[Federal Register Volume 71, Number 10 (Tuesday, January 17, 2006)]
[Proposed Rules]
[Pages 2483-2491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-284]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 71, No. 10 / Tuesday, January 17, 2006 / 
Proposed Rules  

[[Page 2483]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 318, 381, and 439

[Docket No. 03-020P; FDMS Docket Number FSIS-2005-0023]
RIN: 0583-AD09


Accredited Laboratory Program

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
revise, edit, and consolidate provisions of the standards and 
procedures for the accreditation of non-Federal analytical chemistry 
laboratories. Laboratories in the Accredited Laboratory Program (ALP) 
are accredited to analyze official meat and poultry samples for 
specific chemical residues or classes of chemical residues, and 
moisture, protein, fat, and salt. In particular, FSIS is proposing to 
amend its current regulations regarding the accreditation of non-
Federal analytical chemistry laboratories to accommodate the adoption 
of newer methods for analyzing chemical residues and to correct some 
data. In addition, FSIS is proposing to make editorial changes to its 
accredited laboratory regulations to reflect Agency reorganizations and 
program changes and to improve the clarity and consistency of 
application for all laboratories participating in the ALP. Finally, 
FSIS is proposing to consolidate the accredited laboratory regulations 
from 9 CFR Part 318.21 of the meat inspection regulations and 9 CFR 
Part 381.153 of the poultry products inspection regulations into a 
single new part, 9 CFR Part 439, that is applicable to both meat and 
poultry establishments. Along with the consolidation, redundancies 
within the regulations have been reduced, with the net result being a 
more succinct set of regulations.

DATES: Comments must be submitted by March 20, 2006.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by any of the following 
methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. FSIS prefers to 
receive comments through the Federal eRulemaking Portal. Go to http://www.regulations.gov and, in the ``Search for Open Regulations'' box, 
select ``Food Safety and Inspection Service'' from the agency drop-down 
menu, then click on ``Submit.'' In the Docket ID column, select FDMS 
Docket Number FSIS-2005-0023 to submit or view public comments and to 
view supporting and related materials available electronically. After 
the close of the comment period, the docket can be viewed using the 
``Advanced Search'' function in Regulations.gov.
     Mail, including floppy disks or CD-ROM's, and hand- or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., 
Room 102 Cotton Annex, Washington, DC 20250.
     Electronic mail: [email protected].
    All submissions received must include the Agency name and docket 
number 03-020P.
    All comments submitted in response to this proposal, as well as 
research and background information used by FSIS in developing this 
document, will be available for public inspection in the FSIS Docket 
Room at the address listed above between 8:30 a.m. and 4:30 p.m., 
Monday through Friday. The comments also will be posted on the Agency's 
Web site at http://www.fsis.usda.gov/regulations--&--policies/2005--
Proposed--Rules--Index/index.asp.

FOR FURTHER INFORMATION CONTACT: Lynn Larsen, Ph.D., Senior Director 
for Program Services, Office of Public Health Science, FSIS, at (202) 
690-6492 or fax (202) 690-6632.

SUPPLEMENTARY INFORMATION:

Background

    In order to ensure compliance with the regulatory provisions of the 
Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the Poultry 
Products Inspection Act (21 U.S.C. 451 et seq.), samples of meat and 
poultry products are periodically tested to determine moisture, 
protein, fat, and salt content. Analyses also are conducted to 
determine the presence of violative concentrations of drugs or other 
chemical residues.
    When there is an indication of noncompliance with the FMIA and the 
PPIA, FSIS takes appropriate action against the processor of the 
noncompliant product. Depending on the type of product and the severity 
of the noncompliance, such actions may range from requiring that a 
product be reprocessed to the taking of an enforcement action. Because 
correct and accurate test results help prevent the distribution of 
adulterated and misbranded meat and poultry products, it is necessary 
that laboratories that conduct the tests in FSIS' accredited laboratory 
program maintain a high degree of integrity.
    Before 1962, most official samples were analyzed by FSIS 
laboratories. However, in response to the meat and poultry industries' 
need for more rapid analytical results, and because of limitations in 
FSIS laboratory capacity, programs were established to certify non-
Federal laboratories for certain tests of both meat and poultry 
products. In 1980 (45 FR 73947) and again in 1985 (50 FR 15435), the 
Agency proposed to consolidate these programs and establish an 
Accredited Laboratory Program (ALP) that contained standards and 
procedures for non-Federal laboratories eligible to analyze official 
samples. A final rule was issued in 1987 (52 FR 2176). A subsequent 
1993 final rule (58 FR 65254) established user fees for the ALP and 
adjusted the standards and procedures established in the earlier rule 
for this program. User fees, which cover the costs of the ALP, are 
mandated by the Food, Agriculture, Conservation, and Trade Act of 1990 
(the 1990 Farm Bill), as amended.
    A processor whose sample is to be analyzed generally has the option 
of using an FSIS laboratory or a non-Federal FSIS-accredited 
laboratory. The cost of FSIS analysis is borne by the government; the 
cost of non-Federal analysis is borne by the processor. Because of the 
limited number (three) of FSIS laboratories and their heavy workload, 
processors may prefer to use

[[Page 2484]]

non-Federal accredited laboratories given the convenience of their 
location or the fact they can provide test results more quickly. Some 
non-Federal accredited laboratories are separate entities, while others 
are located in and owned by official establishments.

The Proposed Rule

    This proposal updates the regulations governing the accredited 
laboratory program and clarifies and corrects some data. Issuance of 
these proposed regulations will give FSIS more flexibility in keeping 
up with current and future scientific changes without having to 
periodically reissue new regulations. For example, this proposal 
deletes from the regulations all references and footnotes to the 
Association of Official Analytical Chemists (AOAC) contained in the 
current food chemistry accreditation regulations and the definitions. 
The name and address of the organization have changed, and the cited 
edition of the methods manual is not the current edition. AOAC will no 
longer be specifically cited. Instead, the ALP will advise accredited 
laboratories, as provided in the proposed accreditation regulations, 
about suitable methods that are available from various compendia, such 
as FSIS guidebooks or current AOAC manuals, for determining the 
presence of the analytes covered by the ALP.
    This proposed rule deletes all references to split samples because 
they are no longer part of the ALP program. In addition, this rule 
modifies Table 1 of the current regulations in Sec. Sec.  318.21 and 
381.153 by moving its footnote information into the main body of the 
table. The proposed rule modifies Table 2 and provisions for Quality 
Assurance (QA) and Quality Control (QC) recovery throughout the 
regulations by removing explicit figures for minimum proficiency levels 
(MPLs) and recoveries. Information on current recoveries established by 
FSIS for laboratory quality assurance and quality control will be 
available from the ALP Web site at http://www.fsis.gov/Science/
Accredited--Laboratories/index.asp. A link to information on current 
MPLs is available on the ALP Web site, or you can access the 
information directly at http://www.fsis.usda.gov/PDF/2003--Red--Book--
Appendix3-4.PDF.
    Finally, the proposed rule eliminates duplicative provisions within 
the current regulations and consolidates Sec. Sec.  318.21 and 381.153 
into a single set of regulations in new Part 439. For example, new 
Sec.  439.20 contains the criteria for maintaining either a food 
chemistry accreditation or a chemical residue accreditation for both 
meat and poultry products. A summary of the changes made is contained 
in the following table:

----------------------------------------------------------------------------------------------------------------
                 Meat                            Poultry                 New                  Changes
----------------------------------------------------------------------------------------------------------------
318.21................................  381.153..................     Part 439     Editorial and conforming
                                                                                    changes throughout the
                                                                                    regulations are made, along
                                                                                    with certain other
                                                                                    revisions.
318.21(a).............................  381.153(a)...............          439.1   Updated to reflect change of
                                                                                    address and to delete
                                                                                    specific references to the
                                                                                    Association of Official
                                                                                    Analytical Chemists, amended
                                                                                    to delete definition of
                                                                                    split samples, to modify
                                                                                    Tables 1 and 2 to revise
                                                                                    performance standards, to
                                                                                    add new definitions and to
                                                                                    reuse certain current
                                                                                    definitions.
318.21(b)(1), 318.21(c)(1)............  381.153(b)(1),                     439.5   Updated and consolidated
                                         381.153(c)(1).                             application requirements.
318.21(b)(2), 318.21(c)(2)............  381.153(b)(2),                     439.10  Revised, consolidated, and
                                         381.153(c)(2).                             clarified accreditation
                                                                                    criteria.
318.21(b)(3), 318.21(c)(3)............  381.153(b)(3),                     439.20  Revised and consolidated
                                         381.153(c)(3).                             criteria for maintaining
                                                                                    accreditation.
318.21(d).............................  381.153(d)...............          439.50  Deletes current (d)(4) and
                                                                                    replaces it with a cross
                                                                                    reference to ``violations of
                                                                                    law'' in new Sec.   439.60
                                                                                    and makes certain other
                                                                                    revisions.
318.21(e).............................  381.153(e)...............          439.51  Updated to cross reference
                                                                                    sections of new Sec.
                                                                                    439.20 and to make certain
                                                                                    other revisions.
318.21(f).............................  381.153(f)...............          439.52  Deletes current (f) and
                                                                                    instead cross references new
                                                                                    Sec.   439.60.
318.21(g).............................  381.153(g)...............          439.53  Updates and consolidates
                                                                                    bases for revocation of
                                                                                    accreditation. Deletes
                                                                                    current (g)(4) and instead
                                                                                    cross references new Sec.
                                                                                    439.60, ``violations of
                                                                                    law.''
318.21(e), 318.21(f)..................  381.153(e), 381.153(f)...          439.60  New section that consolidates
                                                                                    references to ``violations
                                                                                    of law.''
318.21(h).............................  381.153(h)...............          439.70  Editorial changes.
----------------------------------------------------------------------------------------------------------------

Expansion of the Laboratory Program; Request for Comments
    Although recent rulemakings and Agency policy decisions address a 
range of chemical contaminants, including most that present biosecurity 
concerns, FSIS does not intend to expand the ALP at this time. 
Expansion of the program to other analytes would require a statistical 
evaluation of historical data in order to develop the appropriate 
algorithms and correction factors needed to implement the same type of 
quality assurance procedures that are applied to the analytes currently 
included in the program. It would also require FSIS to make policy 
decisions regarding the acceptance of test results from non-Federal 
laboratories for these new analytes. The Agency does not intend to 
include the additional analytes (e.g., pesticide or drug residues) by 
laboratories in the ALP until such policy decisions have been made, and 
the necessary scientific foundation is established for them.
    FSIS, however, would like to receive comments from the public on 
whether non-Federal laboratories should be accredited to analyze 
official samples for additional analytes and whether the laboratories 
should be used to supplement further the analytical capabilities of the 
three FSIS laboratories.

Executive Order 12778

    This proposed rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. The rule updates the quality standards and 
procedures that govern the accredited laboratory program.
    States and local jurisdictions are preempted under the FMIA and the 
PPIA from imposing any requirements with respect to federally inspected

[[Page 2485]]

premises, facilities, and operations that are in addition to, or 
different than, those imposed under the FMIA or PPIA. However, State or 
local jurisdictions may exercise concurrent jurisdiction over meat and 
poultry products that are outside official establishments for the 
purpose of preventing the distribution of meat and poultry products 
that are misbranded or adulterated under the FMIA or PPIA or, in the 
case of imported products, after their entry into the United States. 
State and local jurisdictions also may take other actions that are 
consistent with the FMIA and PPIA, with respect to any other matters 
regulated under the Acts.
    Under FMIA and PPIA, States that maintain meat and poultry 
inspection programs must impose requirements that are at least equal to 
those required under the Acts. However, these States may impose more 
stringent requirements on such State-inspected products and 
establishments.

Executive Order 12866

    This proposed rule has been determined to be non-significant and 
has not been reviewed by the Office of Management and Budget under 
Executive Order 12866. The rule will not result in an annual effect on 
the economy of $100 million or more. The rule will not cause a major 
increase in costs or prices for consumers, individual industries, 
governments or geographic regions.

Effect on Small Entities

    There are about 90 laboratories that have a total of about 110 
accreditations in the FSIS Accredited Laboratory Program (ALP). About 
three-quarters of these are large entities, based on their volume of 
business, or are part of entities such as large business corporations, 
State universities, or State governments. The smaller laboratories 
participating in the ALP range from medium-sized laboratory facilities 
to one- or two-person operations. These laboratories provide analytical 
services of official samples to large and small establishments.
    Participation in the Agency's ALP is voluntary. It is expected that 
a decision to participate would be based on a calculation of the 
benefits and costs to the firm, including a determination whether the 
resulting loss of business as a result of non-participation in ALP 
would be significant.
    The Administrator has made an initial determination that this 
proposed rule would not have a significant economic impact on a 
substantial number of small entities, as defined by the Regulatory 
Flexibility Act (5 U.S.C. 601). The effects of this proposed rule on 
the laboratories and on the establishments they serve will not be 
significant and will apply equally to large and small entities. The 
proposed rule does not involve a change in the accreditation fee, but 
rather adjustments and clarifications in the operational procedures and 
standards. The cost savings brought about by improved efficiencies in 
the requirements for participants in the ALP are likely to be small.

Paperwork Requirements

    FSIS has reviewed the paperwork and recordkeeping requirements in 
this proposed rule in accordance with the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501 et seq.). The Agency has determined that the 
paperwork requirements for the regulations that govern the 
accreditation of non-Federal analytical chemistry laboratories have 
already been accounted for in the Application for Inspection, 
Sanitation, and Accredited Laboratories information collection approved 
by the Office of Management and Budget (OMB). The OMB approval number 
for the Application for Inspection, Sanitation, and Accredited 
Laboratories information collection is 0583-0082.

Government Paperwork Elimination Act (GPEA)

    FSIS is committed to compliance with the GPEA, which requires 
Government agencies, in general, to provide the public the option of 
submitting information or transacting business electronically to the 
maximum extent possible. The Agency will ensure that to the extent 
possible, all forms used by the laboratories are made available 
electronically.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that the 
public and in particular that minorities, women, and persons with 
disabilities are aware of this proposal, FSIS will announce it online 
through the FSIS Web page located at http://www.fsis.usda.gov/
regulations--&--policies/2005--Proposed--Rules--Index/index.asp.
    The Regulations.gov Web site is the central online rulemaking 
portal of the United States Government. It is being offered as a public 
service to increase participation in the Federal Government's 
regulatory activities. FSIS participates in Regulations.gov and will 
accept comments on documents published on the site. The site allows 
visitors to search by keyword or Department or Agency for rulemakings 
that allow for public comment. Each entry provides a quick link to a 
comment form so that visitors can type in their comments and submit 
them to FSIS. The Web site is located at http://www.regulations.gov.
    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS Web page. Through 
Listserv and the Web page, FSIS is able to provide information to a 
much broader, more diverse audience.
    In addition, FSIS offers an e-mail subscription service which 
provides an automatic and customized notification when popular pages 
are updated, including Federal Register publications and related 
documents. This service is available at http://www.fsis.usda.gov/news--
and--events/email--subscription/ and allows FSIS customers to sign up 
for subscription options across eight categories. Options range from 
recalls to export information to regulations, directives and notices. 
Customers can add or delete subscriptions themselves and have the 
option to password protect their account.

List of Subjects

9 CFR Part 318

    Accredited laboratory program, Meat inspection, Recordkeeping and 
reporting requirements.

9 CFR Part 381

    Accredited laboratory program, Poultry and poultry products 
inspection, Recordkeeping and reporting requirements.

9 CFR Part 439

    Meat inspection, Poultry and poultry products inspection, 
Laboratory accreditation.

    Accordingly, Title 9, Chapter III, Subchapter E of the Code of 
Federal Regulations is proposed to be amended as follows:

[[Page 2486]]

Subchapter E--Regulatory Requirements Under the Federal Meat Inspection 
Act and the Poultry Products Inspection Act

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND 
PREPARATION OF PRODUCTS

    1. The authority citation for part 318 would continue to read as 
follows:

    Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7 
CFR 2.18, 2.53.


Sec.  318.21  [Removed and reserved]

    2. Section 318.21 would be removed and reserved.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    3. The authority citation for part 381 would continue to read as 
follows:

    Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7, 
2.18, 2.53.


Sec.  381.153  [Removed and reserved]

    4. Section 381.153 would be removed and reserved.
    5. A new part 439 would be added to Subchapter E of Chapter III to 
read as follows:

PART 439--ACCREDITATION OF CHEMISTRY LABORATORIES

Sec.
439.1 Definitions.
439.5 Applications for accreditation.
439.10 Criteria for obtaining accreditation.
439.20 Criteria for maintaining accreditation.
439.50 Refusal of accreditation.
439.51 Probation of accreditation.
439.52 Suspension of accreditation.
439.53 Revocation of accreditation.
439.60 Violations of law.
439.70 Notifications and hearings.

    Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 451-470, 
601-695; 7 CFR 2.18, 2.53.


Sec.  439.1  Definitions.

    (a) Accreditation: Determination by FSIS that a laboratory is 
qualified to analyze official samples of raw or processed meat and 
poultry products, because it has met the requirements for accreditation 
specified in this part, for the presence and amount of all four food 
chemistry analytes (protein, moisture, fat, and salt); or a 
determination by FSIS that a laboratory is qualified to analyze 
official samples of raw or processed meat and poultry products, because 
it has met the requirements for accreditation in this part, for the 
presence and amount of a specified chemical residue of any one of 
several classes of chemical residues. A laboratory may hold more than 
one accreditation.
    (b) Accredited laboratory: A non-Federal analytical laboratory that 
has met the requirements for accreditation specified in this Part and, 
therefore, at an establishment's discretion, may be used in lieu of an 
FSIS laboratory for analyzing official regulatory samples. Payment for 
the analysis of official samples is to be made by the establishment 
using the accredited laboratory.
    (c) Accredited Laboratory Program (ALP): The FSIS program in which 
non-Federal laboratories are accredited as eligible to perform analyses 
on official regulatory samples of raw or processed meat and poultry 
products, and through which a check sample program for quality 
assurance is conducted. Program information and guidance can be 
obtained from the ALP Web site at www.fsis.usda.gov/Science/Accredited_Laboratories/index.asp or by writing to: Accredited 
Laboratory Program, Box 17 Aerospace Center, Room 377, 901 D Street SW, 
Washington, DC 20024; facsimile telephone number (202) 690-6632; 
voicemail telephone number (202) 690-6582.
    (d) Chemical residue misidentification: see ``Correct chemical 
residue identification'' definition.
    (e) Coefficient of variation (CV): The standard deviation of a 
distribution of analytical values multiplied by 100 and divided by the 
mean of those values.
    (f) Comparison mean: The average result, for a sample, obtained 
from all submitted results that have a large deviation measure of zero. 
When only two laboratories perform the analysis and the large deviation 
measure is not zero, alternative procedures for establishing a 
comparison mean may be employed by FSIS. For purposes of computing the 
comparison mean, a laboratory's ``result'' for a food chemistry analyte 
is the obtained analytical value; a laboratory's ``result'' for a 
chemical residue is the logarithmic transformation of the obtained 
analytical value.
    (g) Correct chemical residue identification: Reporting by a 
laboratory of the presence and analytical value of a chemical residue 
that was included in the ALP check sample above the minimum reporting 
level. Failure of a laboratory to report the presence of such a 
chemical residue is considered a misidentification. In addition, 
reporting the presence of and analytical value for a residue that was 
not included in the ALP check sample above the minimum reporting level 
is considered a misidentification.
    (h) CUSUM: A class of statistical procedures for assessing whether 
or not a process is ``in control.'' Each CUSUM value is constructed by 
accumulating incremental values obtained from observed results of the 
process, and then determined to either exceed or fall within acceptable 
limits for that process. The initial CUSUM values for each laboratory 
whose application for accreditation is accepted are set at zero. The 
CUSUM values are reset to zero at the beginning of each year; that is, 
the CUSUM values associated with the first maintenance check sample 
each year are set equal to the CUSUM increment for that sample.
    The four CUSUM procedures are:
    (1) Positive systematic laboratory difference CUSUM (CUSUM-P)--
monitors how consistently an accredited laboratory gets numerically 
greater results than the comparison mean;
    (2) Negative systematic laboratory difference CUSUM (CUSUM-N)--
monitors how consistently an accredited laboratory gets numerically 
smaller results than the comparison mean;
    (3) Variability CUSUM (CUSUM-V)--monitors the average ``total 
deviation'' (i.e., the combination of the random fluctuations and 
systematic differences) between an accredited laboratory's results and 
the comparison mean; and
    (4) Individual large deviation CUSUM (CUSUM-D)--monitors the 
magnitude and frequency of large differences between the results of an 
accredited laboratory and the comparison mean.
    (i) Food chemistry: For the purposes of Part 439, ``food 
chemistry'' will refer to analysis of raw or processed meat or poultry 
products for the analytes moisture, protein, fat, and salt. All four 
analytes must be determined when a food chemistry analysis is 
conducted, unless otherwise advised by the ALP.
    (j) Individual large deviation: An analytical result that differs 
from the sample comparison mean by more than would be expected assuming 
normal laboratory variability.
    (k) Initial accreditation check sample: A sample provided by the 
ALP to a non-Federal laboratory to determine whether the laboratory's 
analytical capability meets the standards for granting accreditation.
    (l) Inter-laboratory accreditation maintenance check sample: A 
sample provided by FSIS to an accredited laboratory to assist in 
determining whether the laboratory is maintaining acceptable levels of 
analytical capability.
    (m) Large deviation measure: A measure that quantifies an 
unacceptably large difference between a laboratory's analytical result 
and the sample comparison mean.

[[Page 2487]]

    (n) Minimum proficiency level (MPL): The minimum concentration of a 
residue at which an analytical result will be used to assess a 
laboratory's quantification capability. This concentration is an 
estimate of the smallest concentration for which the average 
coefficient of variation (CV) for reproducibility (i.e., combined 
within and between laboratory variability) does not exceed 20 percent. 
Information on the current MPLs may be obtained from the ALP staff at 
the address provided above in the definition of ``Accredited Laboratory 
Program,'' in Sec.  439.1 or from the ALP Web site at 
http://www.fsis.usda.gov/Science/Accredited--Laboratories/index.as.
    (o) Minimum reporting level (MRL): The number such that if any 
obtained analytical value for a residue in a check sample or official 
sample equals or exceeds this number, then the residue is reported 
together with the obtained analytical value. Information on the current 
MRLs may be obtained from the ALP staff at the address provided above, 
in the definition of ``Accredited Laboratory Program,'' in Sec.  439.1. 
Official sample--A sample selected by an inspector or inspection 
service employee in accordance with FSIS procedures for regulatory use.
    (p) Probation: The period commencing with official notification to 
an accredited laboratory that its check sample results no longer 
satisfy the performance requirements specified in this rule, and ending 
with official notification that accreditation either is fully restored, 
is suspended, or is revoked.
    (q) QA: (See Quality assurance recovery)
    (r) QC: (See Quality control recovery)
    (s) Quality assurance (QA) recovery: The ratio of a laboratory's 
analytical value for a check sample residue to the established level of 
the analyte in the check sample, multiplied by 100. As dictated by the 
procedures for the analyte, the analytical value may be adjusted prior 
to the recovery computation.
    (t) Quality control (QC) recovery: The ratio of a laboratory's 
analytical value of a quality control standard to the established level 
of the analyte in the standard, multiplied by 100. As dictated by the 
procedures for the analyte, the analytical value may be adjusted prior 
to the recovery computation.
    (u) Refusal of accreditation: An action taken by FSIS when a 
laboratory that is applying for accreditation is denied the 
accreditation.
    (v) Responsibly connected: Any individual who or entity which is a 
partner, officer, director, manager, or owner of 10 percent or more of 
the voting stock of the applicant or recipient of accreditation or an 
employee in a managerial or executive capacity or any employee who 
conducts or supervises the chemical analysis of FSIS official samples.
    (w) Revocation of accreditation: An action taken by FSIS against a 
laboratory, removing the laboratory's right to analyze official 
samples.
    (x) Standardizing constant: A number that results from a 
mathematical adjustment to the ``standardizing value'' and is used to 
compute the standardized difference for a check sample result. The 
number takes into consideration the expected variance of the difference 
between the accredited or applying laboratory's result(s) and the 
comparison mean for a sample, the standardizing value, the correlation 
and number of repeated results by a laboratory on a sample, and the 
number of laboratories that analyzed a sample. Information on the 
computation of the standardizing constant may be obtained from the ALP 
staff at the address provided above in the definition of ``Accredited 
Laboratory Program,'' in Sec.  439.1.
    (y) Standardized difference: The quotient of the difference between 
a laboratory's result on a sample and the comparison mean of the sample 
divided by the standardizing constant.
    (z) Standardizing value: A number representing the performance 
standard deviation of an individual result. The number is given, or 
computed by, the information provided in Tables 1 and 2 and their 
footnotes.
    (aa) Suspension of accreditation: Action taken by FSIS against a 
laboratory that temporarily removes the laboratory's right to analyze 
official samples. Suspension of accreditation ends when accreditation 
either is fully restored or is revoked.
    (bb) Systematic laboratory difference: A comparison of one 
laboratory's results with the comparison mean for samples that show, on 
average, a consistent relationship. A laboratory that is reporting, on 
average, numerically greater results than the comparison mean has a 
positive systematic laboratory difference. Conversely, numerically 
smaller results indicate a negative systematic laboratory difference.
    (cc) Variability: Random fluctuations in a laboratory's processes 
that cause its analytical results to deviate from a true value.
    (dd) Variance: The expected average of the squared differences of 
sample results from an expected sample mean.

                                                    Table 1.--Standardizing Values for Food Chemistry
                                                             [By product class and analyte]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Fat \1\                                Salt \1\
              Product/class                  Moisture       Protein \1\  -------------------------------------------------------------------------------
                                                                              <12.5%          >12.5%            <1%            1-4%           >4% \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cured Pork/Canned Ham...................            0.50   0.060 (X0.65)    0.26 (X0.25)    0.30 (X0.25)           0.127   0.127 (X0.25)            0.22
Ground Beef.............................            0.71   0.060 (X0.65)             N/A    0.35 (X0.25)           0.127   0.127 (X0.25)            0.22
Other Meat Products.....................            0.57   0.060 (X0.65)    0.26 (X0.25)    0.30 (X0.25)           0.127   0.127 (X0.25)            0.22
Poultry Products........................            0.57   0.060 (X0.65)    0.26 (X0.25)    0.30 (X0.25)           0.127   0.127 (X0.25)            0.22
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The standardizing value is either the value given in the table or is computed by the formula set forth in the table, where X is the comparison mean
  of the sample. Standardizing values are provided for different percentages of fat and salt as indicated in the table.
\2\ For dry salami and pepperoni products.


[[Page 2488]]


          Table 2.--Standardizing Values for Chemical Residues
------------------------------------------------------------------------
                                                          Standardizing
                   Class of residues                        value \3\
------------------------------------------------------------------------
Chlorinated Hydrocarbons: \1\
  Aldrin..............................................              0.20
  Benzene Hexachloride................................              0.20
  Chlordane...........................................              0.20
  Dieldrin............................................              0.20
  DDT.................................................              0.20
  DDE.................................................              0.20
  TDE.................................................              0.20
  Endrin..............................................              0.20
  Heptachlor..........................................              0.20
  Heptachlor Epoxide..................................              0.20
  Lindane.............................................              0.20
  Methoxychlor........................................              0.20
  Toxaphene...........................................              0.20
  Hexachlorobenzene...................................              0.20
  Mirex...............................................              0.20
  Nonachlor...........................................              0.20
Polychlorinated Biphenyls:............................              0.20
Arsenic \2\...........................................              0.25
Sulfonamides \2\......................................              0.25
------------------------------------------------------------------------
\1\ Laboratory statistics are computed over all results (excluding PCB
  results), and for specific chemical residues.
\2\ Laboratory statistics are only computed for specific chemical
  residues.
\3\ The standardizing value of all initial accreditation and
  probationary check samples computations is 0.15.

Sec.  439.5  Applications for accreditation.

    (a) Application for accreditation shall be made on designated paper 
or electronic forms provided by FSIS, or otherwise in writing, by the 
owner or manager of a non-Federal analytical laboratory. The forms 
shall be sent to the ALP at the address provided above in the 
definition of ``Accredited laboratory'' Sec.  439.1 of this part, or 
may be submitted electronically when so provided for by FSIS. The 
application shall specify the kinds of accreditation that are wanted by 
the owner or manager of the laboratory. A laboratory whose 
accreditation has been refused or revoked may reapply for accreditation 
after 60 days from the effective date of that action, and must provide 
written documentation specifying what corrections were made.
    (b) At the time that an Application for Accreditation is filed with 
the ALP, the management of a laboratory shall, for each accreditation 
sought, submit a check, bank draft, or money order in the amount 
specified in 9 CFR 391.5 made payable to the U.S. Department of 
Agriculture, along with the completed application for the 
accreditation(s). When so provided for by FSIS, electronic transfer of 
funds may be accepted.
    (c) Accreditation will not be granted or continued, without further 
procedure, for failure to pay the accreditation fee(s). The fee(s) paid 
will be nonrefundable and will be credited to the account from which 
the expenses of the laboratory accreditation program are paid.
    (d) Annually on the anniversary date of each accreditation, FSIS 
will issue a bill in the amount specified in 9 CFR 391.5 for each 
accreditation held. Bills are payable upon receipt by check, bank 
draft, or money order made payable to the U.S. Department of 
Agriculture and become delinquent 30 days from the date of the bill.
    (e) Accreditation will be terminated without further procedure for 
having a delinquent account. The fee(s) paid will be nonrefundable and 
will be credited to the account from which the expenses of the ALP are 
paid.


Sec.  439.10  Criteria for obtaining accreditation.

    (a) Analytical laboratories may be accredited for the analyses of 
food chemistry analytes, as defined in Sec.  439.1, or a specific 
chemical residue or a class of chemical residues in raw or processed 
meat and poultry products.
    (b) Accreditation will be given only if the applying laboratory 
successfully satisfies the requirements presented below. For food 
chemistry accreditation, the requirements must be satisfied for all 
four analytes.
    (c) This accreditation authorizes official FSIS acceptance of the 
analytical test results provided by these laboratories on official 
samples.
    (d) To obtain FSIS accreditation, an analytical laboratory must:
    (1) Be supervised by a person holding, as a minimum, a bachelor's 
degree in chemistry, food science, food technology, or a related field.
    (i) For food chemistry accreditation, the supervisor must also have 
1 year's experience in food chemistry analysis, or equivalent 
qualifications, as determined by the Administrator.
    (ii) For chemical residue accreditation, either the supervisor or 
the analyst assigned to analyze the sample must also have 3 years' 
experience determining analytes at or below part per million levels, or 
equivalent qualifications, as determined by the Administrator.
    (2) Demonstrate an ability to achieve quality assurance levels that 
are within acceptable limits for systemic laboratory difference, 
variability, and individual large deviations, in the analyte category 
for which accreditation is sought, using analytical procedures 
designated by the FSIS ALP as being acceptable. An applying laboratory 
will successfully demonstrate these capabilities for:
    (i) Food chemistry if its results from a 36 check sample 
accreditation study each satisfy the criteria presented in paragraph 
(e) of this section.
    (ii) Chemical residues if its analytical results for each specific 
chemical residue provided in a check sample accreditation study 
containing a minimum of 14 check samples satisfy the criteria presented 
in paragraph (e) of this section, including criteria for QA and QC 
recovery and for residue identification. In addition, if the laboratory 
is requesting accreditation for the analysis of chlorinated 
hydrocarbons, all analytical results for the residue class must 
collectively satisfy the criteria. [Conformance to criteria in 
paragraph (e) of this section will only be determined when six or more 
analytical results with associated comparison means at or above the 
logarithm of the minimum proficiency level are available.]
    (3) Round all check sample statistical computations to the nearest 
tenth, except where otherwise noted.
    (4) Complete a second set of the requisite number of check samples 
if the results of the first set of check samples do not meet the 
criteria for obtaining accreditation.
    (i) The second set of check samples will be provided within 30 days 
following the date of receipt by FSIS of a request from the applying 
laboratory. The second set of food chemistry check samples will be 
analyzed for only the analyte(s) for which unacceptable initial results 
had been obtained by the laboratory.
    (ii) If the results of the second set of check samples do not meet 
the accreditation criteria, the laboratory may reapply after a 60-day 
waiting period, commencing from the date of refusal of accreditation by 
FSIS. At that time, a new application, all fees, and all documentation 
of corrective action required for accreditation must be submitted.
    (5) Allow inspection of the laboratory by FSIS officials prior to 
the determination of granting accredited status.
    (6) Pay the accreditation fee by the date required.
    (e) Quality assurance levels. (1) Systematic laboratory difference: 
The absolute value of the average standardized difference must not 
exceed the following:
    (i) For food chemistry, 0.73 minus the product of 0.17 and the 
standard deviation of the standardized differences; and
    (ii) For chemical residues, 1.67 (2.00 if there are less than 12 
analytical results) minus the product of 0.29 and

[[Page 2489]]

the standard deviation of the standardized differences.
    (2) Variability: The estimated standard deviation of the 
standardized difference must not exceed the following:
    (i) For food chemistry, 1.15; and
    (ii) For chemical residues, a computed limit that is a function of 
the number of analytical results used in the computation of the 
standard deviation, and of the amount of variability.
    (3) Individual large deviations: One hundred times the average of 
the large deviation measures of the individual samples must be less 
than 5.0. A result will have a large deviation measure equal to zero 
when the absolute value of the result's standardized difference, (d), 
is less than 2.5 and otherwise a measure equal to 1-(2.5/d).
    (4) For residue analyses, the following additional quality 
assurance requirements must be met.
    (i) QA recovery: The average of the QA recoveries of the individual 
check sample analytical results must lie within ranges established by 
FSIS. Information on recovery ranges may be obtained from the ALP at 
the address provided in Sec.  439.1 of this chapter.
    (ii) QC recovery: All QC recoveries must lie within ranges 
established by FSIS. Information on recovery ranges may be obtained 
from the ALP at the address provided in Sec.  439.1 of this chapter. 
Supporting documentation must be made available to FSIS upon request.
    (iii) Correct identification: There must be correct identification 
of all chemical residues in all samples.


Sec.  439.20  Criteria for maintaining accreditation.

    (a) To maintain accreditation, an analytical laboratory must 
fulfill the requirements of paragraphs (b) through (i) of this section.
    (b) Official samples. (1) An accredited laboratory must 
expeditiously report analytical results, in the analyte category for 
which accreditation was granted, of official samples on designated 
forms to the Data Center Staff, USDA/FSIS Eastern Laboratory, Russell 
Research Center, P.O. Box 6085, Athens, GA 30604 (for U.S. Postal 
Service delivery), or Data Center Staff, USDA/FSIS Eastern Laboratory, 
Russell Research Center, 950 College Station Road, Athens, GA 30605 
(for commercial carrier delivery). When so provided for by FSIS, 
analytical results may be reported to the Data Center Staff by 
facsimile at 706-546-3589, or electronically. The Federal inspector at 
any establishment may assign the analysis of official samples to an 
FSIS laboratory if, in the inspector's judgment, there are delays in 
receiving test results on official samples from an accredited 
laboratory.
    (2) Every QC recovery associated with reporting of official samples 
must lie within ranges established by FSIS. Information on recovery 
ranges may be obtained from the ALP at the address provided in Sec.  
439.1 of this chapter. Supporting documentation must be made available 
to FSIS upon request.
    (c) Records. An accredited laboratory must:
    (1) Maintain laboratory quality control records for the most recent 
3 years that samples have been analyzed under this Program.
    (2) Maintain complete records of the receipt, analysis, and 
disposition of official samples for the most recent 3 years that 
samples have been analyzed under this Program.
    (3) Maintain in a secure electronic format or in a standards book, 
which is preferably a permanently bound book with sequentially numbered 
pages, all records, readings, and calculations for standard solutions. 
All entries are to be dated and signed by the analyst immediately upon 
completion of the entry, and by the supervisor, or in the absence of 
the supervisor by the supervisor's designee, before use of the standard 
solution but no later than within 1 week. The standards book is to be 
retained for 3 years after the last recorded entry.
    (4) Maintain records and supervisor approvals of recoveries, and of 
instrument maintenance and calibration. The records are to be retained 
for 3 years after the last recorded entry.
    (5) As provided in paragraph (f) of this section, records should be 
available for review by any duly authorized representative of the 
Secretary of Agriculture, including ALP personnel or their designees.
    (d) Check samples. (1) An accredited laboratory must analyze 
interlaboratory accreditation maintenance check samples and return the 
results to FSIS within 3 weeks of sample receipt. This must be done 
whenever requested by FSIS and at no cost to FSIS.
    (2) Results must be those of the accredited laboratory. Analyses of 
maintenance check samples shall not be contracted out by the accredited 
laboratory.
    (3) As provided by the requirements in paragraph (h) of this 
section, a check sample report will be considered complete only if 
laboratories report all analytes present in the check sample for the 
analyte category in which accreditation was granted.
    (e) Corporate changes. The ALP must be informed at the address 
provided in Sec.  439.1 in the definition of ``Accredited laboratory'' 
of this part, by certified or registered mail, within 30 days of any 
change of address or in the laboratory's ownership, officers, 
directors, supervisory personnel, or other responsibly connected 
individual or entity.
    (f) On-site review. An accredited laboratory must permit any duly 
authorized representative of the Secretary to perform both announced 
and unannounced on-site laboratory reviews of facilities and records, 
both hard copy and electronic, during normal business hours, and to 
copy any records pertaining to the laboratory's participation in the 
ALP.
    (g) Analytical procedures. An accredited laboratory must use 
analytical procedures designated by the FSIS ALP as being acceptable.
    (h) Quality assurance levels. (1) An accredited laboratory must 
demonstrate an ability to maintain quality assurance levels that are 
within acceptable limits for systematic laboratory difference, 
variability, and individual large deviations in the analysis of 
interlaboratory check samples for the analyte category for which 
accreditation was granted. An accredited laboratory will successfully 
demonstrate the maintenance of these capabilities if its analytical 
results from interlaboratory accreditation maintenance check samples 
satisfy the criteria presented in this paragraph, Sec.  439.20(h). All 
statistical computations are to be rounded to the nearest tenth, except 
where otherwise noted.
    (2) In addition, a laboratory accredited for a specific chemical 
residue or a chemical residue class:
    (i) Must satisfy criteria presented in this paragraph, Sec.  
439.20(h), for chemical residue recoveries and proper identification;
    (ii) Will demonstrate the maintenance of its capabilities by 
reporting its analytical results for each specific chemical residue 
found above the minimum proficiency level; and
    (iii) Must, if accredited for the analysis of chlorinated 
hydrocarbons, obtain analytical results that collectively satisfy the 
criteria.
    (3) Systematic laboratory difference: The standardized difference 
between the accredited laboratory's result and the comparison mean for 
each interlaboratory accreditation maintenance check sample is used to 
determine two CUSUM values, designated as CUSUM-P and CUSUM-N.

[[Page 2490]]

    (i) When determining compliance with this criterion for all 
chlorinated hydrocarbon results in a sample collectively, the following 
statistical procedure must be followed to account for the correlation 
of analytical results within a sample: The average of the standardized 
differences of the analytical results within the sample, divided by a 
constant, is used in place of a single standardized difference to 
determine the CUSUM-P (or CUSUM-N) value for the sample. The constant 
is a function of the number of analytical results used to compute the 
average standardized difference.
    (ii) Positive systematic laboratory difference: This value is 
computed and evaluated as follows:
    (A) Determine the CUSUM-P increment for the sample.
    (1) The CUSUM-P increment for food chemistry, as defined in Sec.  
439.1 of this Chapter, is set equal to:
    2.0, if the standardized difference is greater than 2.4,
    -2.0, if the standardized difference is less than -1.6, or
    the standardized difference minus 0.4, if the standardized 
difference lies between -1.6 and 2.4, inclusive.
    (2) The CUSUM-P increment for chemical residues is set equal to:
    2.0, if the standardized difference is greater than 2.5,
    -2.0, if the standardized difference is less than -1.5, or
    the standardized difference minus 0.5, if the standardized 
difference lies between -1.5 and 2.5, inclusive.
    (B) Compute the new CUSUM-P value. The new CUSUM-P value is 
obtained by adding, algebraically, the CUSUM-P increment to the last 
previously computed CUSUM-P value. If this computation yields a value 
smaller than 0, the new CUSUM-P value is set equal to 0.
    (C) Evaluate the new CUSUM-P value. The new CUSUM-P value must not 
exceed:
    (1) 5.2 for food chemistry.
    (2) 4.8 for chemical residues.
    (iii) Negative systematic laboratory difference: This value is 
computed and evaluated as follows:
    (A) Determine the CUSUM-N increment for the sample.
    (1) The CUSUM-N increment for food chemistry is set equal to:
    2.0, if the standardized difference is greater than 1.6,
    -2.0, if the standardized difference is less than -2.4, or
    the standardized difference plus 0.4, if the standardized 
difference lies between - 2.4 and 1.6, inclusive.
    (2) The CUSUM-N increment for chemical residues is set equal to:
    2.0, if the standardized difference is greater than 1.5,
    -2.0, if the standardized difference is less than -2.5, or
    the standardized difference plus 0.5, if the standardized 
difference lies between -2.5 and 1.5, inclusive.
    (B) Compute the new CUSUM-N value. The new CUSUM-N value is 
obtained by subtracting, algebraically, the CUSUM-N increment from the 
last previously computed CUSUM-N value. If this computation yields a 
value smaller than 0, the new CUSUM-N value is set equal to 0.
    (C) Evaluate the new CUSUM-N value. The new CUSUM-N value must not 
exceed:
    (1) 5.2 for food chemistry.
    (2) 4.8 for chemical residues.
    (4) Variability: The absolute value of the standardized difference 
between the accredited laboratory's result and the comparison mean for 
each interlaboratory accreditation maintenance check sample is used to 
determine a CUSUM value, designated as CUSUM-V.
    (i) When determining compliance with this criterion for all 
chlorinated hydrocarbon results in a sample collectively, the following 
statistical procedure must be followed to account for the correlation 
of analytical results within a sample: The square root of the sum of 
the within sample variance and the average standardized difference of 
the sample, divided by a constant, is used in place of the absolute 
value of the standardized difference to determine the CUSUM-V value for 
the sample. The constant is a function of the number of analytical 
results used to compute the average standardized difference.
    (ii) The variability value is computed and designated as follows:
    (A) Determine the CUSUM-V increment for the sample. The CUSUM 
increment is set equal to the larger of -0.4 or the absolute value of 
the standardized difference minus 0.9. If this computation yields a 
value larger than 1.6, the increment is set equal to 1.6.
    (B) Compute the new CUSUM-V value. The new CUSUM-V value is 
obtained by adding, algebraically, the CUSUM-V increment to the last 
previously computed CUSUM-V value. If this computation yields a value 
less than 0, the new CUSUM-V value is set equal to 0.
    (C) Evaluate the new CUSUM-V value. The new CUSUM-V value must not 
exceed 4.3.
    (5) Large deviations: The large deviation measure of the accredited 
laboratory's result for each interlaboratory accreditation maintenance 
check sample is used to determine a CUSUM value, designated as CUSUM-D.
    (i) A result will have a large deviation measure equal to zero when 
the absolute value of the result's standardized difference, (d), is 
less than 2.5, and otherwise a measure equal to 1-(2.5/d).
    (ii) The large deviation value is computed and evaluated as 
follows:
    (A) Determine the CUSUM-D increment for the sample. The CUSUM 
increment is set equal to the value of the large deviation measure 
minus 0.025.
    (B) Compute the new CUSUM-D value. The new CUSUM-D value is 
obtained by adding, algebraically, the CUSUM-D increment to the last 
previously computed CUSUM-D value. If this computation yields a value 
less than 0, the new CUSUM-D value is set equal to 0.
    (C) Evaluate the new CUSUM-D value. The new CUSUM-D value must not 
exceed 1.0.
    (6) For chemical residues:
    (i) Each QC recovery must lie within ranges established by FSIS. 
Information on recovery ranges may be obtained from the ALP at the 
address provided in Sec.  439.1 of this Chapter. Supporting 
documentation must be made available to FSIS upon request.
    (ii) Not more than 1 residue misidentification may be made in any 2 
consecutive check samples.
    (iii) Not more than 2 residue misidentifications may be made in any 
8 consecutive check samples.
    (i) Fees. An accredited laboratory must pay the required 
accreditation fee when it is due.
    (j) Probation. An accredited laboratory must meet the following 
requirements if placed on probation pursuant to Sec.  439.51 of this 
chapter:
    (1) Send all official samples that have not been analyzed as of the 
date of written notification of probation to a specified FSIS 
laboratory by certified mail or private carrier or, as an alternative 
and as directed by FSIS, to a laboratory accredited by FSIS for the 
designated analyte(s). Mailing expenses will be paid by FSIS.
    (2) Analyze a set of check samples similar to those used for 
initial accreditation, and submit the analytical results to FSIS within 
3 weeks of receipt of the samples.
    (3) Satisfy criteria for accreditation check samples specified in 
Sec.  439.10 of this chapter.


Sec.  439.50  Refusal of accreditation.

    Upon a determination by the Administrator, a laboratory will be 
refused accreditation for the following reasons:

[[Page 2491]]

    (a) A laboratory will be refused accreditation for failure to meet 
the requirements of Sec.  439.5 or Sec.  439.10 of this chapter.
    (b) A laboratory will be refused subsequent accreditation for 
failure to return to an FSIS laboratory, by certified mail or private 
carrier, or, as an alternative and as directed by FSIS, to a laboratory 
accredited by FSIS for the designated analytes, all official samples 
that have not been analyzed as of the notification of a loss of 
accreditation.
    (c) A laboratory will be refused accreditation for the reasons 
described in Sec.  439.60 of this chapter.


Sec.  439.51  Probation of accreditation.

    Upon a determination by the Administrator, a laboratory will be 
placed on probation for the following reasons:
    (a) If the laboratory fails to complete more than one 
interlaboratory accreditation maintenance check sample analysis as 
required by Sec.  439.20(d) of this part within 12 consecutive months, 
unless written permission is granted by the Administrator.
    (b) If the laboratory fails to meet any of the criteria set forth 
in Sec. Sec.  439.20(d) and 439.20(h) of this chapter.


Sec.  439.52  Suspension of accreditation.

    The accreditation of a laboratory will be suspended for the reasons 
described in Sec.  439.60 of this chapter.


Sec.  439.53  Revocation of accreditation.

    The accreditation of a laboratory will be revoked for the following 
reasons:
    (a) An accredited laboratory that is accredited to perform analysis 
under Sec. Sec.  439.5, 439.10 and 439.20 of this chapter will have its 
accreditation revoked for failure to meet any of the requirements of 
Sec.  439.20 of this chapter, except for the following circumstances. 
If the accredited laboratory fails to meet any of the criteria set 
forth in Sec. Sec.  439.20(d) and 439.20(h) of this chapter and it has 
not failed during the 12 months preceding its failure to meet the 
criteria, it shall be placed on probation, but if it has failed at any 
time during those 12 months, its accreditation will be revoked.
    (b) An accredited laboratory will have its accreditation revoked if 
the Administrator determines that the laboratory or any responsibly 
connected individual or any agent or employee has:
    (1) Altered any official sample or analytical finding; or
    (2) Substituted any analytical result from any other laboratory and 
represented the result as its own.
    (c) An accredited laboratory will have its accreditation revoked 
for violations of law as described in Sec.  439.60 of this chapter.


Sec.  439.60  Violations of law.

    An applicant or an accredited laboratory will have its 
accreditation refused, suspended, or revoked, as appropriate, if the 
laboratory or any individual or entity responsibly connected with the 
laboratory is convicted of, or is under indictment for, or has had 
charges on an information brought against them in a Federal or State 
court concerning any of the following violations of law:
    (a) Any felony.
    (b) Any misdemeanor based upon acquiring, handling, or distributing 
of unwholesome, misbranded, or deceptively packaged food or upon fraud 
in connection with transactions in food.
    (c) Any misdemeanor based upon a false statement to any 
governmental agency.
    (d) Any misdemeanor based upon the offering, giving or receiving of 
a bribe or unlawful gratuity.


Sec.  439.70  Notification and hearings.

    Accreditation of any laboratory will be refused, suspended, or 
revoked under the conditions previously described in this Part 439. The 
owner or operator of the laboratory will be sent written notice of the 
refusal, suspension, or revocation of accreditation by the 
Administrator. In such cases, the laboratory owner or operator will be 
provided an opportunity to present, within 30 days of the date of the 
notification, a statement challenging the merits or validity of such 
action and to request an oral hearing with respect to the denial, 
suspension, or revocation decision. An oral hearing will be granted if 
there is any dispute of material fact joined in such responsive 
statement. The proceeding will be conducted thereafter in accordance 
with the applicable rules of practice which will be adopted for the 
proceeding. Any such refusal, suspension, or revocation will be 
effective upon the receipt by the laboratory of the notification and 
will continue in effect until final determination of the matter by the 
Administrator.

    Done in Washington, DC, on January 9, 2006.
Barbara J. Masters,
Administrator.
[FR Doc. 06-284 Filed 1-13-06; 8:45 am]
BILLING CODE 3410-DM-P