83_FR_46654 83 FR 46476 - Joint Public Meeting on the Use of Cell Culture Technology To Develop Products Derived From Livestock and Poultry

83 FR 46476 - Joint Public Meeting on the Use of Cell Culture Technology To Develop Products Derived From Livestock and Poultry

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 178 (September 13, 2018)

Page Range46476-46478
FR Document2018-19907

The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) are hosting a joint public meeting to discuss the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry tissue. FSIS and FDA officials will make presentations on their roles and responsibilities relative to the production and labeling of safe and wholesome food and their respective regulatory frameworks, including their inspection systems, as a basis for discussing what oversight framework might be most appropriate for cell cultured food products derived from livestock and poultry. Representatives of industry, interested individuals, and other stakeholders are invited to participate in the meeting.

Federal Register, Volume 83 Issue 178 (Thursday, September 13, 2018)
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46476-46478]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19907]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FSIS-2018-0036]


Joint Public Meeting on the Use of Cell Culture Technology To 
Develop Products Derived From Livestock and Poultry

AGENCY: Food Safety and Inspection Service, USDA; Food and Drug 
Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food Safety and Inspection Service (FSIS) and the Food and 
Drug Administration (FDA) are hosting a joint public meeting to discuss 
the potential hazards, oversight considerations, and labeling of cell 
cultured food products derived from livestock and poultry tissue. FSIS 
and FDA officials will make presentations on their roles and 
responsibilities relative to the production and labeling of safe and 
wholesome food and their respective regulatory frameworks, including 
their inspection systems, as a basis for discussing what oversight 
framework might be most appropriate for cell cultured food products 
derived from livestock and poultry. Representatives of industry, 
interested individuals, and other stakeholders are invited to 
participate in the meeting.

DATES: The public meeting will be held on Tuesday, October 23, 2018 
from 8:30 a.m. to 4:00 p.m., and Wednesday, October 24, 2018, from 8:30 
a.m. to 3:00 p.m. EDT. Submit either electronic or written comments on 
this public meeting by November 26, 2018.

ADDRESSES: The meeting will be held at the Jefferson Auditorium in the 
South Building, U.S. Department of Agriculture (USDA), 1400 
Independence Avenue SW, Washington, DC 20250. Attendance is free. Non-
USDA employees must enter through the Wing 5 entrance on Independence 
Avenue. The South Building is a Federal facility and attendees should 
plan to take adequate time to pass through the security screening 
system. Attendees must show a valid photo ID to enter the building.

FOR FURTHER INFORMATION CONTACT: Roxanne Smith, Director, Congressional 
and Public Affairs in the FSIS Office of Public Affairs and Consumer 
Education at (202) 720-4413 or [email protected]; as well as 
Juanita Yates, Public Affairs Specialist in the FDA Center for Food 
Safety and Applied Nutrition at (240) 402-1731 or 
[email protected].

SUPPLEMENTARY INFORMATION: Further information on this meeting will be 
posted on the FSIS website at: https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings and through the FSIS Constituent Update, and on 
the FDA website at: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

Background

    FSIS is the public health agency responsible for ensuring that 
meat, poultry, and egg products are safe, wholesome, and accurately 
labeled. FDA has responsibility for ensuring the safety of all other 
foods, including seafood (except catfish) and game animals as well as 
ensuring that the labels of these foods contain useful and reliable 
information.
    Animal cell culture food technology, as will be discussed at the 
public meeting, refers to the controlled growth of animal cells from 
livestock, poultry, fish, or other animals, their subsequent 
differentiation into various cell types, and their collection and 
processing into food. Full tissue formation in culture is

[[Page 46477]]

an active medical research area, as well as a strong focus of 
commercial interest for food applications. Many companies, both 
domestic and foreign, are actively developing products using this 
technology. Some of these products are being designed to have the same 
or similar compositional, nutritional, and organoleptic characteristics 
as traditional meat and poultry products. Once produced, the harvested 
cells could potentially be processed, packaged, and marketed in the 
same, or similar, manner as traditional meat and poultry products.
    In the past several months, FSIS has received a significant amount 
of correspondence regarding the food products of animal cell culture 
technology. Much of the correspondence is in regard to a petition from 
the United States Cattlemen's Association to FSIS requesting, among 
other things, that FSIS prohibit products derived from livestock and 
manufactured using animal cell culture technology from being labeled or 
marketed as ``beef'' or ``meat.'' The publication of this petition and 
related comments received by FSIS has brought significant attention to 
animal cell culture based food products. To date, FSIS has received 
over 6,100 comments on this petition from industry trade associations; 
consumer advocacy groups; firms operating in the meat, poultry, and/or 
cell culture based food product markets; and consumers. In recent 
years, FDA also has been contacted by firms interested in developing 
foods that incorporate cultured animal cells from various species and 
has had a number of stakeholder engagements on this topic.
    FDA, with USDA's participation, is developing technical questions 
related to cell cultured food products to put before FDA's Science 
Advisory Board on October 22, 2018 (notice will be published in an 
upcoming issue of the Federal Register). The intent of these questions 
is to support a process for identifying potential hazards, assessing 
risks, and establishing control measures appropriate to each risk for 
cell cultured food products. The dialogue with stakeholders at the 
joint public meeting that is the subject of this announcement will be 
informed by the FDA Science Board discussion, which will occur the 
previous day.

Topics for Discussion at the Joint Public Meeting

    Given the high level of public interest, FSIS and FDA will be 
holding this joint public meeting in October to further discuss cell 
culture technology and provide the public with an opportunity to 
provide comments. The first day of the meeting will focus primarily on 
the potential hazards that need to be controlled for the safe 
production of animal cell cultured food products and oversight 
considerations by regulatory agencies. The second day of the meeting 
will focus on labeling considerations. General topics to be covered and 
discussed include:
     Potential hazards associated with the production of these 
products and a discussion on whether they are the same hazards as those 
associated with traditional meat and poultry products. What are the 
most significant sources of potential hazards for each and how are they 
similar and different?
     Strategies to ensure that all potential hazards are 
identified and appropriately controlled, including consideration of 
various factors relevant to determining oversight activities for these 
products, such as:
    [cir] Is there an effective and efficient application of pre-market 
programs to ensure the safety of foods produced by animal cell culture?
    [cir] What type and frequency of inspection will be appropriate for 
various stages of the manufacture of these products?
    [cir] What type and frequency of inspection will be appropriate for 
products that combine cell cultured food products and other ingredients 
(e.g., multicomponent foods like soups, protein bars that contain cell 
cultured protein as an ingredient, or products that contain both 
traditional meat or poultry as well as cell cultured ingredients, 
including food products of animal cell culture derived from livestock 
and poultry tissue)?
     FSIS and FDA are actively working to reduce the 
duplicative and inefficient regulation of establishments and products 
under both agencies' jurisdiction. How could this be done for products 
of animal cell culture derived from livestock and poultry?
     What factors should be considered in the labeling of 
products of animal cell culture? Questions include:
    [cir] Should standards of identity or criteria for statements of 
identity be established for these products to ensure that product names 
are truthful, not misleading, and sufficiently differentiate cell 
cultured products from traditional products?
    [cir] Should the methods by which animal cell cultured products are 
produced (i.e., the culturing process be considered required 
information for purposes of labeling? If so, what factors should be 
considered in accurately describing the production methods?
    [cir] Should the source of the animal cells (i.e., the species from 
which the cell line was initiated) be considered required information 
for the purposes of labeling?
    [cir] What factors should be considered in potentially allowing 
health, safety, and other claims in the marketing of animal cell 
cultured products?
    [cir] How should products containing both animal cell cultured 
products and traditional meat and poultry products be labeled?

Public Comments and Participation in Meetings

Registration

    To register for the public meeting, please visit the following 
website: https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/meetings-archive/upcoming-meetings/meeting-registration-cell-culture-technology. Please provide complete contact information for each 
attendee, including name, title, affiliation, address, email, and 
telephone.
    Registration is free and voluntary and based on space availability, 
with priority given to early registrants. Persons interested in 
attending this public meeting are requested to register by Friday, 
October 19, 2018, although non-registered attendees may still 
participate subject to availability. Early registration is recommended 
because seating is limited. Registrants will receive confirmation of 
their registration.

Accommodations for Persons With Disabilities

    To request accommodations due to a disability, please indicate any 
accommodations needed when registering. FSIS and FDA will provide sign 
language interpreters for this meeting.
    Attendees from the media will also be asked to identify themselves 
during the registration process.

Public Comments: Oral Comments

    Stakeholders will have an opportunity to provide oral comments 
during the public meeting. Due to the anticipated high level of 
interest in the opportunity to make public comments and the limited 
time available to do so, FSIS and FDA encourage participants to 
indicate when registering if they wish to give public comment during a 
public comment session and which topic(s) you wish to address. FSIS and 
FDA will do their best to accommodate all persons who wish to express 
an opinion. FSIS and FDA encourage persons and groups who have similar

[[Page 46478]]

interests to consolidate their information for presentation by a single 
representative and request time for a joint presentation. Speakers will 
be limited to making oral remarks; there will not be an opportunity to 
display materials such as slide shows, videos, or other media during 
the meeting. No commercial or promotional material will be permitted to 
be presented or distributed at the public meeting. All requests to make 
oral presentations should be received by Friday, October 19, 2018.

Public Comments: Written Comments

    Any stakeholder wishing to submit written comments prior to the 
meeting may do so, and may also submit comments after the meeting, 
using any of the following methods: Electronically: Go to http://www.regulations.gov/ and follow the online instructions for submitting 
comments to docket FSIS-2018-0036; Mail, including CD-ROMs, etc.: Send 
to Docket Clerk, U.S. Department of Agriculture, Food Safety and 
Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Room 
6065, Washington, DC 20250-3700; Hand- or courier-delivered submittals: 
Deliver to 1400 Independence Avenue SW, Room 6065, Washington, DC 
20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name (in this case FDA and FSIS) and docket number 
FSIS-2018-0036. Comments received in response to this docket will be 
made available for public inspection and posted without change, 
including any personal information, to http://www.regulations.gov/. 
Comments must be received by November 26, 2018.
    On July 12, 2018, FDA held a public meeting on foods produced using 
animal cell culture technology. Comments received in response to that 
meeting will be reviewed jointly by FDA and FSIS. There is no need to 
resubmit comments already submitted to FDA.
    Docket: For access to background documents or comments received, go 
to https://www.regulations.gov and insert docket number FSIS-2018-0036 
into the ``Search'' box and follow the prompts; and/or call (202) 720-
5627 to schedule a time to visit the FSIS Docket Room at 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

Question-and-Answer Periods

    Time has been allotted for audience questions after most 
presentations delivered during the meeting. Participants will have the 
opportunity to ask questions via a microphone in the auditorium.

Streaming Webcast of the Public Meeting

    This public meeting will also be webcast. Webcast participants are 
asked to preregister at https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/meetings-archive/upcoming-meetings/meeting-registration-cell-culture-technology.

Transcripts

    The transcript of the proceedings from the public meeting will 
become part of the administrative record. As soon as the meeting 
transcripts are available, they will be accessible at https://www.regulations.gov; on the FSIS website at http://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings; or on the FDA website at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. 
The transcripts may also be viewed at the FSIS Docket Room at the 
addressed listed above.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register and on the FDA website at: 
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Constituent Update is available on the FSIS web page. 
Through the web page, FSIS can provide information to a much broader, 
more diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination, any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Done at Washington, DC, on September 7, 2018.
Paul Kiecker,
Acting Administrator.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19907 Filed 9-10-18; 4:15 pm]
 BILLING CODE 3410-DM-P



                                               46476

                                               Notices                                                                                                       Federal Register
                                                                                                                                                             Vol. 83, No. 178

                                                                                                                                                             Thursday, September 13, 2018



                                               This section of the FEDERAL REGISTER                    40499), the Department published a                    individuals, and other stakeholders are
                                               contains documents other than rules or                  notice of a request for expression of                 invited to participate in the meeting.
                                               proposed rules that are applicable to the               interest for potential sites for                      DATES: The public meeting will be held
                                               public. Notices of hearings and investigations,         headquarters office locations for NIFA                on Tuesday, October 23, 2018 from 8:30
                                               committee meetings, agency decisions and                and ERS. USDA is interested in
                                               rulings, delegations of authority, filing of
                                                                                                                                                             a.m. to 4:00 p.m., and Wednesday,
                                               petitions and applications and agency
                                                                                                       exploring options to house the                        October 24, 2018, from 8:30 a.m. to 3:00
                                               statements of organization and functions are            headquarters of NIFA and ERS jointly or               p.m. EDT. Submit either electronic or
                                               examples of documents appearing in this                 in separate locations. The original                   written comments on this public
                                               section.                                                deadline to submit an expression of                   meeting by November 26, 2018.
                                                                                                       interest was September 14, 2018. This                 ADDRESSES: The meeting will be held at
                                                                                                       action extends the submission period                  the Jefferson Auditorium in the South
                                               DEPARTMENT OF AGRICULTURE                               for 30 days. Submissions must now be                  Building, U.S. Department of
                                                                                                       received on or before October 15, 2018.               Agriculture (USDA), 1400 Independence
                                               Office of the Secretary                                                                                       Avenue SW, Washington, DC 20250.
                                                                                                         Dated: September 7, 2018.
                                               Extension of Period To Submit                           Donald K. Bice,                                       Attendance is free. Non-USDA
                                               Expression of Interest for Potential                    Deputy Assistant Secretary for                        employees must enter through the Wing
                                               Sites for Headquarters Office                           Administration.                                       5 entrance on Independence Avenue.
                                               Locations                                               [FR Doc. 2018–19877 Filed 9–12–18; 8:45 am]
                                                                                                                                                             The South Building is a Federal facility
                                                                                                                                                             and attendees should plan to take
                                                                                                       BILLING CODE 3410–90–P
                                               AGENCY: Office of the Secretary, USDA.                                                                        adequate time to pass through the
                                               ACTION: Notice.                                                                                               security screening system. Attendees
                                                                                                       DEPARTMENT OF AGRICULTURE                             must show a valid photo ID to enter the
                                               SUMMARY:   The U.S. Department of                                                                             building.
                                               Agriculture (USDA) is extending the                     Food Safety and Inspection Service                    FOR FURTHER INFORMATION CONTACT:
                                               period for interested parties to submit                                                                       Roxanne Smith, Director, Congressional
                                               an expression of interest for a proposed                                                                      and Public Affairs in the FSIS Office of
                                                                                                       DEPARTMENT OF HEALTH AND
                                               new headquarters location for the                                                                             Public Affairs and Consumer Education
                                                                                                       HUMAN SERVICES
                                               National Institute of Food and                                                                                at (202) 720–4413 or roxanne.smith@
                                               Agriculture (NIFA) and the Economic                                                                           fsis.usda.gov; as well as Juanita Yates,
                                                                                                       Food and Drug Administration
                                               Research Service (ERS). The Department                                                                        Public Affairs Specialist in the FDA
                                               is extending the period to submit an                                                                          Center for Food Safety and Applied
                                               expression of interest for 30 days.                     [Docket No. FSIS–2018–0036]
                                                                                                                                                             Nutrition at (240) 402–1731 or
                                               DATES: The notice of a request to submit                                                                      Juanita.yates@fda.hhs.gov.
                                                                                                       Joint Public Meeting on the Use of Cell
                                               expression of interests published on                    Culture Technology To Develop                         SUPPLEMENTARY INFORMATION: Further
                                               Wednesday, August 15, 2018 is being
                                                                                                       Products Derived From Livestock and                   information on this meeting will be
                                               extended. Interested parties wishing to
                                                                                                       Poultry                                               posted on the FSIS website at: https://
                                               submit an expression of interest should
                                                                                                                                                             www.fsis.usda.gov/wps/portal/fsis/
                                               do so in writing by October 15, 2018.                   AGENCY:  Food Safety and Inspection                   newsroom/meetings and through the
                                               ADDRESSES: Interested parties are                       Service, USDA; Food and Drug                          FSIS Constituent Update, and on the
                                               invited to submit comments regarding                    Administration, HHS.                                  FDA website at: https://www.fda.gov/
                                               this notice. All submissions must refer                 ACTION: Notice of public meeting;                     Food/NewsEvents/WorkshopsMeetings
                                               to ‘‘Expression of Interest’’ to ensure                 request for comments.                                 Conferences/default.htm.
                                               proper delivery.
                                                  • Electronic Submission of                           SUMMARY:   The Food Safety and                        Background
                                               Expression of Interest. Interested                      Inspection Service (FSIS) and the Food                   FSIS is the public health agency
                                               persons may submit information                          and Drug Administration (FDA) are                     responsible for ensuring that meat,
                                               electronically to the following email                   hosting a joint public meeting to discuss             poultry, and egg products are safe,
                                               address relocation@usda.gov.                            the potential hazards, oversight                      wholesome, and accurately labeled.
                                                  • Submission of Comments by Mail,                    considerations, and labeling of cell                  FDA has responsibility for ensuring the
                                               Hand delivery, or Courier. Paper, disk,                 cultured food products derived from                   safety of all other foods, including
                                               or CD–ROM submissions should be                         livestock and poultry tissue. FSIS and                seafood (except catfish) and game
                                               submitted to Donald K. Bice, Deputy                     FDA officials will make presentations                 animals as well as ensuring that the
                                               Assistant Secretary, Office of the                      on their roles and responsibilities                   labels of these foods contain useful and
                                               Assistant Secretary for Administration,                 relative to the production and labeling               reliable information.
                                               USDA, Jamie L. Whitten Building, Room                   of safe and wholesome food and their                     Animal cell culture food technology,
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                                               240–W, 1400 Independence Ave. SW,                       respective regulatory frameworks,                     as will be discussed at the public
                                               Washington, DC 20250.                                   including their inspection systems, as a              meeting, refers to the controlled growth
                                               FOR FURTHER INFORMATION CONTACT:                        basis for discussing what oversight                   of animal cells from livestock, poultry,
                                               Donald K. Bice, Telephone Number:                       framework might be most appropriate                   fish, or other animals, their subsequent
                                               (202) 720–3291.                                         for cell cultured food products derived               differentiation into various cell types,
                                               SUPPLEMENTARY INFORMATION: On                           from livestock and poultry.                           and their collection and processing into
                                               Wednesday, August 15, 2018 (83 FR                       Representatives of industry, interested               food. Full tissue formation in culture is


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                                                                        Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices                                           46477

                                               an active medical research area, as well                to provide comments. The first day of                    Æ Should the source of the animal
                                               as a strong focus of commercial interest                the meeting will focus primarily on the               cells (i.e., the species from which the
                                               for food applications. Many companies,                  potential hazards that need to be                     cell line was initiated) be considered
                                               both domestic and foreign, are actively                 controlled for the safe production of                 required information for the purposes of
                                               developing products using this                          animal cell cultured food products and                labeling?
                                               technology. Some of these products are                  oversight considerations by regulatory                   Æ What factors should be considered
                                               being designed to have the same or                      agencies. The second day of the meeting               in potentially allowing health, safety,
                                               similar compositional, nutritional, and                 will focus on labeling considerations.                and other claims in the marketing of
                                               organoleptic characteristics as                         General topics to be covered and                      animal cell cultured products?
                                               traditional meat and poultry products.                  discussed include:                                       Æ How should products containing
                                               Once produced, the harvested cells                         • Potential hazards associated with                both animal cell cultured products and
                                               could potentially be processed,                         the production of these products and a                traditional meat and poultry products be
                                               packaged, and marketed in the same, or                  discussion on whether they are the same               labeled?
                                               similar, manner as traditional meat and                 hazards as those associated with
                                               poultry products.                                                                                             Public Comments and Participation in
                                                                                                       traditional meat and poultry products.
                                                  In the past several months, FSIS has                                                                       Meetings
                                                                                                       What are the most significant sources of
                                               received a significant amount of                        potential hazards for each and how are                Registration
                                               correspondence regarding the food                       they similar and different?
                                               products of animal cell culture                                                                                  To register for the public meeting,
                                                                                                          • Strategies to ensure that all                    please visit the following website:
                                               technology. Much of the                                 potential hazards are identified and
                                               correspondence is in regard to a petition                                                                     https://www.fsis.usda.gov/wps/portal/
                                                                                                       appropriately controlled, including                   fsis/newsroom/meetings/meetings-
                                               from the United States Cattlemen’s                      consideration of various factors relevant
                                               Association to FSIS requesting, among                                                                         archive/upcoming-meetings/meeting-
                                                                                                       to determining oversight activities for               registration-cell-culture-technology.
                                               other things, that FSIS prohibit products               these products, such as:
                                               derived from livestock and                                                                                    Please provide complete contact
                                                                                                          Æ Is there an effective and efficient              information for each attendee, including
                                               manufactured using animal cell culture                  application of pre-market programs to
                                               technology from being labeled or                                                                              name, title, affiliation, address, email,
                                                                                                       ensure the safety of foods produced by                and telephone.
                                               marketed as ‘‘beef’’ or ‘‘meat.’’ The                   animal cell culture?
                                               publication of this petition and related                                                                         Registration is free and voluntary and
                                                                                                          Æ What type and frequency of                       based on space availability, with
                                               comments received by FSIS has brought
                                                                                                       inspection will be appropriate for                    priority given to early registrants.
                                               significant attention to animal cell
                                                                                                       various stages of the manufacture of                  Persons interested in attending this
                                               culture based food products. To date,
                                                                                                       these products?                                       public meeting are requested to register
                                               FSIS has received over 6,100 comments
                                                                                                          Æ What type and frequency of                       by Friday, October 19, 2018, although
                                               on this petition from industry trade
                                                                                                       inspection will be appropriate for                    non-registered attendees may still
                                               associations; consumer advocacy
                                                                                                       products that combine cell cultured                   participate subject to availability. Early
                                               groups; firms operating in the meat,
                                                                                                       food products and other ingredients                   registration is recommended because
                                               poultry, and/or cell culture based food
                                               product markets; and consumers. In                      (e.g., multicomponent foods like soups,               seating is limited. Registrants will
                                               recent years, FDA also has been                         protein bars that contain cell cultured               receive confirmation of their
                                               contacted by firms interested in                        protein as an ingredient, or products                 registration.
                                               developing foods that incorporate                       that contain both traditional meat or
                                                                                                       poultry as well as cell cultured                      Accommodations for Persons With
                                               cultured animal cells from various                                                                            Disabilities
                                               species and has had a number of                         ingredients, including food products of
                                               stakeholder engagements on this topic.                  animal cell culture derived from                        To request accommodations due to a
                                                  FDA, with USDA’s participation, is                   livestock and poultry tissue)?                        disability, please indicate any
                                               developing technical questions related                     • FSIS and FDA are actively working                accommodations needed when
                                               to cell cultured food products to put                   to reduce the duplicative and inefficient             registering. FSIS and FDA will provide
                                               before FDA’s Science Advisory Board                     regulation of establishments and                      sign language interpreters for this
                                               on October 22, 2018 (notice will be                     products under both agencies’                         meeting.
                                               published in an upcoming issue of the                   jurisdiction. How could this be done for                Attendees from the media will also be
                                               Federal Register). The intent of these                  products of animal cell culture derived               asked to identify themselves during the
                                               questions is to support a process for                   from livestock and poultry?                           registration process.
                                               identifying potential hazards, assessing                   • What factors should be considered
                                                                                                       in the labeling of products of animal cell            Public Comments: Oral Comments
                                               risks, and establishing control measures
                                               appropriate to each risk for cell cultured              culture? Questions include:                             Stakeholders will have an opportunity
                                               food products. The dialogue with                           Æ Should standards of identity or                  to provide oral comments during the
                                               stakeholders at the joint public meeting                criteria for statements of identity be                public meeting. Due to the anticipated
                                               that is the subject of this announcement                established for these products to ensure              high level of interest in the opportunity
                                               will be informed by the FDA Science                     that product names are truthful, not                  to make public comments and the
                                               Board discussion, which will occur the                  misleading, and sufficiently                          limited time available to do so, FSIS and
                                               previous day.                                           differentiate cell cultured products from             FDA encourage participants to indicate
                                                                                                       traditional products?                                 when registering if they wish to give
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                                               Topics for Discussion at the Joint Public                  Æ Should the methods by which                      public comment during a public
                                               Meeting                                                 animal cell cultured products are                     comment session and which topic(s)
                                                 Given the high level of public interest,              produced (i.e., the culturing process be              you wish to address. FSIS and FDA will
                                               FSIS and FDA will be holding this joint                 considered required information for                   do their best to accommodate all
                                               public meeting in October to further                    purposes of labeling? If so, what factors             persons who wish to express an
                                               discuss cell culture technology and                     should be considered in accurately                    opinion. FSIS and FDA encourage
                                               provide the public with an opportunity                  describing the production methods?                    persons and groups who have similar


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                                               46478                    Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices

                                               interests to consolidate their                          to ask questions via a microphone in the              USDA Non-Discrimination Statement
                                               information for presentation by a single                auditorium.                                             No agency, officer, or employee of the
                                               representative and request time for a                                                                         USDA shall, on the grounds of race,
                                               joint presentation. Speakers will be                    Streaming Webcast of the Public
                                                                                                       Meeting                                               color, national origin, religion, sex,
                                               limited to making oral remarks; there                                                                         gender identity, sexual orientation,
                                               will not be an opportunity to display                     This public meeting will also be                    disability, age, marital status, family/
                                               materials such as slide shows, videos, or               webcast. Webcast participants are asked               parental status, income derived from a
                                               other media during the meeting. No                      to preregister at https://                            public assistance program, or political
                                               commercial or promotional material                      www.fsis.usda.gov/wps/portal/fsis/                    beliefs, exclude from participation in,
                                               will be permitted to be presented or                    newsroom/meetings/meetings-archive/                   deny the benefits of, or subject to
                                               distributed at the public meeting. All                  upcoming-meetings/meeting-                            discrimination, any person in the
                                               requests to make oral presentations                                                                           United States under any program or
                                                                                                       registration-cell-culture-technology.
                                               should be received by Friday, October                                                                         activity conducted by the USDA.
                                               19, 2018.                                               Transcripts
                                                                                                                                                             How To File a Complaint of
                                               Public Comments: Written Comments                         The transcript of the proceedings from              Discrimination
                                                 Any stakeholder wishing to submit                     the public meeting will become part of
                                                                                                                                                                To file a complaint of discrimination,
                                               written comments prior to the meeting                   the administrative record. As soon as                 complete the USDA Program
                                               may do so, and may also submit                          the meeting transcripts are available,                Discrimination Complaint Form, which
                                               comments after the meeting, using any                   they will be accessible at https://                   may be accessed online at: http://
                                               of the following methods: Electronically:               www.regulations.gov; on the FSIS                      www.ocio.usda.gov/sites/default/files/
                                               Go to http://www.regulations.gov/ and                   website at http://www.fsis.usda.gov/                  docs/2012/Complain_combined_6_8_
                                               follow the online instructions for                      wps/portal/fsis/newsroom/meetings; or                 12.pdf, or write a letter signed by you
                                               submitting comments to docket FSIS–                     on the FDA website at https://                        or your authorized representative.
                                               2018–0036; Mail, including CD–ROMs,                     www.fda.gov/Food/NewsEvents/                             Send your completed complaint form
                                               etc.: Send to Docket Clerk, U.S.                        WorkshopsMeetingsConferences/                         or letter to USDA by mail, fax, or email:
                                               Department of Agriculture, Food Safety                  default.htm. The transcripts may also be                 Mail: U.S. Department of Agriculture,
                                               and Inspection Service, 1400                            viewed at the FSIS Docket Room at the                 Director, Office of Adjudication, 1400
                                               Independence Avenue SW, Mailstop                        addressed listed above.                               Independence Avenue SW, Washington,
                                               3758, Room 6065, Washington, DC                                                                               DC 20250–9410.
                                               20250–3700; Hand- or courier-delivered                  Additional Public Notification
                                                                                                                                                                Fax: (202) 690–7442.
                                               submittals: Deliver to 1400                               Public awareness of all segments of                    Email: program.intake@usda.gov.
                                               Independence Avenue SW, Room 6065,                      rulemaking and policy development is                     Persons with disabilities who require
                                               Washington, DC 20250–3700.                              important. Consequently, FSIS will                    alternative means for communication
                                                 Instructions: All items submitted by                  announce this Federal Register                        (Braille, large print, audiotape, etc.),
                                               mail or electronic mail must include the                publication online through the FSIS                   should contact USDA’s TARGET Center
                                               Agency name (in this case FDA and                       web page located at: http://                          at (202) 720–2600 (voice and TDD).
                                               FSIS) and docket number FSIS–2018–                      www.fsis.usda.gov/federal-register and                  Done at Washington, DC, on September 7,
                                               0036. Comments received in response to                  on the FDA website at: https://                       2018.
                                               this docket will be made available for                  www.fda.gov/Food/NewsEvents/                          Paul Kiecker,
                                               public inspection and posted without                    WorkshopsMeetingsConferences/                         Acting Administrator.
                                               change, including any personal                          default.htm.
                                               information, to http://                                                                                       Leslie Kux,
                                               www.regulations.gov/. Comments must                       FSIS also will make copies of this                  Associate Commissioner for Policy.
                                               be received by November 26, 2018.                       publication available through the FSIS                [FR Doc. 2018–19907 Filed 9–10–18; 4:15 pm]
                                                 On July 12, 2018, FDA held a public                   Constituent Update, which is used to                  BILLING CODE 3410–DM–P
                                               meeting on foods produced using                         provide information regarding FSIS
                                               animal cell culture technology.                         policies, procedures, regulations,
                                               Comments received in response to that                   Federal Register notices, FSIS public                 DEPARTMENT OF COMMERCE
                                               meeting will be reviewed jointly by FDA                 meetings, and other types of information
                                               and FSIS. There is no need to resubmit                  that could affect or would be of interest             Economics and Statistics
                                               comments already submitted to FDA.                      to our constituents and stakeholders.                 Administration
                                                 Docket: For access to background                      The Constituent Update is available on
                                                                                                       the FSIS web page. Through the web                    Performance Review Board
                                               documents or comments received, go to
                                                                                                       page, FSIS can provide information to a               Membership
                                               https://www.regulations.gov and insert
                                               docket number FSIS–2018–0036 into                       much broader, more diverse audience.                  AGENCY: Economics and Statistics
                                               the ‘‘Search’’ box and follow the                       In addition, FSIS offers an email                     Administration, Department of
                                               prompts; and/or call (202) 720–5627 to                  subscription service which provides                   Commerce.
                                               schedule a time to visit the FSIS Docket                automatic and customized access to                    ACTION: Notice.
                                               Room at 1400 Independence Avenue                        selected food safety news and
                                               SW, Room 6065, Washington, DC                           information. This service is available at:            SUMMARY:  In accordance with 5 U.S.C.
daltland on DSKBBV9HB2PROD with NOTICES




                                               20250–3700.                                             http://www.fsis.usda.gov/subscribe.                   4314(c)(4), the Economics and Statistics
                                                                                                       Options range from recalls to export                  Administration (ESA) announces the
                                               Question-and-Answer Periods                             information, regulations, directives, and             appointment of members who will serve
                                                 Time has been allotted for audience                   notices. Customers can add or delete                  on the ESA Performance Review Board
                                               questions after most presentations                      subscriptions themselves, and have the                (PRB). The purpose of the PRB is to
                                               delivered during the meeting.                           option to password protect their                      provide fair and impartial review of
                                               Participants will have the opportunity                  accounts.                                             senior executive service and scientific


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Document Created: 2018-09-13 01:02:10
Document Modified: 2018-09-13 01:02:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public meeting; request for comments.
DatesThe public meeting will be held on Tuesday, October 23, 2018 from 8:30 a.m. to 4:00 p.m., and Wednesday, October 24, 2018, from 8:30 a.m. to 3:00 p.m. EDT. Submit either electronic or written comments on this public meeting by November 26, 2018.
ContactRoxanne Smith, Director, Congressional and Public Affairs in the FSIS Office of Public Affairs and Consumer Education at (202) 720-4413 or [email protected]; as well as Juanita Yates, Public Affairs Specialist in the FDA Center for Food Safety and Applied Nutrition at (240) 402-1731 or [email protected]
FR Citation83 FR 46476 

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