[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28238-28240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12939]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2155]


Foods Produced Using Animal Cell Culture Technology; Public 
Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing a 
public meeting entitled ``Foods Produced Using Animal Cell Culture 
Technology.'' FDA is holding the public meeting to provide the public 
with an opportunity to provide comments related to the production of 
foods using animal cell culture technology.

DATES: The public meeting will be held on July 12, 2018, from 8:30 a.m. 
until 3 p.m. EST. Submit either electronic or written comments on this 
public meeting by September 25, 2018. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at the Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, Wiley 
Auditorium, 5001 Campus Dr., College Park, MD 20740.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before September 25, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 25, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-2155 for ``Foods Produced Using Animal Cell Culture 
Technology; Public Meeting; Request for Comments.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly

[[Page 28239]]

available, you can provide this information on the cover sheet and not 
in the body of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Juanita Yates, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1731, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Technological advances and consumer interest are spurring 
development of commercial-scale production of foods that are intended 
to resemble traditional meat, poultry, and seafood but are manufactured 
using, generally, a small amount of cells from the type of animal the 
food is intended to resemble. The collected cells are multiplied using 
nontraditional food technologies adapted from cell culture applications 
widely used in research and increasingly in medicine. We expect that 
most or all starter cells for food applications will come from living 
animals for the foreseeable future for commercial and marketing reasons 
(for example, firms currently working on developing these food 
applications appear to be targeting consumers motivated by animal 
welfare concerns). Currently, animal cells can be produced from the 
starter cells in bioreactors, a scaled-up application of traditional 
cell culture techniques. Firms are also working to commercialize 
processes by which cells can be cultured using biocompatible 
scaffolding or other techniques to permit the formation of complex 
tissues, similar to strategies being explored for therapeutic organ or 
tissue replacement. In either case, a significant technical challenge 
with respect to the use of animal cell culture technology to develop 
foods intended to resemble traditional meat, poultry, and seafood 
products involves the development of the growth medium used to multiply 
the cells and ensure that they differentiate into the correct cell 
types. Commercial incentives are driving research into non-animal 
derived components for such media instead of traditional animal-derived 
materials. Finally, after creation, both suspension-cultured 
(unstructured) and scaffold-cultured (structured) products would be 
further processed using traditional food technologies, including 
seasoning, forming, and packaging.
    Just as we have been in the past with respect to rapidly evolving 
areas of technological innovation in food, FDA will be involved in the 
regulation of foods generated by animal cell culture technology in 
light of our broad statutory authority and our extensive expertise and 
experience in relevant scientific areas. Currently, FDA evaluates 
microbial, algal, and fungal cells generated by large-scale culture and 
used as direct food ingredients, administers safety assessment programs 
for a broad array of food ingredients and foods derived from 
genetically engineered plants, manages safety issues associated with 
animal cell culture technology in therapeutic settings, and manages 
risks associated with the processing, manufacture, and packaging of 
food incorporating seafood tissues.
    Under the Federal Food, Drug, and Cosmetic Act, FDA has 
jurisdiction over ``food,'' which includes ``articles used for food'' 
and ``articles used for components of any such article.'' Thus, as a 
starting point, both substances used in the manufacture of these 
products of animal cell culture technology and the products themselves 
that will be used for food are subject to FDA's jurisdiction and 
applicable statutory and regulatory food safety and food labeling 
requirements.
    The use of animal cell culture technology as a method of food 
production and manufacturing involves many interesting issues from both 
technical and regulatory perspectives. FDA believes that all 
stakeholders will benefit from a robust and open dialogue that explores 
these issues and gathers relevant data and information. The primary 
subject of this notice is food safety, but FDA recognizes the 
importance of other issues related to foods produced through animal 
cell culture technology such as naming. Although not the primary 
subject of this notice, FDA welcomes comment on these other issues and 
expects that they will be the focus of future engagement with 
stakeholders and the public.

II. Topics for Discussion at the Public Meeting

    FDA is holding the public meeting to provide the public with an 
opportunity to provide comments related to production of foods using 
animal cell culture technology. We invite interested persons, including 
those participating in the public meeting, to provide information on 
topics such as the following (a more detailed agenda will be made 
available prior to the meeting):
     FDA has evaluated a variety of foods produced by cell 
culture, including microbial (e.g., probiotics), algal (e.g., 
spirulina), and fungal products (e.g., mycoprotein). What 
considerations specific to animal cell culture technology would be 
appropriate to include in evaluation of food produced by this method of 
manufacture?
     FDA has issued guidance on how to assess the effects of 
significant manufacturing process changes on the safety of a food 
ingredient. (See ``Guidance for Industry: Assessing the Effects of 
Significant Manufacturing Process Changes, Including Emerging 
Technologies, on the Safety and Regulatory Status of Food Ingredients 
and Food Contact Substances, Including Food Ingredients that Are Color 
Additives'' at https://www.fda.gov/RegulatoryInformation/Guidances/ucm300661.htm.) What kinds of variations in manufacturing methods would 
be relevant to safety for foods produced by animal cell culture 
technology?
     FDA has a variety of pre- and postmarket programs for 
evaluating the safety of substances used in the production and 
manufacture of foods, including, for example, food additive and color 
additive regulations and preventive control requirements. What kinds of 
substances would be used in the manufacture of foods produced using 
animal cell culture technology and what considerations would be 
appropriate in evaluating the safety of these uses?
     Are the hazards associated with production of foods using 
animal cell culture technology different from those associated with 
traditional food production/processing (such as, for example, 
insanitary conditions, improper temperature controls, or control of 
contaminants)? Is there a need for unique control measures to address 
the hazards associated with production of foods using animal cell 
culture technology?

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following

[[Page 28240]]

website: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by July 5, 2018. Early registration is 
recommended because seating is limited; therefore, FDA may limit the 
number of participants from each organization. Registrants will receive 
confirmation when they have been accepted.
    If you need special accommodations due to a disability, please 
contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later 
than June 28, 2018.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session and 
which topic(s) you wish to address. We will do our best to accommodate 
requests to make public comments. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations, and request time for a joint presentation. Following the 
close of registration, we will determine the amount of time allotted to 
each presenter and the approximate time each oral presentation is to 
begin, and will select and notify participants by July 3, 2018. 
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. All requests to make oral presentations must 
be received by June 28, 2018. No commercial or promotional material 
will be permitted to be presented or distributed at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Webcast participants are asked to preregister at 
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
    Other Issues for Consideration: A summary of key information on 
participating in the meeting follows:

                                                  Table 1--Information on Participation in the Meeting
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                                                                                                                                         Submit either
              Date                      Address           Preregister     Electronic address  Request to make an        Special          electronic or
                                                                                               oral presentation    accommodations     written comments
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July 12, 2018, from 8:30 a.m.     Food and Drug       July 5, 2018:       https://            June 28, 2018.....  June 28, 2018:      Submit Comments by
 until 3 p.m. EDT.                 Administration,     Closing date for    www.fda.gov/Food/                       Closing date to     September 25,
                                   Center for Food     registration.       NewsEvents/                             request special     2018 to: https://
                                   Safety and                              WorkshopsMeetings                       accommodations      www.regulations.g
                                   Applied                                 Conferences/                            due to a            ov, or Dockets
                                   Nutrition, Wiley                        default.htm.                            disability.         Management Staff
                                   Auditorium, 5001                                                                                    (HFA-305), Food
                                   Campus Drive,                                                                                       and Drug
                                   College Park, MD                                                                                    Administration,
                                   20740.                                                                                              5630 Fishers
                                                                                                                                       Lane, Rm. 1061,
                                                                                                                                       Rockville, MD
                                                                                                                                       20852.
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    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12939 Filed 6-15-18; 8:45 am]
 BILLING CODE 4164-01-P