[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5728 Introduced in House (IH)]
<DOC>
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
Commerce, and in addition to the Committee on Agriculture, for a period
to be subsequently determined by the Speaker, in each case for
consideration 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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food Safety Modernization for
Innovative Technologies Act''.
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 derived
from cell lines of livestock or poultry.
``(b) Duties.--Pursuant to subsection (a), the Secretary 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 culture technology, derived from cell lines of
livestock or poultry and food intended for humans that is
produced 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;
``(2) oversee initial cell collection and the development
and maintenance of qualified cell banks, including by issuing
regulations or guidance and conducting inspections, as
appropriate;
``(3) oversee proliferation and differentiation of cells
through the time of cell harvest, including by issuing
regulations or guidance and conducting inspections, as
appropriate;
``(4) ensure that cell bank and cell culturing facilities
comply with facility registration, applicable good
manufacturing practices and preventive controls, 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 meaning of this chapter;
``(6) conduct appropriate inspections and follow-up
activities, including taking enforcement action if necessary,
to ensure that cell bank and cell-culturing facilities are in
compliance with applicable laws and regulations;
``(7) coordinate the transfer of regulatory oversight of
harvested cells derived from livestock or poultry to the
Secretary of the Department of Agriculture during cell harvest,
including providing such Secretary with any information
necessary to determine whether harvested cells are eligible to
be processed into food intended for humans that is produced
using animal cell culture technology, derived from cell lines
of livestock or poultry;
``(8) inspect establishments that process, package, and
label food intended for humans that is produced using animal
cell culture technology, derived from cell lines other than
livestock or poultry;
``(9) promulgate regulations regarding the safety and
accurate labeling of food intended for humans that is produced
using animal cell culture technology, derived from cell lines
other than livestock or poultry; and
``(10) establish appropriate nomenclature for food intended
for humans that is produced using animal cell culture
technology, derived from cell lines other than livestock or
poultry.
``(c) Collaboration With USDA.--In carrying out this section, the
Secretary shall share information, as appropriate, with the Department
of Agriculture, including notifying the Department of Agriculture if
objectionable conditions are identified at a facility carrying out any
of the activities described in subsection (b), including conditions
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 Poultry Product Inspection Act, as in effect on the
date of enactment of the Food Safety Modernization for Innovative
Technologies Act, with respect to the regulation of meat and poultry
produced in the traditional manner.
``(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, derived from cell lines of livestock or
poultry, means food--
(A) that bears or contains any poisonous or
deleterious substance which may render it injurious 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 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 rendered injurious to
health;
(E) that, in whole or in part, is the product of a
diseased animal or of an animal which has died
otherwise than by slaughter;
(F) the container of which is composed, in whole or
in part, of any poisonous or deleterious substance
which may render the contents injurious 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 abstracted therefrom;
(ii) for which any substance has been substituted
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
(J) that is transported or offered for transport by
a shipper, carrier by motor vehicle or rail vehicle,
receiver, or any other person engaged in the
transportation of food under conditions that are not in
compliance with regulations 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, derived 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
accordance with subsection (c);
(II) in the case of the food being
fabricated from two or more
ingredients, the common or usual name
of each ingredient, except that spices,
flavorings, and colorings may, when
authorized by the appropriate agency
head, be designated as spices,
flavorings, and colorings without
naming each, provided that to the
extent that compliance is
impracticable, or results in deception
or unfair competition, exemptions shall
be established by regulations
promulgated by the Secretary; or
(III) an official inspection legend
directly on the food or on the
container of the food and such other
information 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 maintain
the food in a wholesome condition;
(B) the label of which is false or misleading;
(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
(ii) an accurate statement of the quantity
of the contents in terms of weight, measure, or
numerical count, subject to--
(I) reasonable variations permitted
by the Secretary; and
(II) in the case of a small package
or container, exemptions established 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 (compared 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
conditions 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'';
(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 Services, determines to be, and by
regulations prescribes as, necessary in order to inform
purchasers fully of the value of the food for those
uses; or
(I) that bears or contains any artificial
flavoring, artificial coloring, or chemical
preservative 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 described 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.
(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 livestock 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 promulgated
under paragraph (3).
(2) Official inspection legend.--The Secretary 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 promulgate
regulations regarding--
(A) the manner and frequency of inspections
required for--
(i) the food described in paragraph (1);
and
(ii) establishments that process, package,
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 inspection legend,
including--
(i) sanitation and physical product
inspection requirements;
(ii) food product testing and recordkeeping
requirements; and
(iii) the requirement for Hazard Analysis
and Critical Control Points verification.
(4) Limitation.--The Secretary shall not inspect 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 commerce, the
labeling of food intended for humans that is produced
using animal cell culture technology, derived from cell
lines of livestock or poultry; and
(B) verify the accuracy of that labeling through
inspection.
(2) Requirements.--The Secretary shall establish, 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 described in paragraph (1)(A).
(3) Regulations.--The Secretary shall promulgate
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 regulation 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.
(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 establishment 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 differentiation of cells.
<all>
Food Safety Modernization for Innovative Technologies Act
#5728 | HR Congress #116
Policy Area: Health
Subjects: Administrative law and regulatory proceduresAdvanced technology and technological innovationsAgricultural practices and innovationsAnimal and plant healthConsumer affairsDepartment of AgricultureFood and Drug Administration (FDA)Food industry and servicesFood supply, safety, and labelingGovernment information and archivesHazardous wastes and toxic substancesLivestockMeatRadiationVeterinary medicine and animal diseases
Last Action: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. (1/30/2020)
Bill Text Source: Congress.gov
Summary and Impacts
Original Text