[Federal Register Volume 59, Number 247 (Tuesday, December 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31639]


[[Page Unknown]]

[Federal Register: December 27, 1994]


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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]
BILLING CODE 3410-OM-P-M