed to the relatively
low level of reported burn injuries associated with sleepwear. However,
existing injury information does not support the assertion that
amendment of the standards to exempt tight-fitting garments made from
fabrics which do not pass the flammability test in the children's
sleepwear standards will expose children to a greater risk of burn
injuries.
Flammability standards for children's sleepwear issued by Canada
and three other countries exempt tight-fitting garments. In 1993, the
government of Canada advised the Commission that a proposed five-year
study of burn injuries to assess the effectiveness of the Canadian
sleepwear standard was discontinued before the end of the five-year
period because of a lack of reported burn cases.(63)
When the Commission began this proceeding in 1993, it also
announced that it would not enforce the children's sleepwear standards
in cases involving garments which are skin-tight or nearly skin-tight
and are similar in fabric and design to underwear.(5) That stay was
continued at the time the Commission published the proposed amendments
of the standards.(21) The garments covered by the stay of enforcement
have somewhat larger dimensions than the ``tight-fitting'' garments
defined in the proposed amendments.
[[Page 47639]]
On the basis of injuries reported to the National Electronic Injury
Surveillance System (NEISS), the Commission estimates that about 2,520
children were treated in hospital emergency rooms for burn injuries
associated with clothing during the years 1993 and 1994. During the
years 1991 and 1992, the Commission estimates that approximately 2,760
children were treated in hospital emergency rooms for burn injuries
associated with clothing.(62) Thus, burn injuries associated with the
general category of children's clothing have not increased since the
Commission issued the stay of enforcement.
During the years 1993 and 1994, the Commission received no reports
of any burn injury to a child younger than 15 years of age associated
with a garment which was identified as one covered by the stay of
enforcement. (62)
Additionally, a Canadian study of 174 burn injuries cases
associated with clothing involving children nine years of age or
younger found that closeness of fit and the presence or absence of an
adult at the time of injury were significantly associated with the
severity of the burn injury. Fiber content was not included as a
variable in this study. Burns tended to be more severe in cases
associated with loose-fitting clothing and the absence of an adult.(11)
Accordingly, the Commission concludes that amending the standards
to exempt tight-fitting sleepwear garments made from fabrics which are
not flame-resistant will not create an unreasonable risk of burn
injuries to children.(8), (10), (11), (62), (65)
4. Definition of ``Tight-Fitting Garment''
The proposed amendments defined the term ``tight-fitting garment''
as one which did not exceed specified dimensions in the chest, seat,
upper arm, thigh, wrist, and ankle for each size ranging from 6-to-9
months through children's size 14.
A comment from one manufacturer of children's garments observes
that the maximum dimensions specified for size 6 in the proposal were
larger than the maximum dimensions specified for size 7.(28) The
Commission agrees that the maximum dimensions for size 7 should be
larger than the maximum dimensions for size 6. In the amendments issued
below, maximum dimensions increase continuously from the smallest to
the largest sizes of garments.
Other comments express the view that the maximum dimensions
specified in the proposal for all sizes are too small. One manufacturer
states that the amendments should exempt garments which fit
``reasonably close to the body,'' such as children's polo pajamas,
rather than define the exempted garments by maximum dimensions intended
to result in a ``skin-tight'' fit.(25) An importer suggests that the
maximum dimensions specified for chest, seat, and thigh in all sizes
should be increased by one or two inches.(35)
Before proposing amendments to exempt tight-fitting garments, the
Commission reviewed technical literature indicating that tight-fitting
garments are less likely to contact an ignition source, and if ignited
to burn less rapidly, than loose-fitting clothing.(8) The Commission
also considered burn injury data indicating that injuries associated
with close-fitting garments are generally less severe than those
associated with loose-fitting garments.(11)
Research on the flammability of wearing apparel indicates that fit
and fiber are both important factors affecting a garment's
flammability. The existing provisions of the children's sleepwear
standards address the risk of burn injury by specifying a test for
flame-resistance. Garments made from fabrics which pass the
flammability test of the children's sleepwear standards do not present
an unreasonable risk of injury, regardless of their fit. Similarly,
tight-fitting garments exempted by the amendments issued below do not
present an unreasonable risk of burn injury, even if they are made from
fabrics which do not pass the flammability test of the children's
sleepwear standards.
Section 4(b) of the FFA requires that an amendment of a
flammability standard must be ``stated in objective terms.'' The term
``tight-fitting garment'' in the amendments issued below is defined by
maximum dimensions at specified locations on the garment for each size.
Although these dimensions include adjustments to provide a continuous
increase in dimensions from the smallest to largest sizes, the
dimensions and points of measurement are substantially similar to those
in the notice of proposed rulemaking.
The final amendments also include language in the definition of
``tight-fitting garment'' to assure that the garment will conform
closely to the contour of the body. Provisions of Secs. 1615.1(o)(3)
through (7) and 1616.2(m)(3) through (7) require that the torso of such
garments must fit closely from chest to waist and from waist to seat;
that the sleeves must taper from upper arm to wrist; and that the legs
must taper from thigh to ankle.
Comments from three manufacturers of children's garments recommend
adjustment of the maximum dimensions to allow for fabric shrinkage
after laundering.(25), (28), (31) One of these comments states that if
the maximum dimensions do not include an allowance for shrinkage,
manufacturers may be required to wash garments before offering them for
sale or to use other means to control shrinkage. This comment states
that those measures would be ``expensive,'' but does not provide
quantitative information about the extent of the additional costs.(28)
At the public meeting on April 25, 1995, one importer recommended that
the Commission allow an additional 10 per cent to the maximum
dimensions for shrinkage.(81)
The maximum dimensions for ``tight-fitting garments'' in the
amendments issued below have not been increased to allow for shrinkage
after laundering or to provide a margin of tolerance for manufacturing
variation. Garment shrinkage depends on the type of fiber or fiber-
blend, method of construction, and finishing process used in the
production of the fabric, and the laundering conditions to which the
garment is exposed after wearing. Increasing the maximum dimensions to
allow for shrinkage could reduce the likelihood that garments will be
tight-fitting when worn by children.(72)
Garments made from knit fabrics have the ability to stretch and
adapt to the shape of the body. For this reason, they are suitable,
although not necessarily required, for production of ``tight-fitting
garments'' exempted from the children's sleepwear standards by the
amendments issued below.(72) Additionally, as indicated by one comment,
various means are available to manufacturers to control shrinkage,
although they may result in higher production costs.(28)
5. Labeling
The proposed amendments included in the definition of ``tight-
fitting garment'' a requirement that when displayed for sale to
consumers, the garment must be clearly and conspicuously labeled with
the statement: ``Garment is not flame-resistant. For child's safety,
garment should be tight fitting. Loose-fitting clothing is more likely
to contact an ignition source and burn.''
Comments from a manufacturer and an importer of children's garments
stated that the proposed labeling statement was too lengthy.(25), (35)
At the Commission's public meeting on April 25, 1995, manufacturers
also expressed the view that the proposed labeling statement was too
negative.(81)
A comment from the National Cotton Council states that children's
garments currently bear labels stating size, information about the
manufacturer,
[[Page 47640]]
fiber content, country of origin, and care instructions. This comment
states that the addition of the language specified by the proposed
amendments would require an unsuitably large label for tight-fitting
sleepwear garments.(33)
The same comment suggests that an educational effort to provide
safety information to consumers about tight-fitting sleepwear by use of
hang tags on garments and signs at retail stores would be a less
expensive way to convey safety information about tight-fitting
sleepwear garments to consumers. At the public meeting in April 1995
and in a subsequent written comment, the National Cotton Council stated
that it would work cooperatively with the Commission to develop an
information and education campaign to inform consumers that garment
design is an important factor in burn injuries associated with
children's sleepwear, and that snug-fitting sleepwear that fits close
to the body is a safer choice than loose-fitting garments.(48), (81)
Individual manufacturers of children's garments have also indicated
their willingness to participate in such an effort.
The amendments issued below do not include the proposed labeling
statement for tight-fitting sleepwear garments exempted from the
flammability requirements of the children's sleepwear standards. The
Commission concludes that a well-designed and broadly disseminated
information and education campaign, developed with guidance from the
Commission, will be a better means to inform consumers about
appropriate selection and use of the tight-fitting garments exempted
from the sleepwear standards by the amendments issued below. Such a
campaign can help consumers understand why sleepwear garments which are
not flame-resistant are being offered for sale and the importance of a
tight fit for those garments; that other children's sleepwear garments
which are not tight-fitting but are manufactured to comply with the
sleepwear standards remain available for purchase; and that loose-
fitting garments which are not flame-resistant (such as those made from
untreated cotton and cotton blends) should not be used for children's
sleepwear.
The Commission expects that point-of-sale materials directed to
consumers, including hang-tags on garments, labeling statements on
packaging, and store signs, will be an important component of the
sleepwear industry's information and education effort. The Commission
also expects that another part of this effort will be directed at
retailers to emphasize the necessity for separation of children's
nonsleepwear garments such as underwear, daywear, and playwear from
sleepwear garments manufactured to comply with the standards and tight-
fitting sleepwear garments exempted from those standards by the
amendments issued below. Separation of non-sleepwear garments from
children's sleepwear is necessary to assure that consumers will not
inadvertently purchase a loose-fitting, non-sleepwear garment which is
not flame-resistant when shopping for children's sleepwear.
H. Effective Date
Section 4(b) of the FFA (15 U.S.C. 1293(b)) provides that an
amendment of a flammability standard shall become effective twelve
months after publication of the notice of final rulemaking unless the
Commission makes a finding for good cause that an earlier or later
effective date is in the public interest and publishes the reasons for
that finding.
On May 23, 1996, members of the Commission staff met with
representatives of manufacturers, importers, and retailers of
children's garments, the National Cotton Council, and other interested
parties to discuss technical issues related to the Commission's
decision to amend the children's sleepwear standards. At this meeting,
representatives of the National Cotton Council and some manufacturers
claimed that the amendments should become effective upon publication.
They observed that the amendments do not impose any additional
requirements on firms, but instead exempt certain garments from the
requirements of the children's sleepwear standards that do not present
an unreasonable risk of burn injury. These proponents of an immediate
effective date asserted that many firms are able to begin marketing the
newly exempted sleepwear garments within a short time after issuance of
the final amendments.
Representatives of several importers claimed that their businesses
would need several months or more after publication of the final
amendments to draft specifications, place orders, and receive
merchandise from overseas suppliers. Similarly, representatives of some
domestic manufacturers stated that they would need time to devise
specifications for fabrics, place orders with fabric suppliers, and
receive fabrics to be used in production of the sleepwear garments that
will be exempted from the requirements of the sleepwear standards.
After considering all information concerning an appropriate
effective date, the Commission concludes that the amendments issued
below shall become effective on January 1, 1997. The Commission finds
for good cause that a short delay in the effective date, less than the
one year specified by the FFA, is in the public interest because it
balances the need of some firms for a period of transition in which to
make those adjustments necessary to market the sleepwear garments
exempted by the amendments with the interest of other firms in
marketing those products as soon as possible.
The Commission is aware that many of the firms favoring a delayed
effective date are producers or importers of children's sleepwear
manufactured to comply with the sleepwear flammability standards. The
Commission recognizes the important role which complying sleepwear
plays in preventing burn injuries. The regulations governing the
flammability of material used to make children's sleepwear garments
other than garments covered by these amendments will continue to apply
to garments such as robes and nightgowns. However, a delay in the
effective date of the amendments issued below beyond January 1, 1997,
postpones the availability of tight-fitting cotton and cotton-blend
sleepwear garments, and prolongs the period during which consumers
seeking untreated cotton sleepwear for their children may purchase
alternative garments which pose greater flammability risks. For these
reasons, the Commission concludes that an effective date of January 1,
1997, is appropriate to: (1) Provide a transition period for
manufacturers and importers of complying sleepwear garments who wish to
sell garments permitted by these amendments; and (2) allow all
companies to take advantage of the amendments within a reasonable
period of time.
The Commission has also extended the stay of enforcement of the
sleepwear standards for 18 months for close-fitting garments labeled
and promoted as underwear. The Commission has taken this action to
minimize costs to manufacturers, distributors, and retailers of
children's sleepwear and other garments which may result from
adjustments of inventories of both sleepwear and non-sleepwear garments
which are subject to the stay of enforcement.(67)
I. Final Regulatory Analysis and Required Findings
Section 4(j) of the FFA (15 U.S.C. 1193(j)) requires that a notice
of final rulemaking must include a final regulatory analysis
containing:
[[Page 47641]]
A discussion of potential benefits and costs of the final
rule, including those which cannot be quantified, and an identification
of those persons likely to receive its benefits and bear its costs;
A description of any alternatives to the final rule which
were considered by the Commission together with a summary description
of their potential benefits and costs and a brief explanation of why
these alternatives were not chosen; and
A summary of significant issues raised by comments on the
preliminary analysis, and the Commission's assessment of those issues.
Additionally, section 4(j) requires that the final rule
must include the Commission's findings that:
The benefits expected from the rule bear a reasonable
relationship to its costs;
It imposes the least burdensome requirement which prevents
or adequately reduces the risk of injury for which it is promulgated.
1. Potential Benefits of the Amendments
The amendments issued below will provide consumers a wider choice
of children's sleepwear. Specifically, the amendments will allow
garments intended for children younger than nine months of age and
tight-fitting garments in sizes as large as children's size 14 to be
made from untreated cotton and cotton blends, which may not currently
be used in the production of children's sleepwear. Although a dollar
value cannot be placed on this benefit, the Commission is aware that
large numbers of consumers have expressed a desire for children's
sleepwear made from cotton rather than the man-made fibers used to
produce most sleepwear garments manufactured to comply with the
children's sleepwear flammability standards.(6), (29), (34), (42),
(66), (67)
The amendments will permit consumers to dress their children for
sleeping in the tight-fitting sleepwear garments exempted from the
requirements of the standards instead of loose-fitting underwear,
playwear, or daywear garments. This, in turn, could reduce the risks of
burn injuries and deaths to children because tight-fitting sleepwear
garments present a lower fire risk to children than loose garments
which are not flame-resistant and do not comply with the children's
sleepwear standards. The extent to which such a substitution will occur
is not known, and therefore any resulting benefit is not
quantifiable.(67)
Manufacturers who elect to produce the garments in infant sizes and
tight-fitting garments exempted from the children's sleepwear standards
will benefit from a wider choice of fabrics and the elimination of
requirements for sampling, testing, and recordkeeping under the
sleepwear standards. The Commission is not able to predict the extent
to which manufacturers will elect to produce sleepwear garments
exempted by the amendments issued below. For that reason, the benefits
to manufacturers from increased choice of fabric and elimination of
sampling, testing, and recordkeeping costs cannot be quantified.(67)
2. Potential Costs of the Amendments
Potential costs of the amendments include those related to
temporary disruptions in the production process as manufacturers make
changes needed to produce garments exempted by the amendments.
According to industry sources, those changes could include
recalibration of cutting and sewing machines. Some costs may be
associated with modification of packaging, but they are expected to be
negligible. To minimize disruptions in the production process, the
Commission has extended a stay of enforcement for close-fitting
garments labeled and promoted for sale as underwear for 18 months to
allow manufacturers, distributors, and retailers to dispose of existing
inventories of those garments.(67)
Because the Commission cannot predict the extent to which
manufacturers will elect to produce the sleepwear garments exempted
from the requirements of the children's sleepwear standards, the
Commission is unable to quantify the costs to manufacturers which may
result.(67) However, the amendments do not require manufacturers to
produce the exempted garments. Consequently, the Commission anticipates
that only those firms which find it profitable to produce the exempted
garments will incur the costs required to begin making them.
The amendments issued below permit the manufacture of certain
children's sleepwear garments which will not pass the flammability test
in the children's sleepwear standards. Consequently, the potential
costs of the amendments include the possibility of increased societal
costs resulting from any burn injuries which may be associated with the
exempted garments.(67) However, during the three-year period in which
the stay of enforcement for close-fitting garments has been in effect,
the Commission has received no reports of burn injuries associated with
ignition of those garments.(62) Additionally, Canada's experience with
sleepwear standards which contain provisions similar to those in the
amendments issued below indicates the risk of increased burn injuries
is extremely low.(63) And if consumers dress their children for
sleeping in the tight-fitting garments exempted by the amendments
instead of loose-fitting T-shirts and other loose-fitting garments
which are not flame-resistant and do not comply with the children's
sleepwear standards, risks of burn injuries to children are expected to
decrease.(67)
3. Alternatives to the Amendments
a. Make no change to the standards. The existing children's
sleepwear flammability standards have contributed to the relatively low
level of burn injuries to children associated with clothing.(10)
Additionally, information is available to demonstrate that a number of
burn injuries to children younger than six years of age were associated
with sleepwear before the flammability standard for sizes 0 through 6X
became effective.(70) If the Commission made no change to the
standards, the level of protection against risks of burn injuries to
children associated with children's sleepwear would not be altered.
However, if the Commission does not amend the standards, consumers
will be unable to purchase children's sleepwear garments made from
untreated cotton and cotton blends. Some consumers have expressed a
strong desire to purchase such garments for their children to wear
while sleeping.(6), (29), (34), (42), (66), (67) In addition, if the
Commission does not make changes to the standards, problems related to
their enforcement in cases where garments resemble children's sleepwear
but are marketed and sold as underwear or playwear are expected to
continue.(68) This has been a problem in the past which the changes to
the standard are expected to alleviate. And, to satisfy their desire
for cotton sleepwear for their children, more people may turn to
looser-fitting substitutes which are not flame-resistant and present a
greater risk of burn injury.
b. Continue the stay of enforcement without amending the standards.
On January 13, 1993, the Commission announced that it would not enforce
the children's sleepwear standards in cases involving close fitting
garments which are similar in design and construction to underwear,
relatively free of ornamentation, and are labeled and marketed as
underwear. The Commission continued this stay of enforcement when it
published the notice of proposed rulemaking on October 25, 1994. During
the period that this stay of enforcement has been in effect, the
Commission has not observed any burn injuries to children associated
[[Page 47642]]
with the garments covered by the stay of enforcement.(62)
However, the tight-fitting garments exempted by the amendments
issued below fit more closely than the garments subject to the stay of
enforcement. Additionally, those tight-fitting garments can be marketed
as children's sleepwear. Consequently, the Commission anticipates the
exempted tight-fitting garments would provide better protection against
risks of burn injuries than the garments covered by the stay of
enforcement.(67)
4. Issues Raised by Comments on the Preliminary Regulatory Analysis
a. Potential benefits. A comment from a manufacturer of children's
garments asserts that issuance of final amendments to exempt garments
in infant sizes and close-fitting garments from the children's
sleepwear standards may result in a decrease, rather than an increase
in consumers' choice of sleepwear garments. This comment states that
retailers devote a limited amount of shelf space to children's
sleepwear. If consumers demonstrate a significant preference for cotton
sleepwear garments exempted from the requirements of the standards,
this comment claims that retailers will stock fewer garments
manufactured to comply with the sleepwear standards, and may eventually
stop selling those garments.(59)
As stated above, in 1993 the Commission published a stay of
enforcement of the sleepwear standards in cases involving skin-tight or
nearly skin-tight garments which are similar in design to the tight-
fitting garments exempted by the amendments issued below. Available
marketing data shows that during 1992, the last year before the stay,
sales of traditional children's sleepwear manufactured to comply with
the flammability standards were approximately 123.6 million units.
During 1994, the second year of the stay of enforcement, sales of
traditional children's sleepwear were 123.5 million units.(66)
The Commission concludes that available information about sales of
children's sleepwear does not support the assertion that the amendments
issued below will result in reduced choice to consumers. Additionally,
many parents and children may prefer the comfort of looser-fitting
garments made from flame-resistant fabrics over the tight-fitting
garments made from cotton or cotton blends. Certain styles of
sleepwear, such as nightgowns, robes, and traditional pajamas will
still be required to be made from fabrics which pass the tests of the
sleepwear standards. The Commission does not expect consumers to cease
purchasing these styles of sleepwear.
b. Potential costs. A comment from the American Burn Association
states that the Commission's preliminary regulatory analysis
underestimated the number of burn injuries which may result from the
proposed amendments and consequently the costs to society for treatment
of those injuries. This comment observes that in the notice proposing
the amendments, the Commission estimated that each year about 1,150
children were treated in hospital emergency rooms for burn injuries
associated with clothing of all types. The comment asserts that the
true number of emergency room visits may be as high as 4,000 a year,
citing a study published in the May-June 1995 issue of the Journal of
Burn Care and Rehabilitation.(38)
The Commission observes that the study cited by this comment
reviewed cases involving children referred to burn centers for burn
injuries of all types, and was not limited to burns associated with
ignition of clothing or sleepwear. Accordingly, the estimates of
children's burn injuries treated in emergency rooms made in this
comment are not comparable to those made by the Commission in the
notice of proposed rulemaking.(10) Additionally, the study cited in
this comment does not contain any information from which to predict the
likely effect of the proposed amendments on the number of children's
burn injuries associated with sleepwear.
A comment from The Learn Not to Burn Foundation of the National
Fire Protection Association asserts that increased burn injuries to
children are likely to result if the Commission issues final amendments
of the children's sleepwear standards.(32) That comment sets forth the
following rationale: At present, children's cotton garments suitable
for use as sleepwear are ``sufficiently expensive'' that they are
purchased primarily by consumers with higher incomes. Higher-income
consumers are more likely to have behaviors that offset the increased
risk of burn injury presented by sleepwear garments which do not comply
with the flammability standards. The proposed amendments will reduce
the cost of the exempted sleepwear garments, thereby making them
available to lower-income consumers. According to this comment, ``low
income correlates negatively with all measures of fire risk.''
However, recent marketing and injury information does not support
the expectations expressed in this comment. As noted in the response to
an earlier comment, since the stay of enforcement of the children's
sleepwear standards was issued in 1993, sales of traditional sleepwear
manufactured to comply with the standards has remained relatively
constant. During the same period of time, sales of children's underwear
garments increased from 476 million units in 1992 to 502.4 million
units in 1994. One trade publication attributes this gain in sales of
children's underwear to the use of some of these garments for
sleeping.(66) Underwear and playwear garments subject to the stay of
enforcement are sold by high-volume retailers and discounters at lower
prices than sleepwear which complies with the children's sleepwear
flammability standards.(87) Consequently, these garments have been
available to both higher- and lower-income consumers. Again, during the
time the stay has been in effect, the Commission has received no
reports of burn injuries associated with the garments identified as
subject to the stay.(62)
c. Regulatory alternatives. A comment from a retired Federal
employee states that as an alternative to the exemption of infant
garments from the standards, the Commission should consider elimination
of requirements for testing seam and trim, but continue to require the
fabric used in those garments to meet the flammability requirements of
the standard for sizes 0 through 6X. The comment states that such a
change would have a negligible effect on safety.(26)
The suggestion in this comment would relieve manufacturers of
garments in infant sizes from some, but not all, of the requirements of
the standard for sizes 0 through 6X. However, if fabric used in those
garments remained subject to the flammability requirements of that
standard, untreated cotton and cotton blends could not be used.
As noted above, one of the principal benefits of the amendments
issued below is to provide consumers with a greater choice of sleepwear
garments by permitting the use of those fabrics for production of
certain types of children's sleepwear. The Commission concludes that
the alternative suggested by this comment would significantly reduce
the potential benefits of the amendments issued below, without a
corresponding reduction in their potential costs.(10)
For these reasons, the Commission affirms the conclusion of its
preliminary and final regulatory analysis that the amendments are not
likely to increase societal costs resulting from burn injuries to
children associated with sleepwear.
[[Page 47643]]
5. Findings
After considering all information concerning benefits and costs of
the amendments, including comments on the preliminary regulatory
analysis, the Commission finds the benefits of the amendments issued
below bear a reasonable relationship to their costs. Although these
benefits are not quantifiable, they include increased choice to
consumers in children's sleepwear garments. To the extent that
consumers choose the tight-fitting sleepwear garments permitted by the
amendments rather than loose-fitting garments which are not flame-
resistant, risks of burn injuries to children may be reduced.
The costs of the amendments include some disruption to the
children's sleepwear industry, and the possibility of increased
societal costs of treating burn injuries associated with the garments
exempted by the amendments. By establishing an effective date of
January 1, 1997, and extending the stay of enforcement for certain
close-fitting children's underwear and playwear, the Commission has
minimized costs associated with disruption of the children's sleepwear
industry. For the reasons set forth in the discussion of potential
costs of the amendments and comments on the preliminary regulatory
analysis, the Commission concludes that the potential costs of the
amendment, although unquantifiable, are minimal.
The Commission also finds that the amendments issued below impose
the least burdensome requirements which adequately reduce the risks of
burn injuries to children associated with sleepwear. The Commission has
considered the possibilities of withdrawing the proposed amendment,
with or without extending the stay of enforcement for certain close-
fitting children's underwear and playwear. For the reasons set forth
above in the discussion of regulatory alternatives, the Commission
finds that none of the alternatives considered will provide the
increased choice to consumers at as low a level of risk as the
amendments issued below.
J. Other Statutory Findings
Section 4(b) of the FFA (15 U.S.C. 1193(b)) states that each
flammability standard or amendment shall be based on findings that the
standard or amendment is: Reasonably needed to protect the public
against an unreasonable risk of the occurrence of fire leading to death
or personal injury, or significant property damage; reasonable,
technologically appropriate, and practicable; and limited to those
fabrics, related materials, or products of wearing apparel or interior
furnishing which have been determined to present an unreasonable risk
of fire leading to death, personal injury, or significant property
damage.
After considering all of the information received during this
rulemaking proceeding, the Commission finds that to the extent that the
Standard for the Flammability of Children's Sleepwear: Sizes 0 Through
6X (16 CFR part 1615) and the Standard for the Flammability of
Children's Sleepwear: Sizes 7 Through 14 (16 CFR part 1616) are
applicable to garments intended for children nine months of age or
younger or to the tight-fitting garments described in the amendments
issued below, those standards are not: (i) Reasonably necessary to
protect the public from risks of fire leading to death, personal
injury, or significant property damage; or (ii) limited to the garments
which present that unreasonable risk. After considering the same
information, the Commission also finds that the amendments issued below
are reasonable, technologically practicable, and appropriate.
K. Future Activities
The Commission will continue to monitor closely and thoroughly
information from all available sources concerning burn injuries to
children from sleepwear and other garments. If at any time, the
Commission detects an increase in burn deaths or injuries to children
associated with any of the garments exempted by these amendments, it
will take any appropriate action, including initiation of rulemaking to
broaden the scope of the children's sleepwear flammability standards.
The Commission will also monitor the information and education
campaign undertaken by manufacturers of children's sleepwear and other
garments to assure that it accurately and effectively informs consumers
about the children's sleepwear flammability standards, garments
manufactured to comply with those standards, and the garments exempted
from those standards by the amendments issued below.
L. Stay of Enforcement
The stay of enforcement which was issued on January 13, 1993, and
continued on October 25, 1994, will end on March 9, 1998. A separate
notice published elsewhere in this issue of the Federal Register
provides additional details about the stay of enforcement and its
termination date.
M. Impact on Small Businesses
In accordance with section 605(b) of the Regulatory Flexibility Act
(5 U.S.C. 605(b)), the Commission hereby certifies that the amendments
to the children's sleepwear standards issued below will not have a
significant economic impact on a substantial number of small entities,
including small businesses.
At this time, about 65 firms manufacture or import traditional
children's sleepwear garments, i.e., nightgowns, pajamas, and
robes.(66). The number of firms in the children's sleepwear industry
has not changed substantially in the past several years.(15) About 45
of these firms have fewer than 500 employees and are considered to be
small businesses.(83) None of the firms which are small businesses
market children's sleepwear exclusively. In addition to traditional
children's sleepwear, these firms also manufacture or import other
types of garments such as infantwear, children's underwear and
playwear, and in some cases, adult underwear and lingerie.(83)
For many years, the market for traditional children's sleepwear has
been relatively small but constant. In 1970, the year before
promulgation of the first children's sleepwear standard, sales of all
new children's sleepwear garments amounted to about 1.4 garments per
child younger than 14 years of age.(83) From 1992 through 1994, sales
volume has been about 124 million units, about two garments per child
each year.(84) This sales information reflects a strong preference for
traditional sleepwear by some consumers.
However, if one assumes that most children use several garments
each year for sleeping, a logical inference is that children are using
many garments other than traditional nightgowns and pajamas for
sleeping.
The amendments issued below exempt sleepwear garments sized for
children nine months of age and younger and certain tight-fitting
sleepwear garments from the requirements of the children's sleepwear
standards. The tight-fitting sleepwear garments exempted by the
amendments are similar in fit and appearance to long underwear.
A decision to produce or import the exempted garments woul
FR Doc. 96-22697 Standard for the Flammability of Children's Sleepwear: Sizes 0 Through 6X; Standard for the Flammability of Children's Sleepwear: Sizes 7 Through 14
d entail
minimal costs for any current manufacturer or importer of children's
sleepwear, regardless of size, for several reasons. First, these firms
have an existing customer base for the sleepwear and other garments
which they currently distribute. Second, in the children's sleepwear
industry, design
[[Page 47644]]
and fabric choices are under continuous reassessment; consumer demand
and production costs are important considerations when deciding on the
design and fabric to be used. Usually, only minor capital costs are
involved in making changes to design or material used to produce these
garments.(83)
Firms which decide to produce or import garments exempted from the
sleepwear standards by the amendments issued below will be able to use
untreated fabrics made from cotton and cotton blends which cannot pass
the flammability test of the standards. Additionally, they will avoid
costs of testing and recordkeeping imposed by the standards.
However, no firm is required to produce or import exempted
garments. Firms which decide that demand for the garments exempted by
the amendments does not justify the costs of producing or importing
them will not be required to make any changes to their current
practices.(67)
For these reasons, the Commission concludes that the final
amendments will not likely have a significant economic impact on a
substantial number of small entities, including small businesses.(83)
N. Environmental Considerations
The amendments issued below fall within the categories of
Commission actions described at 16 CFR 1021.5(c) that have little or no
potential for affecting the human environment. The amendments are not
expected to have a significant effect on production processes or on the
types or amounts of materials used for construction or packaging of
children's sleepwear. The amendments will not render existing
inventories unsalable, or require destruction of existing goods. The
Commission has no information indicating any special circumstances in
which these amendments may affect the human environment. For that
reason, neither an environmental assessment nor an environmental impact
statement is required.(67)
List of Subjects in 16 CFR Parts 1615 and 1616
Clothing, Consumer protection, Flammable materials, Infants and
children, Labeling, Records, Textiles, Warranties.
Conclusion
Therefore, pursuant to the authority of section 30(b) of the
Consumer Product Safety Act (15 U.S.C. 2079(b)) and section 4 of the
Flammable Fabrics Act (15 U.S.C. 1193), the Commission hereby amends
title 16 of the Code of Federal Regulations, Chapter II, Subchapter D,
parts 1615 and 1616 to read as follows:
PART 1615--STANDARD FOR THE FLAMMABILITY OF CHILDREN'S SLEEPWEAR:
SIZES 0 THROUGH 6X
1. The authority for part 1615 continues to read as follows:
Authority: Sec. 4, 67 Stat. 112, as amended, 81 Stat. 569-570;
15 U.S.C. 1193.
2. In Sec. 1615.1, Paragraphs (c) through (m) are redesignated
paragraphs (d) through (n), respectively.
3. Section 1615.1 is amended by revising paragraph (a) and adding
new paragraphs (c) and (o) to read as follows:
Sec. 1615.1 Definitions.
(a) Children's Sleepwear means any product of wearing apparel up to
and including size 6X, such as nightgowns, pajamas, or similar or
related items, such as robes, intended to be worn primarily for
sleeping or activities related to sleeping, except:
(1) Diapers and underwear;
(2) ``Infant garments,'' as defined by section 1615.1(c), below;
and
(3) ``Tight-fitting garments,'' as defined by section 1615.1(o),
below.
* * * * *
(c) Infant garment means a garment which:
(1) Is sized for a child nine months of age or younger;
(2) If a one-piece garment, does not exceed 64.8 centimeters (25.75
inches) in length; if a two-piece garment, has no piece exceeding 40
centimeters (15.75 inches) in length;
(3) Complies with all applicable requirements of the Standard for
the Flammability Clothing Textiles (16 CFR Part 1610) and the Standard
for the Flammability Vinyl Plastic Film (16 CFR part 1611); and
(4) Bears a label stating the size of the garment, expressed in
terms of months of age. For example, ``0 to 3 mos.'' or ``9 mos.'' If
the label is not visible to the consumer when the garment is offered
for sale at retail, the same information must appear legibly on the
package of the garment.
* * * * *
(o) Tight-fitting garment means a garment which:
(1) In each of the sizes listed below does not exceed the maximum
dimension specified below for the chest, waist, seat, upper arm, thigh,
wrist, or ankle:
----------------------------------------------------------------------------------------------------------------
Chest Waist Seat Upper arm Thigh Wrist Ankle
----------------------------------------------------------------------------------------------------------------
Size 9-12 mos
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 48.3 48.3 48.3 14.3 26.7 10.5 13
(inches)....................... (19) (19) (19) (5\5/8\) (10\1/2\) (4\1/8\) (5\1/8\)
----------------------------------------------------------------------------------------------------------------
Size 12-18 mos
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 49.5 49.5 50.8 14.9 28.3 10.5 13.1
(inches)....................... (19\1/2\) (19\1/2\) (20) (5\7/8\) (11\1/8\) (4\1/8\) (5\1/8\)
----------------------------------------------------------------------------------------------------------------
Size 18-24 mos
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 52.1 50.8 53.3 15.6 29.5 11 13.6
(inches)....................... (20\1/2\) (20) (21) (6\1/8\) (11\5/8\) (4\1/4\) (5\3/8\)
----------------------------------------------------------------------------------------------------------------
[[Page 47645]]
Size 2
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 52.1 50.8 53.3 15.6 29.8 11.4 14
(inches)....................... (20\1/2\) (20) (21) (6\1/8\) (11\3/4\) (4\1/2\) (5\1/2\)
----------------------------------------------------------------------------------------------------------------
Size 3
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 53.3 52.1 56 16.2 31.4 11.7 14.9
(inches)....................... (21) (20\1/2\) (22) (6\3/8\) (12\3/8\) (4\5/8\) (5\7/8\)
----------------------------------------------------------------------------------------------------------------
Size 4
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 56 53.3 58.4 16.8 33.0 12.1 15.9
(inches)....................... (22) (21) (23) (6\5/8\) (13) (4\3/4\) (6\1/4\)
----------------------------------------------------------------------------------------------------------------
Size 5
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 58.4 54.6 61.0 17.5 34.6 12.4 16.8
(inches)....................... (23) (21\1/2\) (24) (6\7/8\) (13\5/8\) (4\7/8\) (6\5/8\)
----------------------------------------------------------------------------------------------------------------
Size 6
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 61.0 55.9 63.5 18.1 36.2 12.7 17.8
(inches)....................... (24) (22) (25) (7\1/8\) (14\1/4\) (5) (7)
----------------------------------------------------------------------------------------------------------------
Size 6X
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 62.9 57.2 65.4 18.7 37.8 13.0 18.7
(inches)....................... (24\3/4\) (22\1/2\) (25\3/4\) (7\3/8\) (14\7/8\) (5\1/8\) (7\3/8\)
----------------------------------------------------------------------------------------------------------------
Note: Maximum dimensions are calculated by placing the garment on a horizontal, flat surface with the outer
surface of the garment exposed, measuring the distances between the points specified below; and multiplying
that value by two:
Chest--measure distance from arm pit to arm pit.
Waist--on one-piece garment, measure at the narrowest location between arm pits and crotch. On two-piece
garment, measure width at the bottom of the upper piece, and the top of the lower piece.
Seat--on one-piece garment, measure at widest location between waist and crotch. On two-piece garment, take this
measurement on lower piece only.
Upper arm--measure at a line perpendicular to the sleeve. Extending from the outer edge of the sleeve to the arm
pit.
Thigh--measure at a line perpendicular to the leg extending from the outer edge of the leg to the crotch.
Wrist--measure the width of the end of the sleeve, if intended to extend to the wrist.
Ankle--measure the width of the end of the leg, if intended to extend to the ankle.
(2) Has no item of fabric, ornamentation or trim, such as lace,
appliques, or ribbon, which extends more than 6 millimeters (\1/4\
inch) from the point of attachment to the outer surface of the garment;
(3) Has sleeves which do not exceed the maximum dimension for the
upper arm at any point between the upper arm and the wrist, and which
diminish in width gradually from the upper arm to the wrist;
(4) Has legs which do not exceed the maximum dimension for the
thigh at any point between the thigh and the ankle, and which diminish
in width gradually from the thigh to the ankle;
(5) In the case of a one-piece garment, has a width which does not
exceed the maximum dimension for the chest at any point between the
chest and the waist and which diminishes gradually from the chest to
the waist; and has a width which does not exceed the maximum dimension
for the seat at any point between the seat and the waist and which
diminishes gradually from the seat to the waist;
(6) In the case of a two-piece garment has an upper piece with a
width which does not exceed the maximum dimension for the chest at any
point between the chest and the bottom of that piece and which
diminishes gradually from the chest to the bottom of that piece; in the
case of an upper piece with fastenings, has the lowest fastening within
15 centimeters (6 inches) of the bottom of that piece;
(7) In the case of a two-piece garment, has a lower piece with a
width which does not exceed the maximum dimension for the seat at any
point between the seat and the top of the lower piece and which
diminishes gradually from the seat to the top of that piece;
(8) Complies with all applicable requirements of the Standard for
the Flammability of Clothing Textiles (16 CFR part 1610) and the
Standard for the Flammability of Vinyl Plastic Film (16 CFR part 1611);
and
(9) Bears a label stating the size of the garment in terms of age
in months, or by child's size; for example: ``Size 9 to 12 mos.'' or
``Size 2.'' If the label is not visible to the consumer when the
garment is offered for sale at retail, the same information must appear
legibly on the package of the garment.
[[Page 47646]]
PART 1616--STANDARD FOR THE FLAMMABILITY OF CHILDREN'S SLEEPWEAR:
SIZES 7 THROUGH 14
1. The authority for part 1616 continues to read as follows:
Authority: Sec. 4, 67 Stat. 112, as amended, 81 Stat. 569-570;
15 U.S.C. 1193.
2. Section 1616.2 is amended by revising paragraph (a) and adding a
new paragraph (m), to read as follows:
Sec. 1616.2 Definitions.
In addition to the definitions given in section 2 of the Flammable
Fabrics Act, as amended (sec. 2, 81 Stat. 586; 15 U.S.C. 1191), the
following definitions apply for the purposes of this Standard:
(a) Children's sleepwear means any product of wearing apparel size
7 through 14, such as nightgowns, pajamas, or similar or related items,
such as robes, intended to be worn primarily for sleeping or activities
related to sleeping, except:
(1) Diapers and underwear; and
(2) ``Tight-fitting garments'' as defined by section 1616.2(m),
below.
* * * * *
(m) Tight-fitting garment means a garment which:
(1) in each of the sizes listed below does not exceed the maximum
dimension specified below for the chest, waist, seat, upper arm, thigh,
wrist, or ankle:
----------------------------------------------------------------------------------------------------------------
Chest Waist Seat Upper arm Thigh Wrist Ankle
----------------------------------------------------------------------------------------------------------------
Size 7 Boys \1\
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 63.5 58.4 66 18.7 37.2 13.0 18.7
(inches)....................... (25) (23) (26) (7\3/8\) (14\5/8\) (5\1/8\) (7\3/8\)
----------------------------------------------------------------------------------------------------------------
Size 7 Girls
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 63.5 58.4 67.3 18.7 38.7 13.0 18.7
(inches)....................... (25) (23) (26\1/2\) (7\3/8\) (15\1/4\) (5\1/8\) (7\3/8\)
----------------------------------------------------------------------------------------------------------------
Size 8 Boys \1\
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 66 59.7 67.3 19.4 38.4 13.3 19.1
(inches)....................... (26) (23\1/2\) (26\1/2\) (7\5/8\) (15\1/8\) (5\1/4\) (7\1/2\)
----------------------------------------------------------------------------------------------------------------
Size 8 Girls
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 66 59.7 71.1 19.4 41.3 13.3 19.1
(inches)....................... (26) (23\1/2\) (28) (7\5/8\) (16\1/4\) (5\1/4\) (7\1/2\)
----------------------------------------------------------------------------------------------------------------
Size 9 Boys \1\
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 68.6 61.0 69.2 20 39.7 13.7 19.4
(inches)....................... (27) (24) (27\1/4\) (7\7/8\) (15\5/8\) (5\3/8\) (7\5/8\)
----------------------------------------------------------------------------------------------------------------
Size 9 Girls
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 68.6 61.0 73.7 20 42.6 13.7 19.4
(inches)....................... (27) (24) (29) (7\7/8\) (16\3/4\) (5\3/8\) (7\5/8\)
----------------------------------------------------------------------------------------------------------------
Size 10 \1\ Boys
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 71.1 62.2 71.1 20.6 41.0 14 19.7
(inches)....................... (28) (24\1/2\) (28) (8\1/8\) (16\1/8\) (5\1/2\) (7\3/4\)
----------------------------------------------------------------------------------------------------------------
Size 10 Girls
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 71.1 62.2 76.2 20.6 43.8 14 19.7
(inches)....................... (28) (24\1/2\) (30) (8\1/8\) (17\1/4\) (5\1/2\) (7\3/4\)
----------------------------------------------------------------------------------------------------------------
Size 11 \1\ Boys
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 73.7 63.5 73.7 21 42.2 14.3 20
(inches)....................... (29) (25) (29) (8\1/4\) (16\5/8\) (5\5/8\) (7\7/8\)
----------------------------------------------------------------------------------------------------------------
[[Page 47647]]
Size 11 Girls
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 73.7 63.5 78.7 21 45.1 14.3 20
(inches)....................... (29) (25) (31) (8\1/4\) (17\3/4\) (5\5/8\) (7\7/8\)
----------------------------------------------------------------------------------------------------------------
Size 12 Boys 1
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 76.2 64.8 76.2 21.6 43.5 14.6 20.3
(inches)....................... (30) (25\1/2\) (30) (8\1/2\) (17\1/8\) (5\3/4\) (8)
----------------------------------------------------------------------------------------------------------------
Size 12 Girls
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 76.2 64.8 81.3 21.6 46.7 14.6 20.3
(inches)....................... (30) (25\1/2\) (32) (8\1/2\) (18\1/2\) (5\3/4\) (8)
----------------------------------------------------------------------------------------------------------------
Size 13 Boys
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 78.7 66 78.7 22.2 44.8 14.9 20.6
(inches)....................... (31) (26) (31) (8\3/4\) (17\5/8\) (5\7/8\) (8\1/8\)
----------------------------------------------------------------------------------------------------------------
Size 13 Girls
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 78.7 66 83.8 22.2 47.6 14.9 20.6
(inches)....................... (31) (26) (33) (8\3/4\) (18\3/4\) (5\7/8\) (8\1/8\)
----------------------------------------------------------------------------------------------------------------
Size 14 Boys 1
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 81.3 67.3 81.3 22.9 46 15.2 21
(inches)....................... (32) (26\1/2\) (32) (9) (18\1/8\) (6) (8\1/4\)
----------------------------------------------------------------------------------------------------------------
Size 14 Girls
----------------------------------------------------------------------------------------------------------------
Maximum dimension:
Centimeters.................... 81.3 67.3 86.4 22.9 49.5 15.2 21
(inches)....................... (32) (26\1/2\) (34) (9) (19\1/2\) (6) (8\1/4\)
----------------------------------------------------------------------------------------------------------------
1 Garments not explicitly labeled and promoted for wear by girls must not exceed these maximum dimensions.
Note: Maximum dimensions are calculated by placing the garment on a horizontal, flat surface, with the outer
surface of the garment exposed; measuring the distances at the points specified below; and multiplying that
value by two:
Chest--measure distance from arm pit to arm pit.
Waist--on one-piece garment, measure at narrowest location between arm pits and crotch; on two-piece garment,
measure width at the bottom of the upper piece, and at the top of the lower piece.
Seat--on one-piece garment, measure at widest location between waist and crotch. On two-piece garment, take this
measurement on the lower piece only.
Upper arm--measure at a line perpendicular to the sleeve extending from the outer edge of the sleeve to the arm
pit.
Thigh--measure at a line perpendicular to the leg extending from the outer edge of the leg to the crotch.
Wrist--measure the width of the end of the sleeve, if intended to extend to the wrist.
Ankle--measure the width of the end of the leg, if intended to extend to the ankle.
(2) Has no item of fabric, ornamentation or trim, such as lace,
appliques, or ribbon, which extends more than 6 millimeters (\1/4\
inch) from the point of attachment to the outer surface of the garment;
(3) Has sleeves which do not exceed the maximum dimension for the
upper arm at any point between the upper arm and the wrist and which
diminish in width gradually from the upper arm to the wrist;
(4) Has legs which do not exceed the maximum dimension for the
thigh at any point between the thigh and the ankle, and which diminish
gradually in width between the thigh and the ankle;
(5) In the case of a one-piece garment, has a width which does not
exceed the maximum dimension for the chest at any point between the
chest and the waist and which diminishes gradually from the chest to
the waist; and has a width which does not exceed the maximum dimension
for the seat at any point between the seat and the waist and which
diminishes gradually from the seat to the waist;
(6) In the case of a two-piece garment, has an upper piece with a
width which does not exceed the maximum distance for the chest at any
point between the chest and the bottom of that piece and which
diminishes gradually from the chest to the bottom of that piece; in the
case of an upper piece with fastenings, has the lowest fastening within
15 centimeters (6 inches) of the bottom of that piece;
(7) In the case of a two-piece garment, has a lower piece with a
width which does not exceed the maximum
[[Page 47648]]
dimension for the seat at any point between the seat and the top of the
lower piece and which diminishes gradually from the seat to the top of
that piece;
(8) Complies with all applicable requirements of the Standard for
the Flammability of Clothing Textiles (16 CFR part 1610) and the
Standard for the Flammability of Vinyl Plastic Film (16 CFR part 1611);
and
(9) Bears a label stating the size of the garment; for example
``Size 7.'' If the label is not visible to the consumer when the
garment is offered for sale at retail, the garment size must appear
legibly on the package of the garment.
Effective date: These amendments shall become effective on January
1, 1997, and shall be applicable to garments which are introduced into
commerce on or after that date.
Dated: August 29, 1996.
Todd A. Stevenson,
Deputy Secretary, Consumer Product Safety Commission.
List of Relevant Documents
1. Federal Register notice ``Flammability Standards for
Children's Sleepwear; Statements of Enforcement Policy'' published
by the Consumer Product Safety Commission; 4 pages; March 20, 1984
(49 FR 10249).
2. Supplemental CPSC Staff Guide to the Enforcement Policy
Statements of the Flammability Standard for Children's Sleepwear--
Garment Diagrams and Assessments, published by the Division of
Regulatory Management, Consumer Product Safety Commission; 27 pages;
1989.
3. Memorandum from Terrance R. Karels, ECPA, to the Commission,
entitled ``Children's Sleepwear Project''; 12 pages; July 19, 1994.
4. Federal Register notice ``Standards for the Flammability of
Children's Sleepwear: Sizes 0 Through 6X and 7 Through 14; Advance
Notice of Proposed Rulemaking,'' published by the Consumer Product
Safety Commission; 4 pages; January 13, 1993 (58 FR 4111).
5. Federal Register notice ``Standards for the Flammability of
Children's Sleepwear: Sizes 0 Through 6X and 7 Through 14; Stay of
Enforcement,'' published by the Consumer Product Safety Commission;
1 page; January 13, 1993 (58 FR 4078).
6. Tabular summaries of comments and staff responses to comments
to the Advance Notice of Proposed Rulemaking; 50 pages; July 19,
1994.
7. ``Statement by The Children's Sleepwear Coalition In Response
to the Consumer Product Safety Commission's Advance Notice of
Proposed Rulemaking''; 10 pages; March 25, 1993.
8. Memorandum from Linda Fansler, ESME, to Terrance R. Karels,
ECPA, entitled ``Technical Rationale Supporting Tight-Fitting
Children's Sleepwear Garments''; 11 pages; March 14, 1994.
9. Memorandum from Linda Fansler, ESME, to Terrance R. Karels,
ECPA, entitled ``Recent Conversation Between Staff of Consumer and
Corporate Affairs Canada and Commission Staff''; 4 pages; July 17,
1992.
10. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R.
Karels, ECPA, entitled ``Injury Data Related to the Children's
Sleepwear Standards''; 13 pages; February 8, 1994.
11. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R.
Karels, ECPA, entitled ``Results of Review of Available
Literature,'' and attachments; 21 pages; April 1, 1994.
12. Memorandum from George Sweet, EPHF, to Terrance R. Karels,
ECPA, entitled ``Human Factors Issues Regarding Sleepwear,'' and
attachment; 8 pages; March 8, 1994.
13. Memorandum from George Sweet, EPHF, to Terrance R. Karels,
ECPA, entitled ``Garments Intended for Infants''; 4 pages; July 8,
1994.
14. ``Preliminary Regulatory and Regulatory Flexibility Analyses
for the Proposed Amendments to the Children's Flammability
Standards,'' by Anthony C. Homan, Directorate for Economic Analysis;
7 pages; June, 1994.
15. ``Market Sketch--Children's Sleepwear,'' by Anthony C.
Homan, Directorate for Economic Analysis; 14 pages; March, 1992.
16. Memorandum from Eva S. Lehman, HSPS, to Terrance R. Karels,
ECPA, entitled ``Toxicological Evaluation of Fabrics Used in
Children's Sleepwear''; 3 pages; June 7, 1994.
17. Memorandum from Patricia Fairall, CERM, to Terrance Karels,
ECPA, entitled ``Compliance History--Enforcement of Children's
Sleepwear''; 6 pages; April 20, 1994.
18. Memorandum from James F. Hoebel, Acting Director, ESME, to
Terrance R. Karels, ECPA, entitled ``Amendments to Children's
Sleepwear Standards''; 3 pages; July 7, 1994.
19. Memorandum from Dr. Terry L. Kissinger, EPHA, to Terrance R.
Karels, ECPA, entitled ``Proposed Amendment to Children's Sleepwear
Standards''; 7 pages; July 15, 1994.
20. Federal Register notice ``Standard for the Flammability of
Children's Sleepwear: Sizes 0 Through 6X; Standard for the
Flammability of Children's Sleepwear: Sizes 7 Through 14; Proposed
amendments'' published by the Consumer Product Safety Commission; 11
pages; October 25, 1994 (59 FR 53616).
21. Federal Register notice ``Continuation of Stay of
Enforcement of Standards for the Flammability of Children's
Sleepwear, Sizes 0 Through 6X and 7 Through 14'' published by the
Consumer Product Safety Commission; 1 page; October 25, 1994 (59 FR
53584).
22. Comment on proposed amendments from Aline Farr; 1 page;
September 14, 1994.
23. Comment on proposed amendments from Leonard Schwab, the
Schwab Company; 7 pages; November 29, 1994.
24. Comment on proposed amendments from Kay M. Villa, American
Textile Manufacturers Institute; 1 page; December 22, 1994.
25. Comment on proposed amendments from Carl Schlosser, Salant
Children's Apparel Group; 5 pages; December 28, 1994.
26. Comment on proposed amendments from John F. Krasny; 2 pages;
January 4, 1995.
27. Comment on proposed amendments from student research group,
Florida International University; 2 pages; January 4, 1995.
28. Comment on proposed amendments from Steven E. Loftin, the
William Carter Company; 2 pages; January 5, 1995.
29. Comment on proposed amendments from student research group;
2 pages; January 6, 1995.
30. Comment on proposed amendments from Gerald L. Colliers, the
Children's Sleepwear Coalition; 6 pages; January 8, 1995.
31. Comment on proposed amendments from Mary-beth Boughton,
Oneita Industries; 2 pages; January 9, 1995.
32. Comment on proposed amendments from James McMullen, Learn
Not to Burn Foundation, National Fire Protection Association; 2
pages; January 13, 1995.
33. Comment on proposed amendments from Phillip J. Wakelyn,
Ph.D., National Cotton Council of America; 7 pages; January 9, 1995.
34. Comment on proposed amendments from John Wigodsky, Fruit of
the Loom; 1 page; January 5, 1995.
35. Comment on proposed amendments from Julie Goldscheider,
Impact Imports International, Inc.; 3 pages; January 9, 1995.
36. Comment on proposed amendments from Alfred K. Whitehead,
International Association of Fire Fighters; 1 page; July 31, 1995.
37. Comment on proposed amendments from Frank Albert, Fire
Prevention Canada; 2 pages; August 1, 1995.
38. Comment on proposed amendments from Andrew M. Munster, M.D.,
American Burn Association; 2 pages; August 29, 1995.
39. Comment on proposed amendments from Ramsey J. Choucair,
M.D., Shriners Hospitals for Crippled Children, Burns Institute; 2
pages; August 30, 1995.
40. Comment on proposed amendments from Phillip J. Wakelyn,
Ph.D., National Cotton Council of America; 2 pages; September 8,
1995.
41. Comment on proposed amendments from Anthony R. O'Neill,
National Fire Protection Association, with enclosures; 7 pages;
October 23, 1995.
42. Comment on proposed amendments from Carl Schlosser, Salant
Children's Apparel Group; 1 page; October 10, 1995.
43. Comment on proposed amendments from Mary Jane Murray; 1
page; undated.
44. Comment on proposed amendments from Tim Ackerman, T & G
Associates, Inc., with enclosure; 3 pages; October 25, 1995.
45. Comment on proposed amendments from John McCarthy, Kid Duds,
with enclosure; 3 pages; October 30, 1995.
46. Comment on proposed amendments from Leigh Ann Schwarzkopf,
Kid Duds, with enclosure; 8 pages; January 5, 1996.
47. Comment on proposed amendments from Phillip J. Wakelyn,
Ph.D., National Cotton Council of America; 2 pages; October 30,
1995.
48. Comment on proposed Amendments from Phillip. J. Wakelyn,
Ph.D., National
[[Page 47649]]
Cotton Council of America, with enclosures; 5 pages; December 18,
1995.
49. Comment on proposed Amendments from Phillip. J. Wakelyn,
Ph.D., National Cotton Council of America, with enclosure; 3 pages;
December 21, 1995.
50. Comment on proposed amendments from Leonard S. Bernstein,
Candlesticks, Inc.; 2 pages; October 31, 1995.
51. Comment on proposed amendments from Leonard S. Bernstein,
Candlesticks, Inc., with enclosure; 3 pages; December 14, 1995.
52. Comment on proposed amendments from Leonard S. Bernstein,
Candlesticks, Inc.; 1 page; January 10, 1996.
53. Comment on proposed amendments from Mary-beth Boughton,
Oneita Industries; 2 pages; November 6, 1995.
54. Comment on proposed amendments from G. L. Collier, I-C
Manufacturing Company, with enclosure; 5 pages; December 30, 1995.
55. Comment on proposed amendments from Hy Grubman, InnerWorld;
1 page; December 28, 1995.
56. Comment on proposed amendments from Jack Brownstein,
Waterbury Garment Corporation, with enclosure; 2 pages; January 3,
1996.
57. Comment on proposed amendments from Craig V. Mayer, P.E.; 2
pages; January 5, 1996.
58. Comment on proposed amendments from Gerald L. Collier,
Children's Sleepwear Coalition; 5 pages; January 24, 1996.
59. Comment on proposed amendments from Stephen Schnitzer and
Marvin Sandberg, PCA Apparel; 5 pages; February 6, 1996.
60. Comment on proposed amendments from The Coalition for
American Trauma Care; 2 pages; February 6, 1996.
61. Comment on proposed amendments from Cressie Goff, Sew Sweet
Stitches, and Carol Grider, R.N., with enclosures; 3 pages; February
21, 1996.
62. Memorandum from Terry L. Kissinger, Ph.D., EHHA, to Terrance
R. Karels, ECPA, entitled ``Injury Data Related to the Children's
Sleepwear Standards''; 13 pages; July 12, 1995.
63. Letter from Carole LaCombe, Director, Product Safety Canada,
to Eric C. Peterson, Executive Director, Consumer Product Safety
Commission, concerning Canadian standards for the flammability of
children's sleepwear; 3 pages; September 13, 1993.
64. Memorandum from Linda Fansler, ES, concerning telephone
conversation between staff of the Consumer Product Safety Commission
and staff of Consumer and Corporate Affairs Canada on June 18, 1992,
concerning the Canadian standards for the flammability of children's
sleepwear; 3 pages.
65. Memorandum from Linda Fansler, ESME, to Terrance R. Karels,
ECPA, entitled ``Tight Fitting Children's Sleepwear''; 5 pages; July
14, 1995.
66. Memorandum from Terrance R. Karels, Project Manager, to
Warren J. Prunella, Associate Executive Director for Economic
Analysis, entitled ``Sleepwear Market Update''; 2 pages; October 6,
1995.
67. Final Regulatory Analysis for amendments of the children's
sleepwear standards by Terrance R. Karels; 8 pages; July 1995.
68. Memorandum from David Schmeltzer, Assistant Executive
Director for Compliance, to Terrance Karels, Project Manager,
entitled ``Sleepwear Briefing Package''; 4 pages; August 24, 1995.
69. Memorandum from Patricia Fairall, Compliance Officer, to
Terrance Karels, Project Manager, entitled ``Compliance Discussion
of the Proposed Amendments to the Children's Sleepwear Standards'';
2 pages; June 26, 1995.
70. Memorandum from Terry L. Kissinger, Ph.D., EHHA, to Terrance
R. Karels, ECPA, entitled ``Response to Public Comments Received
after Publication of the Notice of Proposed Rulemaking''; 8 pages;
July 12, 1995.
71. Memorandum from George Sweet, EPHF, to Terrance R. Karels,
ECPA, entitled ``Human Factors Responses to Sleepwear NPR
Comments''; 7 pages; May 5, 1995.
72. Memorandum from Linda Fansler, ESME, to Terrance R. Karels,
ECPA, entitled ``Response to Comments''; 3 pages; July 14, 1995.
73. Memorandum from Suad Nakamura, Ph.D., EHPS, to Terrance R.
Karels, Project Manager, entitled ``Children's Sleepwear--Response
to Comments on the Notice of Proposed Rulemaking''; 2 pages; July
19, 1995.
74. Memorandum from Patricia Fairall, Compliance Officer, to
Terrance R. Karels, Program Manager, entitled ``Response to Comments
from Proposed Amendments to the Children's Sleepwear Standards
published in the Federal Register on October 25, 1994''; 5 pages;
June 26, 1995.
75. Memorandum from Terry L. Kissinger, Ph.D., EHHA, to Terrance
R. Karels, ECPA, entitled ``Response to Letter from John Krasny to
James Hoebel''; 5 pages; August 3, 1995.
76. Memorandum from George Sweet, ESHA, to Terrance R. Karels,
ECPA, entitled ``Issues involved in amendment the sleepwear
flammability regulation: Sizing and Labeling''; 3 pages; September
20, 1995.
77. Memorandum from Karen G. Krushaar, OIPA, to Terrance R.
Karels, ECPA, entitled ``Children's Sleepwear Informational
Campaign''; 2 pages; July 11, 1995.
78. Position statement of the National Fire Protection
Association and the Learn Not to Burn Foundation in Opposition to
the Proposed Amendment of the Children's Sleepwear Standards; 5
pages; July 1995.
79. Letter from John F. Krasny to J. F. Hoebel concerning paper
by Vickers, Krasny, and Tovey entitled ``Some Apparel Fire Hazard
Parameters''; 2 pages; July 17, 1995.
80. Memorandum from Linda Fansler, ESME, concerning telephone
conversation with John Krasny on September 20, 1995; 2 pages.
81. Log of public meeting conducted on April 25, 1995,
concerning proposed amendments of the children's sleepwear
flammability standards; 4 pages.
82. Memorandum from James F. Hoebel, Chief Engineer for Fire
Hazards, to Terrance R. Karels, Project Manager, entitled
``Children's Sleepwear''; 3 pages; October 10, 1995.
83. Memorandum from Warren J. Prunella, Associate Executive
Director for Economic Analysis, to file concerning small business
effects of proposed amendments to the children's sleepwear
flammability standards; 3 pages; February 17, 1995.
84. Memorandum from Warren J. Prunella, Associate Executive
Director for Economic Analysis, to Eric A. Rubel, General Counsel,
concerning requirements for Congressional review of final amendments
to the children's sleepwear standards; 3 pages; undated.
85. Vote sheet to accompany briefing package on children's
sleepwear flammability standards; 2 pages; October 11, 1995.
86. Memorandum from Terrance R. Karels, Project Manager, and
Ronald L. Medford, Assistant Executive Director for Hazard
Identification and Reduction entitled ``Questions Regarding
Children's Sleepwear Amendments,'' with attachments; 21 pages;
January 30, 1996.
[FR Doc. 96-22697 Filed 9-6-96; 8:45 am]
BILLING CODE 6355-01-P
Complete official Federal Register PDF
FR Doc. 96-22600 Airworthiness Directives; de Havilland Model DHC-7 Series Airplanes
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47410-47411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22600]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 95-NM-264-AD; Amendment 39-9746; AD 96-18-19]
RIN 2120-AA64
Airworthiness Directives; de Havilland Model DHC-7 Series
Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This amendment adopts a new airworthiness directive (AD),
applicable to certain de Havilland Model DHC-7 series airplanes, that
requires repetitive non-destructive inspections to detect disbonding of
fuselage skin panels, and repair, if necessary. This amendment is
prompted by a report of disbonding on fuselage skin panels, which was
attributed to a manufacturing process error. The actions specified by
this AD are intended to prevent disbonding of the skin panels of the
fuselage, which could result in degradation of the structural
capability of the airplane fuselage.
DATES: Effective October 15, 1996.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of October 15, 1996.
ADDRESSES: The service information referenced in this AD may be
obtained from Bombardier, Inc., Bombardier Regional Aircraft Division,
Garratt Boulevard, Downsview, Ontario, Canada M3K 1Y5. This information
may be examined at the Federal Aviation Administration (FAA), Transport
Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton,
Washington; or at the FAA, New York Aircraft Certification Office,
Engine and Propeller Directorate, 10 Fifth Street, Third Floor, Valley
Stream, New York; or at the Office of the Federal Register, 800 North
Capitol Street, NW., suite 700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Sol Maroof, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft
Certification Office, Engine and Propeller Directorate, 10 Fifth
Street, Third Floor, Valley Stream, New York 11581; telephone (516)
256-7522; fax (516) 568-2716.
SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal
Aviation Regulations (14 CFR part 39) to include an airworthiness
directive (AD) that is applicable to certain de Havilland Model DHC-7
series airplanes was published in the Federal Register on May 21, 1996
(61 FR 25417). That action proposed to require repetitive non-
destructive inspections to detect disbonding of the fuselage skin
panels, and repair, if necessary.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. Due consideration has been given to
the single comment received.
The commenter supports the proposed rule.
Conclusion
After careful review of the available data, including the comment
noted above, the FAA has determined that air safety and the public
interest require the adoption of the rule as proposed.
Cost Impact
The FAA estimates that 50 de Havilland Model DHC-7 series airplanes
of U.S. registry will be affected by this AD, that it will take
approximately 18 work hours per airplane to accomplish the required
actions, and that the average labor rate is $60 per work hour. Based on
these figures, the cost impact of the AD on U.S. operators is estimated
to be $54,000, or $1,080 per airplane, per inspection cycle.
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of the requirements of this AD
action, and that no operator would accomplish those actions in the
future if this AD were not adopted.
Regulatory Impact
The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this action (1) is
not a ``significant regulatory action'' under
[[Page 47411]]
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act. A final evaluation has been prepared
for this action and it is contained in the Rules Docket. A copy of it
may be obtained from the Rules Docket at the location provided under
the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
96-18-19 De Havilland, Inc.: Amendment 39-9746. Docket 95-NM-264-AD.
Applicability: Model DHC-7 series airplanes, serial numbers 003
through 113 inclusive; certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (b) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent disbonding of the skin panels of the fuselage, which
could result in degradation of the structural capability of the
airplane fuselage, accomplish the following:
(a) Within 6 months after the effective date of this AD, perform
a non-destructive inspection to detect disbonding of the fuselage
skin panels, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin S.B. 7-51-1, Revision 'A', dated March
31, 1995.
(1) If no disbonding is detected, repeat the inspection
thereafter at intervals not to exceed 3 years.
(2) If any disbonding is detected, prior to further flight,
repair it in accordance with a method approved by the Manager, New
York Aircraft Certification Office (ACO), FAA, Engine and Propeller
Directorate.
(b) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the New York Aircraft Certification Office
(ACO), FAA, Engine and Propeller Directorate. Operators shall submit
their requests through an appropriate FAA Principal Maintenance
Inspector, who may add comments and then send it to the Manager, New
York ACO.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the New York ACO.
(c) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
(d) The inspections shall be done in accordance with Bombardier
Service Bulletin S.B. 7-51-1, Revision 'A', dated March 31, 1995.
This incorporation by reference was approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part
51. Copies may be obtained from Bombardier, Inc., Bombardier
Regional Aircraft Division, Garratt Boulevard, Downsview, Ontario,
Canada M3K 1Y5. Copies may be inspected at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or
at the FAA, New York Aircraft Certification Office, Engine and
Propeller Directorate, 10 Fifth Street, Third Floor, Valley Stream,
New York; or at the Office of the Federal Register, 800 North
Capitol Street, NW., suite 700, Washington, DC.
(e) This amendment becomes effective on October 15, 1996.
Issued in Renton, Washington, on August 29, 1996.
Bill R. Boxwell,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-22600 Filed 9-4-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-22597 Airworthiness Directives; Piaggio Model P-180 Airplanes
[Federal Register Volume 61, Number 175 (Monday, September 9, 1996)]
[Rules and Regulations]
[Pages 47409-47410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22597]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 61, No. 175 / Monday, September 9, 1996 /
Rules and Regulations
[[Page 47409]]
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 95-NM-256-AD; Amendment 39-9747; AD 96-18-20]
RIN 2120-AA64
Airworthiness Directives; Piaggio Model P-180 Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This amendment adopts a new airworthiness directive (AD),
applicable to certain Piaggio Model P-180 airplanes, that requires
replacement of outflow/safety valves with serviceable valves. This
amendment is prompted by a report of cracking and subsequent failure of
outflow safety valves in the pressurization system. The actions
specified by this AD are intended to prevent such cracking and
subsequent failure of the outflow/safety valves, which could result in
rapid decompression of the airplane.
DATES: Effective October 15, 1996.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of October 15, 1996.
ADDRESSES: The service information referenced in this AD may be
obtained from Allied Signal Aerospace, Technical Publications, Dept.
65-70, P.O. Box 52170, Phoenix, Arizona 85072-2170. This information
may be examined at the Federal Aviation Administration (FAA), Transport
Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton,
Washington; or at the FAA, Los Angeles Aircraft Certification Office,
Transport Airplane Directorate, 3960 Paramount Boulevard, Lakewood,
California; or at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Walter Eierman, Aerospace Engineer,
Systems and Equipment Branch, ANM-130L, FAA, Los Angeles Aircraft
Certification Office, 3960 Paramount Boulevard, Lakewood, California
90712; telephone (310) 627-5336; fax (310) 627-5210.
SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal
Aviation Regulations (14 CFR part 39) to include an airworthiness
directive (AD) that is applicable to certain Piaggio Model P-180
airplanes was published in the Federal Register on March 13, 1996 (61
FR 10292). That action proposed to require replacement of certain
discrepant outflow/safety valves with serviceable valves.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. No comments were submitted in response
to the proposal or the FAA's determination of the cost to the public.
Conclusion
The FAA has determined that air safety and the public interest
require the adoption of the rule as proposed.
Cost Impact
The FAA estimates that 10 Model P-180 airplanes of U.S. registry
will be affected by this AD, that it will take approximately 12 work
hours per airplane to accomplish the required actions, and that the
average labor rate is $60 per work hour. The parts manufacturer has
advised that it will provide replacement parts at no cost to operators.
Based on these figures, the cost impact of the AD on U.S. operators is
estimated to be $7,200, or $720 per airplane.
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of the requirements of this AD
action, and that no operator would accomplish those actions in the
future if this AD were not adopted.
Regulatory Impact
The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this action (1) is
not a ``significant regulatory action'' under Executive Order 12866;
(2) is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and (3) will not have a
significant economic impact, positive or negative, on a substantial
number of small entities under the criteria of the Regulatory
Flexibility Act. A final evaluation has been prepared for this action
and it is contained in the Rules Docket. A copy of it may be obtained
from the Rules Docket at the location provided under the caption
ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
96-18-20 I.A.M. Rinaldo Piaggio S.P.A.: Amendment 39-9747. Docket
95-NM-256-AD.
Applicability: Model P-180 airplanes; equipped with Allied
Signal outflow/safety valves, as specified in Allied Signal
Aerospace Service Bulletins 103742-21-4059 and 103744-21-4060, both
dated March 31, 1995; certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the
[[Page 47410]]
requirements of this AD is affected, the owner/operator must request
approval for an alternative method of compliance in accordance with
paragraph (c) of this AD. The request should include an assessment
of the effect of the modification, alteration, or repair on the
unsafe condition addressed by this AD; and, if the unsafe condition
has not been eliminated, the request should include specific
proposed actions to address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent cracking and subsequent failure of the outflow/safety
valves, which would result in rapid decompression of the airplanes,
accomplish the following:
(a) Within 18 months after the effective date of this AD,
replace the outflow/safety valve in accordance with Allied Signal
Aerospace Service Bulletin 103742-21-4059 (for airplanes equipped
with valves having part number 103742), or 103744-21-4060 (for
airplanes equipped with valves having part number 103744), both
dated March 31, 1995, as applicable.
(b) As of the effective date of this AD, no person shall install
an outflow/safety valve having a part number and serial number
identified in Allied Signal Aerospace Service Bulletin 103742-21-
4059 (for airplanes equipped with valves having part number 103742)
or 103744-21-4060 (for airplanes equipped with valves having part
number 103744), both dated March 31, 1995, on any airplane unless
that valve is considered to be serviceable in accordance with the
applicable service bulletin.
(c) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Los Angeles Aircraft Certification
Office (ACO), FAA, Transport Airplane Directorate. Operators shall
submit their requests through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Los Angeles ACO.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Los Angeles ACO.
(d) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
(e) The replacement shall be done in accordance with Allied
Signal Aerospace Service Bulletin 103742-21-4059, dated March 31,
1995; or Allied Signal Aerospace Service Bulletin 103744-21-4060,
dated March 31, 1995; as applicable. This incorporation by reference
was approved by the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from
Allied Signal Aerospace, Technical Publications, Dept. 65-70, P.O.
Box 52170, Phoenix, Arizona 85072-2170. Copies may be inspected at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW.,
Renton, Washington; or at the FAA, Los Angeles Aircraft
Certification Office, Transport Airplane Directorate, 3960 Paramount
Boulevard, Lakewood, California; or at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(f) This amendment becomes effective on October 15, 1996.
Issued in Renton, Washington, on August 29, 1996.
Bill R. Boxwell,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-22597 Filed 9-4-96; 8:45 am]
BILLING CODE 4910-13-U
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