[Federal Register Volume 60, Number 75 (Wednesday, April 19, 1995)]
[Rules and Regulations]
[Pages 19491-19492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9592]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR PARTS 318, 381 and 391
[Docket No. 94-033F]
RIN 0583-AB87
Reduction of Accreditation Fees for FSIS Accredited Laboratories
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Confirmation of interim rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is confirming
the interim regulations amending provisions of the Federal meat and
poultry products inspection regulations to reduce the fees charged
participants in the Agency's voluntary Accredited Laboratory Program
(ALP). Non-Federal analytical laboratories are qualified under the ALP
to conduct analyses of official meat and poultry samples. The payment
by laboratories of annual accreditation fees that cover the costs of
the ALP is mandated by the Food, Agriculture, Conservation, and Trade
Act of 1990 (the 1990 Farm Bill), as amended. FSIS determined late last
year that reduced ALP administrative expenditures for fiscal year 1995
would enable the Agency to charge a smaller accreditation fee than it
did last year. Since the amount of the laboratory accreditation fee is
set forth in the regulations, the regulations had to be changed before
the Agency could charge a different fee. To meet fee billing deadlines,
FSIS found it necessary to publish the fee reduction rule on an interim
basis.
The Agency also took the opportunity to make some editorial
corrections to the regulations.
EFFECTIVE DATE: April 19, 1995.
FOR FURTHER INFORMATION CONTACT: Dr. Jess Rajan, Food Safety and
Inspection Service, U.S. Department of Agriculture, Room 516A, Annex
Building, 300 12th Street SW., Washington DC 20250-3700, (202) 205-
0679.
SUPPLEMENTARY INFORMATION:
Background
Section 1327 (7 USC 138f) of the Food, Agriculture, Conservation,
and Trade Act of 1990 (PL 101-624), as amended, known as the 1990 Farm
Bill, requires USDA to charge a nonrefundable accreditation fee for
laboratories seeking accreditation by the Secretary under the authority
of the FMIA or PPIA. The fee is required to be in an amount that
offsets the cost of the ALP administered by FSIS under the authority of
the FMIA and PPIA.
Fees are billed annually on a per-accreditation basis at a rate
that is established by regulation (9 CFR 391.5). The ALP regulations
define an accreditation to be a determination by FSIS that a laboratory
is qualified to analyze official samples of meat and poultry products
for the presence and amount of four food chemistry analytes or a
determination that a laboratory is qualified to analyze official
samples of product for the presence and amount of one of several
classes of chemical residue. The per-accreditation fee for fiscal year
1994 was $3,500.
FSIS projected late last year that the expenses of administering
the ALP during fiscal year 1995 would be less than the expenses for
fiscal year 1994. The reduction came about because of management
savings and, to a lesser extent, a smaller enrollment in the ALP than
anticipated. The Agency determined that the smaller overall cost of
running the program meant that it could reduce the fee per
accreditation. The Agency determined that, for fiscal year 1995, the
fee for original accreditations and renewals would be $2,500.
In order to meet billing deadlines for accreditation renewals,
avoid rebates for renewals paid for at the old rate, and avoid
unnecessary administrative burdens on the Government and industry, the
Agency found it necessary to promulgate an interim rule with request
for comments on December 27, 1994 (59 FR 66446), effective the same
date. The interim rule amended the administrative provisions of the
Federal meat and poultry inspection regulations to change the fee.
Also, some editorial corrections were made to the ALP regulations.
The interim rule provided a 30-day comment period ending January
26, 1995. During this period one comment was received from a trade
association favoring the fee reduction.
Executive Order 12866
This final rule has been determined to be significant and was
reviewed by the Office of Management and Budget under Executive Order
12866.
Executive Order 12778
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. This rule reduces the accreditation fees for non-
Federal analytical chemistry laboratories accredited under the Federal
Meat and Poultry Products Inspection Acts and regulations promulgated
thereunder.
States and local jurisdictions are preempted under the Federal Meat
Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA)
from imposing any requirements with respect to federally inspected
premises and facilities, and operations of such establishments, that
are in addition to, or different than, those imposed under the FMIA or
PPIA. States and local jurisdictions are also preempted under the FMIA
and PPIA from imposing any marking, labeling, packaging, or ingredient
requirements on federally inspected meat or poultry products that are
in addition to, or different than, [[Page 19492]] those imposed under
the FMIA or the PPIA, as well as preempted from imposing, under the
PPIA for poultry products, certain storage and handling requirements.
States and local jurisdictions may, however, exercise concurrent
jurisdiction over meat and poultry products that are outside official
establishments for the purpose of preventing the distribution of meat
or poultry products that are misbranded or adulterated under the FMIA
or PPIA or, in the case of imported articles, which are not at such an
establishment, after their entry into the United States. States and
local jurisdictions may also make requirements or take other actions,
that are consistent with the FMIA and PPIA, with respect to any other
matters regulated under the FMIA and PPIA.
Under the FMIA and the PPIA, States that maintain meat and poultry
inspection programs must impose requirements that are at least equal to
those required under the FMIA or PPIA. These States may, however,
impose more stringent requirements on such State-inspected products and
establishments.
This final rule will have no retroactive effect and applicable
administrative procedures must be exhausted before any judicial
challenge to the application of these provisions. Those administrative
procedures are set forth in 9 CFR Secs. 306.5, 318.21(h), 381.35, and
381.153(h).
Effect on Small Entities
Most of the entities accredited by FSIS that will be affected by
this final rule are large, independent laboratories or official meat
packing establishments or States that own or operate accredited
laboratories.
There are currently approximately 150 laboratories in the FSIS
accredited laboratory program. About three quarters of these are large
entities, with respect to the volume of business, or part of such
entities as large business corporations, State universities, or State
governments. These laboratories provide analytical services to large
and small establishments for analysis of official samples.
Participation in the Agency's Accredited Laboratory Program is
voluntary. The principal burden of the final rule on laboratories will
be the fee charged for FSIS accreditation ($2,500 per accreditation, of
which a laboratory may have more than one) and the minimal billing and
accounting costs. This fee is substantially lower than the fee
previously charged.
Some large laboratories have multiple accreditations for food
chemistry and chemical residues, while many small laboratories are
accredited only for food chemistry. Thus, smaller laboratories (small
entities) tend to pay smaller amounts of accreditation fees than large
laboratories. Balanced against these costs are the revenues from
analyzing official samples, which are likely to be greater because
firms can be expected to pass much of the costs of obtaining
accreditation to clients, and the enhancement of income from other
services provided by the laboratories because of their status as
``accredited by FSIS.'' As a result, the net effect of this rulemaking
on both small and large laboratories will not be significant. The user-
fee costs for having official samples analyzed by accredited
laboratories are passed on to the establishments doing business with
accredited laboratories, or absorbed by the official establishment if
the establishment has an in-house accredited laboratory. Establishments
using the laboratories benefit from the earlier marketing of product
released from official retention. Because of the accreditation fee
reduction authorized by this final rule, the overall benefits to the
meat and poultry industry, including both small and large
establishments, from using accredited laboratories can be expected to
increase very modestly.
It is possible that some small laboratories that are not now
participating in the ALP may choose to apply for the program because of
the lower fee. If they did so, a larger number of accredited
laboratories would be available for use by official establishments,
including small establishments, than there are at present.
For these reasons, the net effects of the final rule, though
beneficial, are not likely to be significant on a substantial number of
small entities.
List of Subjects
9 CFR Part 318
Meat inspection, Laboratory accreditation.
9 CFR Part 381
Poultry and poultry products inspection, Laboratory accreditation.
9 CFR 391
Fees and charges for inspection services, Laboratory accreditation
fees.
Final Rule
For the reasons discussed in the preamble:
Sec. 318.21 [Amended]
1. In part 318, the revisions of Sec. 318.21(c)(3)(ix)(A)(1),
(A)(2), (B), and (C) published December 27, 1994 (59 FR 66446), are
confirmed as final.
Sec. 381.153 [Amended]
2. In part 381, the revisions of Sec. 381.153(c)(3)(ix)(A)(1),
(A)(2), (B), and (C) published December 27, 1994 (59 FR 66446), are
confirmed as final.
Sec. 391.5 [Amended]
3. In part 391, the revision of Sec. 391.5 published December 27,
1994 (59 FR 66446), is confirmed as final.
Done at Washington, DC, on: April 12, 1995.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 95-9592 Filed 4-18-95; 8:45 am]
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