(D) The importer is exempt from the regulations in part 117 of this
chapter in accordance with Sec.  117.5(i).
    (2) Certain meat, poultry, and egg products. Any certification
required under section 801(q) of the FD&C Act does not apply with
respect to:
    (i) Meat food products that at the time of importation are subject
to the requirements of the United States Department of Agriculture
(USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
    (ii) Poultry products that at the time of importation are subject
to the requirements of the USDA under the Poultry Products Inspection
Act (21 U.S.C. 451 et seq.); and
    (iii) Egg products that at the time of importation are subject to
the requirements of the USDA under the Egg Products Inspection Act (21
U.S.C. 1031 et seq.).

Recognition of Accreditation Bodies Under This Subpart

Sec.  1.610  Who is eligible to seek recognition?

    An accreditation body is eligible to seek recognition by FDA if it
can demonstrate that it meets the requirements of Sec. Sec.  1.611
through 1.615. The accreditation body may use documentation of
conformance with International Organization for Standardization/
International Electrotechnical Commission (ISO/IEC) 17011:2004,
supplemented as necessary, in meeting the applicable requirements of
this subpart.

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 as a legal entity
with contractual rights) to perform assessments of a third-party
certification body as are necessary to determine its capability to
conduct audits and certify food facilities and food, including
authority to:
    (1) Review any relevant records;
    (2) Conduct onsite assessments of the performance of third-party
certification bodies, such as by witnessing the performance of a
representative sample of its agents (or, in the case of a third-party
certification body that is an individual, such individual) conducting a
representative sample of audits;
    (3) Perform any reassessments or surveillance necessary to monitor
compliance of accredited third-party 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 the authority (as a governmental entity or as
a legal entity with contractual rights) necessary to meet the
applicable requirements of this subpart, 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 employees and other agents with relevant
knowledge, skills, and experience to effectively evaluate the
qualifications of third-party certification bodies seeking
accreditation and to effectively monitor the performance of accredited
third-party certification bodies; and
    (2) Adequate financial resources for its operations; and
    (b) The capability to meet the applicable assessment and monitoring
requirements, the reporting and notification requirements, and the
procedures of this subpart, 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, employees,
and other agents involved in accreditation activities) and any third-
party certification body (and its officers, employees, and other agents
involved in auditing and certification activities) seeking
accreditation from, or accredited by, such accreditation body; and
    (b) The capability to meet the applicable conflict of interest
requirements of this subpart, 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 evaluating the
performance of its officers, employees, and other agents and its
accreditation program, including procedures to:
    (1) Identify areas in its accreditation program or performance
where deficiencies exist; and
    (2) Quickly execute corrective actions that effectively address
deficiencies when identified; and
    (b) The capability to meet the applicable quality assurance
requirements of this subpart, 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 pertaining to
this subpart and to provide an adequate basis for evaluating its
program and performance; and
    (b) The capability to meet the applicable reporting and
notification requirements of this subpart, if recognized.

Requirements for Accreditation Bodies That Have Been Recognized Under
This Subpart

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

    (a) Prior to accrediting a third-party 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 the government's or agency's
food safety programs, systems, and standards as are necessary to
determine that it meets the eligibility requirements of Sec.  1.640(b).
    (2) In the case of a foreign cooperative or any other third-party
seeking accreditation as a third-party certification body, such reviews
and audits of the training and qualifications of agents conducting
audits for such cooperative or other third party (or in the case of a
third-party certification body that is an individual, such individual)
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).
    (3) In conducting a review and audit under paragraph (a)(1) or (2)
of this section, an observation of a representative sample of onsite
audits examining compliance with the applicable food safety
requirements of the FD&C Act and FDA regulations as conducted by the
third-party

certification body or its agents (or, in the case of a third-party
certification body that is an individual, such individual).
    (b) A recognized accreditation body must require a third-party
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 to FDA, electronically and in
English, any food or facility certifications it issues for purposes of
sections 801(q) or 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
certification body under this subpart. The records must include the
name and contact information for the third-party certification body;
the date of the action; the scope of accreditation denied, withdrawn,
suspended, or reduced; and the basis for such action.
    (d) A recognized accreditation body must notify any third-party
certification body of an adverse decision associated with its
accreditation under this subpart, including denial of accreditation or
the withdrawal, suspension, or reduction in the scope of its
accreditation. The recognized accreditation body must establish and
implement written procedures for receiving and addressing appeals from
any third-party certification body challenging such an adverse decision
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, and include
requirements to:
    (1) Make the appeals procedures publicly available;
    (2) Use competent persons, who may or may not be external to the
recognized accreditation body, who are free from bias or prejudice and
have not participated in the accreditation decision or be subordinate
to a person who has participated in the accreditation decision to
investigate and decide appeals;
    (3) Advise third-party 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 certification bodies it accredited?

    (a) A recognized accreditation body must annually conduct a
comprehensive assessment of the performance of each third-party
certification body it accredited under this subpart by reviewing the
accredited third-party 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 recognized accreditation body
regarding the compliance history of eligible entities the accredited
third-party certification body certified under this subpart; or that is
otherwise relevant to a determination whether the accredited third-
party certification body is in compliance with this subpart.
    (b) No later than 1 year after the initial date of accreditation of
the third-party certification body and every 2 years thereafter for
duration of its accreditation under this subpart, a recognized
accreditation body must conduct onsite observations of a representative
sample of regulatory audits performed by the third-party certification
body (or its audit agents) (or, in the case of a third-party
certification body that is an individual, such individual) accredited
under this subpart and must visit the accredited third-party
certification body's headquarters (or other location that manages audit
agents conducting food safety audits under this subpart, if different
than its headquarters). The recognized accreditation body will consider
the results of such observations and visits in the annual assessment of
the accredited third-party certification body required by paragraph (a)
of this section.

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 compliance with this subpart, including:
    (1) The performance of its officers, employees, or other agents
involved in accreditation activities and the degree of consistency in
conducting accreditation activities;
    (2) The compliance of the recognized accreditation body and its
officers, employees, and other agents involved in accreditation
activities, 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 recognized accreditation body
is in compliance with this subpart.
    (b) As a means to evaluate the recognized accreditation body's
performance, the self-assessment must include onsite observation of
regulatory audits of a representative sample of third-party
certification bodies it accredited under this subpart. In meeting this
requirement, the recognized accreditation body may use the results of
onsite observations performed under Sec.  1.621(b).
    (c) Based on the evaluations conducted under paragraphs (a) and (b)
of this section, the recognized accreditation body must:
    (1) Identify any area(s) where deficiencies exist;
    (2) Quickly implement corrective action(s) that effectively address
those deficiencies; and
    (3) Establish and maintain records of any such corrective action(s)
under Sec.  1.625.
    (d) The recognized 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 the following elements. Documentation of
conformance to ISO/IEC 17011:2004 may be used, supplemented as
necessary, in meeting the requirements of this paragraph.
    (1) A description of any corrective actions taken under paragraph
(c) of this section;
    (2) A statement disclosing the extent to which the recognized
accreditation body, and its officers, employees, and other agents
involved in accreditation activities, complied with the conflict of
interest requirements in Sec.  1.624; and
    (3) A statement attesting to the extent to which the recognized
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 accredited third-party
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 agents used by the accredited third-party certification
body to conduct food safety audits under this subpart.
    (b) Reporting results of recognized accreditation body self-
assessments. A recognized accreditation body must submit to FDA
electronically, in English:
    (1) 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

    (2) For a recognized accreditation body subject to Sec.
1.664(g)(1), a report of such self-assessment to FDA within 60 days of
the third-party certification body's withdrawal. A recognized
accreditation body may use a report prepared for conformance to ISO/IEC
17011:2004, supplemented as necessary, in meeting the requirements this
section.
    (c) Immediate notification to FDA. A recognized accreditation body
must notify FDA electronically, in English, immediately upon:
    (1) Granting (including expanding the scope of) accreditation to a
third-party certification body under this subpart, and include:
    (i) The name, address, telephone number, and email address of the
accredited third-party certification body;
    (ii) The name of one or more officers of the accredited third-party
certification body;
    (iii) A list of the accredited third-party certification body's
audit agents; and
    (iv) The scope of accreditation, the date on which it was granted,
and its expiration date.
    (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 a third-party 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, telephone number, and email address of the
third-party certification body;
    (ii) The name of one or more officers of the third-party
certification body;
    (iii) The scope of accreditation requested; and
    (iv) The scope and basis for such denial.
    (2) Making any significant change that would affect the manner in
which it complies with the applicable requirements of this subpart 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 recognized
accreditation body (and its officers, employees, and other agents
involved in accreditation activities) and any third-party certification
body (and its officers, employees, and other agents involved in
auditing and certification activities) seeking accreditation from, or
accredited by, such recognized accreditation body, including the
following:
    (1) Ensuring that the recognized accreditation body (and its
officers, employees, or other agents involved in accreditation
activities) does not own or have a financial interest in, manage, or
otherwise control the third-party certification body (or any affiliate,
parent, or subsidiary); and
    (2) Prohibiting officers, employees, or other agents involved in
accreditation activities of the recognized accreditation body from
accepting any money, gift, gratuity, or item of value from the third-
party 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 assessment
of the third-party certification body; or
    (ii) Lunch of de minimis value provided during the course of an
assessment and on the premises where the assessment is conducted, if
necessary to facilitate the efficient conduct of the assessment.
    (b) A recognized accreditation body may accept the payment of fees
for accreditation services and the reimbursement of direct costs
associated with assessment of a certification body only after the date
on which the report of such assessment was completed or the date of
which the accreditation was issued, whichever comes later. Such payment
is not considered a conflict of interest for purposes of paragraph (a)
of this section.
    (c) The financial interests of the spouses and children younger
than 18 years of age of a recognized accreditation body's officers,
employees, and other agents involved in accreditation activities will
be considered the financial interests of such officers, employees, and
other agents involved in accreditation activities.
    (d) A recognized accreditation body must maintain on its Web site
an up-to-date list of the third-party certification bodies it
accredited under this subpart and must identify the duration and scope
of each accreditation and the date(s) on which the accredited third-
party certification body paid any fee or reimbursement associated with
such accreditation. If the accreditation of a certification body is
suspended, withdrawn, or reduced in scope, this list must also include
the date of suspension, withdrawal, or reduction in scope and maintain
that information for the duration of accreditation or until the
suspension is lifted, the certification body is reaccredited, or the
scope of accreditation is reinstated, whichever comes first.

Sec.  1.625  What records requirements must an accreditation body that
has been recognized meet?

    (a) An accreditation body that has been recognized must maintain
electronically for 5 years records created while it is recognized
(including documents and data) 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 expand or
reduce the scope of an accreditation;
    (3) Challenges to adverse accreditation decisions under Sec.
1.620(c);
    (4) Its monitoring of accredited third-party 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 third-party certification body may have submitted;
    (7) Any reports or notifications to FDA under Sec.  1.623,
including any supporting information; and
    (8) Records of fee payments and reimbursement of direct costs.
    (b) An accreditation body that has been recognized 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 not later than 10
business days after the date of the request. Additionally, if the
requested records are maintained in a language other than

English, the accreditation body must electronically submit an English
translation within a reasonable time.
    (c) An accreditation body that has been recognized must not prevent
or interfere with FDA's access to its accredited third-party
certification bodies and the accredited third-party 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 requirements of this
subpart.
    (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 during the processing of the
application, including during onsite assessments of the applicant by
FDA.
    (d) Signature. Recognition and renewal applications must be signed
in the manner designated by FDA, by an individual authorized to act on
behalf of the applicant for purposes of seeking recognition or renewal
of recognition.

Sec.  1.631  How will FDA review my application for recognition or
renewal of recognition and what happens once FDA decides on my
application?

    (a) Review of recognition or renewal application. FDA will examine
an accreditation body's recognition or renewal application for
completeness and notify the applicant of any deficiencies. FDA will
review an accreditation body's recognition or renewal application on a
first in, first out basis according to the date on which the completed
application was submitted; however, FDA may prioritize the review of
specific applications to meet the needs of the program.
    (b) Evaluation of recognition or renewal. FDA will evaluate any
completed recognition or renewal application to determine whether the
applicant meets the applicable requirements of this subpart. Such
evaluation may include an onsite assessment of the accreditation body.
FDA will notify the applicant, in writing, regarding whether the
application has been approved or denied. FDA may make such notification
electronically. 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.
    (c) Issuance of recognition. FDA will notify an applicant that its
recognition or renewal application has been approved through issuance
of recognition that will list any limitations associated with the
recognition.
    (d) Issuance of denial of recognition or renewal application. FDA
will notify an applicant that its recognition or renewal application
has been denied through issuance of a denial of recognition or denial
of a renewal application that will state the basis for such denial and
provide the procedures for requesting reconsideration of the
application under Sec.  1.691.
    (e) Notice of records custodian after denial of an application for
renewal of recognition. An applicant whose renewal application was
denied must notify FDA electronically, in English, within 10 business
days of the date of issuance of a denial of a renewal application, of
the name and contact information of the custodian who will maintain the
records required by Sec.  1.625(a) and make them available to FDA as
required by Sec.  1.625(b). The contact information for the custodian
must include, at a minimum, an email address and the physical address
where the records required by Sec.  1.625(a) will be located.
    (f) Effect of denial of an application for renewal of recognition
of an accreditation body on accredited third-party certification
bodies. (1) FDA will issue a notice of the denial of a recognition
renewal to any third-party certification bodies accredited by the
accreditation body whose renewal application was denied. The third-
party certification body's accreditation will remain in effect so long
as the third-party certification body:
    (i) No later than 60 days after FDA's issuance of the notice of the
denial of recognition renewal, 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 issuance of the notice of denial of
recognition renewal or the original date of the expiration of the
accreditation, whichever comes first, becomes accredited by another
recognized accreditation body or by FDA through direct accreditation.
    (2) FDA may withdraw the accreditation of a third-party
certification body whenever FDA determines there is good cause for
withdrawal of accreditation under Sec.  1.664(c).
    (g) Effect of denial of an application for renewal of recognition
of an accreditation body on food or facility certifications issued to
eligible entities. A food or facility certification issued by a third-
party certification body accredited by a recognized accreditation body
prior to issuance of a denial of the renewal application will remain in
effect until the certification expires. If FDA has reason to believe
that a certification issued for purposes of section 801(q) or 806 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 or in determining the
importer's eligibility for participation in the voluntary qualified
importer program (VQIP).
    (h) Public notice of denial of an application for renewal of
recognition of an accreditation body. FDA will provide notice on the
Web site described in Sec.  1.690 of the date of issuance of a denial
of a renewal application and will describe the basis for the denial.

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 from the date of recognition.

Sec.  1.633  How will FDA monitor recognized accreditation bodies?

    (a) FDA will evaluate the performance of each recognized
accreditation body to determine its compliance with the applicable
requirements of this subpart. Such assessment must occur by at least 4
years after the date of recognition for a 5-year recognition period, or
by no later than the mid-term point for a recognition period of less
than 5 years. FDA may conduct additional assessments of a recognized
accreditation body at any time.
    (b) An FDA assessment of a recognized accreditation body may
include onsite assessments of a representative sample of third-party
certification bodies the recognized accreditation body accredited and
onsite audits of a representative sample of eligible entities certified
by such third-party certification bodies under this subpart. These may
be conducted at any time and, as FDA determines necessary

or appropriate, may occur without the recognized accreditation body or,
in the case of an audit of an eligible entity, the accredited third-
party 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 found not to be in compliance with
the requirements of this subpart, including for any one or more of the
following:
    (1) Refusal by the accreditation body to allow FDA to access
records required by Sec.  1.625, or to conduct an assessment or
investigation of the accreditation body or of a third-party
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 a third-party certification body it
accredited is withdrawn by FDA under Sec.  1.664(a);
    (ii) A significant deficiency is identified through self-assessment
under Sec.  1.622, monitoring under Sec.  1.621, or self-assessment by
one or more of its accredited third-party certification bodies under
Sec.  1.655; or
    (iii) Directed to do so 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 third-party certification bodies it accredited under this subpart.
    (c) Issuance of revocation of recognition. (1) FDA will notify an
accreditation body that its recognition has been revoked through
issuance of a revocation that will state 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 issuance of the
revocation, the accreditation body must notify FDA electronically, in
English, of the name of the custodian who will maintain the records and
make them available to FDA as required by Sec.  1.625. The contact
information for the custodian must provide, at a minimum, an email
address and the physical address where the records will be located.
    (d) Effect of revocation of recognition of an accreditation body on
accredited third-party certification bodies. (1) FDA will issue a
notice of the revocation of recognition to any accredited third-party
certification body accredited by the accreditation body whose
recognition was revoked. The third-party certification body's
accreditation will remain in effect if the third-party certification
body:
    (i) No later than 60 days after FDA's issuance of the notice of
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 issuance of the notice of the
revocation, or the original date of expiration of the accreditation,
whichever comes first, becomes accredited by another recognized
accreditation body or by FDA through direct accreditation.
    (2) FDA may withdraw the accreditation of a third-party
certification body whenever FDA determines there is good cause for
withdrawal of accreditation under Sec.  1.664(c).
    (e) Effect of revocation of recognition of an accreditation body on
food or facility certifications issued to eligible entities. A food or
facility certification issued by a third-party certification body
accredited by a recognized accreditation body prior to issuance of the
revocation of recognition will remain in effect until the certificate
terminates by expiration. If FDA has reason to believe that a
certification issued for purposes of section 801(q) or 806 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 or in determining the
importer's eligibility for participation in VQIP.
    (f) Public notice of revocation of recognition. FDA will provide
notice on the Web site described in Sec.  1.690 of the issuance of the
revocation of recognition of an accreditation body and will describe
the basis for revocation.

Sec.  1.635  What if I want to voluntarily relinquish recognition or do
not want to renew recognition?

    (a) Notice to FDA of intent to relinquish or not to renew
recognition. A recognized accreditation body must notify FDA
electronically, in English, at least 60 days before voluntarily
relinquishing recognition or before allowing recognition to expire
without seeking renewal. The recognized accreditation body must provide
the name and contact information of the custodian who will maintain the
records required under Sec.  1.625(a) after the date of relinquishment
or the date recognition expires, as applicable, and make them available
to FDA as required by Sec.  1.625(b). The contact information for the
custodian must include, at a minimum, an email address and the physical
address where the records required by Sec.  1.625(a) will be located.
    (b) Notice to accredited third-party certification bodies of intent
to relinquish or not to renew recognition. No later than 15 business
days after notifying FDA under paragraph (a) of this section, the
recognized accreditation body must notify any currently accredited
third-party certification body that it intends to relinquish
recognition or to allow its recognition to expire, specifying the date
on which relinquishment or expiration will occur. The recognized
accreditation body must establish and maintain records of such
notification under Sec.  1.625.
    (c)(1) Effect of voluntary relinquishment or expiration of
recognition on third-party certification bodies. The accreditation of a
third-party certification body issued prior to the relinquishment or
expiration of its accreditation body's recognition will remain in
effect, so long as the third-party certification body:
    (i) No later than 60 days after the date of relinquishment or the
date of expiration of the recognition, 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 date of relinquishment or the
date of expiration of recognition, or the original date of the
expiration of the accreditation, whichever comes first, becomes
accredited by another recognized accreditation body or by FDA through
direct accreditation.
    (2) FDA may withdraw the accreditation of a third-party
certification body whenever FDA determines there is good cause for
withdrawal of accreditation under Sec.  1.664(c).

    (d) Effect of voluntary relinquishment or expiration of recognition
of an accreditation body on food or facility certifications issued to
eligible entities. A food or facility certification issued by a third-
party certification body accredited by a recognized accreditation body
prior to relinquishment or expiration of its recognition will remain in
effect until the certification expires. If FDA has reason to believe
that a certification issued for purposes of section 801(q) or 806 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 or in determining the
importer's eligibility for participation in VQIP.
    (e) Public notice of voluntary relinquishment or expiration of
recognition. FDA will provide notice on the Web site described in Sec.
1.690 of the voluntary relinquishment or expiration of recognition of
an accreditation body 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. 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 Certification Bodies Under This Subpart

Sec.  1.640  Who is eligible to seek 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. An
accredited third-party certification body may use documentation of
conformance with ISO/IEC 17021: 2011 or ISO/IEC 17065: 2012,
supplemented as necessary, in meeting the applicable requirements of
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 through 1.645.
    (c) A foreign cooperative or other third party is eligible for
accreditation if it can demonstrate that the training and
qualifications of its agents used to conduct audits (or, in the case of
a third-party certification body that is an individual, such
individual) and its internal systems and standards meet the
requirements of Sec. Sec.  1.641 through 1.645.

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

    (a) A third-party certification body seeking accreditation from a
recognized accreditation body or from FDA must demonstrate that it has
the authority (as a governmental entity or as a legal entity with
contractual rights) to perform such examinations of facilities, their
process(es), and food(s) as are necessary to determine compliance with
the applicable food safety requirements of the FD&C Act and FDA
regulations, and conformance with applicable industry standards and
practices and to issue certifications where appropriate based on a
review of the findings of such examinations. This includes authority
to:
    (1) Review any relevant records;
    (2) Conduct onsite audits of an eligible entity; and
    (3) Suspend or withdraw certification for failure to comply with
applicable requirements.
    (b) A third-party certification body seeking accreditation must
demonstrate that it is capable of exerting the authority (as a
governmental entity or as legal entity with contractual rights)
necessary to meet the applicable requirements of accreditation under
this subpart if accredited.

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

    A third-party certification body seeking accreditation must
demonstrate that it has:
    (a) The resources necessary to fully implement its certification
program, including:
    (1) Adequate numbers of employees and other agents with relevant
knowledge, skills, and experience to effectively examine for compliance
with applicable FDA food safety requirements of the FD&C Act and FDA
regulations, conformance with applicable industry standards and
practices, and issuance of valid and reliable certifications; and
    (2) Adequate financial resources for its operations; and
    (b) The competency and capacity to meet the applicable requirements
of this subpart, if accredited.

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

    A third-party certification body must demonstrate that it has:
    (a) Implemented written measures to protect against conflicts of
interest between the third-party certification body (and its officers,
employees, and other agents involved in auditing and certification
activities) and clients seeking examinations or certification from, or
audited or certified by, such third-party 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
certification body have to qualify for accreditation?

    A third-party certification body seeking accreditation must
demonstrate that it has:
    (a) Implemented a written program for monitoring and evaluating the
performance of its officers, employees, and other agents involved in
auditing and certification activities, including procedures to:
    (1) Identify deficiencies in its auditing and certification program
or performance; and
    (2) Quickly execute corrective actions that effectively address any
identified deficiencies; 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 certification
body have to qualify for accreditation?

    A third-party 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 evaluating its program and performance; and
    (b) Is capable of meeting the reporting, notification, and records
requirements of this subpart, if accredited.

Requirements for Third-Party Certification Bodies That Have Been
Accredited Under This Subpart

Sec.  1.650  How must an accredited third-party certification body
ensure its audit agents are competent and objective?

    (a) An accredited third-party certification body that uses audit
agents to conduct food safety audits must ensure that each such audit
agent meets the following requirements with respect to the scope of its
accreditation under this subpart. If the accredited third-party
certification body is an individual, that individual is also subject to
the following requirements, as applicable:
    (1) Has relevant knowledge and experience that provides an adequate
basis for the audit agent to evaluate compliance with applicable food
safety requirements of the FD&C Act and FDA regulations and, for
consultative audits, also includes conformance with applicable industry
standards and practices;
    (2) Has been determined by the accredited third-party certification
body, through observations of a representative sample of audits, to be
competent to conduct food safety audits under this subpart relevant to
the audits they will be assigned to perform;
    (3) Has completed annual food safety training that is relevant to
activities conducted under this subpart;
    (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 audit agent's objectivity;
and
    (5) Agrees to notify its accredited third-party 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 third-party certification
body must determine that the audit 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 third-party certification body cannot use an
audit agent to conduct a regulatory audit at an eligible entity if such
audit 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 third-party certification
body demonstrates to FDA, under Sec.  1.663, there is insufficient
access to audit agents in the country or region where the eligible
entity is located. If the accredited third-party certification body is
an individual, that individual is also subject to such limitations.

Sec.  1.651  How must an accredited third-party 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 third-party certification body must:
    (1) Require the eligible entity seeking a food safety 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
food safety audit is to be conducted as a consultative or regulatory
audit subject to the requirements of this subpart, 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 under this subpart, an accredited third-party
certification body must ensure it has authority, whether contractual or
otherwise, to:
    (1) Conduct an unannounced audit to determine whether the facility,
process(es), and food of the eligible entity (within the scope of the
audit) comply with the applicable food safety requirements of the FD&C
Act and FDA regulations and, for consultative audits, also includes
conformance with applicable industry standards and practices;
    (2) Access any records and any area of the facility, process(es),
and food of the eligible entity relevant to the scope and purpose of
such audit;
    (3) When, for a regulatory audit, sampling and analysis is
conducted, the accredited third-party certification body must use a
laboratory that is accredited in accordance with:
    (i) ISO/IEC 17025:2005; or
    (ii) Another laboratory accreditation standard that provides at
least a similar level of assurance in the validity and reliability of
sampling methodologies, analytical methodologies, and analytical
results.
    (4) Notify FDA immediately if, at any time during a food safety
audit, the accredited third-party 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 audits conducted under this subpart as
follows:
    (i) For consultative audits, prepare reports that contain the
elements specified in Sec.  1.652(a) and maintain such records, subject
to FDA access in accordance with section 414 of the FD&C Act; and
    (ii) For regulatory audits, prepare reports that contain the
elements specified in Sec.  1.652(b) and submit them to FDA and to its
recognized accreditation body (where applicable) under Sec.  1.656(a);
and
    (6) Allow FDA and the recognized accreditation body that accredited
such third-party certification body, if any, to observe any food safety
audit conducted under this subpart for purposes of evaluating the
accredited third-party certification body's performance under
Sec. Sec.  1.621 and 1.662 or, where appropriate, the recognized
accreditation body's performance under Sec. Sec.  1.622 and 1.633.
    (c) Audit protocols. An accredited third-party certification body
(or its audit agent, where applicable) must conduct a food safety audit
in a manner consistent with the identified scope and purpose of the
audit and within the scope of its accreditation.
    (1) With the exception of records review, which may be scheduled,
the audit must be conducted without announcement during the 30-day
timeframe identified under paragraph (a)(1)(ii) of this section and
must be focused on determining whether the facility, its process(es),
and food are in compliance with applicable food safety requirements of
the FD&C Act and FDA regulations, and, for consultative audits, also
includes conformance with applicable industry standards and practices
that are within the scope of the audit.
    (2) The audit must include records review prior to the onsite
examination; an onsite examination of the facility, its process(es),
and the food that results from such process(es); and where appropriate
or when required by FDA, environmental or product sampling and
analysis. When, for a regulatory audit, sampling and analysis is
conducted, the accredited third-party certification body must use a
laboratory that is accredited in accordance with paragraph (b)(3) of
this section. The audit may include any other activities necessary to
determine compliance with applicable food safety requirements of the
FD&C Act and FDA regulations, and, for consultative audits, also
includes conformance with

applicable industry standards and practices.
    (3) The audit must be sufficiently rigorous to allow the accredited
third-party certification body to determine whether the eligible entity
is in compliance with the applicable food safety requirements of the
FD&C Act and FDA regulations, and for consultative audits, also
includes conformance with applicable industry standards and practices,
at the time of the audit; and for a regulatory audit, whether the
eligible entity, given its food safety system and practices would be
likely to remain in compliance with the applicable food safety
requirements of the FD&C Act and FDA regulations for the duration of
any certification issued under this subpart. An accredited third-party
certification body (or its audit agent, where applicable) that
identifies a deficiency requiring corrective action may verify the
effectiveness of a corrective action once implemented by the eligible
entity but must not recommend or provide input to the eligible entity
in identifying, selecting, or implementing the corrective action.
    (4) Audit observations and other data and information from the
examination, including information on corrective actions, must be
documented and must be used to support the findings contained in the
audit report required by Sec.  1.652 and maintained as a record under
Sec.  1.658.

Sec.  1.652  What must an accredited third-party certification body
include in food safety audit reports?

    (a) Consultative audits. An accredited third-party certification
body must prepare a report of a consultative audit not later than 45
days after completing such audit and must provide a copy of such report
to the eligible entity and must maintain such report under Sec.  1.658,
subject to FDA access in accordance with the requirements of section
414 of the FD&C Act. A consultative audit report must include:
    (1) The identity of the site or location where the consultative
audit was conducted, including:
    (i) The name, address and the FDA Establishment Identifier of the
facility subject to the consultative audit and a unique facility
identifier, if designated by FDA; and
    (ii) Where applicable, the FDA registration number assigned to the
facility under subpart H of this part;
    (2) The identity of the eligible entity, if different from the
facility, including the name, address, the FDA Establishment Identifier
and unique facility identifier, if designated by FDA, and, where
applicable, registration number under subpart H of this part;
    (3) The name(s) and telephone number(s) of the person(s)
responsible for compliance with the applicable food safety requirements
of the FD&C Act and FDA regulations
    (4) The dates and scope of the consultative audit;
    (5) The process(es) and food(s) observed during such consultative
audit; and
    (6) Any deficiencies observed that relate to or may influence a
determination of compliance with the applicable food safety
requirements of the FD&C Act and FDA regulations that require
corrective action, the corrective action plan, and the date on which
such corrective actions were completed. Such consultative audit report
must be maintained as a record under Sec.  1.658 and must be made
available to FDA in accordance with section 414 of the FD&C Act.
    (b) Regulatory audits. An accredited third-party certification body
must, no later than 45 days after completing a regulatory audit,
prepare and submit electronically, in English, to FDA and to its
recognized accreditation body (or, in the case of direct accreditation,
only to FDA) and must provide to the eligible entity a report of such
regulatory audit that includes the following information:
    (1) The identity of the site or location where the regulatory audit
was conducted, including:
    (i) The name, address, and FDA Establishment Identifier of the
facility subject to the regulatory audit and a unique facility
identifier, if designated by FDA; and
    (ii) Where applicable, the FDA registration number assigned to the
facility under subpart H of this part;
    (2) The identity of the eligible entity, if different from the
facility, including the name, address, FDA Establishment Identifier,
and unique facility identifier, if designated by FDA, and, where
applicable, registration number under subpart H of this part;
    (3) The dates and scope of the regulatory audit;
    (4) The process(es) and food(s) observed during such regulatory
audit;
    (5) The name(s) and telephone number(s) of the person(s)
responsible for the facility's compliance with the applicable food
safety requirements of the FD&C Act and FDA regulations;
    (6) Any deficiencies observed during the regulatory audit that
present a reasonable probability that the use of or exposure to a
violative product:
    (i) Will cause serious adverse health consequences or death to
humans and animals; or
    (ii) May cause temporary or medically reversible adverse health
consequences or where the probability of serious adverse health
consequences or death to humans or animals is remote;
    (7) The corrective action plan for addressing each deficiency
identified under paragraph (b)(6) of this section, unless corrective
action was implemented immediately and verified onsite by the
accredited third-party certification body (or its audit agent, where
applicable);
    (8) Whether any sampling and laboratory analysis (e.g., under a
microbiological sampling plan) is performed in or used by the facility;
and
    (9) Whether the eligible entity has made significant changes to the
facility, its process(es), or food products during the 2 years
preceding the regulatory audit.
    (c) Submission of regulatory audit report. An accredited third-
party certification body must submit a completed regulatory audit
report as required by paragraph (b) of this section, regardless of
whether the certification body issued a food or facility certification
to the eligible entity.
    (d) Notice and appeals of adverse regulatory audit results. An
accredited third-party certification body must notify an eligible
entity of a denial of certification and must establish and implement
written procedures for receiving and addressing appeals from eligible
entities challenging such adverse regulatory audit results 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 persons, who may or may not be external to the
accredited third-party certification body, who are free from bias or
prejudice and have not participated in the certification decision or be
subordinate to a person who has participated in the certification
decision, to investigate and decide appeals;
    (3) Advise the eligible entity of the final decision on its appeal;
and
    (4) Maintain records under Sec.  1.658 of the appeal, the final
decision, and the basis for such decision.

Sec.  1.653  What must an accredited third-party certification body do
when issuing food or facility certifications?

    (a) Basis for issuance of a food or facility certification. (1)
Prior to issuing a food or facility certification to an eligible
entity, an accredited third-party

certification body (or, where applicable, an audit agent on its behalf)
must complete a regulatory audit that meets the requirements of Sec.
1.651 and any other activities that may be necessary to determine
compliance with the applicable food safety requirements of the FD&C Act
and FDA regulations.
    (2) If, as a result of an observation during a regulatory audit, an
eligible entity must implement a corrective action plan to address a
deficiency, an accredited third-party certification body may not issue
a food or facility certification to such entity until after the
accredited third-party certification body verifies that eligible entity
has implemented the corrective action plan through methods that
reliably verify the corrective action was taken and as a result the
identified deficiency is unlikely to recur, except onsite verification
is required for corrective actions required to address deficiencies
that are the subject of a notification under Sec.  1.656(c).
    (3) An accredited third-party certification body must consider each
observation and the data and other information from a regulatory audit
and other activities conducted under Sec.  1.651 to determine whether
the entity was in compliance with the applicable food safety
requirements of the FD&C Act and FDA regulations at the time of the
audit and whether the eligible entity, given its food safety system and
practices, would be likely to remain in compliance for the duration of
any certification issued under this subpart.
    (4) A single regulatory audit may result in issuance of one or more
food or facility certifications under this subpart, provided that the
requirements of issuance are met as to each such certification.
    (5) Where an accredited third-party certification body uses an
audit agent to conduct a regulatory audit of an eligible entity under
this subpart, the accredited third-party certification body (and not
the audit agent) must make the determination whether to issue a food or
facility certification based on the results of such regulatory audit.
    (b) Issuance of a food or facility certification and submission to
FDA. (1) Any food or facility certification issued under this subpart
must be submitted to FDA electronically and in English. The accredited
third-party certification body may issue a food or facility
certification under this subpart for a term of up to 12 months.
    (2) A food or facility certification must contain, at a minimum,
the following elements:
    (i) The name and address of the accredited third-party
certification body and the scope and date of its accreditation under
this subpart;
    (ii) The name, address, FDA Establishment Identifier, and unique
facility identifier, if designated by FDA, of the eligible entity to
which the food or facility certification was issued;
    (iii) The name, address, FDA Establishment Identifier, and unique
facility identifier, if designated by FDA, of the facility where the
regulatory audit was conducted, if different than the eligible entity;
    (iv) The scope and date(s) of the regulatory audit and the
certification number;
    (v) The name of the audit agent(s) (where applicable) conducting
the regulatory audit; and
    (vi) The scope of the food or facility certification, date of
issuance, and date of expiration.
    (3) FDA may refuse to accept any certification for purposes of
section 801(q) or 806 of the FD&C Act, if FDA determines, that such
food or facility certification is not valid or reliable because, for
example:
    (i) The certification is offered in support of the admissibility of
a food that was not within the scope of the certification;
    (ii) The certification was issued by an accredited third-party
certification body acting outside the scope of its accreditation under
this subpart; or
    (iii) The certification was issued without reliable demonstration
that the requirements of paragraph (a) of this section were met.

Sec.  1.654  When must an accredited third-party certification body
monitor an eligible entity that it has issued a food or facility
certification?

    If an accredited third-party certification body has reason to
believe that an eligible entity to which it issued a food or facility
certification may no longer be in compliance with the applicable food
safety requirements of the FD&C Act and FDA regulations, the accredited
third-party certification body must conduct any monitoring (including
an onsite audit) of such eligible entity necessary to determine whether
the entity is in compliance with such requirements. The accredited
third-party certification body must immediately notify FDA, under Sec.
1.656(d), if it withdraws or suspends a food or facility certification
because it determines that the entity is no longer in compliance with
the applicable food safety requirements of the FD&C Act and FDA
regulations. The accredited third-party certification body must
maintain records of such monitoring under Sec.  1.658.

Sec.  1.655  How must an accredited third-party certification body
monitor its own performance?

    (a) An accredited third-party certification body must annually,
upon FDA request made for cause, or as required under Sec.
1.631(f)(1)(i), Sec.  1.634(d)(1)(i), or Sec.  1.635(c)(1)(i), conduct
a self-assessment that includes evaluation of compliance with this
subpart, including:
    (1) The performance of its officers, employees, or other agents
involved in auditing and certification activities, including the
performance of audit agents in examining facilities, process(es), and
food using the applicable food safety requirements of the FD&C Act and
FDA regulations;
    (2) The degree of consistency among its officers, employees, or
other agents involved in auditing and certification activities,
including evaluating whether its audit agents interpreted audit
protocols in a consistent manner;
    (3) The compliance of the accredited third-party certification body
and its officers, employees, and other agents involved in auditing and
certification activities, with the conflict of interest requirements of
Sec.  1.657;
    (4) Actions taken in response to the results of any assessments
conducted by FDA or, where applicable, the recognized accreditation
body under Sec.  1.621; and
    (5) As requested by FDA, any other aspects of its performance
relevant to a determination of whether the accredited third-party
certification body is in compliance with this subpart.
    (b) As a means to assess its performance, the accredited third-
party certification body may evaluate the compliance of one or more of
eligible entities to which a food or facility certification was issued
under this subpart.
    (c) Based on the assessments and evaluations conducted under
paragraphs (a) and (b) of this section, the accredited third-party
certification body must:
    (1) Identify any deficiencies in complying with the requirements of
this subpart;
    (2) Quickly implement corrective action(s) that effectively address
the identified deficiencies; and
    (3) Under Sec.  1.658, establish and maintain records of such
corrective action(s).
    (d) The accredited third-party certification body must prepare a
written report of the results of its self-assessment that includes:
    (1) A description of any corrective action(s) taken under paragraph
(c) of this section;

    (2) A statement disclosing the extent to which the accredited
third-party certification body, and its officers, employees, and other
agents involved in auditing and certification activities, complied with
the conflict of interest requirements in Sec.  1.657; and
    (3) A statement attesting to the extent to which the accredited
third-party certification body complied with the applicable
requirements of this subpart.
    (e) An accredited third-party certification body may use a report,
supplemented as necessary, on its conformance to ISO/IEC 17021: 2011 or
ISO/IEC 17065: 2012 in meeting the requirements of this section.

Sec.  1.656  What reports and notifications must an accredited third-
party certification body submit?

    (a) Reporting results of regulatory audits. An accredited third-
party certification body must submit a regulatory audit report, as
described in Sec.  1.652(b), electronically, in English, to FDA and to
the recognized accreditation body that granted its accreditation (where
applicable), no later than 45 days after completing such audit.
    (b) Reporting results of accredited third-party certification body
self-assessments. An accredited third-party certification body must
submit the report of its annual self-assessment required by Sec.  1.655
electronically to its recognized accreditation body (or, in the case of
direct accreditation, electronically and in English, to FDA), within 45
days of the anniversary date of its accreditation under this subpart.
For an accredited third-party certification body subject to an FDA
request for cause, or Sec.  1.631(f)(1)(i), Sec.  1.634(d)(1)(i), or
Sec.  1.635(c)(1)(i), the report of its self-assessment must be
submitted to FDA electronically, in English, within 60 days of the FDA
request, denial of renewal, revocation, or relinquishment of
recognition of the accreditation body that granted its accreditation.
Such report must include an up-to-date list of any audit agents it uses
to conduct audits under this subpart.
    (c) Notification to FDA of a serious risk to public health. An
accredited third-party certification body must immediately notify FDA
electronically, in English, if during a regulatory or consultative
audit, any of its audit agents or the accredited third-party
certification body itself discovers a condition that could cause or
contribute to a serious risk to the public health, providing the
following information:
    (1) The name, physical address, and unique facility identifier, if
designated by FDA, of the eligible entity subject to the audit, and,
where applicable, the registration number under subpart H of this part;
    (2) The name, physical address, and unique facility identifier, if
designated by FDA, of the facility where the condition was discovered
(if different from that of the eligible entity) and, where applicable,
the registration number assigned to the facility under subpart H of
this part; and
    (3) The condition for which notification is submitted.
    (d) Immediate notification to FDA of withdrawal or suspension of a
food or facility certification. An accredited third-party certification
body must notify FDA electronically, in English, immediately upon
withdrawing or suspending any food or facility certification of an
eligible entity and the basis for such action.
    (e) Notification to its recognized accreditation body or an
eligible entity. (1) After notifying FDA under paragraph (c) of this
section, an accredited third-party certification body must immediately
notify the eligible entity of such condition and must immediately
thereafter notify the recognized accreditation body that granted its
accreditation, except for third-party certification bodies directly
accredited by FDA. Where feasible and reliable, the accredited third-
party certification body may contemporaneously notify its recognized
accreditation body and/or the eligible entity when notifying FDA.
    (2) An accredited third-party certification body must notify its
recognized accreditation body (or, in the case of direct accreditation,
FDA) electronically, in English, within 30 days after making any
significant change that would affect the manner in which it complies
with the requirements of this subpart and must include with such
notification the following information:
    (i) A description of the change; and
    (ii) An explanation for the purpose of the change.

Sec.  1.657  How must an accredited third-party certification body
protect against conflicts of interest?

    (a) An accredited third-party certification body must implement a
written program to protect against conflicts of interest between the
accredited third-party certification body (and its officers, employees,
and other agents involved in auditing and certification activities) and
an eligible entity seeking a food safety audit or food or facility
certification from, or audited or certified by, such accredited third-
party certification body, including the following:
    (1) Ensuring that the accredited third-party certification body and
its officers, employees, or other agents involved in auditing and
certification activities do not own, operate, have a financial interest
in, manage, or otherwise control an eligible entity to be certified, or
any affiliate, parent, or subsidiary of the entity;
    (2) Ensuring that the accredited third-party certification body
and, its officers, employees, or other agents involved in auditing and
certification activities are not owned, managed, or controlled by any
person that owns or operates an eligible entity to be certified;
    (3) Ensuring that an audit agent of the accredited third-party
certification body does not own, operate, have a financial interest in,
manage, or otherwise control an eligible entity or any affiliate,
parent, or subsidiary of the entity that is subject to a consultative
or regulatory audit by the audit agent; and
    (4) Prohibiting an accredited third-party certification body's
officer, employee, or other agent involved in auditing and
certification activities from accepting any money, gift, gratuity, or
other item of value from the eligible entity to be audited or certified
under this subpart.
    (5) The items specified in paragraph (a)(4) of this section do not
include:
    (i) Money representing payment of fees for auditing and
certification services and reimbursement of direct costs associated
with an onsite audit by the third-party certification body; or
    (ii) Lunch of de minimis value provided during the course of an
audit and on the premises where the audit is conducted, if necessary to
facilitate the efficient conduct of the audit.
    (b) An accredited third-party certification body may accept the
payment of fees for auditing and certification services and the
reimbursement of direct costs associated with an audit of an eligible
entity only after the date on which the report of such audit was
completed or the date a food or facility certification was issued,
whichever is later. Such payment is not considered a conflict of
interest for purposes of paragraph (a) of this section.
    (c) The financial interests of the spouses and children younger
than 18 years of age of accredited third-party certification body's
officers, employees, and other agents involved in auditing and
certification activities will be considered the financial interests of
such officers, employees, and other agents involved in auditing and
certification activities.
    (d) An accredited third-party certification body must maintain on
its Web site an up-to-date list of the eligible

entities to which it has issued food or facility certifications under
this subpart. For each such eligible entity, the Web site also must
identify the duration and scope of the food or facility certification
and date(s) on which the eligible entity paid the accredited third-
party certification body any fee or reimbursement associated with such
audit or certification.

Sec.  1.658  What records requirements must a third-party certification
body that has been accredited meet?

    (a) A third-party certification body that has been accredited must
maintain electronically for 4 years records created during its period
of accreditation (including documents and data) that document
compliance with this subpart, including:
    (1) Any audit report and other documents resulting from a
consultative audit conducted under this subpart, including the audit
agent's observations, correspondence with the eligible entity,
verification of any corrective action(s) taken to address deficiencies
identified during the audit;
    (2) Any request for a regulatory audit from an eligible entity;
    (3) Any audit report and other documents resulting from a
regulatory audit conducted under this subpart, including the audit
agent's observations, correspondence with the eligible entity,
verification of any corrective action(s) taken to address deficiencies
identified during the audit, and, when sampling and analysis is
conducted, laboratory testing records and results from a laboratory
that is accredited in accordance with Sec.  1.651(b)(3), and
documentation demonstrating such laboratory is accredited in accordance
with Sec.  1.651(b)(3);
    (4) Any notification submitted by an audit agent to the accredited
third-party certification body in accordance with Sec.  1.650(a)(5);
    (5) Any challenge to an adverse regulatory audit decision and the
disposition of the challenge;
    (6) Any monitoring it conducted of an eligible entity to which food
or facility certification was issued;
    (7) Its self-assessments and corrective actions taken to address
any deficiencies identified during a self-assessment; and
    (8) Significant changes to its auditing or certification program
that might affect compliance with this subpart.
    (b) An accredited third-party certification body must make the
records of a consultative audit required by paragraph (a)(1) of this
section available to FDA in accordance with section 414 of the FD&C
Act.
    (c) An accredited third-party certification body must make the
records required by paragraphs (a)(2) through (8) 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
accredited third-party certification body or at a reasonably accessible
location. If such records are requested by FDA electronically, the
records must be submitted electronically not later than 10 business
days after the date of the request. Additionally, if the records are
maintained in a language other than English, an accredited third-party
certification body must electronically submit an English translation
within a reasonable time.

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

Sec.  1.660  Where do I apply for accreditation or renewal of
accreditation by a recognized accreditation body and what happens once
the recognized accreditation body decides on my application?

    (a) Submission of accreditation or renewal application to a
recognized accreditation body. A third-party certification body seeking
accreditation must submit its request for accreditation or renewal of
accreditation by a recognized accreditation body identified on the Web
site described in Sec.  1.690.
    (b) Notice of records custodian after denial of application for
renewal of accreditation. An applicant whose renewal application was
denied by a recognized accreditation body must notify FDA
electronically, in English, within 10 business days of the date of
issuance of a denial of accreditation or denial of the renewal
application, of the name and contact information of the custodian who
will maintain the records required by Sec.  1.658(a) and make them
available to FDA as required by Sec.  1.658(b) and (c). The contact
information for the custodian must include, at a minimum, an email
address and the physical address where the records required by Sec.
1.658(a) will be located.
    (c) Effect of denial of an application for renewal of accreditation
on food or facility certifications issued to eligible entities. A food
or facility certification issued by an accredited third-party
certification body prior to issuance of the denial of its renewal
application l will remain in effect until the certification expires. If
FDA has reason to believe that a certification issued for purposes of
section 801(q) or 806 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 or in
determining the importer's eligibility for participation in VQIP.
    (d) Public notice of denial of an application for renewal of
accreditation. FDA will provide notice on the Web site described in
Sec.  1.690 of the date of issuance of a denial of renewal of
accreditation of a third-party certification body that had previous
been accredited.

Sec.  1.661  What is the duration of accreditation by a recognized
accreditation body?

    A recognized accreditation body may grant accreditation to a third-
party certification body under this subpart for a period not to exceed
4 years.

Sec.  1.662  How will FDA monitor accredited third-party certification
bodies?

    (a) FDA will periodically evaluate the performance of each
accredited third-party certification body to determine whether the
accredited third-party certification body continues to comply with the
applicable requirements of this subpart and whether there are
deficiencies in the performance of the accredited third-party
certification body that, if not corrected, would warrant withdrawal of
its accreditation under Sec.  1.664. FDA will evaluate each directly
accredited third-party certification body annually. For a third-party
certification body accredited by a recognized accreditation body, FDA
will evaluate an accredited third-party certification body not later
than 3 years after the date of accreditation for a 4-year term of
accreditation, or by no later than the mid-term point for accreditation
granted for less than 4 years. FDA may conduct additional performance
assessments of an accredited third-party certification body at any
time.
    (b) In evaluating the performance of an accredited third-party
certification body under paragraph (a) of this section, FDA may review
any one or more of the following:
    (1) Regulatory audit reports and food and facility certifications;
    (2) The accredited third-party certification body's self-
assessments under Sec.  1.655;
    (3) Reports of assessments by a recognized accreditation body under
Sec.  1.621;
    (4) Documents and other information relevant to a determination of
the accredited third-party certification body's compliance with the
applicable requirements of this subpart; and
    (5) Information obtained by FDA, including during inspections,
audits,

onsite observations, or investigations, of one or more eligible
entities to which a food or facility certification was issued by such
accredited third-party certification body.
    (c) FDA may conduct its evaluation of an accredited third-party
certification body through a site visit to an accredited third-party
certification body's headquarters (or other location that manages audit
agents conducting food safety audits under this subpart, if different
than its headquarters), through onsite observation of an accredited
third party certification body's performance during a food safety audit
of an eligible entity, or through document review.

Sec.  1.663  How do I request an FDA waiver or waiver extension for the
13-month limit for audit agents conducting regulatory audits?

    (a) An accredited third-party certification body may submit a
request to FDA to waive the requirements of Sec.  1.650(c) preventing
an audit agent from conducting a regulatory audit of an eligible entity
if the audit agent (or, in the case that the third-party certification
body is an individual, the third-party certification body) has
conducted a food safety audit of such entity during the previous 13
months. The accredited third-party certification body seeking a waiver
or waiver extension must demonstrate there is insufficient access to
audit agents and any third-party certification bodies that are
comprised of an individual in the country or region where the eligible
entity is located.
    (b) Requests for a waiver or waiver extension and all documents
provided in support of the request must be submitted to FDA
electronically, in English. The requestor must provide such translation
and interpretation services as are needed by FDA to process the
request.
    (c) The request must be signed by the requestor or by any
individual authorized to act on behalf of the requestor for purposes of
seeking such waiver or waiver extension.
    (d) FDA will review requests for waivers and waiver extensions on a
first in, first out basis according to the date on which the completed
submission is received; however, FDA may prioritize the review of
specific requests to meet the needs of the program. FDA will evaluate
any completed waiver request to determine whether the criteria for
waiver have been met.
    (e) FDA will notify the requestor whether the request for a waiver
or waiver extension is approved or denied.
    (f) If FDA approves the request, issuance of the waiver will state
the duration of the waiver and list any limitations associated with it.
If FDA denies the request, the issuance of a denial of a waiver request
will state the basis for denial and will provide the address and
procedures for requesting reconsideration of the request under Sec.
1.691.
    (g) Unless FDA notifies a requestor that its waiver request has
been approved, an accredited third-party certification body must not
use the audit agent to conduct a regulatory audit of such eligible
entity until the 13-month limit in Sec.  1.650(c) has elapsed.

Sec.  1.664  When would FDA withdraw accreditation?

    (a) Mandatory withdrawal. FDA will withdraw accreditation from a
third-party certification body:
    (1) Except as provided in paragraph (b) of this section, if the
food or facility certified under this subpart is linked to an outbreak
of foodborne illness or chemical or physical hazard that has a
reasonable probability of causing serious adverse health consequences
or death in humans or animals;
    (2) Following an evaluation and finding by FDA that the third-party
certification body no longer complies with the applicable requirements
of this subpart; or
    (3) Following its refusal to allow FDA to access records under
Sec.  1.658 or to conduct an audit, assessment, or investigation
necessary to ensure continued compliance with this subpart.
    (b) Exception. FDA may waive mandatory withdrawal under paragraph
(a)(1) of this section, if FDA:
    (1) Conducts an investigation of the material facts related to the
outbreak of human or animal illness;
    (2) Reviews the relevant audit records and the actions taken by the
accredited third-party certification body in support of its decision to
certify; and
    (3) Determines that the accredited third-party certification body
satisfied the requirements for issuance of certification under this
subpart.
    (c) Discretionary withdrawal. FDA may withdraw accreditation, in
whole or in part, from a third-party certification body when such
third-party certification body is accredited by an accreditation body
for which recognition is revoked under Sec.  1.634, if FDA determines
there is good cause for withdrawal, including:
    (1) Demonstrated bias or lack of objectivity when conducting
activities under this subpart; or
    (2) Performance that calls into question the validity or
reliability of its food safety audits or certifications.
    (d) Records access. FDA may request records of the accredited
third-party certification body under Sec.  1.658 and, where applicable,
may request records under Sec.  1.625 of an accreditation body that has
been recognized under Sec.  1.625, when considering withdrawal under
paragraph (a)(1), (a)(2), or (c) of this section.
    (e) Notice to the third-party certification body of withdrawal of
accreditation. (1) FDA will notify a third-party certification body of
the withdrawal of its accreditation through issuance of a withdrawal
that will state the grounds for withdrawal, the procedures for
requesting a regulatory hearing under Sec.  1.693 on the withdrawal,
and the procedures for requesting reaccreditation under Sec.  1.666.
    (2) Within 10 business days of the date of issuance of the
withdrawal, the third-party certification body must notify FDA
electronically, in English, of the name of the custodian who will
maintain the records required by Sec.  1.658, and provide contact
information for the custodian, which will at least include an email
address, and the street address where the records will be located.
    (f) Effect of withdrawal of accreditation on eligible entities. A
food or facility certification issued by a third-party certification
body prior to withdrawal will remain in effect until the certification
terminates by expiration. If FDA has reason to believe that a
certification issued for purposes of section 801(q) or 806 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 or in determining the
importer's eligibility for participation in VQIP.
    (g) Effect of withdrawal of accreditation on recognized
accreditation bodies. (1) FDA will notify a recognized accreditation
body if the accreditation of a third-party certification body it
accredited is withdrawn by FDA. Such accreditation body's recognition
will remain in effect if, no later than 60 days after withdrawal, the
accreditation body conducts a self-assessment under Sec.  1.622 and
reports the results of the self-assessment to FDA as required by Sec.
1.623(b).
    (2) FDA may revoke the recognition of an accreditation body
whenever FDA determines there is good cause for revocation of
recognition under Sec.  1.634.
    (h) Public notice of withdrawal accreditation. FDA will provide
notice on the Web site described in Sec.  1.690 of its withdrawal of
accreditation of a third-party certification body and

provide a description of the basis for withdrawal.

Sec.  1.665  What if I want to voluntarily relinquish accreditation or
do not want to renew accreditation?

    (a) Notice to FDA of intent to relinquish or not to renew
accreditation. A third-party certification body must notify FDA
electronically, in English, at least 60 days before voluntarily
relinquishing accreditation or before allowing accreditation to expire
without seeking renewal. The certification body must provide the name
and contact information of the custodian who will maintain the records
required under Sec.  1.658(a) after the date of relinquishment or the
date accreditation expires, as applicable, and make them available to
FDA as required by Sec.  1.658(b) and (c). The contact information for
the custodian must include, at a minimum, an email address and the
physical address where the records required by Sec.  1.658(a) will be
located.
    (b) Notice to recognized accreditation body and eligible entities
of intent to relinquish or not to renew accreditation. No later than 15
business days after notifying FDA under paragraph (a) of this section,
the certification body must notify its recognized accreditation body
and any eligible entity with current certifications that it intends to
relinquish accreditation or to allow its accreditation to expire,
specifying the date on which relinquishment or expiration will occur.
The recognized accreditation body must establish and maintain records
of such notification under Sec.  1.625(a).
    (c) Effect of voluntary relinquishment or expiration of
accreditation on food or facility certifications issued to eligible
entities. A food or facility certification issued by a third-party
certification body prior to relinquishment or expiration of its
accreditation will remain in effect until the certification expires. If
FDA has reason to believe that a certification issued for purposes of
section 801(q) or 806 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 or in
determining the importer's eligibility for participation in VQIP.
    (d) Public notice of voluntary relinquishment or expiration of
accreditation. FDA will provide notice on the Web site described in
Sec.  1.690 of the voluntary relinquishment or expiration of
accreditation of a certification body under this subpart.

Sec.  1.666  How do I request reaccreditation?

    (a) Application following withdrawal. FDA will reinstate the
accreditation of a third-party certification body for which it has
withdrawn accreditation:
    (1) If, in the case of direct accreditation, FDA determines, based
on evidence presented by the third-party certification body, that the
third-party certification body satisfies the applicable requirements of
this subpart and adequate grounds for withdrawal no longer exist; or
    (2) In the case of a third-party certification body accredited by
an accreditation body for which recognition has been revoked under
Sec.  1.634:
    (i) If the third-party certification body becomes accredited by
another recognized accreditation body or by FDA through direct
accreditation no later than 1 year after withdrawal of accreditation,
or the original date of the expiration of accreditation, whichever
comes first; or
    (ii) Under such conditions as FDA may impose in withdrawing
accreditation.
    (b) Application following voluntary relinquishment. A third-party
certification body that previously relinquished its accreditation under
Sec.  1.665 may seek accreditation by submitting a new application for
accreditation under Sec.  1.660 or, where applicable, Sec.  1.670.

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

Sec.  1.670  How do I apply to FDA for direct accreditation or renewal
of direct accreditation?

    (a) Eligibility. (1) FDA will accept applications from third-party
certification bodies for direct accreditation or renewal of direct
accreditation only if FDA determines that it has not identified and
recognized an accreditation body to meet the requirements of section
808 of the FD&C Act within 2 years after establishing the accredited
third-party audits and certification program. Such FDA determination
may apply, as appropriate, to specific types of third-party
certification bodies, types of expertise, or geographic location; or
through identification by FDA of any requirements of section 808 of the
FD&C Act not otherwise met by previously recognized accreditation
bodies. FDA will only accept applications for direct accreditation and
renewal applications that are within the scope of the determination.
    (2) FDA may revoke or modify a determination under paragraph (a)(1)
of this section if FDA subsequently identifies and recognizes an
accreditation body that affects such determination.
    (3) FDA will provide notice on the Web site described in Sec.
1.690 of a determination under paragraph (a)(1) of this section and of
a revocation or modification of the determination under paragraph
(a)(1) of this section, as described in paragraph (a)(2) of this
section.
    (b) Application for direct accreditation or renewal of direct
accreditation. (1) A third-party certification body seeking direct
accreditation or renewal of direct accreditation must submit an
application to FDA, demonstrating that it is within the scope of the
determination issued under paragraph (a)(1) of this section, and it
meets the eligibility requirements of Sec.  1.640.
    (2) Applications and all documents provided as part of the
application process must be submitted electronically, in English. An
applicant must provide such translation and interpretation services as
are needed by FDA to process the application, including during an
onsite audit of the applicant.
    (3) The application must be signed in the manner designated by FDA
by an individual authorized to act on behalf of the applicant for
purposes of seeking or renewing direct accreditation.

Sec.  1.671  How will FDA review my application for direct
accreditation or renewal of direct accreditation and what happens once
FDA decides on my application?

    (a) Review of a direct accreditation or renewal application. FDA
will examine a third-party certification body's direct accreditation or
renewal application for completeness and notify the applicant of any
deficiencies. FDA will review applications for direct accreditation and
for renewal of direct accreditation on a first in, first out basis
according to the date the completed submission is received; however,
FDA may prioritize the review of specific applications to meet the
needs of the program.
    (b) Evaluation of a direct accreditation or renewal application.
FDA will evaluate any completed application to determine whether the
applicant meets the requirements for direct accreditation under this
subpart. If FDA does not reach a final decision on a renewal
application before the expiration of the direct accreditation, FDA may
extend the duration of such direct accreditation for a specified

period of time or until the Agency reaches a final decision on the
renewal application.
    (c) Notice of approval or denial. FDA will notify the applicant
that its direct accreditation or renewal application has been approved
through issuance of or denied.
    (d) Issuance of direct accreditation. If an application has been
approved, the issuance of the direct accreditation that will list any
limitations associated with the accreditation.
    (e) Issuance of denial of direct accreditation. If FDA issues a
denial of direct accreditation or denial of a renewal application, the
issuance of the denial of direct accreditation will state the basis for
such denial and provide the procedures for requesting reconsideration
of the application under Sec.  1.691.
    (f) Notice of records custodian after denial of application for
renewal of direct accreditation. An applicant whose renewal application
was denied must notify FDA electronically, in English, within 10
business days of the date of issuance of a denial of a renewal
application, of the name and contact information of the custodian who
will maintain the records required by Sec.  1.658(a) and make them
available to FDA as required by Sec.  1.658(b) and (c). The contact
information for the custodian must include, at a minimum, an email
address and the physical address where the records required by Sec.
1.658(b) will be located.
    (g) Effect of denial of renewal of direct accreditation on food or
facility certifications issued to eligible entities. A food or facility
certification issued by an accredited third-party certification body
prior to issuance of the denial of its renewal application will remain
in effect until the certification expires. If FDA has reason to believe
that a certification issued for purposes of section 801(q) or 806 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 or in determining the
importer's eligibility for participation in VQIP.
    (h) Public notice of denial of renewal of direct accreditation. FDA
will provide notice on the Web site described in Sec.  1.690 of the
issuance of a denial of renewal application for direct accreditation
under this subpart.

Sec.  1.672  What is the duration of direct accreditation?

    FDA will grant direct accreditation of a third-party certification
body for a period not to exceed 4 years.

Requirements for Eligible Entities Under This Subpart

Sec.  1.680  How and when will FDA monitor eligible entities?

    FDA may, at any time, conduct an onsite audit of an eligible entity
that has received food or facility certification from an accredited
third-party certification body under this subpart. Where FDA determines
necessary or appropriate, the unannounced audit may be conducted with
or without the accredited third-party certification body or the
recognized accreditation body (where applicable) present. An FDA audit
conducted under this section will be conducted on an unannounced basis
and may be preceded by a request for a 30-day operating schedule.

Sec.  1.681  How frequently must eligible entities be recertified?

    An eligible entity seeking recertification of a food or facility
certification under this subpart must apply for recertification prior
to the expiration of its certification. For certifications used in
meeting the requirements of section 801(q) or 806 of the FD&C Act, FDA
may require an eligible entity to apply for recertification at any time
FDA determines appropriate under such section.

General Requirements of This Subpart

Sec.  1.690  How will FDA make information about recognized
accreditation bodies and accredited third-party certification bodies
available to the public?

    FDA will place on its Web site a registry of recognized
accreditation bodies and accredited third-party certification bodies,
including the name, contact information, and scope and duration of
recognition or accreditation. The registry may provide information on
third-party certification bodies accredited by recognized accreditation
bodies through links to the Web sites of such recognized accreditation
bodies. FDA will also place on its Web site a list of accreditation
bodies for which it has denied renewal of recognition, for which FDA
has revoked recognition, and that have relinquished their recognition
or have allowed their recognition to expire. FDA will also place in its
Web site a list of certification bodies whose renewal of accreditation
has been denied, for which FDA has withdrawn accreditation, and that
have relinquished their accreditations or have allowed their
accreditations to expire. FDA will place on its Web site determinations
under Sec.  1.670(a)(1) and modifications of such determinations under
Sec.  1.670(a)(2).

Sec.  1.691  How do I request reconsideration of a denial by FDA of an
application or a waiver request?

    (a) An accreditation body may seek reconsideration of the denial of
an application for recognition, renewal of recognition, or
reinstatement of recognition no later than 10 business days after the
date of the issuance of such denial.
    (b) A third-party certification body may seek reconsideration of
the denial of an application for direct accreditation, renewal of
direct accreditation, reaccreditation of directly accredited third-
party certification body, a request for a waiver of the conflict of
interest requirement in Sec.  1.650(b), or a waiver extension no later
than 10 business days after the date of the issuance of such denial.
    (c) A request to reconsider an application or waiver request under
paragraph (a) or (b) of this section must be signed by the requestor or
by an individual authorized to act on its behalf in submitting the
request for reconsideration. The request must be submitted
electronically in English and must comply with the procedures described
in the notice.
    (d) After completing its review and evaluation of the request for
reconsideration, FDA will notify the requestor through the issuance of
the recognition, direct accreditation, or waiver upon reconsideration
or through the issuance of a denial of the application or waiver
request under paragraph (a) or (b) of this section upon
reconsideration.

Sec.  1.692  How do I request internal agency review of a denial of an
application or waiver request upon reconsideration?

    (a) No later than 10 business days after the date of issuance of a
denial of an application or waiver request upon reconsideration under
Sec.  1.691, the requestor may seek internal agency review of such
denial under Sec.  10.75(c)(1) of this chapter.
    (b) The request for internal agency review under paragraph (a) of
this section must be signed by the requestor or by an individual
authorized to act on its behalf in submitting the request for internal
review. The request must be submitted electronically in English to the
address specified in the denial upon reconsideration and must comply
with procedures it describes.
    (c) Under Sec.  10.75(d) of this chapter, internal agency review of
such denial must be based on the information in the administrative
file, which will include any supporting information submitted under
Sec.  1.691(c).

    (d) After completing the review and evaluation of the
administrative file, FDA will notify the requestor of its decision to
overturn the denial and grant the application or waiver request through
issuance of an application or waiver request upon reconsideration or to
affirm the denial of the application or waiver request upon
reconsideration through issuance of a denial of an application or
waiver request upon reconsideration.
    (e) Issuance by FDA of a denial of an application or waiver request
upon reconsideration constitutes final agency action under 5 U.S.C.
702.

Sec.  1.693  How do I request a regulatory hearing on a revocation of
recognition or withdrawal of accreditation?

    (a) Request for hearing on revocation. No later than 10 business
days after the date of issuance of a revocation of recognition of an
accreditation body under Sec.  1.634, an individual authorized to act
on the accreditation body's behalf may submit a request for a
regulatory hearing on the revocation under part 16 of this chapter. The
issuance of revocation issued under Sec.  1.634 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.
    (b) Request for hearing on withdrawal. No later than 10 business
days after the date of issuance of a withdrawal of accreditation of a
third-party certification body under Sec.  1.664, an individual
authorized to act on the third-party certification body's behalf may
submit a request for a regulatory hearing on the withdrawal under part
16 of this chapter. The issuance of withdrawal under Sec.  1.664 will
contain all of the elements required by Sec.  16.22 of this chapter and
will thereby constitute the notice of opportunity of hearing under part
16 of this chapter.
    (c) Submission of request for regulatory hearing. 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 basis for the FDA
decision, as described in the issuance of revocation or withdrawal, as
appropriate, and includes any supporting information upon which the
requestor is relying. The request, appeal, and supporting information
must be submitted in English to the address specified in the notice and
must comply with the procedures it describes.
    (d) Effect of submission of request on FDA decision. The submission
of a request for a regulatory hearing under paragraph (a) or (b) of
this section will not operate to delay or stay the effect of a decision
by FDA to revoke recognition of an accreditation body or to withdraw
accreditation of a third-party certification body unless FDA determines
that a delay or a stay is in the public interest.
    (e) Presiding officer. The presiding officer for a regulatory
hearing for a revocation or withdrawal under this subpart will be
designated after a request for a regulatory hearing is submitted to
FDA.
    (f) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing for a revocation or
withdrawal under Sec.  16.26(a) of this chapter when no genuine or
substantial issue of fact has been raised.
    (g) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing for a revocation or
withdrawal, the hearing will be held within 10 business days after the
date the request was filed or, if applicable, within a timeframe agreed
upon in writing by requestor, the presiding officer, and FDA.
    (2) The presiding officer must conduct the regulatory hearing for
revocation or withdrawal under part 16 of this chapter, except that,
under Sec.  16.5(b) of this chapter, such procedures apply only to the
extent that the procedures are supplementary and do not conflict with
the procedures specified for regulatory hearings under this subpart.
Accordingly, the following requirements of part 16 are inapplicable to
regulatory hearings under this subpart: Sec.  16.22 (Initiation of a
regulatory hearing); Sec.  16.24(e) (timing) and (f) (contents of
notice); Sec.  16.40 (Commissioner); Sec.  16.60(a) (public process);
Sec.  16.95(b) (administrative decision and record for decision); and
Sec.  16.119 (Reconsideration and stay of action).
    (3) A decision by the presiding officer to affirm the revocation of
recognition or the withdrawal of accreditation is considered a final
agency action under 5 U.S.C. 702.

Sec.  1.694  Are electronic records created under this subpart subject
to the electronic records requirements of part 11 of this chapter?

    Records that are established or maintained to satisfy the
requirements of this subpart and that meet the definition of electronic
records in Sec.  11.3(b)(6) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this subpart, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11 of this chapter.

Sec.  1.695  Are the records obtained by FDA under this subpart subject
to public disclosure?

    Records obtained by FDA under this subpart are subject to the
disclosure requirements under part 20 of this chapter.

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
3. The authority citation for 21 CFR part 11 continues to read as
follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.

0
4. In Sec.  11.1, add paragraph (m) to read as follows:

Sec.  11.1  Scope.

* * * * *
    (m) This part does not apply to records required to be established
or maintained by subpart M of part 1 of this chapter. Records that
satisfy the requirements of subpart M of part 1 of this chapter, but
that also are required under other applicable statutory provisions or
regulations, remain subject to this part.

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
5. The authority citation for 21 CFR part 16 continues to read as
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
6. In Sec.  16.1(b)(2), add the following entry in numerical order to
read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. Sec.  1.634 and 1.664, relating to revocation of recognition
of an accreditation body and withdrawal of accreditation of third-party
certification bodies that conduct food safety audits of eligible
entities in the food import supply chain and issue food and facility
certifications.
* * * * *

    Dated: October 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28160 Filed 11-13-15; 8:45 am]
 BILLING CODE 4164-01-P