[Federal Register Volume 73, Number 175 (Tuesday, September 9, 2008)]
[Rules and Regulations]
[Pages 52193-52201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20582]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 318, 381, and 439

[FSIS Docket No. 03-020F; FDMS Docket No. 2005-0023]
RIN <greek-i> 0583-AD09


Accredited Laboratory Program

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is revising, 
editing, and consolidating 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 (1) specific chemical 
residues or classes of chemical residues, and (2) moisture, protein, 
fat, and salt. In particular, FSIS is amending 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 making 
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 consolidating the accredited laboratory 
regulations from 9 CFR 318.21 of the meat inspection regulations and 9 
CFR 381.153 of the poultry products inspection regulations into a 
single new part, 9 CFR part 439.

DATES: This rule will be effective October 9, 2008.

FOR FURTHER INFORMATION CONTACT: Eugene Vickers, Chief of the ALP, 
Office of Public Health Science, FSIS, at (202) 690-6407 or fax (202) 
690-6632, or by writing to the ALP, Box 17 Aerospace Center, Room 377, 
901 D Street, SW., Washington, DC 20024.

SUPPLEMENTARY INFORMATION:

Background

    On January 17, 2006, FSIS proposed to amend the Federal meat and 
poultry products inspection regulations by revising, editing, and 
consolidating provisions of the standards and procedures for the 
accreditation of non-Federal analytical chemistry laboratories (71 FR 
2483).\1\ This final rule is consistent with the proposed rule, except 
for the following technical revisions. First, FSIS had proposed to 
codify the Internet and mailing addresses for obtaining information on 
the ALP and minimum proficiency levels. In the final rule, FSIS is not 
codifying this address information because it is subject to change. 
However, Internet and mailing addresses for obtaining information are 
included in this preamble.
---------------------------------------------------------------------------

    \1\ FSIS laboratories are not part of the ALP. FSIS laboratories 
are ISO17025 accredited. The methods that FSIS laboratories use are 
found on the FSIS Web site.
---------------------------------------------------------------------------

    In addition, FSIS had also proposed to establish a new Sec.  439.60 
that would have consolidated all references to ``violations of law'' 
contained in Sec. Sec.  318.21(d)(4), 318.21(f), 318.21(g)(4), 
381.153(d)(4), 381.153(f), and 381.153(g)(4)). These regulations 
prescribe the conditions under which a laboratory will have its 
accreditation denied, suspended, or revoked. FSIS had proposed to 
consolidate references to violations of law to eliminate duplicative 
provisions within the regulations. The Agency did not intend to propose 
substantive changes to these regulations.
    However, when developing this final rule, FSIS determined that, as 
proposed, Sec.  439.60 did not adequately delineate the circumstances 
in which the Agency would deny, suspend, or revoke a laboratory's 
accreditation for reasons associated with certain violations of law. 
Therefore, instead of consolidating all references to violations of law 
into new Sec.  439.60 as proposed, this final rule describes the 
reasons that FSIS will deny, suspend, or revoke a laboratory's 
accreditation under separate sections that include specific paragraphs 
that contain provisions for violations of law.
    Thus, under this final rule, instead of providing a cross-reference 
to Sec.  439.60 as proposed, Sec.  439.50(c) describes the conditions 
under which FSIS will refuse to provide an accreditation to a 
laboratory for reasons associated with violations of law. In addition, 
instead of providing a cross-reference to Sec.  439.60 as proposed, 
Sec.  439.52 of this final rule provides a complete description of the 
reasons that FSIS will suspend a laboratory's accreditation. Finally, 
instead of providing a cross-reference to Sec.  439.60 as proposed, 
Sec.  439.53(c) of this final rule describes the conditions under which 
FSIS will revoke a laboratory's accreditation for reasons associated 
with violations of law. This final rule also removes proposed Sec.  
439.60, which proposed to consolidate the provisions for violations of 
law, and re-designates proposed Sec.  439.70, the provisions for 
notification and hearings, as Sec.  439.60.

[[Page 52194]]

    As discussed in the proposed rulemaking, this rule updates the 
regulations governing the ALP and clarifies and corrects some data. 
Issuance of this regulation will give FSIS more flexibility in keeping 
up with current and future scientific changes without having to reissue 
new regulations periodically. This rule deletes all references and 
footnotes to the Association of Official Analytical Chemists (AOAC) 
official methods contained in the current food chemistry accreditation 
regulations and the definitions. The AOAC methods will no longer be 
specifically cited. Instead, the ALP will advise accredited 
laboratories, as provided in the accreditation regulations, about 
suitable methods that are available from various compendia, such as 
FSIS guidebooks or current AOAC manuals.
    This 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 
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 is available from the ALP Web 
site at http://www.fsis.usda.gov/Science/Accredited_Laboratories/index.asp.
    A link to information on current MPLs is available on the ALP Web 
site or it can be accessed directly at http://www.fsis.usda.gov/PDF/2003_Red_Book_Appendix3-4.pdf.
    FSIS is also making 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, this 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 are made
                                                                                      throughout the
                                                                                      regulations, along with
                                                                                      certain other revisions.
318.21(a)..........................  381.153(a)............  439.1.................  Amended to delete specific
                                                                                      references to AOAC, to
                                                                                      delete the definition of
                                                                                      split samples, to modify
                                                                                      Tables 1 and 2 to revise
                                                                                      performance standards, and
                                                                                      to add new definitions and
                                                                                      revise 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................  Editorial changes.
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................  Editorial changes.
318.21(g)..........................  381.153(g)............  439.53................  Updates and consolidates
                                                                                      bases for revocation of
                                                                                      accreditation and makes
                                                                                      certain editorial changes.
318.21(h)..........................  381.153(h)............  439.60................  Editorial changes.
----------------------------------------------------------------------------------------------------------------

Expansion of the Laboratory Program

    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 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.

Discussion of Comments

    The Agency received a total of five comments in response to the 
proposed rule, four from consumers and one from a representative of a 
trade industry association. Two of the comments were supportive, one 
was both supportive and critical, and two were opposed to the proposed 
rule.
    Comment: The commenter supported no changes to the current rules. 
The commenter claimed that USDA changes often harm and hurt the public 
and only help the profiteers.
    Response: No evidence was presented by the commenter to show that 
the proposed changes will have adverse effects on the public. FSIS has 
carefully evaluated all changes and determined they will improve the 
ALP.
    Comment: The commenter supported the ALP and asked for 
clarification of the standardized values in classes of residue. The 
commenter wanted to know if the values are for various species.
    Response: The standardized values are for various species. The 
chlorinated hydrocarbons (CHC) and polychlorinated biphenyls (PCB) are 
measured in the fat of various species, such as beef, pork, and 
chicken.
    Comment: The commenter stated there is no need for the FSIS ALP. 
The commenter suggested that FSIS recognize analytical results produced 
by any laboratory accredited according to International Organization 
for Standardization (ISO) 17205, which is the ISO laboratory 
accreditation standard. The commenter would like the resources 
currently expended on the ALP to be re-directed within FSIS.
    Response: The FSIS ALP is a user fee program mandated by the Food, 
Agriculture, Conservation, and Trade Act of 1990 (the 1990 Farm Bill). 
The user fees cover the cost of administering the ALP program. ISO 
accreditation is a third party evaluation of laboratory quality and 
capability. FSIS' ALP is a separate program. While ISO

[[Page 52195]]

accreditation requires, but does not provide, proficiency testing, such 
testing is a cornerstone of the FSIS program. Thus, there are 
differences in the two programs. The ALP is a voluntary program. Many 
of the accredited laboratories are ISO accredited, and they choose to 
be in the FSIS ALP to satisfy their clients' requirements.
    Comment: The commenter supported the proposed rule to the extent 
that it will bring more clarity and consistency to the process of 
analyzing and obtaining results and increase the rapidity of analytical 
results. In addition, this commenter stated that private laboratories 
may well have increased business opportunities, thus possibly reducing 
government cost. The concern expressed by this commenter was that 
consumers may question the accuracy of testing by private laboratories 
as opposed to ``more experienced'' government laboratories. Also, the 
commenter stated that consumers may be concerned that the meat and 
poultry industries will pass the increased cost of testing in private 
laboratories on to the consumers. This same commenter asked if it would 
be possible to do random sampling to ensure the private labs are 
consistently meeting Federal standards.
    Response: Accredited laboratories are held to the same procedures 
and standards as FSIS laboratories. The laboratories' analytical 
performance is continually monitored by proficiency samples and 
periodic on-site reviews.
    Some meat and poultry plants have their own laboratories. Having 
these laboratories accredited by FSIS will facilitate testing without 
costing the industry extra money.
    Comment: An additional commenter supported the proposal without 
qualification.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. States and local jurisdictions are preempted by 
the Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) from imposing any requirements on federally 
inspected premises, facilities, and operations that are in addition to, 
or different than, those imposed under the FMIA and the PPIA. 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 and poultry 
products that are misbranded or adulterated under the FMIA and PPIA, 
or, in the case of imported products, that are not at such an 
establishment, after their entry into the United States.
    This final rule is not intended to have retroactive effect.
    When this final rule is adopted, administrative proceedings will 
not be required before parties may file suit in court challenging this 
rule. However, the administrative procedures specified in 9 CFR 306.5 
and 381.35 must be exhausted prior to any judicial challenge of the 
application of the provisions of this final rule, if the challenge 
involves any decision of an FSIS employee relating to inspection 
services provided under the FMIA or PPIA.

Executive Order 12866

    This final rule has been reviewed under Executive Order 12866. The 
rule has been determined to be not significant for the purpose of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.

Effect on Small Entities

    The Administrator has made a determination that this 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). 
There are about 77 laboratories that have a total of about 92 
accreditations in the FSIS 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.
    The effects of this rule on the laboratories and on the 
establishments they serve will not be significant and will apply 
equally to large and small entities. 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 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 participation in the ALP are likely to be small.

Paperwork Requirements

    FSIS has reviewed the paperwork and recordkeeping requirements in 
this 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 OMB. The OMB approval 
number for the Application for Inspection, Sanitation, and Accredited 
Laboratories information collection is 0583-0082.

E-Government Act Compliance

    FSIS is committed to complying with the E-Government Act, to 
promote the use of the Internet and other information technologies to 
provide increased opportunities for citizen access to Government 
information and services, and for other purposes.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it online through the FSIS Web page located 
at http://www.fsis.usda.gov/regulations_&_policies/2008_Interim_&_Final_Rules_Index/index.asp. FSIS will also 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, and other types of information that could affect or would be 
of interest to constituents and stakeholders. The Update is 
communicated via Listserv, a free electronic mail subscription service 
for industry, trade groups, consumer interest groups, health 
professionals, and other individuals who have asked to be included. The 
Update is also available on the FSIS Web page. Through the Listserv and 
Web page, FSIS is able to provide information to a much broader and 
more diverse audience. In addition, FSIS offers an e-mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Options range 
from recalls to export information to regulations, directives

[[Page 52196]]

and notices. Customers can add or delete subscriptions themselves, and 
have the option to password protect their accounts.

List of Subjects

9 CFR Part 318

    ALP, Meat inspection, Recordkeeping and reporting requirements.

9 CFR Part 381

    ALP, Poultry and poultry products inspection, Recordkeeping and 
reporting requirements.

9 CFR Part 439

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

0
Accordingly, Title 9, Chapter III of the Code of Federal Regulations is 
amended as follows:

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

0
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]

0
2. Remove and reserve Sec.  318.21.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
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]

0
4. Remove and reserve Sec.  381.153.

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

0
5. Subchapter E is amended by adding a new Part 439 to read as follows:

PART 439--ACCREDITATION OF NON-FEDERAL 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 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.
    (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

[[Page 52197]]

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.
    (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.
    (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.
    (p) Official sample--A sample selected by an inspector or 
inspection service employee in accordance with FSIS procedures for 
regulatory use.
    (q) 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.
    (r) QA (See Quality assurance recovery).
    (s) QC (See Quality control recovery).
    (t) 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.
    (u) 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.
    (v) Refusal of accreditation--An action taken by FSIS when a 
laboratory that is applying for accreditation is denied the 
accreditation.
    (w) Responsibly connected--Any individual, or entity, that 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.
    (x) Revocation of accreditation--An action taken by FSIS against a 
laboratory, removing the laboratory's right to analyze official 
samples.
    (y) 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.
    (z) 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.
    (aa) 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 to this 
paragraph (aa).

                                           Table 1 to Paragraph (aa)--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 (X 0.65)      0.26 (X      0.30 (X        0.127  0.127 (X 0.25)         0.22
                                                                                            0.25)        0.25)
Ground Beef............................................         0.71  0.060 (X 0.65)          N/A      0.35 (X        0.127  0.127 (X 0.25)         0.22
                                                                                                         0.25)
Other Meat Products....................................         0.57  0.060 (X 0.65)      0.26 (X      0.30 (X        0.127  0.127 (X 0.25)         0.22
                                                                                            0.25)        0.25)
Poultry Products.......................................         0.57  0.060 (X 0.65)      0.26 (X      0.30 (X        0.127  0.127 (X 0.25)        0.22
                                                                                            0.25)        0.25)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.


  Table 2 to Paragraph (aa)--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
  Volatile Nitrosamine \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.

    (bb) 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.
    (cc) 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.

[[Page 52198]]

Conversely, numerically smaller results indicate a negative systematic 
laboratory difference.
    (dd) Variability--Random fluctuations in a laboratory's processes 
that cause its analytical results to deviate from a true value.
    (ee) Variance--The expected average of the squared differences of 
sample results from an expected sample mean.


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 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 of this part, 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, at 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 
one 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 three 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 criteria for obtaining accreditation, 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 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).

[[Page 52199]]

    (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.
    (ii) QC recovery: All QC recoveries must lie within ranges 
established by FSIS. 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. 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 
three 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 three 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 one week. The standards book is to be 
retained for three 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 three 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 three 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 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 (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 for chemical 
residue recoveries and proper identification;
    (ii) Must 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.
    (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 part, 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,

[[Page 52200]]

    -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.
    Supporting documentation must be made available to FSIS upon 
request.
    (ii) Not more than one residue misidentification may be made in any 
two consecutive check samples.
    (iii) Not more than two residue misidentifications may be made in 
any eight 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 
part:
    (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 
three weeks of receipt of the samples.
    (3) Satisfy criteria for accreditation check samples specified in 
Sec.  439.10 of this part.


Sec.  439.50  Refusal of accreditation.

    Upon a determination by the Administrator, a laboratory will be 
refused accreditation for the following reasons:
    (a) A laboratory will be refused accreditation for failure to meet 
the requirements of Sec.  439.5 or Sec.  439.10 of this part.
    (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 if the laboratory or 
any individual or entity responsibly connected with the laboratory has 
been convicted of, or is under indictment for, or has charges on an 
information brought against them in a Federal or State court concerning 
any of the following violations of law:
    (1) Any felony.
    (2) Any misdemeanor based upon acquiring, handling, or distributing 
of unwholesome, misbranded, or deceptively packaged food or upon fraud 
in connection with transactions in food.
    (3) Any misdemeanor based upon a false statement to any 
governmental agency.
    (4) Any misdemeanor based upon the offering, giving or receiving of 
a bribe or unlawful gratuity.

[[Page 52201]]

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 part.


Sec.  439.52  Suspension of accreditation.

    The accreditation of a laboratory will be suspended if the 
laboratory or any individual or entity responsibly connected with the 
laboratory is indicted or has charges on information brought against 
them in a Federal or State court for 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.  439.53  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 part will have its 
accreditation revoked for failure to meet any of the requirements of 
Sec.  439.20 of this part, 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 part 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 if 
the laboratory or any individual or entity responsibly connected with 
the laboratory is convicted in a Federal or State court of 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.  439.60  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 August 27, 2008.
Alfred V. Almanza,
Administrator.
[FR Doc. E8-20582 Filed 9-8-08; 8:45 am]
BILLING CODE 3410-DM-P