involved in its accreditation activities. We have included a similar
imputation provision in other regulations, including the FSMA
accredited third-party certification regulation. See 21 CFR 1.657(c))
and 21 CFR 516.141(g). We believe this provision would help ensure the
integrity of the food testing program.
    We seek comment on proposed Sec.  1.1119 and whether there are any
other potential conflicts interest for recognized accreditation bodies
that should be addressed in this proposed program. For any comment
recommending that we address other types of conflicts, we request

recommended measures to address such conflicts, and any references or
documents that are available to support the recommendation.
3. How must a recognized accreditation body evaluate laboratories
seeking accreditation and oversee the performance of laboratories it
accredits? (Proposed Sec.  1.1120)
    We anticipate that many laboratories that seek accreditation in our
proposed program already will be accredited to ISO/IEC 17025:2017 by an
accreditation body to which we have granted recognition. To provide
flexibility to such participants, we are proposing laboratory
assessment requirements for our program that build upon, and could be
combined with, the existing assessments of laboratories that
accreditation bodies conduct under ISO/IEC 17011:2017 during an
accreditation cycle. For example, if an accreditation body has
conducted an onsite assessment of an ISO/IEC 17025:2017 accredited
laboratory in the past 2 years, proposed Sec.  1.1120(c) would
potentially allow the initial assessment for accreditation to our
program to be conducted remotely, and to only address whether the
laboratory meets the unique requirements of our program that are not
required by ISO/IEC 17025:2017 (see proposed Sec.  1.1138(a)(1) and
(c)). If such an onsite assessment has not been conducted in the past 2
years, an accreditation body's initial assessment of a laboratory for
accreditation in our program would be required to be conducted onsite
and would be required to address whether the laboratory meets all the
requirements of our program, including the requirements of ISO/IEC
17025:2017 specified in proposed Sec.  1.1138(a)(2) and (b).
    Where the initial assessment for accreditation to our program is
conducted remotely under proposed Sec.  1.1120(c), proposed Sec.
1.1120(e) and (f) would require the recognized accreditation body to
conduct its first assessment of the sample of the scope of
accreditation of the accredited laboratory onsite, and no later than 2
years after the accreditation body last conducted an onsite assessment
of the laboratory, in accordance with ISO/IEC 17011:2017. These
proposed requirements are intended to ensure that recognized
accreditation bodies conduct onsite assessments of accredited
laboratories in our program at least every 2 years. We regard periodic
onsite assessments as necessary to effectively evaluating a laboratory.
In addition, proposed Sec.  1.1120(g) would require that the
reassessment of an accredited laboratory (see ISO/IEC 17011:2017 (Ref.
12, at section 7.9.4)) at the end of the laboratory's accreditation
cycle be conducted onsite.
    However, when conducting an ``onsite'' assessment, if conducting a
particular assessment activity onsite will not aid in the assessment of
a laboratory, proposed Sec.  1.1120(b), (e), and (g), would allow such
activities to be conducted remotely. Our intent is that this exception
would allow assessment activities such as document review or followup
inquiries to a laboratory after an onsite visit to be conducted
remotely. Proposed Sec.  1.1120(h) would allow any assessments
conducted by a recognized accreditation body other than the assessments
referred to in Sec.  1.1120(a), (e), and (g)--that is, the initial
assessment, sample of the scope of accreditation, and reassessment--to
be conducted entirely remotely if it will not aid the assessment to
conduct them onsite.
4. What appeal procedures must a recognized accreditation body provide
for appeals of decisions to not grant accreditation? (Proposed Sec.
1.1121)
    Proposed Sec.  1.1121 provides that a laboratory may appeal a
decision by the recognized accreditation body to not grant the
accreditation (in-whole or in-part) that the laboratory sought, and the
recognized accreditation body must consider the appeal, in accordance
with the requirements of Sec.  1.1118(b). We are proposing this
provision because ISO/IEC 17011:2017 does not explicitly state what
actions by the accreditation body a laboratory may appeal.
    Proposed Sec.  1.1121 would require recognized accreditation bodies
to establish and implement certain written procedures for addressing
appeals from laboratories challenging a recognized accreditation body's
decision to not grant the accreditation (in-whole or in-part) that the
laboratory sought. Specifically, proposed Sec.  1.1121 provides that,
in addition to meeting the requirements of Sec.  1.1118(b) related to
appeals, the recognized accreditation body must establish and implement
written procedures to make the appeals procedures publicly available,
and use a competent person(s), who may or may not be external to the
recognized accreditation body, is free from bias or prejudice and has
not participated in the accreditation decision, and is not the
subordinate of a person who participated in the accreditation decision,
to review and decide appeals. We have tentatively concluded that the
requirements of proposed Sec.  1.1121 are important supplemental
requirements to ISO/IEC 17011:2017 (Ref. 12) section 7.13 that would
provide additional protections to laboratories and help ensure
transparency of the program. We seek comments on these proposed
requirements, including with respect to whether these proposed
requirements would significantly differ from the current appeals
practices of accreditation bodies.
5. 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? (Proposed
Sec.  1.1122)
    Proposed Sec.  1.1122(a) would require recognized accreditation
bodies to withdraw the accreditation of a laboratory it accredits when
the accredited laboratory substantially fails to comply with this rule.
Although section 7.11 of ISO/IEC 17011:2017 (Ref. 12) specifies certain
circumstances that would require the accreditation body to initiate the
process for withdrawing the accreditation of the laboratory--including
fraudulent behavior--it does not articulate a general standard for when
accreditation bodies should initiate the process for withdrawing
accreditation.
    Although we are proposing that withdrawal of accreditation be
initiated by a ``substantial'' failure to comply with this subpart--and
not by minor or de minimis violations--we note that the failure or
refusal by the accredited laboratory to take appropriate corrective
action (as it is required to do under ISO/IEC 17025:2017 (Ref. 13) at
section 8.7) to prevent subsequent minor violations may rise to the
level of substantial failure to comply with this rule. For example, if
on a single occasion an accredited laboratory fails to provide FDA with
documentation of the sampler's qualifications as required by Sec.
1.1152(c)(2), that in and of itself would not generally be considered a
substantial violation. However, frequent and recurring failure by a
laboratory to submit all required components of a full analytical
report, even when each instance constitutes a minor violation, combined
with a failure or refusal by the accredited laboratory to take
appropriate corrective action to prevent such mistakes from recurring,
may in certain circumstances be grounds for withdrawal of
accreditation.
    Proposed Sec.  1.1122(b) provides that a recognized accreditation
body may put an accredited laboratory it accredits on probation if the
recognized accreditation body determines that the laboratory
demonstrates deficiencies in performing

its functions under this program that are less serious than would
justify withdrawal of the accredited laboratory's accreditation (in-
whole or in-part) under proposed Sec.  1.1122(a), and it is reasonably
likely that the accredited laboratory will be able to correct such
deficiencies within a reasonable specified period of time. Our intent
is that probation would allow recognized accreditation bodies to work
with laboratories they accredit to bring such laboratories into
compliance with the program without having to resort to withdrawing
accreditation.
    As noted, this proposed rule refers to reduction of an accredited
laboratory's scope of accreditation by a recognized accreditation body
as withdrawal of accreditation in-part. Proposed Sec.  1.1122(c)
clarifies that when there are grounds for withdrawal of accreditation,
but the deficiencies affect only certain analytical methods within the
accredited laboratory's scope of accreditation, the recognized
accreditation body may withdraw the accredited laboratory's scope of
accreditation for only those affected analytical methods. This
provision is meant to facilitate limited withdrawal of accreditation
when warranted.
    Under proposed Sec.  1.1122(d) a recognized accreditation body may
require from a laboratory that it accredits the submission of records
that the accredited laboratory would be required to maintain under
proposed Sec.  1.1153, in order to assist the recognized accreditation
body in determining whether a withdrawal of accreditation (in-whole or
in-part) or probation is warranted.
    Proposed Sec.  1.1122(e) describes the process a recognized
accreditation body must follow when withdrawing the accreditation of an
accredited laboratory under this program. Under proposed Sec.
1.1122(e), the recognized accreditation body must notify the laboratory
of the withdrawal of the laboratory's accreditation, and the
notification must specify whether the withdrawal of accreditation is
in-whole or in-part, and if it is in-part, to which testing methods it
applies. The notification must also describe the grounds on which the
accreditation was withdrawn and state the procedures for appealing the
withdrawal.
    Proposed Sec.  1.1122(f) provides that the recognized accreditation
body would have to: (1) Notify the laboratory of its probationary
status; (2) describe the grounds for the probation; (3) identify all
deficiencies that the laboratory must correct for the recognized
accreditation body to lift the probation; and (4) either inform the
laboratory that it has a specific timeframe to take particular
corrective actions with respect to the identified deficiencies or
require the laboratory to submit a plan to the recognized accreditation
body for approval that identifies the appropriate corrective actions
the laboratory will take to resolve the identified deficiencies and
that identifies appropriate timeframes for resolution. Our intent is
that while probation is in effect, the recognized accreditation body
will work with the accredited laboratory to bring it into compliance
with the requirements of the program.
    Proposed Sec.  1.1122(g) describes the consequences of withdrawal
of accreditation (in-whole or in-part) or probation. If a recognized
accreditation body withdraws the accreditation of a laboratory in-
whole, the laboratory would be immediately ineligible to conduct food
testing under this rule. If the recognized accreditation body withdraws
the accreditation of a laboratory in-part, the laboratory would be
immediately ineligible to conduct food testing under this rule with
respect to only the specific methods for which accreditation was
withdrawn. An accredited laboratory's substantial failure to comply
with this rule would undermine the integrity and validity of this
proposed program and of the laboratory's affected food testing
conducted under this proposed rule. Withdrawal of the laboratory's
accreditation would ensure that the laboratory does not continue to
conduct the affected food testing under this rule. This consequence is
in accordance with the requirement in section 422(b)(1) of the FD&C Act
that food testing under section 422 may only be conducted by
laboratories that are accredited by recognized accreditation bodies for
the methods of analysis appropriate for such food testing. An
accredited laboratory that is put on probation by an accreditation body
under this proposed rule would be permitted to continue to conduct food
testing under this subpart, because it would still be accredited under
this program. However, an accredited laboratory that is put on
probation under this proposed rule would not be able to submit abridged
analytical reports under Sec.  1.1152(d).
    Proposed Sec.  1.1122(h) discusses requirements related to how the
recognized accreditation body must handle appeals of withdrawals of
accreditation (in-whole or in-part). Under proposed Sec.  1.1122(h), a
laboratory may appeal a decision by the recognized accreditation body
to withdraw the accreditation (in-whole or in-part) of the laboratory,
and the recognized accreditation body must consider the appeal in
accordance with the requirements of ISO/IEC 17011:2017 (Ref. 12)
(specifically, ISO/IEC 17011:2017 at section 7.13). In addition to
meeting the requirements of ISO/IEC 17011:2017 related to appeals, the
recognized accreditation body must establish and implement written
procedures to make the appeals procedures publicly available; and to
use a competent person(s), who may or may not be external to the
recognized accreditation body, who is free from bias or prejudice and
has not participated in the withdrawal decision, and is not the
subordinate of a person who participated in the withdrawal decision, to
review and decide appeals.
6. What reports and notifications must a recognized accreditation body
submit to FDA? (Proposed Sec.  1.1123)
    Proposed Sec.  1.1123 would require recognized accreditation bodies
to submit to FDA reports of their internal audits and notices of
matters affecting their recognition and the accreditation status of
laboratories they accredit, among other notices.
    In proposed Sec.  1.1123 and other provisions in this proposed
rule, we are proposing that information submitted to FDA be submitted
electronically and in English. Electronic submission of information
will help ensure we have ready access to information needed for
monitoring and oversight of the program and promote the overall
efficiency of the program. We have also tentatively concluded that
requiring electronic submission would not be significantly burdensome
for the accreditation bodies and laboratories in this program. FDA
plans to establish an electronic portal for this program and recognized
accreditation bodies would be able to submit all required notification
and reports through that portal.
    Proposed Sec.  1.1123(a) would require all reports and
notifications submitted to FDA under this proposed section to include
contact information for the accreditation body associated with the
report or notification and, if applicable, contact information for the
laboratory associated with the report or notification. Proposed Sec.
1.1123(b) would require recognized accreditation bodies to submit to
FDA electronically, in English, a report of the results of the internal
audit required by section 9.7 of ISO/IEC 17011:2017 (Ref. 12) and the
results of the audit of its compliance with the requirements of Sec.
1.1118(c) and (d), which would be required by proposed Sec.  1.1125, no
later than 45 days after completing the internal audit. Proposed Sec.
1.1123(b) further provides that the report of the recognized

accreditation body's internal audit must include a description of the
internal audit conducted; a description of any identified deficiencies;
a description of any corrective actions taken and any corrective action
the recognized accreditation body will take, including the timeline for
such corrective actions; and a statement disclosing the extent to which
the internal audit was conducted by personnel different from those who
perform the activity or activities that were audited. The report does
not have to be the same report used internally by the recognized
accreditation body, but must be comprehensive enough to demonstrate
whether the accreditation body is complying with the requirements of
ISO/IEC 17011:2017 and the requirements of Sec.  1.1118(c) and (d).
Such reports would provide us with important information about the
extent to which the recognized accreditation body is monitoring its own
performance under this program, any deficiencies the recognized
accreditation body discovered about its activities, and any corrective
actions implemented to address such deficiencies.
    Because recognized accreditation bodies must conduct such internal
audits under ISO/IEC 17011:2017 and to maintain their ILAC membership,
proposed Sec.  1.1123(b) would not require the recognized accreditation
body to engage in duplicative internal audits. We also believe that
providing 45 days for the recognized accreditation body to compile and
submit this report is a reasonable amount of time that strikes a
balance between our interest in reviewing information that is important
to our oversight of the program and providing the recognized
accreditation body sufficient time to initiate any appropriate
corrective actions and develop a meaningful internal audit report. If
the internal audit results in the recognized accreditation body
discovering information that must be submitted to FDA immediately under
proposed Sec.  1.1123(c), we expect the recognized accreditation body
to submit that particular information to us immediately, within 48
hours, in accordance with proposed Sec.  1.1123(c).
    Section 422(a)(1)(C) of the FD&C Act requires, as a condition of
recognition, that recognized accreditation bodies report to us any
changes that would affect the recognition of such recognition body. To
implement this provision, proposed Sec.  1.1123(c)(1) would require the
recognized accreditation body to notify us immediately of any changes
it is aware of that would affect its recognition, including a
description of the change, and, if the change is one made by the
recognized accreditation body, an explanation for the purpose of the
change. Proposed Sec.  1.1123(c)(1) would cover changes in the name or
operations of a recognized accreditation body, such as the purchase of
a recognized accreditation body by a company, as well as changes that
would cause the recognized accreditation body to no longer meet the
requirements of this proposed program, including if the recognized
accreditation body ceases membership in ILAC or is no longer a
signatory of the ILAC MRA demonstrating competence to ISO/IEC
17011:2017. A change that prevents or undermines the accreditation
body's compliance with this proposed program may result in revocation
of recognition under proposed Sec.  1.1131. We would encourage
recognized accreditation bodies to contact us if there are
uncertainties about whether a change should be reported under proposed
Sec.  1.1123(c)(1).
    Proposed Sec.  1.1123(c)(2) through (6) would require recognized
accreditation bodies to immediately notify us, within 48 hours, of
certain information related to the accreditation status of laboratories
they accredit or that have sought their accreditation. Immediate notice
is essential so that we can take timely action to update the public
website described by proposed Sec.  1.1109; accept food testing results
from newly accredited laboratories; refuse to accept food testing
results from laboratories that are no longer accredited for the food
testing at issue; and take any other actions as appropriate based on
such information.
    Proposed Sec.  1.1123(c)(2) and (3) would require recognized
accreditation bodies to submit information to us about their grants and
denials of accreditation (in-whole or in-part) of laboratories. If a
recognized accreditation body received a request for accreditation
(which includes a request from a laboratory to add testing methods to
its scope of accreditation) from a laboratory, and the recognized
accreditation body granted accreditation for certain testing methods in
the laboratory's request but denied accreditation for other testing
methods in the laboratory's request, proposed Sec.  1.1123 would only
require that a recognized accreditation body provide us with a single
notification encompassing this information, as long as the notification
includes all of the information that would be required under proposed
Sec.  1.1123(c)(2) and (3).
    Proposed Sec.  1.1123(c)(2) and (3) would require the notification
to include the scope of accreditation requested by the laboratory, the
scope of accreditation granted and/or denied, and the ground for such
denial, and the date of such grant. This information would be useful
for our program oversight. For example, it would allow us to monitor
accreditation activities, including situations where a laboratory
appears to be successively applying for, and being denied,
accreditation from different recognized accreditation bodies without
changing its practices or application to remedy the basis or bases for
the previous denial(s).
    Proposed Sec.  1.1123(c)(4) would require a recognized
accreditation body to notify us immediately if it receives notice that
an accredited laboratory it accredits intends to relinquish its
accreditation (in-whole or in-part). Proposed Sec.  1.1123(c)(4) would
also require such notification to include the scope of accreditation to
which the relinquishment applies, and the effective date of the
relinquishment.
    Proposed Sec.  1.1123(c)(5) would require a recognized
accreditation body to notify us immediately when it withdraws (in-whole
or in-part) its accreditation of a laboratory. Proposed Sec.
1.1123(c)(5) would also require such notification to include the scope
of accreditation to which the withdrawal applies, and the grounds for
the withdrawal.
    Proposed Sec.  1.1123(c)(6) would require a recognized
accreditation body to notify us immediately when it puts an accredited
laboratory on probation. Proposed Sec.  1.1123(c)(6) would also require
such notification to include the grounds for the probation, and any
date by which the recognized accreditation body has determined the
accredited laboratory must take appropriate corrective action.
    Having information on the reason(s) for probation or withdrawal of
accreditation, and whether such withdrawal is in-whole or in-part, is
important to us because it may affect whether and how we conduct any
followup actions with regards to the laboratory in question or how we
review food testing results from the laboratory in the future.
    Proposed Sec.  1.1123(c)(7) would require recognized accreditation
bodies to notify us immediately when the recognized accreditation body
knows that an accredited laboratory it accredits has committed fraud or
submitted material false statements to FDA. We note that we would also
typically expect the recognized accreditation body to initiate its
process to withdraw accreditation of the laboratory in this
circumstance (in accordance with ISO/IEC 17011:2017 (Ref. 12) section
7.11.2). Proposed Sec.  1.1123(c)(7) would require the notification to
include a description

of the basis for the accreditation body's knowledge of the fraud or
material false statements, a description of the alleged fraud or
material false statements, and the actions taken by the accreditation
body with respect to such laboratory. Recognized accreditation bodies
may be in a better position than us in many cases to determine whether
an accredited laboratory has committed fraud or submitted material
false statements to the FDA, due to recognized accreditation bodies'
role in monitoring the laboratories they accredit. Furthermore,
although proposed Sec.  1.1152(j) would require accredited laboratories
to immediately notify us of any changes that would affect an accredited
laboratory's compliance with the program requirements or that would
otherwise affect the laboratory's accreditation, an accredited
laboratory that has committed fraud or submitted material false
statements to us may be unlikely to notify us that it did so.
7. What records requirements must a recognized accreditation body meet?
(Proposed Sec.  1.1124)
    This proposed rule identifies specific types of records a
recognized accreditation body would be required to control and maintain
to document compliance with applicable requirements. The recognized
accreditation body also would be required to provide FDA access to such
records.
    Proposed Sec.  1.1124(a) provides that, in addition to meeting the
records requirements of ISO/IEC 17011:2017 (as required by proposed
Sec.  1.1118(b)), an accreditation body that has been recognized must
electronically maintain records demonstrating its compliance with the
program, created while it is recognized, for 5 years after the date of
creation of the record. The requirements of Sec.  1.1124 would apply to
accreditation bodies that have been recognized even if they later are
no longer recognized. We are proposing this requirement because
maintenance of such records could be vital to our management of this
program.
    We are not proposing to require records subject to this proposed
section to be maintained in English. In accordance with our position on
this issue in the accredited third-party certification final rule, we
are proposing to allow recognized accreditation bodies to maintain and
submit records in languages other than English, provided that they
electronically submit an English translation within a reasonable time
thereafter. We decline to set a specific timeframe for submission of
the translation because the circumstances surrounding each request will
differ (e.g., varying number of documents/pages). Further, we are
proposing under Sec.  1.1124(b) to require that if FDA requests records
electronically, the records must be submitted no later than 10 business
days after the date of the request, with the exception that records
covered by the immediate notification provision in Sec.  1.1123(c)
would be required to be submitted within 48 hours. By allowing records
to be submitted in a language other than English, we think that it will
not be unduly burdensome for recognized accreditation bodies to provide
most requested records electronically within 10 days.
    We have tentatively concluded that the records maintenance and
access requirements in proposed Sec.  1.1124 are necessary for us to
adequately monitor recognized accreditation bodies, as we are directed
to do by section 422(a)(7) of the FD&C Act. For example, access to such
records could facilitate our determination of whether revocation of the
accreditation body's recognition is warranted.
    Proposed Sec.  1.1124(c) further clarifies that recognized
accreditation bodies must not prevent or interfere with FDA's access to
the records accredited laboratories it accredits are required to
maintain under proposed Sec.  1.1153. When FDA requests, under proposed
Sec.  1.1153 or proposed Sec.  1.1159, that a laboratory submit or
provide FDA access to records the laboratory would be required to
maintain under proposed Sec.  1.1146(b) or proposed Sec.  1.1153, we
expect that the recognized accreditation body that accredits the
laboratory would not interfere with our access to such records.
Maintaining freedom of access to such records is important to
facilitate FDA's ability to provide general oversight of the food
testing program, with respect to both recognized accreditation bodies
and accredited laboratories.
8. What internal audit requirements must a recognized accreditation
body meet? (Proposed Sec.  1.1125)
    Proposed Sec.  1.1125 would require a recognized accreditation body
to audit its compliance with the requirements under Sec.  1.1118(c) and
(d) as part of the internal audit that a recognized accreditation body
conducts under Sec.  1.1118(b). Requiring recognized accreditation
bodies to monitor their conformance to the requirements that are
specific to this program, as well as to the requirements of ISO/IEC
17011:2017, would ensure that accreditation bodies' internal audits
cover all the requirements of this program. As discussed, proposed
Sec.  1.1123(b)(1) would require the results of this audit to be
submitted to us.

E. Proposed Provisions About Procedures for Recognition of
Accreditation Bodies (Proposed Sec. Sec.  1.1128 Through 1.1133)

    In these sections we propose how an accreditation body may apply
for recognition under this rule, propose procedures for recognition,
probation, revocation, and relinquishment of recognition of
accreditation bodies, and propose how FDA would oversee recognized
accreditation bodies.
1. How does an accreditation body apply to FDA for recognition or
renewal of recognition? (Proposed Sec.  1.1128)
    This proposed rule would establish procedures for accreditation
bodies to follow when applying to FDA for recognition or renewal of
recognition. Proposed Sec.  1.1128(a) would provide that an
accreditation body seeking recognition must submit an application to
FDA demonstrating that it meets the eligibility requirements of
proposed Sec.  1.1113, which describes the proposed requirements for
accreditation bodies to become recognized to accredit laboratories to
conduct food testing under this program.
    Similarly, proposed Sec.  1.1128(b) would require an accreditation
body seeking renewal of its recognition to submit a renewal application
to us demonstrating that it continues to meet the requirements of this
program.
    Proposed Sec.  1.1128(c) clarifies that accreditation bodies
applying for recognition or renewal of recognition must submit
documentation of conformance with ISO/IEC 17011:2017, and documentation
of ILAC MRA signatory status demonstrating competence to ISO/IEC
17011:2017, in meeting the requirements of proposed Sec.  1.1113(a) and
(b) or proposed Sec.  1.1118(a) and (b), as applicable. Although we
recognize that documentation of ILAC MRA signatory status under this
program represents a determination that an accreditation body has
demonstrated competence to ISO/IEC 17011:2017, proposed Sec.  1.1128(c)
would require independent documentation that an accreditation body
demonstrates competence to ISO/IEC 17011:2017 to provide us additional
assurance that an accreditation body meets the specific requirements of
the standard. Independent documentation of ISO/IEC 17011:2017
competence could include the report of a peer evaluation by a regional
cooperation group or ILAC conducted as part of the

ILAC MRA application and evaluation process. An accreditation body
applying for recognition or renewal of recognition also would be
required to submit documentation demonstrating it meets the
requirements for accreditation bodies that are specific to this program
under proposed Sec.  1.1113(c) and (d) or proposed Sec.  1.1118(c) and
(d), as applicable. We would expect documentation of proposed Sec.
1.1113(c) and (d) to come in the form of documents such as standard
operating procedures, records procedures, the resumes of the scientific
and technical staff or contractors who review validation and
verification studies, and examples of contracts the accreditation body
uses in its activities, while documentation of proposed Sec.  1.1118(c)
and (d) would consist of documents created during the accreditation
body's term of recognition, such as the internal audit required under
proposed Sec.  1.1125. We request comments on what additional documents
would demonstrate that an accreditation body meets the requirements of
proposed Sec.  1.1113(c) and (d) and proposed Sec.  1.1118(c) and (d).
    Where the application for recognition or renewal of recognition
does not sufficiently demonstrate that the accreditation body meets the
requirements for recognition by FDA, it may be necessary for FDA to
review additional documentation to determine whether the accreditation
body meets the recognition requirements of the program, and FDA also
may, as is noted by proposed Sec.  1.1129(b), request and conduct an
onsite assessment of the applicant if necessary. Such additional
documentation may include the accreditation body's reviews,
assessments, and investigations of laboratories; results of the
accreditation body's self-monitoring and internal audits; documents and
other information regarding the accreditation body's authority,
qualifications (including the expertise and training of its employees
that assess laboratories that conduct food testing), resources, quality
assurance program, and recordkeeping, reporting, notification, and
monitoring procedures. For applications for renewal of recognition, FDA
may also review documents and other information of one or more of the
laboratories that are accredited by the recognized accreditation body.
    Applications for recognition and renewal are subject to certain
requirements for the form and manner of submission. Under paragraphs
(d) and (e) of proposed Sec.  1.1128 the accreditation body must submit
to FDA a signed application (signed by the applicant or by an
individual authorized to act on behalf of the applicant for purposes of
seeking recognition or renewal of recognition), accompanied by any
supporting documents, electronically and in English. We also propose to
require an applicant to provide any translation or interpretation
services we need to process the application. This may include providing
translators or interpreters for FDA staff conducting onsite assessments
of the applicant. We invite comment on our proposal to require
submissions in English and to require translation or interpretation
services as necessary.
2. How will FDA review applications for recognition and applications
for renewal of recognition? (Proposed Sec.  1.1129)
    Under proposed Sec.  1.1129(a), FDA would review an accreditation
body's recognition or renewal application for completeness and would
notify the applicant of any deficiencies. We are proposing to review
applications on a first-in, first-out basis according to the date the
accreditation body submits the completed application. However, we may
prioritize the review of specific applications based on program needs.
To encourage applicants to supply any missing information promptly, we
will not place an application in the queue for review until it is
complete. Allowing incomplete applications in the queue might hold up
applications that are ready for review, but were submitted later in
time.
    Under proposed Sec.  1.1129(b), FDA would evaluate applications to
determine whether the applicant meets the requirements for recognition
or renewal of recognition. The evaluation may include an onsite
assessment of the accreditation body. For renewal applications, if FDA
does not reach a final decision before an accreditation body's
recognition terminates by expiration, FDA may extend the terms of
recognition for a specified period of time or until FDA reaches a final
decision on the renewal application. Proposed Sec.  1.1129(b) further
provides that FDA would notify the applicant, in writing, regarding
whether the application has been approved or denied, and that we may
make such notification electronically.
    Under proposed Sec.  1.1129(c), we would notify applicants of our
decision to approve the application for recognition or renewal through
issuance of recognition that would list any conditions associated with
the recognition, including the duration of recognition.
    Proposed Sec.  1.1129(d) would allow us to grant recognition to an
accreditation body for up to 5 years at a time (except if FDA needs to
extend the term of recognition while it makes a renewal determination,
as described at proposed Sec.  1.1129(b)), although we will determine
the length of recognition on a case-by-case basis. We are proposing the
5-year upper limit in accordance with section 422(a)(7) of the FD&C
Act, which requires us to (in pertinent part), periodically, and in no
case less than once every 5 years, reevaluate accreditation bodies
recognized under this program to assess whether they meet the criteria
for recognition. We do not necessarily expect to grant every
recognition at the maximum 5-year duration. We believe that shorter
terms of recognition may potentially be appropriate in the initial
years of the food testing program or for any accreditation bodies with
fewer years of experience accrediting laboratories to conduct food
testing. When we proposed the same duration for recognition of
accreditation bodies for the accredited third-party certification
regulation, we received support for the proposal and for the
flexibility to determine the length of recognition on a case-by-case
basis, although we also did receive some comments expressing concern
that we did not propose a fixed duration of recognition (80 FR 74570 at
74601). As we noted in the accredited third-party certification final
rule, where appropriate, we would grant recognition for the maximum
duration of 5 years. Id. However, we also recognize it may be
appropriate for the duration of recognition to vary depending on a
number of factors, such as accreditation body experience and, for
example, whether the accreditation body has had problems meeting the
recognition requirements in the past.
    Under proposed Sec.  1.1129(e), if we deny a recognition or renewal
application, we would notify the applicant, through an issuance of a
notification of denial of recognition or denial of renewal application,
that the accreditation body's recognition or renewal application has
been denied. The notification of denial of recognition or denial of
renewal application would state the basis for the denial and describe
the procedures for requesting reconsideration of the application under
Sec.  1.1171.
    Proposed Sec.  1.1129(f) provides that an applicant whose
application for renewal or recognition was denied by FDA must notify
FDA electronically, in English, within 10 business days of the date of
issuance of a denial of a renewal application, of the name and contact
information of the custodian who will maintain the records it is
required to

maintain under proposed Sec.  1.1124(a) and to make them available to
FDA as required by proposed Sec.  1.1124(b). Proposed Sec.  1.1129(f)
would also require that 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.  1.1124 will be located. As noted
previously, under proposed Sec.  1.1124 accreditation bodies that have
been recognized must electronically maintain, for at least 5 years
after the date of creation of the records, records subject to proposed
Sec.  1.1124 that were created during the term of recognition.
    Under proposed Sec.  1.1129(g), FDA would promptly issue a notice
of the denial of the application for renewal of recognition of the
accreditation body to all laboratories accredited by the accreditation
body whose application for renewal of recognition was denied.
    Under proposed Sec.  1.1129(h), FDA would provide public notice on
the website described in proposed Sec.  1.1109 of the issuance of a
denial of a renewal application and include the date of the issuance of
the denial of a renewal application. This is the same approach we took
in the accredited third-party certification regulation with respect to
denials of renewal applications. See 21 CFR 1.631(h). We believe
notification of denial of renewal would be important information to
make easily available to interested parties and the public.
3. How will FDA oversee recognized accreditation bodies? (Proposed
Sec.  1.1130)
    As noted above, section 422(a)(7)(A) of the FD&C Act requires us to
periodically, and in no case less than once every 5 years, reevaluate
recognized accreditation bodies. Section 422(a)(7)(B) of the FD&C Act
requires us to promptly revoke the recognition of a recognized
accreditation body for failure to meet the requirements of section 422
of the FD&C Act.
    As we discuss above, proposed Sec.  1.1129(d) provides that we may
grant recognition of an accreditation body for a period not to exceed 5
years from the date of recognition. Proposed Sec.  1.1130(a) provides
that we will assess each recognized accreditation body to determine its
compliance with the applicable requirements of this proposed rule by no
later than 4 years after the date of recognition for a 5-year
recognition period, or by no later than the midterm point for a
recognition period of less than 5 years. Accordingly, we propose to
assess recognized accreditation bodies at least once during their
period of recognition, in addition to any assessment we may have
conducted during our review of an application for recognition and in
addition to any assessment we may conduct during a review of an
application for renewal of recognition. Proposed Sec.  1.1130(a)
provides that our assessment of a recognized accreditation body may
include review of records, an onsite assessment of the accreditation
body, and onsite assessments of accredited laboratories the recognized
accreditation body accredits, with or without the recognized
accreditation body present (we would conduct such onsite assessments
under proposed Sec.  1.1159).
    Proposed Sec.  1.1130(b) provides that we may conduct additional
assessments of a recognized accreditation body, at any time, to
determine the recognized accreditation body's compliance with the
applicable requirements of the program. We may or may not notify the
recognized accreditation body that we will be conducting such an
assessment, which may be onsite.
    Our assessments of recognized accreditation bodies under proposed
Sec.  1.1130 may be as brief or as extensive as is warranted and may
include our review of an accreditation body's accreditations,
assessments, and investigations of laboratories; results of an
accreditation body's internal audits; documents and other information
accreditation bodies are required maintain under Sec. Sec.  1.1118 and
1.1124 regarding the accreditation body's authority, qualifications,
resources, quality assurance program, and recordkeeping, reporting,
notification, and monitoring procedures.
4. When will FDA revoke the recognition of an accreditation body or put
a recognized accreditation body on probation? (Proposed Sec.  1.1131)
    This proposed rule would establish the criteria and procedures for
revocation of recognition of an accreditation body. Section
422(a)(7)(B) of the FD&C Act requires us to 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. Accordingly, if a
recognized accreditation body ceases to meet the criteria for
recognition we establish under section 422 of the FD&C Act, we must
revoke the recognized accreditation body's recognition.
    Under proposed Sec.  1.1131(a), we would revoke the recognition of
an accreditation body if it fails to meet the requirements of this
program, or where FDA determines the accreditation body has committed
fraud or submitted material false statements to FDA.
    Examples of what would qualify as a failure by a recognized
accreditation body to meet the requirements of this program would
include:
     Refusing to allow FDA to access records as required by
proposed Sec.  1.1124, to allow FDA to conduct an onsite assessment
under proposed Sec.  1.1130, or to allow FDA to otherwise conduct an
assessment under proposed Sec.  1.1130. Denial of access and ability to
perform our oversight functions would prevent us from meeting our
statutory responsibilities under section 422 of the FD&C Act to
periodically reevaluate accreditation bodies and to promptly revoke the
recognition of an accreditation body found not to be in compliance with
section 422 of the FD&C Act.
     Demonstrating bias or lack of objectivity when conducting
activities under this rule would violate the impartiality requirements
of ISO/IEC 17011:2017, which recognized accreditation bodies must meet
in accordance with Sec.  1.1118(b).
     Failing to take timely and appropriate corrective action
in accordance with ISO/IEC 17011:2017 (Ref. 12) section 9.5 (which
proposed Sec.  1.1118(b) of this rule would require the recognized
accreditation body to comply with) after the recognized accreditation
body identifies, or should have identified, that the recognized
accreditation body is not operating in conformance with one or more
requirements of this proposed rule.
    Fraud or the submission of material false statements by recognized
accreditation bodies would undermine our ability to implement the
program and would undermine the program's integrity and credibility. We
request comment on whether this section should also allow for FDA to
revoke a recognized accreditation body's recognition for ``other good
cause.'' If you submit a comment in favor of adding such a provision,
we request the comment provide one or more examples of what would
constitute such other good cause (and yet would not otherwise support
revocation under the proposed Sec.  1.1131(a)).
    Proposed Sec.  1.1131(b)(1) provides that, when we revoke an
accreditation body's recognition we would notify the accreditation body
that its recognition has been revoked through the issuance of a
revocation stating the grounds for revocation, the procedures for
requesting a regulatory hearing on the revocation under proposed Sec.
1.1173, and the procedures for requesting reinstatement of recognition
under proposed Sec.  1.1133.

    Proposed Sec.  1.1131(b)(2) would require the accreditation body
to, within 10 business days of the date of issuance of revocation,
notify us electronically, in English, of the name of the custodian who
will maintain records and make them available to FDA as required by
proposed Sec.  1.1124. Proposed Sec.  1.1131(b)(2) further provides
that the contact information for the custodian must include, at a
minimum, an email address and the street address where the records will
be located. As we have discussed previously, the accreditation body's
responsibility under this proposed rule to maintain certain records
created while it was recognized does not end when the accreditation
body is no longer recognized.
    Proposed Sec.  1.1131(c) provides that if we determine that a
recognized accreditation body has demonstrated deficiencies in
performing its functions under this proposed rule that are less serious
and more limited than those identified in proposed Sec.  1.1131(a), and
it is reasonably likely that the accreditation body will be able to
correct such deficiencies within a reasonable period of time, we may
temporarily put the recognized accreditation body on probation, rather
than revoke its recognition, and request that the accreditation body
take appropriate corrective actions. We expect that the probationary
status of a recognized accreditation body would allow us to work with
the recognized accreditation body to bring it into compliance with the
requirements of the program without having to resort to the more
permanent remedy of revoking recognition.
    Proposed Sec.  1.1131(d) provides that the probationary status of
the recognized accreditation body would remain in effect until the
recognized accreditation body demonstrates to our satisfaction that it
has successfully addressed the deficiencies specified by FDA within the
time period identified by FDA. Proposed Sec.  1.1131(d) also provides
that, alternatively, the probationary period would end if we determine
that revocation of recognition is warranted. We would likely determine
that revocation of recognition is appropriate if the accreditation body
fails or refuses to take appropriate corrective actions, or otherwise
does not comply with the conditions specified by the notification of
probation within the timeframe specified, or if appropriate, an
otherwise reasonable timeframe.
    Proposed Sec.  1.1131(e) provides that if we put the recognized
accreditation body on probation, we would formally notify the
accreditation body of its probation. The notification would describe
the grounds for the probation, identify all deficiencies that must be
corrected for us to lift the probation, would identify a specified
period of time to take certain corrective actions to address the
deficiencies specified by us.
    Proposed Sec.  1.1131(f) would provide that an accreditation body
that has had its recognition revoked may not accredit laboratories
under this program or continue to oversee the laboratories it has
previously accredited. This provision would also clarify that a
recognized accreditation body that has been put on probation by FDA is
expected to continue to oversee laboratories that it has accredited
under this subpart and is permitted to continue to accredit
laboratories under Sec.  1.1120 of this subpart. We would normally
anticipate that such an accreditation body would continue to fulfill
its responsibilities under this program during the probationary period.
Note that FDA may conduct additional oversight of recognized
accreditation bodies that are on probation, to help ensure quality and
competency on the part of that particular accreditation body (and by
extension for the integrity of the overall program).
    Proposed Sec.  1.1131(g) provides that FDA would issue a notice of
the probation or revocation of recognition to all laboratories
accredited by the accreditation body whose recognition was revoked or
who was put on probation. In proposed Sec.  1.1164, we address the
effects on accredited laboratories of the revocation of the recognition
of their accreditation bodies.
    Proposed Sec.  1.1131(h) clarifies that we would also provide
notice on the website described in proposed Sec.  1.1109, in accordance
with proposed Sec.  1.1109, of our issuance of probation or revocation
of recognition of the accreditation body. This is consistent with the
provisions of proposed Sec.  1.1109.
    We solicit comments on our tentative conclusions regarding possible
grounds for probation and revocation of recognition, and with respect
to the procedures and requirements we have proposed here related to
revocation and probation of recognition.
5. What must a recognized accreditation body do if it wants to
voluntarily relinquish its recognition or does not want to renew its
recognition? (Proposed Sec.  1.1132)
    Proposed Sec.  1.1132 requires a recognized accreditation body that
voluntarily relinquishes its recognition before the recognition period
terminates by expiration to follow certain procedures. Relinquishment
on the initiative of the accreditation body is distinct from revocation
of recognition under proposed Sec.  1.1131 and is a mechanism provided
to recognition bodies in the accredited third-party certification
regulation and under FDA's mammography program. See 21 CFR 1.635 and 21
CFR 900.3(e). We are proposing certain procedural requirements, similar
to those in the mammography and third-party accreditation programs,
which accreditation bodies would be required to follow in relinquishing
recognition or when a recognized accreditation body intends to allow
its recognition to expire without seeking renewal. We believe these
procedures are necessary to ensure an orderly transition for
laboratories accredited by an accreditation body that is relinquishing
its recognition or allowing it to expire and for us to make necessary
adjustments in the program based on that relinquishment or expiration.
    Proposed Sec.  1.1132(a) describes the procedures that a recognized
accreditation body would need to follow when it intends to relinquish
its recognition or when it wishes to allow its recognition to expire
without seeking renewal. In order to voluntarily relinquish its
recognition or allow it to expire, a recognized accreditation body
would need to notify FDA electronically and in English at least 60 days
before voluntarily relinquishing its recognition or allowing its
recognition to expire.
    Proposed Sec.  1.1132(a) would also require the recognized
accreditation body to provide the name and contact information of the
custodian who will maintain the records required under proposed Sec.
1.1124 after the date of relinquishment or the date its recognition
expires, as applicable, and make such records available to FDA as
required by proposed Sec.  1.1124. 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.  1.1124 will be
located.
    Under proposed Sec.  1.1132(b), we would require the accreditation
body to notify the laboratories it had accredited that the
accreditation body intends to relinquish its recognition or to allow
its recognition to expire, specifying the date on which relinquishment
or expiration will occur, and at least 60 days in advance.
    Proposed Sec.  1.1132(c) states that we would provide notice on the
website described in proposed Sec.  1.1109 of the voluntary
relinquishment or expiration of recognition of an accreditation body.
This provision is consistent with the provisions of proposed Sec.
1.1109, which

would establish what information we would display on the website
described by Sec.  1.1109.
6. How does an accreditation body request reinstatement of recognition?
(Proposed Sec.  1.1133)
    This proposed section describes the procedures that an
accreditation body would have to follow when seeking reinstatement of
its recognition. The procedures the accreditation body would be
required to follow would differ depending on whether we revoked the
accreditation body's recognition or the accreditation body voluntarily
relinquished its recognition or allowed its recognition to expire.
    Under proposed Sec.  1.1133(a), an accreditation body that has had
its recognition revoked may seek reinstatement of recognition by
submitting a new application for recognition under proposed Sec.
1.1128. The accreditation body must also submit evidence to us that the
grounds for revocation have been resolved, including evidence
addressing the cause(s) or condition(s) that were the basis for
revocation, and it must identify measures it implemented to help ensure
that such cause(s) or condition(s) are unlikely to recur.
    Under proposed Sec.  1.1133(b), an accreditation body that
previously relinquished its recognition or allowed its recognition to
expire may seek recognition by submitting a new application for
recognition under proposed Sec.  1.1128.

F. Proposed Provisions About Accreditation of Laboratories (Proposed
Sec.  1.1138)

    This proposed rule would establish the requirements for a
laboratory seeking accreditation by a recognized accreditation body to
test food in this program. Section 422(a)(2) and (a)(5) of the FD&C Act
mention independent private laboratories, laboratories run and operated
by Federal agencies, States, localities, and foreign laboratories, as
examples of laboratories that recognized accreditation bodies may
accredit under this program, so long as they meet accreditation
requirements for our program. We expect a variety of these types of
laboratories would apply to this program. With regard to States in
particular, it is our understanding that State and public university
laboratories currently conduct a significant portion of the shell egg
testing which would be covered by this proposed rule. We therefore
believe some state laboratories would apply.
    Section 422 of the FD&C Act contains requirements for laboratories
to be accredited, including that they have a demonstrated capability to
conduct one or more sampling and analytical testing methodologies for
food (section 422(a)(2)) and that they meet model laboratory standards
that FDA is required to develop (section 422(a)(6)).
    Section 422(a)(6) of the FD&C Act further requires that the model
laboratory standards include methods to ensure that: (1) Appropriate
analytical procedures (including rapid analytical procedures), and
commercially available techniques are followed and reports of analyses
are certified as true and accurate (section 422(a)(6)(A)(i)); (2)
internal quality systems are established and maintained (section
422(a)(6)(A)(ii)); (3) procedures exist to evaluate and respond
promptly to complaints regarding analyses and other activities for
which the laboratory is accredited (section 422(a)(6)(A)(iii)); and (4)
individuals who conduct the analyses are qualified by training and
experience to do so (section 422(a)(6)(A)(iv)). Section 422(a)(6)(B) of
the FD&C Act also authorizes us to include in the model laboratory
standards any other criteria we determine are appropriate.
    Section 422(a)(6) of the FD&C Act directs us to consult existing
standards for guidance in developing the model laboratory standards for
use in qualifying laboratories for accreditation. As discussed, we have
consulted, and propose to incorporate by reference, ISO/IEC 17025:2017.
The model laboratory standards we are proposing consist of ISO/IEC
17025:2017, which laboratories would be required to meet (except for a
few provisions, as we discuss in more detail below) to become
accredited in accordance with proposed Sec.  1.1138(a)(2), and our
additional proposed requirements in Sec. Sec.  1.1146 through 1.1158.
For example, ISO/IEC 17025:2017 (Ref. 13) section 7.9 requires
accredited laboratories to establish a process for evaluating and
responding to complaints, which we tentatively conclude would fulfill
the model laboratory standard requirement of section 422(a)(6)(A)(iii)
of the FD&C Act.
    We carefully considered whether to include a sampling accreditation
requirement in the proposed rule. Proper sampling procedures are
essential in order for analytical testing results to convey meaningful
information about the food product or environment at issue.
Accreditation for sampling could increase confidence in the training
and procedures of samplers and potentially help ensure the collection
of representative samples.
    According to our analysis (Ref. 1) of the applicable data stored in
our internal systems, from January 1, 2016, to December 31, 2017,
approximately 63 percent of sampling conducted for analysis in support
of admission of food offered for import that we had detained without
physical examination was conducted by five entities accredited for
sampling under ISO/IEC 17025. Approximately 37 percent of such sampling
conducted during that time was conducted by more than 300 entities not
accredited for sampling under any standard.
    It is our understanding that whereas under the 2005 version of ISO/
IEC 17025 only laboratories are eligible for accreditation, starting
with the 2017 version of ISO/IEC 17025, entities that do not conduct
any analyses (i.e., an entity that solely collects samples) may be
considered for accreditation for sampling under ISO/IEC 17025. It is
also our understanding that it will take some time to develop and
implement this new policy. Some of the larger laboratory accreditation
bodies in the United States indicated that demand for accrediting
entities that only conduct sampling is still relatively small, and thus
far, these accreditation bodies have not performed accreditation
assessments of such entities. (See Meeting Minutes, ``Sampling
Accreditation Discussion with A[ccreditation] B[odie]s,'' November 13,
2017 (Ref. 14).) As the ISO/IEC 17025 revision is still relatively new,
FDA is not able to adequately assess the accreditation of entities that
only conduct sampling at this time.
    Given these considerations, we are not proposing requirements for
the accreditation of sampling in this proposed rule. However, we
strongly encourage all samplers to consider accreditation, and we may
reassess our position after accreditation bodies have gained experience
with accrediting entities that only conduct sampling. We will watch
developments in this area with interest, and would be willing to
consider expanding the proposed program to include accreditation of
laboratories and sampling services to perform sampling in the future.
    While we are not proposing requirements for accreditation of
samplers, we invite comment on the matter. More specifically, what is
the current capacity of accredited sampling entities, both laboratories
and sampling services (i.e., entities that only perform sampling)? Are
there attributes unique to sampling that present challenges in terms of
the continued development of this field? What existing standards (e.g.,

ISO/IEC 17025, ISO 9001, ISO/IEC 17020) would be best to use as a basis
for developing a more comprehensive and focused consensus sampling
standard? What are the critical detailed requirements that should be
included in a consensus sampling standard to ensure food safety? What
standards are currently employed to assess samplers, are they
effective, and in what ways are they insufficient?
    We note that because we are not proposing accreditation for
sampling under this proposed rule, we would not expect laboratories
seeking to become accredited under this program to demonstrate the
capability to conduct sampling methods under this program if finalized.
If we were to propose to require accreditation for sampling under the
authority of section 422 of the FD&C Act in the future, at that time we
would likely propose that entities seeking to become accredited for
sampling would have to demonstrate the capability to conduct one or
more methods of sampling for food testing.
What requirements must a laboratory meet to become accredited by a
recognized accreditation body? (Proposed Sec.  1.1138)
    Proposed Sec.  1.1138 states the requirements a laboratory must
meet to be accredited by a recognized accreditation body to conduct
food testing under this program.
    Section 422(a)(2) of the FD&C Act requires, in pertinent part, that
this program provide for the accreditation of laboratories with a
demonstrated capability to conduct one or more analytical testing
methodologies for food and section 422(b)(1) of the FD&C Act requires,
in pertinent part, that food testing under this program be conducted by
laboratories that have been accredited for the appropriate analytical
testing methodology. We have considered these two provisions and
propose to interpret section 422(b)(1) as requiring laboratories to be
accredited on a method-specific basis, and to interpret section
422(a)(2) of the FD&C Act to mean that a laboratory may become
accredited even if it seeks to be accredited for a single method.
Accordingly, proposed Sec.  1.1138(a)(1) would require that a
laboratory seeking to be accredited must demonstrate that it is capable
of conducting each method of food testing for which it seeks to be
accredited. The laboratory would have to do so by meeting the
requirements described under proposed Sec.  1.1138(a)(1)(i) and (ii).
    Proposed Sec.  1.1138(a)(1)(i) and (ii) clarify how an accredited
laboratory must demonstrate it is capable of conducting each method for
which it seeks to be accredited. Proposed Sec.  1.1138(a)(1)(i)
provides that a laboratory must do so by submitting information related
to validation or verification studies.
    Validation studies are required in certain circumstances by ISO/IEC
17025:2017 (Ref. 13) section 7.2, which we have already incorporated by
reference, but which we would explicitly require in proposed Sec.
1.1151(c)(1). For example, a validation study would be required when a
laboratory seeks to be accredited for a non-standard method or for a
standard method it will use outside the method's intended application.
Validation is meant to demonstrate that a method is suitable for the
intended purpose.
    Method verification is meant to verify that the laboratory can
properly apply the method for a specific intended use, specifically
with respect to the limit of detection or probability of detection. We
would require verification studies in proposed Sec.  1.1151(d)(1), and
proposed Sec.  1.1151(d)(2) would require an accredited laboratory to
record certain information related to a verification study (e.g., the
results of the verification, supporting analytical data) (we discuss
proposed Sec.  1.1151(d)(1) and (2) in more detail in section VI.G.7).
Under this program, a laboratory may demonstrate that it is capable of
conducting a particular method by submitting to the recognized
accreditation body the verification study information required in
proposed Sec.  1.1151(d)(2).
    To be clear, under this program a laboratory may fulfill the
requirements of proposed Sec.  1.1138(a)(1)(i) by submitting to the
recognized accreditation body either validation study information or
verification study information.
    Proposed Sec.  1.1138(a)(1)(ii) provides that the laboratory must
also, in order to demonstrate it is capable of conducting a method of
food testing for which it seeks to be accredited, pass, or have passed
within the past year, a proficiency test for the method(s), subject to
the exception that if the laboratory determines there is no proficiency
testing program available that addresses the method, or that
proficiency testing for the method is otherwise impracticable, the
accredited laboratory may instead subject, or have subjected in the
past year, the method to an appropriate comparison program. This
proposed requirement and exception reflect a similar requirement and
exception in AOAC International's Guidelines for Laboratories
Performing Microbiological and Chemical Analyses of Food, Dietary
Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC
17025:2005 (April 2015 revision) (AOAC 17025 Guidelines) (Ref. 9) at
section 5.9.1. Proposed Sec.  1.1138(a)(1)(ii) further provides that
the laboratory's determination there is no proficiency testing program
available that addresses the method must be reviewed, and approved or
denied (as appropriate), by the recognized accreditation body from
which the laboratory is seeking accreditation. For more information
about the exception in proposed Sec.  1.1138(a)(1)(ii), please see our
discussion of proposed Sec.  1.1148(a)(2) below at section VI.G.3.
    Under proposed Sec.  1.1138(a)(2) a laboratory seeking
accreditation under this program must demonstrate it meets (or, with
respect to activities the laboratory may only conduct once accredited,
is capable of meeting) the requirements of ISO/IEC 17025:2017. ISO/IEC
17025:2017 sets general standards for the competence of testing
laboratories, including general management requirements such as
impartiality and quality assurance. There are, however, a few
provisions in ISO/IEC 17025:2017 that we propose to exclude from our
requirements, as reflected in proposed Sec.  1.1138(b). Section 7.3 of
ISO/IEC 17025:2017 (Ref. 13), which addresses sampling, would be
excluded because, as discussed previously, we are not proposing
accreditation of sampling (see the introduction to section VI.F for
additional discussion of this issue). We also are not proposing to
require laboratories to meet ISO/IEC 17025:2017 section 7.8, which
describes requirements for reporting test results to customers, to
avoid potential conflicts with proposed Sec.  1.1152, which contains
requirements for the food testing results and supporting documentation
that are necessary for us to assess the validity of food testing
conducted under this program. We are also proposing in Sec.  1.1138(b)
that laboratories seeking accreditation are not required to meet, or
demonstrate that they are capable of meeting, requirements of ISO/IEC
17025:2017 that relate to the relationship between the laboratory and
its customers, to the extent that such provisions establish obligations
that conflict with the requirements of this rule. For example, ISO/IEC
17025:2017 section 7.1.1(d) would require the laboratory to ensure that
the methods it uses are capable of meeting the customers' requirements,
ISO/IEC 17025:2017 section <IP_ADDRESS> indicates that the laboratory's
customer may choose

the method of analysis to be used for food testing, and ISO/IEC
17025:2017 section <IP_ADDRESS> would restrict the laboratory from deviating
from a method if the customer does not accept the deviation. As such,
requiring accredited laboratories to meet all of the customer
requirement provisions of ISO/IEC 17025:2017 could create potential
conflicts with the requirements of section 422 of the FD&C Act.
    Proposed Sec.  1.1138(c) would require laboratories seeking
accreditation to demonstrate they are capable of meeting and operating
in conformance with all of this subpart's requirements for accredited
laboratories. For example, under proposed Sec. Sec.  1.1152 and 1.1153
laboratories would have to meet certain requirements specific to this
program relating to reporting, notifications, and records, and under
proposed Sec.  1.1148 laboratories would have to meet certain quality
assurance requirements specific to this program and beyond the
requirements in ISO/IEC 17025:2017. A laboratory would have to
demonstrate that it has implemented written procedures to meet those
requirements of this proposed rule so that it will be able to comply
with such requirements once it is accredited.

G. Proposed Requirements for Accredited Laboratories (Proposed
Sec. Sec.  1.1146 Through 1.1153)

    Proposed Sec. Sec.  1.1146 through 1.1153 would establish certain
model laboratory standards that accredited laboratories must meet to
remain accredited. In accordance with section 422(a)(6)(A) of the FD&C
Act, these model laboratory standards would help ensure that
appropriate analytical procedures and commercially available techniques
are followed and reports of analyses are certified as true and
accurate; internal quality systems are established and maintained;
procedures exist to evaluate and respond promptly to complaints
regarding analyses for which the laboratory is accredited; and
individuals who conduct analyses are qualified by training and
experience to do so. In accordance with section 422(a)(6)(B) of the
FD&C Act, we have also proposed additional requirements that
laboratories would have to meet to remain accredited, such as certain
requirements relating to methods of analysis, notifications and
submissions to FDA, and recordkeeping.
1. What are the general requirements for accredited laboratories to
remain accredited? (Proposed Sec.  1.1146)
    Proposed Sec.  1.1146 provides that for an accredited laboratory to
remain accredited, the accredited laboratory must be capable of
conducting each method of analysis for the testing of food for which it
is accredited, continue to conform to the applicable provisions of ISO/
IEC 17025:2017, and fulfill the additional requirements of this
subpart. For a discussion of why we believe these ISO/IEC 17205:2017
requirements are important for laboratories to meet to be accredited
under this proposed rule, please see our previous discussion of
proposed Sec.  1.1138 in section VI.F.1.
2. What impartiality and conflict of interest requirements must
accredited laboratories meet? (Proposed Sec.  1.1147)
    Proposed Sec.  1.1147 would require accredited laboratories to meet
certain requirements related to impartiality and conflicts of interest
in addition to those impartiality and conflict of interest requirements
of ISO/IEC 17025:2017 they would have to meet in accordance with
proposed Sec.  1.1146(b).
    ISO/IEC 17025:2017 contains several requirements related to
impartiality and conflicts of interest that accredited laboratories
would have to meet under proposed Sec.  1.1146(b). For example, ISO/IEC
17025:2017 (Ref. 13) section 4.1 requires the laboratory to conduct its
activities impartially and to be structured and managed so as to
safeguard impartiality, to not allow commercial, financial, or other
pressures to compromise its impartiality, and that, if a risk to
impartiality is identified, the laboratory must be able to demonstrate
how the laboratory eliminates or minimizes the risk.
    However, we have tentatively determined that additional
requirements related to impartiality and conflicts of interest are
appropriate in the context of this rule. With certain exceptions,
proposed Sec.  1.1147(a) would prohibit the accredited laboratory's
officers, employees, contractors, and agents involved in food testing
and related activities from accepting any money, gift, gratuity, or
other item of value from the owner or consignee of the food that is
being tested or will be tested by the accredited laboratory. Proposed
Sec.  1.1147(b)(1) and (2) provide the caveats that the prohibited
items of value specified in proposed Sec.  1.1147(a) do not include
payment of fees for food testing services or reimbursement of direct
costs associated with the food testing by the accredited laboratory.
With respect to accredited laboratories that are owned by the owner or
consignee of the food that is tested or to be tested, proposed Sec.
1.1147(b)(3) provides that the prohibited items of value specified in
proposed Sec.  1.1147(a) also do not include the officer's, employee's,
contractor's, or agent's compensation in the normal course of business.
    Proposed Sec.  1.1147(c) would require the owner or consignee's
payment to the accredited laboratory for food testing services and/or
reimbursement of direct costs associated with food testing to be
independent of whether the test results indicate the tested food is or
appears to be violative. It is crucial that the accredited laboratory
be able to conduct its testing without fear of receiving reduced
payment or no payment from the owner or consignee if the food testing
results are violative. We seek comment with respect to whether there
are more effective provisions that might achieve the aim of impartial
food testing.
3. What quality assurance requirements must accredited laboratories
meet? (Proposed Sec.  1.1148)
    Proposed Sec.  1.1148 would establish quality assurance
requirements accredited laboratories must meet for proficiency testing
and the use of reference materials and quality control samples, in
addition to the ISO/IEC 17025:2017 quality assurance requirements
accredited laboratories would need to meet under proposed Sec.
1.1146(b). Specifically, under proposed Sec.  1.1146(b), accredited
laboratories would have to develop, maintain, and implement a
complaints program (see ISO/IEC 17025:2017 (Ref. 13) section 7.9), a
program to control nonconforming testing work (see ISO/IEC 17025:2017
section 7.10), a program to continually improve (see ISO/IEC 17025:2017
section 8.6), a corrective action program (see ISO/IEC 17025:2017
section 8.7), an internal audit program (see ISO/IEC 17025:2017 section
8.8), a management review program (see ISO/IEC 17025:2017 section 8.9),
and policies for ensuring the validity of test results (see ISO/IEC
17025:2017 section 7.7).
    As described by ISO/IEC 17025:2017, proficiency testing evaluates
laboratory performance against established criteria. ISO/IEC 17025:2017
(Ref. 13) section 7.7.2 provides that accredited laboratories must
participate in proficiency testing and/or interlaboratory comparison
programs other than proficiency testing. ISO/IEC 17011:2017 (which
applies to accreditation bodies), indicates that the accreditation
body's review of proficiency test results may help it assess
laboratories, but ISO/IEC 17011:2017 does not require accreditation
bodies to require the laboratories they accredit to participate in a
proficiency testing program (ISO/

IEC 17011:2017 (Ref. 12) at section 3.24 n.1). Although both ISO/IEC
standards address proficiency testing, we are proposing more specific
proficiency testing requirements in this document to support the
regular evaluation of the performance of accredited laboratories in
this program.
    Proposed Sec.  1.1148(a)(1) would require accredited laboratories
to participate in a proficiency testing program or programs, provided
by a competent proficiency testing organization, and ensure that
proficiency testing is conducted at least once per year for each method
within the accredited laboratory's scope of accreditation (subject to
an exception in proposed Sec.  1.1148(a)(2), which we discuss below).
In developing proposed Sec.  1.1148(a), we considered how various
existing standards address the frequency and coverage of laboratory
proficiency testing. Some accreditation bodies that accredit food
testing laboratories require laboratories they accredit to conduct
proficiency testing on their entire scope of accreditation over a four-
year accreditation period and participate in at least one proficiency
testing activity per year. (See, e.g., ``R103--General Requirements:
Proficiency Testing for ISO/IEC Laboratories,'' American Association
for Laboratory Accreditation (Ref. 15), at p. 6; and ``Accreditation
Requirements: ISO/IEC 17025 Testing Laboratories (Non-Forensics),''
ANSI/ASQ National Accreditation Board (Ref. 16), at pp. 4-5). We note
that if only one proficiency testing activity takes place each year,
the bulk of proficiency testing for a laboratory's scope of
accreditation could occur at one time during the laboratory's
accreditation period. We tentatively conclude that requiring yearly
proficiency testing for each method on a laboratory's scope of
accreditation would encourage more periodic proficiency testing
throughout the accreditation period. This element of proposed Sec.
1.1148(a) is based on the AOAC 17025 Guidelines (Ref. 9) at section
5.9.1, which provides that laboratories participate in at least one
proficiency test annually for each ``test, type of test/method, and/or
technique on the scope of accreditation''. Periodic proficiency testing
throughout the four-year accreditation period should also help the
accredited laboratory manage its other ongoing quality assurance
activities (e.g., its control of nonconforming testing work under ISO/
IEC 17025:2017 (Ref. 13) section 7.10 and its program to continually
improve under ISO/IEC 17025:2017 section 8.6). We seek comments on our
proposed requirements for the frequency of proficiency testing.
    We are proposing to require in Sec.  1.1148(a)(1) that the
proficiency test provider be ``competent.'' We note that ISO/IEC
17043:2010, ``Conformity Assessment--General Requirements for
Proficiency Testing'' (Ref. 17) provides specific standards for
proficiency test providers. We are requesting comment on whether, and
if so, under what circumstances, we should require accredited
laboratories to only use proficiency test providers accredited to ISO/
IEC 17043 for proficiency testing under this proposed rule.
    Proposed Sec.  1.1148(a)(2) describes an exception to the proposed
proficiency testing requirement. Proposed Sec.  1.1148(a)(2) states
that if the accredited laboratory determines there is no proficiency
testing program available that addresses a particular method of
analysis in the accredited laboratory's scope of accreditation, or that
participating in a proficiency testing program for the particular
method is otherwise impracticable, the accredited laboratory may
subject that method to an appropriate comparison program. The
laboratory's determination must be reviewed, and approved or denied (as
appropriate), by the recognized accreditation body that accredits the
laboratory. The AOAC 17025 Guidelines (Ref. 9) at section 5.9.1 provide
a helpful list of examples of such alternative comparison programs.
    Proposed Sec.  1.1148(b) would require accredited laboratories to
ensure their procedures for monitoring the validity of the results of
testing it conducts under this program include the use of reference
materials or quality control samples with each batch of samples it
tests under this program. This requirement reflects a similar
requirement in the AOAC 17025 Guidelines (Ref. 9), at section 5.9.1.
ISO/IEC 17025:2017 (Ref. 13) section 7.7, which accredited laboratories
must comply with under proposed Sec.  1.1146(b), requires that
laboratories' procedures for monitoring the validity of their results
``include, where appropriate'' use of reference materials or quality
control materials. We tentatively agree with the AOAC 17025 Guidelines
that it is always appropriate to use of reference materials or quality
control samples when conducting food testing. Therefore, to encourage
clarity and consistency with respect to the use of reference materials
and quality control samples under this program, we have proposed to
adopt the AOAC 17025 Guidelines' position on this issue.
4. What oversight standards apply to sampling? (Proposed Sec.  1.1149)
    Because we are not proposing accreditation for sampling, we are not
proposing model standards for sampling. However, whether a sample is
collected and maintained properly is integral to whether analysis of
that sample will produce information that is of regulatory
significance. For example, if the analyzed sample(s) is not
representative of the food product or environment at issue, the
analysis of the sample(s) will not result in information that is
meaningful with respect to the food product or environment at issue.
Accordingly, we are proposing provisions that would allow us to
exercise oversight over the sampling conducted as part of this program.
Proposed Sec.  1.1149 would require the accredited laboratory to
develop or obtain (depending on whether the accredited laboratory or a
different entity collected the sample) and submit to FDA certain
information about the sampler and sampling before the accredited
laboratory analyzes the collected sample.
    Specifically, proposed Sec.  1.1149(a) would require that, before
the accredited laboratory analyzes the sample, it must either develop
(if it collected the sample) or obtain (if another entity collected the
sample) the following documentation:
     Written documentation of the sampler's applicable
qualifications by training and experience. If the accredited laboratory
collects the sample, the accredited laboratory would need to develop
such documentation the first time the individual collects a sample
under this subpart. If another entity collects the sample, the
accredited laboratory would need to obtain such documentation the first
time it receives a sample collected under this subpart from that
sampler. The accredited laboratory must also develop or obtain such
documentation if the accredited laboratory learns that the sampler's
qualifications have significantly changed since the accredited
laboratory last developed or obtained documentation of the sampler's
qualifications.
     A written sampling plan used to conduct the sampling. The
written sampling plan must identify the sampler and must list factors
that will be controlled to ensure the sampling does not impact the
validity of the subsequent analytical testing, including controlling
for the representational nature of the sample. This information would
help us determine whether the sampling conducted would result in a

sample that is representative of the food product or environment in
question. Identification of the sampler would allow us to determine
whether we have the sampler's qualifications on file already and/or
whether their qualifications may now be significantly different.
     A written sample collection report for each sample
collected. The written sample collection report must, at a minimum,
include:
    [cir] The product code of the food product sampled (if product is
being sampled) or the location of and a description of the environment
(if environment is being sampled). This information would help us
determine whether the correct lot or lots were sampled and whether the
sample is otherwise representative of the food product or environment
in question.
    [cir] The date(s) of the sampling. This information would help us,
in part, identify whether certain lots were sampled and help us review
the chain of custody of the sample. For example, if the sample was
collected a significant amount of time before the analysis, we may
evaluate whether the documented chain of custody procedures for the
sample would have preserved the sample's integrity.
    [cir] The size, identity, and quantity of the sample(s). This
information would help us determine whether the sample is
representative of the food product or environment in question.
    [cir] Documentation of sample collection procedures and any sample
preparation techniques. This information would help us determine
whether the sampling resulted in a sample that is representative of the
food product or environment at issue.
    [cir] Documentation of the chain of custody of the sample(s), and
of measures taken, to not impact the validity of the subsequent
analytical testing, including controlling for the representational
nature of the sample(s). This information would help us determine
whether the sample received by the laboratory is the sample that was
collected from the product or environment at issue and whether the
integrity of the collected sample was compromised between collection of
the sample and its analysis. Documentation of the chain of custody
should account for the continuous custody of the sample and indicate
any gaps in the chain of custody. Documentation of measures taken to
not impact the validity of the subsequent analytical testing, including
controlling for the representational nature of the sample(s), might
include, for example, documentation of the use of tamper-evident
containers, use of secure storage spaces, and any refrigeration or
freezing of the sample. The documentation should indicate at what point
in the chain of custody such measures were taken.
    Proposed Sec.  1.1149(b) clarifies that we may consider the
analysis of a sample to be invalid if the requirements of Sec.
1.1149(a) are not met.
5. What requirements apply to analysis of samples by an accredited
laboratory? (Proposed Sec.  1.1150)
    Proposed Sec.  1.1150 would establish standards that laboratory
analysis conducted under this proposed rule would need to meet,
procedures the analysis would need to follow, and other requirements
such as the qualifications of the individuals who perform the analysis.
Proposed Sec.  1.1150 explicitly states that accredited laboratories
must meet the requirements of this section in addition meeting to the
requirements in ISO/IEC 17025:2017 relating to analysis that an
accredited laboratory is required to meet under Sec.  1.1146(b).
    Proposed Sec.  1.1150(a) would require the analysis to be conducted
on either the sample(s) received, or, if appropriate for the analysis,
on a representative sample of the sample(s) received. Because the
sample(s) received may consist of too much material to analyze in its
entirety, a laboratory will often take a subsample(s) from the
sample(s) received. The laboratory must ensure that it follows
appropriate procedures so that the subsample(s) they analyze are
representative of the lot. For example, in some circumstances it may be
appropriate to homogenize the sample(s) by grinding, sieving, blending,
or mixing the original sample(s) and taking a subsample(s) from the
resulting mixture.
    Proposed Sec.  1.1150(b) would require that the analyst(s) that
conducts the analysis be qualified by appropriate education, training,
and/or experience to conduct the analysis; to have appropriately
demonstrated their ability to conduct the method properly in the
specific context of the food testing to be conducted; and to be in
compliance with the conflict of interest requirements of proposed Sec.
1.1146(b) (i.e., the applicable sections of ISO/IEC 17025:2017) and
proposed Sec.  1.1147. Of note, under proposed Sec.  1.1152(g)(12)
(which we discuss in more detail at section VI.G.8), the laboratory
must provide certain information about the analyst's or analysts'
qualifications to us at our request.
    Proposed Sec.  1.1150(c) clarifies that the method used to conduct
the food testing must meet the requirements of proposed Sec.  1.1151
(requirements for methods of analysis, which we discuss at section
VI.G.7).
    Proposed Sec.  1.1150(d) requires that the accredited laboratory
document the testing information and test results to the extent
necessary to account for all information that is required to be
included in a full analytical report. Please see our discussion of
proposed Sec.  1.1152(g) for more information about what information
full analytical reports must contain.
5. What requirements apply to the methods of analysis an accredited
laboratory uses to conduct food testing under this subpart? (Proposed
Sec.  1.1151)
    Food testing subject to section 422(b)(1) of the FD&C Act must be
conducted by accredited laboratories that have been accredited for the
appropriate analytical testing methodology or methodologies.'' Proposed
Sec.  1.1151 would establish certain requirements with regard to
methods of analysis, which would apply in addition to the requirements
in ISO/IEC 17025:2017 (Ref. 13) section 7.2 relating to selection,
validation, and verification of methods (under proposed Sec.
1.1146(b)).
    Proposed Sec.  1.1151(a) would require that analysis under this
program be conducted using a method(s) of analysis that: (1) Is fit for
purpose, (2) is within the accredited laboratory's scope of
accreditation, (3) has been appropriately validated for use in such
food testing, in accordance with Sec.  1.1146(b) (i.e., the applicable
ISO/IEC 17025:2017 provisions) and paragraph (c) of Sec.  1.1151, and
(4) has been appropriately verified by the accredited laboratory for
use in such food testing, in accordance with paragraph (d) of Sec.
1.1151.
    As we noted above, proposed Sec.  1.1151(a)(1) would state that all
methods of analysis used in food testing under this rule would have to
be fit for purpose, in that they may only be applied for the food
testing to which they are intended to apply and for the purpose for
which they are validated. For example, if a method of analysis was
developed and validated only for determining the presence and level of
chloramphenicol in shrimp, the method may only be used to determine the
presence and level of chloramphenicol in shrimp. The concept of fit for
purpose is related to the concept of validation, in that successful
validation of a method for a purpose for which the method had not yet
been validated would typically demonstrate that the method is in fact
fit for that purpose. For example, if the method that has

been validated only for determining the presence and level of
chloramphenicol in shrimp is subsequently validated for determining the
presence and level of chloramphenicol in fish, the method could then be
applied as fit for the purpose of determining the presence and level of
chloramphenicol in fish.
    Proposed Sec.  1.1151(a)(2) would require that the method used be
included within the accredited laboratory's scope of accreditation.
This requirement flows from section 422(a)(6) of the FD&C Act, which
requires laboratories to be accredited for the specified testing
methods they use for food testing in this program. Note that while some
of the food testing that would be covered by this program is static
(e.g., the testing of shell eggs described in Sec.  118.4(a)(2)(i))
other testing scenarios covered by this program are dynamic and will
change with different circumstances (e.g., testing to support removal
from Import Alert). Therefore, we are not proposing a defined inventory
of possible scopes; rather, under this program laboratories would be
able to become accredited for a variety of food analytical methods,
such as methods listed in the Bacteriological Analytical Manual (BAM)
of procedures preferred by FDA for the detection of pathogens and
microbial toxins in food (see https://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006949.htm).
    Proposed Sec.  1.1151(a)(3) and (4), respectively, would require
that the method must have been appropriately validated for use in the
food testing to be conducted and have been appropriately verified by
the accredited laboratory for use in such food testing. We have issued
procedures for our laboratories on these issues (e.g., ``Methods,
Method Verification and Validation,'' ORA Laboratory Manual Vol. II
Section 2, document number 5.4.5 (Ref. 18) and ``Guidelines for the
Validation of Chemical Methods for the FDA FVM Program, 2nd Edition''
(Ref. 19)), and we note that many food testing laboratories currently
adhere to voluntary consensus standards and procedures issued by
organizations, such as ISO and AOAC International, that address how to
ensure analytical methods used by the laboratory are fit for purpose
and appropriately validated and verified. Depending on the needs of the
program as it develops, in the future we may issue guidance on this
topic. Note that FDA maintains a website listing of all the FDA
regulatory methods currently being used for food and feed safety
programs, including links to other online manuals/compendia of methods
(at https://www.fda.gov/food/science-research-food/laboratory-methods-food). On that web page we also provide links to the method
development, validation, and implementation guidelines of FDA's Office
of Food Policy and Response, and a list of methods currently undergoing
validation.
    Proposed Sec.  1.1151(b) provides that with respect to food testing
conducted under proposed Sec.  1.1107(a)(1), the method or methods of
analysis (if any) prescribed by the applicable testing requirement in
the FD&C Act or implementing regulations are the only appropriate
methods for the food testing to be conducted; and with respect to food
testing conducted under proposed Sec.  1.1107(a)(2), the method or
methods of analysis (if any) prescribed by the food testing order are
the only appropriate methods for the food testing to be conducted. In
such cases, the statute, regulation, or food testing order would
dictate the appropriate method for the food testing.
    Proposed Sec.  1151.1(c)(1) would make explicit for this program
the validation requirement in ISO/IEC 17025:2017 (Ref. 13) section
7.2.2, which accredited laboratories must follow in accordance with
proposed Sec.  1.1146(b). As stated in ISO/IEC 17025:2017 section
7.2.2, accredited laboratories would be required to validate ``non-
standard methods, laboratory-developed methods and standard methods
used outside their intended scope or otherwise modified.''
    Proposed Sec.  1.1151(c)(2) would require an accredited laboratory
validating a method under this subpart to record all the information
required by ISO/IEC 17025:2017 (Ref. 13) section <IP_ADDRESS> as well as the
supporting analytical data. In the context of validation studies,
supporting analytical data may include information about the detection
limit, selectivity of method, linearity, limit of repeatability and/or
reproducibility (accuracy and precision), robustness against external
influences and/or cross sensitivity against interference from the
matrix of sample. We have tentatively determined that this information
is necessary for us to assess the validation and determine whether it
demonstrates that the accredited laboratory can properly apply the
method for the specific intended use.
    Proposed Sec.  1.1151(d)(1) provides that before an accredited
laboratory conducts food testing under this program using a method for
a specific intended use for which the method has been validated, but
for which the laboratory has not previously applied the method under
this program, the accredited laboratory must have verified it can
properly perform the method for the specific intended use. We propose
to make this requirement explicit for this program; and believe it is
consistent with ISO/IEC 17025:2017 (Ref. 13) section 7.2.1 (which
accredited laboratories must follow in accordance with proposed Sec.
1.1146(b)), which requires that accredited laboratories verify a method
before they introduce the method.
    Proposed Sec.  1.1151(d)(2) would require that an accredited
laboratory performing verification of a method under this subpart must
record: The method that is the subject of the verification, the
intended purpose of the analysis, the results of the verification, the
procedure used for the verification, supporting analytical data, and
whether the accredited laboratory is able to properly perform the
method. We have tentatively determined that this information is
necessary for us to determine whether the verification is valid.
    Section 422(b)(3) of the FD&C Act provides that FDA may waive
requirements of section 422(b) if a new methodology or methodologies
have been developed and validated but a laboratory has not yet been
accredited to perform such methodology or methodologies; and the use of
such methodology or methodologies are necessary to prevent, control, or
mitigate a food emergency or foodborne illness outbreak. In accordance
with this statutory provision, proposed Sec.  1.1151(e) provides that
an accredited laboratory may submit a written request to FDA requesting
FDA's permission to use a method or methods outside of its scope of
accreditation for food testing. FDA may approve the request if both of
the following conditions are satisfied: (1) A new methodology or
methodologies have been developed and validated but no reasonably
available laboratory has been accredited to perform such methodology or
methodologies and (2) the use of such method or methods is necessary to
prevent, control, or mitigate a food emergency or foodborne illness
outbreak. We propose to interpret section 422(b)(3)(A) of the FD&C Act
to allow waiver of section 422(b)'s requirements when no ``reasonably
available'' laboratory has been accredited to perform such a
methodology. If an accredited laboratory exists but is not reasonably
available (e.g., due to geographic location, capacity constraints, or
other factors), such a laboratory would not be able to address the
emergent circumstances in which section 422(b)(3) applies. Therefore,
if no ``reasonably available'' laboratory has been accredited to

perform the methodology in question, we believe section 422(b)(3)(A) of
the FD&C Act may be interpreted to permit waiver of section 422(b)'s
requirements. We have tentatively determined that any laboratory that
conducts food testing under the exception of section 422(b)(3) of the
FD&C Act must be accredited for at least one method under this program,
because such accreditation would ensure that all of the requirements
for this program apply to the laboratory and would ensure an important
level of general competence and reliability.
7. What notifications, results, and reports must accredited
laboratories submit to FDA? (Proposed Sec.  1.1152)
    Proposed Sec.  1.1152 would require that accredited laboratories
submit test results, sampling reports, analytical reports, validation
and verification studies, and certain other notifications to FDA about
food testing they conduct under this program. Proposed Sec.  1.1152
would also establish requirements for such submissions, including
requirements about what information the submissions must contain. Under
section 422(b)(2) of the FD&C Act, the results of food testing
conducted under this program must be submitted directly to FDA. To
facilitate our meaningful review of such test results, it is critical
that we receive supporting information necessary for us to understand
the test results and to assess the validity of the underlying testing
conducted in that instance. Section 422 of the FD&C Act acknowledges
that other information may be sent to FDA under this program,
specifically requiring that the model standards we establish under this
program must ensure that reports of analyses, which laboratories
currently routinely submit to us as testimony in the circumstances
described by section 422(b)(1)(B) of the FD&C Act, are certified as
true and accurate (see section 422(a)(6) of the FD&C Act).
    Proposed Sec.  1.1152(a) through (c) address what information
(e.g., test results, sample collection reports, and analytical reports)
about the food testing conducted under this program must be submitted
to FDA. We have proposed in Sec.  1.1152(d) that accredited
laboratories that meet certain requirements may submit abridged
analytical reports in lieu of full analytical reports, subject to
certain exceptions in proposed Sec.  1.1152(e). Proposed Sec.
1.1152(f) would establish what information must be in an abridged
analytical report, and proposed Sec.  1.1152(g) would establish what
information must be in a full analytical report. Proposed Sec.
1.1152(h) would require an accredited laboratory using a non-standard
method to provide FDA with documentation of the method. By
``documentation'' we mean the method standard operating procedure, or
some other document that describes the steps within the method.
Proposed Sec.  1.1152(i) would establish requirements for the
submission of advance notices of sampling to FDA. Proposed Sec.
1.1152(j) would establish requirements for notifications to FDA of
significant changes affecting the accreditation of the accredited
laboratory. Proposed Sec.  1.1152(k) would state if FDA does not
receive all information required under this section we may consider the
related testing to be invalid.
    Proposed Sec.  1.1152(a) would require all documentation submitted
to us by accredited laboratories under the subpart, which includes test
results, sampling reports, analytical reports, validation and
verification studies, and certain notifications, to be submitted to us
electronically and in English, and to contain certain generally
applicable information. More specifically, proposed Sec.
1.1152(a)(1)(i) would require all such notifications, results, reports,
and studies submitted to us to include the legal name and street
address of the accredited laboratory submitting the information, and
would require the documents to identify an appropriate point-of-contact
for the accredited laboratory who FDA may contact with questions or
comments regarding the notification, result, report, or study, and to
include the email address and telephone number of the point of contact.
Identification of the accredited laboratory submitting the report would
help us identify which accredited laboratory is responsible for the
submissions. The identification of a point-of-contact for the
accredited laboratory, and the email address and telephone number of
the point-of-contact, would help us efficiently conduct any followup
communications, as appropriate, with the accredited laboratory that
submitted the information. Proposed Sec.  1.1152(a)(1) would also
require all documents submitted to FDA under this section to display an
identification unique to each test result, report, notification, or
study. Of note, proposed Sec.  1.1152(b)(3) would require the test
results to cross reference the unique identifiers of all associated
reports, notifications, and studies. These requirements are intended to
help us quickly identify which submissions are related to each other as
we receive them. This provision also reflects a similar provision in
ISO/IEC 17025:2017 (Ref. 13) at section 7.8.2, ``Common requirements
for reports.'' The last general requirement for submissions, per
proposed Sec.  1.1152(a)(iii), is that each submission must be true,
accurate, unambiguous, and objective. This requirement would implement
the requirement underlying section 422(a)(6)(A)(i) of the FD&C Act that
the model standards established by this program for accredited
laboratories must ensure that ``reports of analyses are certified as
true and accurate,'' and help ensure that accredited laboratories
submissions clearly and correctly communicate the information the
submission is based on and is intended to communicate. We have
tentatively concluded that it is appropriate to establish such a
requirement for all submissions under this program to FDA from
accredited laboratories.
    Proposed Sec.  1.1152(a)(2) would clarify that the accredited
laboratory that conducts the analysis of the sample under this program
is responsible for the submission of all related notifications,
results, reports, and studies to FDA as required by this section.
    Proposed Sec.  1.1152(a)(3) provides that if the accredited
laboratory that is responsible for the submission becomes aware that
any aspect of the submission is inaccurate, the accredited laboratory
or sampling service must immediately inform FDA and submit a corrected
version. Proposed Sec.  1.1152(a)(3) further provides that such
corrections to the notification, result, report, or study must meet the
requirements for amendments to reports specified by ISO/IEC 17025:2017
(Ref. 13) section 7.8.8 (incorporated by reference, see Sec.
1.1138(a)(2)). This requirement is important so that we may easily
determine when and how a submission has been amended and to which prior
submissions the amended submission relates.
    Proposed Sec.  1.1152(a)(4) would require that any opinions and
interpretations in any notification, result, report, or study submitted
to FDA must meet the requirements in ISO/IEC 17025:2017 (Ref. 13)
section 7.8.7 (which is incorporated by reference, see proposed Sec.
1.1138(a)(2)), and any statements of conformity to a specification or
standard in any notification, result, report, or study submitted to FDA
under this subpart must meet the requirements of ISO/IEC 17025:2017
section 7.8.6 (incorporated by reference, see proposed Sec.
1.1138(a)(2)). We have tentatively determined that ISO/IEC 17025:2017
section 7.8.7 provides rules that will be effective at ensuring that
opinions and interpretations in submissions to FDA are appropriate and
clearly identified. Similarly, we have tentatively determined that ISO/
IEC 17025:2017

section 7.8.6 provides rules that will be effective at ensuring that
statements of conformity in submissions to FDA under this section are
accompanied by appropriate disclosures.
    Proposed Sec.  1.1152(b) would establish requirements for
submission of test results to FDA. In accordance with section 422(b)(2)
of the FD&C Act, proposed Sec.  1.1152(b)(1) provides that the results
of all tests conducted under this subpart must be directly submitted to
FDA. Proposed Sec.  1.1152(b)(2) specifies that the accredited
laboratory that conducted the analysis must submit the results of the
food testing to FDA via the website described by Sec.  1.1109, unless
FDA has directed a different method of submission in connection with
the testing conducted under Sec.  1.1107(a)(2) or (3).
    Proposed Sec.  1.1152(b)(3) would require the test results
submitted to FDA under this section to be clear, and identify the
unique identification of the associated notifications, reports, and
studies. These requirements would help us ensure that we can
efficiently review the test results and associated submissions as one
package.
    Proposed Sec.  1.1152(c) would require certain documentation to be
submitted with the test results. Specifically, we would require
submission to FDA of the following documentation with each test
results:
     All sampling plans and sample collection reports related
to the food testing conducted, as obtained or developed by the
accredited laboratory in accordance with proposed Sec.  1.1149.
     Written documentation of the sampler's qualifications, if
proposed Sec.  1.1149(a)(1) requires the accredited laboratory to
obtain or develop such documentation.
     The analytical report or reports documenting the analysis
related to the food testing. The analytical reports would have to be
either abridged or full, depending on whether the accredited laboratory
is permitted under proposed Sec.  1.1152(d) to submit abridged
analytical reports to FDA. For more information about our proposed
requirements for abridged and full analytical reports, see our
discussion of proposed Sec.  1.1152(d) through (g) below.
     For any validation studies required by proposed Sec.
1.1151(c)(1), any documentation required by proposed Sec.
1.1151(c)(2), except when the circumstances of proposed Sec.
1.1152(c)(6) (which we discussed in connection with Sec.
1.1138(a)(1)(a), previously) apply with respect to the validation
study.
     For any verification studies required by Sec.
1.151(d)(1), the documentation required by Sec.  1.1151(d)(2), except
when the circumstances of proposed Sec.  1.1152(c)(6) (which we
discussed in connection with Sec.  1.1138(a)(1)(A), previously) apply
with respect to the verification study.
     Proposed Sec.  1.1152(c)(6) would establish an important
exception to the above two validation and verification study
documentation requirements. Proposed Sec.  1.1152(c)(6) provides that
we would not require the accredited laboratory to submit the validation
or verification study to FDA if the accredited laboratory submitted the
validation or verification study to its recognized accreditation body
as required by proposed Sec.  1.1138(a)(1) (which addresses certain
requirements a laboratory must meet to become accredited by a
recognized accreditation body). We have tentatively determined that it
is not appropriate under this program for us to duplicate, on a routine
basis, the accreditation efforts of accredited laboratory's recognized
accreditation body. If the accredited laboratory submitted the
validation or verification study to its accreditation body as required
by Sec.  1.1138(a)(1), the accreditation body must instead submit to
FDA, in lieu of the validation or verification study, a statement that
the validation or verification study has been submitted to its
recognized accreditation body in accordance with Sec.  1.1138(a)(1),
and the accredited laboratory must identify the method, analyte, and
matrix that were the subject of the validation or verification study.
This information would provide us with sufficient information to
determine whether the accredited laboratory's invocation of this
exception is appropriate. As discussed in relation to proposed Sec.
1.1113(c), we expect recognized accreditation bodies to substantively
review the validation and verification studies they receive from
laboratories participating in this program.
     A certification from one or more members of the accredited
laboratory's management certifying that the test results,
notifications, reports, and studies are true and accurate, and that the
documentation includes the results of all tests conducted under this
subpart. The certification must specify the name, title, and signature
of the certifier or certifiers. The certification that reports are true
and accurate is required by section 422(a)(6)(A)(i) of the FD&C Act,
but we propose to require the certification to also extend to the test
results and related submissions. We propose to include a certification
that the laboratory has submitted all tests conducted under this
subpart not only because direct submission of test results to FDA is a
statutory directive, but because it is vital to the integrity of this
program. We expect this certification to help ensure that appropriate
laboratory personnel have confirmed the accuracy of the statement.
    Note that we do not intend for this certification to mean that the
laboratory is attesting that the tested product satisfies regulatory
requirements as it is FDA's purview (and not the laboratory's) to
determine whether the product meets our regulatory standards. Although
the word ``certification'' has such meaning in conformity assessment
terminology, we intend a different meaning here. We are using the word,
``certification'' to mean that the management of the laboratory
acknowledges that the test was conducted and vouches that the test was
conducted properly according to laboratory defined procedures, that the
report is true and accurate, and that the report represents all the
testing conducted by that laboratory of that particular product for
this program.
    We propose in Sec.  1.1152(d) that accredited laboratories that
meet certain requirements may submit abridged analytical reports under
this program in lieu of full analytical reports. We would require full
analytical reports to document, in full and step-by-step, the analysis
conducted by the accredited laboratory, so that we can engage in a
meaningful indepth scientific review of the analysis to determine
whether, in that instance, the analysis was valid. For example, we
propose in Sec.  1.1152(g) that a full analytical report must include
all original compilations of raw data, identify and describe negative
and positive quality controls, and include all calculations, among
other documentation. Abridged analytical reports, in contrast to full
analytical reports, would only need to include certain more limited
information describing the analysis.
    We view the standards we are creating in this program as relatively
rigorous. Accreditation to ISO/IEC 17025:2017, along with the quality
assurance, conflict of interest, and other additional requirements
contained in this proposed rule, enhance our confidence in the
laboratories that participate. In addition, the recognized
accreditation bodies will serve an ongoing role monitoring the
laboratories they have accredited under this program, helping ensure
that the required standards are maintained and serving as an additional
observer of the laboratories. For those reasons, and contingent on a
positive experience with the accredited laboratories' initial

reports, we would have adequate assurance in the validity of the test
results to permit abridged analytical reports, and we tentatively
conclude that such abridged analytical reports will provide an adequate
basis for FDA to make regulatory decisions.
    In addition, we believe that allowing the submission of abridged
analytical reports under this food testing program may provide
advantages to FDA and the public. We should be able to review abridged
analytical reports more quickly than we review full analytical reports,
and this may enable us to decide more quickly whether a food safety
problem has been addressed and whether to admit an article of food into
the United States. This may further allow us to allocate our own
laboratory and field resources more efficiently. Furthermore, not
requiring accredited laboratories to compile and submit a full
analytical report every time they conduct food testing under this
program may reduce some of the paperwork and administrative costs of
food testing conducted under this program.
    At the same time, we note that this laboratory accreditation
program would not guarantee that testing by participating laboratories
will be valid in every instance. Indeed, a single false negative test
result submitted to us under this program could lead us to admit
violative food into the United States, or to incorrectly determine that
a food safety problem has been adequately addressed, thus potentially
harming U.S. consumers. Accordingly, we do not propose to automatically
or always allow all accredited laboratories to submit abridged
analytical reports under this program. Instead, we have proposed that
only accredited laboratories that have fulfilled certain conditions may
submit abridged analytical reports to us under this program, and that
in certain circumstances we may require such accredited laboratories to
submit full analytical reports.
    Proposed Sec.  1.1152(e)(1) provides that FDA will occasionally
require an accredited laboratory permitted to submit abridged
analytical reports to submit to FDA, within 48 hours of the request,
the full version of the analytical report. Such a policy will serve the
purposes of auditing abridged analytical reports and otherwise
protecting the public health and the integrity of this food testing
program. By ``occasionally,'' we tentatively conclude that we would not
invoke the exception for more than approximately 10 percent of the
abridged analytical reports that any given accredited laboratory
submits to us per year. We would invoke this exception at our
discretion, sometimes on a random basis and sometimes based on risk.
With regard to risk, we may be more likely to invoke this requirement
where the analysis conducted is for an analyte that presents a
relatively high risk to public health (e.g., Clostridium botulinum). We
may also invoke the exception where something in the abridged
laboratory report appears to be amiss (e.g., the method used does not
appear to be appropriate). However, we may also invoke the exception on
a random basis and in relatively low-risk situations to ensure
consistent laboratory performance across the program. At a minimum, we
expect to invoke this exception to require each accredited laboratory
permitted to submit abridged analytical reports to us to submit at
least one full analytical report to us per year. We also note that this
provision (along with proposed Sec.  1.1150(d)) would effectively
require that accredited laboratories permitted to submit abridged
analytical reports to us must still consistently document their
analyses internally to such a degree that the accredited laboratory
would be able to complete and submit a full analytical report for the
analysis to FDA within forty-eight hours of when FDA requests the full
analytical report.
    We have proposed an additional exception, in proposed Sec.
1.1152(e)(2), to accredited laboratories' ability to submit abridged
analytical reports to us under this program. Proposed Sec.
1.1152(e)(2) provides that FDA may require an accredited laboratory
that is permitted to submit abridged analytical reports to submit full
analytical reports to FDA under this program if such analytical reports
relate to an FDA investigation or FDA enforcement proceeding. We may
invoke this exception, for example, in the case of a food testing order
involving a potentially high risk to public health, or as part of
evidence for a hearing under section 423(c) of the FD&C Act, in which
case we would have determined that not only does a suspected or
identified food safety problem exist but that there is also reasonable
probability that the use of or exposure to an article of food will
cause serious adverse health consequences or death to humans or
animals.
    Proposed Sec.  1.1152(d)(1) describes the criteria for an
accredited laboratory seeking initial permission to submit abridged
analytical reports. Accredited laboratories that are not currently
disqualified from submitting abridged analytical reports (see our
discussion about disqualification under proposed Sec.  1.1152(d)(6) and
(7)) and that are not on probation would become permitted to submit
abridged analytical reports to FDA under this program on an ongoing
basis after FDA has given notice that all four of the following
conditions are fulfilled: (1) The accredited laboratory submits 10
consecutive full analytical reports to FDA under this program, (2) the
consecutive full analytical reports include at least one full
analytical report relating to each major food testing discipline
represented by the methods in the accredited laboratory's scope of
accreditation for which it seeks to submit abridged analytical reports,
(3) none of the consecutive full analytical reports demonstrate any
material substantive shortcoming in the food testing, and (4) the
consecutive full analytical reports submitted by the accredited
laboratory do not contain repeated administrative deficiencies.
Accordingly, when laboratories become accredited under the program they
must first submit full laboratory analytical reports under Sec.
1.1152(g), along with the test results and the other documentation
required under proposed Sec.  1.1152(c), which FDA will assess to
determine whether the four conditions are fulfilled. FDA will track
whether the accredited laboratory has fulfilled the four conditions.
    As we state above, we are proposing to require that the 10
consecutive full analytical reports includes least one full analytical
report relating to each major food testing discipline represented by
the methods in the accredited laboratory's scope of accreditation for
which the accredited laboratory seeks to submit abridged analytical
reports. Three examples of the ``major food testing disciplines''
relevant in this context are microbiology, chemistry, and physical
(filth).
    Proposed Sec.  1.1152(d)(2) addresses the impact of an accredited
laboratory's failure to initially satisfy the four criteria of Sec.
1.1152(d)(1). Under proposed Sec.  1.1152(d)(2)(i), if any analytical
report submitted by the accredited laboratory to FDA under this program
demonstrates a material substantive shortcoming in the food testing,
the accredited laboratory would become disqualified from submitting
abridged analytical reports, in accordance with proposed Sec.
1.1152(d)(6)(i). If the 10 full analytical reports submitted by an
accredited laboratory are substantively satisfactory but suffer from
repeated administrative deficiencies, the accredited laboratory would
have another chance to submit consecutive full analytical reports that
fulfill the criteria in Sec.  1.1152(d)(1)(i) through (iv). Repeated
administrative deficiencies during the second set of 10 full analytical
reports would result in

disqualification in accordance with proposed Sec.  1.1152(d)(6)(i).
    We propose that a single material substantive shortcoming in the
food testing in any of the initial 10 full analytical reports would
disqualify an accredited lab, for the period described in Sec.
1.1152(d)(6). We would consider a material substantive shortcoming in
the food testing to be incompetence or dishonesty resulting in an
invalid test result. FDA will be relying on the food testing conducted
under this program to make regulatory decisions, which will impact
public health. It is critical that the testing be valid. We have a duty
to monitor the testing conducted by an accredited laboratory that
submits a full analytical report containing a material substantive
shortcoming, so it is appropriate that such a laboratory be
disqualified from the privilege of submitting abridged analytical
reports (see Sec.  1.1152(d)(6)). Note also that under proposed Sec.
1.1160(a) and (b), if we find a material substantive shortcoming in the
food testing, we may consider the analysis to be invalid, and will
notify the accredited laboratory, and potentially its recognized
accreditation body and the owner or consignee of the food, of the
deficiency. For further information on proposed Sec.  1.1160, see
section VI.I.3. Note also that under proposed Sec.  1.1146(b), the
accredited laboratory would have to treat the feedback as a complaint,
in accordance with sections 3.2 and 7.9 of ISO/IEC 17025:2017 (Ref.
13).
    Proposed Sec.  1.1152(d)(3) discusses the criteria that
laboratories, already submitting abridged analytical reports, must meet
in order to begin submitting abridged analytical reports for additional
disciplines. Specifically, proposed Sec.  1.1152(d)(3) allows
accredited laboratories, not on probation and already permitted to
submit abridged analytical reports for at least one major food testing
discipline, to submit to abridged analytical reports relating to
additional major food testing discipline(s), after FDA has given notice
that the following conditions are fulfilled: (1) The accredited
laboratory submits to FDA at least one full analytical report for each
additional major food testing discipline for which the accredited
laboratory seeks to submit abridged analytical reports; (2) there is no
material substantive shortcoming in the full analytical report(s) for
the additional major food testing discipline(s); and (3) the full
analytical reports for the additional major food testing discipline(s)
do not contain repeated administrative deficiencies.
    Proposed Sec.  1.1152(d)(4) addresses the impact of an accredited
laboratory's failure to initially satisfy the three criteria of Sec.
1.1152(d)(3). Under proposed Sec.  1.1152(d)(4)(i), if any analytical
report submitted by the accredited laboratory to FDA under this program
demonstrates a material substantive shortcoming in the food testing,
the accredited laboratory would become disqualified from submitting
abridged analytical reports for the food testing discipline that was
represented in the analytical report containing the material
substantive shortcoming, in accordance with proposed Sec.
1.1152(d)(6)(ii). If any full analytical reports relating to a food
testing discipline submitted by an accredited laboratory are
substantively satisfactory but suffer from repeated administrative
deficiencies, the accredited laboratory would have another chance to
submit a full analytical report for that food testing discipline that
fulfills the criteria in Sec.  1.1152(d)(3)(i) through (iii). Repeated
administrative deficiencies in the second full analytical report would
result in disqualification in accordance with proposed Sec.
1.1152(d)(6)(ii).
    Proposed Sec.  1.1152(d)(5) provides that if an accredited
laboratory, permitted to submit abridged analytical reports for a
particular discipline, 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, the accredited laboratory would be disqualified for that
discipline. The period of disqualification should be governed by Sec.
1.1152(d)6)(ii) if the accredited laboratory is permitted to submit
abridged analytical reports for other disciplines, and with Sec.
1.1152(d)(6)(i) if not.
    For accredited laboratories that currently do not have permission
to submit any abridged analytical reports for any disciplines, proposed
Sec.  1.1152(d)(6)(i) states that the period of disqualification is
either 2 years or until the accredited laboratory submits 20 more