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. 94-033I]

RIN: 0583-AB87

Reduction of Accreditation Fees for FSIS Accredited Laboratories

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim rule with request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending

provisions of the Federal meat and poultry products inspection

regulations to reduce the fees charged participants in the Agency's

Accredited Laboratory Program (ALP). Non-Federal analytical

laboratories are qualified under the ALP to conduct analyses of

official meat and poultry samples. Laboratory accreditation fees that

cover the costs of the ALP are mandated by the Food, Agriculture,

Conservation, and Trade Act of 1990 (the 1990 Farm Bill), as amended.

The same Act mandates annual payment of the fees on the anniversary

date of each accreditation. FSIS has determined that reduced ALP

administrative expenditures for fiscal year 1995 will enable the Agency

to charge a smaller accreditation fee than last year. However, because

the laboratory accreditation fee is set forth in the regulations, the

regulations must be changed before the Agency can charge a different

fee. Since the anniversary date of most current accreditations is

December 13, FSIS would like to begin billing the laboratories at the

reduced rate on that date. FSIS is also making an editorial correction

to the Federal meat and poultry products inspection regulations.

EFFECTIVE DATE: December 27, 1994. Comments must be received by:

January 26, 1995.

ADDRESSES: Send written comments, in triplicate, to Policy, Evaluation

and Planning Staff, ATTN: Diane Moore, FSIS Docket Clerk, room 3171,

South Building, Food Safety and Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250. Oral comments, as provided by the

Poultry Products Inspection Act, should be presented to Dr. Jess Rajan,

Chief, Quality Systems Branch, Chemistry Division, Science and

Technology, (202) 205-0679.

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:

Comments

Interested persons are invited to submit comments concerning this

interim rule. Written comments should be sent in triplicate to the

Policy, Evaluation and Planning Staff and should refer to docket number

94-033I. Any person desiring opportunity for oral presentation of

views, as provided under the Poultry Products Inspection Act, must make

such request to Dr. Rajan so that arrangements may be made for such

views to be presented. A record will be made of all views orally

presented. All comments submitted in response to this interim rule will

be available for public inspection in the FSIS Docket Room, room 3171,

South Agriculture Building, Washington, DC 20250, from 9 a.m. to 12:30

p.m. and from 1:30 p.m. to 4 p.m., Monday through Friday.

Background

To assure compliance with the Federal Meat Inspection Act (FMIA--21

U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA--21

U.S.C. 451 et seq.), and regulations promulgated under the Acts,

samples of meat and poultry products are tested periodically to

determine protein, moisture, fat, and salt content. Analyses are also

conducted to determine the presence of any violative concentrations of

drugs or other chemical residues.

When FSIS finds that a product is not in compliance, the Agency is

required to take appropriate action against the processor of that

product. Depending on the type of product and the severity of the

noncompliance, such action may range from product reprocessing to

litigation proceedings. In view of the critical nature of product

testing, it is necessary for laboratories that analyze official samples

of meat and poultry products to maintain a high degree of integrity.

A processor whose sample is to be analyzed generally has the option

of using either an FSIS laboratory or an accredited laboratory. The

cost of FSIS analysis is borne by the Government while the cost of non-

Federal analysis is borne by the processor. Due to the limited number

of FSIS laboratories and their heavy workload, many processors prefer

to use the non-Federal laboratories either for convenience of location

or to obtain test results more quickly.

Section 1327 (7 U.S.C. 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 will offset the cost of the ALP. All fees

collected by the Secretary of Agriculture are credited to an account

from which the expenses of the Accredited Laboratory Program are paid,

and are available immediately and remain available until expended for

the ALP.

Fees are billed annually on a per-accreditation basis. 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 all four food chemistry

analytes (protein, moisture, fat, and salt) or a determination by the

Agency that a laboratory is qualified to analyze official samples of

product for the presence and amount of one of several classes of

chemical residues. Accreditations are granted separately for the food

chemistry analysis of official samples and for the analysis of such

samples for any one of the several classes of chemical residue. A

laboratory may hold more than one accreditation.

The user-fee-funded ALP has been in operation since December 13,

1993, the effective date of the final rule that, among other things,

established the accreditation fee (58 FR 65254). FSIS has reviewed its

costs incurred to grant and/or renew a laboratory's accreditation

status. A cost analysis was performed on the 1994 rate and it was

determined that the 1995 rate should be reduced. The revised fee was

determined by an analysis of the fixed and variable costs of the

service. The cost was calculated to be $2,500 per year, a reduction of

$1000 from the 1994 fee.\1\ This reduction was due to administrative

and managerial efficiencies, and the use of interlaboratory

accreditation maintenance check samples only, rather than both check

and split samples, to demonstrate acceptable laboratory performance.

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\1\A copy of the cost analysis is available from the FSIS Docket

Clerk, USDA, Food Safety and Inspection Service, Room 3171, South

Agriculture Building, 14th Street and Independence Avenue,

Washington, DC 20250.

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Each year, FSIS will perform a cost analysis to determine whether

the current accreditation fee is adequate to recover the costs of

providing the service for the next year. If the fee is not adequate or

is in excess of that required to recover the costs, a new fee will be

established.

The Agency has determined that the fee for original accreditations

and renewals, beginning December 13, 1994 (the anniversary date for the

accreditations of most laboratories in the program), will be $2,500.

Because the amount of the accreditation fee is mandated by

regulation, the regulations must be amended before laboratories can be

billed at the new, reduced rate. As the regulations are now written,

the Agency must begin billing December 13 at the existing, higher fee

rate of $3,500. However, the Agency has determined that a lower fee

should be charged. The Agency has determined that the lower fee needs

to be made effective immediately in order to assure that it collects

the fee it has determined is appropriate and in order to assure that

industry will not be burdened unnecessarily by the charging of a fee

that is higher than what is needed.

FSIS is also making an editorial correction to

Sec. 318.21(c)(3)(ix), paragraphs (A), (B), and (C), and

Sec. 381.153(c)(3)(ix), paragraphs (A), (B), and (C), of the Federal

meat and poultry products inspection regulations. In the final rule,

the option for using interlaboratory accreditation check samples was

inadvertently omitted from these paragraphs but included in the

introductory sections for these paragraphs. This interim rule merely

corrects that editorial error and makes no substantive change.

In accordance with section 553 of the Administrative Procedure Act

(5 U.S.C. 553), for the reasons listed above, the Agency finds good

cause for making this interim rule effective upon publication. At the

same time, however, FSIS is providing for a 30-day comment period.

Executive Order 12866

This interim 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 interim 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, 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 interim 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

There are currently approximately 150 laboratories in the FSIS

accredited laboratory program. About one quarter (37) of these are

considered small entities.

This interim rule reduces the fee charged for FSIS accreditation

from $3,500 per accreditation, per year, to $2,500 per accreditation,

per year. All small accredited laboratories are affected by this

interim rule. Since the payment of fees to begin or renew a

laboratory's status as ``accredited by FSIS'' is a very small part of

total business costs, FSIS has determined that this rule will not have

a significant effect on 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 Part 391

Fees and charges for inspection services, Laboratory accreditation

fees.

For the reasons discussed in the preamble, FSIS is amending 9 CFR

parts 318, 381, and 391, as follows:

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND

PREPARATION OF PRODUCTS

1. The authority citation for part 318 continues to read as

follows:

Authority: 7 U.S.C. 138f; 21 U.S.C. 450, 1901-1906; 21 U.S.C.

601-695; 7 CFR 2.17, 2.55.

2. The first sentence in Paragraphs (c)(3)(ix) (A)(1), (A)(2), (B),

and (C) of Sec. 318.21 are revised to read as follows:

Sec. 318.21 Accreditation of chemistry laboratories.

* * * * *

(c) * * *

(3) * * *

(ix) * * *

(A) Systematic laboratory difference:

(1) Positive systematic laboratory difference: The standardized

difference between the accredited laboratory's result and that of the

FSIS laboratory for each split and/or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as CUSUM-P.\11\ * * *

* * * * *

(2) Negative systematic laboratory difference: The standardized

difference between the accredited laboratory's result and that of the

FSIS laboratory for each split and/or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as CUSUM-N.\12\ * * *

* * * * *

(B) Variability: The absolute value of the standardized difference

between the accredited laboratory's result and that of the FSIS

laboratory for each split and/or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as CUSUM-V.\13\ * * *

* * * * *

(C) Large Deviations: The large deviation measure of the accredited

laboratory's result for each split and/or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as CUSUM-D.\14\ * * *

* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

3. The authority citation for part 381 continues to read as

follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR

2.17, 2.55.

4. The first sentence in Paragraphs (c)(3)(ix) (A)(1), (A)(2), (B),

and (C) of Sec. 381.153 are revised to read as follows:

Sec. 381.153 Accreditation of chemistry laboratories.

* * * * *

(c) * * *

(3) * * *

(ix) * * *

(A) Systematic laboratory difference:

(1) Positive systematic laboratory difference: The standardized

difference between the accredited laboratory's result and that of the

FSIS laboratory for each split and/or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as CUSUM-P.\11\ * * *

* * * * *

(2) Negative systematic laboratory difference: The standardized

difference between the accredited laboratory's result and that of the

FSIS laboratory for each split and/or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as CUSUM-N.\12\ * * *

* * * * *

(B) Variability: The absolute value of the standardized difference

between the accredited laboratory's result and that of the FSIS

laboratory for each split and/or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as CUSUM-V.\13\ * * *

* * * * *

(C) Large Deviations: The large deviation measure of the accredited

laboratory's result for each split and/or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as CUSUM-D.\14\ * * *

* * * * *

PART 391--FEES AND CHARGES FOR INSPECTION SERVICES AND LABORATORY

ACCREDITATION

5. The authority citation for part 391 continues to read as

follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 394, 1622, 1624; 21 U.S.C.

450 et seq.; 21 U.S.C. 601-695.

6. Paragraph (a) of Sec. 391.5 is revised to read as follows:

Sec. 391.5 Laboratory accreditation fees.

(a) The annual fee for the initial accreditation and maintenance of

accreditation provided pursuant to Secs. 318.21 and 381.153 shall be

$2,500 per accreditation.

* * * * *

Done at Washington, DC, on: December 19, 1994.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 94-31639 Filed 12-23-94; 8:45 am]

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