Rule2022-18274
Changes to Accreditation of Non-Federal Analytical Testing Laboratories
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 24, 2022
Effective
October 24, 2022
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
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.
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18274]
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Rules and Regulations
Federal Register
________________________________________________________________________
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having general applicability and legal effect, most of which are keyed
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The Code of Federal Regulations is sold by the Superintendent of 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.
<bullet> 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.
<bullet> 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 <a href="https://www.fsis.usda.gov/science-data/laboratories-procedures/accredited-laboratory-program">https://www.fsis.usda.gov/science-data/laboratories-procedures/accredited-laboratory-program</a> (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:
<a href="https://www.fsis.usda.gov/federal-register">https://www.fsis.usda.gov/federal-register</a>.
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: <a href="https://www.fsis.usda.gov/subscribe">https://www.fsis.usda.gov/subscribe</a>. 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 <a href="https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint">https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint</a> 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: <a href="/cdn-cgi/l/email-protection#b4c4c6dbd3c6d5d99adddac0d5dfd1f4c1c7d0d59ad3dbc2"><span class="__cf_email__" data-cfemail="1f6f6d70786d7e723176716b7e747a5f6a6c7b7e31787069">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#ce8f829e8ebbbdaaafe0a9a1b8"><span class="__cf_email__" data-cfemail="57161b07172224333679303821">[email protected]</span></a>. 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
<a href="http://www.fsis.usda.gov">www.fsis.usda.gov</a>. AOAC procedures may be found on the AOAC website at
<a href="http://www.aoac.org">www.aoac.org</a>.
(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
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