Foods Produced Using Animal Cell Culture Technology; Public Meeting; Request for Comments, 28238-28240 [2018-12939]
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28238
Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Establishment of a Docket
[Docket No. FDA–2018–N–2155]
FDA is establishing a public docket so
that anyone can share information,
comments, and ideas on any matters
related to the use of technical
specifications that are not specific to the
documents or issues addressed in other
dockets. This information will give the
Agency insight into stakeholders’
experiences and views regarding the use
of technical specifications guidances
and the data standards they contain.
The docket also permits anyone to share
information, comments, or ideas that are
specific to one or more technical
specifications guidances. Instructions
regarding how to submit comments to
specific technical specifications
documents have been posted within the
docket.
This docket will be open for comment
simultaneously with several other
dockets that are specific to particular
electronic common technical document
(eCTD) submissions and FDA data
standards documents. (For more
information on eCTD submissions and
FDA data standards, see https://
www.fda.gov/Drugs/
DevelopmentApprovalProcess/
FormsSubmissionRequirements/
ElectronicSubmissions/ucm153574.htm
and https://www.fda.gov/ForIndustry/
DataStandards/default.htm,
respectively). Do not submit comments
to this general docket that have already
been submitted to other dockets. As
FDA finalizes specific documents or
requests comments on specific issues for
which another docket exists, the Agency
will generally consider only those
comments that have been submitted to
that specific docket. Do not submit
comments related to another specific
docket to this general technical
specifications docket, as the Agency
may not consider them. FDA will not
respond directly to questions or requests
submitted to this docket but will
consider any submitted information in
its work to develop and issue technical
specifications guidances.
amozie on DSK3GDR082PROD with NOTICES1
in regulatory submissions. Technical
specifications guidances are available at:
https://www.fda.gov/ForIndustry/
DataStandards/default.htm.
Foods Produced Using Animal Cell
Culture Technology; Public Meeting;
Request for Comments
Dated: June 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12969 Filed 6–15–18; 8:45 am]
BILLING CODE 4164–01–P
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Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
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.
SUMMARY:
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.
DATES:
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
PO 00000
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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
E:\FR\FM\18JNN1.SGM
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Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
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/201523389.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,
Juanita.yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
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
VerDate Sep<11>2014
18:00 Jun 15, 2018
Jkt 244001
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.
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28239
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
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Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices
website: https://www.fda.gov/
Food/NewsEvents/WorkshopsMeetings
Conferences/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/WorkshopsMeetings
Conferences/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/WorkshopsMeetings
Conferences/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
Date
Address
Preregister
July 12, 2018,
Food and Drug Adfrom 8:30 a.m.
ministration, Center
until 3 p.m. EDT.
for Food Safety and
Applied Nutrition,
Wiley Auditorium,
5001 Campus
Drive, College Park,
MD 20740.
Electronic address
July 5, 2018:
Closing date
for registration.
https://www.fda.gov/
Food/NewsEvents/
WorkshopsMeetings
Conferences/default.htm.
Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2016]
Epidermolysis Bullosa: Developing
Drugs for Treatment of Cutaneous
Manifestations; Draft Guidance for
Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Epidermolysis Bullosa: Developing
Drugs for Treatment of Cutaneous
Manifestations.’’ The purpose of this
draft guidance is to assist sponsors with
the development of drugs for treatment
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
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18:00 Jun 15, 2018
Jkt 244001
Special
accommodations
Submit either electronic or written
comments
June 28, 2018
June 28, 2018: Closing date to request
special accommodations due to a
disability.
Submit Comments by September
25,
2018
to:
https://
www.regulations.gov, or Dockets Management Staff (HFA–
305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD
20852.
or prevention of the serious cutaneous
manifestations of the heterogeneous
group of disorders collectively known as
epidermolysis bullosa (EB). There is an
unmet medical need for EB patients due
to the paucity of effective treatment
options.
DATES: Submit either electronic or
written comments on the draft guidance
by August 17, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
[FR Doc. 2018–12939 Filed 6–15–18; 8:45 am]
AGENCY:
Request to
make an oral
presentation
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,
PO 00000
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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
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
