satisfactory full analytical reports to FDA under this program,
whichever period is longer. During this period of disqualification the
accredited laboratory would be ineligible to submit, and to request
permission to submit, abridged analytical reports under this program.
It is important that this period of disqualification be of sufficient
length to establish a meaningful consequence for accredited
laboratories that are seeking permission to submit abridged analytical
reports but who demonstrate a single material substantive shortcoming
in testing or repeated significant administrative deficiencies. We also
propose that shortcomings during the disqualification period under
Sec.  1.1152(d)(6)(i) would extend the disqualification. Such a policy
would help ensure that disqualified laboratories have every incentive
to maintain excellent performance during the disqualification period.
We propose that any material substantive shortcoming in testing would
extend the disqualification period by 6 months, and repeated
administrative deficiencies would extend the disqualification period by
2 months.
    For an accredited laboratory that currently is permitted to submit
abridged analytical reports for at least one food testing discipline
and is subject to disqualification for at least one additional food
testing discipline, proposed Sec.  1.1152(d)(6)(ii) states that the
period of disqualification is either 2 years or until the accredited
laboratory submits two or more satisfactory full analytical reports to
FDA under this program, whichever period is longer. During this period
of disqualification, the accredited laboratory would be ineligible to
submit, and to request permission to submit, abridged analytical
reports for the testing discipline(s) that is subject to the
disqualification period. We also propose that shortcomings during the
disqualification period under Sec.  1.1152(d)(6)(ii) would extend the
disqualification. Such a policy would help ensure that disqualified
laboratories have every incentive to maintain excellent performance
during the disqualification period. We propose that any material
substantive shortcoming in testing would extend the disqualification
period by 6 months, and repeated administrative deficiencies would
extend the disqualification period by 2 months.
    While the policy in proposed Sec.  1.1152(d)(1) for becoming
permitted to submit abridged analytical reports to FDA under this
program would apply to newly accredited laboratories that have never
been disqualified under proposed Sec.  1152(d)(1), the policy and
procedures would be somewhat different for accredited laboratories that
have been disqualified. Proposed Sec.  1.1152(d)(7) provides that an
accredited laboratory that has fulfilled the criteria under Sec.
1.1152(d)(6), as applicable, and is not on probation, may submit a
request (via a portal we would establish on our website) to FDA to
submit abridged analytical reports under Sec.  1.1152(d)(1) or (3), as
applicable. After FDA receives the request, FDA will consider
permitting the accredited laboratory to

fulfill the conditions of proposed Sec.  1.1152(d)(1) or (3), as
applicable. If FDA grants permission, and once the conditions described
by proposed Sec.  1.1152(d)(1) and (3), as applicable, are fulfilled,
FDA will provide notice that the accredited laboratory is permitted to
submit to FDA on an ongoing basis abridged analytical reports relating
to the discipline(s) for which the conditions are fulfilled.
    As we have noted above, if an accredited laboratory submits one or
more test results, notifications, reports, and/or studies that
demonstrate a single material substantive shortcoming in testing or
repeated significant administrative deficiencies we may also take other
appropriate action under this proposed rule, including notifying the
accredited laboratory's recognized accreditation body (in accordance
with proposed Sec.  1.1160) and/or, in more egregious cases, even
putting an accredited laboratory on probation or revoking the
accredited laboratory's accreditation, if appropriate under proposed
Sec.  1.1161.
    We request comment on all aspects of our proposed approach to
allowing accredited laboratories to submit abridged analytical reports
to FDA, including with respect to the practicality and potential
consequences of the approach.
    Abridged analytical reports, in contrast to full analytical
reports, would have to include only certain limited information
describing the analysis. Proposed Sec.  1.1152(f) provides that
abridged analytical reports must contain:
     All information described by ISO/IEC 17025:2017 (Ref. 13)
sections <IP_ADDRESS>(a) through (p) and <IP_ADDRESS>(a) through (d).
     The justification for any modification or deviation to the
method(s) of analysis used, and documentation of the accredited
laboratory's authorization for the modification or deviation. Although
ISO/IEC 17025:2017 (Ref. 13) section <IP_ADDRESS> requires disclosure of
additions to, deviations, or exclusions from the method, we have
tentatively determined that abridged analytical reports should also
include the justification and authorization for any modification or
deviation to the method. This proposed requirement should help us
understand whether the method, although modified, is within the
accredited laboratory's scope of accreditation, and otherwise help us
determine whether we should require submission of the full analytical
report version of the abridged analytical report.
    Although the information in abridged analytical reports are not
sufficient to allow us to engage in a meaningful indepth scientific
review of the analysis, and ISO/IEC 17025:2017 section 7.8 appears to
relate more to reports laboratories submit to their customers rather
than reports laboratories submit to regulatory authorities, we have
tentatively determined that the information in abridged analytical
reports, as proposed by Sec.  1.1152(f), would be sufficient
information for us to make other meaningful decisions related to the
analysis, such as whether the method used is appropriate or whether
certain risks are present that warrant the submission of the full
analytical report. We request comments on what other information
should, or should not be, in an abridged analytical report.
    Proposed Sec.  1.1152(g) establishes what information full
analytical reports submitted under this program must contain. We
developed the proposed requirements for what information full
analytical reports must contain based on what information we have found
is necessary for us to assess the validity of the analyses that private
laboratories currently conduct in support of admission of an article of
food under section 801(a) of the FD&C Act and to support removal from
an import alert through successful consecutive testing. We have
tentatively determined that the information we propose full analytical
reports must contain is necessary for us to engage in a meaningful
indepth scientific review of the analysis to determine that the
analysis is valid. Proposed Sec.  1.1152(g) would require full
analytical reports to include the following information:
     All information that must be included in an abridged
analytical report. As noted previously, this information consists
primarily of administrative items and limited substantive information
about the analysis performed. It also includes the justification for
any modification or deviation to the method(s) of analysis used and
documentation of the accredited laboratory's authorization for the
modification or deviation.
     Documentation of references for the method or methods of
analysis used. Here we simply mean that the package must include the
name (e.g., ``Concentration, Extraction, and Detection of Norovirus and
Hepatitis A Virus in Molluscan Shellfish'') and source (e.g., AOAC, FDA
BAM) of the method used.
     Identification of the analyst or analysts who conducted
each analytical step, validation step (if applicable), and verification
step (if applicable), including the analyst's or analysts' legal name
and signature, and the date each analytical step, validation step (if
applicable), and verification step (if applicable) was performed. This
information is important because, in accordance with section
422(a)(6)(A)(iv) of the FD&C Act and proposed Sec.  1.1150(b), the
analysts must be appropriately qualified.
     Calculations presented in a legible and logical manner. We
may need to verify the calculations to verify whether the results of
the testing are valid.
     As applicable, references to chromatograms, charts,
graphs, observations, photographs of thin layer chromatographic plates,
and spectra. References must be in color when appropriate and made in a
clear order. These items represent objective evidence and raw data
supporting the test results. We may need to review such information to
understand and verify the validity of the results of the testing.
     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, date of
preparation, expiration date, chemical balance, and solvent used.
     A copy of the label from any immediate container sampled
and any additional labeling needed to evaluate the product. Many
products are shipped in a variety of different forms, container
quantities, and may have varying packaging or labels. The label would
likely include important information about the form, unit quantity, or
packaging of the food, which we may use to verify that the laboratory
analyzed the samples using an appropriate method. The label and
labeling would provide additional information which may be helpful to
the analysis and our review, such as the ingredient list of the food.
For example, if the ingredient list indicates that the food contains an
ingredient, additive, or pesticide at a violative level, we may subject
to higher scrutiny test results that indicate the food is free from the
ingredient, additive, or pesticide or that indicate the food contains
the ingredient, additive, or pesticide at a lower level than the
ingredient list indicates.
     All original compilations of raw data secured in the
course of the analysis, including discarded, unused,

or reworked data with the justification for discarding or reworking
such data, corresponding supporting data, and quality control results
all identified with unique sample identification, date and time,
associated with the test. This information is important for us to
understand and to verify the validity of the test results. Furthermore,
requiring submission of discarded, unused, or reworked data, along with
a justification for discarding, not using, or reworking such data,
should discourage testing into compliance.
     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.
     Identification of any software used, including any
certificate or certificates of analysis for standards and software
used. This information helps us understand the associated test results
and verify that the standards used are valid and that the software used
is functioning properly.
     The following information about the qualifications of the
analyst or analysts who were involved in the analysis conducted under
this program, if the accredited laboratory has not previously submitted
documentation of the analyst's qualifications to FDA or the analyst's
qualifications have significantly changed since the accredited
laboratory last submitted documentation of the analyst's qualifications
to FDA:
    [cir] The analyst's curriculum vitae;
    [cir] Training records with regards to methods that the analyst is
qualified to perform, including the dates of such training and the name
of the trainer or training provider;
    [cir] Any other documentation of analyst's ability to perform the
method properly in the specific context of the food testing to be
conducted, under Sec.  1.1150(b) (e.g., a certificate of completion of
a relevant training and/or documentation that the analyst was the
investigator for the relevant validation or verification study); and
    [cir] Individual proficiency test worksheets relevant to the
analysis being performed.
    We invite comment on our proposed requirements for what information
full analytical reports must contain. If commenters believe we are
proposing to require too much information to be included in full
analytical reports, please specifically address in your comments which
requirements of Sec.  1.1152(g) we should delete or revise, and why
that piece of information is not necessary for us to engage in a
meaningful indepth scientific review of the analysis to determine
whether the analysis is valid. For commenters who believe we have not
proposed sufficient information to be included in full analytical
reports, please specify what additional information we should require
and why it is critical to our assessment of the analysis and test
results.
    Proposed Sec.  1.1152(h) would require that if the 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 accredited
laboratory must submit documentation of the method to FDA. If the
method used has been published in a reputable international or national
standard (e.g., in the Official Methods of Analysis of AOAC
International) or the method is otherwise publicly available (readily
available, so that a reasonable analyst would be able to easily find
the method), we would be able to look up the method ourselves. However,
if the method is not published in a reputable international or national
standard or otherwise readily publicly available, the accredited
laboratory would need to share information about the method with us, if
requested, as we may have no other way to access the information. For
example, in the case of a method developed by the laboratory, the
laboratory would need to submit to us sufficient information about the
method for us to understand how the method is applied, such as the
method standard operating procedure, or some other document that
describes the steps within the method. Such information would be in
addition to the validation or verification information that would be
required under proposed Sec.  1.1152(c)(4), (5), or (6).
    Proposed Sec.  1.1152(i) addresses advance notice of sampling. We
are proposing to require advance notice of sampling in certain
circumstances as an additional technique to exercise oversight over
sampling conducted for food testing in this program. Under proposed
Sec.  1.1152(i)(1), if we determine that the sampling conducted by a
sampler may materially differ from the sampling documented in the
associated sampling plan or sample collection report, or if we
determine that the sampling may have been otherwise improper, we may
require the accredited laboratory that analyzed the associated
sample(s), and other accredited laboratories under this program that
have analyzed samples collected by the sampler previously, to request
and receive from the sampler, and submit or require the sampler to
submit, an advance notice of sampling to the destination specified by
the laboratory accreditation program website portal 48 hours before
each of the 10 occasions that the sampler will collect a sample that
the accredited laboratory will analyze under this program. As we
discuss below, we also propose at Sec.  1.1152(i)(2)(ii) and (iii) to
be able to specify certain timeframes other than 48 hours and to
specify a number other than 10 occasions.
    We intend advance notice of sampling to encourage the use of
sampling techniques that will allow for a meaningful analysis, by
facilitating our observation of sampling and collection of audit
samples before we receive the test results with the accompanying sample
collection report. Audit samples are samples we collect from the lot or
environment at issue, which we then analyze, and compare our test
results with the test results of the accredited laboratory. We believe
it is reasonable to generally require the notice of sampling to be
submitted to us 48 hours prior to collection of the sample(s) to allow
us time to determine whether to observe the sampling and/or take an
audit sample, and assign appropriate personnel to the task. Note that
we may take audit samples (as we currently do) even if we have not
required advance notice of sampling.
    Proposed Sec.  1.1152(i)(2) elaborates that we may, as appropriate
(based on the relevant circumstances): Specify the type of food product
or environment that requires advance notice of sampling under this
section; determine that an amount of time other than 48 hours in
advance is required, to a minimum of 24 hours and up to 7 business days
in advance; determine that a number of occasions other than 10 are
required, to a minimum of one occasion and up to a maximum of 20
occasions; and notify affected accredited laboratories that submission
of additional notices of sampling are not required. We would typically
notify affected accredited laboratories that submission of additional
notices of sampling are not required after we have observed and/or
audit an amount of sampling conducted by the sampler sufficient for us
to determine whether the sampler appears to be conducting sampling
properly.
    Proposed Sec.  1.1152(i)(3) would require that the advance notice
of sampling include the following information:
     A unique identification code for the notice of sampling.
This would help us identify, review, and record the notification
efficiently and would help

us identify associated submissions. The test results would reference
the identification numbers of each associated submission.
     The name of the accredited laboratory that will conduct
analysis of the sample. This would allow us to, for example, followup
with the accredited laboratory that will conduct the analysis, if
appropriate, before or during the accredited laboratory's analysis of
the samples.
     The name and street address of the sampler that will
conduct the sampling. This information will help us organize our review
of notices of sampling as they are submitted to us.
     A primary contact (name and phone number) for the sampler.
This information would be necessary if we need to contact the sampler.
For example, we may need to contact the sampler if we choose to observe
or audit the sampling, but the food product or environment at issue is
not at the location specified on the notice of sampling.
     The reason(s) why the food product or environment will be
sampled. We would want to know, for example, if the sample to be
collected will be analyzed by an accredited laboratory with regards to
a particular import alert. We expect this information to help us
determine whether to observe or audit the sampling.
     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. This would help us locate the
food product or environment in the case we would want to observe the
sampling or take an audit sample.
     As applicable, the U.S. Customs and Border Protection
entry and line number(s) and the product code(s) of the food. This
would help us identify the food product at issue if we choose to
observe or audit the sampling. In the import context, we would want to
know the FDA product code. In the domestic context, the U.S. Customs
and Border Protection entry and line number(s) would be inapplicable,
and we would instead want to know the product code assigned by the
manufacturer, packager, labeler, as applicable. In the context of
environmental sampling, both items are inapplicable.
     The date and approximate time the sampling will begin. The
date must be correct and we would expect the estimated time to be as
close to the actual time of the sampling as reasonably possible.
    Proposed Sec.  1.1152(j) provides that when any changes occur that
affect the accreditation of the accredited laboratory, the accredited
laboratory must immediately send FDA, within 48 hours, and the
accreditation body that accredited it notice of such changes, a
detailed description of such changes, and an explanation of how such
changes affect the accreditation of the accredited laboratory. This
provision would cover changes in the name or operations of an
accredited laboratory, such as the purchase of an accredited laboratory
by a company, as well as changes that would cause the accredited
laboratory to no longer meet the requirements of this program. We have
proposed this requirement in accordance with section 422(a)(1)(C) of
the FD&C Act, which requires that, in pertinent part, as a condition of
accreditation, as appropriate, accredited laboratories must report to
FDA any changes that would affect the accreditation of the laboratory.
Proposed Sec.  1.1152(j) would not require accredited laboratories to
notify us of changes covered by proposed Sec.  1.1123(c), which
requires recognized accreditation bodies to immediately notify us of
certain information related to the accreditation status of laboratories
they accredit or that have sought their accreditation (e.g., certain
changes initiated by the recognized accreditation body, and findings of
fraud).
    Proposed Sec.  1.1152(k) provides that if FDA does not receive all
information required to be submitted to FDA by proposed Sec.  1.1152(a)
through (j), FDA may consider the related food testing to be invalid.
For example, if we do not receive a validation study when its
submission to FDA is required, we would not be able to determine
whether the method is appropriate for the intended use; if we do not
receive a full analytical report when we require its submission, we
would be unable to conduct the necessary indepth scientific review of
the analysis to determine whether, in that instance, the analysis was
valid; and if we do not receive all the required information about the
sampling, we would not be able to determine whether the sample that was
analyzed was representative of the food product or environment at
issue.
8. What other records requirements must an accredited laboratory meet?
(Proposed Sec.  1.1153)
    This proposed rule would establish requirements for accredited
laboratories to establish, control, and retain records relating to
their food testing activities under this program. In addition to
meeting the ISO/IEC 17025:2017 records requirements (in accordance with
proposed Sec.  1.1146(b)), accredited laboratories would have to meet
the additional records requirements of this proposed section.
    Proposed Sec.  1.1153(a) would require laboratories that have been
accredited to maintain electronically, for 5 years after the date of
creation, certain records created and received during their period of
accreditation that relate to compliance with this proposed rule. Even
if no longer accredited, laboratories that used to be accredited would
have an obligation under this proposed rule to maintain records created
and received during their period of accreditation. Proposed Sec.
1.1153(a) elaborates that these records include: (1) Documents related
to the accredited laboratory's grant (and, if applicable, extensions)
of accreditation from its accreditation body; (2) documentation of food
testing the accredited laboratory conducted under this program, in
accordance with proposed Sec.  1.1150(d); (3) all documents that the
accredited laboratory was required to submit to FDA under Sec.  1.1152,
and associated correspondence by the accredited laboratory (and its
officers, employees, and other agents) with the owner or consignee (and
its officer, employees, and other agents) of the tested food product or
environment; (4) all requests for food testing from an owner or
consignee that would be conducted under this proposed rule; (5)
documentation of any internal investigations, internal audits, and
corrective actions taken to address any problems or deficiencies
related to activities under this proposed rule; (6) documentation
related to probation or withdrawal from accreditation under this
program; and (7) documentation of changes to its management system or
food testing activities that may affect its compliance with this
proposed rule. We believe it appropriate to require maintenance of
these records for purposes of this proposed rule.
    Proposed Sec.  1.1153(b) provides that within 30 days of the
receipt of proficiency testing results by the accredited laboratory,
the accredited laboratory must submit the proficiency testing results
to the recognized accreditation body that accredits the accredited
laboratory, and, if the accredited laboratory failed the proficiency
test, also to FDA, via the destination specified by the website
described by Sec.  1.1109. During our conversations with certain
laboratories and accreditation bodies, we received feedback that this
proposed rule would benefit from a requirement that proficiency testing
results be submitted to the recognized accreditation body that
accredits the laboratory. See

``Record of Outreach Sessions on FDA Proposed Rules, Conference call
between the FSMA Lab Accreditation Workgroup and the Food Laboratory
Alliance, July 21, 2015'' (Ref. 20), and attached meeting minutes. Our
understanding is that there is currently no such requirement, and
accredited laboratories may decline to submit proficiency test results
to their accreditation body. Proficiency test results would provide
accreditation bodies with valuable information about the food testing
capabilities and proficiencies of the accredited laboratories they
accredit. Furthermore, because proficiency testing providers are
typically uninterested third parties, there is little risk that
submitting the proficiency test results to the accreditation body and
potentially FDA would affect the conduct of the proficiency testing. We
also believe we may find proficiency testing results helpful as well,
particularly if the proficiency testing was unsuccessful and related to
food testing results submitted to us under proposed Sec.  1.1152.
    Proposed Sec.  1.1153(c) provides that laboratories that have been
accredited must make these records available for inspection and copying
upon written request of an authorized officer or employee of FDA. The
authorized officer or employee of FDA may request that the laboratory
submit such records to FDA electronically or that the laboratory 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 the records be submitted
electronically, the records must be submitted electronically not later
than 10 business days after the date of the request. However, records
related to the immediate notification requirements in Sec.  1.1152(j)
must be submitted within 48 hours. If the authorized FDA officer or
employee requests records that are maintained in a language other than
English, the laboratory must electronically submit an English
translation of the records to FDA within a reasonable time. We are not
proposing that the records themselves be maintained in English, as we
believe such an approach would be unduly burdensome, particularly for
foreign laboratories.
    Proposed Sec.  1.1153(d) would require laboratories that have been
accredited to ensure that significant amendments to records described
by proposed Sec.  1.1153(a) and (b) can be tracked to previous and
original versions. Proposed Sec.  1.1153(d) further provides that if
such a significant amendment is made, both the original document and
amended document must be maintained by the laboratory that has been
accredited during the time period that the amended document must be
maintained. Further, 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 a more recent version of the document
exists. This provision is based on ISO/IEC 17025:2017 (Ref. 13) at
section 7.5.2. However, section 7.5.2 of ISO/IEC 17025:2017 applies to
``technical records,'' while proposed Sec.  1.1153 applies to a wider
category of records.
    We acknowledge that the requirements of proposed Sec.  1.1153 may
require revisions to contracts and perhaps other documents establishing
the scope of a laboratory's authority with respect to granting records
access. We nonetheless have tentatively concluded that the records
maintenance and access requirements in proposed Sec.  1.1153 are
necessary for us to maintain an appropriate degree of oversight over
accredited laboratories (in accordance with proposed Sec.  1.1159) and
for recognized accreditation bodies to monitor and assess laboratories
they accredit.

H. Proposed Provisions About Procedures for Accreditation of
Laboratories (Proposed Sec. Sec.  1.1158 Through 1.1165)

    This proposed rule would establish procedures for laboratories to
apply for accreditation or relinquish accreditation, and for our
oversight of accredited laboratories, including procedures for our
review of test results and supporting information, and for probation
and revocation of the accreditation of laboratories.
1. How does a laboratory apply for accreditation or modification of its
scope of accreditation by a recognized accreditation body? (Proposed
Sec.  1.1158)
    Proposed Sec.  1.1158 explains how laboratories must apply for
accreditation; reinstatement of accreditation or modification of their
scope of accreditation; addresses the duration of accreditation; and
describes the effects of a denial of an application for accreditation.
Section 422 of the FD&C Act establishes a structure whereby FDA
recognizes accreditation bodies, who, in turn, accredit laboratories
that meet the applicable requirements of the program. As we indicate in
proposed Sec.  1.1109, we will maintain a list of recognized
accreditation bodies, who may perform accreditation, along with the
contact information of these recognized accreditation bodies, so that
laboratories would be able to use our website as a resource to find a
recognized accreditation body that can assess whether the laboratory is
eligible for accreditation.
    Proposed Sec.  1.1158(a) provides that a laboratory seeking
accreditation must submit its application for accreditation to a
recognized accreditation body identified on the website described in
proposed Sec.  1.1109. Proposed Sec.  1.1158(a) further provides that
the recognized accreditation body will review and assess the
application in accordance with the applicable requirements of this
program. Proposed Sec.  1.1158(a) also provides that if the laboratory
seeking accreditation had its accreditation (in-whole or in-part)
withdrawn by a recognized accreditation body, or revoked by FDA the
previous time it was accredited under this program, the laboratory must
meet the additional requirements specified by proposed Sec.  1.1165
(which addresses the question of how a laboratory requests
reinstatement of accreditation).
    Proposed Sec.  1.1158(b) clarifies that a laboratory may use
documentation of conformance with ISO/IEC 17025:2017, as applicable and
supplemented as necessary, in meeting the applicable requirements of
this program. For example, if a laboratory is already accredited to
ISO/IEC 17025:2017 by a recognized accreditation body, the recognized
accreditation body could accept this accreditation as evidence that the
laboratory meets the requirements of ISO/IEC 17025:2017 the laboratory
must meet under proposed Sec.  1.1138 to become accredited under this
proposed rule.
    Proposed Sec.  1.1158(c) clarifies that an accredited laboratory's
accreditation continues until withdrawn, revoked, or relinquished under
this program. It is our understanding that the current practice by
accreditation bodies and laboratories is that the laboratory's intent
to remain accredited is generally assumed, and the accreditation body
continues to accredit the laboratory and conduct assessments and
reassessments under that understanding. We seek comment with regards to
whether this is correct.
2. How will FDA oversee accredited laboratories? (Proposed Sec.
1.1159)
    Proposed Sec.  1.1159 would establish certain requirements related
to our oversight of accredited laboratories. Although the recognized
accreditation

bodies have primary oversight responsibility over accredited
laboratories, we would also exercise some ability to oversee accredited
laboratories, via requesting records and, if appropriate, conducting
onsite assessments. We note that in contrast to recognized
accreditation bodies, under section 422(b)(2) of the FD&C Act, FDA will
routinely receive the results of food testing conducted under section
422(b)(1), along with supporting information, which will provide us
with information on accredited laboratories' compliance with this
program.
    Proposed Sec.  1.1159(a) provides that we may assess accredited
laboratories at any time to determine whether they continue to comply
with the applicable requirements of the program and whether there are
any deficiencies in the performance of the accredited laboratory that,
if not corrected, would warrant probation or revocation of its
accreditation.
    Proposed Sec.  1.1159(b) clarifies that, in the course of our
evaluation of the performance of an accredited laboratory, we may
review any of the following: Records the accredited laboratory would be
required to maintain under this proposed rule; records the recognized
accreditation body that accredited the accredited laboratory is
required to maintain under this proposed rule; information we obtain
during an onsite assessment of the accredited laboratory (conducted
under proposed Sec.  1.1159(c)); information we obtain during our
assessment of the recognized accreditation body that accredited the
laboratory; and any other information we obtain, including during FDA's
inspections or investigations of one or more owners or consignees of
food subject to food testing under this proposed rule.
    Proposed Sec.  1.1159(c) provides that our assessment may include
our own onsite assessment of the accredited laboratory at any
reasonable time, with or without a recognized accreditation body (or
its officers, employees, and other agents) present, to assess an
accredited laboratory. We would exercise this authority as appropriate
to followup on potential problems that come to our attention, for which
referral to a recognized accreditation body may be inefficient or
otherwise inappropriate, and to otherwise verify compliance with the
program. Proposed Sec.  1.1159(d) clarifies that we will also report
any of our observations and findings of our assessment to the
accredited laboratory's recognized accreditation body.
    We seek comments regarding this proposed section and how
accreditation bodies and FDA should share oversight of accredited
laboratories under this proposed program.
3. How will FDA review submitted test results and analytical reports?
(Proposed Sec.  1.1160)
    Proposed Sec.  1.1160(a) clarifies that if we find that any test
results, analytical report, related documents (for example, the
sampling plan, verification studies, and validation studies) or the
associated analysis, contains deficiencies or otherwise indicates that
any aspect of the food testing is not being conducted in compliance
with the program, FDA may consider the analysis to be invalid. We will
notify the accredited laboratory that appears to be responsible for the
deficiency, and we may also notify the owner or consignee of the food
of the deficiency. When we notify the accredited laboratory that
appears to be responsible for the deficiency, our notice would be
considered a complaint that would be treated in accordance with the
laboratory's established procedures for complaints under section 7.9 of
ISO/IEC 17025:2017 (Ref. 13). When we notify the laboratory of the
deficiency, the laboratory must respond, in writing, to us regarding
the deficiency within 30 days or an agreed-upon timeframe, including a
statement with respect to how the accredited laboratory intends to
address the deficiency, and/or a statement describing the extent to
which the laboratory has addressed the deficiency.
    Proposed Sec.  1.1160(b) clarifies that we may also report any of
our determinations of deficiencies resulting from our review of any
test results, reports, and related documents under this rule to the
recognized accreditation body that accredits the accredited laboratory.
    Proposed Sec.  1.1160(c) clarifies that if the deficiency in the
test result, analytical report, and/or the associated analysis
demonstrates a material substantive shortcoming in the related food
testing or demonstrates repeated administrative deficiencies, FDA will
also consider whether disqualification from being eligible for
permission to submit abridged analytical reports under proposed Sec.
1.1152(d), and/or other action under this program, is appropriate.
    Proposed Sec.  1.1160(d) reiterates the language of section 422(d)
of the FD&C Act, stating that nothing in this rule shall be construed
to limit our ability to review and act upon information from food
testing, including determining the sufficiency of such information and
testing. For example, we would typically consider analysis of a non-
representative sample to be invalid.
4. When will FDA put an accredited laboratory on probation or revoke
the accreditation of a laboratory? (Proposed Sec.  1.1161)
    This proposed rule would establish the conditions under which we
could put an accredited laboratory on probation or revoke a
laboratory's accreditation to conduct food testing under this proposed
program. Under this proposal, we could put an accredited laboratory on
probation or revoke accreditation only in limited circumstances,
including where the recognized accreditation body that accredits the
accredited laboratory does not withdraw accreditation itself.
    Proposed Sec.  1.1161(a) provides that we may revoke the
accreditation (in whole or in part) of an accredited laboratory program
for good cause, which may include any of the following reasons: (1)
Demonstrated bias or lack of objectivity when conducting food testing
under this subpart where the laboratory's recognized accreditation body
fails to withdraw accreditation of the laboratory; (2) performance that
calls into question the validity or reliability of its food testing
under this subpart where the laboratory's recognized accreditation body
fails to withdraw accreditation of the laboratory; or (3) other failure
to substantially comply with this rule where the laboratory's
recognized accreditation body fails to withdraw accreditation of the
laboratory.
    Proposed Sec.  1.1161(b) provides that if we determine that an
accredited laboratory has demonstrated deficiencies in performing its
functions that are less serious and more limited than would warrant
revocation of accreditation, and it is reasonably likely that the
accredited laboratory will be able to correct such deficiencies within
a specified period of time, we may temporarily put the laboratory on
probation and request that the laboratory take appropriate corrective
actions.
    Proposed Sec.  1.1161(c) further clarifies that when there are
grounds for revocation of accreditation, but the deficiencies are
associated with or affect only certain methods within the accredited
laboratory's scope of accreditation, we may revoke the accredited
laboratory's accreditation only for those affected methods.
    Proposed Sec.  1.1161(d) clarifies that our probation of a
laboratory's accreditation shall remain in effect until the laboratory
demonstrates to our satisfaction that the laboratory has

successfully implemented appropriate corrective actions, or until we
determine that revocation of accreditation is warranted.
    If we determine that revocation is warranted, under proposed Sec.
1.1161(e) we would notify the laboratory and its recognized
accreditation body of the revocation of its accreditation through the
issuance of a revocation notice. The revocation notice would state the
grounds for revocation; whether the revocation of accreditation is in-
whole or in-part, and if it is in-part, to which methods it applies;
state the procedures for requesting a regulatory hearing on the
revocation under proposed Sec.  1.1173; and state the procedures for
requesting reinstatement of accreditation under proposed Sec.  1.1165.
    Similarly, if we determine that probation of an accredited
laboratory is warranted, under proposed Sec.  1.1161(f) we would notify
the laboratory and its recognized accreditation body of the probation,
describe the grounds for the probation, and specify other key details,
including all deficiencies that must be corrected for FDA to lift the
probation. Furthermore, the probation notice would either inform the
laboratory that the laboratory has a specified time period to take
corrective actions specified by FDA; or request that the laboratory
submit a corrective action plan to FDA for FDA's approval that
identifies the corrective actions it will take to address deficiencies
identified in the notice and identify timeframes for completion.
    Proposed Sec.  1.1161(g) provides that we may revoke (in-whole or
in-part) the accreditation of the laboratory that has been put on
probation if we determine that the laboratory is not implementing
appropriate corrective actions.
    Proposed Sec.  1.1161(h) reiterates the provision of proposed Sec.
1.1109 that we will provide notice on the website described in proposed
Sec.  1.1109 of our probation or revocation of the laboratory's
accreditation.
5. What are the consequences if FDA puts an accredited laboratory on
probation or revokes the accreditation of a laboratory? (Proposed Sec.
1.1162)
    Under proposed Sec.  1.1162(a), if we revoke the accreditation in
whole of a laboratory, the laboratory would be immediately ineligible
to conduct food testing under this rule. Proposed Sec.  1.1162(a)
further provides that if we revoke the accreditation of laboratory in-
part, the laboratory is immediately ineligible to use the methods that
are subject to the revocation to conduct food testing under this
subpart. An accredited laboratory that is put on probation by FDA would
be permitted to continue to conduct food testing under this proposed
program.
    Proposed Sec.  1.1162(b) further provides that, with respect to
food testing conducted by the laboratory prior to our revocation of
accreditation, we may refuse to consider specific food testing results
and associated reports of food testing conducted under this program by
the accredited laboratory if the basis for our revocation of
accreditation of the laboratory indicates that the specific food
testing conducted by the laboratory may not be reliable.
    Proposed Sec.  1.1162(c) would require that within 10 business days
of the date of issuance of the revocation of accreditation, the
laboratory must notify us electronically, in English, of the name of
the custodian who will maintain the records required by proposed Sec.
1.1153, and the contact information for the custodian, which must
include an email address, and the street address where the records will
be located.
    Proposed Sec.  1.1162(d) would require that within 10 business days
of the date of issuance of the probation or revocation the laboratory
notify any owners or consignees for whom it is conducting food testing
under this proposed rule that it is on probation or its accreditation
has been revoked.
6. What if a laboratory wants to voluntarily relinquish its
accreditation? (Proposed Sec.  1.1163)
    This proposed rule would offer accredited laboratories a mechanism
for voluntarily relinquishing their accreditation. We are proposing
certain procedural requirements, similar to those in the accredited
third-party certification regulation, that accredited laboratories must
follow to relinquish their accreditation. We believe these procedures
are necessary to ensure an orderly accreditation relinquishment process
and so that we may exercise appropriate oversight and timely update the
website described by proposed Sec.  1.1109.
    Proposed Sec.  1.1163(a) would require accredited laboratories to
notify us electronically, in English, and notify their recognized
accreditation body, at least 60 days before voluntarily relinquishing
its accreditation in whole or in part. The notice would need to include
the date on which relinquishment will occur. If the relinquishment is
of the laboratory's accreditation in-whole, the notification must also
include the name and contact information of the custodian who will
maintain the records required under proposed Sec.  1.1153 after the
date of relinquishment or the date accreditation expires, as
applicable, and make them available to FDA as required by proposed
Sec.  1.1153. The contact information for the custodian must include,
at a minimum, an email address and the street address where the records
required by proposed Sec.  1.1153 will be located.
    For food testing that is subject to proposed Sec.  1.1107(a), we
would consider food testing conducted by a laboratory that is not
accredited at the time of the food testing to be invalid. This position
is in accordance with section 422(b)(1) of the FD&C Act, which requires
such food testing to be conducted only by accredited laboratories.
    Proposed Sec.  1.1163(b) reiterates that we will provide notice on
the website described in Sec.  1.1109 of the voluntary relinquishment
of accreditation of the laboratory.
7. What is the effect on accredited laboratories if their accreditation
body voluntarily or involuntarily loses its recognition? (Proposed
Sec.  1.1164)
    Section 422(a)(7)(B) of the FD&C Act provides that we must promptly
revoke the recognition of any accreditation body found not to be in
compliance with the requirements of section 422 of the FD&C Act,
specifying, as appropriate, any terms and conditions necessary for
laboratories accredited by such body to continue to perform food
testing under this proposed program. We would establish those terms and
conditions in Sec.  1.1164 of this proposed rule. Accordingly, proposed
Sec.  1.1164(a) provides that when an accreditation body has its
recognition revoked, relinquishes its recognition, allows its
recognition to expire, or has its application for renewal of
recognition denied, a laboratory accredited by the accreditation body
must take the following actions (subject to an exception in paragraph
(b), which we discuss below): (1) No later than 30 days after FDA
issues the notice to the laboratory under proposed Sec.  1.1129, Sec.
1.1130, or Sec.  1.1131 that its accreditation body is no longer
recognized, the laboratory submits to FDA documentation of the
accredited laboratory's most recent internal audit, which all
accredited laboratories would be required to maintain under proposed
Sec.  1.1153(a)(5), documentation showing compliance with the conflict
of interest requirements in proposed Sec.  1.1147, and documentation of
the most recent proficiency test for each test method for which the
laboratory is accredited under this subpart, to show compliance with
proposed Sec.  1.1138(a)(1)(ii); and (2) no

later than 1 year after FDA issues the applicable notice under proposed
Sec.  1.1129, Sec.  1.1130, or Sec.  1.1131 to the laboratory, the
laboratory becomes accredited by a recognized accreditation body.
    Our review of accredited laboratories' quality assurance records in
accordance with proposed Sec.  1.1164(a)(1) would allow us to ensure
that the accredited laboratory is in compliance with this rule while it
transitions. We believe a period of one year, in accordance with
proposed Sec.  1.1164(a)(2), gives the laboratory sufficient time to
find a recognized accreditation body and complete its accreditation
process while limiting the time the laboratory conducts food testing
without the oversight of a recognized accreditation body. We may be
more proactive in our oversight of such accredited laboratories during
the period they are not subject to the oversight of a recognized
accreditation body.
    Proposed Sec.  1.1164(b) would establish an exception to the above-
described requirements. Under proposed Sec.  1.1164(b), the accredited
laboratory may choose to relinquish its accreditation in lieu of
meeting the requirements of proposed Sec.  1.1164(a). In such case, the
accredited laboratory would have to initiate relinquishment of its
accreditation in-whole under proposed Sec.  1.1163 not later than 15
days after FDA issues the applicable notice to the accredited
laboratory under proposed Sec.  1.1129, Sec.  1.1130, or Sec.  1.1131,
and the relinquishment would need to occur within 90 days. Of note,
proposed Sec.  1.1163(a) would typically require an accredited
laboratory to submit the relinquishment notice to its recognized
accreditation body and to FDA.
    However, for a relinquishment initiated in accordance with proposed
Sec.  1.1164(b), the accredited laboratory would submit the
relinquishment notice under proposed Sec.  1.1163(a) to FDA only, as
the accredited laboratory would have no recognized accreditation body
at the time.
    Generally, if the accredited laboratory does not meet the
requirements of either proposed Sec.  1.1164(a) or (b), the accredited
laboratory would no longer be in substantial compliance with this
proposed rule and its accreditation would generally be subject to
revocation under proposed Sec.  1.1161.
8. How does a laboratory request reinstatement of accreditation?
(Proposed Sec.  1.1165)
    Proposed Sec.  1.1165 describes how a laboratory may obtain
reinstatement of its accreditation if we revoked its accreditation, if
a recognized accreditation body withdrew its accreditation, or if the
laboratory voluntarily relinquished its accreditation.
    Proposed Sec.  1.1165(a) addresses how a laboratory may obtain
reaccreditation if its accreditation was withdrawn (in whole or in
part) by a recognized accreditation body or revoked (in-whole or in-
part) by FDA. The laboratory may seek reaccreditation by submitting a
new application for accreditation (in-whole or in-part, as applicable)
under proposed Sec.  1.1158 to a recognized accreditation body.
Proposed Sec.  1.1165(a) further provides that the laboratory must
also: (1) Notify us, before it submits the new application for
accreditation to the recognized accreditation body, that the laboratory
will be submitting a new application for accreditation to the
recognized accreditation body, including in the notification the legal
name of the laboratory, valid contact information for the laboratory,
the legal name of the recognized accreditation body the laboratory will
be submitting the application to, and the date that the laboratory
expects to submit the new application for accreditation; and (2)
demonstrate, to the satisfaction of the recognized accreditation body
it is submitting the new application to, that the grounds for the
withdrawal of accreditation have been resolved and that the laboratory
has implemented measures to prevent such grounds from recurring. If the
laboratory's accreditation had been withdrawn by a recognized
accreditation body, the requirement to notify us would allow us to
check whether the laboratory had been recently denied reaccreditation
by a different recognized accreditation body, which could possibly
indicate whether the laboratory is successively seeking approval of
accreditation without changing its practices. Alternatively, if we
revoked the laboratory's accreditation, we may want to contact the
recognized accreditation body to which the laboratory is applying, to,
for example, explain to the accreditation body why we found it
necessary to revoke the laboratory's accreditation.
    Proposed Sec.  1.1165(b) addresses how a laboratory may obtain
reaccreditation after it voluntarily relinquishes its accreditation. A
laboratory that voluntarily relinquished its accreditation may seek
reinstatement of accreditation by submitting a new application for
accreditation under proposed Sec.  1.1158 to a recognized accreditation
body.

I. Proposed Provisions About Requesting FDA Reconsideration, FDA
Internal Review, or Regulatory Hearings of FDA Decisions Under This
Rule (Proposed Sec. Sec.  1.1171 Through 1.1174)

    This proposed rule would establish requirements and procedures an
accreditation body would have to follow to request that we reconsider
our decision to deny its application for recognition, to request we
internally review our decision to deny its request to reconsider its
application for recognition, and to request a regulatory hearing on our
decision to take adverse action with respect to its recognition. This
proposed rule would also establish requirements and procedures a
laboratory would have to follow to request a regulatory hearing on our
decision to take an adverse action with respect to the laboratory's
accreditation. Further, this proposed rule would establish requirements
and procedures owners and consignees would have to follow to request a
regulatory hearing on a food testing order. Finally, this proposed rule
would establish procedures for the conduct of such reconsiderations,
internal reviews, and regulatory hearings.
    1. How does an accreditation body request reconsideration by FDA of
a decision to deny its application for recognition, renewal, or
reinstatement? (Proposed Sec.  1.1171)
    This proposed rule would establish procedures for an accreditation
body to seek reconsideration of our denial of its application for
recognition, renewal of recognition, or reinstatement of recognition.
    The procedures described by proposed Sec.  1.1171 require
submission of the request for reconsideration within 10 business days
of the issuance of such denial. The request for reconsideration must be
submitted to us electronically, in English, and in accordance with the
procedures described in the notice of denial. The request must also be
signed by the accreditation body or by an individual authorized to act
on its behalf. Within a reasonable time after we complete our review
and evaluation of the request for reconsideration and the supporting
information submitted, we would notify the requestor through the
issuance of the recognition upon reconsideration or through the
issuance of a denial of recognition upon reconsideration. We note that
should FDA issue a denial after a request for reconsideration, the
accreditation body would be able to request the review of such decision
under 21 CFR 10.75.

2. How does an accreditation body or laboratory request a regulatory
hearing on FDA's decision to revoke the recognized accreditation body's
recognition or revoke the accredited laboratory's accreditation?
(Proposed Sec.  1.1173)
    This proposed rule explains the procedures that would be used for
challenges to our revocation of an accreditation body's recognition or
our revocation of a laboratory's accreditation.
    Under proposed Sec.  1.1173(a), an accreditation body whose
recognition was revoked or a laboratory whose accreditation was revoked
(or an individual authorized to act on the accreditation body's or
laboratory's behalf) may submit a request for a regulatory hearing,
under part 16, on the revocation. The request must be submitted within
10 business days of the date of revocation. Written notices of
revocation will contain all the elements required by Sec.  16.22 and
will thereby constitute the notice of an opportunity for hearing under
part 16.
    Under proposed Sec.  1.1173(b), the request for a regulatory
hearing must be submitted with a written appeal that responds to the
bases for our decision described in the written notice of revocation
together with any supporting information upon which the requestor is
relying. The request, appeal, and supporting information must be
submitted to us electronically, in English, and in accordance with the
procedures described in the notice of revocation.
    Proposed Sec.  1.1173(c) makes clear that the submission of a
request for a regulatory hearing under this rule will not operate to
delay or stay the effect of our decision to revoke recognition of an
accreditation body or to revoke accreditation of a laboratory unless we
determine that delay or a stay is in the public interest.
    Under proposed Sec.  1.1173(d) and (e), the presiding officer for a
regulatory hearing under this proposed rule will be designated after
the request for a regulatory hearing is submitted to us. The presiding
officer may deny a request for regulatory hearing under this proposed
rule under 21 CFR 16.26(a) when no genuine or substantial issue of fact
has been raised.
    Proposed Sec.  1.1173(f) states that if a hearing request is
granted, the hearing will be held within 10 business days after the
date the request was filed or, if applicable, within a timeframe agreed
upon in writing by requestor and the presiding officer and FDA.
    The presiding officer must conduct the hearing under part 16,
except that, under Sec.  16.5(b), the procedures for a regulatory
hearing described in part 16 apply only to the extent that such
procedures are supplementary and not in conflict with the procedures
specified for the conduct of regulatory hearings under this rule. The
following requirements of part 16 are inapplicable to regulatory
hearings conducted under this rule: Sec.  16.22 (Initiation of a
regulatory hearing); Sec.  16.24(e) (Timing) and (f) (Contents of
notice); Sec.  16.40 (Commissioner); Sec.  16.60(a) (public process);
Sec.  16.95(b) (Administrative decision and record for decision); and
Sec.  16.119 (Reconsideration and stay of action).
    Proposed Sec.  1.1173(f)(3) clarifies that a decision by the
presiding officer to affirm the revocation of recognition or the
revocation of accreditation that served as the basis for the request
for a regulatory hearing is considered a final Agency action for
purposes of 5 U.S.C. 702.
3. How does an owner or consignee request a regulatory hearing on a
food testing order? (Proposed Sec.  1.1174)
    This proposed rule explains the procedures that would be used for
challenges to our issuance of a food testing order.
    Proposed Sec.  1.1174(a) provides that no later than 24 hours after
we issue the food testing order, the owner or consignee who is the
subject of the food testing order may submit a request for a regulatory
hearing, conducted under part 16, on the food testing order. The food
testing order will contain all of the elements required by Sec.
16.22(a) and will thereby constitute the notice of an opportunity for
hearing under part 16.
    Proposed Sec.  1.1174(b) provides that the request for a regulatory
hearing must be submitted with a written appeal that responds to the
bases for our determinations described in the food testing order,
together with any supporting information upon which the requestor is
relying. The request, appeal, and supporting information must be
submitted in English to the address specified in such notice and in
accordance with the procedures described therein. The request, appeal,
and supporting information may be submitted electronically.
    Proposed Sec.  1.1174(c) states that the presiding officer for the
regulatory hearing will be designated after a request for the
regulatory hearing is submitted to FDA. Proposed Sec.  1.1174(c) states
that the presiding officer may deny a request for regulatory hearing
under this rule under Sec.  16.26(a).
    Proposed Sec.  1.1174 provides that if the presiding officer grants
a request for a regulatory hearing, the hearing will be held within 2
business days after the date the request was filed or, if applicable,
within a time frame agreed upon in writing by requestor and the
presiding officer and FDA. Furthermore, the presiding officer may
require that a hearing conducted under this proposed rule be completed
within one business day, as appropriate. We believe that it is in the
interest of both public health and the owner and consignee that
regulatory hearings on food testing orders be resolved quickly and
efficiently. As noted, however, this proposed rule would allow for
flexibility by allowing the requestor, the presiding officer, and FDA
to agree on an alternative timeframe for holding the hearing.
    Proposed Sec.  1.1174(e)(3) provides that the presiding officer
must conduct the hearing in accordance with part 16, except that,
consistent with Sec.  16.5(b), the procedures for a regulatory hearing
described in part 16 apply only to the extent that such procedures are
supplementary and not in conflict with the procedures specified for the
conduct of regulatory hearings under this proposed rule. Accordingly,
the following requirements of part 16 would be inapplicable to
regulatory hearings conducted under this proposed rule: The
requirements of Sec. Sec.  16.22 (Initiation of a regulatory hearing);
16.24(e) (timing) and (f) (contents of notice); 16.26(a) (denial of
hearing); 16.40 (Commissioner); 16.42(a) (presiding officer); 16.60(a)
(public process); 16.95(b) (Administrative decision and record for
decision); and 16.120 (Reconsideration and stay of action) of this
chapter.
    Proposed Sec.  1.1174 clarifies that a decision by the presiding
officer to affirm the testing order would be considered a final Agency
action under 5 U.S.C. 702.

J. Proposed Provisions About Electronic Records and Public Disclosure
Requirements Under This Rule (Proposed Sec. Sec.  1.1199 Through
1.1200)

1. Are electronic records created under this rule subject to the
electronic records requirements of part 11 of this chapter? (Proposed
Sec.  1.1199)
    We are proposing to exempt from the requirements of 21 CFR part 11
records that meet the definition of electronic records in Sec.
11.3(b)(6) and are established or maintained to satisfy the
requirements of this proposed rule. We believe it would be
unnecessarily burdensome to require such records to

comply with the requirements in part 11. However, records that are
established or maintained to satisfy the requirements of this program
but that also are required under other applicable statutory provisions
or regulations remain subject to part 11 of this chapter. This is the
same approach we took when finalizing our rule on accredited third-
party certification.
2. Are the records obtained by FDA under this rule subject to public
disclosure? (Proposed Sec.  1.1200)
    We understand that notifications, records, and reports required
under this program will often contain commercially sensitive
information. Information submitted to the Agency, including reports and
notifications submitted under proposed Sec. Sec.  1.1123 and 1.1152,
becomes an Agency record. We are proposing to clarify at proposed Sec.
1.1200 that records under this proposed rule are subject to 21 CFR part
20, which provides protections for trade secrets and confidential
commercial information from public disclosure (see, e.g., Sec.  20.61,
``Trade secrets and commercial or financial information which is
privileged or confidential''). This is the same approach we took when
finalizing our rule on accredited third-party certification.

K. Proposed Revisions to 21 CFR Part 1, Subpart M

    On November 27, 2015, FDA published in the Federal Register a final
rule, ``Accreditation of Third-Party Certification Bodies to Conduct
Food Safety Audits and to Issue Certifications'' (accredited third-
party certification regulation), to implement section 808 of the FD&C
Act on accreditation of third-party certification bodies to conduct
food safety audits and to certify that eligible foreign entities
(including registered food facilities) and the human and animal food
produced by such entities meet applicable FDA food safety requirements
(80 FR 74570). The accredited third-party certification regulation,
codified at part 1, subpart M, establishes the requirements for how an
accredited third-party certification body must conduct a food safety
audit--i.e., a regulatory audit or a consultative audit that is
conducted to determine compliance with the applicable requirements of
the FD&C Act, FDA regulations, and for consultative audits, also
includes conformance with industry standards and practices.
    Under the accredited third-party certification regulation, an
accredited third-party certification body must use an accredited
laboratory when sampling and analysis is conducted for a regulatory
audit (Sec.  1.651(c)(2)). Laboratories may be accredited in accordance
with ISO/IEC 17025:2005 or another laboratory accreditation standard
that provides at least a similar level of assurance in the validity and
reliability of the sampling methodologies, analytical methodologies,
and analytical results (Sec.  1.651(b)(3)). For consistency between the
accredited third-party certification regulation and this rulemaking, we
propose to revise Sec.  1.651(b)(3) to cite the current version of the
ISO/IEC laboratory accreditation standard by striking ``ISO/IEC
17025:2005'' and inserting ``ISO/IEC 17025:2017.'' This would mean that
a laboratory accredited under this proposed rule, if finalized, would
be among the laboratories that a third-party certification body could
use to perform analysis.
    In addition, we propose to remove the option in Sec.
1.651(b)(3)(ii) for an accredited third-party certification body to use
a laboratory accredited under a standard other than ISO/IEC 17025 when
sampling and analysis is conducted for a regulatory audit. In
developing this proposed rule, we have gathered additional information
about the number and capacity of laboratories accredited under ISO/IEC
17025 to conduct food testing. Based on this information and in the
interest of consistency, we are proposing to remove the option in Sec.
1.651(b)(3)(ii) for an accredited third-party certification body to use
a laboratory accredited under a standard other than ISO/IEC 17025 when
sampling and analysis is conducted for a regulatory audit.
    Finally, we are proposing clarifying edits to Sec. Sec.
1.651(b)(3) and 1.651(c)(2) make it clear that the requirement to use a
laboratory accredited under ISO/IEC 17025 to conduct food testing
applies only to the analysis of the sample and not the collection of
the sample itself. As discussed previously in this rule, we are not at
this time proposing requirements for the accreditation of samplers.
    We solicit comment on the effect, if any, of these proposed changes
on an accredited third-party certification body's ability to meet the
requirements in Sec. Sec.  1.651(b)(3) and 1.651(c)(2) to use an
accredited laboratory when analyzing samples collected during a
regulatory audit.

L. Proposed Revisions to 21 CFR Part 11

    As we discussed in section VI.K.2, we are proposing to exempt from
the requirements of part 11 records that meet the definition of
electronic records in Sec.  11.3(b)(6) and are established or
maintained to satisfy the requirements of this proposed rule.
Consistent with that provision, we are making a conforming change in
part 11 by adding a paragraph (p) to Sec.  11.1 to that effect. The new
paragraph (p) would also clarify that records that satisfy the
requirements of this program but that also are required under other
statutory provisions or regulations remain subject to part 11 to the
extent that they are not separately exempted.

M. Proposed Revisions to 21 CFR Part 16

    As we discussed in section VI.J, at proposed Sec. Sec.  1.1171
through 1.1174 we have proposed to establish procedures for regulatory
hearings for certain actions we may take under this proposed rule. We
are proposing a conforming change to part 16, which describes
procedures for regulatory hearings, to add revocation of recognition of
an accreditation body, revocation of accreditation of a laboratory, and
issuance of a food testing order to the list of actions for which a
regulation hearing under part 16 may be held. The affected section is
Sec.  16.1.

N. Proposed Revisions to 21 CFR Part 129

    As noted above at section VI.B.1, where we discuss proposed Sec.
1.1107, the regulations on the processing and bottling of bottled
drinking water at part 129 contain an explicit testing requirement that
addresses an identified or suspected food safety problem and that
therefore would have to be conducted by a laboratory accredited under
this proposed rule. Specifically, Sec.  129.35(a)(3)(i) contains a
requirement that a source previously found to contain E. coli will be
considered negative for E. coli after five samples collected over a 24-
hour period from the same sampling site that originally tested positive
for E. coli are tested and found to be E. coli negative. Section
129.35(a)(3)(i) contains additional routine testing requirements that
do not address an identified or suspected food safety problem and are
not subject to this proposed rule.
    Section 129.35(a)(3)(iii) provides that the analysis of samples
taken under Sec.  129.35(a)(3)(i) ``may be performed for the plant by
competent commercial laboratories (e.g., Environmental Protection
Agency and State-certified laboratories).'' Section 129.35(a)(3)(iii)
has the potential to conflict with this proposed rule because section
422(b)(1)(A)(i) of the FD&C Act requires food testing conducted in
response to the explicit testing requirement that ``address[es] an
identified or suspected food safety problem'' in Sec.  129.35(a)(3)(i)

to be conducted by a laboratory accredited under this proposed program.
A laboratory may qualify as a ``competent commercial laboratory'' but
not be accredited under this proposed program. Accordingly, we are
proposing a conforming change to Sec.  129.35(a)(3)(iii) to clarify
that the explicit testing requirement in Sec.  129.35(a)(3)(i) that
addresses an identified or suspected food safety problem must be
conducted under this proposed program, which would require, in
pertinent part, the laboratory conducting the testing to be accredited
under this proposed program.

VII. Proposed Effective Date and Implementation Steps

    The effective date is the date that provisions in the rule affect
the current Code of Federal Regulations. We propose that the effective
date of this rule would be 60 days after publication of the final rule
in the Federal Register.
    FDA intends to implement this program as expeditiously as
practicable. Implementation of this laboratory accreditation program
will necessarily need to occur in a stepwise fashion. We would announce
when, after the effective date, we are prepared to accept applications
for recognition from accreditation bodies. We would announce when we
have recognized a sufficient number of accreditation bodies, at which
point laboratories could then apply to the recognized accreditation
bodies for accreditation. FDA would publish in the Federal Register, at
least 6 months in advance, notice that we have attained sufficient
laboratory capacity such that owners/consignees in the circumstances
described in proposed Sec.  1.1107 will be required to utilize
laboratories accredited under this program.

VIII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order (E.O.) 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility
Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). E.O.s 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
E.O. 13771 requires that the costs associated with significant new
regulations ``shall, to the extent permitted by law, be offset by the
elimination of existing costs associated with at least two prior
regulations.'' We believe that this proposed rule is not a significant
regulatory action as defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because a significant number of testing laboratories are
small businesses and due to initial one-time costs we find that the
proposed rule may have a significant economic impact on a substantial
number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.

Summary of Costs and Benefits

    The proposed rule, if finalized, would require that testing of food
in certain circumstances be performed by an accredited laboratory
(participating lab) accredited to the proposed standards by a
recognized accreditation body (participating accreditation body), and
for the results to be submitted to us. The costs of the proposed rule,
if finalized, would be incurred primarily by participating
accreditation bodies, participating labs, shell-egg producers, sprouts
producers, bottled water manufacturers, and owners and consignees of
human and animal food offered for import covered by the proposed rule.
We would incur costs to establish and maintain the program for
recognizing accreditation bodies hoping to participate in our program,
assessing participating accreditation bodies and participating labs,
and for reviewing associated documents and reports. The present value
of the cost of the proposed rule, if finalized, would range from $34
million to $78 million when discounted by 7 percent over 10 years. When
discounted by 3 percent over 10 years the present value of the cost
would range from $39 million to $92 million.
    The proposed rule, if finalized, would generate some quantified and
unquantified benefits. Quantified benefits include cost-savings from
the proposed clarifications of the process for compiling, submitting
and reviewing analytical reports for human and animal food offered for
import covered under the proposed rule, and a reduced burden from the
proposed abbreviated reporting requirements. In addition, there would
be savings from fewer false positive test results. We anticipate a
reduction in the number of foodborne illnesses from fewer false
negative test results for human and animal food offered for import
covered under the proposed rule and for shell eggs, sprouts, bottled
water, and other food subject to specific testing requirements covered
under the proposed rule. Unquantified benefits could include fewer
illnesses from deterring unsafe manufacturing practices by all entities
affected by the proposed rule. The present value of the quantified
benefits of the proposed rule, if finalized, would range from $26
million to $81 million when discounted by 7 percent over 10 years. When
discounted by 3 percent over 10 years the present value of the
quantified benefits would range from $32 million to $98 million. We
expect that specific test reporting requirements would result in more
accurate analytical reports and reporting.\7\
---------------------------------------------------------------------------

    \7\ There are currently no reporting requirements for tests of
shell eggs, sprouts, or bottled water.
---------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. In table 1, we
provide the Regulatory Information Service Center and Office of
Information and Regulatory Affairs Consolidated Information System
accounting information.

                                   Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ---------------------------------------
                  Category                     Primary        Low          High                                  Period                Notes
                                               estimate     estimate     estimate       Year       Discount     covered
                                                                                dollars      rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year....        $7.56        $3.71       $11.52         2016            7           10  Cost savings.
                                                    7.56         3.71        11.52         2016            3           10  Cost savings.
    Annualized Quantified..................  ...........  ...........  ...........  ...........            7  ...........
                                             ...........  ...........  ...........  ...........            3  ...........
                                            ------------------------------------------------------------------------------------------------------------
    Qualitative............................  Reduced risk of food-related illness
                                             from improper test reporting
                                             practices imported human and animal
                                             food covered under the proposed rule,
                                             and shell eggs, sprouts and bottled
                                             water and other tests subject to
                                             specific testing requirements.
                                             Reduced risk of food-related illness
                                             from unsafe food manufacturing
                                             practices.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year....        $6.73        $4.64        $9.27         2016            7           10
                                                    6.76         4.73         9.28         2016            3           10
    Annualized Quantified..................  ...........  ...........  ...........  ...........            7  ...........
                                             ...........  ...........  ...........  ...........            3  ...........
    Qualitative............................  ...........  ...........  ...........  ...........  ...........  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/  ...........  ...........  ...........  ...........            7  ...........
     year.
                                             ...........  ...........  ...........  ...........            3  ...........
                                            ------------------------------------------------------------------------------
    From/To................................  From:
                                             To:
                                            ------------------------------------------------------------------------------
    Other Annualized Monetized $millions/    ...........  ...........  ...........  ...........            7  ...........
     year.
                                             ...........  ...........  ...........  ...........            3  ...........
                                            ------------------------------------------------------------------------------
    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 labs program described by
     the proposed rule..
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The lower bound equals the 5th percentile and the upper bound equals the 95th percentile.

    In line with E.O. 13771, in table 2 we estimate present and
annualized values of costs and cost savings over an infinite time
horizon.

                                                            Table 2--E.O. 13771 Summary Table
                                        [in $ millions 2016 dollars discounted over an infinite time horizon] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................         $100.29          $56.49         $144.54         $216.92         $115.07         $319.32
Present Value of Cost Savings...........................          101.85           71.15          134.87          237.65          172.25          307.92
Present Value of Net Costs..............................           -1.56          -57.43           53.51          -20.73         -149.76          110.77
Annualized Costs........................................            7.02            3.95           10.12            6.51            3.45            9.58
Annualized Cost Savings.................................            7.13            5.17            9.24            7.13            5.17            9.24
Annualized Net Costs....................................           -0.11           -3.99            3.84           -0.62           -4.49            3.32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The lower bound equals the 5th percentile and the upper bound equals the 95th percentile.

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 21) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IX. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of
this action. We have concluded, 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. Therefore, neither an
environmental assessment nor an environmental impact statement is
required (Ref. 22).

X. Paperwork Reduction Act of 1995

    This proposed 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 (PRA) (44 U.S.C. 3501-3520).
This analysis provides a description of these

provisions and an estimate of the annual reporting and recordkeeping
burden associated with the proposed rule. 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.
    We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Laboratory Accreditation for Analyses of Foods.
    Description: As mandated by section 422 of the FD&C Act, we are
establishing of a program for the testing of food by accredited
laboratories; establishing a publicly available registry of recognized
accreditation bodies and accredited laboratories; and establishing
procedures for reporting any changes affecting the recognition of such
accreditation bodies or 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 accreditation
from recognized accreditation bodies, and accredited laboratories. We
estimate the burden of the information collection as follows:
    Reporting Burden: Consistent with figures discussed in our
Preliminary Regulatory Impact Analysis (PRIA) (see Section II.D, Number
of Entities), we estimate a total of 66 respondents. We estimate that
five to 80 accreditation bodies would apply for FDA recognition under
the rule, with a mean distribution of 17.5 accreditation bodies. For
this analysis we round up to 18. Similarly, we estimate of a mean of 48
laboratories will participate in the program, for a total of 66
respondents to the information collection. The reporting burden
includes a burden of 8,820 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 2,940 hours. Cumulatively, this results in
a total annual reporting burden of 15,049.05 hours, as reflected in
table 3.

                                   Table 3--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
    21 CFR part 1, subpart R citation; IC      Number of      Number of       Total      burden per
                  activity                    respondents   responses per     annual      response   Total hours
                                                             respondent     responses    (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.1113/1.1128(a); Accreditation           18               1           18           20          360
 bodies (ABs) application for recognition
 (one-time submission)......................
Sec.   1.1123(b) and (c); ABs--general                 18              12          216         * .5          108
 reporting requirements.....................
Sec.   1.1128(b); ABs--application for                 18               1           18          3.6         64.8
 renewal of recognition.....................
Sec.  Sec.   1.1138 and 1.1158;                        48               1           48           20          960
 laboratories--submission of application for
 accreditation (one-time submission)........
Sec.   1.1152(c)(1) and (2); laboratories--            48           88.48        4,247         1.75        7,432
 Submission of sampling plan, sample
 collection report, and sampler
 qualifications.............................
Sec.   1.1152(d); laboratories--                       48              10          480            2          960
 qualification to submit abridged analytical
 reports (one-time submission)..............
Sec.   1. 1152(c)(3); laboratories--abridged           48           88.48        4,247         1.16        4,927
 analytical reports submissions.............
Sec.   1.1152(c)(4) and (5); laboratories--             9               1            9  [dagger].25         2.25
 validation and verification studies
 submissions................................
Sec.   1.1152(i); laboratories--advance                48               3          144          1.5          216
 notice of sampling submissions.............
Sec.   1.1152(j); laboratories--immediate              48             1.5           72          .25           18
 notification...............................
Sec.  Sec.   1.1165; 1.1171; 1.1173; and                1               1            1            1            1
 1.1174; requests in response to FDA action.
                                             -------------------------------------------------------------------
    Total...................................  ...........  ..............  ...........  ...........    15,049.05
----------------------------------------------------------------------------------------------------------------
* (30 mins.)
[dagger] (15 mins.)

    Proposed Sec.  1.1128(a) would require accreditation bodies that
wish to be recognized to submit an application to FDA that demonstrates
their qualifications (those qualifications are specified by proposed
Sec.  1.1113) to accredit laboratories under this rule. We estimate
this process would take one analyst between 40 and 80 hours to compile
all the relevant information, prepare for an assessment, and complete
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 360 hours of
burden for initial applications submitted by 18 accreditation bodies
(18 applications x 20 hours per application), as reflected in row 1.
    Proposed Sec.  1.1123 would require a recognized accreditation body
to report information, including significant changes affecting its
accreditation program or the accreditation status of laboratories it
accredits, and ensure FDA has access to these and other records. We
estimate recognized accreditation bodies would incur a burden of 1 hour
per month, or 12 hours per year, complying with both the reporting
requirements of proposed Sec.  1.1123 and the recordkeeping
requirements of proposed Sec.  1.1124. For this analysis, we identify
recordkeeping and reporting burdens separately and assume 6 of the 12
hours (i.e., 30 minutes per month) would be spent meeting the reporting
requirements of Sec.  1.1123. Annually, this results in 108 hours (18
recognized accreditation bodies x 6 hours per year), as reflected in
row 2.
    Proposed Sec.  1.1128(b) would require accreditation bodies 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 18 accreditations
bodies for a total of 64.8 hours annually for the submission of renewal
of applications (18 applications x 3.6 hours per application), as
reflected in row 3.
    Proposed Sec.  1.1158 would require a laboratory seeking
accreditation to submit an application for accreditation to a
recognized accreditation body, demonstrating that it meets the
requirements for accreditation under the proposed rule (those
requirements are specified by proposed Sec.  1.1138). We estimate 48
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 48 laboratories would be 960 hours (48
applications x 20 hours per application), as reflected in row 4.
    Proposed Sec.  1.1152(a) through (i) would require accredited
laboratories to submit testing results of testing conducted under the
program and include supporting documentation. However, 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 4,197, 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
a count of 50 submissions for a total of 4,247.
    Proposed Sec.  1.1152(c)(1) would require accredited laboratories
to obtain, or develop, and submit a sample collection plan and sample
collection report (the contents of which would be prescribed by
proposed Sec.  1.1149) with each test result. Under proposed Sec.
1.1152(c)(2), laboratories would also be required to include
documentation of the sampler's qualifications the first time the
sampler collects a sample, or when the sampler's qualifications have
significantly changed. We assume that it would take 30 minutes to 1
hour to compile a sampling plan, 30 minutes to one 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 credentials.
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 of time per test results 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 credential requirements (48 accredited laboratories x 88.48
sampling plans and sample collection reports x 1.75 hours) is 7,432
hours, as reflected in row 5.
    Proposed Sec.  1.1152(d) would allow accredited laboratories to
qualify to submit abridged analytical reports in lieu of full
analytical reports. At this time we expect this would be a one-time
burden, but we may revisit this assumption in the future based on
actual disqualification rates if the proposed rule is finalized and
implemented. We assume that each accredited laboratory would submit 10
consecutive full analytical reports to qualify to submit abbreviated
reports. We also assume accredited laboratories 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 accredited
laboratories to qualify to submit abridged analytical reports of 960
hours (48 laboratories x 10 full analytical reports each x 2 hours per
analytical report), as reflected in row 6.
    After an accredited laboratory qualifies to submit abridged
analytical reports, we assume it would submit abridged analytical
reports to us thereafter. We may revisit this assumption in the future
based on actual disqualification rates if the proposed rule is
finalized and implemented. 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 an accredited laboratory 1.74 hours to compile
and submit an abridged analytical report (29 percent x 6 hours). This
results in an annual total reporting burden for the 48 accredited
laboratories to compile and submit abridged analytical reports of
approximately 4,927 hours (48 laboratories x 88.48 abridged analytical
reports x 1.16 hours per abridged analytical report), as reflected in
row 7.
    The proposed rule would also require the participating lab to
submit verification and validation studies to FDA as part of an
analytical report, or to an accreditation body as a prerequisite for
participation in the labs program. The ISO/IEC 17025 standard requires
the use of validated and verified methods for testing foods. However,
the proposed rule, if finalized, would require additional verification
studies over and above the requirements of ISO/IEC 17025. 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 laboratories to submit verification
studies such as matrix extensions under this proposed rule to be a
middle value of approximately 3 percent of the time burden incurred by
laboratories to maintain accreditation to ISO/IEC 17025 (the PRIA
estimates a range of 1 percent to 5 percent). In the PRIA 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.
    With regard to validation requirements, we assume that methods used
to test shell eggs, sprouts, and bottled water are either already
validated or the costs to doing so would be included in the costs to
maintain accreditation to the ISO/IEC 17025 standard. Consequently, we
assume that shell eggs, sprouts, and bottled water producers would
incur no burden from this requirement beyond the burden of the proposed
rule's requirements to meet the validation requirements of ISO/IEC
17025.
    We estimate the time required to perform a matrix extension is a
middle value of 34 hours (the PRIA 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 proposed rule would be approximately 3 percent of the time
burden incurred by laboratories to maintain accreditation to ISO 17025,
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 proposed 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 .17708
matrix extensions per accredited laboratory (8.5 / 48). Because the
number of respondents and the annual responses per respondent in a PRA
analysis must be whole numbers, we instead estimate that nine
accredited laboratories (48 x .17708, rounded to 9 from 8.5) 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 proposed rule is 2.25 hours (9
accredited laboratories x 1 verification studies x .25 hours per
study), as reflected in row 8.
    Proposed Sec.  1.1152(i) would provide that, under certain
circumstances, FDA may require one or more accredited laboratories to
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
accredited laboratory will analyze under this program. We assume that
it would take a laboratory analyst between 1 and 2 hours to compile the
required information and submit the information, and we assume that
between one percent and five percent of all test results submitted
annually under this program would be subject to the notice of sampling
requirement. For this analysis we assume middle values of 1.5 hours and
three percent, respectively. Thus, we estimate that 127.41 test results
(4,247 x 3%) would require submission of advance notice of sampling
under the proposed rule. For this analysis we assume that each of the
estimated 48 accredited laboratories would be required to submit three
notices of advance sampling annually under the proposed rule (127.41 /
48 = 2.65; rounded to 3). Thus, the annual reporting burden on
accredited laboratories due to the proposed advance notice of sampling
requirement would be 216 hours (48 laboratories x 3 advance notices of
sampling x 1.5 hours), as reflected in row 9.
    Proposed Sec.  1.1152(j) would require accredited laboratories to
notify FDA and the accreditation body of any changes that affect the
laboratory's accreditation. Note, however, that under Sec.  1.1123(c),
recognized accreditation bodies also have a duty to immediately notify
FDA of changes in an accredited laboratory's status. Thus, an
accredited laboratory is not required to notify FDA of changes that
fall under Sec.  1.1123(c). To be conservative we estimate that every
lab that participates will have some change about which it must notify
its accreditation body, and for half of those changes the accredited
laboratory will also need to notify FDA. We estimate it will take an
accredited laboratory 15 minutes per notification. Thus we estimate the
burden associated with Sec.  1.1152(j) would be 18 hours (48 accredited
laboratories x 1.5 notifications x 0.25 hours per notification), as
reflected in row 10.
    Proposed Sec. Sec.  1.1165, 1.1171, 1.1173, and 1.1174 provide for
requests to FDA. Specifically, Sec.  1.1165 provides for requests for
reinstatement of 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 are
estimating a cumulative total of 1 respondent and 1 burden hour, as
reflected in row 11, however we invite specific comment in this regard.
Upon implementation of any final rule, we will reevaluate our burden
estimate in light of overall submissions to the Agency and public
comments received.
    Recordkeeping Burden: Recordkeeping requirements associated with
the proposed rule include a one-time burden of 1,366.05 hours and
annual burden of 41,912.74 hours. In this analysis, we annualize the
one-time recordkeeping burden using a 3-year period horizon and zero
percent discount rate, for an annualized one-time recordkeeping burden
of 455.35. Cumulatively, we estimate an annual recordkeeping burden
under this proposed rule of 43,278.79 hours, as reflected in table 4.

                                 Table 4--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                Average
   Proposed 21 CFR part 1, subpart R; IC      Number of      Number of      Total       burden per
                 activity                   recordkeepers   records per     annual    recordkeeping  Total hours
                                                           recordkeeper    records      (in hours)
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.113 and 1.1118;                        18              1           18             1            18
 recordkeeping associated with ISO/IEC
 17011....................................
Sec.   1.1124; ABs--additional                        18              1           18             6           108
 recordkeeping requirements...............
Sec.   1.1138; laboratories--becoming                  5              1            5         91.06        455.35
 accredited to ISO/IEC 17025 (one-time)...
Sec.   1.1146; laboratories--maintaining              48              1           48        889.53     42,697.44
 ISO/IEC 17025 accreditation..............
                                           ---------------------------------------------------------------------
    Total.................................  .............  ............  ...........  .............    43,278.79
----------------------------------------------------------------------------------------------------------------

    Proposed Sec.  1.1113 and Sec.  1.1118 would require accreditation
bodies to meet the requirements of ISO/IEC 17011 to be recognized.
While ISO/IEC 17011 includes recordkeeping requirements, as noted above
we estimate that all of the 18 accreditation bodies that would become
recognized under the proposed rule currently adhere to ISO/IEC 17011.
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.
    Proposed Sec.  1.1124, however, provides for the maintenance of
certain records in addition to those required by ISO/IEC 17011. We
estimate recognized accreditation bodies would incur a burden of 12
hours per year to comply with both the recordkeeping requirements of
proposed Sec.  1.1124 and the reporting requirements of proposed Sec.
1.1123. For this analysis, we identify the recordkeeping and reporting
burdens separately, assuming six of those 12 annual hours would be
spent complying with the recordkeeping requirements of proposed Sec.
1.1124. Thus, the annual recordkeeping burden for the 18 recognized
accreditation bodies to meet the additional recordkeeping requirements
of proposed Sec.  1.1124 would be 108 hours, as reflected in row 2.
    Proposed Sec.  1.1138 would require laboratories to meet certain
requirements of ISO/IEC 17025, including its recordkeeping
requirements, to be accredited under the proposed rule. We estimate
that between two to eight laboratories not

currently accredited to ISO/IEC 17025 would become accredited. We use a
middle estimate of five laboratories and also estimate that it would
take a mean of 91.06 hours for the associated recordkeeping activities.
This results in an annualized burden of 455.35, as reflected in row 3.
    Proposed Sec.  1.1146 would require laboratories to maintain
conformance with ISO/IEC 17025, including its recordkeeping
requirements. Based on available data, and as discussed in our PRIA, we
estimate a mean of 889.53 hours for this recordkeeping. This results in
an annual burden of 42,697.44 hours, as reflected in row 4.
    The proposed rule also affects currently approved information
collections. Information collection provisions found in part 11 of our
regulations are currently approved under OMB Control No. 0910-0303.
Information collection provisions found in part 129 of our regulations
are currently approved under OMB Control No. 0910-0658. Although no new
information collection or no material modification is being introduced
by the proposed rule, upon implementation of any final rule we will
reevaluate our burden estimates for these collections accordingly.
Finally, information collection provisions found in part 16 of our
regulations are exempt from OMB review and approval under the PRA, as
the information collection occurs during the conduct of an official
administrative action (see 5 CFR 1320.4(a)(2)).
    To ensure that comments on this information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB (see ADDRESSES). All
comments should be identified with the title of the information
collection.
    In compliance with the PRA, the Agency has submitted the
information collection provisions of this proposed rule to OMB for
review. These information collection requirements will not be effective
until FDA publishes a final rule, OMB approves the information
collection requirements, and the rule goes into effect. We will publish
a notice concerning OMB approval of these requirements in the Federal
Register.

XI. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13132. We have determined that the
proposed rule does not contain policies that have a substantial direct
effect 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 have tentatively concluded that the proposed 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.

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.

* 1. 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.
* 2. 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 on June 17,
2019.
* 3. ``Private Laboratory Guidance,'' ORA Laboratory Manual, Vol.
III, Section 7, document number III-07. FDA. January 30, 2013.
https://www.fda.gov/media/81810/download. Accessed on June 17, 2019.
4. ``ISO/IEC 17025:2005 ``General Requirements for the Competence of
Testing and Calibration Laboratories'' (withdrawn). International
Organization for Standardization/International Electrotechnical
Commission. May 2005. 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/39883.html, or may be viewed on the internet
through, https://www.surveymonkey.com/r/KFJMZ67 or may be examined
at the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325
and/or RIN 0910-AH31).
*5. ``Action Plan for Import Safety.'' Interagency Working Group on
Import Safety. November 2007. http://www.itagc.org/docs/ITAGC-2010-11-10-FDA-4.pdf. Accessed June 17, 2019.
* 6. GAO Report, ``Federal Oversight of Food Safety: FDA's Food
Protection Plan Proposes Positive First Steps, but Capacity to Carry
Them Out Is Critical (GAO-08-435T).'' Government Accountability
Office. January 29, 2008. https://www.gao.gov/assets/120/118821.pdf.
Accessed on June 17, 2019.
* 7. GAO Report, ``Food Safety: FDA's Imported Seafood Safety
Program Shows Some Progress, but Further Improvements are Needed
(GAO-04-246).'' Government Accountability Office. January 30, 2004.
https://www.gao.gov/assets/250/241327.pdf. Accessed on June 17,
2019.
* 8. FDA Draft Guidance for Industry, ``Submission of Laboratory
Packages by Accredited Laboratories'' (withdrawn). FDA. January 16,
2009.
9. ``Guidelines for Laboratories Performing Microbiological and
Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals,
An Aid to Interpretation of ISO/IEC 17025:2005.'' AOAC
International. April 2015. Copies are available from AOAC
International, 2275 Research Blvd., Ste. 300, Rockville, MD 20850-
3250, USA, or on the internet at http://www.aoac.org/aoac_prod_imis/AOAC/AOAC_Member/PUBSCF/ALACCCF/ALACC_M.aspx, or may be examined at
the Dockets Management Staff (Ref. Docket No. FDA-2019-N-3325 and/or
RIN 0910-AH31).
* 10. ``IAF/ILAC Multi-Lateral Mutual Recognition Arrangements
(Arrangements): Requirements and Procedures for Evaluation of a
Single Accreditation Body.'' International Accreditation Forum/
International Laboratory Accreditation Cooperation. January 2018.
Available at https://ilac.org/publications-and-resources/joint-ilac-iaf-series/. Accessed on June 17, 2019.
* 11. ``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.whitehouse.gov/sites/whitehouse.gov/files/omb/inforeg/inforeg/revised_circular_a-119_as_of_1_22.pdf. Accessed on
June 17, 2019.
* 12. ``ISO/IEC 17011:2017(E), ``Conformity Assessment--Requirements
for Accreditation Bodies Accrediting Conformity Assessment Bodies.''
International Organization for Standardization/International
Electrotechnical Commission. 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).
13. ISO/IEC 17025:2017(E), ``General Requirements for the Competence
of

Testing and Calibration Laboratories.'' International Organization
for Standardization/International Electrotechnical Commission.
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).
* 14. Meeting Minutes, ``Sampling Accreditation Discussion with
ABs.'' FDA. November 13, 2017.
* 15. ``R103--General Requirements: Proficiency Testing for ISO/IEC
Laboratories.'' American Association for Laboratory Accreditation.
September 19, 2013. https://portal.a2la.org/requirements/R103_2013.pdf. Accessed on June 17, 2019.
*16. ``Accreditation Requirements: ISO/IEC 17025 Testing
Laboratories (Non-Forensics).'' ANSI/ASQ National Accreditation
Board. October 9, 2018. https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=8160. Accessed on June 17, 2019.
17. ISO/IEC 17043:2010, ``Conformity Assessment--General
Requirements for Proficiency Testing.'' International Organization
for Standardization/International Electrotechnical Commission.
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).
* 18. ``Methods, Method Verification and Validation,'' ORA
Laboratory Manual, Vol. II, Section 2, document number ORA-
LAB.5.4.5. FDA. August 29, 2014. https://www.fda.gov/media/73920/download. Accessed on June 17, 2019.
* 19. FDA Memorandum, ``Guidelines for the Validation of Chemical
Methods for the FDA FVM Program, 2nd Edition.'' FDA Foods and
Veterinary Medicine Science and Research Steering Committee. May 19,
2015. https://www.fda.gov/media/81810/download. Accessed on June 17,
2019.
* 20. Meeting Record, ``FSMA Lab Accreditation/Food Laboratory
Alliance Meeting Record August 21, 2015.'' FDA. July 21, 2015.
* 21. FDA. Accreditation of Laboratories to Conduct Food Testing:
Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, Unfunded Mandates Reform Act Analysis, 2019.
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
* 22. FDA Memorandum. ``Proposed Rule: Amendment of 21 CFR parts 1,
11, 16, and 129 to Establish a Program for Laboratory Accreditation
for Analyses of Foods as Required by FD&C Act.'' Leah D. Proffitt,
FDA, June 14, 2019.

List of Subjects

21 CFR Part 1

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

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, it is
proposed that 21 CFR parts 1, 11, 16, and 129 be 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, 381, 382, 384a, 384b, 384d, 387, 387a, 387c,
393; 42 U.S.C. 216, 241, 243, 262, 264, 271.

0
2. In Sec.  [thinsp]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 Federal Food, Drug, and Cosmetic 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.  1.1102 through 1.1200, to
read as follows:

Subpart R--Accreditation of Laboratories to Conduct Food Testing

General Provisions

Sec.
1.1102 What definitions apply to this subpart?
1.1103 Who is subject to this subpart?

General Requirements of this Subpart

1.1107 Under what circumstances must food testing be conducted under
this subpart by an accredited laboratory?
1.1108 When and how will FDA issue a food testing order?
1.1109 How will FDA make information about recognized accreditation
bodies and accredited laboratories available to the public?

Recognition of Accreditation Bodies

1.1113 What requirements must an accreditation body meet to be
recognized by FDA?

Requirements for Recognized Accreditation Bodies

1.1118 What are the general requirements for recognized
accreditation bodies to remain recognized?
1.1119 What requirements apply to how a recognized accreditation
body must protect against conflicts of interests?
1.1120 How must a recognized accreditation body evaluate
laboratories seeking accreditation and oversee the performance of
laboratories it accredits?
1.1121 What appeal procedures must a recognized accreditation body
provide for appeals of decisions to not grant accreditation?
1.1122 When must a recognized accreditation body withdraw or reduce
the scope of the accreditation of a laboratory, and when may a
recognized accreditation body put an accredited laboratory on
probation?
1.1123 What reports and notifications must a recognized
accreditation body submit to FDA?
1.1124 What records requirements must a recognized accreditation
body meet?
1.1125 What internal audit requirements must a recognized
accreditation body meet?

Procedures for Recognition of Accreditation Bodies

1.1128 How does an accreditation body apply to FDA for recognition
or renewal of recognition?

1.1129 How will FDA review applications for recognition and
applications for renewal of recognition?
1.1130 How will FDA oversee recognized accreditation bodies?
1.1131 When will FDA revoke the recognition of an accreditation body
or put a recognized accreditation body on probation?
1.1132 What must a recognized accreditation body do if it wants to
voluntarily relinquish its recognition or does not want to renew its
recognition?
1.1133 How does an accreditation body request reinstatement of
recognition?

Accreditation of Laboratories

1.1138 What requirements must a laboratory meet to become accredited
by a recognized accreditation body?

Requirements for Accredited Laboratories

1.1146 What are the general requirements for accredited laboratories
to remain accredited?
1.1147 What impartiality and conflict of interest requirements must
accredited laboratories meet?
1.1148 What quality assurance requirements must accredited
laboratories meet?
1.1149 What oversight standards apply to sampling?
1.1150 What requirements apply to analysis of samples by an
accredited laboratory?
1.1151 What requirements apply to the methods of analysis an
accredited laboratory uses to conduct food testing under this
subpart?
1.1152 What notifications, results, and reports must accredited
laboratories submit to FDA?
1.1153 What other records requirements must an accredited laboratory
meet?

Procedures for Accreditation of Laboratories

1.1158 How does a laboratory apply for accreditation or modification
of its scope of accreditation by a recognized accreditation body?
1.1159 How will FDA oversee accredited laboratories?
1.1160 How will FDA review submitted test results and analytical
reports?
1.1161 When will FDA put an accredited laboratory on probation or
revoke the accreditation of a laboratory?
1.1162 What are the consequences if FDA puts an accredited
laboratory on probation or revokes the accreditation of a
laboratory?
1.1163 What if a laboratory wants to voluntarily relinquish its
accreditation?
1.1164 What is the effect on accredited laboratories if their
accreditation body voluntarily or involuntarily loses its
recognition?
1.1165 How does a laboratory request reinstatement of accreditation?

Requesting FDA Reconsideration, FDA Internal Review, 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's decision to revoke the recognized
accreditation body's recognition or revoke the accredited
laboratory's accreditation?
1.1174 How does an owner or consignee request a regulatory hearing
on a food testing order?

Electronic Records and Public Disclosure Requirements Under This
Subpart

1.1199 Are electronic records created under this subpart subject to
the electronic records requirements of part 11 of this chapter?