FD&C Act (21 U.S.C. 350c). Section 414 of the FD&C Act, among other
things, gives us access to records if we have a reasonable belief that
an article of food, and any other article of food that we reasonably
believe is likely to be affected in a similar manner, is adulterated
and presents a threat of serious adverse health consequences or death
to humans or animals (SAHCODHA) (21 U.S.C. 350c(a)). Although Congress
chose to incorporate SAHCODHA by referencing section 414 of the FD&C
Act as authority for us to access records of consultative audits under
section 808(c)(3)(C) of the FD&C Act, Congress did not use the SAHCODHA
standard in describing the types of conditions that could cause or
contribute to a serious risk to the public health and that must be
reported to FDA under section 808(c)(4)(A) of the FD&C Act. We believe
Congress intended the standard for notification to be a different
standard than SAHCODHA.
    We invite comment from interested parties interpreting the
notification standard in section 808(c)(4)(A) of the FD&C Act and
providing examples of circumstances that stakeholders believe do and do
not rise to the level of a ``condition that could cause or contribute
to a serious risk to the public health.'' We are particularly
interested in receiving input on whether our existing Class I and Class
II recall standards (Ref. 33), taken together, might adequately address
any condition covered by section 808(c)(4)(A) of the FD&C Act. An FDA
Class I recall occurs in a situation in which there is a reasonable
probability that the use of or exposure to a violative product will
cause serious adverse health consequences or death. An FDA Class II
recall occurs in a situation in which use of or exposure to a violative
product may cause temporary or medically reversible adverse health
consequences or where the probability of serious adverse health
consequences is remote.
    We also note that international standards for [auditors/
]certification bodies have exceptions to confidentiality agreements
where disclosure is required by law. For example, ISO/IEC Guide
17021:2011 (Ref. 19), clause 8.5.3, requires an auditor/certification
body that is required by law to release confidential information to a
third party, to notify the client before providing such information to
a third party, ``unless regulated by law.'' Based on section
808(c)(4)(A) of the FD&C Act, which

requires that the accredited third-party certification body
``immediately'' notify us, proposed Sec.  1.656(c) requires an
accredited auditor/certification body to notify us of a serious risk to
public health prior to notifying its client, the eligible entity. We
recommend that accredited auditors/certification bodies include a
provision explaining this notification requirement in their contracts
with eligible entities. We believe this will help ensure that eligible
entities are aware of the notification requirement and will help
emphasize to the accredited auditors/certification bodies their
obligation to notify FDA of such condition.
    Proposed Sec.  1.656(d) requires an accredited auditor/
certification body to immediately notify us electronically, in English,
upon withdrawing or suspending the food or facility certification of an
eligible entity. The notice must describe the basis for withdrawal or
suspension. We believe immediate notification of suspension or
withdrawal of certifications is necessary because of how we use these
certifications: As a condition of granting admission to a food subject
to an risk determination under section 801(q) of the FD&C Act and as a
criteria for an importer's eligibility to participate in VQIP under
section 806 of the FD&C Act. We realize that certification bodies
currently withdraw and suspend certifications for a number of reasons,
some of which relate to payment of fees and others relate to food
safety matters. Therefore, having information on the fact that a
certification has been withdrawn or suspended, as well as the reason(s)
for the action, allows us to determine the effect of suspension or
withdrawal on our use of the certifications under sections 801(a) and
806 of the FD&C Act. Depending on the reasons for suspension or
withdrawal of certification, we may conduct an inspection or take other
action.
    Under proposed Sec.  1.656(e)(1), an accredited auditor/
certification body that notifies us under proposed Sec.  1.656(c) must
immediately thereafter notify the eligible entity where the condition
was discovered. Proposed Sec.  1.656(e)(2) requires an accredited
auditor/certification body to notify its accreditation body (or, in the
case of direct accreditation, to us) electronically, in English, within
30 days after making any significant change that may affect its
compliance with the requirements of Sec. Sec.  1.640 through 1.658. The
notice must describe the purpose of the change and an explanation for
whether and how the change might affect its accreditation under this
program. In that proposed Sec.  1.640 requires auditors/certification
bodies to maintain compliance with the requirements of this rule as a
condition of their accreditation, this notification is necessary for
our program oversight. We will use this information in monitoring the
certification body as required by section 808(f)(2) of the FD&C Act and
may use the notification (or the failure to notify under proposed Sec.
1.656(e)(2)) in determining whether to withdraw accreditation under
section 808(c)(6) of the FD&C Act.
    h. How must an accredited auditor/certification body protect
against conflicts of interest? (Proposed Sec.  1.657). This proposed
rule would require accredited auditors/certification bodies to have
procedures to ensure against financial conflicts of interest and to
make annual financial disclosure statements available to us, as
required by section 808(c)(5)(A) and (c)(5)(B) of the FD&C Act.
Additionally, section 808(c)(5)(C) of the FD&C Act directs us to issue
implementing regulations including requirements for unannounced audits,
a structure to decrease the potential for conflicts of interest
(including requirements for timing and public disclosure of fee
payments), and appropriate limits on financial affiliations between
certification bodies (and their audit agents) and eligible entities to
be certified.
    Proposed Sec.  1.657 sets out the elements of a conflict of
interest program we believe are appropriate to implement this mandate
and to ensure the objectivity and independence of accredited auditors/
certification bodies necessary for to maintain the credibility of the
program. Proposed Sec.  1.657(a) requires the accredited auditor/
certification body to have written program that covers the
certification body itself and any of its officers, employees, or other
agents (e.g., audit agents) conducting audits or certification
activities under this program.
    Based in large part on section 808(c)(5)(A)(i) of the FD&C Act,
proposed Sec.  1.657(a)(1) prohibits an accredited auditor/
certification body and its officers, personnel, and other agents
(except for audit agents subject to paragraph (a)(2)) from owning,
controlling, managing, or otherwise having a financial interest in an
eligible entity, or an affiliate, parent, or subsidiary of such entity,
to be certified by the auditor/certification body . The effect of the
language in proposed Sec.  1.657(a)(1) would be to prevent a foreign
food firm with its own audit team from conducting regulatory audits and
issuing certifications for its own facilities, processes, or products
(i.e., first-party audits) or for an affiliate or for its parent or
subsidiary (i.e., second-party audits). Given the multinational nature
and multiple corporate interests of many food companies, we have
tentatively concluded it is important to extend the conflict of
interest safeguards in proposed Sec.  1.657 to subsidiaries,
affiliates, and parent organizations. We seek comment on this tentative
conclusion.
    Proposed Sec.  1.657(a)(2) prohibits an audit agent of an
accredited auditor/certification body from conducting a food safety
audit of an eligible entity, or an affiliate, parent, or subsidiary of
such entity, that the agent owns or operates. This provision is largely
based on the section 808(c)(5)(B)(i) of the FD&C Act, which prohibits
an audit agent from owning or operating an eligible entity to be
audited by the agent, coupled with language covering financial
interests associated with an affiliate, parent, or subsidiary of the
eligible entity, for the reasons previously described.
    To be clear, proposed Sec.  1.657(a)(2) does not go so far as to
prohibit audit agents from having any financial interest in any food
company; rather, it prevents an audit agent from conducting a
consultative or regulatory audit of an eligible entity or an affiliate,
parent, or subsidiary of such entity, owned or operated by such agent.
We believe that requiring any audit agent conducting audits under this
program to divest all interests in FDA-regulated food firms might
unnecessarily limit the pool of qualified audit agents.
    We seek comment on these tentative conclusions and on the approach
we propose in Sec.  1.657(a)(2), including whether this approach might
unnecessarily limit the availability of competent audit agents to
conduct audits under this program and whether removing the restriction
relating to interests in affiliates, parents, or subsidiaries might
create, or create the appearance of, bias.
    Proposed Sec.  1.657(a)(3) prohibits officers, employees, or other
agents of an accredited auditor/certification body from accepting any
gift, gratuity, or item of value from the entity subject to audit. A
gift, gratuity, or item of value would not include meals of a de
minimis value provided on the premises where the audit or assessment is
being conducted, recognizing that some facilities may be remotely
located and allowing onsite meals is appropriate in the interest of
efficiency. We seek comment on whether to interpret de minimis value
according to the limits for gifts or items of value applicable to U.S.
Government employees. Proposed Sec.  1.657(a)(3) also

allows for authorized officials, employees, or agents to accept
payments of fees for the audit and certification, as described in
proposed Sec.  1.657(b).
    Proposed Sec.  1.657(b) addresses the requirement, in section
808(c)(5)(C) of the FD&C Act, to issue implementing regulations that
include a structure to decrease the potential for conflicts of
interest, including timing and public disclosure, for fees paid by
eligible entities to accredited third-party certification bodies. After
considering this statutory provision, we have tentatively concluded
that an appropriate structure to decrease the potential for conflicts
of interests between an eligible entity and an accredited auditor/
certification body would be one in which there was public disclosure of
the point at which the entity paid fees for audit and certification
services. Proposed Sec.  1.657(b) provides that that payment of such
fees does not constitute a covered financial conflict of interest.
    Proposed Sec.  1.657(c) imputes to an officer, employee, or other
agent of an accredited auditor/certification body the financial
interests of his or her spouse and minor children, if any. This
proposed requirement is based on the approach we recommended in the
2009 Guidance that no auditor acting for the [auditor/]certification
body (or spouse or minor children) should have any significant
ownership or other financial interest regarding any product of the type
it certifies (Ref. 5). As another example, FDA regulations on conflicts
of interest of experts serving on panels for unapproved new animal
drugs imputes the financial interests and arrangements of an expert's
spouse and minor children to the expert him- or herself (21 CFR
516.141(g)).
    We believe that imposing a similar requirement on the immediate
family of the officers, employees, or other agents of an accredited
auditor/certification body will help to ensure the credibility of the
accredited third-party audits and certification program at every level.
We seek comment on this tentative conclusion.
    Proposed Sec.  1.657(d) requires accredited certification bodies to
maintain on their Web sites an up-to-date list of eligible entities to
which they issued certifications under this subpart, the duration and
scope of each such certifications, and the date on which the eligible
entity paid any fee or reimbursement under proposed Sec.  1.657(c).
Information on timing of fee payments is required by section
808(b)(5)(C)(iii) of the FD&C Act and is necessary, we believe, in the
interest of transparency.
    We seek comment on the tentative conclusions identified here--
namely, we should require accredited certification bodies to: (1) Have
a written program to safeguard against conflicts of interest; (2)
include the interest of any affiliate, parent, or subsidiary of a
certification body within the scope of interests covered by its
conflict of interest program; (3) impute the interests of immediate
family members of an officer, employee, or other agent to such officer,
employee, or other agent; and (4) to maintain on its Web site a list of
its certified eligible entities, including duration and scope of each
such certification, and disclosure of the date(s) on which an eligible
entity paid the accredited auditor/certification body any fee or
reimbursement associated with an audit or certification under this
program.
    i. What records requirements must an accredited auditor/
certification body meet? (Proposed Sec.  1.658). This proposed rule
would establish requirements for accredited auditors/certification
bodies to establish, control, and retain records relating to their
auditing and certification activities under our program.
    Proposed Sec.  1.658 requires accredited auditors/certification
bodies to maintain certain documents and data electronically, in
English, for 4 years, to document compliance with this rule.\34\ These
records include: (1) Requests for regulatory audits; (2) audit reports
and other documents resulting from a consultative or regulatory audit;
(3) any notification of a condition under proposed Sec.  1.650(a)(5) or
by the accredited auditor/certification body to FDA under proposedSec.
1.656(c); (4) any food or facility certification issued under this
program; (5) any challenge to an adverse regulatory audit decision and
its disposition; (6) any monitoring it conducted of a certified
eligible entity; (7) the auditor's/certification body's self-
assessments and corrective actions; and (8) any significant change to
the auditing and certification program that might affect compliance
with this rule.
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    \34\ We are proposing records be maintained for 4 years, which
aligns with the maximum length of time for which accreditation may
be granted. This will be particularly useful in decisionmaking on an
application to renew accreditation, because the accrediting body
will have access to data and information on activities conducted at
any time during its current accreditation. We used a similar
rationale in proposing to require recognized accreditation bodies to
maintain their records for 5 years, which is the maximum length of
time for which recognition may be granted.
---------------------------------------------------------------------------

    Maintenance of records on requests for regulatory audits under
proposed Sec.  1.658(a)(1) is one means to verify the adequacy of audit
planning under proposed Sec.  1.651(a). Records associated with audits,
certifications, challenges to auditor/certification body decisions,
internal reviews, significant changes, and monitoring (also known as
surveillance) of eligible entities are among the records commonly
required to be maintained by international standards. We believe it
appropriate to require maintenance of similar records for purposes of
this rule.
    We propose to require accredited auditors/certification bodies
choosing to participate in this program to maintain their program
records in English. We believe this English-language records
requirement is necessary for our oversight based on, among other
things, our experience with the shrimp pilot (Ref. 6). During the pilot
project, we faced costly delays and logistical hurdles in attempting to
assess third-party [auditors/]certification bodies, because we needed
English-language translations of their records to be able to conduct
performance audits. Based on that experience, we believe that having
real-time access to English-language records is necessary for
conducting efficient and effective assessments to the fullest extent of
our authority.
    We solicit comment on the English-language records requirement in
proposed Sec.  1.658 and on whether other approaches might be similarly
efficient and effective. For example, should we allow an accredited
auditor/certification body to maintain its records in a language other
than English, if the auditor/certification body would be required to
make an English translation of its records available ``promptly'' upon
a written FDA request? What should ``promptly'' mean in this context
(e.g., 2 business days of the written request)? Would such an approach
be as efficient and effective as the proposed English-language records
requirement would be? For comments offering other approaches, we
request a detailed description of the alternative, an analysis of the
impacts of the alternative on our ability to ensure the compliance of
accredited auditors/certification bodies with applicable FDA
requirements.
    Based on section 808(c)(3)(B) of the FD&C Act, proposed Sec.
1.658(b) and (c) require an accredited auditor/certification body to
provide FDA access to records upon request of an officer or employee we
designate, except that reports or other documents of a consultative
audit must be made available to us only in accordance with the
requirements of subpart J (records access under section 414 of the FD&C
Act). Proposed Sec.  1.658(b) reflects section 808(c)(3)(C) of the FD&C
Act, which

states that reports or other documents resulting from a consultative
audit are accessible to us only under circumstances that meet the
threshold for records access under section 414 of the FD&C Act (21
U.S.C. 350c). Based on these statutory requirements, we can access such
documents from consultative audits in either of the following
circumstances: If we have a reasonable belief that an article of food,
and any other article of food that we reasonably believe is likely to
be affected in a similar manner, is adulterated and presents a threat
of SAHCODHA; or if we believe that there is a reasonable probability
that the use of or exposure to an article of food, and any other
article of food that we reasonably believe is likely to be affected in
a similar manner, will cause SAHCODHA, as described in Sec.  1.361 of
this part.
    We have tentatively concluded that the records identified and the
records maintenance and access requirements in proposed Sec.  1.658 are
necessary to monitor and evaluate accredited certification bodies, as
directed by section 808(f)(2) of the FD&C Act. We believe it is
reasonable to require accredited auditors/certification bodies to
maintain such records for the maximum length of accreditation, 4 years.
We acknowledge that the requirements of proposed Sec.  1.658 may
require revisions to contracts and perhaps other documents establishing
and limiting the scope of an auditor's/certification body's authority
with respect to granting records access. We nonetheless have
tentatively concluded that such access is necessary to help ensure the
credibility of the program. We seek comment on this tentative
conclusion and on the specific records requirements we propose.
7. Procedures for Accreditation of Third-Party Auditors/Certification
Bodies

   Table 7--Proposed Procedures for Third-Party Auditors/Certification
                                 Bodies
------------------------------------------------------------------------
 Proposed rule section                        Title
------------------------------------------------------------------------
1.660..................  Where do I apply for accreditation or renewal
                          of accreditation by a recognized accreditation
                          body?
1.661..................  What is the duration of accreditation?
1.662..................  How will FDA monitor accredited auditors/
                          certification bodies?
1.663..................  How do I request an FDA waiver or waiver
                          extension for the 13-month limit for audit
                          agents conducting regulatory audits?
1.664..................  When can FDA withdraw accreditation?
1.665..................  How do I voluntarily relinquish accreditation?
1.666..................  How do I request reaccreditation?
------------------------------------------------------------------------

    a. Where do I apply to obtain accreditation from a recognized
accreditation body? (Proposed Sec.  1.660). This proposed rule explains
where interested third-party auditors/certification bodies could apply
for accreditation under our accredited third-party audits and
certification program.
    Proposed Sec.  1.660 informs third-party auditors/certification
bodies that they must apply directly to a recognized accreditation body
for accreditation, except for those circumstances meeting the
requirements of proposed Sec.  1.670 for direct accreditation.
    b. What is the duration of accreditation? (Proposed Sec.  1.661).
Proposed Sec.  1.661 states that accreditation of a third-party
auditor/certification body may be granted for a period up to 4 years.
This applies both to accreditations granted by recognized accreditation
bodies and to direct accreditations that we grant under proposed Sec.
1.672. We have tentatively concluded that 4 years is an appropriate
duration for an accreditation, because we believe the rigor and
credibility of this new program rests, in part, on the extent of
oversight of accredited third-party auditors/certification bodies to
conduct audits and to certify eligible foreign entities.
    The process for renewal of accreditation provides an opportunity
for recognized accreditation bodies (and us, for directly accredited
auditors/certification bodies) to look closely at all aspects of the
auditor's/certification body's program and performance and to decide
anew whether the auditor/certification body meets the eligibility
requirements.
    We note proposed Sec.  1.661 set the duration of accreditation in
the new accredited third-party auditor/certification body program for a
shorter period than the duration of accreditation we allow in the
mammography program under 21 CFR part 900, which is a time-tested
program. As we and the recognized accreditation bodies participating in
the accredited third-party audits and certification program for food
gain experience with the program, we may revisit this matter. For these
reasons, we have tentatively concluded that accreditation should be
granted for a period of no longer than 4 years. We seek comment on this
tentative conclusion.
    c. How will FDA monitor accredited auditors/certification bodies?
(Proposed Sec.  1.662). This proposed rule would establish requirements
for our evaluation of the performance of accredited auditors/
certification bodies, based on section 808(f)(2) of the FD&C Act, which
requires us to monitor accredited auditors/certification bodies
periodically, or at least once every 4 years.
    The statute makes no distinction between the frequency of our
monitoring necessary for auditors/certification bodies accredited by
recognized accreditation bodies and for auditors/certification bodies
that we directly accredit. However, we are proposing, in Sec.  1.621,
to require a recognized accreditation body to conduct annual
assessments of the performance of each third-party auditor/
certification body it accredited under this program. Under proposed
Sec.  1.662(a) we will perform our own performance evaluations of
auditors/certification bodies accredited by recognized accreditation
bodies at least once every 3 years for auditors/certifications bodies
accredited for 4 year terms, and at the mid-term point for auditors/
certification bodies accredited for less than 4 years. Proposed Sec.
1.662(a) also establishes requirements for our monitoring of directly
accredited auditors/certification bodies. In these circumstances, we
act in the role of a recognized accreditation body and will perform
annual monitoring. Not only would annual monitoring by us provide
oversight similar to the annual monitoring requirements of proposed
Sec.  1.621, but also it would satisfy the monitoring requirement of
section 808(f)(2) of the FD&C Act with respect to monitoring of
directly accredited auditors/certification bodies.

    Proposed Sec.  1.662(b) identifies the types of information we may
review in conducting our evaluations of accredited auditors/
certification bodies. Proposed Sec.  1.662(c) makes clear that we can
conduct our evaluation of an auditor/certification body through onsite
observations of performance during the conduct of food safety audits
and through document review.
    For both directly accredited auditors/certification bodies and
those accredited by recognized accreditation bodies, we will evaluate
performance based on whether the auditor/certification body continues
to comply with the requirements of Sec. Sec.  1.640 through 1.658 and
whether there are performance deficiencies that would warrant
withdrawal of accreditation under this rule. We seek comment on whether
the criteria in proposed Sec.  1.662(a) and (b) are appropriate for
evaluating accredited auditors/certification bodies under this program.
Additionally, we seek recommendations for possible approaches we might
use to monitor performance, such as conducting our inspections of a
certain number of eligible entities, shortly after the accredited
auditor/certification body conducted a food safety audit of an eligible
entity. For each such recommendation, we seek comment on the how the
approach might affect: (1) The incentives for auditors/certification
bodies to seek accreditation under our program, and (2) the degree of
oversight needed to meet the objectives of section 808 of the FD&C Act.
    d. How do I request a waiver or waiver extension for the 13-month
limit for audit agents conducting regulatory audits? (Proposed Sec.
1.663). This proposed rule would allow accredited auditors/
certification bodies to seek an FDA waiver of the limit on audit agents
conducting regulatory audits of an eligible entity where they conducted
a regulatory or consultative audit in the preceding 13 months. Under
section 808(c)(4)(C)(ii) of the FD&C Act, we may waive the limit, which
appears in proposed Sec.  1.650(c), where there is insufficient access
to accredited certification bodies in the country or region where an
eligible entity is located. Proposed Sec.  1.663(a) establishes the
requirements for a waiver or waiver extension and proposed Sec.
1.663(b) to (f) describes the procedural requirements for a waiver or
waiver extension request, including electronic submission, in English.
Under proposed Sec.  1.663(g), we explain that an accredited auditor/
certification body should not use an audit agent subject to the 13-
month limit in proposed Sec.  1.650 unless we have granted the request
or the 13-month limit has elapsed. The procedural requirements in
proposed Sec.  1.663 mirror the procedural requirements for other
applications submitted to us.
    e. When can FDA withdraw accreditation? (Proposed Sec.  1.664).
This proposed rule would establish the conditions under which we could
withdraw accreditation from an auditor/certification body, regardless
of whether it was directly accredited or accredited by a recognized
accreditation body.
    Proposed Sec.  1.664(a) describes criteria for mandatory withdrawal
that reflect section 808(c)(6)(A) of the FD&C Act, which requires us to
withdraw accreditation in certain outbreak situations, whenever we find
that an accredited auditor/certification body is no longer meeting the
requirements for accreditation, or following a refusal to allow U.S.
officials to conduct audits and investigations to ensure compliance
with these requirements. The statute directs us to withdraw
accreditation if a food or facility certified by an accredited auditor/
certification body under our program is linked to an outbreak of
foodborne illness that has a reasonable probability of causing serious
adverse health consequences or death in human or animals, except under
section 808(c)(6)(C) of the FD&C Act, if we conduct an investigation of
the material facts of the outbreak, review the steps and actions taken
by the auditor/certification body, and determine that the accredited
auditor/certification body satisfied the requirements for issuance of
certification under this rule. The exception is set out in proposed
Sec.  1.664(b).
    Section 808(c)(6)(B) of the FD&C Act allows us to withdraw
accreditation from an accredited auditor/certification body whose
accrediting body had its recognition revoked, if we determine there is
good cause for withdrawal. This statutory provision is reflected in
Sec.  1.664(c), which also provides two examples of circumstances we
believe provide good cause for withdrawal, including bias or lack of
objectivity and performance calling into question the validity or
reliability of its food safety audits and certifications.
    In proposed Sec.  1.664(d) we provide for records access when
considering possible withdrawal of accreditation. In proposed Sec.
1.664(e) we provide for notice of withdrawal of accreditation and
describe the processes to challenge such withdrawal.
    Proposed Sec.  1.665(f) describes the effect of withdrawal on
eligible entities. In general, a food or facility certification issued
by an accredited auditor/certification prior to withdrawal of
accreditation will remain in effect until it terminates by expiration,
except if we have reason to believe a certification issued for purposes
of section 801(q) of the FD&C Act is not valid or reliable, we can
refuse to accept the certification.
    Proposed Sec.  1.664(g)(1) explains that FDA will notify the
recognized accreditation body that accredited the third-party auditor/
certification body whose accreditation was withdrawn by FDA. In such
circumstances, proposed Sec.  1.664(g)(1) requires the recognized
accreditation body to conduct a self-assessment, as described in Sec.
1.622, and report the results of such self-assessment to FDA within 2
months after withdrawal, as required by Sec.  1.623(b). Proposed Sec.
1.664(g)(2) explains that FDA may revoke recognition of an
accreditation body whenever FDA determines there is good cause for
revocation under proposed Sec.  1.634.
    Proposed Sec.  1.664(h) provides for public notice of withdrawal of
accreditation on FDA's Web site. We believe this information is
necessary in the interest of transparency.
    f. How do I voluntarily relinquish accreditation? (Proposed Sec.
1.665). This proposed rule would allow accredited auditors/
certification bodies to voluntarily relinquish their accreditations
before they expire and without having them withdrawn by FDA.
    Proposed Sec.  1.665 offers the mechanism for voluntarily
relinquishment before it terminates by expiration. Relinquishment on
the initiative of the auditor/certification body is distinct from
withdrawal of accreditation for cause.
    The mammography regulations in 21 CFR 900.3 offer accreditation
bodies the opportunity to voluntarily relinquish their authority to
grant accreditation. We believe that auditors/certification bodies
operating under our accredited third-party audits and certification
program should have the option to voluntarily relinquish their
accreditation for their business reasons. We are proposing certain
procedural requirements--similar to those contained in the mammography
regulations--which auditors/certification bodies must follow in
relinquishing accreditation. We believe these measures are necessary to
ensure an orderly transition for eligible entities certified by the
auditor/certification body that is relinquishing its accreditation, and
for us to make the necessary adjustments in the program.
    Proposed Sec.  1.665(a) requires auditors/certification bodies to
notify us and to

notify their accreditation body (where applicable) at least 6 months
before relinquishing accreditation. We propose to require such
notifications to be submitted electronically and in English. To ensure
that we have the ability to maintain adequate oversight of the program,
including through access the records of the auditor/certification body,
the notice required under proposed Sec.  1.665(a) must identify the
location where the records required by proposed Sec.  1.658 will be
maintained.
    The decision to relinquish accreditation is made solely by the
third-party auditor/certification body, without FDA involvement.
Therefore, in relinquishing accreditation under proposed Sec.
1.665(a), the auditor/certification body would waive its rights to
appeal, because there is no FDA action to serve as the basis for
appeal.
    Proposed Sec.  1.665(b) requires the accreditation body to notify
any eligible entity to which it issued a food or facility certification
no later than 15 business days after notifying FDA of its intent to
voluntarily relinquish accreditation.
    Proposed Sec.  1.665(c) describes the effects of relinquishment of
accreditation on certification issued by an auditor/certification body
prior to relinquishing its accreditation. In considering the impact of
relinquishment on eligible entities, we were mindful that such entities
would likely have little, if any, opportunity to provide input on a
decision by its auditor/certification body whether or not to relinquish
accreditation. We believe that, under most circumstances, the fact that
an auditor/certification body decided to relinquish its accreditation
is likely to have no bearing on the validity or reliability of
certifications it issued. Therefore, we have tentatively concluded that
the certification of an eligible entity whose auditor/certification
body voluntarily relinquished its accreditation under proposed Sec.
1.665 will remain in effect (subject to recertification under proposed
Sec.  1.681), except that we may refuse to consider a certification
issued for purposes of section 801(q) of the FD&C Act, if we have
reason to believe the certification is not valid or reliable.
    Proposed Sec.  1.665(d) provides for public notice on our Web site
of the voluntary relinquishment of accreditation by an auditor/
certification body.
    g. How do I request reaccreditation? (Proposed Sec.  1.666). This
proposed rule would allow a third-party auditor/certification body to
become reaccredited after withdrawal or relinquishment of its
accreditation.
    Section 808(c)(7) of the FD&C Act requires us to establish
procedures to reinstate the accreditation of an auditor/certification
body for which we have withdrawn accreditation. Under proposed Sec.
1.666(a), we will reinstate accreditation if the auditor/certification
body can demonstrate that the grounds for withdrawal no longer exist,
or if the withdrawal was prompted by the revocation of recognition of
its accreditation body and the auditor/certification body finds a new
recognized accreditation body, becomes directly accredited, or
otherwise meets conditions we impose in the withdrawal. Under proposed
Sec.  1.666(b), an auditor/certification body that voluntarily
relinquished its accreditation may become reaccredited by submitting a
new application for accreditation under proposed Sec.  1.660 or Sec.
1.670 (where the criteria for direct accreditation are met).
8. Additional Procedures for Direct Accreditation of a Third-Party
Auditors/Certification Bodies

   Table 8--Additional Procedures Proposed for Direct Accreditation of
                Third-Party Auditors/Certification Bodies
------------------------------------------------------------------------
 Proposed rule section                        Title
------------------------------------------------------------------------
1.670..................  How do I apply to FDA for direct accreditation
                          or renewal of direct accreditation?
1.671..................  How will FDA review applications for direct
                          accreditation and for renewal of direct
                          accreditation?
1.672..................  What is the duration of direct accreditation?
------------------------------------------------------------------------

    a. How do I apply to FDA for direct accreditation or renewal of
direct accreditation? (Proposed Sec.  1.670). This proposed rule
describes the circumstances and procedures that would apply for direct
accreditation and renewal of direct accreditation.
    Proposed Sec.  1.670 describes the conditions under which we will
accept applications for direct accreditation, reflecting the statutory
language in section 808(b)(1)(A)(ii) of the FD&C Act, which allows us
to directly accredit auditors/certification bodies if we have not
identified and recognized an accreditation body to meet the
requirements of section 808 of the FD&C Act within 2 years after
establishing our program. Proposed Sec.  1.670(a)(1) identifies certain
circumstances and criteria that we have tentatively concluded are
relevant for determining whether we have not identified and recognized
an accreditation body to meet the requirements of section 808 of the
FD&C Act. Proposed Sec.  1.670(a)(2) specifies conditions under which
we may revoke or modify such a determination. Proposed Sec.
1.670(a)(3) provides for public notice of such determination or its
revocation or revision.
    Proposed Sec.  1.670(b) sets out the procedures for applying for
direct accreditation or renewal of direct accreditation. This mirrors
the procedures for applications established elsewhere under this rule.
    b. How will FDA review applications for direct accreditation and
for renewal of direct accreditation? (Proposed Sec.  1.671). This
proposed rule would establish procedures for processing applications
for direct accreditation and for renewal of direct accreditation.
    Proposed Sec.  1.671 describes a process for reviewing and deciding
on applications for direct accreditation and renewal that is consistent
with the procedures for reviewing and deciding on applications under
other provisions in this rule. For example, we propose to establish a
queue for direct accreditation and renewal applications based on the
date on which an application was completed, and we will review
applications on a first in, first out basis. We will inform applicants
of deficiencies in application documentation. To encourage applicants
to supply any missing information promptly, we will not place an
application in the queue until it is complete. Allowing incomplete
applications in the queue might block applications that are ready for
review, but were submitted later in time.
    We will inform an applicant once its application has been placed in
the queue. We will review each application for direct accreditation or
renewal of direct accreditation to determine

whether the applicant meets the eligibility requirements of proposed
Sec.  1.640. We will communicate anticipated processing periods to
applicants. We are not proposing to include specific timeframes for
review in the regulation, for the following reasons: (1) It is
difficult to project, at this time, the amount of resources that will
be available to us for this program, which under section 808(c)(8) of
the FD&C Act, is funded through user fees established by regulation;
and (2) we anticipate that, as we gain experience in reviewing
applications and in overall administration of the program, we will
become more efficient in processing applications but currently lack
data that would allow us to reasonably estimate the effect of
efficiency gains on review times.
    Under proposed Sec.  1.671(c), (d), and (e), we will notify an
applicant, in writing, whether the application has been approved or
denied. If approved, the notice will describe any conditions imposed on
the direct accreditation. If denied, the notice will state the basis
for the denial and will describe procedures for requesting
reconsideration of the decision. We believe this provision offers
necessary protections for applicants. We seek comment on the process
and procedures required by proposed Sec.  1.671.
    c. What is the duration of direct accreditation? (Proposed Sec.
1.672). This proposed rule would establish the duration of
accreditation.
    Proposed Sec.  1.672 states that direct accreditation of a third-
party auditor/certification body may be granted for a period up to 4
years. Similarly, proposed Sec.  1.661 allows a recognized
accreditation body to grant accreditation for a period of up to 4
years. We have tentatively concluded that 4 years is an appropriate
duration for an accreditation--whether granted by a recognized
accreditation body or by us--because we believe the rigor and
credibility of this new program rests, in part, on the extent of
oversight of accredited third-party auditors/certification bodies to
conduct audits and to certify eligible foreign entities. The process
for renewal of accreditation provides an opportunity for us to look
closely at all aspects of the auditor's/certification body's program
and performance and to decide anew whether the auditor/certification
body meets the eligibility requirements for accreditation.
    We are proposing to set the duration of accreditation under this
new program for a shorter period than the duration of accreditation we
allow under 21 CFR part 900, which is the mammography program
established several years ago. As we gain experience with accredited
auditors/certification bodies in the food and feed programs, we may
revisit this matter. For these reasons, we have tentatively concluded
that accreditation should be granted for a period of no longer than 4
years. We seek comment on this tentative conclusion.
9. Requirements for Eligible Entities

          Table 9--Proposed Requirements for Eligible Entities
------------------------------------------------------------------------
 Proposed rule section                        Title
------------------------------------------------------------------------
1.680..................  How and when will FDA monitor eligible
                          entities?
1.681..................  How frequently must eligible entities be
                          recertified?
------------------------------------------------------------------------

    a. How and when will FDA monitor eligible entities? (Proposed Sec.
1.680). This proposed rule would provide for FDA monitoring of eligible
entities that choose to be audited under our program.
    Proposed Sec.  1.680(a) states that we may conduct an onsite audit
of an eligible entity that has received certification under this
program, as allowed under section 808(f)(3) of the FD&C Act, which
specifies that we may conduct an onsite audit of a certified entity at
any time, with or without the accredited auditor/certification body
present. Proposed Sec.  1.680(b) reflects section 808(h)(1) of the FD&C
Act, explaining that a food safety audit conducted under this program
is not considered an inspection under section 704 of the FD&C Act.
    b. How frequently must eligible entities be recertified? (Proposed
Sec.  1.681). This proposed rule would require eligible entities to be
recertified annually.
    Section 808(d) of the FD&C Act requires eligible entities to apply
for annual certification for food required to have certification under
section 801(q) of the FD&C Act or for its facility, if it intends the
certification to be used by an importer in establishing eligibility to
participate in VQIP under section 806 of the FD&C Act. This statutory
requirement is reflected in proposed Sec.  1.681(a). Proposed Sec.
1.681(b) states that FDA may require renewal of a food certification at
any time FDA determines appropriate under section 801(q)(4)(A) of the
FD&C Act.
10. General Requirements

                 Table 10--Proposed General Requirements
------------------------------------------------------------------------
 Proposed rule section                        Title
------------------------------------------------------------------------
1.690..................  How will FDA make information about recognized
                          accreditation bodies and accredited auditors/
                          certification bodies available to the public?
1.691..................  How do I request reconsideration of a denial by
                          FDA of an application or a waiver request?
1.692..................  How do I request internal agency review of a
                          denial of an application or waiver request
                          upon reconsideration?
1.693..................  How do I request a regulatory hearing on a
                          revocation of recognition or withdrawal of
                          accreditation?
------------------------------------------------------------------------

    a. How will FDA make information about recognized accreditation
bodies and accredited auditors/certification bodies available to the
public? (Proposed Sec.  1.690). This proposed rule explains how and
where we would make information on the accredited third-party audits
and certification program public. Section 808(g) of the FD&C Act
requires us to establish a publicly available registry of recognized
accreditation bodies and accredited auditors/certification bodies,
including their names and contact information.
    Proposed Sec.  1.690 provides that we will post on our Web site a
registry of recognized accreditation bodies and of accredited auditors/
certification bodies

and explains that we may meet the obligation with respect to accredited
auditors/certification bodies by establishing links on our Web site to
the Web sites of recognized accreditation bodies, who are required to
maintain this information for auditors/certification bodies they
accredit under this program. As appropriate based on available
resources, we may use such links in the interest of minimizing the
administrative burden on us and in acknowledgement that some
accreditation bodies currently maintain such information on their Web
sites. We are seeking comment on our proposed public registry.
    b. How do I request reconsideration of a denial by FDA of an
application or a waiver request? (Proposed Sec.  1.691). This proposed
rule would establish procedures for an applicant or requestor to seek
reconsideration of a denial. Under proposed Sec.  1.691, accreditation
bodies and certification bodies may ask us to reconsider an application
or waiver request we previously denied. The types of applications and
requests that may be reconsidered are: (1) Denial of an application for
recognition or for renewal of recognition; (2) denial of an application
submitted to reinstate recognition; or (3) denial of a request for a
waiver of the 13-month limit on audit agents or for a waiver extension;
(4) denial of an application for direct accreditation or for renewal of
direct accreditation; and (5) denial of an application for
reaccreditation.
    The procedures described in proposed Sec.  1.691 require submission
of the request for reconsideration within 10 business days of the date
of such decision, in accordance with the procedures described in the
notice of denial, including requirements relating to submission of
supporting information. Within a reasonable time after completing its
review and evaluation of the request for reconsideration and the
supporting information (if any) submitted, we will notify the
requestor, in writing, of our decision to grant the application or
waiver request upon reconsideration, or our decision to deny upon
reconsideration the application or waiver request.
    c. How do I request internal Agency review of a denial of an
application or waiver request upon reconsideration? (Proposed Sec.
1.692). This proposed rule would offer additional process for
applicants or requestors whose request for reconsideration was denied.
    Proposed Sec.  1.692 states that the requestor who received a
denial upon reconsideration may seek internal Agency review of such
denial under 21 CFR 10.75(c)(1), which is a currently established
process for review but different than the initial review process under
proposed Sec.  1.691. The request for internal Agency review must be
submitted within 10 business days of the date of denial upon
reconsideration, in accordance with procedures described in the denial
upon reconsideration and must be signed by the accreditation body or
certification body, as appropriate, or by an individual authorized to
act on its behalf. Internal Agency review of the denial upon
reconsideration must be based on the information in the administrative
file, which will include any supporting information submitted under
proposed Sec.  1.691(c). Within a reasonable time after completing the
review and evaluation of the administrative file, we will notify the
requestor, in writing, of our decision to overturn the denial and grant
the application or waiver request or to affirm the denial. Affirmation
of a denial constitutes final Agency action for purposes of 5 U.S.C.
702.
    d. How do I request a regulatory hearing on a revocation of
recognition or withdrawal of accreditation? (Proposed Sec.  1.693).
This proposed rule explains the procedures that would be used for
challenges to revocation of recognition or withdrawal of accreditation.
    Under proposed Sec.  1.693(a) an accreditation body whose
recognition was revoked (or an individual authorized to act on its
behalf) may submit a request for a regulatory hearing, under part 16,
on the revocation. The request must be submitted within 10 business
days of the date of revocation. Similarly, under proposed Sec.
1.693(b) a certification body whose accreditation was withdrawn by FDA
may submit a request for a part 16 regulatory hearing on the
withdrawal. Such request must be submitted within 10 business days of
the date of withdrawal. Written notices of revocation and of withdrawal
will contain all of the elements required by Sec.  16.22 of this
chapter and will thereby constitute the notice of an opportunity for
hearing under part 16 of this chapter.
    Under proposed Sec.  1.693(c), the request for a regulatory hearing
under paragraph (a) or (b) of this section must be submitted with a
written appeal that responds to the bases for our decision described in
the written notice of revocation or withdrawal, as appropriate,
together with any supporting information upon which the requestor is
relying. The request, appeal, and supporting information must be
submitted in accordance with the procedures described in the notice.
    Proposed Sec.  1.693 makes clear that the submission of a request
for a regulatory hearing under this subpart will not operate to delay
or stay the effect of our decision to revoke recognition of an
accreditation body or to withdraw accreditation of a certification body
unless we determine that delay or a stay is in the public interest.
    Under proposed Sec.  1.693(e) and (f), the presiding officer for a
regulatory hearing under this subpart will be designated after a
request for a regulatory hearing is submitted to us. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec.  16.26(a) of this chapter.
    Proposed Sec.  1.693(g) states that if a hearing request is
granted, the hearing will be held within 10 business days after the
date the request was filed or, if applicable, within a time frame
agreed upon in writing by requestor and the presiding officer. The
presiding officer may require that a hearing conducted under this
subpart be completed within 1 business day, as appropriate.
    The presiding officer must conduct the hearing under part 16 of
this chapter, except that, under Sec.  16.5(b) of this chapter, the
procedures for a regulatory hearing described in part 16 of this
chapter apply only to the extent that such procedures are supplementary
and not in conflict with the procedures specified for the conduct of
regulatory hearings under this subpart. Based on Sec.  16.5(b), the
following requirements of part 16 of this chapter are inapplicable to
regulatory hearings conducted under this subpart: The requirements of
Sec.  16.22 (Initiation of a regulatory hearing), Sec.  16.24(e)
(Timing) and (f) (Contents of notice), Sec.  16.40 (Commissioner),
Sec.  16.95(b) (Administrative decision and record for decision), and
Sec.  16.119 (Reconsideration and stay of action).
    Proposed Sec.  1.693(g)(4) states that a decision by the presiding
officer to affirm the revocation of recognition or the withdrawal of
accreditation that served as the basis for the request for a regulatory
hearing is considered a final Agency action for purposes of 5 U.S.C.
702.
11. Audits for Other Purposes

   Table 11--Proposed Use of Regulatory Audit Reports Under Subpart L
------------------------------------------------------------------------
 Proposed rule section                        Title
------------------------------------------------------------------------
1.698..................  May importers use reports of regulatory audits
                          by accredited auditors/certification bodies
                          for purposes of subpart L of this part?
------------------------------------------------------------------------

    May importers use reports of regulatory audits by accredited
auditors/certification bodies for purposes of subpart L of this part?
(Proposed Sec.  1.698). This proposed rule would allow importers to use
certain information from accredited auditors/certification bodies in
meeting the Foreign Supplier Verification Program (FSVP) requirements.
    Proposed Sec.  1.698 allows an importer, as defined in the proposed
regulations for the FSVP published elsewhere in this edition of the
Federal Register, to use a report of a regulatory audit of a foreign
supplier (which is an eligible entity), in meeting the verification
requirements under the proposed FSVP regulations.
    The FSVP proposed rule would require importers to verify that
hazards identified as reasonably likely to occur are being adequately
controlled. Onsite auditing may be used under the FSVP proposed rule.
While the FSVP proposed rule would not require use of accredited
auditors/certification bodies, we believe accredited auditor/
certification body program we are establishing under section 808 of the
FD&C Act will help ensure the rigor and objectivity of audits performed
by auditors/certification bodies accredited under our program.
    Proposed Sec.  1.698 allows an importer required (or having the
option) to perform onsite auditing of its foreign supplier to comply
with the FSVP proposed rule to use the results of a regulatory audit in
meeting such requirement. The regulatory audit report of the foreign
supplier would be the documentation of such verification activity. (We
have tentatively concluded that the report of a consultative audit
would not be appropriate documentation for purposes of the proposed
FSVP rule. Among other things, consultative audits are defined as being
conducted for internal purposes only and are conducted against industry
standards as well as the requirements of the FD&C Act.)
    We see significant value in having the food industry use competent
and impartial auditors/certification bodies to conduct food safety
audits of their facilities and are aware that many leaders in the food
industry are working to assure those objectives are achieved. We
believe that the accredited third-party audits and certification
program we are establishing to implement section 808 of the FD&C Act
offers a credible system to help ensure that the audits conducted by
auditors/certification bodies accredited under our program and the
certifications they issue based on the results of those audits are
valid and reliable not only to us, but also to companies throughout the
supply chain of the audited facility. We further believe that our
involvement, as the regulator responsible with oversight of these
facilities, offers an added level of assurance to consumers in the
validity of these third-party audits--a confidence they otherwise might
not gain from private audit systems.
    It is our intent that the program we establish for foreign food
safety audits be solidly grounded in the key principles set out in the
statute and in the international standards and best practices that are
currently used by leaders at the forefront of efforts to ensure auditor
competency and objectivity. We realize that the same principles and
standards that are features of a rigorous and credible program for
audits of foreign firms would likewise hold great merit for audits of
domestic food facilities.
    We seek comment on the value of, and need for, a program
established and administered by FDA for the use of accredited auditors/
certification bodies to conduct domestic food safety audits. We seek
input on whether accreditation bodies, auditors/certification bodies,
and domestic food facilities might be interested in such a program and
the incentives we might offer to encourage participation.

B. Proposed Revisions to Part 16

    We are proposing a conforming change to the section of the CFR that
describes procedures for regulatory hearings that would add revocation
of recognition of an accreditation body and withdrawal of accreditation
of a third-party auditor/certification body to the list of actions for
which a hearing under this part may be held. The affected section in
title 21 of the CFR is 16.1.

V. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of
this action. We have concluded, under 21 CFR 25.30(h), that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required (Ref. 34).

VI. Federalism

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

VII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VIII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified all the Web site addresses in this References
section, but FDA is not responsible for any subsequent changes to the
Web sites after this document publishes in the Federal Register).

1. Centers for Disease Control and Prevention. ``CDC research shows
outbreaks linked to imported foods increasing.'' http://www.cdc.gov/media/releases/2012/p0314_foodborne.html. Accessed April 23, 2013.

2. ``Notification to the World Trade Organization (G/SPS/N/USA/
2156).'' Food and Drug Administration, 2011. https://docs.wto.org/imrd/directdoc.asp?DDFDocuments/t/G/SPS/NUSA2156.DOC.
3. International Organization for Standardization/CASCO. ``Building
Trust: The Conformity Assessment Toolbox,'' 2009. http://www.iso.org/iso/casco_building-trust.pdf. Accessed April 23, 2013.
4. U.S. Agency for International Development. ``The Relationship of
Third-Party Certification (TPC) to Sanitary/Phytosanitary (SPS)
Measures and the International Agri-Food Trade: Final Report,''
2005. http://cs3.msu.edu/d/pubs/
The%20Relationship%20of%20TPC%20to%20SPS%20Measures--
Final%20Report%20+%20Annexes.pdf. Accessed April 23, 2013.
5. ``Guidance for Industry--Voluntary Third-Party Certification
Program for Foods and Feeds,'' 2009. Food and Drug Administration.
http://www.fda.gov/regulatoryinformation/guidances/ucm125431.html.
6. ``Assessment of the Third-Party Certification Program for
Aquacultured Shrimp,'' 2011. Food and Drug Administration. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm265934.htm.
7. ``Mammography Quality Standards Act and Program, Facility
Certification and Inspection (MQSA).'' Food and Drug Administration.
http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/AbouttheMammographyProgram/default.htm. Accessed on April 23, 2013. Last Modified 2012.
8. ``Import Alert 28-20 Detention Without Physical Examination of
Indian Pepper.'' http://www.accessdata.fda.gov/cms_ia/importalert_90.html. Accessed April 23, 2013. Last Modified 2011.
9. ``Memorandum of Understanding Between the Food and Drug
Administration, Department of Health and Human Services, United
States of America and the Ministry of Agriculture of the Republic of
France Covering Caseins, Caseinates, and Mixtures Thereof Exported
to the United States of America.'' Food and Drug Administration.
http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm107563.htm. Accessed on April 23, 2013.
Last Modified 1987. ``Cooperative Arrangement with the Department of
Agriculture, Fisheries, and Food of Ireland Concerning Certification
Requirements for Caseins, Caseinates, and Mixtures Thereof Exported
from Ireland to the United States of America.'' Food and Drug
Administration. http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm107596.htm. Accessed on April 23, 2013.
Last Modified 2010. ``Memorandum of Understanding Between the Food
and Drug Administration and the Royal Norwegian Ministry of
Agriculture Covering Rennet Casein Exported to the United States of
America.'' Food and Drug Administration. http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm107618.htm. Accessed on April 23, 2013. Last Modified 1982.
10. Government Accountability Office. ``Food Safety: FDA Can Better
Oversee Food Imports by Assessing and Leveraging Other Countries'
Oversight Resources (GAO-12-933),'' 2012. http://www.gao.gov/assets/650/649010.pdf.
11. National Academies Press. ``Enhancing Food Safety: The Role of
the Food and Drug Administration,'' 2010. http://www.iom.edu/Reports/2010/Enhancing-Food-Safety-The-Role-of-the-Food-and-Drug-Administration.aspx.
12. ``Manufactured Foods Regulatory Program Standards.'' Food and
Drug Administration. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125448.pdf. Accessed on April 23,
2013. Last Modified 2007.
13. ``Ensuring the Safety of Imported Foods and Animal Feed:
Comparability of Food Safety Systems and Import Practices of Foreign
Countries; Notice of Public Hearing; Request for Comments, 2011.''
Food and Drug Administration. http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/ucm243781.htm. Accessed on April 23,
2013.
14. ``Draft International Comparability Assessment Tool, 2010.''
Food and Drug Administration. http://www.fda.gov/downloads/Food/InternationalInteragencyCoordination/UCM331177.pdf. Accessed on
April 23, 2013.
15. ``Circular A-119 Federal Participation in the Development and
Use of Voluntary Consensus Standards and in Conformity Assessment
Activities, 1998.'' Office of Management and Budget. http://www.whitehouse.gov/omb/circulars_a119. Accessed on April 23, 2013.
16. ``Federal Participation in the Development and Use of Voluntary
Consensus Standards and in Conformity Assessment Activities; Request
for Information and Notice of Public Workshop, 2012.'' Office of
Management and Budget. http://www.regulations.gov/#!documentDetail;D=OMB-2012-0003-0001. Accessed on April 23, 2013.
17. ``ISO/IEC 17000:2004 Conformity assessment--Vocabulary and
General Principles.'' International Organization for
Standardization/International Electrotechnical Commission. Accessed
on April 23, 2013. Copies are available from the International
Organization for Standardization, 1, rue de Varembe, Case postale
56, CH-1211 Geneve 20, Switzerland, or on the Internet at http://www.iso.org/iso/catalogue_detail.htm?csnumber=29316 or may be
examined at the Division of Dockets Management (see ADDRESSES) (Ref.
Docket No. FDA-2011-N-0146 and/or RIN 0910-AG66).
18. ``ISO/IEC 17011:2004 Conformity assessment--General requirements
for accreditation bodies accrediting conformity assessment bodies.''
International Organization for Standardization/International
Electrotechnical Commission. Accessed on April 23, 2013. Copies are
available from the International Organization for Standardization,
1, rue de Varembe, Case postale 56, CH-1211 Geneve 20, Switzerland,
or on the Internet at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=29332 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
19. ``ISO/IEC 17021: 2006/2011 Conformity assessment--Requirements
for bodies providing audit and certification of management
systems.'' International Organization for Standardization/
International Electrotechnical Commission. Accessed on April 23,
2013. Last Modified 2011. Copies are available from the
International Organization for Standardization, 1, rue de Varembe,
Case postale 56, CH-1211 Geneve 20, Switzerland, or on the Internet
at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=46568 or may be examined at the Division of
Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-2011-N-0146
and/or RIN 0910-AG66).
20. ``ISO/IEC Guide 65:1996 General requirements for bodies
operating product certification systems.'' International
Organization for Standardization/International Electrotechnical
Commission. Accessed on February 27, 2013. Copies are available from
the International Electrotechnical Commission, 3, rue de Varembe,
P.O. Box 131, CH-1211 Geneva 20--Switzerland, or on the Internet at
http://webstore.iec.ch/webstore/webstore.nsf/Artnum_PK/40140, or
may be examined at the Division of Dockets Management (see
ADDRESSES) (Ref. Docket No. FDA-2011-N-0146 and/or RIN 0910-AG66).
``ISO/IEC 17065:2012 Conformity assessment--Requirements for bodies
certifying products, processes and services.'' International
Organization for Standardization/International Electrotechnical
Commission. Accessed on April 23, 2013. Copies are available from
the International Organization for Standardization, 1, rue de
Varembe, Case postale 56, CH-1211 Geneve 20, Switzerland, or on the
Internet at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=46568 or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
21. ``ISO/TS 22003:2007 Food safety management systems--Requirements
for bodies providing audit and certification of food safety
management systems.'' International Organization for
Standardization/International Electrotechnical Commission. Accessed
on April 23, 2013. Copies are available from the International
Organization for

Standardization, 1, rue de Varembe, Case postale 56, CH-1211 Geneve
20, Switzerland, or on the Internet at http://www.iso.org/iso/home/store/cataloguetc/catalogue_detail.htm?csnumber=39834 or may be
examined at the Division of Dockets Management (see ADDRESSES) (Ref.
Docket No. FDA-2011-N-0146 and/or RIN 0910-AG66).
22. ``Enhancing Food Safety Through Third-Party Certification.''
Global Food Safety Initiative. http://www.mygfsi.com/technical-resources/global-regulatory-affairs-working-group.html. Accessed on
April 23, 2013. Last Modified 2011.
23. ``GFSI Guidance Document Sixth Edition, Version 6.2.'' Global
Food Safety Initiative. http://www.mygfsi.com/gfsifiles/GFSI_Guidance_Document_Sixth_Edition_Version_6.2.pdf. Accessed on
April 23, 2013. Last Modified 2012.
24. ``Accreditation Services,'' 2013. American National Standards
Institute. https://www.ansica.org/wwwversion2/outside/PROsectorprograms.asp?menuID=1. Accessed on April 23, 2013.
25. Food and Drug Administration. Analysis to examine the impacts of
the proposed rules for the Foreign Supplier Verification Program and
the Accreditation of Third-Party Auditors/Certification Bodies to
Conduct Food Safety Audits and to Issue Certifications under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), and the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520), 2013. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. Accessed
on July 22, 2013.
26. Codex Alimentarius Commission. Principles for Food Import and
Export Inspection and Certification (CAC/GL 20-1995).
www.codexalimentarius.org/input/download/standards/37/CXG_020e.pdf.
Accessed on April 23, 2013.
27. ``Policy Memorandum, Certification of Grower Groups,'' 2011.
U.S. Department of Agriculture Agricultural Marketing Service
National Organic Program. http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088955. Accessed on April 23, 2013.
28. ``NVCASE Program Handbook: Procedures for Obtaining NIST
Recognition as an Accreditor (NISTIR 6440),'' 2004. National
Institute for Standards and Technology. http://gsi.nist.gov/global/docs/NVCASE_Handbook.pdf. Accessed on April 23, 2013.
29. ``GFSI Requirements on the Application of ISO/IEC 17011:2004,''
2009. Global Food Safety Initiative. http://www.mygfsi.com/gfsifiles/GFSI_ISO_17011_Requirements_190209_Final_IAF.pdf.
Accessed April 23, 2013.
30. ``Multilateral Recognition Arrangement Documents (ML Series).''
International Accreditation Forum. http://www.iaf.nu/articles/MRA_Documents/39. Accessed April 23, 2013.
31. ``Letter to Interested Parties re: Draft WaterSense[supreg]
Program,'' 2007. Environmental Protection Agency. http://www.epa.gov/watersense/docs/cert_scheme_cover_letter508.pdf.
Accessed on April 23, 2013. ``WaterSense[supreg] Program, Product
Certification System, Version 2.0,'' 2011. Environmental Protection
Agency. http://www.epa.gov/watersense/docs/cert_system_508.pdf.
Accessed on April 23, 2013.
32. ``Global Standard for Food Safety, Issue 6,'' 2012. British
Retail Consortium. Copies are available from the British Retail
Consortium, Second Floor, 21 Dartmouth Street, London SW1H 9BP, or
on the Internet at http://www.brcglobalstandards.com/GlobalStandards/Standards/Food.aspx or may be examined at the
Division of Dockets Management (see ADDRESSES) (Ref. Docket No. FDA-
2011-N-0146 and/or RIN 0910-AG66).
33. ``Recalls Background and Definitions.'' Food and Drug
Administration. http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129337.htm. Accessed on April 23, 2013. Last Modified 2009.
34. McCarthy, A. and Food and Drug Administration. ``Memorandum:
Establishment of regulation to accredit third-party auditors and
laboratories as required by the Food Safety Modernization Act of
2011.''

List of Subjects

21 CFR Part 1

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

21 CFR Part 16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 1 and 16 be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 350k, 352,
355, 360b, 362, 371, 374, 381, 382, 384a, 384b, 384d, 393, 42 U.S.C.
216, 241, 243, 262, 264.

0
2. Add subpart M, consisting of Sec. Sec.  1.600 through 1.698, to read
as follows:
Subpart M--Accredited Third-Party Food Safety Audits and Food or
Facility Certification
1.600 What definitions apply to this subpart?
1.601 Who is subject to this subpart?

Recognition of Accreditation Bodies Under This Subpart

1.610 Who is eligible for recognition?
1.611 What legal authority must an accreditation body have to
qualify for recognition?
1.612 What competency and capacity must an accreditation body have
to qualify for recognition?
1.613 What protections against conflicts of interest must an
accreditation body have to qualify for recognition?
1.614 What quality assurance procedures must an accreditation body
have to qualify for recognition?
1.615 What records procedures must an accreditation body have to
qualify for recognition?

Requirements for Recognized Accreditation Bodies Under This Subpart

1.620 How must a recognized accreditation body assess third-party
auditors/certification bodies seeking accreditation?
1.621 How must a recognized accreditation body monitor the
performance of third-party auditors/certification bodies it
accredits?
1.622 How must a recognized accreditation body monitor its own
performance?
1.623 What reports and notifications must a recognized accreditation
body submit to FDA?
1.624 How must a recognized accreditation body protect against
conflicts of interest?
1.625 What records requirements must a recognized accreditation body
meet?

Procedures for Recognition of Accreditation Bodies Under This Subpart

1.630 How do I apply to FDA for recognition or renewal of
recognition?
1.631 How will FDA review applications for recognition and for
renewal of recognition?
1.632 What is the duration of recognition?
1.633 How will FDA monitor recognized accreditation bodies?
1.634 When will FDA revoke recognition?
1.635 How do I voluntarily relinquish recognition?
1.636 How do I request reinstatement of recognition?

Accreditation of Third-Party Auditors/Certification Bodies Under This
Subpart

1.640 Who is eligible for accreditation?
1.641 What legal authority must a third-party auditor/certification
body have to qualify for accreditation?
1.642 What competency and capacity must a third-party auditor/
certification body have to qualify for accreditation?
1.643 What protections against conflicts of interest must a third-
party auditor/certification body have to qualify for accreditation?
1.644 What quality assurance procedures must a third-party auditor/
certification body have to qualify for accreditation?
1.645 What records procedures must a third-party auditor/
certification body have to qualify for accreditation?

Requirements for Accredited Auditors/Certification Bodies Under This
Subpart

1.650 How must an accredited auditor/certification body ensure its
audit agents are competent and objective?
1.651 How must an accredited auditor/certification body conduct a
food safety audit of an eligible entity?
1.652 What must an accredited auditor/certification body include in
food safety audit reports?
1.653 What must an accredited auditor/certification body do when
issuing food or facility certifications?
1.654 When must an accredited auditor/certification body monitor an
eligible entity with food or facility certification?
1.655 How must an accredited auditor/certification body monitor its
own performance?
1.656 What reports and notifications must an accredited auditor/
certification body submit?
1.657 How must an accredited auditor/certification body protect
against conflicts of interest?
1.658 What records requirements must an accredited auditor/
certification body meet?

Procedures for Accreditation of Third-Party Auditors/Certification
Bodies Under This Subpart

1.660 Where do I apply for accreditation or renewal of accreditation
by a recognized accreditation body?
1.661 What is the duration of accreditation?
1.662 How will FDA monitor accredited auditors/certification bodies?
1.663 How do I request an FDA waiver or waiver extension for the 13-
month limit for audit agents conducting regulatory audits?
1.664 When can FDA withdraw accreditation?
1.665 How do I voluntarily relinquish accreditation?
1.666 How do I request reaccreditation?

Additional Procedures for Direct Accreditation of Third-Party Auditors/
Certification Bodies Under This Subpart

1.670 How do I apply to FDA for direct accreditation or renewal of
direct accreditation?
1.671 How will FDA review applications for direct accreditation and
for renewal of direct accreditation?
1.672 What is the duration of direct accreditation?

Requirements for Eligible Entities Under This Subpart

1.680 How and when will FDA monitor eligible entities?
1.681 How frequently must eligible entities be recertified?

General Requirements of This Subpart

1.690 How will FDA make information about recognized accreditation
bodies and accredited auditors/certification bodies available to the
public?
1.691 How do I request reconsideration of a denial by FDA of an
application or a waiver request?
1.692 How do I request internal agency review of a denial of an
application or waiver request upon reconsideration?
1.693 How do I request a regulatory hearing on a revocation of
recognition or withdrawal of accreditation?

Audits for Other Purposes

1.698 May importers use reports of regulatory audits by accredited
auditors/certification bodies for purposes of subpart L of this
part?

Subpart M--Accredited Third-Party Food Safety Audits and Food or
Facility Certification

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 350k, 352,
355, 360b, 362, 371, 374, 381, 382, 384a, 384b, 384d, 393, 42 U.S.C.
216, 241, 243, 262, 264.

Sec.  1.600  What definitions apply to this subpart?

    (a) The FD&C Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Except as otherwise defined in paragraph (c) of this section,
the definitions of terms in section 201 of the FD&C Act apply when the
terms are used in this subpart.
    (c) In addition, for the purposes of this subpart:
    Accreditation means a determination by a recognized accreditation
body (or, in the case of direct accreditation, by FDA) that a third-
party auditor/certification body meets the applicable requirements of
this subpart, including the model accreditation standards.
    Accreditation body means an authority that performs accreditation
of third-party auditors/certification bodies.
    Accredited auditor/certification body means a third-party auditor/
certification body that a recognized accreditation body (or, in the
case of direct accreditation, FDA) has determined meets the applicable
requirements of this subpart and is authorized to conduct food safety
audits and to issue food or facility certifications to eligible
entities.
    Audit means:
    (1) With respect to an accreditation body, the systematic,
independent, and documented examination (through observation,
investigation, and records review) by FDA to assess the accreditation
body's authority, qualifications (including its expertise and training
program), and resources; its procedures for quality assurance,
conflicts of interest, and records; its performance in accreditation
activities; and its capability to meet the applicable requirements of
this subpart.
    (2) With respect to a third-party auditor/certification body, the
systematic, independent, and documented examination (through
observation, investigation, and records review) by a recognized
accreditation body (or, in the case of direct accreditation, by FDA) to
assess the third-party auditor's/certification body's authority,
qualifications (including its expertise and training program), and
resources; its procedures for quality assurance, conflicts of interest,
and records; its performance in auditing and certification activities;
and its capability to meet the applicable requirements of this subpart;
and
    (3) With respect to an eligible entity, the systematic,
independent, and documented examination (through observation,
investigation, records review, and as appropriate, sampling and
laboratory analysis) by an accredited auditor/certification body to
assess the entity, its facility, system(s), and food using audit
criteria for consultative or regulatory audits, including compliance
with any applicable requirements for preventative controls, sanitation,
monitoring, verification, corrective actions, and recalls, and, for
consultative audits, also includes an assessment of compliance with
applicable industry standards and practices.
    Audit agent means an individual who is an employee or other agent
of an accredited auditor/certification body who, although not
individually accredited, is qualified to conduct food safety audits on
behalf of an accredited auditor/certification body. An audit agent
includes a contractor of the accredited auditor/certification body.
    Certification body means a foreign government, agency of a foreign
government, foreign cooperative, or any other third party that is
eligible to be considered for accreditation to conduct food safety
audits and to certify that eligible entities meet applicable
requirements of the FD&C Act. A certification body may be a single
individual or an organization. A certification body may use audit
agents to conduct food safety audits. Certification body has the same
meaning as Third-party auditor as that term is defined in section 808
of the FD&C Act and in this subpart.
    Consultative audit means an audit of an eligible entity:
    (1) To determine whether such entity is in compliance with
applicable requirements of the FD&C Act and industry standards and
practices; and
    (2) The results of which are for internal purposes only and cannot
be used to determine eligibility for a food or facility certification
issued under this subpart or in meeting the requirements

for an onsite audit of a foreign supplier under subpart L of this part.
    Direct accreditation means accreditation of a third-party auditor/
certification body by FDA.
    Eligible entity means a foreign entity that chooses to be subject
to a food safety audit by an accredited auditor/certification body.
Eligible entities include foreign facilities subject to the
registration requirements of subpart H of this part.
    Facility means any structure, or structures of an eligible entity
under one ownership at one general physical location, or, in the case
of a mobile facility, traveling to multiple locations, that
manufactures/processes, packs, or holds food for consumption in the
United States. Transport vehicles are not facilities if they hold food
only in the usual course of business as carriers. A facility may
consist of one or more contiguous structures, and a single building may
house more than one distinct facility if the facilities are under
separate ownership. The private residence of an individual is not a
facility. Non-bottled water drinking water collection and distribution
establishments and their structures are not facilities.
    Facility certification means an attestation, issued for purposes of
section 806 of the FD&C Act by an accredited auditor/certification
body, after conducting a regulatory audit and any other activities
necessary to establish that a facility meets the applicable
requirements of the FD&C Act.
    Food certification means an attestation, issued for purposes of
section 801(q) of the FD&C Act by an accredited auditor/certification
body, after conducting a regulatory audit and any other activities
necessary to establish that a food meets the applicable requirements of
the FD&C Act.
    Food safety audit means a regulatory audit or a consultative audit.
    Foreign cooperative means an entity that aggregates food from
growers or processors that is intended for export to the United States.
    Recognized accreditation body means an accreditation body that FDA
has determined meets the applicable requirements of this subpart and is
authorized to accredit third-party auditors/certification bodies under
this subpart.
    Regulatory audit means an audit of an eligible entity:
    (1) To determine whether such entity is in compliance with the
provisions of the FD&C Act; and
    (2) The results of which are used in determining eligibility for
food certification under section 801(q) of the FD&C Act or facility
certification under section 806 of the FD&C Act, and may be used by an
importer in meeting the requirements for an onsite audit of a foreign
supplier under subpart L of this part.
    Relinquishment means:
    (1) With respect to an accreditation body, a decision to cede
voluntarily its authority to accredit third-party auditors/
certification bodies as a recognized accreditation body; and
    (2) With respect to a third-party auditor/certification body, a
decision to cede voluntarily its authority to conduct food safety
audits and to issue food and facility certifications to eligible
entities.
    Self-assessment means a systematic assessment conducted by an
accreditation body or by a third-party auditor/certification body to
determine whether it meets the applicable requirements of this subpart.
    Third-party auditor means a foreign government, agency of a foreign
government, foreign cooperative, or any other third party that is
eligible to be considered for accreditation to conduct food safety
audits and to certify that eligible entities meet the applicable
requirements of the FD&C Act. A third-party auditor may be a single
individual or an organization. A third-party auditor may use audit
agents to conduct food safety audits. Third-party auditor has the same
meaning as Certification body as that term is defined in this subpart.

Sec.  1.601  Who is subject to this subpart?

    (a) Accreditation bodies. Any accreditation body seeking
recognition from FDA to accredit third-party auditor/certification
bodies for conducting food safety audits and for issuing food and
facility certifications to eligible entities.
    (b) Third-party auditors/certification bodies. Any third-party
auditor/certification body seeking accreditation from a recognized
accreditation body or direct accreditation by FDA for:
    (1) Conducting food safety audits; and
    (2) Issuing food and facility certifications that may be used in
satisfying a condition of admissibility of an article of food under
section 801(q) of the FD&C Act; or in meeting the eligibility
requirements for the Voluntary Qualified Importer Program under section
806 of the FD&C Act.
    (c) Eligible entities. Any eligible entity seeking a food safety
audit or a food or facility certification from an accredited auditor/
certification body, except as provided in paragraph (d) of this
section.
    (d) Limited exemptions from section 801(q) of the FD&C Act. (1) The
certification of food under section 801(q) of the FD&C Act does not
apply with respect to alcoholic beverages from an eligible entity that
is a facility that meets the following two conditions:
    (i) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et
seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986
(26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type
that, if it were a domestic facility, would require obtaining a permit
from, registering with, or obtaining approval of a notice or
application from the Secretary of the Treasury as a condition of doing
business in the United States; and
    (ii) Under section 415 of the FD&C Act, the facility is required to
register as a facility because it is engaged in manufacturing/
processing one or more alcoholic beverages.
    (2) Certification of food under section 801(q) of the FD&C Act does
not apply with respect to food other than alcoholic beverages that is
from a facility described in paragraph (d)(1) of this section, provided
such food:
    (i) Is in prepackaged form that prevents any direct human contact
with such food; and
    (ii) Constitutes not more than 5 percent of the overall sales of
the facility, as determined by the Secretary of the Treasury.

Recognition of Accreditation Bodies Under This Subpart

Sec.  1.610  Who is eligible for recognition?

    An accreditation body is eligible for recognition by FDA if it can
demonstrate that it meets the requirements of Sec. Sec.  1.611 to
1.615.

Sec.  1.611  What legal authority must an accreditation body have to
qualify for recognition?

    (a) An accreditation body seeking recognition must demonstrate that
it has the authority (as a governmental entity or through contractual
rights) to perform such assessments of a third-party auditor/
certification body as are necessary to determine its capability to
audit and certify food facilities and food, including authority to:
    (1) Review any relevant records;
    (2) Conduct onsite assessments of the performance of third-party
auditors/certification bodies, such as by witnessing the performance of
a statistically significant number of personnel and other agents
conducting assessments;
    (3) Perform any reassessments or surveillance necessary to monitor

compliance of accredited auditors/certification bodies; and
    (4) Suspend, withdraw, or reduce the scope of accreditation for
failure to comply with the requirements of accreditation.
    (b) An accreditation body seeking recognition must demonstrate that
it is capable of exerting any authority necessary to meet the
requirements of recognition in Sec. Sec.  1.620 to 1.625 and the
procedures in Sec. Sec.  1.630, 1.635, and 1.636, if recognized.

Sec.  1.612  What competency and capacity must an accreditation body
have to qualify for recognition?

    An accreditation body seeking recognition must demonstrate that it
has:
    (a) The resources required to adequately implement its
accreditation program, including:
    (1) Adequate numbers of personnel and other agents with relevant
knowledge, skills, and experience to effectively assess the
qualifications of third-party auditors/certification bodies seeking
accreditation and to effectively monitor the performance of third-party
auditors/certification bodies; and
    (2) Adequate financial resources for its operations; and
    (b) The capability to meet the assessment and monitoring
requirements of Sec. Sec.  1.620 and 1.621, the reporting and
notification requirements of Sec.  1.623, and the procedures in
Sec. Sec.  1.630, 1.631, 1.635, and 1.636, if recognized.

Sec.  1.613  What protections against conflicts of interest must an
accreditation body have to qualify for recognition?

    An accreditation body must demonstrate that it has:
    (a) Implemented written measures to protect against conflicts of
interest between the accreditation body (and its officers, personnel,
and other agents) and third-party auditors/certification bodies (and
their officers, personnel, and other agents) seeking accreditation
from, or accredited by, such accreditation body; and
    (b) The capability to meet the conflict of interest requirements in
Sec.  1.624, if recognized.

Sec.  1.614  What quality assurance procedures must an accreditation
body have to qualify for recognition?

    An accreditation body seeking recognition must demonstrate that it
has:
    (a) Implemented a written program for monitoring and assessing the
performance of its officers, personnel and other agents and its
accreditation program, including procedures to:
    (1) Identify areas in its accreditation program or performance that
need improvement; and
    (2) Quickly execute appropriate corrective actions when problems
are found; and
    (b) The capability to meet the quality assurance requirements of
Sec.  1.622, if recognized.

Sec.  1.615  What records procedures must an accreditation body have to
qualify for recognition?

    An accreditation body seeking recognition must demonstrate that it
has:
    (a) Implemented written procedures to establish, control, and
retain records (including documents and data) for the period of time
necessary to meet its contractual and legal obligations and to provide
an adequate basis for assessing its program and performance; and
    (b) Is capable of meeting the reporting and notification
requirements of Sec.  1.623 and the records requirements of Sec.
1.625, if recognized.

Requirements for Recognized Accreditation Bodies Under This Subpart

Sec.  1.620  How must a recognized accreditation body assess third-
party auditors/certification bodies seeking accreditation?

    (a) Prior to accrediting a third-party auditor/certification body
under this subpart, a recognized accreditation body must perform, at a
minimum, the following:
    (1) In the case of a foreign government or an agency of a foreign
government, such reviews and audits of its food safety programs,
systems, and standards as are necessary to determine that it meets the
eligibility requirements of Sec.  1.640(b) and any requirements
specified in FDA model accreditation standards regarding qualifications
for accreditation, including legal authority, competency, capacity,
conflicts of interest, quality assurance, and records.
    (2) In the case of a foreign cooperative that aggregates the
products of growers or processor or any other third-party seeking
accreditation as a third-party auditor/certification body, such reviews
and audits of the training and qualifications of audit agents used by
such cooperative or other third party and such reviews of internal
systems and any other investigation of the cooperative or other third
party necessary to determine that it meets the eligibility requirements
of Sec.  1.640(c) and any requirements specified in FDA model
accreditation standards regarding qualifications for accreditation,
including legal authority, competency, capacity, conflicts of interest,
quality assurance, and records.
    (3) In conducting a review and audit under paragraph (a)(1) or
(a)(2) of this section, observe a statistically significant number of
onsite audits conducted by the third-party auditor/certification body
(or its audit agents) to assess compliance with the applicable
requirements of the FD&C Act.
    (b) A recognized accreditation body must require a third-party
auditor/certification body, as a condition of accreditation under this
subpart, to comply with the reports and notification requirements of
Sec. Sec.  1.652 and 1.656 and to agree to submit electronic food and
facility certifications, in English, to FDA for purposes of sections
801(q) and 806 of the FD&C Act.
    (c) A recognized accreditation body must maintain records on any
denial of accreditation (in whole or in part) and on any withdrawal,
suspension, or reduction in scope of accreditation of a third-party
auditor/certification body under this subpart. The records must include
the name and contact information for the third-party auditor/
certification body; the scope of accreditation denied, withdrawn,
suspended, or reduced; and the basis for such action.
    (d) A recognized accreditation body must implement written
procedures for receiving and addressing appeals from any third-party
auditor/certification body challenging an adverse decision associated
with accreditation under this subpart and for investigating and
deciding on appeals in a fair and meaningful manner. The appeals
procedures must provide similar protections to those offered by FDA
under Sec. Sec.  1.692 and 1.693, including requirements to:
    (1) Make the appeals procedures publicly available;
    (2) Use competent, independent persons to investigate and decide
appeals;
    (3) Advise third-party auditors/certification bodies of the final
decisions on their appeals; and
    (4) Maintain records under Sec.  1.625 of appeals, final decisions
on appeals, and the bases for such decisions.

Sec.  1.621  How must a recognized accreditation body monitor the
performance of third-party auditors/certification bodies it accredits?

    A recognized accreditation body must annually conduct a
comprehensive assessment of the performance of each auditor/
certification body it accredited under this subpart by reviewing the
auditor's/certification body's self-assessments (including information
on

compliance with the conflict of interest requirements of Sec. Sec.
1.643 and 1.657); its regulatory audit reports and notifications
submitted to FDA under Sec.  1.656; and any other information
reasonably available to the accreditation body:
    (a) Regarding the compliance history of eligible entities it
certified; or
    (b) That is otherwise relevant to a determination whether the
accredited auditor/certification body is in compliance with this
subpart.

Sec.  1.622  How must a recognized accreditation body monitor its own
performance?

    (a) A recognized accreditation body must annually, and as required
under Sec.  1.664(g), conduct a self-assessment that includes
evaluation of:
    (1) The performance of its officers, personnel, or other agents in
activities under this subpart and the degree of consistency among such
performances;
    (2) The compliance of the accreditation body and its officers,
personnel, and other agents, with the conflict of interest requirements
of Sec.  1.624; and
    (3) If requested by FDA, any other aspects of its performance
relevant to a determination whether the accreditation body is in
compliance with this subpart.
    (b) As a means to evaluate the accreditation body's performance,
the self-assessment must include onsite observation of regulatory
audits by a statistically significant number of third-party auditors/
certification bodies it accredited under this subpart.
    (c) Based on the evaluations conducted under paragraphs (a) and (b)
of this section, the accreditation body must:
    (1) Identify any area(s) needing improvement;
    (2) Quickly implement effective corrective action(s) to address
those area(s); and
    (3) Establish and maintain records of such corrective action(s)
under Sec.  1.625.
    (d) The accreditation body must prepare, and as required by Sec.
1.623(b) submit, a written report of the results of its self-assessment
that includes:
    (1) A description of any corrective actions taken under paragraph
(c) of this section;
    (2) A statement disclosing the extent to which the accreditation
body, and its officers, personnel, and other agents, complied with the
conflict of interest requirements in Sec.  1.624; and
    (3) A statement attesting to the extent to which the accreditation
body complied with applicable requirements of this subpart.

Sec.  1.623  What reports and notifications must a recognized
accreditation body submit to FDA?

    (a) Reporting results of assessments of certification body
performance. A recognized accreditation body must submit to FDA
electronically, in English, a report of the results of any assessment
conducted under Sec.  1.621, no later than 45 days after completing
such assessment. The report must include an up-to-date list of any
audit agent used by the accredited auditor/certification body to
conduct food safety audits under this subpart.
    (b) Reporting results of accreditation body self-assessments. A
recognized accreditation body must submit to FDA electronically, in
English, a report of the results of an annual self-assessment required
under Sec.  1.622, no later than 45 days after completing such self-
assessment and, for a recognized accreditation body subject to Sec.
1.664(g)(1), must submit a report of such self-assessment to FDA within
2 months.
    (c) Immediate notification to FDA. A recognized accreditation body
must notify FDA electronically, in English, immediately upon:
    (1) Granting accreditation to an auditor/certification body under
this subpart, and include:
    (i) The name, address, and telephone number of the auditor/
certification body;
    (ii) The name of one or more officers of the auditor/certification
body;
    (iii) A list of the auditor's/certification body's audit agents;
and
    (iv) The scope of accreditation and the date on which it was
granted.
    (2) Withdrawing, suspending, or reducing the scope of an
accreditation under this subpart, and include:
    (i) The basis for such action; and
    (ii) Any additional changes to accreditation information previously
submitted to FDA under paragraph (c)(1) of this section.
    (3) Determining that an auditor/certification body it accredited
failed to comply with Sec.  1.653 in issuing a food or facility
certification under this subpart, and include:
    (i) The basis for such determination; and
    (ii) Any changes to accreditation information previously submitted
to FDA under paragraph (c)(1) of this section.
    (d) Other notification to FDA. A recognized accreditation body must
notify FDA electronically, in English, within 30 days after:
    (1) Denying accreditation (in whole or in part) under this subpart
and include:
    (i) The name, address, and telephone number of the auditor/
certification body;
    (ii) The name of one or more officers of the auditor/certification
body;
    (iii) The scope of accreditation requested; and
    (iv) The basis for such denial.
    (2) Making any significant change that would affect the manner in
which it complies with the requirements in Sec. Sec.  1.610 to 1.625
and include:
    (i) A description of the change; and
    (ii) An explanation for the purpose of the change.

Sec.  1.624  How must a recognized accreditation body protect against
conflicts of interest?

    (a) A recognized accreditation body must implement a written
program to protect against conflicts of interest between the
accreditation body (and its officers, personnel, and other agents) and
a third-party auditor/certification body (and its officers, personnel,
and other agents) seeking accreditation from, or accredited by, such
accreditation body, including the following:
    (1) Ensuring that the accreditation body (and its officers,
personnel, or other agents) do not own or have a financial interest in,
manage, or otherwise control the third-party auditor/certification body
(or any affiliate, parent, or subsidiary); and
    (2) Prohibiting officers, personnel, or other agents of the
accreditation body from accepting any money, gift, gratuity, or item of
value from the third-party auditor/certification body.
    (3) The items specified in paragraph (a)(2) of this section do not
include:
    (i) Money representing payment of fees for accreditation services
and reimbursement of direct costs associated with an onsite audit or
assessment of the third-party auditor/certification body; or
    (ii) Meals, of de minimis value, provided on the premises where the
audit or assessment is conducted.
    (b) The financial interests of the spouses and children younger
than 18 years of age of officers, personnel, and other agents of a
recognized accreditation body will be considered the financial
interests of such officers, personnel, and other agents of the
accreditation body.
    (c) A recognized accreditation body must maintain on its Web site
an up-to-date list of the auditors/certification bodies it accredited
under this subpart and must identify the duration and scope of each
accreditation and date(s) on each the accredited auditor/certification
body paid any fee or reimbursement associated with such accreditation.

Sec.  1.625  What records requirements must a recognized accreditation
body meet?

    (a) A recognized accreditation body must maintain electronically
for 5 years records (including documents and data), in English,
demonstrating its compliance with this subpart, including records
relating to:
    (1) Applications for accreditation and renewal of accreditation
under Sec.  1.660;
    (2) Decisions to grant, deny, suspend, withdraw, or reduce the
scope of an accreditation;
    (3) Challenges to adverse accreditation decisions under Sec.
1.620(c);
    (4) Its monitoring of accredited auditors/certification bodies
under Sec.  1.621;
    (5) Self-assessments and corrective actions under Sec.  1.622;
    (6) Regulatory audit reports, including any supporting information,
that an accredited auditor/certification body may have submitted; and
    (7) Any reports or notifications to FDA under Sec.  1.623,
including any supporting information.
    (b) A recognized accreditation body must make records required by
paragraph (a) of this section available for inspection and copying
promptly upon written request of an authorized FDA officer or employee
at the place of business of the accreditation body or at a reasonably
accessible location. If the records required by paragraph (a) of this
section are requested by FDA electronically, the records must be
submitted to FDA electronically, in English, not later than 10 business
days after the date of the request.
    (c) A recognized accreditation body must not prevent or interfere
with FDA's access to its accredited auditors/certification bodies and
the auditor/certification body records required by Sec.  1.658.

Procedures for Recognition of Accreditation Bodies Under This Subpart

Sec.  1.630  How do I apply to FDA for recognition or renewal of
recognition?

    (a) Applicant for recognition. An accreditation body seeking
recognition must submit an application demonstrating that it meets the
eligibility requirements in Sec.  1.610.
    (b) Applicant for renewal of recognition. An accreditation body
seeking renewal of its accreditation must submit a renewal application
demonstrating that it continues to meet the eligibility requirements in
Sec.  1.610.
    (c) Submission. Recognition and renewal applications and any
documents provided as part of the application process must be submitted
electronically, in English. An applicant must provide any translation
and interpretation services needed by FDA to process the application,
including during onsite audits or assessments of the applicant by FDA.
    (d) Signature. Recognition and renewal applications must be signed
by the applicant or by any individual authorized to act on behalf of
the applicant for purposes of seeking recognition or renewal of
recognition.

Sec.  1.631  How will FDA review applications for recognition and for
renewal of recognition?

    (a) FDA will review a recognition or renewal application on a first
in, first out basis according to the date on which the application was
submitted in complete form.
    (b) FDA will evaluate any completed recognition or renewal
application to determine whether the applicant meets the eligibility
requirements in Sec.  1.610 and will notify the applicant, in writing,
whether the application has been approved or denied. FDA may make such
notification electronically.
    (c) When FDA notifies an applicant that its recognition or renewal
application has been approved, the notification will list any
conditions associated with the recognition.
    (d) If FDA denies a recognition or renewal application, the
notification will state the basis for such denial and will provide the
address and procedures for requesting reconsideration of the
application under Sec.  1.691.
    (e) If FDA does not reach a final decision on a renewal application
before an accreditation body's recognition terminates by expiration,
FDA may extend such recognition for a specified period of time or until
the agency reaches a final decision on the renewal application.

Sec.  1.632  What is the duration of recognition?

    FDA may grant recognition of an accreditation body for a period not
to exceed 5 years.

Sec.  1.633  How will FDA monitor recognized accreditation bodies?

    (a) FDA will periodically evaluate the performance of each
recognized accreditation body to determine its compliance with the
applicable requirements of this subpart. Such evaluation must occur by
at least 4 years after the date of accreditation for a 5-year term of
recognition, or by no later than mid-term point for recognition granted
for less than 5 years. FDA may conduct additional performance
evaluations of a recognized accreditation body at any time.
    (b) An FDA performance evaluation may include onsite assessments of
statistically significant numbers of auditors/certification bodies the
recognized accreditation body accredited and onsite audits of eligible
entities such auditors/certification bodies certified. These may be
conducted at any time, with or without the accreditation body or
auditor/certification body present.

Sec.  1.634  When will FDA revoke recognition?

    (a) Grounds for revocation of recognition. FDA will revoke the
recognition of an accreditation body for any one or more of the
following:
    (1) Refusal to allow FDA to access records required by Sec.  1.625,
or to conduct an audit, assessment, or investigation of the
accreditation body or of a third-party auditor/certification body it
accredited to ensure the accreditation body's continued compliance with
the requirements of this subpart.
    (2) Failure to take timely and necessary corrective action when:
    (i) The accreditation of an auditor/certification body it
accredited is withdrawn by FDA under Sec.  1.664(a);
    (ii) A significant problem with the accreditation body is
identified through self-assessment under Sec.  1.622, monitoring under
Sec.  1.621, or self-assessment by one or more of its accredited
auditors/certification bodies under Sec.  1.655; or
    (iii) Directed by FDA to ensure compliance with this subpart.
    (3) A determination by FDA that the accreditation body has
committed fraud or has submitted material false statements to the
agency.
    (4) A determination by FDA that there is otherwise good cause for
revocation, including:
    (i) Demonstrated bias or lack of objectivity when conducting
activities under this subpart; or
    (ii) Failure to adequately support one or more decisions to grant
accreditation under this subpart.
    (b) Records request associated with revocation. To assist in
determining whether revocation is warranted under paragraph (a) of this
section, FDA may request records of the accreditation body required by
Sec.  1.625 or the records, required by Sec.  1.658, of one or more of
the auditors/certification bodies it accredited under this subpart.
    (c) Notice to the accreditation body of revocation of recognition.
(1) Upon revocation, FDA will notify the accreditation body
electronically, in English, stating the grounds for revocation, the
procedures for requesting a regulatory hearing under

Sec.  1.693 on the revocation, and the procedures for requesting
reinstatement of recognition under Sec.  1.636.
    (2) Within 10 business days of the date of revocation, the
accreditation body must notify FDA electronically, in English, of the
location where the records required by Sec.  1.625 will be maintained.
    (d) Effect of revocation of recognition on accredited auditors/
certification bodies. (1) FDA will notify an accredited auditor/
certification body, electronically and in English, if the recognition
of its accreditation body is revoked. Such auditor's/certification
body's accreditation will remain in effect if the auditor/certification
body:
    (i) No later than 2 months after the revocation, conducts a self-
assessment under Sec.  1.655 and reports the results of the self-
assessment to FDA under Sec.  1.656(b); and
    (ii) No later than 1 year after the revocation, becomes accredited
by a recognized accreditation body or by FDA through direct
accreditation.
    (2) FDA may withdraw the accreditation of a third-party auditor/
certification body whenever FDA determines there is good cause for
withdrawal of accreditation under Sec.  1.664.
    (e) Effect of revocation of recognition on food or facility
certifications issued to eligible entities. A food or facility
certification issued by an auditor/certification body accredited by an
accreditation body prior to revocation of recognition will remain in
effect until the certificate terminates by expiration. If FDA has
reason to believe that a food certification issued for purposes of
section 801(q) of the FD&C Act is not valid or reliable, FDA may refuse
to consider the certification in determining the admissibility of the
article of food for which the certification was offered.
    (f) Public notice of revocation and the status of accreditations
and food and facility certifications. FDA will provide notice on the
Web site described in Sec.  1.690 of the revocation of recognition of
an accreditation body under this subpart.

Sec.  1.635  How do I voluntarily relinquish recognition?

    (a) An accreditation body that decides to relinquish recognition
before it terminates by expiration must notify FDA electronically, in
English, at least 6 months before relinquishing such authority and must
identify the location where the records required by Sec.  1.625 will be
maintained. An accreditation body waives the right to a hearing when
relinquishing its recognition under this subpart.
    (b) No later than 15 business days after notifying FDA, the
accreditation body must notify any third-party auditor/accreditation
body currently accredited that it intends to relinquish its
recognition, specify the date on which it will occur. The accreditation
body must establish and maintain records of such notification under
Sec.  1.625.
    (c) An accreditation granted by an accreditation body prior to
relinquishing its recognition will remain in effect, subject to
reaccreditation under Sec.  1.665, except where FDA determines that
there is good cause for withdrawal of accreditation under Sec.  1.664.
    (d) A food certification issued by such accredited auditor/
certification body will remain in effect until it terminates by
expiration, unless FDA requires renewal of the certification under
section 801(q)(4)(A) of the FD&C Act prior to its expiration. If FDA
has reason to believe that a certification issued for purposes of
section 801(q) of the FD&C Act is not valid or reliable, FDA may refuse
to consider the certification in determining the admissibility of the
article of food for which the certification was offered.
    (e) FDA will provide notice on the Web site described in Sec.
1.690 of the voluntary relinquishment of recognition of an
accreditation body. The notice will describe the effect, if any, on any
third-party auditor/certification body it accredited and on any food or
facility certifications such auditor/certification body issued under
this subpart.

Sec.  1.636  How do I request reinstatement of recognition?

    (a) Application following revocation. An accreditation body that
has had its recognition revoked may seek reinstatement by submitting a
new application for recognition under Sec.  1.630, or may be required
to submit such application after a determination in a regulatory
hearing under Sec.  1.693 that revocation was appropriate. The
accreditation body must submit evidence that the grounds for revocation
have been resolved, including evidence addressing the cause or
conditions that were the basis for revocation and identifying measures
that have been implemented to help ensure that such cause(s) or
condition(s) are unlikely to recur.
    (b) Application following relinquishment. An accreditation body
that previously relinquished its recognition under Sec.  1.635 may seek
recognition by submitting a new application for recognition under Sec.
1.630.

Accreditation of Third-Party Auditors/Certification Bodies Under This
Subpart

Sec.  1.640  Who is eligible for accreditation?

    (a) A foreign government, agency of a foreign government, foreign
cooperative, or any other third party may seek accreditation from a
recognized accreditation body (or, where direct accreditation is
appropriate, FDA) to conduct food safety audits and to issue food and
facility certifications to eligible entities under this subpart.
    (b) A foreign government or an agency of a foreign government is
eligible for accreditation if it can demonstrate that its food safety
programs, systems, and standards meet the requirements of Sec. Sec.
1.641 to 1.645, as specified in FDA model standards on qualifications
for accreditation, including legal authority, competency, capacity,
conflicts of interest, quality assurance, and records.
    (c) A foreign cooperative or other third party is eligible for
accreditation if it can demonstrate that the training and
qualifications of its audit agents and its internal systems and
standards meet the requirements of Sec. Sec.  1.641 to 1.645, as
specified in FDA model standards on qualifications for accreditation,
including legal authority, competency, capacity, conflicts of interest,
quality assurance, and records.

Sec.  1.641  What legal authority must a third-party auditor/
certification body have to qualify for accreditation?

    (a) A third-party auditor/certification body seeking accreditation
from a recognized accreditation body or from FDA must demonstrate that
it has the authority (as a governmental entity or through contractual
rights) to perform such assessments of facilities, their process(es),
and food(s) as are necessary to determine compliance with the FD&C Act
and with industry standards and practices and to issue certifications
where appropriate based on a review of the findings of such
assessments. This includes authority to:
    (1) Review any relevant records;
    (2) Conduct onsite audits of the eligible entity, such as
witnessing the performance of a statistically significant number of
personnel and other agents conducting audits of food facilities; and
    (3) Suspend or withdraw certification for failure to comply with
applicable requirements.
    (b) A third-party auditor/certification body seeking accreditation
must demonstrate that it is capable of exerting any authority necessary
to meet the requirements of accreditation in Sec. Sec.  1.650 to 1.658
and the procedures in Sec. Sec.  1.660, 1.663, 1.665, 1.666, and 1.670,
if accredited.

Sec.  1.642  What competency and capacity must a third-party auditor/
certification body have to qualify for accreditation?

    A third-party auditor/certification body seeking accreditation must
demonstrate that it has:
    (a) The resources necessary to fully implement its audit and
certification program, including:
    (1) Adequate numbers of personnel and other agents with relevant
knowledge, skills, and experience to effectively audit and assess
compliance with applicable FDA requirements and industry standards and
practices and to issue valid and reliable certifications; and
    (2) Adequate financial resources for its operations; and
    (b) The competency and capacity to meet the requirements of
Sec. Sec.  1.650 to 1.658 and the procedures in Sec. Sec.  1.660,
1.663, 1.665, 1.666, and 1.670, if accredited.

Sec.  1.643  What protections against conflicts of interest must a
third-party auditor/certification body have to qualify for
accreditation?

    A third-party auditor/certification body must demonstrate that it
has:
    (a) Implemented written measures to protect against conflicts of
interest between the auditor/certification body (and its officers,
personnel, and other agents) and eligible entities (and their owners
and operators) seeking assessment and certification from, or assessed
and certified by, such auditor/certification body; and
    (b) The capability to meet the conflict of interest requirements in
Sec.  1.657, if accredited.

Sec.  1.644  What quality assurance procedures must a third-party
auditor/certification body have to qualify for accreditation?

    A third-party auditor/certification body seeking accreditation must
demonstrate that it has:
    (a) Implemented a written program for monitoring and assessing the
performance of its officers, personnel, and other agents involved in
auditing and certification activities, including procedures to:
    (1) Identify areas in its auditing and certification program or
performance that need improvement; and
    (2) Quickly execute appropriate corrective actions when problems
are found; and
    (b) The capability to meet the quality assurance requirements of
Sec.  1.655, if accredited.

Sec.  1.645  What records procedures must a third-party auditor/
certification body have to qualify for accreditation?

    A third-party auditor/certification body seeking accreditation must
demonstrate that it:
    (a) Implemented written procedures to establish, control, and
retain records (including documents and data) for a period of time
necessary to meet its contractual and legal obligations and to provide
an adequate basis for assessing its program and performance; and
    (b) Is capable of meeting the reporting and notification
requirements of Sec.  1.656 and the records requirements of Sec.
1.658, if accredited.

Requirements for Accredited Auditors/Certification Bodies Under This
Subpart

Sec.  1.650  How must an accredited auditor/certification body ensure
its audit agents are competent and objective?

    (a) An accredited auditor/certification body that uses audit agents
to conduct food safety audits must ensure that each such agent meets
the following requirements with respect to the scope of its
accreditation under this subpart:
    (1) Has relevant knowledge and experience that provides an adequate
basis for the agent to assess compliance with the FD&C Act and, for
consultative audits, industry standards and practices;
    (2) Has been determined by the accredited auditor/certification
body, through observations of a representative number of audits, to be
competent to conduct food safety audits under this subpart;
    (3) Participates in annual food safety training under the
accredited auditor's/certification body's training plan;
    (4) Is in compliance with the conflict of interest requirements of
Sec.  1.657 and has no other conflicts of interest with the eligible
entity to be audited that might impair the agent's objectivity; and
    (5) Agrees to notify its accredited auditor/certification body
immediately upon discovering, during a food safety audit, any condition
that could cause or contribute to a serious risk to the public health.
    (b) In assigning an audit agent to conduct a food safety audit at a
particular eligible entity, an accredited auditor/certification body
must determine that the agent is qualified to conduct such audit under
the criteria established in paragraph (a) of this section and based on
the scope and purpose of the audit and the type of facility, its
process(es), and food.
    (c) An accredited auditor/certification body cannot use an audit
agent to conduct a regulatory audit at an eligible entity if such agent
conducted a consultative audit or regulatory audit for the same
eligible entity in the preceding 13 months, except that such limitation
may be waived if the accredited auditor/certification body demonstrates
to FDA, under Sec.  1.663, there is insufficient access to accredited
auditors/certification bodies in the country or region where the
eligible entity is located or in the country of export.

Sec.  1.651  How must an accredited auditor/certification body conduct
a food safety audit of an eligible entity?

    (a) Audit planning. Before beginning to conduct a food safety audit
under this subpart, an accredited auditor/certification body must:
    (1) Require the entity seeking an audit to:
    (i) Identify the scope and purpose of the food safety audit,
including the facility, process(es), or food to be audited; whether the
audit is to be conducted as a consultative or regulatory audit, and if
a regulatory audit, the type(s) of certification(s) sought; and
    (ii) Provide a 30-day operating schedule for such facility that
includes information relevant to the scope and purpose of the audit;
and
    (2) Determine whether the requested audit is within its scope of
accreditation.
    (b) Authority to audit. In arranging a food safety audit with an
eligible entity, an accredited auditor/certification body must ensure
it has authority, whether contractual or otherwise, to:
    (1) Conduct an unannounced audit to verify whether the activities
and results of the eligible entity (within the scope of the audit)
comply with the applicable requirements of the FD&C Act and, for
consultative audits, industry standards and practices;
    (2) Access any records and any area of the facility, its
process(es), and food of the eligible entity relevant to the scope and
purpose of such audit and, where appropriate, to issue food and
facility certifications;
    (3) Where FDA requires sampling and analysis, use of validated
sampling or analytical methodologies and analysis by a laboratory that
is accredited, in accordance with the requirements of section 422 of
the FD&C Act;
    (4) Notify FDA immediately if, at any time during a food safety
audit, the accredited auditor/certification body (or its audit agent,
where applicable) discovers a condition that could cause or contribute
to a serious risk to the public health and provide information required
by Sec.  1.656(c);
    (5) Prepare reports of consultative audits that contain the
elements

specified in Sec.  1.652(a) and, for regulatory audits, prepare reports
that contain the elements specified in Sec.  1.652(b) and submit them