1.1200 Are the records obtained by FDA under this subpart subject to
public disclosure?

Subpart R--Accreditation of Laboratories To Conduct Food Testing

General Provisions

Sec.  1.1102  What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act apply to such terms when used in this subpart, unless
otherwise specified. For the purposes of this subpart, the following
definitions also apply:
    Accreditation means a determination by a recognized accreditation
body that a laboratory meets the applicable requirements of this
subpart to conduct food testing under this subpart using one or more
methods of analysis.
    Accredited laboratory means a laboratory that a recognized
accreditation body has determined meets the applicable requirements of
this subpart and has been accredited to conduct food testing using one
or more methods of analysis under this subpart.
    Analyst means an individual who analyzes samples.
    Food has the meaning given in section 201(f) of the Federal Food,
Drug, and Cosmetic Act, except that food does not include pesticides
(as defined in 7 U.S.C. 136(u)).
    Food testing and testing of food means the analysis of food product
samples or environmental samples.
    Food testing order means an order issued by FDA under Sec. Sec.
1.1107(a)(2) and 1.1108 requiring food testing to be conducted under
this subpart by or on behalf of an owner or consignee.
    Owner or consignee means any person with an ownership or
consignment interest in:
    (1) The food product or environment that is the subject of food
testing conducted under Sec.  1.1107(a)(1);
    (2) Food product or environment that is the subject of the order
issued under Sec.  1.1107(a)(2);
    (3) The food product or environment that is the subject of food
testing conducted under Sec.  1.1107(a)(3);
    (4) The article of food for which food testing is being conducted
under Sec.  1.1107(a)(4); or
    (5) The food subject to an import alert for which food testing is
conducted under Sec.  1.1107(a)(5).
    Recognition means a determination by FDA that an accreditation body
meets the applicable requirements of this subpart and is authorized to
accredit laboratories under this subpart.
    Recognized accreditation body means an accreditation body that FDA
has determined meets the applicable requirements of this subpart and is
authorized to accredit laboratories under this subpart.
    Representative sample means a sample that accurately, to a
scientifically acceptable degree, represents the characteristics and
qualities of the food product or environment that the sample was
collected from.
    Sampler means an individual or individuals who perform sampling.
    Scope of accreditation refers to the methods of analysis for which
the accredited laboratory is accredited. References in this subpart to
accreditation ``in-whole'' refers to all methods in the accredited
laboratory's scope of accreditation and references to accreditation
``in-part'' refers to only certain methods in the accredited
laboratory's scope of accreditation.

Sec.  1.1103  Who is subject to this subpart?

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

General Requirements of This Subpart

Sec.  1.1107  Under what circumstances must food testing be conducted
under this subpart by an accredited laboratory?

    (a) Food testing must be conducted under this subpart whenever such
testing is conducted by or on behalf of an owner or consignee:
    (1) In response to explicit testing requirements that address an
identified

or suspected food safety problem, which are contained in the following
provisions:
    (i) Sprouts. 21 CFR 112.146(a), (c) and (d);
    (ii) Shell eggs. 21 CFR 118.4(a)(2)(iii), 118.5(a)(2)(ii) and
(b)(2)(ii), and 118.6(a)(2) and (e); and
    (iii) Bottled drinking water. 21 CFR 129.35(a)(3)(i) (for the
requirement to test five samples from the same sampling site that
originally tested positive for Escherichia coli);
    (2) As required by FDA in a food testing order;
    (3) To address an identified or suspected food safety problem and
presented to FDA as part of evidence for a hearing under section 423(c)
of the Federal Food, Drug, and Cosmetic Act prior to the issuance of a
mandatory food recall order, as part of a corrective action plan under
section 415(b)(3)(A) of the Federal Food, Drug, and Cosmetic Act
submitted after an order suspending the registration of a food
facility, or as part evidence submitted for an appeal of an
administrative detention order under section 304(h)(4)(A) of the
Federal Food, Drug, and Cosmetic Act.
    (4) In support of admission of an article of food under section
801(a) of the Federal Food, Drug, and Cosmetic Act;
    (5) To support removal from an import alert through successful
consecutive testing;
    (b) When food testing is conducted under paragraph (a) of this
section, analysis of samples must be conducted by accredited
laboratories that are accredited for the appropriate analytical method
or methods by a recognized accreditation body.
    (c) Food testing conducted on articles of food offered for import
into the United States under section 801(a) of the Federal Food, Drug,
and Cosmetic Act pursuant to paragraph (a)(4) or (a)(5) of this section
may only be conducted after the articles offered for import have
arrived in the United States unless FDA has determined, and responded
in writing to the owner/consignee, that a sample(s) taken prior to
arrival is or would be representative sample(s) of such article(s)
offered for import into the United States.

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

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

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

    (a) Except as provided by paragraph (b) of this section, FDA will
place on its website a list of:
    (1) Recognized accreditation bodies, including for each recognized
accreditation body: The name, contact information, and duration of
recognition of the recognized accreditation body;
    (2) Accreditation bodies that have their recognition revoked by FDA
or are put on probation, and accreditation bodies that have
relinquished their recognition or have allowed their recognition to
expire, including for each accreditation body: The name of the
accreditation body, whether FDA revoked recognition of the
accreditation body or put the recognized accreditation body on
probation, or whether the accreditation body relinquished its
recognition or allowed its recognition to expire, and the date of the
probation, revocation, relinquishment, or expiration;
    (3) Laboratories accredited under this subpart, including for each
laboratory: The name, contact information, and scope of accreditation
of the accredited laboratory, and the name and contact information of
the accreditation body that accredits the accredited laboratory; and
    (4) Laboratories that have been put on probation or have had their
accreditation withdrawn or revoked (in-whole or in-part) by a
recognized accreditation body or by FDA, or have relinquished their
accreditation (in-whole or in-part), including for each laboratory: The
name of the laboratory, whether a recognized accreditation body or FDA
put the laboratory on probation, or withdrew or revoked the
accreditation of the laboratory, or whether the laboratory relinquished
its accreditation, and the date of the probation, withdrawal,
revocation, or relinquishment.
    (b) In the interest of national security, FDA, in coordination with
the Secretary of Homeland Security, may determine an alternate time,
manner, and form in which the list described in paragraph (a) of this
section is made publicly available.

Recognition of Accreditation Bodies

Sec.  1.1113   What requirements must an accreditation body meet to
become recognized by FDA?

    To become recognized by FDA, an accreditation body seeking
recognition by FDA must:
    (a) Be a full member of the International Laboratory Accreditation
Cooperative (ILAC) and a signatory to the ILAC Mutual Recognition
Arrangement (MRA) that has demonstrated competence to ISO/IEC
17011:2017;
    (b) Demonstrate it complies with ISO/International Electrotechnical
Commission (IEC) 17011:2017, ``Conformity assessment--Requirements for
accreditation bodies accrediting conformity assessment bodies,'' Second
edition, November 2017. The Director of the Federal Register approves
this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part
51. The approved material is available for inspection at Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, and is available
from International Organization for Standardization (ISO), Chemin de
Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01
11, https://www.iso.org/home.html. It is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to www.archives.gov/federal-register/cfr/ibr-locations; and
    (c) Demonstrate that it possesses sufficient scientific/technical
expertise to be able to:
    (1) Review the validation and verification studies required by
Sec.  1.1138(a)(1), including reviewing the verification studies for
fitness for purpose;
    (2) Assess an accredited laboratory's determination under Sec.
1.1148(a)(2) that no proficiency testing program is available or
practicable for a particular method of analysis; and
    (3) Assess whether the comparison program proposed by the
accredited laboratory under Sec.  1.1148(a)(2) would provide the
recognized accreditation

body with the ability to monitor the quality of the laboratory's
performance to a degree comparable to a proficiency test.
    (d) Demonstrate it is capable of complying with all requirements
under this subpart for recognized accreditation bodies.

Requirements for Recognized Accreditation Bodies

Sec.  1.1118  What are the general requirements for recognized
accreditation bodies to remain recognized?

    To remain recognized, a recognized accreditation body must:
    (a) Be a full member of the International Laboratory Accreditation
Cooperative (ILAC) and a signatory to the ILAC Mutual Recognition
Arrangement (MRA) that has demonstrated competence to ISO/IEC
17011:2017;
    (b) Meet, with respect to activities under this subpart, the
requirements of ISO/IEC 17011:2017, which is incorporated by reference
(see Sec.  1.1113(b)); and
    (c) Demonstrate that it possesses sufficient scientific/technical
expertise to be able to:
    (1) Review the validation and verification studies required by
Sec.  1.1138(a)(1), including reviewing the verification studies for
fitness for purpose;
    (2) Assess an accredited laboratory's determination under Sec.
1.1148(a)(2) that no proficiency testing program is available or
practicable for a particular method of analysis; and
    (3) Assess whether the comparison program proposed by the
accredited laboratory under Sec.  1.1148(a)(2) would provide the
recognized accreditation body with the ability to monitor the quality
of the laboratory's performance to a degree comparable to a proficiency
test.
    (d) Comply with all of the additional requirements under this
subpart for recognized accreditation bodies.

Sec.  1.1119   What requirements apply to how a recognized
accreditation body must protect against conflicts of interests?

    (a) In addition to meeting the impartiality and conflict of
interest requirements of Sec.  1.1118(b), the recognized accreditation
body must:
    (1) Ensure 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 any laboratory (or any affiliate, parent, or
subsidiary) it accredits; and
    (2) Prohibit, subject to the exceptions in paragraph (b) of this
section, officers, employees, or other agents involved in accreditation
activities of the recognized accreditation body from accepting any
money, gift, gratuity, or other item of value from any laboratory they
accredit or that is seeking their accreditation that conducts food
testing.
    (b) The prohibited items of value specified in paragraph (a)(2) of
this section do not include:
    (1) Money representing payment of fees for accreditation services
or reimbursement of direct costs associated with an onsite assessment
or reassessment of the laboratory; or
    (2) Lunch of de minimis value provided during the course of an
assessment or reassessment and on the premises where the assessment or
reassessment is conducted, if necessary to facilitate the efficient
conduct of the assessment or reassessment.
    (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 are
considered the financial interests of such officers, employees, and
other agents involved in accreditation activities.

Sec.  1.1120   How must a recognized accreditation body evaluate
laboratories seeking accreditation and oversee the performance of
laboratories it accredits?

    (a) A recognized accreditation body must conduct an initial
assessment of a laboratory seeking accreditation in accordance with the
requirements of Sec.  1.1118(b), to determine whether the laboratory
meets the requirements of Sec.  1.1138.
    (b) Subject to the exception in paragraph (c) of this section, the
initial assessment must be conducted onsite, although certain
assessment activities may be conducted remotely if it will not aid the
assessment to conduct them onsite.
    (c) If, within the previous 2 years, the accreditation body
conducted an onsite assessment of the laboratory in accordance with
ISO/IEC 17011:2017 to assess whether the laboratory meets the
requirements of ISO/IEC 17025:2017, then the initial assessment under
this section:
    (1) May be conducted remotely, and
    (2) Need only address whether the laboratory meets the requirements
of Sec.  1.1138(a)(1) and (c).
    (d) A recognized accreditation body must oversee the performance of
a laboratory it accredits in accordance with the applicable
requirements of Sec.  1.1118(b), except as otherwise provided by this
subpart, to determine whether the accredited laboratory continues to
meet the applicable requirements of this subpart.
    (e) The assessment of the sample of the scope of accreditation of
the accredited laboratory, which the recognized accreditation body must
conduct at least every 2 years in accordance with Sec.  1.1118(b), must
be conducted onsite, although certain assessment activities may be
conducted remotely if it will not aid the assessment to conduct them
onsite.
    (f) If the recognized accreditation body conducted the initial
assessment of the laboratory remotely in accordance with paragraph (c)
of this section, the recognized accreditation body must conduct its
first assessment of the sample of the scope of accreditation of the
accredited laboratory no later than 2 years after the recognized
accreditation body last conducted an onsite assessment of the
laboratory in accordance with ISO/IEC 17011:2017 to assess whether the
laboratory meets the requirements of ISO/IEC 17025:2017.
    (g) The reassessment at the end of the accredited laboratory's
accreditation cycle, which the recognized accreditation body must
conduct in accordance with Sec.  1.1118(b), must be conducted onsite,
although certain assessment activities may be conducted remotely if it
will not aid the assessment to conduct them onsite.
    (h) Any assessments conducted by a recognized accreditation body
that are in addition to the assessments referred to in paragraphs (a),
(e), and (g) of this section may be conducted remotely if it will not
aid the assessment to conduct them onsite.

Sec.  1.1121   What appeal procedures must a recognized accreditation
body provide for appeals of decisions to not grant accreditation?

    A laboratory may appeal a decision by the recognized accreditation
body to not grant the accreditation (in-whole or in-part) that the
laboratory sought, and the recognized accreditation body must consider
the appeal in accordance with the requirements of Sec.  1.1118(b). In
addition to meeting the requirements of Sec.  1.1118(b) relating to
appeals, the recognized accreditation body must make the appeals
procedures publicly available. It must also establish and implement
written procedures to use a competent person(s) who may or may not be
external to the recognized accreditation body, who is free from bias or
prejudice and has not participated in the accreditation decision and is
not the subordinate of a person who participated in the accreditation
decision, to review and decide appeals.

Sec.  1.1122   When must a recognized accreditation body withdraw or
reduce the scope of the accreditation of a laboratory, and when may a
recognized accreditation body put an accredited laboratory on
probation?

    (a) Grounds for withdrawal of accreditation. A recognized
accreditation body must withdraw the accreditation of a laboratory it
accredits when the accredited laboratory substantially fails to comply
with this subpart.
    (b) Grounds for probation. If a recognized accreditation body
determines that an accredited laboratory it accredits demonstrates
deficiencies in performing its functions under this subpart that are
less serious than those identified in paragraph (a) of this section,
and it is reasonably likely that the accredited laboratory will be able
to correct such deficiencies within a specified period of time, the
recognized accreditation body may temporarily put the accredited
laboratory on probation.
    (c) Withdrawal in-part. When there are grounds for withdrawal of
accreditation of an accredited laboratory that the recognized
accreditation body accredits, but the deficiencies affect only certain
methods within the accredited laboratory's scope of accreditation, the
recognized accreditation body may withdraw the accredited laboratory's
accreditation for only for those affected methods.
    (d) Records request associated with withdrawal of accreditation or
probation. To assist the recognized accreditation body in determining
whether a withdrawal of accreditation (in-whole or in-part) or
probation is warranted under paragraph (a), (b), or (c) of this
section, the recognized accreditation body may require from a
laboratory that it accredits the submission of records that the
accredited laboratory is required to maintain under Sec.  1.1153.
    (e) Notification of withdrawal of accreditation. The recognized
accreditation body must notify the laboratory of the withdrawal (in-
whole or in-part) of the laboratory's accreditation, and such
notification must:
    (1) Specify whether the withdrawal of accreditation is in-whole or
in-part, and if it is in-part, to which method or methods it applies;
    (2) Describe the grounds for withdrawal; and
    (3) State the procedures for appealing the withdrawal.
    (f) Notification of probation. The recognized accreditation body
must notify the laboratory of the laboratory's probation, and such
notification must:
    (1) Describe the grounds for the probation;
    (2) Identify all deficiencies that the laboratory must correct for
the recognized accreditation body to lift the probation; and either
    (i) Inform the laboratory that it has a specific timeframe to take
particular corrective actions with respect to the deficiencies
identified by the recognized accreditation body, or
    (ii) Require the laboratory to submit a plan to the recognized
accreditation body for approval that identifies the appropriate
corrective actions the laboratory will take to resolve the deficiencies
identified by the recognized accreditation body, and identify
appropriate timeframes for resolution; and
    (g) Consequences of probation or withdrawal of accreditation, in-
whole or in-part. If the recognized accreditation body withdraws the
accreditation of a laboratory in-whole, the laboratory is immediately
ineligible to conduct food testing under this subpart. If the
recognized accreditation body withdraws the accreditation of a
laboratory in-part, the laboratory is immediately ineligible to conduct
food testing under this subpart with respect to only the specific
method or methods for which accreditation was withdrawn. An accredited
laboratory that is put on probation by an accreditation body is
permitted to continue to conduct food testing under this subpart.
    (h) Appeals procedures. A laboratory may appeal a decision by the
recognized accreditation body to withdraw the accreditation (in-whole
or in-part) of the laboratory, and the recognized accreditation body
must consider the appeal in accordance with Sec.  1.1118(b). In
addition to meeting the requirements of Sec.  1.1118(b) related to
appeals, the recognized accreditation body must establish and implement
written procedures to:
    (1) Make the appeals procedures publicly available; and
    (2) Use a competent person or 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 withdrawal decision, and
are not the subordinate of a person who participated in the withdrawal
decision, to review and decide appeals.

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

    (a) General requirements. All reports and notifications required by
this section to be submitted to FDA must be submitted to FDA
electronically and in English, and include:
    (1) The name, street address, telephone number, and email address
of the accreditation body associated with the report or notification,
and the name of an appropriate point-of-contact for the accreditation
body, and
    (2) If there is a laboratory associated with the report or
notification, the name, street address, telephone number, and email
address of the laboratory associated with the report or notification,
and the name of an appropriate point-of-contact for the laboratory.
    (b) Reporting results of recognized accreditation body internal
audits. A recognized accreditation body must submit to FDA a report of
the results of the internal audit it is required to conduct pursuant to
Sec.  1.1118(b), including results of the audit of its compliance with
the requirements of Sec.  1.1118(c) and (d), conducted pursuant to
Sec.  1.1125, no later than 45 days after completing such internal
audit, and the report must include:
    (1) A description of the internal audit conducted;
    (2) A description of any identified deficiencies;
    (3) A description of any corrective actions taken and any
corrective action the recognized accreditation body will take,
including the timeline for such corrective actions; and
    (4) A statement disclosing the extent to which the internal audit
was conducted by personnel different from those who perform the
activity or activities that were audited.
    (c) Immediate notification to FDA. A recognized accreditation body
must immediately, within 48 hours, notify FDA when the recognized
accreditation body:
    (1) Is aware of a change that would affect the recognition of such
accreditation body, and the notification must include:
    (i) A description of the change, and
    (ii) If the change is one made by the recognized accreditation
body, an explanation of the purpose of the change;
    (2) Grants accreditation of a laboratory, and the notification must
include:
    (i) The scope of accreditation requested by the laboratory,
    (ii) The scope of accreditation granted, and
    (iii) The date on which accreditation was granted;
    (3) Denies accreditation (in-whole or in-part) of a laboratory, and
the notification must include:
    (i) The scope of accreditation requested by the laboratory,

    (ii) The scope of accreditation denied, and
    (iii) The grounds for the denial;
    (4) Receives notice that an accredited laboratory it accredited
intends to relinquish its accreditation (in-whole or in-part), and the
notification must include:
    (i) The scope of accreditation to which the relinquishment applies,
as applicable, and
    (ii) The effective date of the relinquishment;
    (5) Withdraws (in-whole or in-part) the accreditation of a
laboratory; and the notification must include:
    (i) The scope of accreditation to which the withdrawal applies, and
    (ii) The grounds for the withdrawal;
    (6) Puts an accredited laboratory on probation, and the
notification must include:
    (i) The grounds for the probation, and
    (ii) Any date by which the recognized accreditation body has
determined the accredited laboratory must take appropriate corrective
action; and
    (7) Knows that an accredited laboratory it accredits has committed
fraud or submitted material false statements to FDA, and the
notification must include:
    (i) A description of the basis for the accreditation body's
knowledge of the fraud or material false statements,
    (ii) A description of the alleged fraud or material false
statements, and
    (iii) The actions taken by the recognized accreditation body with
respect to such laboratory.

Sec.  1.1124   What records requirements must a recognized
accreditation body meet?

    (a) In addition to meeting the requirements of Sec.  1.1118(b)
related to records, a recognized accreditation body must maintain
electronically, for 5 years after the date of creation of the records,
records created while it is recognized demonstrating its compliance
with this subpart, including records relating to:
    (1) Applications for accreditation;
    (2) Assessments, reassessments, and decisions to grant, renew,
deny, withdraw, expand, or reduce the scope of an accreditation or
place an accredited laboratory on probation;
    (3) Appeals of probation and denials and withdrawals of
accreditation, final decisions on such appeals, and the bases for such
final decisions;
    (4) Its oversight of accredited laboratories it accredited;
    (5) Its oversight of its own performance, including all records
related to internal audits, complaints, and corrective actions;
    (6) Any reports or notifications required to be submitted to FDA
under Sec.  1.1123, including any supporting information; and
    (7) Records of fee payments and reimbursement of direct costs.
    (b) An accreditation body that has been recognized must make
records it is required to maintain under paragraph (a) of this section
available to FDA for inspection and copying promptly upon written
request by 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) A recognized accreditation body must not prevent or interfere
with FDA's access to the records the accredited laboratories it
accredits are required to maintain under Sec.  1.1153.

Sec.  1.1125  What internal audit requirements must a recognized
accreditation body meet?

    As part of the internal audit a recognized accreditation body is
required to conduct pursuant to Sec.  1.1118(b), the recognized
accreditation body must audit its compliance with the requirements of
Sec.  1.1118(c) and (d).

Procedures for Recognition of Accreditation Bodies

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

    (a) Applicant for recognition. An accreditation body seeking
recognition must submit an application to FDA demonstrating that it
meets the eligibility requirements in Sec.  1.1113.
    (b) Applicant for renewal of recognition. An accreditation body
seeking renewal of its recognition must submit a renewal application
demonstrating that it continues to meet the requirements of this
subpart.
    (c) Documentation of conformance with requirements. The
accreditation body must submit documentation of conformance with ISO/
IEC 17011:2017 and separate documentation of ILAC MRA signatory status
demonstrating competence to ISO/IEC 17011:2017, in meeting the
requirements of Sec.  1.1113(a) and (b) or Sec.  1.1118(a) and (b), as
applicable. The accreditation body also must submit documentation of
its compliance with Sec.  1.1113(c) and (d) or Sec.  1.1118(c) and (d),
as applicable.
    (d) Submission. An accreditation body must submit recognition and
renewal applications and any documents provided as part of the
application process to FDA electronically, in English. The applicant
must provide any translation and interpretation services needed by FDA
during the processing of the application, including during any onsite
assessments of the applicant by FDA.
    (e) Signature. An accreditation body must sign the recognition and
renewal applications in the manner designated by FDA. Recognition and
renewal application must be signed by the applicant or by an individual
authorized to act on behalf of the applicant for purposes of seeking
recognition or renewal of recognition.

Sec.  1.1129   How will FDA review applications for recognition and
applications for renewal of recognition?

    (a) Review of application for recognition or renewal of
recognition. FDA will examine an accreditation body's application for
recognition or renewal of recognition for completeness and notify the
applicant of any deficiencies. FDA will review an accreditation body's
application for recognition or renewal of recognition 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 program needs.
    (b) Evaluation of application for recognition or renewal of
recognition. FDA will evaluate any submitted application for
recognition or renewal of recognition to determine whether the
applicant meets the requirements for recognition. 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 the existing term of recognition for a specified period of time
or until FDA reaches a final decision on the renewal application.
    (c) Issuance of recognition. FDA will notify the applicant that its
application for recognition or renewal of recognition has been approved
through issuance of recognition that will list any conditions
associated with the recognition.
    (d) Duration of recognition. FDA may grant recognition of an
accreditation body for a period not to exceed 5 years

from the date of recognition, except under the circumstances described
in paragraph (b) of this section.
    (e) Issuance of denial of application for recognition or renewal of
recognition. If FDA denies an applicant's application for recognition
or renewal of recognition, FDA will notify the applicant, through an
issuance of a notification of denial of recognition or denial of
renewal of recognition. The notification of denial of recognition or
denial of renewal of recognition will state the basis for such denial
and describe the procedures for requesting reconsideration of the
application under Sec.  1.1171.
    (f) Notice of records custodian after denial of an application for
renewal of recognition. An applicant whose application for renewal of
recognition was denied by FDA must notify FDA electronically, in
English, within 10 business days of the date of issuance of a denial of
a renewal application, of the name and contact information of the
custodian who will maintain the records required by Sec.  1.1124 and
make them available to FDA as required by Sec.  1.1124. The contact
information for the custodian must include, at a minimum, an email
address and the street address where the records required by Sec.
1.1124 will be located.
    (g) FDA notice to accredited laboratories. FDA will promptly issue
a notice of the denial of the application for renewal of recognition of
the accreditation body to all laboratories accredited by the
accreditation body whose application for renewal of recognition was
denied.
    (h) Public notice of denial of an application for renewal of
recognition of an accreditation body. FDA will provide public notice on
the website described in Sec.  1.1109 of the issuance of a denial of a
renewal application and will include the date of the issuance of the
denial of a renewal application.

Sec.  1.1130   How will FDA oversee recognized accreditation bodies?

    (a) FDA will assess each recognized accreditation body to determine
its compliance with the applicable requirements of this subpart. Such
assessment will 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. An FDA assessment of a
recognized accreditation body may include review of records, an onsite
assessment of the accreditation body, and onsite assessments of one or
more accredited laboratories the recognized accreditation body
accredits, with or without the recognized accreditation body present.
    (b) FDA may conduct additional assessments of a recognized
accreditation body at any time to determine the recognized
accreditation body's compliance with the applicable requirements of
this subpart.

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

    (a) Grounds for revocation of recognition. FDA will revoke the
recognition of an accreditation body if it fails to meet the
requirements of this subpart, or where FDA determines the accreditation
body has committed fraud or submitted material false statements to FDA.
    (b) Issuance of revocation. (1) FDA will notify the accreditation
body that its recognition has been revoked through the issuance of a
revocation that will state the grounds for revocation, the procedures
for requesting a regulatory hearing under Sec.  1.1173 on the
revocation, and the procedures for requesting reinstatement of
recognition under Sec.  1.1133.
    (2) Within 10 business days of the date of issuance of revocation,
the accreditation body must notify FDA electronically, in English, of
the name of the custodian who will maintain records and make them
available to FDA as required by Sec.  1.1124. The contact information
for the custodian must provide, at a minimum, an email address and the
street address where the records will be located.
    (c) Grounds for probation. If FDA determines that a recognized
accreditation body has demonstrated deficiencies in performing its
functions that are less serious and more limited than those identified
in paragraph (a) of this section, and it is reasonably likely that the
accreditation body will be able to correct such deficiencies within a
reasonable period of time, FDA may temporarily put the recognized
accreditation body on probation and request that the accreditation body
take appropriate corrective actions.
    (d) Length of probation. FDA's probation of an accreditation body's
recognition shall remain in effect until the accreditation body
demonstrates to FDA's satisfaction that the accreditation body has
successfully implemented appropriate corrective actions to address the
deficiencies specified by FDA within the time period identified by FDA,
or until FDA revokes the recognition of the accreditation body.
    (e) Notification of probation. FDA will notify the accreditation
body of its probation and such notification will:
    (1) Describe the grounds for the probation;
    (2) Identify all deficiencies that must be corrected for FDA to
lift the probation and identify a specified period of time to take
corrective actions to address the deficiencies specified by FDA.
    (f) Effect of revocation of recognition or probation on the
accreditation body. (1) An accreditation body that has had its
recognition revoked by FDA may not accredit laboratories under this
subpart or continue to oversee the laboratories it has previously
accredited.
    (2) A recognized accreditation body that is put on probation by FDA
will be expected to continue to oversee laboratories that it has
accredited under this subpart and is permitted to continue to accredit
laboratories under Sec.  1.1120 of this subpart.
    (g) FDA notice to the accredited laboratories. FDA will issue a
notice of the probation or revocation of recognition to all
laboratories accredited by the recognized accreditation body that was
put on probation or the accreditation body whose recognition was
revoked.
    (h) Public notice of probation or revocation of recognition. FDA
will provide notice on the website described in Sec.  1.1109 of the
issuance of the probation or revocation of recognition of an
accreditation body.

Sec.  1.1132   What must a recognized accreditation body do if it wants
to voluntarily relinquish its recognition or does not want to renew its
recognition?

    (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 its recognition or before allowing its 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.  1.1124 after the date of
relinquishment or the date recognition expires, as applicable, and make
them available to FDA as required by Sec.  1.1124. The contact
information for the custodian must include, at a minimum, an email
address and the street address where the records required by Sec.
1.1124 will be located.
    (b) Notice to accredited laboratories of intent to relinquish or
not to renew recognition. At least 60 days before voluntarily
relinquishing its recognition

or before allowing its recognition to expire without seeking renewal, a
recognized accreditation body must notify the laboratories it
accredited of its intention to leave the program, specifying the date
on which relinquishment or expiration will occur.
    (c) Public notice of voluntary relinquishment or expiration of
recognition. FDA will provide notice on the website described in Sec.
1.1109 of the voluntary relinquishment or expiration of recognition of
an accreditation body.

Sec.  1.1133   How does an accreditation body request reinstatement of
recognition?

    (a) Application following revocation of recogniion. An
accreditation body that has had its recognition revoked by FDA may seek
reinstatement by submitting a new application for recognition under
Sec.  1.1128. The accreditation body must also submit evidence to FDA
with its application that the grounds for revocation have been
resolved, including evidence addressing the cause(s) or condition(s)
that were the grounds for revocation and must identify measures that
have been implemented to help ensure that such cause(s) or condition(s)
are unlikely to recur.
    (b) Application following relinquishment or expiration of
recognition. An accreditation body that previously relinquished its
recognition or allowed its recognition to expire may seek recognition
by submitting a new application for recognition under Sec.  1.1128.

Accreditation of Laboratories

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

    (a) To become accredited by a recognized accreditation body, an
accredited laboratory must:
    (1) Demonstrate it is capable of conducting each method of food
testing for which it seeks to be accredited, by:
    (i) Submitting information to demonstrate appropriate verification
or validation of the method(s), including the information required by
Sec.  1.1151(c)(2) and (d)(2), and a statement by the laboratory based
on the verification or validation results of whether the laboratory is
able to properly apply the method; and
    (ii) Passing, or having passed within the past year, a proficiency
test for the method, subject to the exception that if the laboratory
determines there is no proficiency testing program available that
addresses the method, or that proficiency testing for the method is
otherwise impracticable, the accredited laboratory may instead subject,
or have subjected in the past year, the method to an appropriate
comparison program. The laboratory's determination must be reviewed by,
and approved or denied (as appropriate) by, the recognized
accreditation body from which the laboratory is seeking accreditation.
    (2) Except as provided in paragraph (b) of this section,
demonstrate it complies with ISO/IEC 17025:2017, ``General Requirements
for the Competence of Testing and Calibration Laboratories,'' Third
edition, November 2017. The Director of the Federal Register approves
this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part
51. The approved material is available for inspection at Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, and is available
from International Organization for Standardization (ISO), Chemin de
Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01
11, https://www.iso.org/home.html. It is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to www.archives.gov/federal-register/cfr/ibr-locations.
    (b) For purposes of this program the laboratory is not required to
satisfy the following provisions of ISO/IEC 17025:2017:
    (1) That relate to the relationship between the laboratory and its
customers, to the extent that such provisions establish obligations
that conflict with the requirements of this subpart;
    (2) In section 7: 7.3; or
    (3) In section 7: 7.8.
    (c) Demonstrate it is capable of meeting and operating in
conformance with all of this subpart's additional requirements for
accredited laboratories.

Requirements for Accredited Laboratories

Sec.  1.1146   What are the general requirements for accredited
laboratories to remain accredited?

    To remain accredited, the accredited laboratory must:
    (a) Be capable of conducting the methods of analysis for the
testing of food for which it is accredited;
    (b) Maintain conformance with the provisions of ISO/IEC 17025:2017,
``General Requirements for the Competence of Testing and Calibration
Laboratories,'' Third edition, November 2017. The Director of the
Federal Register approves this incorporation by reference under 5
U.S.C. 552(a) and 1 CFR part 51. The approved material is available for
inspection at Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-
827-6860, and is available from International Organization for
Standardization (ISO), Chemin de Blandonnet 8, 1214 Vernier, Geneva,
Switzerland; Telephone 41 22 749 01 11, https://www.iso.org/home.html.
It is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, email<EMAIL_ADDRESS>or go to
www.archives.gov/federal-register/cfr/ibr-locations. This requirement
is subject to the exceptions in Sec.  1.1138(b); and
    (c) Operate in conformance with the additional requirements of this
subpart.

Sec.  1.1147   What impartiality and conflict of interest requirements
must accredited laboratories meet?

    (a) In addition to the requirements relating to impartiality and
conflict of interest an accredited laboratory is required to meet under
Sec.  1.1146(b), the accredited laboratory must, subject to the
exceptions in paragraph (b) of this section, prohibit the accredited
laboratory's employees, contractors, and agents involved in food
testing and related activities from accepting any money, gift,
gratuity, or other item of value from the owner or consignee of the
food that is being tested or will be tested by the accredited
laboratory.
    (b) The prohibited items of value specified in paragraph (a) of
this section do not include:
    (1) Payment of fees for food testing services;
    (2) Reimbursement of direct costs associated with the food testing
by the accredited laboratory; and
    (3) With respect to accredited laboratories that are owned by the
owner or consignee of the food that is tested or to be tested, payment
of the officer's, employee's, contractor's, or agent's compensation in
the normal course of business.
    (c) The owner or consignee's payment to the accredited laboratory
of fees for food testing services and/or reimbursement of direct costs
associated with food testing must be independent of whether the test
results indicate that food is or appears to be violative.

Sec.  1.1148   What quality assurance requirements must accredited
laboratories meet?

    In addition to the requirements relating to quality assurance an
accredited laboratory is required to meet by Sec.  1.1146(b),
accredited labs must:

    (a) Meet the following proficiency testing requirements:
    (1) Accredited laboratories must participate in a proficiency
testing program or programs provided by a competent proficiency testing
organization, except as provided in paragraph (a)(2) of this section.
The accredited laboratory must ensure such proficiency testing is
conducted at least once per year for each method within the accredited
laboratory's scope of accreditation.
    (2) If the accredited laboratory determines there is no proficiency
testing program available that addresses a particular method of
analysis in the accredited laboratory's scope of accreditation, or that
participating in a proficiency testing program for the particular
method of analysis is otherwise impracticable, the accredited
laboratory may subject that method of analysis to an appropriate
comparison program. The determination must be reviewed, and approved or
denied (as appropriate), by the recognized accreditation body that
accredits the accredited laboratory.
    (b) Ensure its procedures for monitoring the validity of the
results of testing it conducts under this subpart include the use of
reference materials or quality control samples with each batch of
samples it tests under this subpart.

Sec.  1.1149   What oversight standards apply to sampling?

    (a) Before analyzing a sample, the accredited laboratory must
develop (if it collected the sample) or obtain (if another entity
collected the sample):
    (1) Written documentation of the sampler's applicable
qualifications by training and experience. An accredited laboratory
only needs to develop or obtain documentation of a sampler's
qualifications the first time that individual collects a sample under
this subpart, unless the accredited laboratory learns that the
sampler's qualifications have significantly changed since the
accredited laboratory last obtained documentation of the sampler's
qualifications;
    (2) A written sampling plan used to conduct the sampling. The
written sampling plan must identify the sampler and must list factors
that will be controlled to ensure the sampling does not impact the
validity of the subsequent analytical testing, including controlling
for the representational nature of the sample; and
    (3) A written sample collection report for each sample collected.
The written sample collection report must, at a minimum, include:
    (i) The product code of the food product sampled (if product is
being sampled) or the location of and a description of the environment
(if environment is being sampled);
    (ii) The date(s) of the sampling;
    (iii) The size, identity, and quantity of the sample(s);
    (iv) Documentation of sample collection procedures and any sample
preparation techniques; and
    (v) Documentation of the chain of custody of the sample(s), and of
measures taken, to not impact the validity of the subsequent analytical
testing, including controlling for the representational nature of the
sample(s).
    (b) If any of the requirements in paragraph (a) of this section are
not met, FDA may consider the analysis of the sample to be invalid.

Sec.  1.1150   What requirements apply to analysis of samples by an
accredited laboratory?

    In addition to meeting the requirements of Sec.  1.1146(b):
    (a) The analysis must be conducted on either the sample(s) received
from the sampler or, if appropriate, on a representative sample of the
sample(s) received from the sampler.
    (b) The analyst(s) that conducts the analysis must:
    (1) Be qualified by appropriate education, training, and/or
experience to conduct the analysis;
    (2) Have appropriately demonstrated their ability to perform the
method properly in the specific context of the food testing to be
conducted; and
    (3) Be in compliance with the conflict of interest requirements of
Sec. Sec.  1.1146(b) and 1.1147.
    (c) The method used to conduct the food testing must meet the
requirements of Sec.  1.1151.
    (d) The accredited laboratory must document the testing information
and test results to the extent necessary to account for all information
that is required to be included in a full analytical report (see Sec.
1.1152(g)).

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

    In addition to meeting the requirements of Sec.  1.1146(b), an
accredited laboratory must meet the following requirements:
    (a) Analysis under this subpart must be conducted using a method of
analysis that:
    (1) Is fit for purpose;
    (2) Is within the accredited laboratory's scope of accreditation;
    (3) Has been appropriately validated for use in such food testing,
in accordance with paragraph (c) of this section; and
    (4) Has been appropriately verified by the accredited laboratory
for use in such food testing, in accordance with paragraph (d) of this
section.
    (b) With respect to food testing conducted under:
    (1) Section 1.1107(a)(1), if the Federal Food, Drug, and Cosmetic
Act or implementing regulations prescribes a test method, that is the
only appropriate method that may be conducted for such food testing;
    (2) Section 1.1107(a)(2), if the food testing order prescribes a
test method, that is the only appropriate method that may be conducted
for such food testing.
    (c)(1) An accredited laboratory must validate methods in accordance
with the requirements of Sec.  1.1146(b).
    (2) An accredited laboratory performing validation of a method
under this subpart must record the information required by the
requirements of Sec.  1.1146(b), and the supporting analytical data.
    (d)(1) Before an accredited laboratory conducts food testing under
this subpart using a method for a specific intended use for which the
method has been validated, but for which the laboratory has not
previously applied the method under this subpart, the accredited
laboratory must have verified it can properly perform the method for
the specific intended use.
    (2) An accredited laboratory performing verification of a method
under this subpart must record the method that is the subject of the
verification, the intended purpose of the analysis, the results of the
verification, the procedure used for the verification, supporting
analytical data, and whether the accredited laboratory is able to
properly perform the method.
    (e) An accredited laboratory may submit a written request to FDA
requesting FDA's permission to use a method or methods outside of its
scope of accreditation for food testing. FDA may approve the request if
both following conditions are satisfied:
    (1) A new methodology or methodologies have been developed and
validated but no reasonably available laboratory has been accredited to
perform such methodology or methodologies, and
    (2) The use of such method or methods is necessary to prevent,
control, or mitigate a food emergency or foodborne illness outbreak.

Sec.  1.1152   What notifications, results, and reports must accredited
laboratories submit to FDA?

    (a) General requirements. (1) All notifications, results, reports,
and

studies required to be submitted to FDA by accredited laboratories
under this subpart must be submitted to FDA electronically and in
English, and:
    (i) Include the legal name and street address of the accredited
laboratory, identify a point-of-contact for the accredited laboratory
that FDA may contact with questions or comments regarding the
notification, result, report, or study, and include the email address
and telephone number of the point-of-contact;
    (ii) Display an identification unique to the test results, report,
notification, or study; and
    (iii) Be true, accurate, unambiguous, and objective.
    (2) The accredited laboratory that conducts the analysis of the
sample under this subpart is responsible for the submission of all
notifications, results, reports, and studies to FDA as required by this
section.
    (3) If the accredited laboratory that is responsible for the
submission of same becomes aware that any aspect of the submitted
material is inaccurate, the accredited laboratory must immediately
inform FDA and submit a corrected version. Such corrections must meet
the requirements for amendments to reports specified by ISO/IEC
17025:2017 section 7.8.8. ISO/IEC 17025:2017, ``General Requirements
for the Competence of Testing and Calibration Laboratories,'' Third
edition, November 2017. The Director of the Federal Register approves
this incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part
51. The approved material is available for inspection at Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, and is available
from International Organization for Standardization (ISO), Chemin de
Blandonnet 8, 1214 Vernier, Geneva, Switzerland; Telephone 41 22 749 01
11, https://www.iso.org/home.html. It is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to www.archives.gov/federal-register/cfr/ibr-locations.
    (4) Any opinions and interpretations in any notification, result,
report, or study submitted to FDA under this subpart must meet the
requirements in ISO/IEC 17025:2017 section 7.8.7 and any statements of
conformity to a specification or standard in any notification, result,
report, or study submitted to FDA under this subpart must meet the
requirements of ISO/IEC 17025:2017 section 7.8.6.
    (b) Test results. (1) The results of any and all tests conducted by
an accredited laboratory under this subpart must be submitted directly
to FDA.
    (2) The accredited laboratory must submit the results of testing
conducted under this subpart directly to FDA via the destination
specified by the website described by Sec.  1.1109, unless directed to
use a different method of submission by FDA regarding testing conducted
under Sec.  1.1107(a)(2) or (3).
    (3) The test results must be clear and identify the associated
notifications, reports, and studies required to be submitted with the
test results under this subpart.
    (c) Documentation required to be submitted with test results. The
following documentation must be submitted to FDA with each test result
submitted to FDA under this subpart:
    (1) All sampling plans and sample collection reports related to the
food testing conducted, as developed or obtained by the accredited
laboratory in accordance with Sec.  1.1149;
    (2) Written documentation of the sampler's qualifications, if Sec.
1.1149(a)(1) requires the accredited laboratory to obtain such
documentation;
    (3) The full analytical report required by paragraph (g) of this
section, documenting the analysis related to the food testing, except
that if the accredited laboratory is permitted in accordance with
paragraph (d) of this section to submit abridged analytical reports,
the accredited laboratory may instead submit an abridged analytical
report, which must contain the information required by paragraph (f) of
this section;
    (4) For any validation studies required by Sec.  1.1151(c)(1), the
documentation required by Sec.  1.1151(c)(2), except when the
circumstances of paragraph (c)(6) of this section apply with respect to
the validation study.
    (5) For any verification studies required by Sec.  1.1151(d)(1),
the documentation required by Sec.  1.1151(d)(2), except when the
circumstances of paragraph (c)(6) of this section apply with respect to
the verification study.
    (6) Paragraphs (c)(4) and (5) of this section do not require the
accredited laboratory to submit the validation or verification study to
FDA if the accredited laboratory submitted the validation or
verification study to its accreditation body as required by Sec.
1.1138(a)(1)(i). If the accredited laboratory submitted the validation
or verification study to its accreditation body as required by Sec.
1.1138(a)(1)(i), the accredited laboratory must instead submit to FDA,
in lieu of the validation or verification study, a statement that the
validation or verification study has been submitted to its recognized
accreditation body in accordance with Sec.  1.1138(a)(1)(i), and the
accredited laboratory must identify the method, analyte, and matrix
that were the subject of the validation or verification study;
    (7) A certification from one or more members of the accredited
laboratory's management certifying that the test results,
notifications, reports, and studies are true and accurate; and that the
documentation includes the results of all tests conducted under this
subpart. The certification must include the name, title, and signature
of the certifier(s).
    (d) Permission to submit abridged analytical reports. (1)
Accredited laboratories that are not disqualified under paragraphs
(d)(6)(i) and (d)(7) of this section or on probation are permitted to
submit to FDA on an ongoing basis abridged analytical reports relating
to a specific major food testing discipline(s) that is represented in
the reports described in paragraph (d)(1)(ii) of this section, after
FDA has given notice that the following conditions are fulfilled:
    (i) The accredited laboratory submits 10 consecutive full
analytical reports to FDA under this subpart;
    (ii) The consecutive full analytical reports include at least one
full analytical report relating to each major food testing discipline
for which the accredited laboratory seeks to submit abridged analytical
reports;
    (iii) None of the consecutive full analytical reports demonstrate
any material substantive shortcoming in the food testing; and
    (iv) The consecutive full analytical reports do not contain
repeated administrative deficiencies.
    (2)(i) Accredited laboratories that fail to satisfy the condition
in paragraph (d)(1)(iii) of this section are subject to the
disqualification period described in paragraph (d)(6)(i) of this
section.
    (ii) Accredited laboratories that fail to satisfy the condition in
paragraph (d)(1)(iv) of this section have a second attempt to satisfy
the conditions in paragraphs (d)(1)(i) to (iv) of this section with 10
subsequent consecutive full analytic reports. If one of those
subsequent consecutive full analytical reports demonstrate any material
substantive shortcoming in the food testing, or the subsequent
consecutive full analytical reports contain repeated administrative
deficiencies, the accredited laboratory is subject to the
disqualification period described in paragraph (d)(6)(i) of this
section.

    (3) Accredited laboratories that are not on probation and are
currently permitted to submit abridged analytical reports for at least
one major food testing discipline under this paragraph are permitted to
submit to FDA on an ongoing basis abridged analytical reports relating
to any additional major food testing disciplines that were not
represented in the reports described in paragraph (d)(1)(ii) of this
section, after FDA has given notice that the following conditions are
fulfilled:
    (i) The accredited laboratory submits to FDA at least one full
analytical report for each additional major food testing discipline for
which the accredited laboratory seeks to submit abridged analytical
reports;
    (ii) None of the full analytical reports for each additional major
food testing discipline demonstrate any material substantive
shortcoming in the food testing; and
    (iii) None of the full analytical reports for each additional major
food testing discipline contain repeated administrative deficiencies.
    (4)(i) Accredited laboratories that fail to satisfy the condition
in paragraph (d)(3)(ii) of this section for an additional major food
testing discipline(s) are subject to the disqualification period
described in paragraph (d)(6)(ii) of this section for such additional
major food testing discipline(s).
    (ii) Accredited laboratories that fail to satisfy the condition in
paragraph (d)(3)(iii) of this section for an additional major food
testing discipline(s) have a second attempt to satisfy the conditions
in paragraphs (d)(3)(i) to (iii) of this section with at least one full
analytic report for each additional major food testing discipline for
which the accredited laboratory is seeking to submit abridged
analytical reports. If that subsequent full analytical report(s)
demonstrates any material substantive shortcoming in the food testing,
or the subsequent full analytical report(s) contains repeated
administrative deficiencies, the accredited laboratory is subject to
the disqualification period described in paragraph (d)(6)(ii) of this
section for the major food testing discipline that was the subject of
the full analytical report containing the shortcoming or deficiencies.
    (5) If one or more test results, notifications, reports, and/or
studies relating to a specific major food testing discipline submitted
to FDA under this subpart by an accredited laboratory that is permitted
to submit abridged analytical reports for that major food testing
discipline demonstrates any material substantive shortcoming in the
related food testing or demonstrates repeated administrative
deficiencies, the accredited laboratory is disqualified to submit
abridged reports for that specific major food testing discipline in
accordance with either paragraph (d)(6)(ii) of this section (if the
accredited laboratory is permitted to submit abridged analytical
reports for another discipline) or paragraph (d)(6)(i) of this section
(if the accredited laboratory is not permitted to submit abridged
analytical reports for any another discipline).
    (6)(i) The period of disqualification is either 2 years or until
the accredited laboratory submits 20 more full analytical reports to
FDA under this subpart, whichever period of time is longer, after which
time the accredited laboratory may request permission under paragraph
(d)(7) of this section to fulfill the eligibility conditions under
paragraph (d)(1) of this section.
    (ii) The period of disqualification is either 2 years or until the
accredited laboratory submits two more full analytical reports to FDA
under this subpart, whichever period of time is longer, after which
time the accredited laboratory may request permission under paragraph
(d)(7) of this section to fulfill the eligibility conditions under
paragraph (d)(3) of this section.
    (iii) Whenever, during the period of disqualification described
under paragraph (d)(6)(i) or (ii) of this section, a full analytical
report submitted by an accredited laboratory demonstrates any material
substantive shortcoming in the food testing, that accredited
laboratory's disqualification period is extended by 6 months.
    (iv) Whenever, during the period of disqualification described
under paragraph (d)(6)(i) or (ii) of this section, the full analytical
reports submitted by an accredited laboratory contain repeated
administrative deficiencies, that accredited laboratory's
disqualification period is extended by 2 months.
    (7) An accredited laboratory that has fulfilled the conditions of
paragraph (d)(6)(i) or (ii) of this section, as applicable, and that is
not on probation, may submit a request to FDA via the destination
specified by the website described by Sec.  1.1109 to attempt to
fulfill the conditions as described in paragraphs (d)(1) and (3) of
this section, as applicable. FDA will consider permitting the
accredited laboratory to again try and fulfill the conditions of
paragraph (d)(1) or (3) of this section, as applicable. If FDA grants
permission and upon fulfillment of those conditions, FDA will provide
notice that the accredited laboratory is permitted to submit to FDA on
an ongoing basis abridged analytical reports relating to the
disciplines for which the conditions are fulfilled.
    (e) Exceptions to permission to submit abridged analytical reports.
(1) Occasionally, for the purposes of auditing abridged analytical
reports and otherwise protecting the public health and the integrity of
this food testing program, FDA will require that an accredited
laboratory that is permitted to submit abridged analytical reports
additionally submit to FDA the full analytical report within 48 hours
of FDA's notice.
    (2) FDA may require an accredited laboratory that is permitted to
submit abridged analytical reports under this subpart to submit full
analytical reports if such analytical reports relate to an FDA
investigation or FDA enforcement proceeding.
    (f) Abridged analytical report contents. Abridged analytical
reports must contain:
    (1) All information described by ISO/IEC 17025:2017 sections
<IP_ADDRESS>(a) through (p) and <IP_ADDRESS>(a) through (d). ISO/IEC 17025:2017,
``General Requirements for the Competence of Testing and Calibration
Laboratories,'' Third edition, November 2017. The Director of the
Federal Register approves this incorporation by reference under 5
U.S.C. 552(a) and 1 CFR part 51. The approved material is available for
inspection at Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-
827-6860, and is available from International Organization for
Standardization (ISO), Chemin de Blandonnet 8, 1214 Vernier, Geneva,
Switzerland; Telephone 41 22 749 01 11, https://www.iso.org/home.html.
It is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, email<EMAIL_ADDRESS>or go to
www.archives.gov/federal-register/cfr/ibr-locations; and
    (2) The justification for any modification or deviation to the
method(s) of analysis used and documentation of the accredited
laboratory's authorization for the modification or deviation.
    (g) Full analytical report contents. Full analytical reports must
contain:
    (1) All information described by paragraphs (f)(1) and (2) of this
section;
    (2) Documentation of references for the method or methods of
analysis used;
    (3) Identification of the analyst or analysts who conducted each
analytical step, validation step (if applicable), and verification step
(if applicable),

including the analyst's or analysts' legal name and signature, and the
date each analytical step, validation step (if applicable), and
verification step (if applicable) was performed;
    (4) Calculations, presented in a legible and logical manner;
    (5) As applicable, references to chromatograms; charts; graphs;
observations; photographs of thin layer chromatographic plates; and
spectra. References must be in color when appropriate and made in a
clear order;
    (6) Identification of the source and purity of reference standards
used, and, as applicable: Certified reference materials, certified
reference cultures traceable to a nationally or internationally
recognized type culture collection (including concentration, units
preparation, and storage conditions), and reference standard
preparation information (including who prepared the reference standard,
date of preparation, expiration date, chemical balance, and solvent
used);
    (7) A copy of the label from any immediate container sampled and
any additional labeling needed to evaluate the product;
    (8) All original compilations of raw data secured in the course of
the analysis, including discarded, unused or re-worked data, with the
justification for discarding or re-working such data, corresponding
supporting data, and quality control results all identified with unique
sample identification, date and time, associated with the test;
    (9) Any other relevant additional supporting information such as
the storage location of analyzed samples, appropriate attachments such
as instrument printouts, computer generated charts and data sheets, and
photocopies or original labels for the product analyzed;
    (10) Identification of any software used;
    (11) Any certificate or certificates of analysis for standards and
software; and
    (12) The following information about the qualifications of the
analyst or analysts who were involved in the analysis conducted under
this subpart, if the accredited laboratory has not previously submitted
documentation of the analyst's qualifications to FDA or the analyst's
qualifications have significantly changed since the accredited
laboratory last submitted documentation of the analyst's qualifications
to FDA:
    (i) The analyst's curriculum vitae;
    (ii) Training records with regards to methods that the analyst is
qualified to perform, including the dates of such training and the name
of the trainer or training provider;
    (iii) Any other documentation of the analyst's ability to perform
the method properly in the context of the food testing to be conducted,
pursuant to Sec.  1.1150(b); and
    (iv) Individual proficiency test worksheets relevant to the
analysis being performed.
    (h) Additional information about non-standard methods. If the
accredited laboratory conducts the analysis using a method that is not
published in a reputable international or national standard or that is
otherwise not publicly and readily available, upon request by FDA the
accredited laboratory must submit documentation of the method to FDA.
    (i) Advance notice of sampling. (1) If FDA determines that the
sampling conducted by a sampler may materially differ from the sampling
documented in the associated sampling plan or sample collection report,
or if FDA determines that the sampling may have been otherwise
improper, FDA may require the accredited laboratory that analyzed the
associated sample(s), and other accredited laboratories that have
analyzed samples collected by the sampler previously, to request and
receive from the sampler, and submit or require the sampler to submit,
an advance notice of sampling to FDA 48 hours before each of the next
10 occasions that the sampler will collect a sample that the accredited
laboratory will analyze under this subpart.
    (2) FDA may, as appropriate:
    (i) Specify the type of food product or environment that requires
advance notice of sampling under this subpart,
    (ii) Determine that an amount of time other than 48 hours in
advance is required, to a minimum of 24 hours and up to 7 business days
in advance, and
    (iii) Determine that a number of occasions other than 10 are
required, to a minimum of 1 occasion and up to a maximum of 20
occasions.
    (iv) Notify affected accredited laboratories that submission of
additional notices of sampling are not required.
    (3) The advance notice of sampling must contain:
    (i) A unique identification code for the advance notice of
sampling;
    (ii) The name of the accredited laboratory that will conduct
analysis of the sample;
    (iii) The name and street address of the sampler that will conduct
the sampling;
    (iv) A primary contact (name and phone number) for the sampler;
    (v) The reason(s) why the food product or environment will be
sampled;
    (vi) The location of the food product or environment that will be
sampled, including sufficient information to identify the food product
or environment to be sampled;
    (vii) As applicable, the U.S. Customs and Border Protection entry
and line number(s) and the FDA product code(s) of the food; and
    (viii) The date and approximate time the sampling will begin.
    (j) Immediate notification of significant changes. When any changes
occur that affect the accreditation of the accredited laboratory, the
accredited laboratory must immediately, within 48 hours, send FDA and
the accreditation body that accredited it notice of such changes, a
detailed description of such changes, and an explanation of how such
changes affect the accreditation of the accredited laboratory.
Accredited laboratories are not required to notify FDA of changes that
recognized accreditation bodies must provide notification of under
Sec.  1.1123(c).
    (k) Consequence of omission. If FDA does not receive all
information required to be submitted to FDA by paragraphs (a) through
(j) of this section, FDA may consider the related food testing to be
invalid.

Sec.  1.1153   What other records requirements must an accredited
laboratory meet?

    In addition to meeting the requirements of Sec.  1.1146(b) related
to records, laboratories that have been accredited must meet the
following requirements:
    (a) Maintain electronically, for 5 years after the date of
creation, records created and received while they are accredited that
relate to compliance with this subpart, including:
    (1) Documents related to the accredited laboratory's grant (and, if
applicable, expansions and reductions) of accreditation from its
recognized accreditation body;
    (2) Documentation of food testing the accredited laboratory
conducted under this subpart, in accordance with Sec.  1.1150(d);
    (3) All documents that the accredited laboratory was required to
submit to FDA under Sec.  1.1152, and associated correspondence by the
accredited laboratory (and its officers, employees, and other agents)
with the owner or consignee (and its officer, employees, and other
agents) of the tested food product or environment;
    (4) All requests for food testing from an owner or consignee that
would be conducted under this subpart;
    (5) Documentation of any internal investigations, internal audits,
and corrective actions taken to address any

problems or deficiencies related to activities under this subpart;
    (6) Any and all documentation related to probation or withdrawal
from accreditation under this subpart; and
    (7) Documentation of changes to its management system or food
testing activities that may affect its compliance with this subpart.
    (b) Within 30 days of the receipt of proficiency testing results,
submit the results:
    (1) To the recognized accreditation body that accredits the
accredited laboratory; and
    (2) If the accredited laboratory failed the proficiency test, to
FDA, via the destination specified by the website described by Sec.
1.1109.
    (c) Make the records required by paragraphs (a) and (b) of this
section available for inspection and copying upon written request of an
authorized officer or employee of FDA. The authorized officer or
employee of FDA may request that the laboratory that has been
accredited submit such records to FDA electronically or that the
laboratory make such records promptly available at the physical
location of the laboratory or at another reasonably accessible
location. If the authorized officer or employee of FDA requests the
records be submitted electronically, the records must be submitted
electronically not later than 10 business days after the date of the
request, except that records related to the immediate notification
provision in Sec.  1.1152(j) must be submitted within 48 hours.
Additionally, if the authorized FDA officer or employee requests
records that are maintained in a language other than English, the
laboratory that has been accredited must electronically submit an
English translation of the records to FDA within a reasonable time.
    (d) Ensure that significant amendments to records described by
paragraphs (a) and (b) of this section can be tracked to previous and
original versions. If such a significant amendment is made, both the
original document and amended document must be maintained by the
laboratory that has been accredited during the time period that the
amended document must be maintained under this subpart. The laboratory
must also document the date of amendment, the personnel responsible for
the amendment, and a conspicuous indication on the original document
stating that the document has been altered and a more recent version of
the document exists.

Procedures for Accreditation of Laboratories

Sec.  1.1158   How does a laboratory apply for accreditation or
modification of its scope of accreditation by a recognized
accreditation body?

    (a) Submission of application for accreditation to a recognized
accreditation body. A laboratory seeking accreditation must submit its
application for accreditation to a recognized accreditation body
identified on the website described in Sec.  1.1109. The recognized
accreditation body will review and assess the application in accordance
with the requirements of this subpart. If the laboratory seeking
accreditation had its accreditation (in-whole or in-part) withdrawn by
a recognized accreditation body or revoked by FDA the previous time it
was accredited under this subpart, the laboratory must meet the
additional requirements specified by Sec.  1.1165.
    (b) Documentation of conformance with ISO/IEC 17025:2017. The
laboratory may use documentation of conformance with ISO/IEC
17025:2017, as applicable and supplemented as necessary, in meeting the
applicable requirements of this subpart.
    (c) Duration of accreditation. If an accredited laboratory
maintains compliance with all requirements of this subpart including
maintaining accreditation to ISO/IEC 17025:2017, the laboratory's
accreditation does not end until withdrawn, revoked, or relinquished
under this subpart.

Sec.  1.1159   How will FDA oversee accredited laboratories?

    (a) FDA may assess accredited laboratories at any time to determine
whether the accredited laboratory continues to comply with the
applicable requirements of this subpart and whether there are
deficiencies in the performance of the accredited laboratory that, if
not corrected, would warrant probation or revocation of its
accreditation under Sec.  1.1161.
    (b) In evaluating the performance of an accredited laboratory under
paragraph (a) of this section, FDA may review any of the following:
    (1) Records the accredited laboratory is required to maintain under
this subpart;
    (2) Records the accreditation body that accredited the accredited
laboratory is required to maintain under this subpart;
    (3) Information obtained by FDA during an onsite assessment by FDA
of the accredited laboratory conducted pursuant to paragraph (c) of
this section;
    (4) Information obtained by FDA during an assessment of the
recognized accreditation body that accredited the laboratory; and
    (5) Any other information obtained by FDA, including during FDA's
inspections or investigations of one or more owners or consignees of
food subject to food testing under this subpart.
    (c) FDA may conduct an onsite assessment of an accredited
laboratory at any reasonable time, with or without a recognized
accreditation body (or its officers, employees, and other agents)
present, to assess an accredited laboratory.
    (d) FDA will report any of its observations and findings of its
assessment to the accredited laboratory's recognized accreditation
body.

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

    (a) If FDA finds that any test result, analytical report, related
documents, or the associated analysis contains deficiencies or
otherwise indicates that any aspect of the food testing is not being
conducted in compliance with this subpart, FDA:
    (1) May consider the analysis to be invalid; and/or
    (2) Will notify the accredited laboratory that appears to be
responsible for the deficiency and may also notify the owner or
consignee of the food of the deficiency. When we notify the accredited
laboratory that appears to be responsible for the deficiency, the
accredited laboratory must respond, in writing, to FDA regarding the
deficiency within 30 days or an agreed-upon timeframe, including a
statement with respect to how the accredited laboratory intends to
address the deficiency, and/or a statement describing the extent to
which the laboratory has addressed the deficiency.
    (b) FDA may report FDA's determinations of any deficiencies
resulting from its review of any test results, reports, and related
documents under this subpart to the recognized accreditation body that
accredits the accredited laboratory.
    (c) If the deficiency in the test result, analytical report, and/or
associated analysis demonstrates a material substantive shortcoming in
the related food testing or demonstrates repeated administrative
deficiencies, FDA will also consider whether disqualification from
being eligible for permission to submit abridged analytic reports under
Sec.  1.1152(d), and/or other action under this subpart, is
appropriate.
    (d) Nothing in this subpart shall be construed to limit the ability
of FDA to review and act upon information

received about food testing, including determining the sufficiency of
such information and testing.

Sec.  1.1161   When will FDA put an accredited laboratory on probation
or revoke the accreditation of a laboratory?

    (a) Grounds for revocation of accreditation. FDA may revoke the
accreditation (in-whole or in-part) of an accredited laboratory to
conduct food testing under this subpart for good cause, which may
include any of the following reasons:
    (1) Demonstrated bias or lack of objectivity when conducting food
testing under this subpart where the laboratory's recognized
accreditation body fails to withdraw accreditation of the laboratory.
    (2) Performance that calls into question the validity or
reliability of its food testing under this subpart where the
laboratory's recognized accreditation body fails to withdraw
accreditation of the laboratory.
    (3) Other failure to substantially comply with this subpart where
the laboratory's recognized accreditation body fails to withdraw
accreditation of the laboratory.
    (b) Grounds for probation. If FDA determines that an accredited
laboratory has demonstrated deficiencies in performing its functions
that are less serious and more limited than those identified in
paragraph (a) of this section, and it is reasonably likely that the
accredited laboratory will be able to correct such deficiencies within
a specified period of time, FDA may temporarily put the accredited
laboratory on probation and request that the laboratory take
appropriate corrective actions.
    (c) Revocation in-part. When there are grounds for revocation of
accreditation of a laboratory, but the deficiencies affect only certain
methods within the accredited laboratory's scope of accreditation, FDA
may revoke the accredited laboratory's accreditation only for those
affected methods.
    (d) Length of probation. FDA's probation of a laboratory's
accreditation shall remain in effect until the laboratory demonstrates
to FDA's satisfaction that the laboratory has successfully implemented
appropriate corrective actions, or until FDA determines that revocation
of accreditation is warranted.
    (e) Notice to the accredited laboratory of revocation of
accreditation. FDA will notify a laboratory and its accreditation body
of the revocation of its accreditation through issuance of a revocation
notice that will state:
    (1) The grounds for revocation;
    (2) Whether the revocation of accreditation is in-whole or in-part,
and if it is in-part, to which method or methods it applies;
    (3) The procedures for requesting a regulatory hearing under Sec.
1.1173 on the revocation; and
    (4) The procedures for requesting reinstatement of accreditation
under Sec.  1.1165.
    (f) Notification of probation. FDA will notify a laboratory and its
accreditation body of the probation and such notification will:
    (1) Describe the grounds for the probation; and
    (2) Identify all deficiencies that must be corrected for FDA to
lift the probation; and will either:
    (i) Inform the laboratory that the laboratory has a specified time
period to take corrective actions specified by FDA; or
    (ii) Request that the laboratory submit a corrective action plan to
FDA for FDA's approval that identifies the corrective actions it will
take to address deficiencies identified in the notice and identify
timeframes for completion.
    (g) Revocation following probation. FDA may revoke (in-whole or in-
part) the accreditation of a laboratory that has been put on probation
if FDA determines that the laboratory is not implementing appropriate
corrective actions.
    (h) Public notice of probation or revocation of accreditation. FDA
will provide notice on the website described in Sec.  1.1109 of
probation or revocation of accreditation of a laboratory.

Sec.  1.1162   What are the consequences if FDA puts an accredited
laboratory on probation or revokes the accreditation of a laboratory?

    (a) If FDA revokes the accreditation of a laboratory in-whole, the
laboratory is immediately ineligible to conduct food testing under this
subpart. If FDA revokes the accreditation of a laboratory in-part, the
laboratory is immediately ineligible to use the methods that are
subject to the revocation to conduct food testing under this subpart.
An accredited laboratory that is put on probation by FDA is permitted
to continue to conduct food testing under this subpart.
    (b) With respect to food testing conducted by the laboratory prior
to the revocation of accreditation, FDA may refuse to consider specific
food testing results and associated reports of food testing conducted
under this subpart by the laboratory if the basis for the revocation of
accreditation of the laboratory indicates that the specific food
testing conducted by the laboratory may not be reliable.
    (c) Within 10 business days of the date of issuance of revocation,
the laboratory must notify FDA electronically, in English, of the name
of the custodian who will maintain the records required by Sec.
1.1153, 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.
    (d) Within 10 business days of the date of issuance of probation or
revocation, the laboratory must notify any owners or consignees that it
is conducting food testing on behalf of under this subpart that it is
on probation or its accreditation has been revoked.

Sec.  1.1163   What if a laboratory wants to voluntarily relinquish its
accreditation?

    (a) Notice to FDA and the recognized accreditation body of intent
to relinquish. An accredited laboratory must notify FDA electronically,
in English, and must notify its recognized accreditation body at least
60 days before voluntarily relinquishing accreditation (in-whole or in-
part). The notice must include the date on which relinquishment will
occur. If the relinquishment is of the laboratory's accreditation in-
whole, the notification must also include the name and contact
information of the custodian who will maintain the records required
under Sec.  1.1153 after the date of relinquishment, and the laboratory
must make such records available to FDA as required by Sec.  1.1153.
The contact information for the custodian must include, at a minimum,
an email address and the street address where the records required by
Sec.  1.1153 will be located.
    (b) Public notice of voluntary relinquishment of accreditation. FDA
will provide notice on the website described in Sec.  1.1109 of the
voluntary relinquishment of accreditation of a laboratory.

Sec.  1.1164   What is the effect on accredited laboratories if their
accreditation body voluntarily or involuntarily loses its recognition?

    (a) If an accreditation body has its recognition revoked,
relinquishes its recognition, allows its recognition to expire, or has
its application for renewal of recognition denied, the laboratory
accredited by the accreditation body must take the following actions
(subject to the exception in paragraph (b) of this section):
    (1) No later than 30 days after FDA issues the notice to the
accredited laboratory under Sec.  1.1129, Sec.  1.1130, or Sec.  1.1131
that the accreditation body that accredits the laboratory has had its

recognition revoked, has relinquished its recognition, has allowed its
recognition to expire, or has had its application for renewal of
recognition denied, the accredited laboratory submits to FDA
documentation of the accredited laboratory's most recent internal
audit, which all accredited laboratories are required to maintain under
Sec.  1.1153(a)(5), documentation showing compliance with the conflict
of interest requirements in Sec.  1.1147, and documentation of the most
recent proficiency test for each test method for which the laboratory
is accredited under this subpart, to show compliance with Sec.
1.1138(a)(1)(ii); and
    (2) No later than 1 year after FDA issues the applicable notice
under Sec.  1.1129, Sec.  1.1130, or Sec.  1.1131 to the accredited
laboratory, the laboratory becomes accredited under this subpart by a
recognized accreditation body.
    (b) The accredited laboratory does not have to comply with
paragraph (a) of this section if, no later than 15 days after FDA
issues the applicable notice to the accredited laboratory under Sec.
1.1129, Sec.  1.1130, or Sec.  1.1131, the accredited laboratory
initiates relinquishment of its accreditation in-whole under Sec.
1.1163, with the relinquishment to occur within no more than 90 days.

Sec.  1.1165   How does a laboratory request reinstatement of
accreditation?

    (a) Application following withdrawal of accreditation by a
recognized accreditation body or revocation of accreditation by FDA. A
laboratory that had its accreditation (in-whole or in-part) withdrawn
by a recognized accreditation body or revoked by FDA may seek
reinstatement of accreditation by submitting a new application for
accreditation (in-whole or in-part, as applicable) to a recognized
accreditation body under Sec.  1.1158, and the laboratory must also:
    (1) Notify FDA, before it submits the new application for
accreditation to the recognized accreditation body, that the laboratory
will be submitting a new application for accreditation to the
recognized accreditation body, including in the notification the legal
name of the laboratory, valid contact information for the laboratory,
the legal name of the recognized accreditation body the laboratory will
be submitting the application to, and the date that the laboratory
expects to submit the new application for accreditation; and
    (2) Demonstrate, to the satisfaction of the recognized
accreditation body it is submitting the new application to, that the
grounds for the withdrawal of accreditation have been resolved and that
the laboratory has implemented measures to prevent such grounds from
recurring.
    (b) Application following voluntary relinquishment of
accreditation. A laboratory that voluntarily relinquished its
accreditation (in-whole or in-part), pursuant to Sec.  1.1163, may seek
reaccreditation by submitting a new application for accreditation to a
recognized accreditation body under Sec.  1.1158.

Requesting FDA Reconsideration, FDA Internal Review, or Regulatory
Hearings of FDA Decisions Under This Subpart

Sec.  1.1171   How does an accreditation body request reconsideration
by FDA of a decision to deny its application for recognition, renewal,
or reinstatement?

    (a) Timing of request. An accreditation body may seek
reconsideration of FDA's decision to deny its 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) Submission of request. The request to reconsider an application
under paragraph (a) of this section must be signed by the accreditation
body, as appropriate, or by an individual authorized to act on its
behalf. The accreditation body must submit the request to FDA
electronically, in English, and in accordance with the procedures
described in the notice of denial.
    (c) Notification of FDA's decision. After completing its review and
evaluation of the request for reconsideration and any supporting
information submitted pursuant to paragraph (b) of this section, FDA
will notify the accreditation body of its decision to grant recognition
upon reconsideration or deny recognition upon reconsideration.

Sec.  1.1173   How does an accreditation body or laboratory request a
regulatory hearing on FDA's decision to revoke the recognized
accreditation body's recognition or revoke the accredited laboratory's
accreditation?

    (a) Request for hearing. No later than 10 business days after the
date FDA issued a revocation of recognition of an accreditation body
pursuant to Sec.  1.1131 or revocation of accreditation of a laboratory
pursuant to Sec.  1.1161, the accreditation body, laboratory, or an
individual authorized to act on the accreditation body's or
laboratory's behalf, may submit a request for a regulatory hearing,
conducted pursuant to part 16 of this chapter, on the revocation. The
notice of revocation issued under Sec.  1.1131 or Sec.  1.1161, as
applicable, will contain all the elements required by Sec.  16.22(a) of
this chapter and will thereby constitute the notice of an opportunity
for hearing under part 16 of this chapter.
    (b) Submission of request for regulatory hearing. The request for a
regulatory hearing under this subpart must be submitted with a written
appeal that responds to the bases for the FDA decision described in the
written notice of revocation, together with any supporting information
upon which the requestor is relying. The request, appeal, and
supporting information must be submitted to FDA electronically, in
English, in accordance with the procedures described in the notice of
revocation.
    (c) Effect of submitting a request for a regulatory hearing on an
FDA decision. The submission of a request for a regulatory hearing
under this subpart will not operate to delay or stay the effect of a
decision by FDA to revoke recognition of an accreditation body or
revoke the accreditation of laboratory unless FDA determines that delay
or a stay is in the public interest.
    (d) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a request for a
regulatory hearing is submitted to FDA.
    (e) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec.  16.26(a) of this chapter when no genuine or
substantial issue of fact has been raised.
    (f) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, 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 the
accreditation body, laboratory, and the presiding officer and FDA.
    (2) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec.  16.5(b) of
this chapter, the procedures for a regulatory hearing apply only to the
extent that such procedures are supplementary and do not conflict with
the procedures specified for regulatory hearings under this subpart.
Accordingly, the following requirements of part 16 of this chapter are
inapplicable to regulatory hearings conducted under this subpart: The
requirements of Sec.  16.22 (Initiation of a regulatory hearing); Sec.
16.24(e) (timing) and (f) (contents of notice); Sec.  16.40
(Commissioner); Sec.  16.60(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 revocation of accreditation is considered a final agency
action under 5 U.S.C. 702.

Sec.  1.1174   How does an owner or consignee request a regulatory
hearing on a food testing order?

    (a) Request for hearing. No later than 24 hours after the time at
which FDA issued the food testing order, an owner or consignee may
submit a request for a regulatory hearing, conducted pursuant to part
16 of this chapter, on the food testing order. The food testing order
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) Submission of request for regulatory hearing. The request for a
regulatory hearing must be submitted with a written appeal that
responds to the bases, as appropriate, for FDA's determinations
described in the food testing order, together with any supporting
information upon which the requestor is relying. The request, appeal,
and supporting information must be submitted in English to the
destination specified in such notice and in accordance with the
procedures described therein. The request, appeal, and supporting
information may be submitted electronically.
    (c) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a request for a
regulatory hearing is submitted to FDA.
    (d) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec.  16.26(a) of this chapter.
    (e) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, such hearing will be held
within 2 business days after the date the request was filed or, if
applicable, within a timeframe agreed upon in writing by the requestor
and the presiding officer and FDA.
    (2) The presiding officer may require that a hearing conducted
under this subpart be completed within 1 business day, as appropriate.
    (3) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec.  16.5(b) of
this chapter, the procedures for a regulatory hearing described in part
16 of this chapter apply only to the extent that such procedures are
supplementary and not in conflict with the procedures specified for the
conduct of regulatory hearings under this subpart. Accordingly, the
following requirements of part 16 of this chapter are inapplicable to
regulatory hearings conducted 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).
    (4) A decision by the presiding officer to affirm the food testing
order is considered a final agency action under 5 U.S.C. 702.

Electronic Records and Public Disclosure Requirements Under This
Subpart

Sec.  1.1199   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.  1.1200   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
4. The authority citation for part 11 continues to read as follows:

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

0
5. In Sec.  11.1, add paragraph (p) to read as follows:

Sec.  11.1   Scope.

* * * * *
    (p) This part does not apply to records required to be established
or maintained by subpart R of part 1 of this chapter. Records that
satisfy the requirements of subpart R 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
6. The authority citation for 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
7. In Sec.  16.1, add the following entries in numerical order to
paragraph (b)(2) to read as follows:

Sec.  16.1   Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec.  1.1173, relating to the revocation of recognition of an
accreditation body, and revocation of accreditation of a laboratory,
with respect to food testing conducted under part 1, subpart R of this
chapter.
    Sec.  1.1174, relating to the issuance of a food testing order by
FDA pursuant to Sec.  1.1107(a)(2).
* * * * *

PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

0
8. The authority citation for part 129 is revised to read as follows:

    Authority:  21 U.S.C. 342, 348, 350k, 371, 374, 42 U.S.C. 264.

0
9. Amend Sec.  129.35 by revising paragraph (a)(3)(iii) to read as
follows:

Sec.  129.35   Sanitary facilities.

* * * * *
    (a) * * *
    (3) * * *
    (iii) Analysis of the sample may be performed for the plant by
competent commercial laboratories (e.g., Environmental Protection
Agency (EPA) and State-certified laboratories), except that the
analysis of the five samples from the same sampling site that
originally tested positive for E. coli, as required by paragraph (a)(3)
of this section, must be conducted under part 1, subpart R of this
chapter.
* * * * *

    Dated: September 30, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
    Dated: October 25, 2019.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-23870 Filed 11-1-19; 8:45 am]
 BILLING CODE 4164-01-P