Reduction of Accreditation Fees for FSIS Accredited Laboratories

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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