Changes to Accreditation of Non-Federal Analytical Testing Laboratories, 51861-51867 [2022-18274]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Rules and Regulations]
[Pages 51861-51867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18274]



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Rules and Regulations
                                                Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents 
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Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / 
Rules and Regulations

[[Page 51861]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 439

[Docket No. FSIS-2021-0013]
RIN 0583-AD70


Changes to Accreditation of Non-Federal Analytical Testing 
Laboratories

AGENCY: Food Safety and Inspection Service (FSIS), Department of 
Agriculture (USDA).

ACTION: Final rule.

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SUMMARY: FSIS is revising the regulations prescribing the statistical 
methods used in measuring the performance of chemistry laboratories in 
its voluntary Accredited Laboratory Program (ALP) and expanding the 
scope of accreditations offered by the program. Currently, participants 
in the ALP are accredited for the analysis of food chemistry (moisture, 
protein, fat, and salt), specific chemical residues, and classes of 
chemical residues. FSIS also is providing for the ALP to accredit non-
Federal laboratories for microbiological indicator organisms and 
pathogen testing. FSIS is changing the statistical method the ALP uses 
to evaluate laboratory proficiency testing (PT). Additionally, FSIS is 
making various minor edits and changes to the regulation for the sake 
of clarity and to incorporate all sample types under the jurisdiction 
of FSIS.

DATES: This rule is effective October 24, 2022.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture; Telephone: 
(202) 720-0399.

SUPPLEMENTARY INFORMATION:

Background

    FSIS accredits non-Federal analytical laboratories under its 
Accredited Laboratory Program (ALP). Under this voluntary program, FSIS 
accredits laboratories to conduct analyses of official meat and poultry 
samples for food chemistry (moisture, protein, fat, and salt), specific 
chemical residues, and classes of chemical residues. In response to the 
meat and poultry industries' need for more rapid analytical results as 
food testing expanded, and because of limitations in FSIS laboratory 
capacity at the time of this need, these programs were established to 
accredit non-Federal laboratories for certain tests of both meat and 
poultry products.
    The ALP monitors each non-Federal laboratory currently accredited 
under the program to ensure that these laboratories are operating at a 
level of quality that produces reliable results that can be used to 
support decisions in establishments' food safety systems. The 
Proficiency Testing (PT) program administered by the ALP supports this 
effort. Monitoring is achieved by evaluating PT results for acceptable 
analytical performance and assessing quality assurance through on-site 
reviews of each laboratory's management system and facility assets.
    On December 14, 2020, FSIS proposed changes to its ALP regulations 
(85 FR 80668). Specifically, FSIS proposed to change the statistical 
method it uses to evaluate laboratory PT sample results to the z score 
approach for those accreditations that are currently evaluated by 
Cumulative Summation (CUSUM). FSIS also proposed to accredit non-
Federal laboratories for microbiological indicator organisms and 
pathogen testing, in response to industry interest. This second change 
will allow ALP-accredited laboratories to support statistical process 
control testing. FSIS intends to announce additional criteria for 
submitting test results in a future Federal Register document. 
Additionally, FSIS proposed to make various minor edits and changes to 
the regulations for the sake of clarity and to incorporate all sample 
types under the jurisdiction of FSIS (e.g., to include egg products), 
as appropriate for the associated analyte, and to improve program 
flexibility.
    The comment period ended on February 12, 2021. After reviewing 
comments, FSIS is finalizing the rule as proposed.

Comments and Responses

    FSIS received seven comments on the proposed rule. Commenters 
included representatives from laboratories, an association of 
laboratory scientists, a State Department of Agriculture, a nationwide 
laboratory network, and a trade association. Four of the seven 
commenters expressed overall support for the proposed rule. Some 
commenters raised questions and made suggestions, and two of the 
commenters expressed concern with making International Organization for 
Standardization (ISO) 17025 accreditation a prerequisite to 
participation in the program, a possibility upon which FSIS requested 
comment in the proposal. No commenter expressed broad opposition to the 
proposal, as a whole, for updating the statistical PT scoring and 
expanding the program to include accreditations for microbiological 
indicator organisms and pathogen testing.
    The following is a discussion of the relevant issues raised in the 
comments.

Statistical Methods

    Comments: All commenters generally agreed with the proposed change 
from CUSUM to z scores. One commenter from a State Department of 
Agriculture asked at which point a lab would be considered on probation 
under the new statistical analysis using z scores; how grading will be 
applied; and whether a z score will be determined per event.
    Response: Per 9 CFR 439.20 and ISO 13528, the PT scoring changes 
will be applied per event. The ALP will also monitor laboratory 
performance over time. After adopting the proposed changes, probation 
imposed for performance issues will be administered the same way it has 
with CUSUMs, but assessment will rely instead on unacceptable z scores 
and monitoring for persistent bias. Unacceptable z scores are greater 
than 3 and less than -3. FSIS intends to determine probation for PT 
performance issues as follows.
     A laboratory will be placed on probation for having two z 
scores that exceed the action level of [verbar] z [verbar] >= 3.0 for 
the same analyte or class of analytes within six consecutive PT events.
     A laboratory may be placed on probation for having a 
persistent bias of an analyte or class of analytes compared

[[Page 51862]]

to the accepted values of ALP PT samples. As a general practice under 
ISO 13528, FSIS intends that the ALP will use control charts to monitor 
for this aspect of performance. Bias occurs once eight or more 
consecutive values fall above or below the center or mean line. Under 
the ALP, FSIS reserves the right to consider other factors (such as 
magnitude or significance) when determining the impact of bias.

Management of Associated Data

    Comments: Two commenters stated that ALP data should be managed 
through a website portal or other similar option. One commenter 
representing an association of scientists strongly supported the FSIS 
vision of utilizing the ALP to allow regulated establishments to 
voluntarily submit test results to FSIS. Another commenter representing 
a nationwide laboratory network suggested that accredited laboratories 
should maintain complete records of all aspects of the testing process 
and that the records should be securely maintained in an electronic 
format that is adequately backed up. In addition, the commenter 
recommended that key components of ALP data should be clearly defined 
to assure proper data interpretation and that definitions used by 
ISO13528:2015(E) should be consistent with USDA to assure uniformity.
    Response: FSIS intends to develop a web-based platform for ALP test 
result submissions to FSIS. FSIS will announce the availability of the 
web-based platform in a future Constituent Update. Per 9 CFR 439.20, 
the FSIS ALP regulations require a secure management system that is 
adequate for tracking samples and related analyses and test results. 
The ALP does allow, but does not require, electronic records, and it 
does require that records be secure. Test result definitions used by 
the ALP are consistent with ISO 13528:2015(E). Any electronic system 
for submitting test results to FSIS will have to be compatible with 
FSIS data management systems.

Desired Food Matrix and Analyte Pairs

    Comments: One commenter representing a laboratory did not see the 
benefit of adding pathogens and indicator organism constituents to the 
ALP. Five commenters recommended that FSIS expand the ALP offerings to 
include such items as pH in meat, beta-agonists in beef/pork muscle/
organs, Campylobacter in chicken, Salmonella in meat products, Listeria 
spp. in swabs/sponges, Listeria monocytogenes in meat products, 
Escherichia coli in carcass swabs, Enterobacter in swabs/sponges, Shiga 
toxin-producing Escherichia coli in meat products, generic Escherichia 
coli, total coliform, Aerobic Plate Count, and drug residues in animal 
products, including antibiotics and pesticides. Other commenters 
recommended the ALP include microbiology qualitative and quantitative 
testing and requested that FSIS revisit approved analytes in the ALP on 
a systematic basis.
    Response: Per 9 CFR 439.1 and 439.10, FSIS will consider all 
requests for accredited matrix and analyte pairs for the ALP that are 
within FSIS's jurisdiction. FSIS will also consider qualitative and 
quantitative testing for chemical and microbiological components under 
the ALP. Finally, FSIS will routinely examine the ALP offerings when 
appropriate.

ISO Accreditation

    Comments: Two commenters representing laboratories did not support 
making ISO 17025 accreditation a prerequisite to participating in the 
ALP and stated such a requirement could cause an undue burden on 
smaller laboratories wishing to join the ALP. Two commenters 
representing a laboratory association and a laboratory network 
supported making ISO 17025 accreditation a prerequisite to 
participating in the ALP but also stated that the requirement may be 
unnecessary. One of these commenters suggested that laboratories not 
accredited to ISO 17025 should operate under a robust quality 
management system or ``ISO-like'' environment. One commenter 
representing a laboratory network supported the rule and stated that 
ISO 17025 accreditation should be a prerequisite to membership in the 
ALP.
    Response: This final rule expands the ALP in a way that is 
inclusive for all interested laboratories and establishments that can 
successfully meet the program requirements and, per 9 CFR 439.20, the 
ALP will require participating laboratories to have a management system 
in place that includes traceability, document control, and secure 
record retention. Laboratories may choose whether to be accredited to 
the ISO 17025 standard; however, FSIS will not require ISO 17025 
accreditation under the ALP. Laboratories seeking ALP accreditation 
without ISO 17025 accreditation are often very small and conduct meat 
and poultry analyses only. In these cases, the ALP accreditation 
provides value by affirming that the lab can do independent PT analysis 
with those PT samples made by and coming from the ALP.
    Comments: Three commenters responded that if a laboratory is 
accredited to ISO 17025, the FSIS ALP audit should be streamlined to 
account for this and offer fee discounts. One commenter representing a 
network of laboratories responded that the ALP proficiency testing 
program should be accredited to the ISO 17043 standard if it is to 
attract members from the governmental sector. One commenter 
representing an association of laboratories stated that a reduction in 
fees would be welcomed by laboratories interested in the ALP, but the 
best way to incentivize laboratories to become ALP members is to expand 
the scope of testing. The commenter pointed out that most laboratories 
providing services to meat and poultry companies are focused on 
supporting their clients' food safety programs. The commenter stated 
that laboratories' clients view their being an FSIS ALP laboratory as 
positive, which is beneficial to the laboratory.
    Response: FSIS will continue to accept the management systems of 
laboratories that are accredited to ISO 17025 by an International 
Laboratory Accreditation Cooperation recognized accrediting body as 
meeting ALP requirements. The laboratories must be in good standing 
with their ISO accreditation for the ALP to accept the management 
systems. The ALP performs onsite reviews of participating laboratories 
to ensure they are following management system requirements, as well as 
the technical and method requirements for participation in the program. 
FSIS estimates that the ALP review for ISO 17025 accredited 
laboratories will be reduced by a range of 0.5 to 1 hour. The ALP has 
been ISO 17043 accredited as a proficiency testing provider since 2015. 
The ALP has also been ISO 17034 accredited as a reference material 
producer since 2017. Both accreditations are kept current. Because 
comments have been supportive of expanding the ALP offerings, FSIS 
intends to develop new offerings from the ALP. The new offerings may be 
found on the ALP website as they are developed and available.

Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs

[[Page 51863]]

and benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This final rule has been designated as a ``non-
significant'' regulatory action under section 3(f) of E.O. 12866. 
Accordingly, the rule has not been reviewed by the Office of Management 
and Budget under E.O. 12866.

Need for the Rule

    There were approximately 55 food chemistry laboratories 
participating in the ALP in 2012. Since then, participation has 
declined to 34 laboratories in 2021. Of those laboratories, 25 were 
accredited for food chemistry, 13 for chemical residue chlorinated 
pesticides analysis, and 4 for chemical residue PCBs analysis (some 
laboratories have multiple accreditations).\1\ Participation in the ALP 
will likely be bolstered by expanding the ALP to include additional 
analytes, such as indicator organisms and foodborne pathogens. In 
addition, switching from the CUSUM PT sample scoring system currently 
used by the ALP to z score-based statistics should simplify the 
accreditation process for both the laboratories and FSIS. The program 
generally facilitates industry testing to verify that food is safe and 
properly labeled.
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    \1\ A list of current FSIS Accredited Laboratories can be found 
at https://www.fsis.usda.gov/science-data/laboratories-procedures/accredited-laboratory-program (last accessed on June 22, 2021). PCBs 
stands for Polychlorinated Biphenyls.
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Expected Industry Costs and Savings

    Although the final rule does not change the current accreditation 
fee structure,\2\ it will reduce the number of samples non-Federal food 
chemistry laboratories will have to analyze to attain and maintain food 
chemistry accreditation. Based on industry data, non-ALP laboratories 
charge approximately $108 \3\ per sample. Current criteria for 
obtaining accreditation (9 CFR 439.10(d)(2)(i)) require that 
laboratories analyze a set of 36 samples (9 CFR 439.1(k) ``Initial 
accreditation check sample'') for food chemistry to obtain initial 
accreditation or to remove probationary status in food chemistry. The 
estimated cost for analyzing the sample set (also known as 
qualification set) is approximately $3,888 (36 x $108 = $3,888). This 
number of samples is not necessary to statistically evaluate laboratory 
performance for admittance to the program. Under this final rule, FSIS 
removed the requirement for the set of 36 samples. This will permit the 
ALP to offer laboratories smaller sets for food chemistry 
accreditation. The smaller qualification sets will reduce costs for 
laboratories and still be large enough to evaluate laboratory 
performance. FSIS experts provided an estimated cost of analysis of 
approximately $1,512 when using 14 samples per set (14 x $108 = 
$1,512), a reduction of $2,376 ($3,888-$1,512 = $2,376) per 
qualification set for food chemistry. This analysis assumes that 
between 1 and 6 establishments will have to complete qualification sets 
in any given year.\4\ Based on this assumption the annual savings 
ranges from $2,376 (1 x $2,376) to $14,256 (6 x $2,376), with a mid-
point of $8,316 (3.5 x $2,376).
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    \2\ Fees and charges for laboratory accreditation are provided 
in 9 CFR part 391.
    \3\ This cost is based on publicly listed industry prices in 
2021 charged by N.P Analytical Laboratories, Great Lakes Scientific, 
New Jersey Feed Laboratory Inc (NJFL), and Analytical Feed and Food 
Lab accessed on June 22, 2021.
    \4\ For instance, in 2016, there were 2 new applicants and 4 
probation applicants and, in 2021, there are no new applicants and 1 
probation applicant.
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    Additionally, the changes to the accreditation process (9 CFR 
439.10(d)(4)(ii)) are also expected to reduce industry costs. Current 
criteria state that if a laboratory's second set of qualification 
samples do not meet the criteria for obtaining accreditation, 
laboratories must submit a new application, all fees, and all 
documentation of corrective action required for accreditation. FSIS 
will no longer require food chemistry laboratories to reapply and pay 
the fees again before receiving the third qualification sample set. 
Instead, fees will be paid after the third set or if the initial 
accreditation process is not completed within eleven months (per 9 CFR 
439.10(c)). This is expected to reduce an applicable laboratory's 
accreditation cost by between $2,100 and $5,000.

Regulatory Flexibility Analysis

    The FSIS Administrator (Administrator) has made a determination 
that this final rule will not have a significant economic impact on a 
substantial number of small entities in the United States, as defined 
by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). First, this 
rule's impact is limited to a small number of entities and 
participation in the program is voluntary. Second, while the changes 
are expected to reduce accreditation costs, these cost savings are not 
anticipated to be significant and will apply to accredited laboratories 
regardless of size.

Paperwork Reduction Act

    FSIS has reviewed this rule under the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501-3520) and has determined that there is no new 
information collection related to this final rule. FSIS collects 
information for the ALP under Office of Management and Budget (OMB) 
approval numbers 0583-0082 and 0583-0163.

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, Consultation and Coordination with Indian Tribal 
Governments. The review reveals that this regulation will not have 
substantial and direct effects on Tribal governments and will not have 
significant Tribal implications.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
https://www.fsis.usda.gov/federal-register.
    FSIS will also announce and provide a link to this Federal Register 
publication 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 our 
constituents and stakeholders. The Constituent Update is available on 
the FSIS web page. Through the web page, FSIS can provide information 
to a much broader, more diverse audience. In addition, FSIS offers an 
email subscription service which provides automatic and customized 
access to selected food safety news and information. This service is 
available at: https://www.fsis.usda.gov/subscribe. Options range from 
recalls to export information, regulations, directives, and notices. 
Customers can add or delete subscriptions themselves and have the 
option to password protect their accounts.

[[Page 51864]]

USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of 
Agriculture (USDA) civil rights regulations and policies, the USDA, its 
Agencies, offices, and employees, and institutions participating in or 
administering USDA programs are prohibited from discriminating based on 
race, color, national origin, religion, sex, gender identity (including 
gender expression), sexual orientation, disability, age, marital 
status, family/parental status, income derived from a public assistance 
program, political beliefs, or reprisal or retaliation for prior civil 
rights activity, in any program or activity conducted or funded by USDA 
(not all bases apply to all programs). Remedies and complaint filing 
deadlines vary by program or incident.
    Persons with disabilities who require alternative means of 
communication for program information (e.g., Braille, large print, 
audiotape, American Sign Language, etc.) should contact the responsible 
FSIS or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or 
contact USDA through the Federal Relay Service at (800) 877-8339. 
Additionally, program information may be made available in languages 
other than English.
    To file a program discrimination complaint, complete the USDA 
Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and 
at any USDA office or write a letter addressed to USDA and provide in 
the letter all of the information requested in the form. To request a 
copy of the complaint form, call (866) 632-9992.
    Submit your completed form or letter to USDA by: (1) mail: U.S. 
Department of Agriculture, Office of the Assistant Secretary for Civil 
Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; (2) 
fax: (202) 690-7442; or (3) email: [email protected].
    USDA is an equal opportunity provider, employer, and lender.

List of Subjects in 9 CFR Part 439

    Laboratories, Meat inspection, Poultry and poultry products.
    For the reasons discussed in the preamble, FSIS revises 9 CFR part 
439 to read as follows:

PART 439--ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL 
TESTING OF MEAT, POULTRY, AND EGG PRODUCTS

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, 1622(o); 21 U.S.C. 
451-470, 601-695; 7 CFR 2.18, 2.53.


Sec.  439.1  Definitions.

    (a) Accredited Laboratory Program (ALP). The voluntary Food Safety 
and Inspection Service (FSIS) program in which non-Federal laboratories 
are accredited as capable of performing analyses with the level of 
quality that is necessary to maintain accreditation in the program, on 
samples of raw or processed meat, poultry, and egg products, and 
through which a proficiency testing sample program for quality 
assurance is conducted.
    (b) Food chemistry. Analysis of raw or processed meat or poultry 
products for the components moisture, protein, fat, and salt.
    (c) Initial accreditation proficiency testing sample. A sample 
provided by the FSIS ALP to a non-Federal laboratory to determine 
whether the laboratory's analytical capability meets the standards for 
acceptance into the program. The concentration or presence of the 
targeted analyte(s) and the composition of the components in the sample 
is unknown to the laboratory.
    (d) Inter-laboratory accreditation maintenance proficiency testing 
sample. A sample provided by the FSIS ALP to an accredited laboratory 
to assist in determining whether the laboratory is maintaining 
acceptable analytical performance for a given analyte or component. The 
concentration or presence of the targeted analyte(s) and the 
composition of the components in the sample is unknown to the 
laboratory.
    (e) International Organization for Standardization (ISO) 13528. ISO 
13528:2015(E) Corrected version 2016, ``Statistical methods for use in 
proficiency testing by interlaboratory comparison,'' October 15, 2016, 
or updated versions.
    (f) Probation. The period commencing with official notification to 
an accredited laboratory that it no longer satisfies the ALP 
performance requirements specified in this part and ending with 
official notification that accreditation is fully restored, is 
suspended, or is revoked.
    (g) Refusal of accreditation. An action taken by FSIS when a 
laboratory that is applying for accreditation is denied the 
accreditation.
    (h) 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 analysis of FSIS samples.
    (i) Revocation of accreditation. An action taken by FSIS against a 
laboratory thereby removing the laboratory's certification of 
accreditation and participation in inter-laboratory accreditation 
maintenance proficiency testing sample events.
    (j) Suspension of accreditation. An action taken by FSIS against a 
laboratory thereby temporarily removing the laboratory's certification 
of accreditation and participation in the inter-laboratory 
accreditation maintenance proficiency testing sample events. Suspension 
of accreditation ends when accreditation either is fully restored or is 
revoked.
    (k) z score. A statistically derived number representing a 
laboratory's performance for analyzing quantitative proficiency testing 
samples. The ALP calculates and interprets z scores consistent with the 
ISO 13528 standard.


Sec.  439.5  Applications for accreditation.

    (a) Participation in the ALP is voluntary. Application for 
accreditation must 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. Application forms may be obtained by 
contacting the ALP at [email protected]. The forms must be sent to the ALP 
or may be submitted electronically. The application must specify the 
kinds of accreditation sought by the owner or manager of the 
laboratory. A laboratory whose accreditation has been refused or 
revoked for performance reasons may reapply for accreditation after 60 
days from the effective date of that action and must provide written 
documentation specifying what corrections were made and illustrate to 
FSIS that the corrections are effective or would reasonably be expected 
to be effective.
    (b) At the time that an application for accreditation is filed with 
the ALP, the laboratory must submit fees payable to the U.S. Department 
of Agriculture by check, bank draft, money order, or other form of 
payment accepted by the U.S. Department of Agriculture, in the amount 
specified by FSIS as directed in 9 CFR 391.5, along with the completed 
application for the accreditation(s).
    (c) An application for accreditation will not be processed or 
allowed to advance, without further procedure, if the accreditation 
fee(s) is delinquent.

[[Page 51865]]

    (d) FSIS will issue a bill annually in the amount specified by FSIS 
in 9 CFR 391.5 for each accreditation held and are due by the date 
required. Bills are payable to the U.S. Department of Agriculture by 
check, bank draft, money order, or other form of payment accepted by 
the U.S. Department of Agriculture.


Sec.  439.10  Criteria for obtaining accreditation.

    (a) Analytical laboratories may be accredited for the analyses of 
foodborne indicator and pathogen analytes, or a specified chemical 
residue or a class of chemical residues, in raw or processed meat, 
poultry, and egg products. Analytical laboratories also may be 
accredited for the analyses of food chemistry components in raw or 
processed meat and poultry products.
    (b) Accreditation will be granted only if the applying laboratory 
successfully satisfies FSIS requirements that are stated in this part.
    (c) To obtain FSIS accreditation, an analytical laboratory must:
    (1) Be supervised by a person holding, at a minimum, a bachelor's 
degree in biology, chemistry, microbiology, food science, food 
technology, or a related field.
    (i) For food chemistry accreditation, the supervisor must also have 
one year of experience in food chemistry analysis, or equivalent 
qualifications.
    (ii) For chemical residue accreditation, either the supervisor or 
the analyst assigned to analyze the sample must also have three years 
of experience determining analytes at or below part per million levels, 
or equivalent qualifications.
    (iii) For indicator organisms or pathogen accreditation, either the 
supervisor or the analyst assigned to analyze the sample must also have 
three years of experience in foodborne pathogen analyses or equivalent 
qualifications.
    (2) Demonstrate the capability to achieve quality assurance levels 
that are within acceptable limits as determined by evaluation that is 
consistent with ISO 13528 for the analysis of initial accreditation 
proficiency testing samples, in the analyte category for which 
accreditation is sought. FSIS and some Association of Official 
Analytical Collaboration (AOAC) International analytical test 
procedures are acceptable for use in this program. FSIS procedures may 
be found on the U.S. Department of Agriculture (USDA) FSIS website at 
www.fsis.usda.gov. AOAC procedures may be found on the AOAC website at 
www.aoac.org.
    (3) Complete a second set of proficiency testing samples if the 
results of the first set of proficiency testing samples are 
unsuccessful.
    (i) The second set of proficiency testing 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 proficiency testing samples 
will be analyzed only for the analyte(s) or analyte classes for which 
unacceptable initial results had been obtained by the laboratory.
    (ii) If the results of the second set of proficiency testing 
samples are unsuccessful, the laboratory may request a third set of 
proficiency testing samples after a 60-day waiting period, commencing 
from the date of notification by FSIS of unsuccessful results. The 
third set of proficiency testing samples will be analyzed only for the 
analyte(s) or analyte classes for which unacceptable initial results 
had been obtained by the laboratory.
    (iii) If the laboratory is unsuccessful for the third set and still 
wishes to pursue accreditation, the ALP will require a new application 
and an application fee if the initial accreditation process is not 
completed within eleven months. Documentation of corrective action(s) 
related to the previous unsuccessful accreditation attempt must be 
submitted to and accepted by the ALP.
    (4) Allow inspection of the laboratory facility and pertinent 
documents by FSIS officials prior to the determination of granting 
accredited status.
    (5) Pay the accreditation fee by the date required.


Sec.  439.20  Criteria for maintaining accreditation.

    (a) Criteria. To maintain accreditation, an analytical laboratory 
must fulfill the requirements of this section.
    (b) Records. To demonstrate traceable and appropriate application 
of equipment, standards, procedures, analysts, and approvals related to 
accreditation, an accredited laboratory must:
    (1) Maintain laboratory quality control records for the most recent 
three years that samples have been analyzed.
    (2) Maintain complete records of the receipt, analysis, and 
disposition of samples for the most recent three years that samples 
have been analyzed.
    (3) Maintain in a secure electronic format or in a standards book, 
all records, readings, and calculations for prepared standards. Entries 
are to be dated and the analyst identified at the time of the entry, 
and manual calculations verified and documented by the supervisor, or 
by the supervisor's designee, before use of the standard. The standards 
records are to be retained for three years after the last recorded 
entry. The certificates of analysis are to be kept on file for 
purchased standards for at least the period of time that the materials 
are in use.
    (4) Maintain records of instrument maintenance and calibration. The 
records are to be retained for three years after the last recorded 
entry.
    (5) As provided in paragraph (e) of this section, records are to be 
made available for review by any duly authorized representative of the 
Secretary of Agriculture, including ALP personnel or their designees.
    (c) Inter-laboratory accreditation maintenance proficiency testing 
sample. (1) An accredited laboratory must analyze inter-laboratory 
accreditation maintenance proficiency testing samples and return the 
results to the ALP by the due date, which is usually within 
approximately 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 
proficiency testing samples must not be contracted out by the 
accredited laboratory.
    (d) 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.
    (e) 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.
    (f) Analytical test procedures. An accredited laboratory must use 
analytical test procedures designated by the FSIS ALP as being 
acceptable. FSIS and some AOAC analytical test procedures are 
acceptable.
    (g) Quality assurance levels. An accredited laboratory must 
demonstrate the capability to maintain quality assurance levels that 
are within acceptable limits as evaluated by the ALP in the analysis of 
inter-laboratory accreditation maintenance proficiency testing samples 
for the analyte category for which accreditation was granted. An 
accredited laboratory will successfully demonstrate the maintenance of 
these capabilities if its results from inter-

[[Page 51866]]

laboratory accreditation maintenance proficiency testing samples 
satisfy ALP evaluation criteria based on the ISO 13528 standard, to 
include performance evaluation by z score statistics.
    (h) Fees. An accredited laboratory must pay the annual required 
accreditation fee when it is due.
    (i) Probation. If placed on probation, an accredited laboratory 
must meet the ALP requirements as prescribed in this section in order 
to remove the probation status.
    (1) The laboratory must successfully analyze a set of initial 
accreditation proficiency testing samples for the analyte(s) that 
triggered the probation and submit the analytical results to FSIS by 
the due date, which is typically within approximately three weeks of 
receipt of the samples.
    (2) Similarly satisfy criteria for accreditation maintenance 
proficiency testing samples specified by the ALP in this part.
    (3) Provide written corrective action documentation, related to the 
issue that triggered the probation, to the ALP by the date required.
    (j) Suspension. If placed on suspension, an accredited laboratory 
must meet the ALP requirements as prescribed in this section in order 
to remove the suspension status. If the laboratory is unsuccessful in 
meeting the requirements to remove the suspension status, accreditation 
will be revoked.
    (1) Laboratories that are suspended due to performance or response 
issues enter a waiting period of 60 days from the effective date of 
that action. After the 60-day period has passed, if the laboratory 
wishes to pursue reinstatement to the ALP, the laboratory must submit a 
written corrective action plan specifying what corrections were made 
and illustrate to FSIS that the corrections are effective or would 
reasonably be expected to be effective.
    (i) After the corrective action plan has been accepted by the ALP, 
the laboratory must successfully analyze a set of initial accreditation 
proficiency testing samples for the analyte(s) that triggered the 
suspension and meet all other program requirements including payment of 
any annual fees that are due. The ALP may perform an on-site inspection 
at the laboratory's facility and/or require the laboratory to provide 
documentation to confirm that it meets the requirements of the program.
    (ii) The suspended laboratory is allowed two attempts to 
successfully analyze the initial accreditation proficiency testing 
set(s) of samples.
    (2) Laboratories that are suspended due to indictment or charges as 
described in Sec.  439.52 may not seek removal of suspension status 
until being cleared of said indictment or charges.


Sec.  439.50  Refusal of accreditation.

    Upon a determination by the FSIS Administrator (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 the ALP as stated in this part.
    (b) 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 any 
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.
    (5) Altering any official sample or analytical finding; or 
substituting any analytical result from any other laboratory and 
representing the result as its own.


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 inter-
laboratory accreditation maintenance proficiency testing sample 
analysis within 12 consecutive months, unless written permission is 
granted by the Administrator.
    (b) If the laboratory does not respond to ALP inquiries related to 
its participation in the program or fails to meet any of the 
requirements or criteria set in this part.
    (c) If the laboratory does not successfully demonstrate the 
maintenance of quality assurance capabilities including its results 
from inter-laboratory accreditation maintenance proficiency testing 
samples. ALP evaluation criteria are based on the ISO 13528 standard, 
to include performance evaluation by z score statistics.


Sec.  439.52   Suspension of accreditation.

    A laboratory will be suspended from the program if probation status 
is not rectified according to program requirements stated in this part. 
The accreditation of a laboratory will be immediately 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 laboratory must notify the ALP within 30 calendar days if any of 
these situations occur.
    (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.
    (e) Altering any official sample or analytical finding; or 
substituting any analytical result from any other laboratory and 
representing the result as its own.


Sec.  439.53  Revocation of accreditation.

    A laboratory will have its accreditation revoked from the program 
if suspension status is not rectified. The accreditation of a 
laboratory will also be revoked for the following reasons:
    (a) 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.
    (b) 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 laboratory must notify the ALP within 30 
calendar days if any of these situations occur.
    (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.

[[Page 51867]]

    (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.


Sec.  439.60  Notifications and hearings.

    Accreditation of any laboratory will be refused, suspended, or 
revoked under the conditions previously described in this part. 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.

Paul Kiecker,
Administrator.
[FR Doc. 2022-18274 Filed 8-23-22; 8:45 am]
BILLING CODE 3410-DM-P