80 FR 44137 - Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 142 (July 24, 2015)

Page Range		44137-44138
FR Document		2015-18142

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.'' The draft guidance, when finalized, will contain FDA recommendations on third-party auditor/ certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA).

Federal Register, Volume 80 Issue 142 (Friday, July 24, 2015)

[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44137-44138]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-18142]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0146]

Third-Party Auditor/Certification Body Accreditation for Food
Safety Audits: Model Accreditation Standards; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and FDA staff entitled
``Third-Party Auditor/Certification Body Accreditation for Food Safety
Audits: Model Accreditation Standards.'' The draft guidance, when
finalized, will contain FDA recommendations on third-party auditor/
certification body qualifications for accreditation to conduct food
safety audits and to issue food and/or facility certifications under an
FDA program required by the FDA Food Safety Modernization Act (FSMA).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on this draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments by October 7, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to Charlotte A. Christin, Office of Compliance, Center for
Food Safety and Applied Nutrition (HFS-605), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Charlotte A. Christin, Center for Food
Safety and Applied Nutrition (HFS-605), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-3708.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a draft guidance for industry
and FDA staff entitled ``Third-Party Auditor/Certification Body
Accreditation for Food Safety Audits: Model Accreditation Standards''
(draft guidance). This draft guidance is being made available
consistent with our good guidance practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will represent our current thinking
on ``Third-Party Auditor/Certification Body Accreditation for Food
Safety Audits: Model Accreditation Standards.'' It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such an approach
satisfies the requirements of the applicable statutes and regulations.
Section 808 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 384d) was added by FSMA and directs FDA to establish a
program for the recognition of accreditation bodies that accredit
third-party auditors/certification bodies to conduct food safety audits
and to issue food and/or facility certifications that FDA may use in
certain circumstances to facilitate the entry of foods presented for
import.

[[Page 44138]]

Section 808(b)(2) of the FD&C Act requires FDA to develop model
accreditation standards that recognized accreditation bodies shall use
to qualify third-party auditors/certification bodies for accreditation,
and in so doing, to look to existing standards for certification bodies
(as of the date of enactment of FSMA) to avoid unnecessary duplication
of efforts and costs. This draft guidance, when finalized, will
constitute the model accreditation standards referred to in section
808(b)(2) of the FD&C Act. The draft guidance contains FDA
recommendations on third-party auditor/certification body
qualifications for accreditation to conduct food safety audits and to
issue food and/or facility certifications under an FDA program required
by FSMA.
FDA was guided in developing this draft guidance, in part, by the
National Technology Transfer and Advancement Act of 1995, which directs
Federal Agencies to use voluntary consensus standards in lieu of
government-unique standards, except where inconsistent with law or
otherwise impractical.
In developing the draft guidance, FDA considered several voluntary
consensus standards for their relevance to the qualifications of third-
party auditors/certification bodies that would certify foreign food
facilities and/or their foods for conformance with the requirements of
the FD&C Act. FDA also sought to identify the standards most commonly
used by stakeholders (e.g., other governments, public and private
accreditation bodies, the food industry, and the international
standards community) in qualifying third-party auditors/certification
bodies for conducting food safety audits. As a result, FDA was guided
in developing the draft model accreditation standards guidance document
by International Organization for Standardization (ISO)/International
Electrotechnical Commission (IEC) ISO/IEC 17021: Conformity
Assessment--Requirements for bodies providing audit and certification
management systems (2011) (``ISO/IEC 17021:2011'') and included an
appendix containing a crosswalk between ISO/IEC 17021:2011 and ISO/IEC
17065: Conformity assessment--Requirements for bodies certifying
products, processes and services (``ISO/IEC 17065:2012'').
The draft guidance document is issued as a companion to the
proposed rule ``Accreditation of Third-Party Auditors/Certification
Bodies to Conduct Food Safety Audits and to Issue Certifications'' that
was published in the Federal Register of July 29, 2013 (78 FR 45781).
When this guidance is finalized, it will serve as a companion guidance
document to the final rule.

II. Paperwork Reduction Act of 1995

This draft guidance refers to proposed collections of information
described in FDA's July 29, 2013, proposed rule on Accreditation of
Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits
and to Issue Certifications, which this draft guidance is intended to
interpret. The proposed collections of information in the proposed rule
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
As required by the PRA, FDA has published an analysis of the
information collection provisions of the proposed rule (see 78 FR 45781
at 45825, reference 25, pages 216-239, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm) and
has submitted the proposed collections to OMB for approval.

III. Comments

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

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

Dated: July 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18142 Filed 7-23-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices 44137

FDA will begin the meeting by health care delivery system and the DATES: Although you can comment on
soliciting feedback regarding how impact on patient access. any guidance at any time (see 21 CFR
stakeholders, such as patients and Discussion will focus on identifying 10.115(g)(5)), to ensure that we consider
health care providers, think about the most effective methods for your comment on this draft guidance
burden related to REMS. The meeting evaluating the burden of REMS on the before we begin work on the final
will then focus on strategies for health care delivery system and the version of the guidance, submit either
anticipating and addressing REMS impact on patient access, with a goal of electronic or written comments by
burden and access issues in several not only characterizing and quantifying October 7, 2015.
broad topic areas (including several these effects, but also identifying ADDRESSES: Submit written requests for
areas identified in the key opinions and opportunities for improvements to a single copies of the draft guidance to
recommendations from stakeholders in REMS program and better Charlotte A. Christin, Office of
the Standardizing and Evaluating REMS understanding the effect of changes to a Compliance, Center for Food Safety and
Report). Potential discussion topics are program. This may include discussion Applied Nutrition (HFS–605), Food and
described in this document. For topics of how to address methodological Drug Administration, 5100 Paint Branch
related to strategies for minimizing challenges in the measurement of Pkwy., College Park, MD 20740. Send
burden and barriers to patient access burden and access, and how to two self-addressed adhesive labels to
(topics 1–3), FDA will present ongoing incorporate stakeholder input into assist that office in processing your
and planned Agency initiatives, solicit REMS design and assessment. request. See the SUPPLEMENTARY
feedback on these initiatives, and ask for FDA intends to make background
INFORMATION section for electronic
feedback on other opportunities for material available to the public no later
access to the draft guidance.
anticipating and minimizing burden and than 2 business days before the meeting. Submit electronic comments on the
patient access issues. If FDA is unable to post the background
draft guidance to http://
Potential topics for discussion include material on its Web site prior to the
www.regulations.gov. Submit written
the following: meeting, the background material will
comments to the Division of Dockets
• Topic 1: Understanding the be made publicly available at the
Management (HFA–305), Food and Drug
stakeholder perspective. location of the public meeting, and the
Administration, 5630 Fishers Lane, Rm.
Discussion will focus on gaining a background material will be posted on
1061, Rockville, MD 20852.
better understanding of how FDA’s Web site after the meeting at
stakeholders, such as patients, health http://www.fda.gov/Drugs/NewsEvents/ FOR FURTHER INFORMATION CONTACT:
care providers, dispensers, and others, ucm132703.htm, and to the docket at Charlotte A. Christin, Center for Food
think about burden and access issues http://www.regulations.gov. Safety and Applied Nutrition (HFS–
related to REMS—for example, 605), Food and Drug Administration,
Dated: July 20, 2015.
understanding the different dimensions 5100 Paint Branch Pkwy., College Park,
Leslie Kux, MD 20740, 240–402–3708.
of burden (e.g., administrative, Associate Commissioner for Policy.
logistical, workflow) and better SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–18149 Filed 7–23–15; 8:45 am]
understanding the different types of I. Background
BILLING CODE 4164–01–P
patient access issues that are implicated
by REMS. We are announcing the availability of
• Topic 2: Improved communication a draft guidance for industry and FDA
DEPARTMENT OF HEALTH AND staff entitled ‘‘Third-Party Auditor/
about the existence of a REMS and
HUMAN SERVICES Certification Body Accreditation for
about what is required of stakeholders
under that REMS. Food Safety Audits: Model
Food and Drug Administration
Discussion will focus on strategies to Accreditation Standards’’ (draft
improve communications about REMS, [Docket No. FDA–2011–N–0146] guidance). This draft guidance is being
including communications about the made available consistent with our good
Third-Party Auditor/Certification Body guidance practices regulation (21 CFR
existence of a particular REMS or the
Accreditation for Food Safety Audits: 10.115). The draft guidance, when
requirements under a particular REMS
Model Accreditation Standards; Draft finalized, will represent our current
program, and how to improve the clarity
Guidance for Industry and Food and thinking on ‘‘Third-Party Auditor/
of REMS materials.
• Topic 3: Improved integration of Drug Administration Staff; Availability Certification Body Accreditation for
activities required under a REMS. AGENCY: Food and Drug Administration, Food Safety Audits: Model
Discussion will focus on two closely HHS. Accreditation Standards.’’ It does not
related subtopics: (1) Strategies to ACTION: Notice. create or confer any rights for or on any
improve the integration of REMS person and does not operate to bind
requirements into the health care SUMMARY: The Food and Drug FDA or the public. An alternative
delivery system through process Administration (FDA) is announcing the approach may be used if such an
improvement (e.g., streamlining REMS availability of a draft guidance for approach satisfies the requirements of
processes that have an impact on industry and FDA staff entitled ‘‘Third- the applicable statutes and regulations.
stakeholder workflow or the care Party Auditor/Certification Body Section 808 of the Federal Food, Drug,
process, and reducing redundancies by Accreditation for Food Safety Audits: and Cosmetic Act (the FD&C Act) (21
leveraging existing training or Model Accreditation Standards.’’ The U.S.C. 384d) was added by FSMA and
asabaliauskas on DSK5VPTVN1PROD with NOTICES

certification requirements to meet REMS draft guidance, when finalized, will directs FDA to establish a program for
requirements); and (2) strategies to contain FDA recommendations on third- the recognition of accreditation bodies
integrate REMS into electronic health party auditor/certification body that accredit third-party auditors/
care systems (e.g., electronic health qualifications for accreditation to certification bodies to conduct food
records, decision support systems, and conduct food safety audits and to issue safety audits and to issue food and/or
pharmacy management systems). food and/or facility certifications under facility certifications that FDA may use
• Topic 4: Improved methods for an FDA program required by the FDA in certain circumstances to facilitate the
measuring the burden of REMS on the Food Safety Modernization Act (FSMA). entry of foods presented for import.

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44138 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices

Section 808(b)(2) of the FD&C Act finalized, it will serve as a companion DEPARTMENT OF HEALTH AND
requires FDA to develop model guidance document to the final rule. HUMAN SERVICES
accreditation standards that recognized
accreditation bodies shall use to qualify II. Paperwork Reduction Act of 1995 Health Resources and Services
third-party auditors/certification bodies This draft guidance refers to proposed Administration
for accreditation, and in so doing, to collections of information described in
look to existing standards for Advisory Committee on Infant
FDA’s July 29, 2013, proposed rule on
certification bodies (as of the date of Mortality: Change in Meeting Dates
Accreditation of Third-Party Auditors/
enactment of FSMA) to avoid
unnecessary duplication of efforts and Certification Bodies to Conduct Food
Safety Audits and to Issue ACTION: Notice of change in meeting
costs. This draft guidance, when dates.
finalized, will constitute the model Certifications, which this draft guidance
accreditation standards referred to in is intended to interpret. The proposed
collections of information in the SUMMARY: Health Resources and
section 808(b)(2) of the FD&C Act. The Services Administration is issuing this
draft guidance contains FDA proposed rule are subject to review by
the Office of Management and Budget notice to change the meeting dates for
recommendations on third-party
auditor/certification body qualifications (OMB) under the Paperwork Reduction the Notice is hereby given of a change
for accreditation to conduct food safety Act of 1995 (PRA) (44 U.S.C. 3501– in the meeting of the Secretary’s
audits and to issue food and/or facility 3520). As required by the PRA, FDA has Advisory Committee on Infant Mortality
certifications under an FDA program published an analysis of the information (SACIM). The meeting was originally
required by FSMA. collection provisions of the proposed scheduled for July 13–14, 2015 and was
FDA was guided in developing this rule (see 78 FR 45781 at 45825, published in the Federal Register on
draft guidance, in part, by the National reference 25, pages 216–239, available at June 26, 2015, 80 FR 123 (page 36826).
Technology Transfer and Advancement http://www.fda.gov/AboutFDA/ DATES: The meeting dates have changed
Act of 1995, which directs Federal ReportsManualsForms/Reports/ to August 10, 2015, starting at 8:30 a.m.
Agencies to use voluntary consensus
EconomicAnalyses/default.htm) and has (EST) and ending at 5 p.m. (EST) and
standards in lieu of government-unique
submitted the proposed collections to August 11, 2015, starting at 8:30 a.m.
standards, except where inconsistent
with law or otherwise impractical. OMB for approval. (EST) and ending at 3:30 p.m. (EST).
In developing the draft guidance, FDA III. Comments The meeting remains virtual via
considered several voluntary consensus webinar and phone using the following
standards for their relevance to the Interested persons may submit either links: URL: https://
qualifications of third-party auditors/ electronic comments regarding the draft hrsa.connectsolutions.com/sacim_
certification bodies that would certify guidance to http://www.regulations.gov seminar_200/. Call-In Number:
foreign food facilities and/or their foods or written comments to the Division of 1.888.942.8170. Passcode: 3494113.
for conformance with the requirements Dockets Management (see ADDRESSES). It
of the FD&C Act. FDA also sought to For more details, please visit the
is only necessary to send one set of
identify the standards most commonly ACIM Web site: http://www.hrsa.gov/
comments. Identify comments with the
used by stakeholders (e.g., other advisorycommittees/mchbadvisory/
docket number found in brackets in the
governments, public and private InfantMortality/index.html. The meeting
heading of this document. Received
accreditation bodies, the food industry, is open to the public with attendance
comments may be seen in the Division
and the international standards limited to availability of call-in lines.
of Dockets Management between 9 a.m.
community) in qualifying third-party FOR FURTHER INFORMATION CONTACT:
and 4 p.m., Monday through Friday, and
auditors/certification bodies for
will be posted to the docket at http:// Anyone requiring information regarding
conducting food safety audits. As a
www.regulations.gov. the Committee should contact Michael
result, FDA was guided in developing
the draft model accreditation standards C. Lu, M.D., M.P.H., Executive
IV. Electronic Access Secretary, ACIM, Health Resources and
guidance document by International
Organization for Standardization (ISO)/ Persons with access to the Internet Services Administration, Room 18 W,
International Electrotechnical may obtain the draft guidance at either Parklawn Building, 5600 Fishers Lane,
Commission (IEC) ISO/IEC 17021: http://www.fda.gov/FoodGuidances or Rockville, Maryland 20857, Telephone:
Conformity Assessment—Requirements http://www.regulations.gov. Use the (301) 443–2170.
for bodies providing audit and FDA Web site listed in the previous Individuals who are submitting public
certification management systems sentence to find the most current comments or who have questions
(2011) (‘‘ISO/IEC 17021:2011’’) and version of the guidance. regarding the meeting and location
included an appendix containing a should contact David S. de la Cruz,
crosswalk between ISO/IEC 17021:2011 Dated: July 20, 2015.
Ph.D., M.P.H., SACIM Designated
and ISO/IEC 17065: Conformity Leslie Kux,
Federal Official, HRSA, Maternal and
assessment—Requirements for bodies Associate Commissioner for Policy.
Child Health Bureau, telephone: (301)
certifying products, processes and [FR Doc. 2015–18142 Filed 7–23–15; 8:45 am]
443–0543, email: David.delaCruz@
services (‘‘ISO/IEC 17065:2012’’).
asabaliauskas on DSK5VPTVN1PROD with NOTICES

The draft guidance document is
BILLING CODE 4164–01–P hrsa.hhs.gov. Public comments must be
issued as a companion to the proposed submitted to Dr. de la Cruz by email no
rule ‘‘Accreditation of Third-Party later than August 3, 2015.
Auditors/Certification Bodies to Jackie Painter,
Conduct Food Safety Audits and to
Director, Division of the Executive Secretariat.
Issue Certifications’’ that was published
[FR Doc. 2015–18179 Filed 7–23–15; 8:45 am]
in the Federal Register of July 29, 2013
(78 FR 45781). When this guidance is BILLING CODE 4165–15–P

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Document Created: 2018-02-23 09:25:12
Document Modified: 2018-02-23 09:25:12

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments by October 7, 2015.
Contact		Charlotte A. Christin, Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-3708.
FR Citation		80 FR 44137

80 FR 44137 - Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 142 (July 24, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration