[Federal Register Volume 85, Number 195 (Wednesday, October 7, 2020)]
[Notices]
[Pages 63277-63280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22140]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1720]


Labeling of Foods Comprised of or Containing Cultured Seafood 
Cells; Request for Information

AGENCY: Food and Drug Administration, HHS.

[[Page 63278]]


ACTION: Notice; request for information.

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

SUMMARY: The Food and Drug Administration (FDA or we) is requesting 
information pertaining to the labeling of foods comprised of or 
containing cultured seafood cells. Foods comprised of or containing 
cultured seafood cells are being developed and may soon enter the 
marketplace. Therefore, we intend to use information and data resulting 
from this notice to determine what type(s) of action, if any, we should 
take to ensure that these foods are labeled properly.

DATES: Submit either electronic or written comments on the notice by 
March 8, 2021.

ADDRESSES: You may submit comments and information as follows. Please 
note that late, untimely filed comments will not be considered. 
Electronic comments must be submitted on or before March 8, 2021]. The 
https://www.regulations.gov electronic filing system will accept 
comments until 11:59 p.m. Eastern Time at the end of March 8, 2021. 
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-2020-N-1720 for ``Labeling of Foods Comprised of or Containing 
Cultured Seafood Cells; Request for Information.'' Received comments 
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, 240-402-7500.
     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 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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

A. FDA Jurisdiction Over Cultured Animal Cells

    Efforts are underway to develop various food products comprised of 
or containing cultured animal cells, including cells from livestock, 
poultry, and seafood \1\ species, using a process often referred to as 
animal cell culture technology. Animal cell culture technology involves 
the controlled growth of animal cells, their subsequent differentiation 
into various cell types, and their harvesting and processing into food. 
Once produced, the harvested cells could potentially be processed into 
or combined with other foods and marketed in the same, or similar, 
manner as conventionally produced meat, poultry, and seafood. In this 
document we refer to these foods as ``foods comprised of or containing 
cultured animal cells.'' Many companies, both domestic and foreign, are 
developing products using this technology. Given these technological 
advances, it is appropriate to consider what actions, if any, may be 
needed to ensure the safe production and accurate labeling of these 
products.
---------------------------------------------------------------------------

    \1\ The use of the term ``seafood'' refers to all fish 
(freshwater and saltwater) and other seafood species (e.g., 
molluscs, crustaceans) under FDA jurisdiction.
---------------------------------------------------------------------------

    FDA will be involved in the regulation of foods generated by animal 
cell culture technology consistent with our current legal authorities. 
We are responsible for implementing and enforcing the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.), the Public 
Health Service Act (42 U.S.C. 201 et seq.), and the Fair Packaging and 
Labeling Act (15 U.S.C. 1451 et seq.). In carrying out our 
responsibilities under these laws, we maintain responsibility for 
ensuring that food is safe and not misbranded.

B. Relevant Misbranding Provisions Under the FD&C Act

    This document primarily pertains to representations about the 
identity of foods comprised of or containing cultured seafood cells. 
Such representations include the name of the food and descriptions 
about its nature, source, or characteristics. There are

[[Page 63279]]

several provisions in the FD&C Act under which food may be misbranded 
with respect to representations about identity. In general, the 
representations made or suggested must not cause the labeling to be 
misleading, either affirmatively or by omission of material facts (21 
U.S.C. 343(a)(1) and 321(n)). The FD&C Act prohibits offering a food 
for sale under the name of another food (21 U.S.C. 343(b)). It requires 
the labels of non-standardized foods to bear the common or usual name 
of the food if such a name exists (21 U.S.C. 343(i)(1)). Common or 
usual names are generally established by common usage, though in some 
cases may be established by regulation pursuant to the principles in 21 
CFR 102.5(a)-(c) (see 21 CFR 102.5(d)). In the absence of a common or 
usual name or other name established by federal law or regulation, food 
sold in packaged form is required to be labeled with an accurate 
description of the food or a fanciful name commonly used by the public 
(Sec.  101.3(b)(3) (21 CFR 101.3(b)(3))). Such description or name must 
not be false or misleading (21 U.S.C. 343(a)(1)) and is referred to as 
the statement of identity (Sec.  101.3(b)). Finally, the FD&C Act 
provides that words or statements required to appear on the label or 
labeling be in such terms as to render them likely to be understood by 
the ordinary individual under customary conditions of purchase and use 
(21 U.S.C. 343(f)).

C. FDA-USDA Agreement Regarding Oversight of Human Food Produced Using 
Animal Cell Technology Derived From Cell Lines of USDA-Amenable Species

    In November 2018, FDA and the U.S. Department of Agriculture (USDA) 
formally announced that they will jointly oversee the production of 
cultured cell food products derived from livestock and poultry (Ref. 
1). On March 7, 2019, FDA and USDA signed an agreement that described 
each entity's intended roles with respect to the oversight of human 
food produced using animal cell culture technology, derived from cell 
lines of those species \2\ covered under the Federal Meat Inspection 
Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products Inspection 
Act (PPIA) (21 U.S.C. 451 et seq.) (Ref. 2). In summary, FDA will 
oversee the collection, growth and differentiation of livestock and 
poultry cells until cell harvest. A transition from FDA to USDA's Food 
Safety and Inspection Service oversight will occur during the cell 
harvest stage. USDA then will oversee the processing, packaging, and 
labeling of the resulting food products derived from the cultured cells 
of livestock and poultry. FDA will continue to regulate foods comprised 
of or containing cultured animal cells from other species under FDA's 
jurisdiction, such as seafood species other than Siluriformes fish.
---------------------------------------------------------------------------

    \2\ Products made from cattle, sheep, swine, goats, and 
Siluriformes fish are subject to the FMIA. Products made from 
domesticated chickens, turkeys, ducks, geese, guineas, ratites, and 
squab are subject to the PPIA.
---------------------------------------------------------------------------

    In the FDA-USDA agreement, FDA and USDA have agreed to develop 
joint principles for product labeling and claims to ensure that 
products are labeled consistently and transparently.

D. Public Meetings on Animal Cell Culture Technology

    Participation in public meetings is an important opportunity to 
share our current thinking on the science surrounding new technologies, 
how our regulatory framework may apply to new technology, and most 
importantly, to hear from the public. On July 12, 2018, we held a 
public meeting, ``Foods Produced Using Animal Cell Culture 
Technology,'' to give the public an opportunity to provide comments 
related to the production of foods using animal cell culture 
technology. In this meeting, we discussed our expected involvement in 
the oversight of products of cell culture technology and solicited 
feedback from stakeholders. Building on this effort, on October 23 to 
24, 2018, USDA and FDA hosted a joint public meeting entitled, ``Joint 
Public Meeting on the Use of Cell Culture Technology to Develop 
Products Derived From Livestock and Poultry.'' This meeting presented 
the opportunity for FDA and USDA to hear from stakeholders about 
various issues, including the labeling of food products comprised of or 
containing cultured livestock and poultry cells.

II. Issues for Consideration and Request for Information

    We invite comment in response to the questions below. Our use of 
the term ``cultured seafood cells'' in these questions is intended to 
distinguish between the foods, which are the subject of this document, 
and conventionally produced seafood. It is not intended to establish or 
suggest nomenclature for labeling purposes. The names and descriptions 
in food labeling should be based on consumer understanding and usage as 
described in section I.B.
    We invite comment, particularly data and other evidence, about: (1) 
Names or statements of identity for foods comprised of or containing 
cultured seafood cells; (2) consumer understanding of terms that have 
been suggested for the names or statements of identity of foods 
comprised of or containing cultured seafood cells; and (3) how to 
assess material differences between the foods that are the subject of 
this document and conventionally produced foods. In responding to these 
questions, please identify the question by its associated letter and 
number (such as ``2(a)'') so that we can associate your response with a 
specific question.
    1. Should the name or statement of identity of foods comprised of 
or containing cultured seafood cells inform consumers about how the 
animal cells were produced? Please explain your reasoning.
    2. What terms should be in the name or statement of identity of a 
food comprised of or containing cultured seafood cells to convey the 
nature or source of the food to consumers? (For example, possible terms 
could be ``cell cultured'' or ``cell based'' or ``cell cultivated.'') 
Please explain your reasoning and provide any studies or data about 
consumer understanding of such terms.
    a. How do these terms inform consumers of the nature or source of 
the food?
    b. If foods comprised of or containing cultured seafood cells were 
to be labeled with the term ``culture'' or ``cultured'' in their names 
or statements of identity (e.g., ``cell culture[d]''), would labeling 
differentiation be necessary to distinguish these products from other 
types of foods where the term ``culture'' or ``cultured'' is used (such 
as ``aquaculture'')? Please explain your reasoning and provide any 
studies or data about consumer understanding of such terms.
    3. The names of many conventionally produced seafood products have 
been established by common usage or by statute or regulation. Names are 
also recommended for seafood species in The Seafood List.\3\ In FDA's 
view, foods comprised of or containing cultured seafood cells are not 
yet in the marketplace and, therefore, do not have common or usual 
names established by common usage.
---------------------------------------------------------------------------

    \3\ The Seafood List provides guidance to industry about 
specificity in the naming of seafood sold in interstate commerce and 
to assist manufacturers in labeling seafood products.
---------------------------------------------------------------------------

    a. If you disagree with FDA's view, what are these names and what 
evidence demonstrates that the names are commonly used and understood 
by the American public for foods derived from cultured animal cells?
    b. Should names for conventionally produced seafood products 
established by common usage, statute, or regulation

[[Page 63280]]

be included in the names or statements of identity of food derived from 
cultured seafood cells? Please explain your reasoning.
    c. If so, is additional qualifying language necessary? What 
qualifying terms or phrases would be appropriate? Please explain your 
reasoning.
    d. Do these names, with or without qualifying language, clearly 
distinguish foods derived from seafood cell culture from conventionally 
produced seafood? Please explain your reasoning.
    e. Should FDA update The Seafood List to include foods comprised of 
or containing cultured seafood cells? Please explain your reasoning.
    4. Should terms that specify a certain type of seafood (such as 
``fillet'' or ``steak'') be included in or accompany the name or 
statement of identity of foods comprised of or containing cultured 
animal cells?
    a. Under what circumstances should these terms be used? What 
information would they convey to consumers? For example, would such 
terms convey the physical form or appearance of the food? Please 
explain your reasoning. Additionally, please provide any studies or 
data about consumer understanding of such terms when used to describe 
foods comprised of or containing cultured seafood cells.
    b. Would these terms be misleading to consumers? Please explain 
your reasoning and provide any supporting studies or data.
    5. When comparing conventionally produced seafood to foods 
comprised of or containing cultured seafood cells, what attributes 
(such as nutrition, taste, texture, or aroma) vary between the foods 
and should FDA consider to be material to consumers' purchasing and 
consumption decisions? Please explain your reasoning.
    a. Are there other characteristics beyond nutritional attributes or 
organoleptic properties that may be material differences? These could 
relate either to cellular constituents or characteristics influenced by 
the cell culture production process. Please be specific in your 
response and explain your reasoning.

III. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. FDA, Statement from USDA Secretary Perdue and FDA Commissioner 
Gottlieb on the Regulation of Cell Cultured Food Products from Cell 
Lines of Livestock and Poultry, Nov. 16, 2018, available at https://www.fda.gov/news-events/press-announcements/statement-usda-secretary-perdue-and-fda-commissioner-gottlieb-regulation-cell-cultured-food-products.
2. Formal Agreement Between FDA and USDA Regarding Oversight of 
Human Food Produced Using Animal Cell Technology Derived from Cell 
Lines of USDA-amenable Species, March 7, 2019, available at https://www.fda.gov/food/domestic-interagency-agreements-food/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell.

    Dated: October 1, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22140 Filed 10-6-20; 8:45 am]
BILLING CODE 4164-01-P