80 FR 15612 - The Food and Drug Administration Food Safety Modernization Act: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards; Public Meeting and Establishment of Docket
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 56 (March 24, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 56 (March 24, 2015)
| Page Range | 15612-15614 | |
| FR Document | 2015-06656 |
[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)] [Notices] [Pages 15612-15614] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06656] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0797] The Food and Drug Administration Food Safety Modernization Act: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards; Public Meeting and Establishment of Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting and establishment of docket. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to obtain comments that will inform our development of FDA Food Safety Modernization Act (FSMA) implementation work plans. FDA is also announcing a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.'' At the public meeting, we will share our current thinking on our operational strategy for implementation work plans. We will also provide interested persons an opportunity to provide input on this operational strategy and the risk- based industry oversight framework that is at the core of FSMA. 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, requesting special accommodations due to disability, and information on deadlines for submitting either electronic or written comments to FDA's Division of Dockets Management. 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 Dr., 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 to establish the foundation of a modernized, prevention- based food safety system. Among other things, FSMA requires FDA to issue regulations regarding produce safety, preventive controls for foods for humans and animals, intentional adulteration, the foreign supplier verification program (FSVP), and the FDA third-party accreditation program. While FSMA reinforces industry's primary role and responsibility for food safety, it also builds on and strengthens FDA's oversight role in establishing food safety standards, fostering compliance with those standards through guidance and technical assistance, and enforcing the standards to protect public health when problems occur. In fact, more so than ever before, we are called upon by FSMA to play a central leadership and operational role in the future global food safety system. Meeting this challenge--and successfully implementing FSMA's new prevention-oriented, systems approach to food safety--necessitates a new strategy for how we perform our food safety role and meet our new responsibilities. On May 2, 2014, we released our ``Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA),'' available electronically at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm395105.htm, to guide the next phase of FSMA implementation. The operational strategy broadly outlines our approach to food safety and the operational strategy for our food safety program and implementation of FSMA after the rulemaking is complete. Within the ``Operational Strategy for Implementing FSMA,'' there is an appendix that outlines guiding principles for how the operational strategy can be implemented with respect to food and feed facilities, produce safety standards, and import oversight. The guiding principles include the following: Expanding inspection and surveillance; administering new administrative enforcement tools; developing guidance, education, and technical assistance tools; and building a prevention-oriented import system. [[Page 15613]] The public meeting is an opportunity for interested persons to share views concerning how FDA should address the operational aspects of FSMA implementation as suggested by the guiding principles. However, the guiding principles do not lay out an exhaustive list of operational issues to be considered. Therefore, interested persons will have an opportunity at the public meeting to share views and suggest new ideas on a range of operational issues that FDA might consider in our FSMA implementation approach. Furthermore, the public meeting is an opportunity for FDA to share our current thinking on our implementation plans. We encourage interested persons to provide feedback on any ideas that we present at the public meeting related to the operational aspects of FSMA implementation. We are also establishing a docket to obtain comments that will inform our development of FSMA implementation work plans. The agenda and other documents will be accessible on our FSMA Web site at http://www.fda.gov/FSMA before the public meeting. II. Purpose and Format of the Public Meeting FDA is holding this public meeting on FSMA implementation to provide an update on current planning efforts and to receive input from the public to inform the development of operational work plans in the areas of produce safety, preventive controls for foods for humans and animals, measures to address intentional adulteration, FSVP, and the FDA third-party accreditation program. Please note that input received previously through our continued engagement with interested parties as part of the FSMA proposed rules' rulemaking process will also be considered in the development of operational work plans. However, the Agency will not accept any new information or data submitted during the public meeting or through the docket to inform any rulemaking. FDA will provide multiple opportunities for individuals to actively express their views. At the meeting, following introductory presentations by FDA, stakeholders will have an opportunity to participate in their choice of breakout sessions on the topics discussed at the meeting and engage in an open comment and question and answer session. Interested parties may also submit electronic or written comments to the docket by May 26, 2015. Breakout sessions will cover operational aspects of produce safety, preventive controls for human and animal food, intentional adulteration, FSVP, and the FDA third-party accreditation program, as well as overarching topics. We invite the public to provide information, share experiences, and raise issues on topics that will be addressed in the breakout sessions including (but limited to): increasing awareness/reaching the regulated community, potential partners on outreach and implementation, state of readiness, barriers to implementation, training and education for industry and regulators, guidance needs, promotion of best practices, technical assistance, data needs, inspection changes/approaches, compliance and enforcement issues, and long-term implementation success. There will be an opportunity for stakeholders who are unable to participate in person to join the meeting via Web cast. (See section III of this document for more information on the Web cast option.) III. How To Participate in the Public Meeting FDA is holding the public meeting on April 23, 2015, from 8:30 a.m. to 5:30 p.m. and April 24, 2015, from 8:30 a.m. to 12:30 p.m. 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. Onsite registration will be accepted, as space permits, after all preregistered attendees are seated. While there is not a formal comment session planned for the public meeting, it is anticipated that stakeholders will have ample opportunity to provide comments and opinions during the public meeting through their participation in breakout sessions and in the dialogue and question and answer session. Table 1 of this document provides information on participation in the public meeting. Table 1--Information on Participation in the Meeting and on Submitting Comments to the Docket ---------------------------------------------------------------------------------------------------------------- Dates Electronic addresses Addresses Other information ---------------------------------------------------------------------------------------------------------------- Attend public meeting........ April 23, 2015, Please preregister Washington Marriott Registration check- from 8:30 a.m. at http:// at Metro Center, in begins at 8 a.m. to 5:30 p.m., www.fda.gov/Food/ 775 12th St. NW., and April 24, NewsEventsWorkshops Washington, DC 2015, from MeetingsConferences/ 20005. 8:30 a.m. to default.htm. 12:30 p.m. View Web cast................ April 23, 2015, Individuals who wish .................... The Web cast will from 8:30 a.m. to participate by have closed to 5:30 p.m., Web cast are asked captioning. and April 24, to preregister at 2015, from http://www.fda.gov/ 8:30 a.m. to Food/NewsEvents/. 12:30 p.m. WorkshopsMeetingsCon ferences/ default.htm. Preregister.................. Register by Individuals who wish We encourage the use There is no April 16, 2015. to participate in of electronic registration fee person are asked to registration, if for the public preregister at possible.\1\. meeting. http://www.fda.gov/Food/NewsEvents/ Food/NewsEvents/. WorkshopsMeetingsCon ferences/ default.htm. Request special Request by Juanita Yates, See FOR FURTHER .................... accommodations due to April 8, 2015. email: INFORMATION CONTACT. disability. [email protected]. [[Page 15614]] Submit electronic or written Submit comments Federal eRulemaking Mail/Hand delivery/ Identify your comments. by May 26, Portal: http:// Courier (for paper comments with the 2015. www.regulations.gov submissions): docket number . Follow the Division of Dockets listed in brackets instructions for Management (HFA- in the heading of submitting comments. 305), Food and Drug this document. We Administration, encourage you to 5630 Fishers Lane, submit electronic rm. 1061, comments by using Rockville, MD 20852. the Federal eRulemaking Portal. ---------------------------------------------------------------------------------------------------------------- \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 Dr., suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email: [email protected]. IV. Comments, Transcripts, and Recorded Video Regardless of attendance at the public meeting, interested persons may submit to FDA's Division of Dockets Management (see Addresses in table 1 of this document) either electronic or written comments on FSMA implementation issues. You only need to send one set of comments. Identify the comments with the docket number listed in brackets in the heading of this document. However, we will not use any information or data submitted during the public meeting or through the docket to inform any FSMA rulemakings where the comment periods have closed. With respect to transcripts, 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. Send written requests to the Division of Freedom of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. 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: March 18, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-06656 Filed 3-23-15; 8:45 am] BILLING CODE 4164-01-P
![15612 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices
Place: CDC, Building 19, Rooms DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION:
256/257, 1600 Clifton Road, NE., HUMAN SERVICES I. Background
Atlanta, Georgia 30333.
Food and Drug Administration The FDA Food Safety Modernization
Status: Open to the public, limited
only by the space available. The meeting [Docket No. FDA–2015–N–0797] Act (FSMA) (Pub. L. 111–353), signed
room accommodates approximately 50 into law by President Obama on January
people. The public is welcome to The Food and Drug Administration 4, 2011, enables FDA to better protect
participate during the public comment Food Safety Modernization Act: Focus public health by helping to ensure the
on Implementation Strategy for safety and security of the food supply.
period, which is tentatively scheduled
Prevention-Oriented Food Safety FSMA amends the Federal Food, Drug,
from 5:30 to 5:45 p.m. This meeting is
Standards; Public Meeting and and Cosmetic Act to establish the
also available by teleconference, please
Establishment of Docket foundation of a modernized, prevention-
dial (866) 763–0273 and enter code
based food safety system. Among other
6158968. AGENCY: Food and Drug Administration, things, FSMA requires FDA to issue
Purpose: The Subcommittee will HHS. regulations regarding produce safety,
provide advice to the CDC Director ACTION: Notice of public meeting and preventive controls for foods for
through the ACD on strategic and other establishment of docket. humans and animals, intentional
health disparities and health equity SUMMARY: The Food and Drug adulteration, the foreign supplier
issues and provide guidance on Administration (FDA or we) is verification program (FSVP), and the
opportunities for CDC. announcing the establishment of a FDA third-party accreditation program.
Matters To Be Discussed: The Health docket to obtain comments that will While FSMA reinforces industry’s
Disparities Subcommittee members will inform our development of FDA Food primary role and responsibility for food
discuss health equity in injury Safety Modernization Act (FSMA) safety, it also builds on and strengthens
prevention, progress toward the ACD, implementation work plans. FDA is also FDA’s oversight role in establishing
CDC-approved Health Disparities announcing a public meeting entitled food safety standards, fostering
Subcommittee recommendations, and ‘‘FDA Food Safety Modernization Act: compliance with those standards
updates on selected priorities of the Focus on Implementation Strategy for through guidance and technical
Health Disparities Subcommittee. Prevention-Oriented Food Safety assistance, and enforcing the standards
Standards.’’ At the public meeting, we to protect public health when problems
The agenda is subject to change as will share our current thinking on our occur. In fact, more so than ever before,
priorities dictate. operational strategy for implementation we are called upon by FSMA to play a
Web links: work plans. We will also provide central leadership and operational role
Windows Media: http:// interested persons an opportunity to in the future global food safety system.
wm.onlinevideoservice.com/CDC1. provide input on this operational Meeting this challenge—and
strategy and the risk-based industry successfully implementing FSMA’s new
Flash: http:// oversight framework that is at the core prevention-oriented, systems approach
www.onlinevideoservice.com/clients/ of FSMA. to food safety—necessitates a new
CDC/?mount=CDC3. DATES: See section III, ‘‘How to strategy for how we perform our food
If you are unable to connect using the Participate in the Public Meeting’’ in the safety role and meet our new
link, copy and paste the link into your SUPPLEMENTARY INFORMATION section of responsibilities.
web browser. this document for dates and times of the On May 2, 2014, we released our
Number for Technical Support: 404– public meeting, closing dates for ‘‘Operational Strategy for Implementing
639–3737. advance registration, requesting special the FDA Food Safety Modernization Act
accommodations due to disability, and (FSMA),’’ available electronically at
Contact Person For More Information: information on deadlines for submitting http://www.fda.gov/Food/
Leandris Liburd, Ph.D., M.P.H., M.A., either electronic or written comments to GuidanceRegulation/FSMA/
Designated Federal Officer, Health FDA’s Division of Dockets Management. ucm395105.htm, to guide the next phase
Disparities Subcommittee, Advisory ADDRESSES: See section III, ‘‘How to of FSMA implementation. The
Committee to the Director, CDC, 1600 Participate in the Public Meeting’’ in the operational strategy broadly outlines our
Clifton Road NE., M/S K–77, Atlanta, SUPPLEMENTARY INFORMATION section of approach to food safety and the
Georgia 30333, Telephone 770–488– this document. operational strategy for our food safety
8343, Email: LEL1@cdc.gov. FOR FURTHER INFORMATION CONTACT: For program and implementation of FSMA
The Director, Management Analysis questions about registering for the after the rulemaking is complete. Within
and Services Office, has been delegated meeting or to register by phone: the ‘‘Operational Strategy for
the authority to sign Federal Register Courtney Treece, Planning Professionals Implementing FSMA,’’ there is an
notices pertaining to announcements of Ltd., 1210 West McDermott Dr., suite appendix that outlines guiding
meetings and other committee 111, Allen, TX 75013, 704–258–4983, principles for how the operational
management activities, for both the FAX: 469–854–6992, email: strategy can be implemented with
Centers for Disease Control and ctreece@planningprofessionals.com. respect to food and feed facilities,
Prevention and the Agency for Toxic For general questions about the produce safety standards, and import
mstockstill on DSK4VPTVN1PROD with NOTICES
Substances and Disease Registry. meeting or for special accommodations oversight. The guiding principles
due to a disability: Juanita Yates, Center include the following: Expanding
Elaine L. Baker, for Food Safety and Applied Nutrition inspection and surveillance;
Director, Management Analysis and Services (HFS–009), Food and Drug administering new administrative
Office, Centers for Disease Control and Administration, 5100 Paint Branch enforcement tools; developing guidance,
Prevention (CDC). Pkwy., College Park, MD 20740, 240– education, and technical assistance
[FR Doc. 2015–06645 Filed 3–23–15; 8:45 am] 402–1731, email: tools; and building a prevention-
BILLING CODE 4163–18–P Juanita.yates@fda.hhs.gov. oriented import system.
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![15614 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET—
Continued
Dates Electronic addresses Addresses Other information
Submit electronic Submit com- Federal eRulemaking Portal: Mail/Hand delivery/Courier (for Identify your comments with the
or written com- ments by May http://www.regulations.gov. Fol- paper submissions): Division of docket number listed in brack-
ments. 26, 2015. low the instructions for submit- Dockets Management (HFA– ets in the heading of this docu-
ting comments. 305), Food and Drug Adminis- ment. We encourage you to
tration, 5630 Fishers Lane, rm. submit electronic comments by
1061, Rockville, MD 20852. using the Federal eRulemaking
Portal.
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 Dr., suite 111, Allen, TX 75013, 704–
258–4983, FAX: 469–854–6992, email: ctreece@planningprofessionals.com.
IV. Comments, Transcripts, and DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
Recorded Video HUMAN SERVICES HUMAN SERVICES
Regardless of attendance at the public Centers for Disease Control and Agency for Toxic Substances and
meeting, interested persons may submit Prevention Disease Registry
to FDA’s Division of Dockets
[60Day–15–15TG; Docket No. CDC–2015–
Management (see Addresses in table 1 of Interagency Committee on Smoking 0009]
this document) either electronic or and Health: Notice of Charter Renewal
written comments on FSMA Proposed Data Collection Submitted
implementation issues. You only need This gives notice under the Federal for Public Comment and
to send one set of comments. Identify Advisory Committee Act (Pub. L. 92– Recommendations
the comments with the docket number 463) of October 6, 1972, that the
AGENCY: Agency for Toxic Substances
listed in brackets in the heading of this Interagency Committee on Smoking and and Disease Registry (ATSDR), Centers
document. However, we will not use Health, Department of Health and for Disease Control and Prevention
any information or data submitted Human Services, has been renewed for (CDC).
during the public meeting or through a 2-year period through March 20, 2017. ACTION: Notice with comment period.
the docket to inform any FSMA For information, contact Simon
rulemakings where the comment McNabb, Designated Federal Officer, SUMMARY: The Agency for Toxic
periods have closed. Interagency Committee on Smoking and Substances and Disease Registry
Health, Centers for Disease Control and (ATSDR), as part of its continuing
With respect to transcripts, please be
efforts to reduce public burden and
advised that as soon as a transcript is Prevention, Department of Health and
maximize the utility of government
available it will be accessible at http:// Human Services, Patriot’s Plaza, 395 E
information, invites the general public
www.regulations.gov and at FDA’s Street SW., M/S P06, Washington, DC
and other Federal agencies to take this
FSMA Web site at http://www.fda.gov/ 20201, telephone 202/245–0550 or fax opportunity to comment on proposed
FSMA. You may also view the transcript 202/245–0599, Email: BOL1@cdc.gov. and/or continuing information
at the Division of Dockets Management The Director, Management Analysis collections, as required by the
(HFA–305), Food and Drug and Services Office, has been delegated Paperwork Reduction Act of 1995. This
Administration, 5630 Fishers Lane, rm. the authority to sign Federal Register notice invites comment on Promotion of
1061, Rockville, MD 20852. A transcript notices pertaining to announcements of the National Amyotrophic Lateral
will also be available in either hardcopy meetings and other committee Sclerosis (ALS) Registry to Non-referral
or on CD–ROM, after submission of a management activities, for both the Centers.
Freedom of Information request. Send Centers for Disease Control and DATES: Written comments must be
written requests to the Division of Prevention and the Agency for Toxic received on or before May 26, 2015.
Freedom of Information (ELEM–1029), Substances and Disease Registry. ADDRESSES: You may submit comments,
12420 Parklawn Dr., Element Bldg., identified by Docket No. CDC–2015–
Rockville, MD 20857. Elaine L. Baker, 0009 by any of the following methods:
Additionally, we will be video
Director, Management Analysis and Services • Federal eRulemaking Portal:
Office, Centers for Disease Control and Regulation.gov. Follow the instructions
recording the public meeting. Once the Prevention.
recorded video is available, it will be for submitting comments.
[FR Doc. 2015–06649 Filed 3–23–15; 8:45 am] • Mail: Leroy A. Richardson,
accessible at FDA’s FSMA Web site at
BILLING CODE 4163–18–P Information Collection Review Office,
http://www.fda.gov/FSMA. Centers for Disease Control and
Dated: March 18, 2015. Prevention, 1600 Clifton Road NE., MS–
mstockstill on DSK4VPTVN1PROD with NOTICES
Leslie Kux, D74, Atlanta, Georgia 30329.
Associate Commissioner for Policy. Instructions: All submissions received
must include the agency name and
[FR Doc. 2015–06656 Filed 3–23–15; 8:45 am]
Docket Number. All relevant comments
BILLING CODE 4164–01–P
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
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Document Created: 2015-12-18 11:45:08
Document Modified: 2015-12-18 11:45:08
| 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 of public meeting and establishment of docket. | |
| 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, requesting special accommodations due to disability, and information on deadlines for submitting either electronic or written comments to FDA's Division of Dockets Management. | |
| Contact | For questions about registering for the meeting or to register by phone: Courtney Treece, Planning Professionals Ltd., 1210 West McDermott Dr., suite 111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email: [email protected] | |
| FR Citation | 80 FR 15612 |
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