[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Proposed Rules]
[Pages 57136-57137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24027]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, 
211, 225, 500, 507, and 579

[Docket No. FDA-2015-N-001]
RIN 0910-AG10 and 0910-AG36


The Food and Drug Administration Food Safety Modernization Act: 
Final Rules To Establish Requirements for Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
and Animal Food; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing a 
public meeting entitled ``FDA Food Safety Modernization Act: Final 
Rules to Establish Requirements for Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
and Animal Food.'' The public meeting will provide interested persons 
an opportunity to discuss the final rules for current good 
manufacturing practice, hazard analysis, and risk-based preventive 
controls for human and animal food (the preventive controls final 
rules) and FDA's comprehensive planning effort for the next phase of 
the FDA Food Safety Modernization Act (FSMA) implementation, which 
involves putting in place the new public health prevention measures and 
the risk-based industry oversight framework that is at the core of 
FSMA. The purpose of the public meeting is to brief stakeholders and 
interested persons on the key components of the preventive controls 
final rules, respond to questions, and discuss the next phase of FSMA 
implementation with respect to human and animal food preventive 
controls requirements.

DATES: See section III, ``How to Participate in the Public Meeting'' in 
the SUPPLEMENTARY INFORMATION section of this document for dates and 
times of the public meeting, closing dates for advance registration, 
and requesting special accommodations due to disability.

ADDRESSES: See section III, ``How to Participate in the Public 
Meeting'' in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: For questions about registering for 
the meeting or to register by phone: Courtney Treece, Planning 
Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 
75013, 704-258-4983, FAX: 469-854-6992, email: 
[email protected].
    For general questions about the meeting or for special 
accommodations due to a disability: Juanita Yates, Center for Food 
Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1731, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L.111-353), 
signed into law by President Obama on January 4, 2011, enables FDA to 
better protect public health by helping to ensure the safety and 
security of the food supply. FSMA amends the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) to establish the foundation of a 
modernized, prevention-based food safety system. Among other things, 
FSMA requires FDA to issue regulations requiring preventive controls 
for human food and animal food, setting standards for produce safety, 
and requiring importers to perform certain activities to help ensure 
that the food they bring into the United States is produced in a manner 
consistent with U.S. standards.
    FSMA was the first major legislative reform of FDA's food safety 
authorities in more than 70 years. In the Federal Register of January 
16, 2013 (78 FR 3646), we proposed to amend our regulations for Current 
Good Manufacturing Practice In Manufacturing, Packing, or Holding Human 
Food to modernize it and to add requirements for domestic and foreign 
facilities that are required to register under the FD&C Act to 
establish and implement hazard analysis and risk-based preventive 
controls for human food. We also proposed to revise certain definitions 
in our current regulation for Registration of Food Facilities to 
clarify the scope of the exemption from registration requirements 
provided by the FD&C Act for ``farms.'' In the Federal Register of 
October 29, 2013 (78 FR 64735), we proposed regulations for domestic 
and foreign facilities that are required to register under the FD&C Act 
to establish requirements for current good manufacturing practice in 
manufacturing, processing, packing, and holding of animal food. We 
proposed to require that certain facilities establish and implement 
hazard analysis and risk-based preventive controls for food for animals 
to provide greater assurance that animal food is safe and will not 
cause illness or injury to animals or humans.
    Based on input we received from public comments, in the Federal 
Register of September 29, 2014 (79 FR 58476 and 79 FR 58524), we 
proposed to amend our 2013 proposed rules for Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human and Animal Food and reopened the comment period only 
with respect to specific issues identified in supplemental proposed 
rules.
    In the Federal Register of September 17, 2015 (80 FR 55908), we 
issued a final rule to establish the requirements for Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Base Preventive 
Controls for Human Food. In the Federal Register of September 17, 2015 
(80 FR 56170), we issued a final rule to establish requirements for 
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Food for Animals. The preventive controls final 
rules apply to human and animal food and require domestic and foreign 
facilities that are required to register under the FD&C Act to have 
written plans that identify hazards, specify the preventive controls 
that will be put in place to significantly minimize or prevent those 
hazards, include procedures to monitor the implementation of the 
preventive controls, and include corrective action procedures for use 
when preventive controls are not properly implemented. We also revised 
certain definitions in the regulation for Registration of Food 
Facilities to clarify the scope of the exemption from registration 
requirements provided for ``farms'' and, in so doing, to clarify which 
domestic and foreign facilities are subject to the requirements for 
hazard analysis and risk-based preventive controls for food. The 
preventive controls final rules and related fact sheets are available 
on FDA's FSMA Web page located at http://www.fda.gov/FSMA.

[[Page 57137]]

II. Purpose and Format of the Public Meeting

    FDA is holding the public meeting on the two preventive controls 
final rules to address what is different from the proposals; discuss 
the plans for guidance documents and outstanding issues that might be 
addressed in guidance; provide an update on the development of 
implementation work plans; and answer questions.
    These two preventive controls final rules are the first of several 
final rules that will establish the foundation of, and central 
framework for, the modern food safety system envisioned by Congress in 
FSMA. We will not use any information or data submitted during the 
public meeting to inform any FSMA rulemakings where the comment periods 
have closed.
    There will be an opportunity for stakeholders who are unable to 
participate in person to join the meeting via webcast. (See section III 
of this document for more information on the webcast option.)

III. How To Participate in the Public Meeting

    We are holding the public meeting on October 20, 2015, from 8:30 
a.m. until 5 p.m., at Chicago Marriott Downtown Magnificent Mile, 540 
North Michigan Ave, Chicago, IL 60611. Due to limited space and time, 
we encourage all persons who wish to attend the meeting to register in 
advance. There is no fee to register for the public meeting, and 
registration will be on a first-come, first-served basis. Early 
registration is recommended because seating is limited. Onsite 
registration will be accepted, as space permits, after all 
preregistered attendees are seated.
    Table 1 of this document provides information on participation in 
the public meeting.

                                                  Table 1--Information on Participation in the Meeting
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  Date                  Electronic address                Address                 Other information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attend public meeting...............  October 20, 2015, from 8:30  Please preregister at http:/ Chicago Marriott Downtown    Registration check-in
                                       a.m. to 5 p.m. CDT.          /www.fda.gov/Food/           Magnificent Mile, 540        begins at 8 a.m.
                                                                    NewsEvents/                  North Michigan Ave,
                                                                    WorkshopsMeetingsConferenc   Chicago, IL 60611.
                                                                    es/default.htm.
View webcast........................  October 20, 2015, from 8:30  Individuals who wish to      ...........................  The webcast will have
                                       a.m. to 5 p.m. CDT.          participate by webcast are                                closed captioning.
                                                                    asked to preregister at
                                                                    http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Preregister.........................  Register by October 12,      Individuals who wish to      We encourage the use of      There is no registration
                                       2015.                        participate in person are    electronic registration,     fee for the public
                                                                    asked to preregister at      if possible.\1\.             meeting.
                                                                    http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Request special accommodations due    Request by October 6, 2015.  Juanita Yates, email:        See For Further Information  ...........................
 to disability.                                                     [email protected].   Contact.
Submit electronic questions about     ...........................  Submit questions to the FDA  ...........................  For more information about
 the FSMA final rules.                                              FSMA Technical Assistance                                 the FDA FSMA Technical
                                                                    Network at http://                                        Assistance Network, visit
                                                                    www.fda.gov/Food/                                         http://www.fda.gov/Food/
                                                                    GuidanceRegulation/FSMA/                                  GuidanceRegulation/FSMA/
                                                                    ucm459719.htm.                                            ucm459719.htm.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration
  information and send to: Courtney Treece, Planning Professionals Ltd., 1210 West McDermott St., Suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-
  6992, email: [email protected].

IV. Transcripts and Recorded Video

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov and at FDA's FSMA Web 
site at: http://www.fda.gov/FSMA. You may also view the transcript at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 the Agency's Web site at 
http://www.fda.gov. Additionally, we will be video recording the public 
meeting. Once the recorded video is available, it will be accessible at 
FDA's FSMA Web site at http://www.fda.gov/FSMA.

    Dated: September 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24027 Filed 9-21-15; 8:45 am]
 BILLING CODE 4164-01-P