80_FR_57319 80 FR 57136 - 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

80 FR 57136 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 183 (September 22, 2015)

Page Range57136-57137
FR Document2015-24027

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.

Federal Register, Volume 80 Issue 183 (Tuesday, September 22, 2015) 
[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Proposed Rules]
[Pages 57136-57137]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24027]


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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.

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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

57136 Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Proposed Rules the rule would submit detailed comments public meeting, closing dates for FR 64735), we proposed regulations for weighing the burdens against benefits of advance registration, and requesting domestic and foreign facilities that are continuing to include such non-material special accommodations due to required to register under the FD&C Act terms. disability. I look forward to thoughtful comments on to establish requirements for current all aspects of the proposal. ADDRESSES: See section III, ‘‘How to good manufacturing practice in [FR Doc. 2015–24021 Filed 9–21–15; 8:45 am] Participate in the Public Meeting’’ in the manufacturing, processing, packing, and SUPPLEMENTARY INFORMATION section of holding of animal food. We proposed to BILLING CODE 6351–01–P this document. require that certain facilities establish FOR FURTHER INFORMATION CONTACT: For and implement hazard analysis and questions about registering for the risk-based preventive controls for food DEPARTMENT OF HEALTH AND meeting or to register by phone: for animals to provide greater assurance HUMAN SERVICES Courtney Treece, Planning Professionals that animal food is safe and will not Food and Drug Administration Ltd., 1210 West McDermott St., Suite cause illness or injury to animals or 111, Allen, TX 75013, 704–258–4983, humans. 21 CFR Parts 1, 11, 16, 106, 110, 114, FAX: 469–854–6992, email: ctreece@ Based on input we received from 117, 120, 123, 129, 179, 211, 225, 500, planningprofessionals.com. For general questions about the public comments, in the Federal 507, and 579 Register of September 29, 2014 (79 FR meeting or for special accommodations [Docket No. FDA–2015–N–001] due to a disability: Juanita Yates, Center 58476 and 79 FR 58524), we proposed for Food Safety and Applied Nutrition to amend our 2013 proposed rules for RIN 0910–AG10 and 0910–AG36 Current Good Manufacturing Practice (HFS–009), Food and Drug The Food and Drug Administration Administration, 5100 Paint Branch and Hazard Analysis and Risk-Based Food Safety Modernization Act: Final Pkwy., College Park, MD 20740, 240– Preventive Controls for Human and Rules To Establish Requirements for 402–1731, email: Juanita.yates@ Animal Food and reopened the Current Good Manufacturing Practice, fda.hhs.gov. comment period only with respect to Hazard Analysis, and Risk-Based SUPPLEMENTARY INFORMATION: specific issues identified in Preventive Controls for Human and supplemental proposed rules. I. Background Animal Food; Public Meeting In the Federal Register of September The FDA Food Safety Modernization 17, 2015 (80 FR 55908), we issued a AGENCY: Food and Drug Administration, Act (FSMA) (Pub. L.111–353), signed HHS. final rule to establish the requirements into law by President Obama on January for Current Good Manufacturing ACTION: Notification of public meeting. 4, 2011, enables FDA to better protect Practice, Hazard Analysis, and Risk- public health by helping to ensure the SUMMARY: The Food and Drug Base Preventive Controls for Human safety and security of the food supply. Administration (FDA or we) is FSMA amends the Federal Food, Drug, Food. In the Federal Register of announcing a public meeting entitled and Cosmetic Act (the FD&C Act) to September 17, 2015 (80 FR 56170), we ‘‘FDA Food Safety Modernization Act: establish the foundation of a issued a final rule to establish Final Rules to Establish Requirements modernized, prevention-based food requirements for Current Good for Current Good Manufacturing safety system. Among other things, Manufacturing Practice, Hazard Practice, Hazard Analysis, and Risk- FSMA requires FDA to issue regulations Analysis, and Risk-Based Preventive Based Preventive Controls for Human requiring preventive controls for human Controls for Food for Animals. The and Animal Food.’’ The public meeting food and animal food, setting standards preventive controls final rules apply to will provide interested persons an for produce safety, and requiring human and animal food and require opportunity to discuss the final rules for importers to perform certain activities to domestic and foreign facilities that are current good manufacturing practice, help ensure that the food they bring into required to register under the FD&C Act hazard analysis, and risk-based the United States is produced in a to have written plans that identify preventive controls for human and manner consistent with U.S. standards. hazards, specify the preventive controls animal food (the preventive controls FSMA was the first major legislative that will be put in place to significantly final rules) and FDA’s comprehensive reform of FDA’s food safety authorities minimize or prevent those hazards, planning effort for the next phase of the in more than 70 years. In the Federal include procedures to monitor the FDA Food Safety Modernization Act Register of January 16, 2013 (78 FR implementation of the preventive (FSMA) implementation, which 3646), we proposed to amend our controls, and include corrective action involves putting in place the new public regulations for Current Good health prevention measures and the procedures for use when preventive Manufacturing Practice In controls are not properly implemented. risk-based industry oversight framework Manufacturing, Packing, or Holding that is at the core of FSMA. The purpose We also revised certain definitions in Human Food to modernize it and to add of the public meeting is to brief the regulation for Registration of Food requirements for domestic and foreign stakeholders and interested persons on Facilities to clarify the scope of the facilities that are required to register the key components of the preventive under the FD&C Act to establish and exemption from registration controls final rules, respond to implement hazard analysis and risk- requirements provided for ‘‘farms’’ and, questions, and discuss the next phase of in so doing, to clarify which domestic Lhorne on DSK5TPTVN1PROD with PROPOSALS based preventive controls for human FSMA implementation with respect to food. We also proposed to revise certain and foreign facilities are subject to the human and animal food preventive definitions in our current regulation for requirements for hazard analysis and controls requirements. Registration of Food Facilities to clarify risk-based preventive controls for food. DATES: See section III, ‘‘How to the scope of the exemption from The preventive controls final rules and Participate in the Public Meeting’’ in the registration requirements provided by related fact sheets are available on SUPPLEMENTARY INFORMATION section of the FD&C Act for ‘‘farms.’’ In the FDA’s FSMA Web page located at this document for dates and times of the Federal Register of October 29, 2013 (78 http://www.fda.gov/FSMA. VerDate Sep<11>2014 14:51 Sep 21, 2015 Jkt 235001 PO 00000 Frm 00031 Fmt 4702 Sfmt 4702 E:\FR\FM\22SEP1.SGM 22SEP1

Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Proposed Rules 57137 II. Purpose and Format of the Public Congress in FSMA. We will not use any 5 p.m., at Chicago Marriott Downtown Meeting information or data submitted during Magnificent Mile, 540 North Michigan FDA is holding the public meeting on the public meeting to inform any FSMA Ave, Chicago, IL 60611. Due to limited the two preventive controls final rules rulemakings where the comment space and time, we encourage all to address what is different from the periods have closed. persons who wish to attend the meeting proposals; discuss the plans for There will be an opportunity for to register in advance. There is no fee guidance documents and outstanding stakeholders who are unable to to register for the public meeting, and issues that might be addressed in participate in person to join the meeting registration will be on a first-come, first- guidance; provide an update on the via webcast. (See section III of this served basis. Early registration is development of implementation work document for more information on the recommended because seating is plans; and answer questions. webcast option.) limited. Onsite registration will be These two preventive controls final accepted, as space permits, after all III. How To Participate in the Public preregistered attendees are seated. rules are the first of several final rules Meeting that will establish the foundation of, Table 1 of this document provides and central framework for, the modern We are holding the public meeting on information on participation in the food safety system envisioned by October 20, 2015, from 8:30 a.m. until public meeting. TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING Date Electronic address Address Other information Attend public October 20, 2015, from 8:30 Please preregister at http:// Chicago Marriott Downtown Registration check-in begins meeting. a.m. to 5 p.m. CDT. www.fda.gov/Food/ Magnificent Mile, 540 North at 8 a.m. NewsEvents/ Michigan Ave, Chicago, IL WorkshopsMeetingsConfer- 60611. ences/default.htm. View webcast October 20, 2015, from 8:30 Individuals who wish to par- ........................................... The webcast will have closed a.m. to 5 p.m. CDT. ticipate by webcast are captioning. asked to preregister at http://www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsConfer- ences/default.htm. Preregister ..... Register by October 12, 2015 Individuals who wish to par- We encourage the use of There is no registration fee ticipate in person are asked electronic registration, if for the public meeting. to preregister at http:// possible.1 . www.fda.gov/Food/ NewsEvents/ WorkshopsMeetingsConfer- ences/default.htm. Request spe- Request by October 6, 2015 Juanita Yates, email: Jua- See For Further Information cial accom- nita.yates@fda.hhs.gov. Contact. modations due to dis- ability. Submit elec- ........................................... Submit questions to the FDA ........................................... For more information about tronic ques- FSMA Technical Assistance the FDA FSMA Technical tions about Network at http:// Assistance Network, visit the FSMA www.fda.gov/Food/ http://www.fda.gov/Food/ final rules. 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 reg- istration 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: ctreece@planningprofessionals.com. IV. Transcripts and Recorded Video on the Agency’s Web site at http:// DEPARTMENT OF HEALTH AND www.fda.gov. Additionally, we will be HUMAN SERVICES Please be advised that as soon as a video recording the public meeting. transcript is available, it will be Once the recorded video is available, it Food and Drug Administration accessible at http://www.regulations.gov will be accessible at FDA’s FSMA Web and at FDA’s FSMA Web site at: 21 CFR Part 108 site at http://www.fda.gov/FSMA. http://www.fda.gov/FSMA. You may also view the transcript at the Division Dated: September 17, 2015. [Docket No. FDA–2015–N–2819] Lhorne on DSK5TPTVN1PROD with PROPOSALS of Dockets Management (HFA–305), Leslie Kux, Food and Drug Administration, 5630 Emergency Permit Control Associate Commissioner for Policy. Fishers Lane, rm. 1061, Rockville, MD Regulations; Technical Amendments [FR Doc. 2015–24027 Filed 9–21–15; 8:45 am] 20852. A transcript will also be AGENCY: Food and Drug Administration, BILLING CODE 4164–01–P available in either hardcopy or on CD– HHS. ROM, after submission of a Freedom of Proposed rule; technical ACTION: Information request. The Freedom of amendments. Information office address is available VerDate Sep<11>2014 14:51 Sep 21, 2015 Jkt 235001 PO 00000 Frm 00032 Fmt 4702 Sfmt 4702 E:\FR\FM\22SEP1.SGM 22SEP1


Document Created: 2015-12-15 09:35:24
Document Modified: 2015-12-15 09:35:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotification of public meeting.
DatesSee 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.
ContactFor 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]
FR Citation80 FR 57136 
RIN Number0910-AG10 and 0910-AG36
CFR Citation21 CFR 1
21 CFR 106
21 CFR 11
21 CFR 110
21 CFR 114
21 CFR 117
21 CFR 120
21 CFR 123
21 CFR 129
21 CFR 16
21 CFR 179
21 CFR 211
21 CFR 225
21 CFR 500
21 CFR 507
21 CFR 579
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