
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Notices]
[Pages 4896-4899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00821]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4662]


Public Hearing: Strategic Partnerships To Enhance the Safety of 
Imported Foods: Capacity Building, Risk-Based Decisionmaking, 
Recognition of Commodity Food Control Programs, and Systems 
Recognition; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing a 
public hearing regarding FDA initiatives for enhancing the safety of 
foods (for humans and animals) imported into the United States. The 
hearing will focus on partnerships to improve safety capabilities 
through capacity building; partnerships that incorporate information 
from private entities and foreign competent authorities to inform risk-
based decisionmaking; partnerships that recognize commodity-specific 
export programs; and partnerships that recognize the robustness of a 
nation's entire food safety system. In addition, we are seeking 
information from a variety of viewpoints, including from competent 
authorities in other countries and from private entities, to help 
inform FDA regarding risk-based decisionmaking, commodity-specific 
export control programs in other countries, and systems recognition.

DATES: See ``How to Participate in the Hearing'' in the SUPPLEMENTARY 
INFORMATION section of this document for dates and times of the public 
meetings, closing dates for advance registration, requesting special 
accommodations due to disability, closing date to submit comments to 
the docket, and other information regarding meeting participation.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-4662 for ``Public Hearing: Strategic Partnerships to Enhance 
the Safety of Imported Foods: Capacity Building, Risk-Based 
Decisionmaking, Recognition of Commodity Food Control Programs, and 
Systems Recognition.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Division of Dockets Management. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Wade Woolfolk, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-550), 
5001

[[Page 4897]]

Campus Dr., College Park, MD 20740, 240-402-6411, FAX: 301-436-2618, 
email: wade.woolfolk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On March 30-31, 2011, we held a public hearing to discuss our use 
of international comparability assessments as a mechanism to help 
enhance the safety of imported foods (see ``Ensuring the Safety of 
Imported Foods and Animal Feed: Comparability of Food Safety Systems 
and Import Practices of Foreign Countries; Public Hearing; Request for 
Comments'' (76 FR 13638, March 14, 2011; available at https://www.regulations.gov, in docket FDA-2011-N-0135)). At the public hearing 
we presented information on our food safety capacity building efforts 
related to the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-
353). We also held a public meeting on June 19, 2012, to discuss our 
comprehensive plan to expand the technical, scientific, and regulatory 
capacity of foreign governments and their respective food industries in 
countries that export foods to the United States (see ``International 
Capacity Building with Respect to Food Safety Public Meeting'' (77 FR 
30017, May 21, 2012; available at https://www.regulations.gov, in 
docket FDA-2011-N-0135)). This meeting invited discussion on the 
International Capacity Building plan development under FSMA. Following 
these discussions we issued the final International Capacity Building 
Plan in February 2013. See http://www.fda.gov/food/guidanceregulation/fsma/ucm301708.htm.
    FSMA has enabled us to better protect public health through new 
authorities to help ensure that imported foods meet the same safety 
standards as foods produced in the United States.
    In implementing FSMA, we recognize the importance of strengthening 
the existing collaborations among food safety regulators (U.S. Federal, 
State, local, territorial, tribal, and foreign) to achieve our public 
health goals. We continue to engage in a variety of partnerships that, 
collectively, are intended to enhance the safety of foods imported into 
the United States.
    At the public hearing that is the subject of this notice, we will 
provide an update on our food safety capacity building efforts, as well 
as additional updates and information on the approach we will use to 
help ensure the safety of imported foods. In addition, the public 
hearing will provide an opportunity for FDA to obtain testimony from 
diverse stakeholder groups as we seek to develop, expand, or refine key 
partnership activities.
    We seek input from a variety of perspectives on the following 
topics:
     How to expand performance measurement for FDA's capacity 
building activities to ensure that we collaborate effectively with 
other nations, multilateral organizations, donor organizations, and 
industry.
     How to operationalize the concept of ``same level of 
public health protection'' that is part of the rule on Foreign Supplier 
Verification Programs (FSVP) (80 FR 74226, November 27, 2015) and what 
types of partnerships facilitate application of this concept. (The FSVP 
regulation requires importers to implement FSVPs to provide adequate 
assurances that the importer's foreign suppliers produce food in 
compliance with processes and procedures, including risk-based 
preventive controls, that provide the same level of public health 
protection as those required under section 418 (concerning hazard 
analysis and preventive controls) or 419 (concerning produce safety) of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as 
appropriate, and in compliance with sections 402 (concerning 
adulteration) and 403(w) (concerning misbranding regarding allergen 
labeling) of the FD&C Act.)
     Whether and how we should consider private standards in 
risk-based decisionmaking, including how other competent authorities 
use information, such as third-party certifications or other 
assurances, from private entities.
     Whether and how we should expand our systems recognition 
framework to include consideration of the recognition of commodity-
specific export control programs.
    The initiatives that will be discussed at the public hearing align 
with and support FSMA implementation. Day one of the hearing will seek 
input on partnerships to improve food safety capabilities in other 
countries, tools to inform FDA's risk based decisionmaking, and methods 
to assess the effectiveness of our capacity building efforts. We also 
seek input on whether and how best to incorporate input from private 
entities and other competent authorities into our risk-based 
decisionmaking framework. Day two will seek input on partnerships that 
recognize the robustness of commodity-specific export programs 
including export certification programs and whether and how we should 
consider such programs. In addition, we seek input on the 
implementation of the systems recognition program. Interested parties 
may submit comments, data, and supporting information on the issues 
described in part II of this document.

II. Purpose and Format of the Public Hearing

A. Day One of Hearing

1. Partnerships To Improve Food Safety Capabilities: International 
Capacity Building
    Section 305 of FSMA requires the Secretary of Health and Human 
Services to develop a comprehensive plan to expand the technical, 
scientific, and regulatory food safety capacity of foreign governments, 
and their respective food industries, from which foods are exported to 
the United States. This authority was delegated to FDA, and we 
developed an International Food Safety Capacity Building Plan (the 
Plan). The Plan gives us a strategic framework to expand the technical, 
scientific, and regulatory capacity of foreign governments and their 
food industries. We developed the Plan in consultation with many 
partners, such as officials from other parts of the U.S. government; 
foreign government officials; non-governmental organizations (NGOs) 
that represent consumer interests; food industry representatives; and 
others. We seek input on successful models for continuing capacity 
building to further implement the plan. At this hearing, we will seek 
comment on food safety capacity building and development and invite 
comment, particularly publications and data, on food safety performance 
monitoring regimes; how donor organizations minimize duplication and 
support leveraged partnerships; how providers of training programs 
assure affordable, accessible, and culturally specific information is 
available to various regions of the world; how development agencies 
interface with food industry supply chain management programs; and 
whether we and industry can leverage each other's efforts.
2. Partnerships To Incorporate Information From Competent Authorities 
and Private Entities To Inform Risk-Based Decisionmaking
    In the Federal Register of November 27, 2015 (80 FR 74570), we 
published a final rule entitled, ``Accreditation of Third-Party 
Certification Bodies To Conduct Food Safety Audits and To Issue 
Certifications.'' The final rule established a voluntary program for 
the accreditation of third-party certification bodies to conduct food 
safety audits of foreign food facilities and to issue food and facility 
certifications. The requirements in the final rule will help

[[Page 4898]]

ensure the competence and independence of the accreditation bodies and 
third-party certification bodies participating in the program. We are 
aware that other countries incorporate information from private 
entities into their regulatory decisionmaking. We are interested in 
learning more about the policies, practices, and programs used by 
foreign regulators to ensure the safety of food imported into their 
countries. We seek comment and examples on how other countries use 
information from private entities; how other countries ensure parity in 
audit, inspectional, verification, and overall oversight between 
domestic and import activities; and how transparency can be best 
achieved.

B. Day Two of Hearing

1. Partnerships That Recognize Commodity-Specific Exports and Programs
    We are interested in identifying successful models that recognize 
commodity specific food safety control systems (including export 
certification programs), how they are established, and how they 
operate.
    We seek comment and views on the best practices, strengths and 
weaknesses of commodity export programs or export certification 
systems; how commodity recognition programs factor into risk-based 
inspectional systems; and once adopted, how the programs are monitored 
over time.
2. Partnerships That Recognize the Robustness of the Entire Food Safety 
System: Systems Recognition
    FDA's systems recognition assessment process established in 2011 
has progressed from a pilot to a robust program that has resulted in 
signed arrangements with New Zealand's Ministry for Primary Industries 
(2012) and Canada's Canadian Food Inspection Agency (CFIA) and the 
Department of Health Canada (Health Canada) (2016). We seek comment on 
what indicators we should consider to determine whether the program 
meets expected outcomes and best practices on how to identify robust 
food safety systems.

III. Notice of Hearing Under Part 15

    The Commissioner of Food and Drugs (the Commissioner) is announcing 
that the public hearing will be held in accordance with part 15 (21 CFR 
part 15). The hearing will be conducted by a presiding officer(s), 
accompanied by FDA senior management and staff from the relevant 
centers/offices (FDA panelists/experts).
    Under Sec.  15.30(f), the hearing is informal, and the rules of 
evidence do not apply. We encourage interested parties to submit 
comments to the docket. We also have invited certain members of the 
public to participate as guest presenters. Only the presiding 
officer(s) and FDA panelists/experts may question any person during or 
at the conclusion of each presentation by the FDA and guest presenters 
(Sec.  15.30(e)). At their discretion, the presiding officer(s) may 
permit questions to be submitted from the audience for response by FDA 
or other persons attending the hearing (Sec.  15.30(e)). Finally, time 
permitting, stakeholders may be allowed to provide testimony at the 
hearing. Time will be limited to 2 minutes and requests to make an oral 
presentation must be written and received by February 8, 2017. Please 
include the details of your presentation when making your request. All 
testimony will be entered into the docket. Public hearings under part 
15 are subject to FDA's policy and procedures for electronic media 
coverage of FDA's public administrative proceedings (21 CFR part 10, 
subpart C) (Sec.  10.203(a)). Under Sec.  10.205, representatives of 
the electronic media may be permitted, subject to certain limitations, 
to videotape, film, or otherwise record FDA's public administrative 
proceedings, including presentations by participants. The hearing will 
be transcribed as stipulated in Sec.  15.30(b) (see part IV of this 
document). To the extent that the conditions for the hearing as 
described in this document conflict with any provisions set out in part 
15, this notice acts as a waiver of those provisions as specified in 
Sec.  15.30(h).
    Comments may also be submitted after the hearing. The docket will 
remain open for such comments until May 16, 2017.

IV. How To Participate in the Public Hearing

    Advance registration by submission of a notice of participation is 
necessary to ensure participation and will be accepted on a first-come, 
first-served basis.
    Notices of participation may be submitted electronically (see table 
1 of this document); FDA encourages the use of electronic means of 
advance registration. Notices of participation may also be submitted 
orally or by mail, fax, or email (see FOR FURTHER INFORMATION CONTACT). 
See table 1 of this document for the dates by which notices of 
participation must be submitted. A single copy of any notice of 
participation is sufficient.
    Table 1 of this document provides information on participation in 
the public meetings.

                                                  Table 1--Information on Participation in the Meeting
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Activity                          Date                       Electronic address                     Address            Other information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attend Public Hearing...............  February 14-15, 2017,    Please preregister at www.fda.gov/Food/    FDA Center for Food     Registration check-in
                                       from 9 a.m. to 5:00      NewsEvents/Workshops/Meetings/             Safety and Applied      begins at 8 a.m.
                                       p.m.                     Conferences/default.htm.                   Nutrition, Wiley
                                                                                                           Auditorium, 5001
                                                                                                           Campus Dr., College
                                                                                                           Park, MD 20740.
View Webcast........................  February 14-15, 2017,    Individuals who wish to participate by     We encourage you to     The Webcast will have
                                       from 9 a.m. to 5:00      Webcast are asked to preregister at        use electronic          closed captioning.
                                       p.m.                     www.fda.gov/Food/NewsEvents/               registration if
                                                                WorkshopsMeetings/Conferences/             possible.
                                                                default.htm.
Advance registration................  Register by February 8,  www.fda.gov/Food/NewsEvents/Workshops/     We encourage you to     There is no
                                       2017.                    Meetings Conferences/default.htm.          use electronic          registration fee for
                                                                                                           registration if         the public hearing.
                                                                                                           possible \1\.           Early registration is
                                                                                                                                   recommended because
                                                                                                                                   seating is
                                                                                                                                   limited.\1\

[[Page 4899]]

 
Request to make an oral presentation  Request by February 8,   Individuals who wish to make a public      See FOR FURTHER
                                       2017.                    comment during the designated times in     INFORMATION CONTACT.
                                                                the hearing are asked to submit request
                                                                and presentation at
                                                                IASEvents@fda.hhs.gov.
Submitting either electronic or       Submit all other         https://www.regulations.gov..............  Division of Dockets     See ADDRESSES for
 written comments.                     comments by May 16,                                                 Management (HFA-305),   information on
                                       2017.                                                               Food and Drug           submitting comments.
                                                                                                           Administration, 5630
                                                                                                           Fishers Lane, Rm.
                                                                                                           1061, Rockville, MD
                                                                                                           20852.
Request special accommodations due    Request by February 8,   Wade Woolfolk, email:                      See FOR FURTHER
 to a disability.                      2017.                    wade.woolfolk@fda.hhs.gov.                 INFORMATION CONTACT.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Onsite registration will not be available at the meeting site.

V. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at https://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (see ADDRESSES). A transcript will 
also be available in either hardcopy or on CD-ROM, after submission of 
a Freedom of Information request. The Freedom of Information office 
address is available on FDA's Web site at http://www.fda.gov.

    Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00821 Filed 1-13-17; 8:45 am]
 BILLING CODE 4164-01-P


