I 
116TH CONGRESS 
2D SESSION 
H. R. 5728 
To provide for the regulation, inspection, and labeling of food produced 
using animal cell culture technology, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 30, 2020 
Mr. JOHNSON of South Dakota (for himself and Mr. SOTO) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Agriculture, for a period to 
be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To provide for the regulation, inspection, and labeling of 
food produced using animal cell culture technology, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food Safety Mod-
ernization for Innovative Technologies Act’’. 
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SEC. 2. REGULATION OF FOOD PRODUCED USING ANIMAL 
CELL CULTURE TECHNOLOGY. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 424. FOOD PRODUCED USING ANIMAL CELL CULTURE 
TECHNOLOGY. 
‘‘(a) IN GENERAL.—The Secretary shall regulate 
food intended for humans that is produced using animal 
cell culture technology derived from cell lines of animals 
other than livestock or poultry and, in coordination with 
the Secretary of Agriculture, food intended for humans 
that is produced using animal cell culture technology de-
rived from cell lines of livestock or poultry. 
‘‘(b) DUTIES.—Pursuant to subsection (a), the Sec-
retary shall— 
‘‘(1) conduct premarket consultation processes 
to evaluate production materials, processes, and 
manufacturing controls with respect to food intended 
for humans that is produced using animal cell cul-
ture technology, derived from cell lines of livestock 
or poultry and food intended for humans that is pro-
duced using animal cell culture technology, derived 
from cell lines of animals other than livestock or 
poultry, including oversight of tissue collection, cell 
lines, cell banks, and all components and inputs; 
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‘‘(2) oversee initial cell collection and the devel-
opment and maintenance of qualified cell banks, in-
cluding by issuing regulations or guidance and con-
ducting inspections, as appropriate; 
‘‘(3) oversee proliferation and differentiation of 
cells through the time of cell harvest, including by 
issuing regulations or guidance and conducting in-
spections, as appropriate; 
‘‘(4) ensure that cell bank and cell culturing fa-
cilities comply with facility registration, applicable 
good manufacturing practices and preventive con-
trols, and requirements applicable to substances that 
become a component of food or otherwise affect the 
characteristics of food; 
‘‘(5) develop pursuant to notice and comment 
rulemaking additional requirements for cell bank 
and cell culturing facility conditions and processes to 
ensure that biological material exiting the culture 
process is safe and not adulterated within the mean-
ing of this chapter; 
‘‘(6) conduct appropriate inspections and fol-
low-up activities, including taking enforcement ac-
tion if necessary, to ensure that cell bank and cell- 
culturing facilities are in compliance with applicable 
laws and regulations; 
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notifying the Department of Agriculture if objectionable 
conditions are identified at a facility carrying out any of 
the activities described in subsection (b), including condi-
tions which may result in production of adulterated or 
misbranded food, collaborating with such department to 
address such conditions with respect to the harvesting of 
cell cultures, and rely on the Department of Agriculture 
to address such conditions with respect to processing, 
packaging, and labeling. 
‘‘(d) LIMITATION.—The Secretary shall not inspect 
activities of an establishment that are solely regulated by 
the Secretary of Agriculture. 
‘‘(e) DEFINITIONS.—In this section— 
‘‘(1) the term ‘livestock’ means cattle, sheep, 
swine, goats, and fish of the order Siluriformes; and 
‘‘(2) the term ‘poultry’ means any domesticated 
bird, whether live or dead. 
‘‘(f) AUTHORITIES RELATED
TO LIVESTOCK
AND 
POULTRY.—Notwithstanding any other provision of law, 
the provisions of this section shall not derogate from any 
authority under the Federal Meat Inspection Act or Poul-
try Product Inspection Act, as in effect on the date of 
enactment of the Food Safety Modernization for Innova-
tive Technologies Act, with respect to the regulation of 
meat and poultry produced in the traditional manner. 
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‘‘(g) NO INSPECTION OF FARMS.—Nothing in this 
section shall be construed to authorize the Secretary to 
conduct an inspection of a farm.’’. 
SEC. 3. INSPECTION AND LABELING OF FOOD PRODUCED 
USING ANIMAL CELL CULTURE TECHNOLOGY 
FROM 
LIVESTOCK 
AND 
POULTRY 
CELL 
LINES. 
(a) DEFINITIONS.—In this section: 
(1) ADULTERATED.—The term ‘‘adulterated’’, 
with respect to food intended for humans that is 
produced using animal cell culture technology, de-
rived from cell lines of livestock or poultry, means 
food— 
(A) that bears or contains any poisonous 
or deleterious substance which may render it in-
jurious to health, except that the food shall not 
be considered adulterated if the substance is 
not an added substance and the quantity of the 
substance in the food does not ordinarily render 
the food injurious to health; 
(B)(i) that bears or contains any added 
poisonous or added deleterious substance (other 
than a substance that is a pesticide chemical 
residue in or on a raw agricultural commodity 
or processed food, a food additive, or a color 
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additive) that is unsafe within the meaning of 
section 406 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 346); 
(ii) that bears or contains a pesticide 
chemical residue that is unsafe within the 
meaning of section 408(a) of that Act (21 
U.S.C. 346a(a)); or 
(iii) that bears or contains— 
(I) any food additive that is unsafe 
within the meaning of section 409 of that 
Act (21 U.S.C. 348); or 
(II) a new animal drug (or conversion 
product thereof) that is unsafe within the 
meaning of section 512 of that Act (21 
U.S.C. 360b); 
(C) that consists in whole or in part of any 
filthy, putrid, or decomposed substance, or if 
the food is otherwise unfit for food; 
(D) that has been prepared, packed, or 
held under insanitary conditions whereby it may 
have become contaminated with filth or ren-
dered injurious to health; 
(E) that, in whole or in part, is the prod-
uct of a diseased animal or of an animal which 
has died otherwise than by slaughter; 
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(F) the container of which is composed, in 
whole or in part, of any poisonous or deleterious 
substance which may render the contents inju-
rious to health; 
(G) that has been intentionally subjected 
to radiation, unless the use of the radiation was 
in conformity with a regulation or exemption in 
effect pursuant to section 409 of that Act (21 
U.S.C. 348); 
(H)(i) of which any valuable constituent 
has been in whole or in part omitted or ab-
stracted therefrom; 
(ii) for which any substance has been sub-
stituted in whole or in part; 
(iii) for which damage or inferiority has 
been concealed in any manner; or 
(iv) to which any substance has been added 
or mixed or packed so as to increase the bulk 
or weight of the food, reduce the quality or 
strength of the food, or make the food appear 
better or of greater value than the food is; 
(I) that bears or contains a color additive 
which is unsafe within the meaning of section 
721(a) of that Act (21 U.S.C. 379e(a)); or 
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(J) that is transported or offered for 
transport by a shipper, carrier by motor vehicle 
or rail vehicle, receiver, or any other person en-
gaged in the transportation of food under con-
ditions that are not in compliance with regula-
tions promulgated under section 416 of that 
Act (21 U.S.C. 350e). 
(2) LIVESTOCK.—The term ‘‘livestock’’ has the 
meaning given the term in section 424(e) of the 
Federal Food, Drug, and Cosmetic Act. 
(3) MISBRANDED.—The term ‘‘misbranded’’, 
with respect to food intended for humans that is 
produced using animal cell culture technology, de-
rived from cell lines of livestock or poultry, means 
food— 
(A) the label of which— 
(i) does not bear— 
(I) the name of the food, in ac-
cordance with subsection (c); 
(II) in the case of the food being 
fabricated from two or more ingredi-
ents, the common or usual name of 
each ingredient, except that spices, 
flavorings, and colorings may, when 
authorized by the appropriate agency 
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head, be designated as spices, flavor-
ings, and colorings without naming 
each, provided that to the extent that 
compliance is impracticable, or results 
in deception or unfair competition, ex-
emptions shall be established by regu-
lations promulgated by the Secretary; 
or 
(III) an official inspection legend 
directly on the food or on the con-
tainer of the food and such other in-
formation as the Secretary requires to 
assure that the food will not have 
false or misleading labeling and that 
the public will be informed of the 
manner of handling required to main-
tain the food in a wholesome condi-
tion; 
(B) the label of which is false or mis-
leading; 
(C) that is in a package or other container 
the label of which does not bear— 
(i) the name and place of business of 
the manufacturer, packer, or distributor; 
or 
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(ii) an accurate statement of the 
quantity of the contents in terms of 
weight, measure, or numerical count, sub-
ject to— 
(I) reasonable variations per-
mitted by the Secretary; and 
(II) in the case of a small pack-
age or container, exemptions estab-
lished by the Secretary by regulation; 
(D) for which any word, statement, or 
other information required by the Secretary to 
appear on the label is not prominently placed 
on the label with such conspicuousness (com-
pared to any other words, statements, designs, 
or devices on the label) and in such terms as 
to render it likely to be read and understood by 
the ordinary individual under customary condi-
tions of purchase and use; 
(E) that is offered for sale under the name 
of another food; 
(F) that is an imitation of another food, 
unless the label bears the word ‘‘imitation’’, in 
type of uniform size and prominence, and the 
name of the food imitated immediately after the 
word ‘‘imitation’’; 
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(G) the container of which is made, 
formed, or filled as to be misleading; 
(H) that purports to be or is represented 
for special dietary uses but the label of which 
does not bear such information concerning the 
vitamin, mineral, and other dietary properties 
of the food as the Secretary, after consultation 
with the Secretary of Health and Human Serv-
ices, determines to be, and by regulations pre-
scribes as, necessary in order to inform pur-
chasers fully of the value of the food for those 
uses; or 
(I) that bears or contains any artificial fla-
voring, artificial coloring, or chemical preserva-
tive but the label of which does not state that 
fact, subject to exemptions established by the 
Secretary by regulation in cases of compliance 
being impracticable. 
(4) OFFICIAL INSPECTION LEGEND.—The term 
‘‘official inspection legend’’ means the symbol de-
scribed in subsection (b)(2). 
(5) POULTRY.—The term ‘‘poultry’’ has the 
meaning given the term in section 424(e) of the 
Federal Food, Drug, and Cosmetic Act. 
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(6) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Agriculture. 
(b) INSPECTIONS.— 
(1) IN GENERAL.—The Secretary shall inspect 
establishments that process, package, and label food 
intended for humans that is produced using animal 
cell culture technology, derived from cell lines of live-
stock or poultry— 
(A) to ensure that— 
(i) the food is— 
(I) not adulterated; and 
(II) not misbranded; and 
(ii) the establishment is operating in 
accordance with the regulations promul-
gated under paragraph (3). 
(2) OFFICIAL INSPECTION LEGEND.—The Sec-
retary shall establish an official inspection legend for 
the food described in paragraph (1), which shall be 
a symbol that shows that a product made from that 
food was inspected and passed in accordance with 
the regulations described in paragraph (3). 
(3) REGULATIONS.—The Secretary shall pro-
mulgate regulations regarding— 
(A) the manner and frequency of inspec-
tions required for— 
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(i) the food described in paragraph 
(1); and 
(ii) establishments that process, pack-
age, and label that food; and 
(B) the requirements for a product of the 
food described in paragraph (1) to satisfactorily 
pass an inspection and receive an official in-
spection legend, including— 
(i) sanitation and physical product in-
spection requirements; 
(ii) food product testing and record-
keeping requirements; and 
(iii) the requirement for Hazard Anal-
ysis and Critical Control Points verifica-
tion. 
(4) LIMITATION.—The Secretary shall not in-
spect activities of an establishment under section 
424 of the Federal Food, Drug, and Cosmetic Act 
that are solely regulated by the Secretary of Health 
and Human Services. 
(c) LABELING.— 
(1) IN GENERAL.—The Secretary shall— 
(A) approve, before introduction into com-
merce, the labeling of food intended for humans 
that is produced using animal cell culture tech-
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nology, derived from cell lines of livestock or 
poultry; and 
(B) verify the accuracy of that labeling 
through inspection. 
(2) REQUIREMENTS.—The Secretary shall es-
tablish, after providing notice and an opportunity for 
comment, any appropriate requirements in addition 
to the requirements under paragraph (1) to ensure 
the safety and accurate labeling of the food de-
scribed in paragraph (1)(A). 
(3) REGULATIONS.—The Secretary shall pro-
mulgate regulations— 
(A) to establish appropriate nomenclature 
for the labeling approved under paragraph 
(1)(A); and 
(B) to carry out paragraph (1)(B). 
(d) ENFORCEMENT.—The Secretary shall, pursuant 
to relevant enforcement authorities governing the regula-
tion of amenable species (as defined in section 1 of the 
Federal Meat Inspection Act (21 U.S.C. 601)), conduct 
such enforcement action as is necessary to ensure that 
food intended for humans that is produced using animal 
cell culture technology, derived from cell lines of livestock 
or poultry, that is adulterated or misbranded does not 
enter or is removed from commerce. 
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(e) COLLABORATION WITH HHS.—In carrying out 
this section, the Secretary shall— 
(1) review information shared by the Secretary 
of Health and Human Services under section 424(c) 
of the Federal Food, Drug, and Cosmetic Act; 
(2) share appropriate information relating to 
food intended for humans that is produced using 
animal cell culture technology, derived from cell lines 
of livestock or poultry, with the Secretary of Health 
and Human Services, as appropriate; and 
(3)(A) notify the Secretary of Health and 
Human Services if objectionable conditions at an es-
tablishment are identified under an inspection under 
subsection (b)(1); 
(B) collaborate with the Secretary of Health 
and Human Services to address those conditions 
with respect to cell harvesting; and 
(C) rely on the Secretary of Health and Human 
Services to address those conditions with respect to 
initial cell collection, development and maintenance 
of qualified cell banks, and proliferation and dif-
ferentiation of cells. 
Æ 
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