[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Pages 46476-46478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19907]



Food Safety and Inspection Service


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 roxanne.smith@fsis.usda.gov; as well as 
Juanita Yates, Public Affairs Specialist in the FDA Center for Food 
Safety and Applied Nutrition at (240) 402-1731 or 

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.


    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 
    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


    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 
    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 
    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.


    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: 
    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: program.intake@usda.gov.
    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]