$millions/year.
    From/To......................  From:
                                   To:
----------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None.....................................................................
    Small Business: Potential impacts on laboratories currently not accredited to ISO/IEC 17025 that would
     participate in the LAAF program described by this rule.
    Wages: None.................................................................................................
    Growth: None................................................................................................
----------------------------------------------------------------------------------------------------------------
\1\ The lower bound equals the 5th percentile and the upper bound equals the 95th percentile.

    The full analysis of economic impacts is available in the docket
for this final rule (Ref. 4) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as
stated in the proposed rule (84 FR 59452 at 59496). We stated that we
had determined, under 21 CFR 25.30(h), that this action ``is of a type
that does not individually or cumulatively have a significant effect on
the human environment'' such that neither an environmental assessment
nor an environmental impact statement is required. We have not received
any new information or comments that would affect our previous
determination (Ref. 22).

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title,
description, and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual reporting and recordkeeping burden. Included in the estimate
is the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing each collection of information.
    Title: Laboratory Accreditation for Analyses of Foods; OMB Control
Number 0910-0898.
    Description: As mandated by section 422 of the FD&C Act, we are
establishing a program for the testing of food by accredited
laboratories (LAAF program); establishing the standards and procedures
for recognizing accredited laboratories and for recognized
accreditation bodies that LAAF-accredit laboratories; establishing a
publicly available registry of recognized accreditation bodies and
LAAF-accredited laboratories; and establishing procedures for reporting
any changes affecting the recognition of such accreditation bodies or
LAAF-accreditation of such laboratories.
    Description of Respondents: Respondents to the collection of
information are accreditation bodies seeking recognition from FDA,
recognized accreditation bodies, laboratories seeking LAAF-
accreditation from recognized accreditation bodies, and LAAF-accredited
laboratories.
    We estimate the burden of the information collection as follows:

                                   Table 14--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
  Part 1, Subpart R Citation;      Number of     responses per   Total annual   per response (in    Total hours
           Activity               respondents     respondent       responses         hours)
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.1113 and                      4               1               4  20..............              80
 1.1114; Accreditation bodies
 (ABs) application for
 recognition (one-time
 submission).
Sec.  Sec.   1.1113 and                      4               1               4  3.6.............            14.4
 1.1114; ABs--application for
 renewal of recognition.
Sec.   1.1116(a) and (b); ABs--              0               3               0  3...............               0
 notices of intent to
 relinquish, records custodian.
Sec.   1.1123; ABs--reports,                 4              42             168  1.75............             294
 notifications, and
 documentation requirements.
Sec.  Sec.   1.1138 and                    170               1             170  20..............           3,400
 1.1139; laboratories--
 submission of application for
 LAAF-accreditation (one-time
 submission).
Sec.   1.1140(a);                            2               3               6  1...............               6
 laboratories--notices of
 intent to relinquish, records
 custodian.
Sec.  Sec.   1.1149(a) and                 170              25           4,250  1.75............         7,437.5
 1.1152(c)(1), (2);
 laboratories--submission of
 sampling plan, sample
 collection report, and
 sampler qualifications.
Sec.  Sec.   1.1152(d) and                 170              10           1,700  2...............           3,400
 1.1153(a); laboratories--
 qualification to submit
 abridged analytical reports
 (one-time submission).
Sec.   1.1153; laboratories--              170              25           4,250  1.16............           4,930
 abridged analytical reports
 submissions.
Sec.   1.1152(c)(3), (4), and                9               1               9  .25 (15 minutes)            2.25
 (5); laboratories--validation
 and verification studies
 submissions.
Sec.   1.1149(c);                          170               1             170  1.5.............             255
 laboratories--advance notice
 of sampling submissions.
Sec.   1.1152(f);                          170             1.5             255  .25 (15 minutes)           63.75
 laboratories--immediate
 notification.
Sec.  Sec.   1.1142; 1.1171;                 1               1               1  1...............               1
 1.1173; and 1.1174--requests
 in response to FDA action.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................        19,883.9
----------------------------------------------------------------------------------------------------------------

    Reporting Burden: Consistent with estimates in our FRIA (see
section II.F, Costs of this Rule (Ref. 4)), we estimate a total of 174
respondents. We estimate that 5 to 80 accreditation bodies could apply
for FDA recognition under this final rule and assume that 4
accreditation bodies will apply for FDA recognition. We estimate 170
laboratories will participate in the program. The reporting burden
includes a burden of 20,640 hours associated with one-time submissions.
In this analysis, we annualize the one-time submission burden using a
3-year

period horizon and zero percent discount rate, for an annualized one-
time reporting burden of 6,880 hours. Cumulatively, this results in a
total annual reporting burden of 19,883.9 hours, as reflected in table
14.
    Section 1.1114 requires an accreditation body seeking initial
recognition to submit an application to FDA demonstrating it meets the
eligibility requirements described in Sec.  1.1113 of the final rule.
The burden to prepare and submit an application is an initial burden
and, once realized, would apply only to respondents new to the program.
We estimate this process would take one analyst between 40 and 80 hours
to compile all the relevant information, prepare for an assessment,
complete the initial application process, and submit the application.
For this analysis we assume a middle value of 60 hours. Also for this
analysis, we use a 3-year period horizon and zero percent discount rate
to convert the one-time submission burden to an annualized figure
(i.e., 60 hours / by 3 = 20 hours). Annually this results in 80 hours
of burden for initial applications submitted by 4 accreditation bodies
(4 applications x 20 hours per application), as reflected in row 1.
    Section 1.1114 requires a recognized accreditation body to apply
for renewal of recognition at least every 5 years. We believe renewal
would take less time than an initial application because much of the
information will have already been compiled and therefore assume
between 20 and 40 hours. For this analysis we use a middle value and
calculate that each recognized accreditation body will spend 30 hours
every 5 years to complete and submit an application for renewal of its
recognition. This results in 6 hours per year (30 hours / 5 years) for
each accreditation body. Because we use a 3-year period horizon and
zero percent discount rate for this analysis, we annualize that figure
to three-fifths or 3.6. We multiply this figure by 4 accreditation
bodies for a total of 14.4 hours annually for the submission of renewal
of applications (4 applications x 3.6 hours per application), as
reflected in row 2.
    Section 1.1116 requires that if a recognized accreditation body
voluntarily chooses to relinquish or not renew its recognition, it must
notify FDA and the laboratories it LAAF-accredits of its intention to
depart the program at least 60 days ahead of the departure. The
recognized accreditation body must also provide FDA with the name and
contact information of the custodian who will maintain and make
available to FDA requisite program records. We estimate a 1 percent
voluntary departure rate, which equates to the departure of 0.04
recognized accreditation body annually. We estimate it would take a
recognized accreditation body one hour for each of the three required
notices. Accordingly, with rounding, the estimate for the burden
associated with Sec.  1.1116 is zero (0.04 recognized accreditation
body x 3 notices = .12 annual responses, which rounds to 0; 0 annual
response x 3 hours = 0 total hours), as reflected in row 3.
    Section 1.1123 requires a recognized accreditation body to submit
certain reports, notifications, and documentation to FDA, including
significant changes affecting its accreditation program or the
accreditation status of laboratories it LAAF-accredits, and to ensure
FDA has access to these and other records. We estimate recognized
accreditation bodies would incur a burden of 3.5 hours per month, or 42
hours per year, complying with the reporting requirements of Sec.
1.1123 and the recordkeeping requirements of Sec.  1.1124. For this
analysis, we identify recordkeeping and reporting burdens separately
and assume 21 of the 42 hours (i.e., 1.75 hours per month) would be
spent meeting the reporting requirements of Sec.  1.1123. Annually,
this results in 294 hours (4 recognized accreditation bodies x 42
responses per accreditation body x 1.75 hours per response), as
reflected in row 4.
    Section 1.1139 requires a laboratory seeking LAAF-accreditation to
submit an application to a recognized accreditation body, demonstrating
that it meets the eligibility requirements specified in Sec.  1.1138.
We estimate 170 laboratories will apply and assume it would take one
analyst an average of 60 hours to compile all the relevant information;
however we regard the burden as a one-time burden and therefore have
annualized it by 3 years (20 hours annually). This results in an annual
reporting burden for initial applications by 170 laboratories being
3,400 hours (170 applications x 20 hours per application), as reflected
in row 5.
    Section 1.1140 provides that if a laboratory voluntarily chooses to
relinquish or not renew its LAAF-accreditation, it must notify FDA and
its recognized accreditation body of its intention to do so at least 60
days ahead of the departure. If the laboratory is voluntarily
relinquishing or not renewing all methods within its scope, it must
also provide FDA with the name and contact information of the custodian
who will maintain and make available to FDA requisite program records.
We estimate a 1 percent program departure rate, which equates to the
departure of 1.70 LAAF-accredited laboratories each year, which we
round to 2. We estimate it would take a laboratory one hour for each of
the three required notices. Accordingly, we estimate a burden of 6
hours per year under Sec.  1.1140 (2 laboratories x 3 notices = 6
annual responses; 6 annual responses x 1 hour = 6 total hours), as
reflected in row 6.
    Section 1.1152(a) through (e) requires a LAAF-accredited laboratory
to submit results of testing required to be conducted under the LAAF
program and include supporting documentation. As discussed in our
supporting statement, only a percentage of that testing would be
defined as information collection under the PRA. For this analysis we
assume a mean figure of 4,065 test result and supporting documentation
submissions (4,065.2 rounded to the nearest integer) as the basis for
factoring a corresponding information collection burden. This figure is
derived using lower and upper bound estimates of submissions we expect
under the rule. To allow for adjustment and potential increase we have
added 50 submissions for a total of 4,115.
    Section 1.1152(c)(1) requires a LAAF-accredited laboratory to
submit a sample collection plan and sample collection report (the
contents of which are described in Sec.  1.1149(a)) with each test
result. Under Sec.  1.1152(c)(2), a LAAF-accredited laboratory must
include documentation of the sampler's qualifications the first time
the sampler collects a sample. We assume that it would take 30 minutes
to 1 hour to compile a sampling plan, 30 minutes to 1 hour to compile a
sample collection report, and an average of 10 to 20 minutes to obtain
the sampling plan, sample collection report, and sampler's
qualifications. Using a middle value of 1.5 hours to generate the
sampling plan and the sample collection report, and a middle value of
15 minutes (.25 hours) to obtain those two documents and documentation
of the sampler's qualifications, we calculate a total time per test
result of 1.75 hours (1.5 + .25). When multiplied together the total
reporting burden for the submission of sampling plans, sample
collection reports, and sampler qualification requirements (170
accredited laboratories x 25 sampling plans and sample collection
reports x 1.75 hours) is 7,437.5 hours, as reflected in row 7.
    Section 1.1153(a) allows a LAAF-accredited laboratory to qualify to
submit abridged analytical reports in lieu of full analytical reports.
We expect

this will be a one-time burden, but we may revisit this assumption in
the future based on actual rates of revocation of permission to submit
abridged analytical reports. We assume that each LAAF-accredited
laboratory would submit 10 consecutive full analytical reports (for the
middle value of 2 major food testing disciplines per laboratory) to
qualify to submit abridged analytical reports. We also assume that a
LAAF-accredited laboratory will spend 4 to 8 hours to compile and
submit a full analytical report, and we use the middle value of 6 hours
for this analysis. For initial or one-time burdens we use a 3-year
period horizon and zero percent discount rate to convert the one-time
burden to an annualized figure (2 hours). When multiplied together,
this results in a total reporting burden for the LAAF-accredited
laboratories to qualify to submit abridged analytical reports of 3,400
hours (170 laboratories x 10 full analytical reports each x 2 hours per
analytical report), as reflected in row 8.
    Once a LAAF-accredited laboratory qualifies to submit abridged
analytical reports, we assume it will submit abridged analytical
reports to us thereafter. We may revisit this assumption in the future
based on actual rates of revocation of permission to submit abridged
analytical reports. We estimate the burden to compile and submit an
abridged analytical report to be between 25 percent and 33 percent of
the burden of compiling and submitting a full analytical report, and we
use a middle value of 29 percent here. Thus, using these figures we
calculate it would take a LAAF-accredited laboratory 1.16 hours to
compile and submit an abridged analytical report (29 percent x 4
hours). This results in an annual total reporting burden for the 170
LAAF-accredited laboratories to compile and submit abridged analytical
reports of approximately 4,930 hours (170 laboratories x 25 abridged
analytical reports x 1.16 hours per abridged analytical report), as
reflected in row 9.
    The final rule also requires a LAAF-accredited laboratory to submit
verification and validation studies to FDA as part of an analytical
report. The ISO/IEC 17025:2017 standard requires the use of validated
and verified methods for food testing. However, the final rule requires
additional verification studies over and above the requirements of ISO/
IEC 17025:2017. Additional studies may include information to verify
that a method previously validated for a specific food item is also
valid for a different food item, in what is called a ``matrix
extension.'' We estimate that the additional time burden of requiring a
LAAF-accredited laboratory to submit verification studies such as
matrix extensions under this final rule to be a middle value of
approximately 3 percent of the time burden incurred by laboratories to
maintain accreditation to ISO/IEC 17025:2017 (the FRIA estimates a
range of 1 percent to 5 percent). In the FRIA we also note that
internal FDA experts suggest that between 5 percent and 30 percent of
import food testing results require verification studies such as matrix
extensions. We use a middle value of 17.5 percent for this analysis.
    Regarding validation requirements, we assume that methods used to
test shell eggs, sprouts, and bottled drinking water are either already
validated or that the costs of doing so would be included in the costs
to maintain ISO/IEC 17025:2017 accreditation. Consequently, we assume
that shell eggs, sprouts, and bottled drinking water producers would
incur no burden from this requirement beyond the burden of the final
rule's requirement to meet the validation requirements of ISO/IEC
17025:2017.
    We estimate the time required to perform a matrix extension is a
middle value of 34 hours (the FRIA estimates a range of 22 to 46
hours). We do not distinguish between the burden of reporting the study
and the burden of conducting the study. We assume 25 percent of the 34
hours (8.5 hours) is attributable to the associated reporting burden.
Because we estimate that the additional time burden of requiring
laboratories to submit verification studies such as matrix extensions
under this final rule would be approximately 3 percent of the time
burden incurred by laboratories to maintain accreditation to ISO/IEC
17025:2017, we multiply 8.5 hours by 3 percent to get the additional
reporting burden of .255 hours (15.3 minutes, which we round to 15
minutes, which is .25 hours) per study imposed by the verification
study submission requirements of the final rule. To estimate the number
of test results that would require matrix extensions, we multiply the
number of import testing results that would be submitted to us under
this rule annually that are subject to PRA requirements (50) by the
share of test results submitted to us for import food testing that
require matrix extensions (17.5 percent), for a total of 8.75 matrix
extensions per year. This equates to an average of .3241 matrix
extensions per LAAF-accredited laboratory conducting food testing for
imports (8.75 / 27). Because the number of respondents and the annual
responses per respondent in a PRA analysis must be whole numbers, we
instead estimate that nine LAAF-accredited laboratories (27 x .3241,
rounded to 9 from 8.75) will submit one full verification study to FDA
annually. Therefore, the annual reporting burden of requiring the
submission of validation and verification studies under this final rule
is 2.25 hours (9 accredited laboratories x 1 verification studies x .25
hours per study), as reflected in row 10.
    Under section 1.1149(c), FDA may require under certain
circumstances, that a LAAF-accredited laboratory submit an advance
notice of sampling to FDA before each of the next several occasions
that the sampler will a collect a sample that the LAAF-accredited
laboratory will analyze under the LAAF program. We assume that it would
take a laboratory analyst between 1 and 2 hours to compile and submit
the required information, and we assume that between one percent and
five percent of all test results submitted annually under the LAAF
program will be subject to the advance notice of sampling requirement.
For this analysis we assume middle values of 1.5 hours and three
percent, respectively. Thus, we estimate that 123.45 test results
(4,115 x 3%) will require submission of advance notice of sampling
under the final rule. For this analysis we assume that each of the
estimated 170 LAAF-accredited laboratories will be required to submit
three advance notices sampling annually under the final rule (123.45 /
170 = 0.74; rounded to 1). Thus, the annual reporting burden on LAAF-
accredited laboratories for the advance notice of sampling requirement
would be 255 hours (170 laboratories x 1 advance notices of sampling x
1.5 hours), as reflected in row 11.
    Section 1.1152(f) requires a LAAF-accredited laboratory to notify
FDA and the recognized accreditation body of any changes that affect
the laboratory's LAAF-accreditation. Note, however, that a LAAF-
accredited laboratory is not required to notify FDA of changes that the
recognized accreditation body must provide to FDA under Sec.
1.1123(d). As a conservative estimate, we assume that each LAAF-
accredited laboratory will have some change requiring notification of
its recognized accreditation body, and for half of those changes the
LAAF-accredited laboratory will also need to notify FDA. We estimate it
will take a LAAF-accredited laboratory 15 minutes per notification.
Thus, we estimate the burden associated with Sec.  1.1152(f) would be
63.75 hours (170 accredited laboratories x 1.5 notifications x 0.25
hours per notification), as reflected in row 12.

    Sections 1.1142, 1.1171, 1.1173, and 1.1174 provide for requests to
FDA. Specifically, Sec.  1.1142 provides for requests for reinstatement
of LAAF accreditation; Sec.  1.1171 provides for requests for
reconsideration of denials; and Sec. Sec.  1.1173 and 1.1174 provide
for requests for hearings. Because this is a new collection, we
estimate a cumulative total of 1 respondent and 1 burden hour, as
reflected in row 13.

                                 Table 15--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average burden
    21 CFR part 1, subpart R;        Number of       Number of     Total annual         per
            activity               recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.   1.1113; recordkeeping                   4               1               4               1               4
 associated with ISO/IEC
 17011:2017.....................
Sec.   1.1124; ABs--additional                 4               1               4              21              84
 recordkeeping requirements.....
Sec.   1.1138; laboratories--                  9               1               9           91.06          819.54
 becoming accredited to ISO/IEC
 17025:2017 (one-time)..........
Sec.   1.1138; laboratories--                170               1             170          889.53      151,220.10
 maintaining ISO/IEC 17025:2017
 accreditation..................
Sec.   1.1154; laboratories--                170               1             170              12           2,040
 additional recordkeeping
 requirements...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............      154,167.64
----------------------------------------------------------------------------------------------------------------

    Recordkeeping Burden: We estimate the annual recordkeeping
requirements associated with the final rule to be 154,167.64 hours, as
reflected in table 15.
    Section 1.1113 requires a recognized accreditation body to meet the
requirements of ISO/IEC 17011:2017. While ISO/IEC 17011:2017 includes
recordkeeping requirements, as noted above we anticipate that all 4 of
the accreditation bodies that we estimate will apply to become
recognized currently adhere to ISO/IEC 17011:2017. We therefore regard
these activities as usual and customary; however, we include a place
holder of one response and one burden hour for each respondent, as
reflected in row 1.
    Section 1.1124 requires maintenance of certain records in addition
to those required by ISO/IEC 17011:2017. We estimate that a recognized
accreditation body will incur a burden of 12 hours per year to comply
with both the recordkeeping requirements of Sec.  1.1124 and the
reporting requirements of Sec.  1.1123. For this analysis, we identify
the recordkeeping and reporting burdens separately, assuming 21 of
those 42 annual hours would be spent complying with the recordkeeping
requirements of Sec.  1.1124. Thus, the annual recordkeeping burden for
the 4 recognized accreditation bodies to meet the additional
recordkeeping requirements of Sec.  1.1124 would be 84 hours, as
reflected in row 2.
    Section 1.1138 requires a laboratory to be ISO/IEC 17025:2017-
accredited, including meeting its recordkeeping requirements, to become
LAAF-accredited under the rule. We estimate that 7 to 10 laboratories
not currently accredited to ISO/IEC 17025:2017 would become so
accredited to participate in the LAAF program. For this estimate, we
assume the middle value of 8.5 laboratories, which we round up to 9,
would become ISO/IEC 17025-accredited to participate in the LAAF
program. The burden to become ISO/IEC 17025:2017-accredited is an
initial burden and, once realized, would apply only to respondents
becoming accredited to ISO/IEC 17025:2017 to participate in the LAAF
program. We estimate that it would take a mean of 91.06 hours for the
associated recordkeeping activities. In this analysis, we annualize
this recordkeeping burden using a 3-year period horizon and zero
percent discount rate, for an annualized recordkeeping burden of 819.54
hours, as reflected in row 3.
    Section 1.1138 requires a LAAF-accredited laboratory to maintain
conformance with ISO/IEC 17025:2017, including its recordkeeping
requirements. As discussed in the proposed rule, we estimate a mean of
889.53 hours for this recordkeeping. This results in an annual burden
of 151,220.10 hours, as reflected in row 4.
    Section 1.1154 requires maintenance of certain records in addition
to those required by ISO/IEC 17025:2017. We estimate that a LAAF-
accredited laboratory will incur a burden of about 1 hour per month (12
hours per year) to comply with the recordkeeping requirements in Sec.
1.1154. This results in an annual burden of 2,040 hours, as reflected
in row 5.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

X. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule

does not contain policies that have tribal implications as defined in
the Executive Order and, consequently, a tribal summary impact
statement is not required.

XII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

    * Ref. 1. Congressional Hearing, ``The Safety of Food Imports:
Fraud & Deception in the Food Import Process; Hearings Before the
Senate Committee on Governmental Affairs, Permanent Subcommittee on
Investigations.'' September 10, 1998. https://www.gpo.gov/fdsys/pkg/CHRG-105shrg51562/pdf/CHRG-105shrg51562.pdf. Accessed November 4,
2021.
    Ref. 2. ISO/IEC 17011:2017(E), ``Conformity Assessment--
Requirements for Accreditation Bodies Accrediting Conformity
Assessment Bodies.'' ISO/IEC. November 2017. Copies are available
from the International Organization for Standardization, Chemin de
Blandonnet 8, 1214 Vernier, Geneva, Switzerland, or on the internet
at https://www.iso.org/standard/67198.html, or may be examined at
the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or
RIN 0910-AH31).
    Ref. 3. ISO/IEC 17025:2017(E), ``General Requirements for the
Competence of Testing and Calibration Laboratories.'' ISO/IEC.
November 2017. Copies are available from the International
Organization for Standardization, Chemin de Blandonnet 8, 1214
Vernier, Geneva, Switzerland, or on the internet at https://www.iso.org/standard/66912.html, or may be examined at the Dockets
Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or RIN 0910-
AH31).
    * Ref. 4. FDA. LAAF: Final Regulatory Impact Analysis, Final
Regulatory Flexibility Analysis, Unfunded Mandates Reform Act
Analysis, 2021. https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
    * Ref. 5. Partnership for Food Protection, ``Human and Animal
Food Testing Laboratories Best Practices Manual,'' December 2018,
available at https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/. Accessed November 4, 2021.
    * Ref. 6. Association for Public Health Laboratories, ``Best
Practices for Submission of Actionable Human and Animal Food Testing
Data Generated in State and Local Laboratories,'' January 2019,
available at https://www.aphl.org/aboutAPHL/publications/Documents/FS-2019Jan-Best-Practices-Human-Animal-Food-Data.pdf. Accessed
November 4, 2021.
    * Ref. 7. The Cambridge Dictionary, https://dictionary.cambridge.org/us/dictionary/english/assess. Accessed
November 4, 2021.
    * Ref. 8. ``OMB Circular A-119: Federal Participation in the
Development and Use of Voluntary Consensus Standards and in
Conformity Assessment Activities.'' Office of Management and Budget.
January 2016. https://www.nist.gov/system/files/revised_circular_a-119_as_of_01-22-2016.pdf. Accessed November 4, 2021.
    * Ref. 9. National Institute of Standards and Technology Special
Publication 2000-02, ``Conformity Assessment Considerations for
Federal Agencies,'' September 2018. https://doi.org/10.6028/NIST.SP.2000-02. Accessed November 4, 2021.
    * Ref. 10. Codex Alimentarius Commission, ``General Guidelines
on Sampling,'' CAC/GL-50-2004. http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B50-2004%252FCXG_050e.pdf. Accessed November
4, 2021.
    * Ref. 11. FDA, ``Control of Listeria monocytogenes in Ready-To-
Eat Foods: Guidance for Industry,'' Draft Guidance, January 2017.
https://www.fda.gov/media/102633/download. Accessed November 4,
2021.
    * Ref. 12. FDA, ``Outbreak Investigation of Scombrotoxin Fish
Poisoning: Yellowfin/Ahi Tuna (November 2019).'' https://
www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-
scombrotoxin-fish-poisoning-yellowfinahi-tuna-november-
2019#:~:text=%2C%20WV%20(1)-
,What%20is%20Scombrotoxin%20Fish%20Poisoning%3F,eating%20mishandled%2
0and%20decomposed%20fish. Accessed November 4, 2021.
    Ref. 13. AOAC International, ``Guidelines for Laboratories
Performing Microbiological and Chemical Analyses of Food, Dietary
Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/
IEC 17025:2017.'' August 2018. Copies are available from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-
3250, USA, or on the internet at https://www.aoac.org/aoac-accreditation-guidelines-for-laboratories-alacc/, or may be examined
at the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325
and/or RIN 0910-AH31).
    Ref. 14. Association of American Feed Control Officials, ``2014
Quality Assurance/Quality Control Guidelines for Feed Laboratories,
2014.'' Copies are available from Association of American Feed
Control Officials, 1800 South Oak St., Suite 100, Champaign, IL
61820 or on the internet at https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories, or may be examined at the
Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or RIN
0910-AH31).
    * Ref. 15. FDA Memorandum, ``Assessment of DWPE Sampling and
Analysis Data to Determine what Portion of Sampling and Analysis of
Food under DWPE is Conducted by Accredited Entities.'' Toni Morales
and Tyler Scandalios, FDA. November 20, 2018.
    Ref. 16. ISO/IEC 17043:2010, ``Conformity Assessment--General
Requirements for Proficiency Testing.'' ISO/IEC. February 2010.
Copies are available from the International Organization for
Standardization, Chemin de Blandonnet 8, 1214 Vernier, Geneva,
Switzerland, or on the internet at https://www.iso.org/standard/29366.html, or may be examined at the Dockets Management Staff (Ref.
Docket No. FDA-2019-N-3325 and/or RIN 0910-AH31).
    * Ref. 17. FDA, Investigations Operations Manual, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual. Accessed November 4, 2021.
    * Ref. 18. University of Georgia Extension, Bulletin 1306,
``Biosecurity Basics for Poultry Growers,'' March 2020. https://secure.caes.uga.edu/extension/publications/files/pdf/B%201306_6.PDF.
Accessed November 4, 2021.
    * Ref. 19. Association of American Food Control Officials,
``GOODSamples: Guidance On Obtaining Defensible Samples,'' October
2015. https://www.aafco.org/Portals/0/SiteContent/Publications/GOODSamples.pdf. Accessed November 4, 2021.
    * Ref. 20. Association of American Food Control Officials,
``GOOD Test Portions: Guidance On Obtaining Defensible Test
Portions,'' June 2018. http://www.aafco.org/Publications/GOODTestPortions. Accessed November 4, 2021.
    * Ref. 21. FDA, ``Methods, Method Verification and Validation,''
ORA Laboratory Manual, Vol. II, Section 2, document number ORA-
LAB.5.4.5. June 30, 2020. https://www.fda.gov/media/73920/download.
Accessed November 4, 2021.
    * Ref. 22. FDA Memorandum, ``Categorical Exclusion--Final Rule
Laboratory Accreditation for Analyses of Foods [Docket No. FDA-2019-
N-3325].'' Mariellen Pfeil, FDA. July 21, 2021.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Incorporation by
reference, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 11

    Computer technology, Reporting and recordkeeping requirements.

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 129

    Beverages, Bottled water, Food packaging, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under

authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
1, 11, 16, and 129 are amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2,
362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a,
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188,
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.

0
2. In Sec.  1.651, revise paragraphs (b)(3) and (c)(2) to read as
follows:

Sec.  1.651  How must an accredited third-party certification body
conduct a food safety audit of an eligible entity?

* * * * *
    (b) * * *
    (3) When, for a regulatory audit, sampling and analysis is
conducted, the accredited third-party certification body must use a
laboratory that is accredited in accordance with ISO/IEC 17025:2017 to
perform the analysis.
* * * * *
    (c) * * *
    (2) The audit must include records review prior to the onsite
examination; an onsite examination of the facility, its process(es),
and the food that results from such process(es); and where appropriate
or when required by FDA, environmental or product sampling and
analysis. When, for a regulatory audit, sampling and analysis is
conducted, the accredited third-party certification body must use a
laboratory that is accredited in accordance with paragraph (b)(3) of
this section to conduct the analysis. The audit may include any other
activities necessary to determine compliance with applicable food
safety requirements of the FD&C Act and FDA regulations, and, for
consultative audits, also includes conformance with applicable industry
standards and practices.
* * * * *

0
3. Add subpart R, consisting of Sec. Sec.  1.1101 through 1.1201, to
read as follows:
Subpart R--Laboratory Accreditation for Analyses of Foods

General Provisions

Sec.
1.1101 What documents are incorporated by reference in this subpart?
1.1102 What definitions apply to this subpart?
1.1103 Who is subject to this subpart?

General Requirements

1.1107 When must food testing be conducted under this subpart?
1.1108 When and how will FDA issue a directed food laboratory order?
1.1109 How will FDA make information about recognized accreditation
bodies and LAAF-accredited laboratories available to the public?
1.1110 What are the general requirements for submitting information
to FDA under this subpart?

FDA Recognition of Accreditation Bodies

1.1113 What are the eligibility requirements for a recognized
accreditation body?
1.1114 How does an accreditation body apply to FDA for recognition
or renewal of recognition?
1.1115 How will FDA evaluate applications for recognition and
renewal of recognition?
1.1116 What must a recognized accreditation body do to voluntarily
relinquish or not renew its recognition?
1.1117 How may an accreditation body request reinstatement of
recognition?

Requirements for Recognized Accreditation Bodies

1.1119 What are the conflict of interest requirements for a
recognized accreditation body?
1.1120 How must a recognized accreditation body assess laboratories
seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
1.1121 When must a recognized accreditation body require corrective
action, suspend a LAAF-accredited laboratory, or reduce the scope of
or withdraw the LAAF-accreditation of a laboratory?
1.1122 What procedures must a recognized accreditation body provide
for appeals of decisions to suspend, reduce the scope of, withdraw,
or deny LAAF-accreditation?
1.1123 What reports, notifications, and documentation must a
recognized accreditation body submit to FDA?
1.1124 What are the records requirement for a recognized
accreditation body?
1.1125 What are the internal audit requirements for a recognized
accreditation body?

FDA Oversight of Recognized Accreditation Bodies

1.1130 How will FDA oversee recognized accreditation bodies?
1.1131 When will FDA require corrective action, put a recognized
accreditation body on probation, or revoke the recognition of an
accreditation body?

LAAF-Accreditation of Laboratories

1.1138 What are the eligibility requirements for a LAAF-accredited
laboratory?
1.1139 How does a laboratory apply for LAAF-accreditation or extend
its scope of LAAF-accreditation?
1.1140 What must a LAAF-accredited laboratory do to voluntarily
relinquish its LAAF-accreditation?
1.1141 What is the effect on a LAAF-accredited laboratory if its
recognized accreditation body is no longer recognized by FDA?
1.1142 How does a laboratory request reinstatement of LAAF-
accreditation?

Requirements for LAAF-Accredited Laboratories

1.1147 What are the impartiality and conflict of interest
requirements for a LAAF-accredited laboratory?
1.1149 What oversight standards apply to sampling?
1.1150 What are the requirements for analysis of samples by a LAAF-
accredited laboratory?
1.1151 What requirements apply to the methods of analysis a LAAF-
accredited laboratory uses to conduct food testing under this
subpart?
1.1152 What notifications, results, reports, and studies must a
LAAF-accredited laboratory submit to FDA?
1.1153 What are the requirements for submitting abridged analytical
reports?
1.1154 What other records requirements must a LAAF-accredited
laboratory meet?

FDA Oversight of LAAF-Accredited Laboratories

1.1159 How will FDA oversee LAAF-accredited laboratories?
1.1160 How will FDA review test results and analytical reports?
1.1161 When will FDA require corrective action, put a LAAF-
accredited laboratory on probation, or disqualify a LAAF-accredited
laboratory from submitting analytical reports?
1.1162 What are the consequences if FDA puts a LAAF-accredited
laboratory on probation or disqualifies a LAAF-accredited
laboratory?

Requesting FDA Reconsideration or Regulatory Hearings of FDA
Decisions Under This Subpart

1.1171 How does an accreditation body request reconsideration by FDA
of a decision to deny its application for recognition, renewal, or
reinstatement?
1.1173 How does an accreditation body or laboratory request a
regulatory hearing on FDA'sdecision to revoke the accreditation
body's recognition or disqualify a LAAF-accredited laboratory?
1.1174 How does an owner or consignee request a regulatory hearing
on a directed food laboratory order?

Electronic Records and Public Disclosure Requirements

1.1199 Are electronic records created under this subpart subject to
the electronic records requirements of part 11 of this chapter?
1.1200 Are the records obtained by FDA under this subpart subject to
public disclosure?

Subpart R--Laboratory Accreditation for Analyses of Foods

General Provisions

Sec.  1.1101  What documents are incorporated by reference in this
subpart

    (a) Certain material is incorporated by reference into this subpart
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. All approved material is available for
inspection at the Food and Drug Administration's Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>,
and is available from the source listed elsewhere in this section. It
is also available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, email [email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (b) International Organization for Standardization (ISO), Chemin de
Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; Telephone 41
22 749 01 11, https://www.iso.org/home.html.
    (1) ISO/IEC 17011:2017(E), Conformity assessment--Requirements for
accreditation bodies accrediting conformity assessment bodies, Second
edition, November 2017, IBR approved for Sec. Sec.  1.1113(a) and (c),
1.1114(b), 1.1120(c), 1.1131(a).
    (2) ISO/IEC 17025:2017(E), General requirements for the competence
of testing and calibration laboratories, Third edition, November 2017,
IBR approved for Sec. Sec.  1.1120(c), 1.1121(a), 1.1138(a), 1.1139(b)
and (c), 1.1141(a), 1.1152(a) and (d), 1.1153(c), and 1.1161(a).

Sec.  1.1102  What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act apply to such terms when used in this subpart, unless
otherwise specified. For the purposes of this subpart, the following
definitions also apply:
    Analyst means an individual who analyzes samples.
    Corrective action means an action taken by an accreditation body or
laboratory to investigate and eliminate the cause of a deficiency so
that it does not recur.
    Directed food laboratory order means an order issued by FDA under
Sec.  1.1108 requiring food testing to be conducted under this subpart
by or on behalf of an owner or consignee.
    Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act, except that food does not include pesticides
(as defined in 7 U.S.C. 136(u)).
    Food testing and testing of food means the analysis of food product
samples or environmental samples.
    Laboratory accreditation for analyses of foods (LAAF)-accreditation
means a determination by a recognized accreditation body that a
laboratory meets the applicable requirements of this subpart to conduct
food testing under this subpart using one or more methods of analysis.
    LAAF-accredited laboratory means a laboratory that a recognized
accreditation body has determined meets the applicable requirements of
this subpart and has been LAAF-accredited to conduct food testing under
this subpart using one or more methods of analysis.
    Owner or consignee means any person with an ownership or
consignment interest in the food product or environment that is the
subject of food testing conducted under Sec.  1.1107(a).
    Recognition means a determination by FDA that an accreditation body
meets the applicable requirements of this subpart and is authorized to
LAAF-accredit laboratories under this subpart.
    Recognized accreditation body means an accreditation body that FDA
has determined meets the applicable requirements of this subpart and is
authorized to LAAF-accredit laboratories under this subpart.
    Representative sample means a sample that accurately, to a
statistically acceptable degree, represents the characteristics and
qualities of the food product or environment from which the sample was
collected.
    Sampler means an individual who collects samples.
    Sampling firm means an entity that provides sampling services.
    Scope of LAAF-accreditation refers to the methods of analysis for
which the laboratory is LAAF-accredited.
    Street address means the full physical address, including the
country. For purposes of this rule, a post office box number alone is
insufficient; however, a post office box number may be provided in
addition to the street address.

Sec.  1.1103  Who is subject to this subpart?

    (a) Accreditation bodies. An accreditation body is subject to this
subpart if it has been or is seeking to be recognized by FDA to LAAF-
accredit laboratories to conduct food testing under this subpart.
    (b) Laboratories. A laboratory is subject to this subpart if it has
been or is seeking to be LAAF-accredited by a recognized accreditation
body to conduct food testing under this subpart.
    (c) Owners and consignees. An owner or consignee is subject to this
subpart if it is required to use a LAAF-accredited laboratory to
conduct food testing under this subpart.

General Requirements

Sec.  1.1107  When must food testing be conducted under this subpart?

    (a) Food testing must be conducted under this subpart whenever such
testing is conducted by or on behalf of an owner or consignee:
    (1) In response to explicit testing requirements that address an
identified or suspected food safety problem, which are contained in the
following provisions:
    (i) Sprouts. Section 112.146(a), (c), and (d) of this chapter;
    (ii) Shell eggs. Sections 118.4(a)(2)(iii), 118.5(a)(2)(ii) and
(b)(2)(ii), and 118.6(a)(2) and (e) of this chapter; and
    (iii) Bottled drinking water. Section 129.35(a)(3)(i) of this
chapter (for the requirement to test five samples from the same
sampling site that originally tested positive for Escherichia coli);
    (2) As required by FDA in a directed food laboratory order issued
under Sec.  1.1108;
    (3) To address an identified or suspected food safety problem and
presented to FDA as part of evidence for a hearing under section 423(c)
of the Federal Food, Drug, and Cosmetic Act prior to the issuance of a
mandatory food recall order, as part of a corrective action plan under
section 415(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act
submitted after an order suspending the registration of a food
facility, or as part of evidence submitted for an appeal of an
administrative detention order under section 304(h)(4)(A) of the
Federal Food, Drug, and Cosmetic Act.
    (4) In support of admission of an article of food under section
801(a) of the Federal Food, Drug, and Cosmetic Act; and
    (5) To support removal from an import alert through successful
consecutive testing.
    (b) When food testing is conducted under paragraph (a) of this
section, analysis of samples must be conducted by a laboratory that is
LAAF-accredited for the appropriate analytical method by a recognized
accreditation body under this subpart.
    (c) Food testing conducted on articles of food offered for import
into the United States under section 801(a) of the Federal Food, Drug,
and Cosmetic

Act pursuant to paragraph (a)(4) or (a)(5) of this section may only be
conducted after the articles offered for import have arrived in the
United States unless the owner or consignee has written approval from
FDA that a sample taken prior to arrival is or would be a
representative sample of the article offered for import into the United
States.

Sec.  1.1108  When and how will FDA issue a directed food laboratory
order?

    (a) FDA may require the owner or consignee to conduct food testing,
or to have food testing conducted on their behalf, under this subpart
to address an identified or suspected food safety problem, as FDA deems
appropriate.
    (b) The directed food laboratory order will specify the food
product or environment to be tested; whether the food testing may be
conducted using a LAAF-accredited laboratory that is owned, operated,
or controlled by the owner or consignee; the timeframe in which the
food testing must be conducted; and the manner of the food testing,
such as the methods that must be used.
    (c) The directed food laboratory order will contain all the
elements required by Sec.  16.22(a) of this chapter and will thereby
constitute the notice of an opportunity for hearing under part 16 of
this chapter. An affected owner or consignee may request a regulatory
hearing on a directed food laboratory order pursuant to Sec.  1.1174.

Sec.  1.1109  How will FDA make information about recognized
accreditation bodies and LAAF-accredited laboratories available to the
public?

    FDA will place on its website a publicly available registry listing
of:
    (a) Recognized accreditation bodies, including for each: the name,
contact information, and duration of recognition of the recognized
accreditation body;
    (b) Accreditation bodies that have a change in recognition,
including for each: the name of the accreditation body, the specific
change in recognition (i.e., probation, revocation of recognition,
denial of renewal of recognition, relinquishment of recognition, or
expiration of recognition) and the effective date of the change;
    (c) LAAF-accredited laboratories, including for each: the name,
contact information, and scope of LAAF-accreditation, and the name and
contact information of the recognized accreditation body that has LAAF-
accredited the laboratory; and
    (d) Laboratories that have a change in LAAF-accreditation,
including for each: the name of the laboratory, the specific change in
LAAF-accreditation (i.e., suspension, reduction of scope, or withdrawal
of LAAF-accreditation by the recognized accreditation body, probation
or disqualification by FDA, or relinquishment of LAAF-accreditation),
and the effective date of the change.

Sec.  1.1110  What are the general requirements for submitting
information to FDA under this subpart?

    (a) All applications, reports, notifications, and records submitted
to FDA under this subpart must be submitted electronically and in
English unless otherwise specified. If FDA requests inspection or
submission of records that are maintained in any language other than
English, the recognized accreditation body or LAAF-accredited
laboratory must provide an English translation within a reasonable
time.
    (b) A program applicant must provide any translation and
interpretation services needed by FDA during the processing of the
application, including during any onsite assessments of the applicant
by FDA.

FDA Recognition of Accreditation Bodies

Sec.  1.1113  What are the eligibility requirements for a recognized
accreditation body?

    A recognized accreditation body or an accreditation body seeking
recognition must meet all of the following requirements:
    (a) Demonstrates compliance with ISO/IEC 17011:2017(E)
(incorporated by reference, see Sec.  1.1101).
    (b) Demonstrates that it is a full member of the International
Laboratory Accreditation Cooperative (ILAC).
    (c) Demonstrates that it is a signatory to the ILAC Mutual
Recognition Arrangement (MRA) that has demonstrated competence to ISO/
IEC 17011:2017(E) with a scope of ``Testing: ISO/IEC 17025.''
    (d) Will comply with all additional requirements for recognized
accreditation bodies under this subpart while recognized.

Sec.  1.1114  How does an accreditation body apply to FDA for
recognition or renewal of recognition?

    (a) Application for recognition or renewal of recognition. An
accreditation body seeking initial recognition or renewal of
recognition must submit an application to FDA demonstrating that it
meets the eligibility requirements in Sec.  1.1113.
    (b) Documentation of conformance with requirements. The
accreditation body must submit documentation of conformance with ISO/
IEC 17011:2017(E) (incorporated by reference, see Sec.  1.1101) and
separate documentation of ILAC membership and ILAC MRA signatory status
demonstrating competence to ISO/IEC 17011:2017(E) with a scope of
``Testing: ISO/IEC 17025,'' in meeting the requirements of Sec.
1.1113(a) through (c). The accreditation body also must submit
documentation of its compliance with Sec.  1.1113(d).
    (c) Signature. An application for recognition or renewal of
recognition must be signed in the manner designated by FDA by an
individual authorized to act on behalf of the applicant for purposes of
seeking recognition or renewal of recognition.

Sec.  1.1115  How will FDA evaluate applications for recognition and
renewal of recognition?

    (a) Review of application for recognition or renewal of
recognition. FDA will review an accreditation body's application for
recognition or renewal of recognition for completeness and notify the
applicant of any insufficiencies. FDA generally will review
accreditation body applications for recognition or renewal of
recognition in the order in which completed applications are received;
however, FDA may prioritize the review of specific applications to meet
program needs.
    (b) Evaluation of application for recognition or renewal of
recognition. FDA will evaluate a complete application for recognition
or renewal of recognition to determine whether the applicant meets the
requirements for recognition. Such evaluation may include an onsite
evaluation of the accreditation body. If FDA does not reach a final
decision on an application for renewal of recognition before an
accreditation body's recognition expires, FDA may extend the existing
term of recognition for a specified period of time or until FDA reaches
a final decision on the application for renewal of recognition.
    (c) Grant of recognition. FDA will notify the applicant that its
application for recognition or renewal of recognition has been approved
and will include any conditions associated with the recognition.
    (d) Duration of recognition. FDA may grant recognition of an
accreditation body for a period not to exceed 5 years from the date of
recognition, except under the circumstances described in paragraph (b)
of this section.
    (e) Denial of application for recognition or renewal of
recognition. FDA will notify the applicant that its

application for recognition or renewal of recognition has been denied
and will state the basis for such denial and describe the procedures
for requesting reconsideration of the application under Sec.  1.1171.
    (f) Notice of records custodian after denial of an application for
renewal of recognition. Within 10 business days of the date of FDA's
issuance of a denial of an application for renewal of recognition, the
applicant must provide the name and contact information of the
custodian who will maintain required records and make them available to
FDA under Sec.  1.1124. The contact information must include an email
address for the records custodian and the street address where the
records required under Sec.  1.1124 will be located.
    (g) FDA notice to LAAF-accredited laboratories. FDA will promptly
notify all laboratories LAAF-accredited by the accreditation body whose
application for renewal of recognition was denied, informing them of
such denial.
    (h) Public notice of denial of an application for renewal of
recognition of an accreditation body. FDA will provide public notice on
the website described in Sec.  1.1109 of the issuance of a denial of an
application for renewal of recognition and will include the date of the
issuance of such denial.

Sec.  1.1116  What must a recognized accreditation body do to
voluntarily relinquish or not renew its recognition?

    (a) Notice to FDA of intent to relinquish or not to renew
recognition. At least 60 calendar days before voluntarily relinquishing
its recognition or before allowing its recognition to expire without
seeking renewal, a recognized accreditation body must notify FDA of its
intention to leave the program, specifying the date on which the
relinquishment or expiration will occur. The recognized accreditation
body must provide the name and contact information of the custodian who
will maintain and make available to FDA the records required by Sec.
1.1124 after the date of relinquishment or the date recognition
expires, as applicable. The contact information must include an email
address for the records custodian and the street address where the
records required under Sec.  1.1124 will be located.
    (b) Notice to LAAF-accredited laboratories of intent to relinquish
or not to renew recognition. At least 60 calendar days before
voluntarily relinquishing its recognition or before allowing its
recognition to expire without seeking renewal, a recognized
accreditation body must notify the laboratories it LAAF accredits of
its intention to leave the program, specifying the date on which
relinquishment or expiration will occur.
    (c) Public notice of voluntary relinquishment or expiration of
recognition. FDA will provide notice on the website described in Sec.
1.1109 of the voluntary relinquishment or expiration of recognition of
an accreditation body.

Sec.  1.1117  How may an accreditation body request reinstatement of
recognition?

    (a) Application following revocation of recognition. An
accreditation body that has had its recognition revoked by FDA (as
described in Sec.  1.1131) may seek reinstatement by submitting a new
application for recognition under Sec.  1.1114. The accreditation body
must also submit evidence to FDA with its application to demonstrate
that the issues resulting in revocation of recognition have been
resolved, including evidence addressing the cause or condition of the
grounds for revocation of recognition. The evidence also must identify
measures that have been implemented to help ensure that such cause or
condition is unlikely to recur.
    (b) Application following relinquishment or expiration of
recognition. An accreditation body that previously relinquished its
recognition or allowed its recognition to expire (as described in Sec.
1.1116) may seek reinstatement by submitting a new application for
recognition under Sec.  1.1114.

Requirements for Recognized Accreditation Bodies

Sec.  1.1119  What are the conflict of interest requirements for a
recognized accreditation body?

    (a) In addition to meeting the impartiality and conflict of
interest requirements of Sec.  1.1113(a), a recognized accreditation
body must:
    (1) Ensure that the recognized accreditation body (and its
officers, employees, or other agents involved in LAAF-accreditation
activities) does not own or have a financial interest in, manage, or
otherwise control any laboratory (or any affiliate, parent, or
subsidiary) it LAAF-accredits, subject to the exceptions in paragraphs
(c) and (d) of this section; and
    (2) Prohibit, subject to the exceptions in paragraph (e) of this
section, officers, employees, or other agents involved in LAAF-
accreditation activities of the recognized accreditation body from
accepting any money, gift, gratuity, or other item of value from any
laboratory the recognized accreditation body LAAF-accredits or assesses
for LAAF-accreditation.
    (b) The financial interests of any children younger than 18 years
of age or a spouse of a recognized accreditation body's officers,
employees, and other agents involved in LAAF-accreditation activities
are considered the financial interests of such officers, employees, and
other agents involved in LAAF-accreditation activities.
    (c) An accreditation body (and its officers, employees, or other
agents involved in LAAF-accreditation activities) may have an interest
in a publicly traded or publicly available investment fund (e.g., a
mutual fund), or a widely held pension or similar fund if the
accreditation body (and its officers, employees, or other agents
involved in LAAF-accreditation activities) neither exercises control
nor has the ability to exercise control over the financial interests
held in the fund.
    (d) A recognized accreditation body's agent that is a contract
assessor will be permitted to own or have a financial interest in,
manage, or otherwise control a LAAF-accredited laboratory if all of the
following circumstances apply:
    (1) The contract assessor's primary occupation is owning or having
a financial interest in, managing, or otherwise controlling a LAAF-
accredited laboratory;
    (2) The assessor contracts with the recognized accreditation body
to provide assessment services on an intermittent or part-time basis;
    (3) The contract assessor does not assess the LAAF-accredited
laboratory that the assessor owns or has a financial interest in,
manages, or otherwise controls; and
    (4) The contract assessor and the recognized accreditation body
inform any laboratory that the contract assessor may assess or reassess
for LAAF-accreditation that the contract assessor owns or has a
financial interest in, manages, or otherwise controls a LAAF-accredited
laboratory. The laboratory seeking LAAF-accreditation assessment or
reassessment must acknowledge that the contract assessor owns or has a
financial interest in, manages, or otherwise controls a LAAF-accredited
laboratory and be provided the option to be assessed by a different
representative of the recognized accreditation body.
    (e) The prohibited items of value specified in paragraph (a)(2) of
this section do not include:
    (1) Money representing payment of fees for LAAF-accreditation
services or reimbursement of direct costs associated with an onsite
assessment or reassessment of the laboratory; or
    (2) Meal of de minimis value provided during the course of an
assessment or reassessment and on the premises where

the assessment or reassessment is conducted, if necessary for the
efficient conduct of the assessment or reassessment.

Sec.  1.1120  How must a recognized accreditation body assess
laboratories seeking LAAF-accreditation and oversee LAAF-accredited
laboratories?

    (a) A recognized accreditation body must conduct an initial
assessment of a laboratory seeking LAAF-accreditation in accordance
with the requirements of this subpart, to determine whether the
laboratory meets the requirements of Sec.  1.1138.
    (b) Subject to the exception in paragraph (c) of this section, the
initial assessment must be conducted onsite, although certain
assessment activities may be conducted remotely if it will not aid the
assessment to conduct them onsite.
    (c) If, within the previous 2 years, the recognized accreditation
body conducted an onsite assessment of the laboratory in accordance
with ISO/IEC 17011:2017(E) (incorporated by reference, see Sec.
1.1101) to assess whether the laboratory meets the requirements of ISO/
IEC 17025:2017(E) (incorporated by reference, see Sec.  1.1101), then
the initial assessment under this section:
    (1) May be conducted remotely, and
    (2) Need only address whether the laboratory meets the requirements
of Sec.  1.1138(a)(2) and (3) and (b).
    (d) A recognized accreditation body must oversee the performance of
a laboratory it LAAF-accredits in accordance with the requirements of
Sec.  1.1113(a), except as otherwise provided by this subpart, to
determine whether the LAAF-accredited laboratory continues to meet the
applicable requirements of this subpart.
    (e) A recognized accreditation body must conduct a reassessment of
a LAAF-accredited laboratory in accordance with this subpart at least
every 2 years. Such reassessment must be conducted onsite, although
certain reassessment activities may be conducted remotely if it will
not aid in the reassessment to conduct the activities onsite.
    (f) If the recognized accreditation body conducted the initial
assessment of the LAAF-accredited laboratory remotely in accordance
with paragraph (c) of this section, the recognized accreditation body
must conduct its first reassessment of the LAAF-accredited laboratory
no later than 2 years after the recognized accreditation body last
conducted an onsite assessment of the laboratory.
    (g) The reassessment at the end of the LAAF-accredited laboratory's
ISO/IEC 17025:2017-accreditation cycle, which the recognized
accreditation body must conduct in accordance with this subpart, must
be conducted onsite, although certain reassessment activities may be
conducted remotely if it will not aid the reassessment to conduct them
onsite.
    (h) Any assessments or reassessments conducted by a recognized
accreditation body in addition to the assessments or reassessments
referred to in paragraphs (a), (e), and (g) of this section may be
conducted remotely if it will not aid the assessment or reassessment to
conduct it onsite.

Sec.  1.1121  When must a recognized accreditation body require
corrective action, suspend a LAAF-accredited laboratory, or reduce the
scope of or withdraw the LAAF-accreditation of a laboratory?

    (a) Corrective action. A recognized accreditation body may require
corrective action using the procedures described by ISO/IEC
17025:2017(E) (incorporated by reference, see Sec.  1.1101) section 8.7
to address any deficiencies identified while assessing and overseeing a
LAAF-accredited laboratory.
    (1) The recognized accreditation body must notify the LAAF-
accredited laboratory of all deficiencies requiring corrective action
and will either specify a deadline to implement corrective action or
will require the LAAF-accredited laboratory to submit a corrective
action plan and timeframe for implementation to the recognized
accreditation body for approval.
    (2) The LAAF-accredited laboratory must implement appropriate
corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit
the results of the corrective action to the recognized accreditation
body.
    (3) The recognized accreditation body will review the corrective
action and will notify the LAAF-accredited laboratory whether the
corrective action is acceptable.
    (b) Suspension. If a recognized accreditation body determines that
a laboratory it LAAF-accredits has not effectively implemented
corrective action or otherwise fails to address deficiencies
identified, the recognized accreditation body may temporarily suspend
the LAAF-accredited laboratory for one or more LAAF-accredited methods,
and require corrective action under paragraph (a) of this section.
    (1) The recognized accreditation body must notify the LAAF-
accredited laboratory of the grounds for the suspension, the LAAF-
accredited methods subject to the suspension, and all deficiencies that
must be addressed via the process described in paragraph (a) of this
section.
    (2) The recognized accreditation body must notify FDA of the
suspension under this section in accordance with the requirements of
Sec.  1.1123(d)(5). FDA will provide notice of the LAAF-accredited
laboratory's suspension on the website described in Sec.  1.1109.
    (3) The recognized accreditation body will review the corrective
action required under paragraph (b) of this section and will notify the
LAAF-accredited laboratory whether the corrective action is acceptable.
    (4) A LAAF-accredited laboratory shall remain suspended until it
demonstrates to the recognized accreditation body's satisfaction that
the LAAF-accredited laboratory has successfully implemented appropriate
corrective action.
    (5) If the recognized accreditation body determines that a LAAF-
accredited laboratory on suspension has failed to implement appropriate
corrective action or otherwise fails to address deficiencies
identified, the recognized accreditation body may reduce the scope of
or withdraw the LAAF-accreditation of the laboratory under paragraph
(c) of this section.
    (c) Reduction of scope or withdrawal of LAAF-accreditation. A
recognized accreditation body must reduce the scope of or withdraw the
LAAF-accreditation of a laboratory it LAAF-accredits when the
laboratory substantially fails to comply with this subpart. When only
certain methods within the laboratory's scope of LAAF-accreditation are
affected by the noncompliance, the recognized accreditation body may
reduce the scope of the laboratory's LAAF-accreditation for only those
affected methods. If all methods are affected, the recognized
accreditation body must withdraw the laboratory's LAAF-accreditation.
    (d) Procedures for reduction of scope or withdrawal of LAAF-
accreditation. (1) The recognized accreditation body must notify the
laboratory of any reduction of scope or withdrawal of LAAF-
accreditation, including:
    (i) The grounds for the reduction of scope or withdrawal of LAAF-
accreditation;
    (ii) The method(s) to which the reduction of scope applies;
    (iii) The procedures for appealing the reduction of scope or
withdrawal of LAAF-accreditation as described in Sec.  1.1122; and
    (iv) The date the reduction of scope or withdrawal of LAAF-
accreditation is effective.

    (2) The recognized accreditation body must notify FDA of the
reduction of scope or withdrawal of LAAF-accreditation under this
section in accordance with the requirements in Sec.  1.1123(d)(4). FDA
will provide notice of the reduction of scope or withdrawal of the
laboratory's LAAF-accreditation on the website described in Sec.
1.1109.
    (e) Records request associated with suspension, reduction of scope,
or withdrawal of LAAF-accreditation. To assist the recognized
accreditation body in determining whether a suspension, reduction of
scope, or withdrawal of LAAF-accreditation is warranted under this
section, the recognized accreditation body may require the submission
of records that the LAAF-accredited laboratory is required to maintain
under Sec.  1.1154.
    (f) Consequences of suspension, reduction of scope, or withdrawal
of LAAF-accreditation. (1) A LAAF-accredited laboratory may not conduct
food testing under this subpart using suspended methods.
    (2) If the recognized accreditation body withdraws the laboratory's
LAAF-accreditation, the laboratory is immediately ineligible to conduct
any food testing under this subpart. If the recognized accreditation
body reduces the laboratory's scope of LAAF-accreditation, the
laboratory is immediately ineligible to use the methods to which the
reduction of scope applies to conduct food testing under this subpart.

Sec.  1.1122  What procedures must a recognized accreditation body
provide for appeals of decisions to suspend, reduce the scope of,
withdraw, or deny LAAF-accreditation?

    A recognized accreditation body must consider a laboratory's appeal
regarding a decision to suspend, reduce the scope of, withdraw, or deny
LAAF-accreditation in accordance with the requirements of Sec.
1.1113(a). Appeals must be reviewed and decided by a competent
person(s) free from bias or prejudice who has not participated in the
LAAF-accreditation decision and is not the subordinate of a person who
participated in the LAAF-accreditation decision. For the purposes of
appeals, the competent person(s) may be external to the recognized
accreditation body.

Sec.  1.1123  What reports, notifications, and documentation must a
recognized accreditation body submit to FDA?

    (a) General requirements. All reports and notifications required by
this section must include:
    (1) The name, street address, telephone number, and email address
of the recognized accreditation body associated with the report or
notification, and the name of an appropriate point of contact for the
recognized accreditation body, and
    (2) If the report or notification concerns a LAAF-accredited
laboratory, the name, street address, telephone number, and email
address of the LAAF-accredited laboratory, and the name of an
appropriate point of contact for the LAAF-accredited laboratory.
    (b) Internal audit reports. A recognized accreditation body must
submit to FDA a report of the results of the internal audit conducted
pursuant to Sec.  1.1125 within 45 calendar days of completing the
audit. The audit report must include:
    (1) A description of the internal audit conducted;
    (2) A description of any identified deficiencies;
    (3) A description of any corrective action taken or planned,
including the timeline for such corrective action; and
    (4) A statement disclosing the extent to which the internal audit
was conducted by personnel different from those who perform the
activity or activities that were audited.
    (c) Changes affecting recognition. A recognized accreditation body
must notify FDA within 48 hours when the recognized accreditation body
is aware of a change that would affect the recognition of such
accreditation body, and the notification must include:
    (1) A description of the change, and
    (2) If the change is one made by the recognized accreditation body,
an explanation of the purpose of the change.
    (d) Changes in LAAF-accreditation. A recognized accreditation body
must notify FDA and submit a certificate reflecting the scope of
accreditation within 48 hours when any of the following occur:
    (1) The recognized accreditation body grants or extends LAAF-
accreditation of a laboratory, and the notification must include:
    (i) The scope of LAAF-accreditation requested by the laboratory,
    (ii) The scope of LAAF-accreditation granted, and
    (iii) The effective date of the grant or extension;
    (2) The recognized accreditation body denies LAAF-accreditation of
a laboratory, and the notification must include:
    (i) The scope of LAAF-accreditation requested by the laboratory,
    (ii) The scope of LAAF-accreditation denied, and
    (iii) The grounds for the denial;
    (3) The recognized accreditation body receives notice that a
laboratory it LAAF-accredits intends to relinquish its LAAF-
accreditation and the laboratory has not provided notice to FDA 60
calendar days prior to relinquishment as required under Sec.  1.1140.
The recognized accreditation body's notification must include:
    (i) The scope of LAAF-accreditation to which the relinquishment
applies, as applicable, and
    (ii) The effective date of the relinquishment;
    (4) The recognized accreditation body reduces the scope of or
withdraws the LAAF-accreditation of a laboratory, and the notification
must include:
    (i) The scope of LAAF-accreditation to which the reduction applies,
    (ii) The grounds for the reduction of scope or withdrawal, and
    (iii) The effective date of the reduction of scope or withdrawal;
    (5) The recognized accreditation body suspends or lifts the
suspension of a LAAF-accredited laboratory, and the notification must
include:
    (i) The scope of LAAF-accreditation to which the suspension
applies,
    (ii) The grounds for the suspension or for lifting the suspension,
and
    (iii) The effective date of the suspension or date the suspension
is lifted.
    (e) Laboratory fraud. A recognized accreditation body must notify
FDA within 48 hours if the recognized accreditation body knows that a
laboratory it LAAF-accredits has committed fraud or submitted material
false statements to FDA, and the notification must include:
    (1) A description of the basis for the recognized accreditation
body's knowledge of the fraud or material false statements,
    (2) A description of the fraud or material false statements, and
    (3) The action(s) taken by the recognized accreditation body with
respect to such LAAF-accredited laboratory.

Sec.  1.1124  What are the records requirements for a recognized
accreditation body?

    (a) In addition to meeting the requirements of Sec.  1.1113(a)
related to records, a recognized accreditation body must maintain, for
5 years after the date of creation of the records, records created
while it is recognized demonstrating its compliance with this subpart,
including records relating to:
    (1) Applications for LAAF-accreditation;
    (2) Assessments, reassessments, and decisions to grant, extend the
scope of, renew, deny, reduce the scope of, or withdraw LAAF-
accreditation or to

suspend or lift the suspension of a LAAF-accredited laboratory;
    (3) Appeals of suspensions, denials, reductions of scope of, and
withdrawals of LAAF-accreditation, final decisions on such appeals, and
the bases for such final decisions;
    (4) Its oversight of laboratories it has LAAF-accredited;
    (5) Its oversight of its own performance, including all records
related to internal audits, complaints, and corrective actions;
    (6) Any reports or notifications required to be submitted to FDA
under Sec.  1.1123, including any supporting information;
    (7) Records of fee payments and reimbursement of direct costs; and
    (8) Any documents demonstrating compliance with the requirements
for assessment activities by contract assessors with certain financial
interests described in Sec.  1.1119(d).
    (b) A recognized accreditation body must make the records it is
required to maintain by paragraph (a) of this section available for
inspection and copying or for electronic submission upon written
request of an authorized officer or employee of FDA. If FDA requests
records for inspection and copying, the recognized accreditation body
must make such records promptly available at the physical location of
the recognized accreditation body or at another reasonably accessible
location. If FDA requests electronic submission, the records must be
submitted within 10 business days of the request.
    (c) A recognized accreditation body must not prevent or interfere
with FDA's access to the records the LAAF-accredited laboratories it
LAAF-accredits are required to maintain under Sec.  1.1154.

Sec.  1.1125  What are the internal audit requirements for a recognized
accreditation body?

    As part of the internal audit a recognized accreditation body is
required to conduct pursuant to Sec.  1.1113(a), the recognized
accreditation body must audit its compliance with the requirements of
Sec.  1.1113(d).

FDA Oversight of Recognized of Accreditation Bodies

Sec.  1.1130  How will FDA oversee recognized accreditation bodies?

    (a) FDA will evaluate each recognized accreditation body to
determine its compliance with the applicable requirements of this
subpart no later than:
    (1) Year 4 of a 5-year recognition period; or
    (2) The midpoint of a recognition period less than 5 years.
    (b) An FDA evaluation of a recognized accreditation body may
include review of records, an onsite evaluation of the accreditation
body, and onsite reviews of one or more LAAF-accredited laboratories
the recognized accreditation body LAAF-accredits, with or without the
recognized accreditation body present. Certain evaluation activities
may be conducted remotely if it will not aid in the evaluation to
conduct them onsite.
    (c) FDA may conduct additional evaluations of a recognized
accreditation body at any time to determine whether the recognized
accreditation body complies with the applicable requirements of this
subpart.

Sec.  1.1131  When will FDA require corrective action, put a recognized
accreditation body on probation, or revoke the recognition of an
accreditation body?

    (a) Corrective action. FDA may require corrective action to address
any deficiencies identified while evaluating a recognized accreditation
body under this subpart.
    (1) FDA will notify the recognized accreditation body of all
deficiencies requiring corrective action and will either specify a
deadline to implement corrective action or will require the recognized
accreditation body to submit a corrective action plan and timeframe for
implementation to FDA for approval.
    (2) The recognized accreditation body must handle FDA's
notification as a complaint under ISO/IEC 17011:2017(E) (incorporated
by reference, see Sec.  1.1101) section 7.12, implement appropriate
corrective action under ISO/IEC 17011:2017 section 9.5, and submit both
the results of the complaint investigation and subsequent corrective
action to FDA.
    (3) FDA will review the corrective action and will notify the
recognized accreditation body whether the corrective action is
acceptable.
    (b) Probation. If FDA determines that a recognized accreditation
body has not effectively implemented corrective action or otherwise
fails to address deficiencies identified, FDA may put the recognized
accreditation body on probation and require corrective action under
paragraph (a) of this section.
    (1) FDA will notify the recognized accreditation body of the
grounds for the probation and all deficiencies requiring corrective
action via the process described in paragraph (a) of this section.
    (2) FDA will notify all laboratories LAAF-accredited by the
recognized accreditation body that the recognized accreditation body is
on probation and will provide notice of the probation on the website
described in Sec.  1.1109.
    (3) FDA will review the corrective action and will notify the
recognized accreditation body whether the corrective action is
acceptable.
    (4) A recognized accreditation body shall remain on probation until
the recognized accreditation body demonstrates to FDA's satisfaction
that it has successfully implemented appropriate corrective action.
    (5) If FDA determines that a recognized accreditation body on
probation has failed to implement appropriate corrective action or
otherwise fails to address deficiencies identified, FDA may revoke
recognition of the recognized accreditation body under paragraph (c) of
this section.
    (c) Revocation of recognition. FDA will revoke the recognition of
an accreditation body if it fails to meet the requirements of this
subpart, if FDA determines the accreditation body has committed fraud
or submitted material false statements to FDA, or if FDA determines
that a recognized accreditation body on probation has failed to
implement appropriate corrective action or otherwise fails to address
deficiencies identified.
    (d) Revocation of recognition procedures. (1) FDA will issue a
notice of revocation of recognition to the recognized accreditation
body that will include the grounds for revocation, the date on which
revocation is effective, the procedures for requesting a regulatory
hearing on the revocation under Sec.  1.1173, and the procedures for
requesting reinstatement of recognition under Sec.  1.1117.
    (2) FDA will notify all laboratories LAAF-accredited by the
recognized accreditation body that recognition has been revoked and
will provide notice of the revocation of recognition of an
accreditation body on the website described in Sec.  1.1109.
    (3) Within 10 business days of the date of issuance of revocation,
the accreditation body must provide the name and contact information of
the custodian who will maintain records and make them available to FDA
as required by Sec.  1.1124. The contact information must include an
email address for the records custodian and the street address where
the records required by Sec.  1.1124 will be located.
    (e) Effect of probation or revocation of recognition on the
accreditation body. (1) A recognized accreditation body that is put on
probation by FDA must continue to oversee laboratories that it has
LAAF-accredited under this subpart

and may continue to LAAF-accredit laboratories under Sec.  1.1120.
    (2) An accreditation body that has had its recognition revoked by
FDA may not LAAF-accredit laboratories under this subpart or continue
to oversee the laboratories it has previously LAAF-accredited while the
accreditation body is not recognized.

LAAF-Accreditation of Laboratories

Sec.  1.1138  What are the eligibility requirements for a LAAF-
accredited laboratory?

    (a) A laboratory that is LAAF-accredited or seeking LAAF-
accreditation must demonstrate it is capable of conducting each method
of food testing for which it is or will be LAAF-accredited by meeting
all of the following requirements:
    (1) For each method, the laboratory is accredited by a recognized
accreditation body to ISO/IEC 17025:2017(E) (incorporated by reference,
see Sec.  1.1101).
    (2)(i) Except as provided in paragraph (a)(2)(ii) of this section,
the laboratory has successfully passed a proficiency test provided by a
competent proficiency testing organization within the last 12 months
for each method within the scope of LAAF-accreditation.
    (ii) If the laboratory determines there is no proficiency testing
program available or practicable for a method, it may use a comparison
program. A laboratory must request approval from the recognized
accreditation body regarding the determination prior to using a
comparison program in lieu of an annual proficiency test. The
laboratory is required to demonstrate competency through participation
in the comparison program.
    (iii) A laboratory must submit all proficiency test and comparison
program results, regardless of outcome, to the recognized accreditation
body within 30 calendar days of receipt.
    (3) The laboratory ensures that its procedures for monitoring the
validity of the results of testing it conducts under this subpart
include the use of reference materials or quality control samples with
each batch of samples it tests under this subpart.
    (b) Will comply with all additional requirements for LAAF-
accredited laboratories under this subpart while LAAF-accredited.

Sec.  1.1139  How does a laboratory apply for LAAF-accreditation or
extend its scope of LAAF-accreditation?

    (a) Application for LAAF-accreditation. A laboratory seeking LAAF-
accreditation or extension of its scope of LAAF-accreditation must
submit its application for LAAF-accreditation to a recognized
accreditation body identified on the website described in Sec.  1.1109.
The recognized accreditation body will review and assess the
application in accordance with the requirements of this subpart. If the
laboratory seeking LAAF-accreditation had its LAAF-accreditation
withdrawn or one or more methods within its scope of LAAF-accreditation
reduced by a recognized accreditation body or has been previously
disqualified by FDA, the laboratory must meet the additional
requirements specified by Sec.  1.1142(a).
    (b) Documentation of conformance with ISO/IEC 17025:2017(E). The
laboratory may use documentation of conformance with ISO/IEC
17025:2017(E) (incorporated by reference, see Sec.  1.1101), as
applicable and supplemented as necessary, in meeting the applicable
requirements of this subpart.
    (c) Duration of accreditation. If a LAAF-accredited laboratory
maintains compliance with all requirements of this subpart, including
accreditation to ISO/IEC 17025:2017(E), the laboratory's LAAF-
accreditation will not end until reduced in scope, withdrawn,
relinquished, or the laboratory is disqualified, under this subpart.

Sec.  1.1140  What must a LAAF-accredited laboratory do to voluntarily
relinquish its LAAF-accreditation?

    (a) Notice to FDA and the recognized accreditation body of intent
to relinquish. A LAAF-accredited laboratory must notify FDA and its
recognized accreditation body at least 60 calendar days before
voluntarily relinquishing LAAF-accreditation or any method within the
scope of LAAF-accreditation. The notice must include the date on which
relinquishment will occur. If the laboratory will relinquish all
methods within its scope of LAAF-accreditation, the notification must
also include the name and contact information of the custodian who will
maintain the records required by Sec.  1.1154 after the date of
relinquishment. The contact information for the records custodian must
include an email address and the street address where the records
required by Sec.  1.1154 will be located.
    (b) Public notice of voluntary relinquishment of accreditation. FDA
will provide notice on the website described in Sec.  1.1109 of the
voluntary relinquishment of LAAF-accreditation of a laboratory.

Sec.  1.1141  What is the effect on a LAAF-accredited laboratory if its
recognized accreditation body is no longer recognized by FDA?

    If a recognized accreditation body has its application for renewal
of recognition denied, relinquishes its recognition or allows its
recognition to expire, or has its recognition revoked, any laboratory
LAAF-accredited by the accreditation body must take either the actions
in paragraph (a) of this section or the action in paragraph (b) of this
section no later than 30 calendar days after receiving the notice to
the LAAF-accredited laboratory required under Sec.  1.1115(g), Sec.
1.1116(b), or Sec.  1.1131(d)(2):
    (a)(1) The LAAF-accredited laboratory must submit to FDA
documentation of the LAAF-accredited laboratory's most recent internal
audit, required under Sec.  1.1154(a)(5), documentation showing
compliance with the conflict of interest requirements in Sec.  1.1147,
and documentation of the most recent proficiency test or comparison
program result for each test method within the laboratory's scope of
LAAF-accreditation, to show compliance with Sec.  1.1138(a)(2); and
    (2) The laboratory must become LAAF-accredited by another
recognized accreditation body before the laboratory's ISO/IEC
17025:2017(E) (incorporated by reference, see Sec.  1.1101)
accreditation lapses or not later than 1 year after the LAAF-accredited
laboratory receives the applicable notice under Sec.  1.1115(g), Sec.
1.1116(b), or Sec.  1.1131(d)(2), whichever is sooner.
    (b) The LAAF-accredited laboratory initiates relinquishment of its
LAAF-accreditation under Sec.  1.1140, with the relinquishment to occur
within 90 calendar days.

Sec.  1.1142  How does a laboratory request reinstatement of LAAF-
accreditation?

    (a) Application following reduction of scope or withdrawal of LAAF-
accreditation by a recognized accreditation body or disqualification by
FDA. A laboratory that has had any methods within its scope of LAAF-
accreditation reduced or has had its LAAF-accreditation withdrawn by a
recognized accreditation body or that has been disqualified by FDA may
seek reinstatement of LAAF-accreditation by submitting a new
application for LAAF-accreditation to a recognized accreditation body
under Sec.  1.1139. The laboratory must also:
    (1) Notify FDA prior to submitting a new application for LAAF-
accreditation to the recognized accreditation body, including in the
notification the name of the laboratory, contact information for

the laboratory, the name of the recognized accreditation body to which
the laboratory will be submitting the application, and the date that
the laboratory expects to submit the new application for LAAF-
accreditation; and
    (2) Demonstrate, to the satisfaction of the recognized
accreditation body to which it is submitting the new application, that
the grounds for the reduction of scope or withdrawal of LAAF-
accreditation or disqualification have been resolved and that the
laboratory has implemented measures to prevent such grounds from
recurring.
    (b) Application following voluntary relinquishment of LAAF-
accreditation. A laboratory that voluntarily relinquished any methods
within the scope of its LAAF-accreditation pursuant to Sec.  1.1140,
may seek reaccreditation by submitting a new application for LAAF-
accreditation to a recognized accreditation body under Sec.  1.1139.

Requirements for LAAF-Accredited Laboratories

Sec.  1.1147  What are the impartiality and conflict of interest
requirements for a LAAF-accredited laboratory?

    (a) In addition to the impartiality and conflict of interest
requirements in Sec.  1.1138(a)(1), a LAAF-accredited laboratory must,
subject to the exceptions in paragraph (b) of this section, prohibit
the LAAF-accredited laboratory's employees, contractors, and agents
involved in food testing under this subpart and related activities from
accepting any money, gift, gratuity, or other item of value from the
owner or consignee of the food that is being tested or will be tested
by the LAAF-accredited laboratory.
    (b) The prohibited items of value in paragraph (a) of this section
do not include:
    (1) Payment of fees for food testing under this subpart and related
services;
    (2) Reimbursement of direct costs associated with the food testing
by the LAAF-accredited laboratory; and
    (3) With respect to a LAAF-accredited laboratory that is owned by
the owner or consignee of the food that is or will be tested, payment
of the officer's, employee's, contractor's, or agent's compensation in
the normal course of business.
    (c) The LAAF-accredited laboratory must require the owner's or
consignee's payment to the LAAF-accredited laboratory of fees for food
testing services and reimbursement of direct costs associated with food
testing to be independent of the outcome of the test results.

Sec.  1.1149  What oversight standards apply to sampling?

    (a) Documents. Before analyzing a sample, the LAAF-accredited
laboratory must develop (if it collected the sample) or obtain (if
another firm collected the sample) the following information to be
submitted with test results (see Sec.  1.1152(c)):
    (1) Written documentation of the sampler's applicable
qualifications by training and experience. A LAAF-accredited laboratory
only needs to develop or obtain documentation of a sampler's
qualifications the first time that sampler collects a sample for the
LAAF-accredited laboratory under this subpart. If a LAAF-accredited
laboratory has previously submitted the sampler's qualifications to FDA
under Sec.  1.1152(c), the LAAF-accredited laboratory may refer to its
previously submitted qualifications.
    (2) The written sampling plan used to conduct the sampling. The
written sampling plan must identify the sampler and sampling firm and
must list factors that will be controlled to ensure the sampling does
not impact the validity of the subsequent analytical testing, including
controlling for the representational nature of the sample; and
    (3) A written sample collection report for each sample collected.
The written sample collection report must include:
    (i) The product code of the food product (if product is being
sampled) or the location and a description of the environment (if
environment is being sampled);
    (ii) The date of the sampling;
    (iii) The lot number, size, identity, and quantity of the sample;
    (iv) Documentation of sample collection procedures and any sample
preparation techniques; and
    (v) Documentation of the chain of custody of the sample and of
measures taken to ensure the validity of the subsequent analytical
testing, including controlling for the representational nature of the
sample.
    (b) Potential consequences. If any of the requirements in paragraph
(a) of this section is not met, FDA may consider the analysis of the
sample to be invalid.
    (c) Advance notice of sampling. (1) If FDA determines that sampling
conducted may materially differ from the sampling documented in the
associated sampling plan or sample collection report, or if FDA
determines that the sampling otherwise may have been improper, FDA may
require the LAAF-accredited laboratory that analyzed the associated
sample, and other LAAF-accredited laboratories that have analyzed
samples previously collected by the sampling firm, to obtain from the
sampling firm, and submit, or require the sampling firm to submit, an
advance notice of sampling. The advance notice of sampling must be
submitted to FDA at least 48 hours before each of the next 10 occasions
that the sampling firm will collect a sample that the LAAF-accredited
laboratory will analyze under this subpart.
    (2) FDA may, as appropriate:
    (i) Specify that the requirement applies to samples collected by a
particular sampler;
    (ii) Specify the type of food product or environment that requires
advance notice of sampling under this subpart;
    (iii) Determine that an amount of time other than 48 hours in
advance is required, from a minimum of 24 hours up to 7 business days
in advance;
    (iv) Determine that a number of occasions other than 10 is
required, from a minimum of 1 occasion to a maximum of 20 occasions;
    (v) Notify affected LAAF-accredited laboratories that submission of
additional notices of sampling are not required; and
    (vi) Notify the owner or consignee that the advance notice applies
to sampling for food testing being conducted on their behalf.
    (3) The advance notice of sampling must contain:
    (i) A unique identification for the advance notice of sampling;
    (ii) The name of the LAAF-accredited laboratory that will conduct
analysis of the sample;
    (iii) The name and street address of the sampling firm that will
conduct the sampling;
    (iv) A primary contact (name and phone number) for the sampling
firm;
    (v) The reason why the food product or environment will be sampled;
    (vi) The location of the food product or environment that will be
sampled, including sufficient information to identify the food product
or environment to be sampled;
    (vii) As applicable, the U.S. Customs and Border Protection entry
and line number;
    (viii) The product code of the food product (if product is being
sampled) or the location and a description of the environment (if
environment is being sampled); and
    (ix) The date and approximate time the sampling will begin.

Sec.  1.1150  What are the requirements for analysis of samples by a
LAAF-accredited laboratory?

    In addition to the sample analysis requirements of Sec.  1.1138(a):
    (a) The analysis must be conducted on either the sample received
from the

sampling firm or, if appropriate, on a representative sample of the
sample received from the sampling firm.
    (b) The analyst must:
    (1) Be qualified by appropriate education, training, and/or
experience to conduct the analysis;
    (2) Have appropriately demonstrated their ability to perform the
method properly in the specific context of the food testing to be
conducted; and
    (3) Be in compliance with the conflict of interest requirements of
Sec. Sec.  1.1138(a) and 1.1147.
    (c) The method used to conduct the food testing must meet the
requirements of Sec.  1.1151.
    (d) The LAAF-accredited laboratory must document the testing
information and test results to the extent necessary to account for all
information that is required to be included in a full analytical report
(see Sec.  1.1152(d)).

Sec.  1.1151  What requirements apply to the methods of analysis a
LAAF-accredited laboratory uses to conduct food testing under this
subpart?

    In addition to the requirements of Sec.  1.1138(a), a LAAF-
accredited laboratory must meet the following requirements:
    (a) The method of analysis used to conduct food testing under this
subpart must be:
    (1) Fit for purpose;
    (2) Within the laboratory's scope of LAAF-accreditation;
    (3) Appropriately validated for use in such food testing, in
accordance with paragraph (c) of this section; and
    (4) Appropriately verified by the LAAF-accredited laboratory for
use in such food testing, in accordance with paragraph (d) of this
section.
    (b) Food testing must be conducted using the specified method:
    (1) Under Sec.  1.1107(a)(1), if the Federal Food, Drug, and
Cosmetic Act or implementing regulations prescribe a test method.
    (2) Under Sec.  1.1107(a)(2), if the directed food laboratory order
prescribes a test method.
    (c)(1) A LAAF-accredited laboratory must validate methods in
accordance with the requirements of Sec.  1.1138(a).
    (2) A LAAF-accredited laboratory performing validation of a method
under this subpart must record the information required by Sec.
1.1138(a) and the supporting analytical data.
    (d)(1) Before a LAAF-accredited laboratory conducts food testing
under this subpart using a method for a specific intended use for which
the method has been validated, but for which the LAAF-accredited
laboratory has not previously applied the method under this subpart,
the LAAF-accredited laboratory must have verified it can properly
perform the method for the specific intended use.
    (2) A LAAF-accredited laboratory performing verification of a
method under this subpart must record the method that is the subject of
the verification, the intended purpose of the analysis, the results of
the verification, the procedure used for the verification, supporting
analytical data, and whether the LAAF-accredited laboratory is able to
properly perform the method.
    (e) A LAAF-accredited laboratory may submit a written request to
FDA requesting permission to use a method outside of its scope of LAAF-
accreditation for food testing. FDA may approve the request if both
following conditions are satisfied:
    (1) A new method or methodology has been developed and validated
but no reasonably available laboratory has been LAAF-accredited to
perform such method or methodology, and
    (2) The use of such method is necessary to prevent, control, or
mitigate a food emergency or foodborne illness outbreak.

Sec.  1.1152  What notifications, results, reports, and studies must a
LAAF-accredited laboratory submit to FDA?

    (a) General requirements. (1) All notifications, results, reports,
and studies required to be submitted to FDA by a LAAF-accredited
laboratory under this subpart must:
    (i) Include the name and street address of the LAAF-accredited
laboratory;
    (ii) Identify a point of contact for the LAAF-accredited
laboratory, including email and telephone number, whom FDA may contact
with questions or comments;
    (iii) Display an identification unique to the test results, report,
notification, or study; and
    (iv) Be true, accurate, unambiguous, and objective.
    (2) The LAAF-accredited laboratory that conducts the analysis of
the sample under this subpart is responsible for the submission of all
notifications, results, reports, and studies to FDA as required by this
section.
    (3) If the LAAF-accredited laboratory becomes aware that any aspect
of the submitted material is inaccurate, the LAAF-accredited laboratory
must immediately inform FDA and submit a corrected version. Such
corrections must meet the requirements for amendments to reports
specified by ISO/IEC 17025:2017(E) (incorporated by reference, see
Sec.  1.1101) section 7.8.8.
    (4) Any opinions and interpretations in any notification, result,
report, or study submitted to FDA under this subpart must meet the
requirements in ISO/IEC 17025:2017(E) section 7.8.7 and any statements
of conformity to a specification or standard in any notification,
result, report, or study submitted to FDA under this subpart must meet
the requirements of ISO/IEC 17025:2017(E) section 7.8.6.
    (b) Test results. (1) The LAAF-accredited laboratory must submit
the results of all testing required to be conducted under this subpart
directly to FDA via the location specified by the website described in
Sec.  1.1109, unless another location is specified by FDA regarding
testing conducted under Sec.  1.1107(a)(2) or (3).
    (2) The test results must be clear and identify:
    (i) The name and street address of the owner or consignee for which
the testing was conducted,
    (ii) As appropriate, the U.S. Customs and Border Protection entry
and line number(s), and
    (iii) The associated notifications, reports, and studies required
to be submitted with the test results under this subpart.
    (c) Documentation required to be submitted with test results. The
following documentation must be included with each full analytical
report (see paragraph (d) of this section) and each abridged analytical
report (see Sec.  1.1153) submitted to FDA under this subpart:
    (1) All sampling plans and sample collection reports related to the
food testing conducted as developed or obtained by the LAAF-accredited
laboratory in accordance with Sec.  1.1149;
    (2) Written documentation of the sampler's qualifications or an
indication that the sampler's qualifications have been submitted
previously, in accordance with Sec.  1.1149(a)(1);
    (3) For any validation studies required by Sec.  1.1151(c)(1), the
documentation required by Sec.  1.1151(c)(2);
    (4) For any verification studies required by Sec.  1.1151(d)(1),
the documentation required by Sec.  1.1151(d)(2);
    (5) The justification for any modification to or deviation from the
method(s) of analysis used and documentation of the LAAF-accredited
laboratory's authorization for the modification or deviation; and
    (6) A certification from one or more members of the LAAF-accredited
laboratory's management certifying that the test results,
notifications, reports, and studies are true and accurate; and that the
documentation includes the results of all tests conducted under this
subpart. The certification must include

the name, title, and signature of any certifiers.
    (d) Full analytical report contents. In addition to the
documentation required to be submitted with all test results (see
paragraph (c) of this section), a full analytical report must include:
    (1) All information described by ISO/IEC 17025:2017(E) sections
<IP_ADDRESS>(a) through (p) and <IP_ADDRESS>(a) through (d);
    (2) Documentation of references for the method of analysis used;
    (3) Name and signature of the analyst who conducted each analytical
step, including any applicable validation and verification steps, and
the date each step was performed;
    (4) Calculations, presented in a legible and logical manner;
    (5) As applicable, references to chromatograms, charts, graphs,
observations, photographs of thin layer chromatographic plates, and
spectra. References must be in color when appropriate and presented in
a clear order;
    (6) Identification of the source and purity of reference standards
used, and, as applicable: Certified reference materials, certified
reference cultures traceable to a nationally or internationally
recognized type culture collection (including concentration, units,
preparation, and storage conditions), and reference standard
preparation information (including who prepared the reference standard,
date of preparation, expiration date, chemical balance, and solvent
used);
    (7) A copy of the label from any immediate container sampled, if
available, and any additional labeling needed to evaluate the product;
    (8) All original compilations of raw data secured in the course of
the analysis, including discarded, unused, or re-worked data, with the
justification for discarding or re-working such data, corresponding
supporting data, and quality control results (including the expected
result and whether it is acceptable), all identified with unique sample
identification, date, and time, associated with the test;
    (9) Any other relevant additional supporting information such as
the storage location of analyzed samples, appropriate attachments such
as instrument printouts, computer generated charts and data sheets, and
photocopies or original labels for the product analyzed;
    (10) Identification of any software used;
    (11) Any certificate of analysis for standards and software; and
    (12) The following information about the qualifications of each
analyst involved in the analysis conducted under this subpart, if the
LAAF-accredited laboratory has not previously submitted documentation
of the analyst's qualifications to FDA or the analyst's qualifications
have significantly changed since the LAAF-accredited laboratory last
submitted documentation of the analyst's qualifications to FDA:
    (i) The analyst's curriculum vitae;
    (ii) Training records for the applicable methods that the analyst
is qualified to perform, including the dates of such training and the
name of the trainer or training provider; and
    (iii) Any other documentation of the analyst's ability to perform
the method properly in the context of the food testing to be conducted,
pursuant to Sec.  1.1150(b).
    (e) Additional information about non-standard methods. If the LAAF-
accredited laboratory conducts the analysis using a method that is not
published in a reputable international or national standard or that is
otherwise not publicly and readily available, upon request by FDA the
LAAF-accredited laboratory must submit documentation of the method to
FDA.
    (f) Immediate notification of significant changes. The LAAF-
accredited laboratory must notify FDA and the recognized accreditation
body that LAAF-accredited the laboratory of changes that affect the
LAAF-accreditation of the laboratory within 48 hours, including a
detailed description of such changes, and an explanation of how such
changes affect the LAAF-accreditation of the laboratory. LAAF-
accredited laboratories are not required to notify FDA of changes that
a recognized accreditation body must provide to FDA under Sec.
1.1123(d).
    (g) Consequence of omission. If FDA does not receive all
information required to be submitted to FDA under this section, FDA may
consider the related food testing to be invalid.

Sec.  1.1153  What are the requirements for submitting abridged
analytical reports?

    (a) Requesting permission. A LAAF-accredited laboratory may request
permission to submit abridged analytical reports for each major food
testing discipline: Biological, chemical, and physical.
    (1) FDA will grant permission to submit abridged analytical reports
for a single major food testing discipline if all of the following
conditions are met:
    (i) The LAAF-accredited laboratory is not on suspension or
probation for any method within the major food testing discipline that
is the subject of its request (see Sec.  1.1121(b) or Sec.  1.1161(b));
    (ii) The LAAF-accredited laboratory has successfully implemented
any required corrective action under Sec.  1.1121(a) or Sec.
1.1161(a); and
    (iii) The last five full analytical reports for the major food
testing discipline contain no shortcomings that call into question the
validity of the test results or repeated administrative errors.
    (2) FDA will notify the LAAF-accredited laboratory if permission is
granted or denied.
    (b) FDA review of abridged analytical reports. (1) FDA will review
all abridged analytical reports submitted.
    (2) FDA will notify the LAAF-accredited laboratory if FDA
identifies a shortcoming that calls into question the validity of the
test results or repeated administrative errors, will require corrective
action under Sec.  1.1161(a), and may revoke permission to submit
abridged analytical reports for the specific major food testing
discipline.
    (3) If FDA identifies a shortcoming that calls into question the
validity of the test results or repeated administrative errors in
abridged analytical reports from a LAAF-accredited laboratory that has
previously had its permission to submit abridged analytical reports
revoked for any major food testing discipline, FDA may put the LAAF-
accredited laboratory on probation for one or more methods under Sec.
1.1161(b). Under Sec.  1.1162(a), a laboratory on probation for one or
more methods may not submit abridged analytical reports for the major
food testing disciplines of which the probationary methods are a part.
    (4) A LAAF-accredited laboratory that has had permission to submit
abridged analytical reports revoked for one or more major food testing
disciplines may request permission to submit abridged analytical
reports as described in paragraph (a) of this section for each major
food testing discipline.
    (c) Contents of abridged analytical reports. In addition to the
documentation required to be submitted with all test results (see Sec.
1.1152(c)), an abridged analytical report must include:
    (1) All information described by ISO/IEC 17025:2017(E)
(incorporated by reference, see Sec.  1.1101) sections <IP_ADDRESS>(a)
through (p) and <IP_ADDRESS>(a) through (d); and
    (2) Quality control results (including the expected result and
whether it is acceptable).
    (d) Exceptions. FDA may require additional documentation or a full
analytical report from a LAAF-accredited laboratory permitted to submit
abridged analytical reports in the following circumstances:

    (1) FDA may require a full analytical report related to an FDA
investigation or FDA enforcement proceeding.
    (2) Occasionally, for the purposes of auditing abridged analytical
reports and otherwise protecting the public health and the integrity of
this food testing program, FDA will require additional documentation or
a full analytical report within 72 hours of FDA's request.
    (e) Consequence of omission. If FDA does not receive all
information required to be submitted to FDA under paragraph (c) of this
section, FDA may consider the related food testing to be invalid.

Sec.  1.1154  What other records requirements must a LAAF-accredited
laboratory meet?

    (a) In addition to the records requirements of Sec.  1.1138(a), a
LAAF-accredited laboratory must maintain, for 5 years after the date of
creation, records created and received while it is LAAF-accredited that
relate to compliance with this subpart, including:
    (1) Documents related to the LAAF-accredited laboratory's grant of
LAAF-accreditation (and, if applicable, extensions and reductions of
scope of LAAF-accreditation) from its recognized accreditation body,
including all required proficiency test and comparison program records
for each method within the scope of LAAF-accreditation under Sec.
1.1138(a)(2);
    (2) Documentation of food testing the LAAF-accredited laboratory
conducted under this subpart sufficient to account for all information
required by Sec.  1.1152(d), in accordance with Sec.  1.1150(d);
    (3) All documents that the LAAF-accredited laboratory was required
to submit to FDA under Sec. Sec.  1.1152 and 1.1153, and associated
correspondence between the LAAF-accredited laboratory (and its
officers, employees, and other agents) and the owner or consignee (and
its officers, employees, and other agents) regarding food testing under
this subpart;
    (4) All requests for food testing from an owner or consignee that
would be conducted under this subpart;
    (5) Documentation of any internal investigations, internal audits,
and corrective action taken to address any problems or deficiencies
related to activities under this subpart;
    (6) All documentation related to suspension, probation, reduction
of scope, or withdrawal of LAAF-accreditation, or laboratory
disqualification under this subpart; and
    (7) Documentation of changes to its management system or food
testing activities that may affect its compliance with this subpart.
    (b) Make the records required by paragraph (a) of this section
available for inspection and copying or for electronic submission upon
written request of an authorized officer or employee of FDA. If FDA
requests records for inspection and copying, the laboratory must make
such records promptly available at the physical location of the
laboratory or at another reasonably accessible location. If the
authorized officer or employee of FDA requests electronic submission,
the records must be submitted within 10 business days of the request.
    (c) Ensure that significant amendments to records described by this
section can be tracked to previous and original versions. If such a
significant amendment is made, both the original document and amended
document must be maintained by the LAAF-accredited laboratory during
the time period for which the amended document must be maintained under
this subpart. The laboratory must also document the date of amendment,
the personnel responsible for the amendment, and a conspicuous
indication on the original document stating that the document has been
altered and that a more recent version of the document exists.

FDA Oversight of LAAF-Accredited Laboratories

Sec.  1.1159  How will FDA oversee LAAF-accredited laboratories?

    (a) FDA may review the performance of LAAF-accredited laboratories
at any time to determine whether the LAAF-accredited laboratory
continues to comply with the applicable requirements of this subpart
and whether there are deficiencies in the performance of the LAAF-
accredited laboratory that, if not corrected, would warrant corrective
action, probation, or disqualification under Sec.  1.1161.
    (b) In evaluating the performance of a LAAF-accredited laboratory,
FDA may review any of the following:
    (1) Records the LAAF-accredited laboratory is required to maintain
under this subpart;
    (2) Records the recognized accreditation body that LAAF-accredited
the laboratory is required to maintain under this subpart;
    (3) Information obtained by FDA during a review of the LAAF-
accredited laboratory conducted pursuant to paragraph (c) of this
section;
    (4) Information obtained by FDA during an evaluation of the
recognized accreditation body that LAAF-accredits the laboratory;
    (5) Analytical reports and test results submitted to FDA; and
    (6) Any other information obtained by FDA, including during FDA's
inspections or investigations of one or more owners or consignees.
    (c) FDA may conduct an onsite review of a LAAF-accredited
laboratory at any reasonable time, with or without a recognized
accreditation body (or its officers, employees, and other agents)
present, to review the performance of a LAAF-accredited laboratory
under this subpart. Certain review activities may be conducted remotely
if it will not aid in the review to conduct them onsite.
    (d) FDA may report any observations and deficiencies identified
during its review of LAAF-accredited laboratory performance under this
subpart to the recognized accreditation body.

Sec.  1.1160  How will FDA review test results and analytical reports?

    (a) If FDA finds that any test result, analytical report, related
documents, or the associated analysis contains deficiencies or
otherwise indicates that any aspect of the food testing is not being
conducted in compliance with this subpart, FDA will notify the LAAF-
accredited laboratory that submitted the analytical report of any
deficiency and may:
    (1) Require the laboratory to correct the test result, analytical
report, related documents, or the associated analysis;
    (2) Revoke permission to submit abridged reports for that major
food testing discipline under Sec.  1.1153(b);
    (3) Require a corrective action under Sec.  1.1161(a);
    (4) Consider the analysis to be invalid; and/or
    (5) Notify the owner or consignee of the deficiency.
    (b) FDA may report any deficiencies identified during its review of
any test results, reports, and related documents under this subpart to
the recognized accreditation body that LAAF-accredits the laboratory.
    (c) Nothing in this subpart shall be construed to limit the ability
of FDA to review and act on information received about food testing,
including determining the sufficiency of such information and testing.

Sec.  1.1161  When will FDA require corrective action, put a LAAF-
accredited laboratory on probation, or disqualify a LAAF-accredited
laboratory from submitting analytical reports?

    (a) Corrective action. FDA may require corrective action to address
any deficiencies identified while reviewing a LAAF-accredited
laboratory's performance under this subpart.
    (1) FDA will notify the LAAF-accredited laboratory of all
deficiencies requiring corrective action and will

either specify a deadline to implement corrective action or will
require the LAAF-accredited laboratory to submit a corrective action
plan and timeframe for implementation to FDA for approval.
    (2) The LAAF-accredited laboratory must handle FDA's notification
as a complaint under ISO/IEC 17025:2017(E) (incorporated by reference,
see Sec.  1.1101) section 7.9, implement appropriate corrective action
under ISO/IEC 17025:2017(E) section 8.7, and submit both the results of
the complaint investigation and subsequent corrective action to FDA.
    (3) FDA will review the corrective action and will notify the LAAF-
accredited laboratory whether the corrective action is acceptable.
    (b) Probation. If FDA determines that a LAAF-accredited laboratory
has not effectively implemented corrective action or otherwise fails to
address deficiencies identified, FDA may put the LAAF-accredited
laboratory on probation for one or more methods and require corrective
action under paragraph (a) of this section.
    (1) FDA will notify the LAAF-accredited laboratory and its
recognized accreditation body of the grounds for the probation, the
method(s) covered by the probation, and all deficiencies requiring
corrective action via the process described in paragraph (a) of this
section.
    (2) FDA will provide notice of a LAAF-accredited laboratory's
probation on the website described in Sec.  1.1109.
    (3) FDA will review the corrective action and will notify the LAAF-
accredited laboratory and its recognized accreditation body whether the
corrective action is acceptable.
    (4) A LAAF-accredited laboratory will remain on probation until the
LAAF-accredited laboratory demonstrates to FDA's satisfaction that it
has successfully implemented appropriate corrective action.
    (5) If FDA determines that a LAAF-accredited laboratory on
probation has failed to implement appropriate corrective action or
otherwise fails to address deficiencies identified, FDA may disqualify
the LAAF-accredited laboratory under paragraph (c) of this section.
    (c) Disqualification. FDA may disqualify a LAAF-accredited
laboratory from submitting analytical reports under this subpart for
one or more methods for good cause, which may include any of the
following reasons:
    (1) Deliberate falsification of analytical reports, testing
results, or other records submitted to FDA.
    (2) Failure of a LAAF-accredited laboratory on probation to
effectively implement corrective action or otherwise address identified
deficiencies.
    (3) Other failure to substantially comply with this subpart where
the laboratory's recognized accreditation body has not reduced the
scope of or withdrawn LAAF-accreditation of the laboratory.
    (d) Disqualification procedures. (1) FDA will issue a notice of
disqualification to a LAAF-accredited laboratory and its recognized
accreditation body, which will include:
    (i) The grounds for disqualification;
    (ii) The method or methods to which the disqualification applies;