[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Proposed Rules]
[Pages 84269-84275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28534]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 /
Proposed Rules
[[Page 84269]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Chapter I
Food Safety and Inspection Service
9 CFR Chapter III
[Docket No. APHIS-2020-0079]
RIN 0579-AE60
Regulation of the Movement of Animals Modified or Developed by
Genetic Engineering
AGENCY: Animal and Plant Health Inspection Service, Department of
Agriculture (USDA); Food Safety and Inspection Service, USDA.
ACTION: Advance notice of proposed rulemaking and request for comments.
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SUMMARY: We are soliciting public comment on establishing regulations
for the movement of certain animals modified or developed by genetic
engineering. Under the regulatory framework being contemplated, the
United States Department of Agriculture would promulgate regulations
using the authorities granted to the Department through the Animal
Health Protection Act, the Federal Meat Inspection Act (FMIA), and the
Poultry Products Inspection Act (PPIA). Pursuant to these authorities,
the Animal and Plant Health Inspection Service would conduct a safety
assessment of animals subject to the FMIA or PPIA that have been
modified or developed using genetic engineering that may increase the
animal's susceptibility to pests or diseases of livestock, including
zoonotic diseases, or ability to transmit the same. The Food Safety and
Inspection Service would conduct a pre-slaughter food safety assessment
to ensure that the slaughter and processing of certain animals modified
or developed using genetic engineering would not result in a product
that is adulterated or misbranded.
DATES: We will consider all comments that we receive on or before
February 26, 2021.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0079.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2020-0079, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2020-
0079 or in our reading room, which is located in room 1620 of the USDA
South Building, 14th Street and Independence Avenue SW, Washington, DC.
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 799-7039 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. Alan Pearson, Assistant Deputy
Administrator, Biotechnology Regulatory Services; APHIS, 4700 River
Road, Unit 98, Riverdale, MD 20737-1238; (301) 851-3944;
[email protected]. Dr. Kis Robertson Hale, Deputy Assistant
Administrator, Office of Public Health Science, USDA Food Safety and
Inspection Service, 1400 Independence Avenue SW, Room 341-E. Whitten
Building; (202) 720-4819; [email protected].
SUPPLEMENTARY INFORMATION:
Background
Statutory Authorities
Under the Animal Health Protection Act (7 U.S.C. 8301, et seq.)
(AHPA), the Animal and Plant Health Inspection Service (APHIS) of the
United States Department of Agriculture (USDA) is authorized, among
other things, to prohibit or restrict the importation and interstate
movement of live animals to prevent the introduction and dissemination
of diseases and pests of livestock within the United States. The AHPA
broadly defines the terms ``livestock'' as ``all farm-raised animals''
(7 U.S.C. 8302(10)), and ``animal'' as ``any member of the animal
kingdom (except a human)'' (7 U.S.C. 8302(1)). Importantly, these
definitions do not place any conditions or restrictions on the method
by which the animal has been produced, whether it is through
conventional breeding or genetic engineering. (We provide illustrative
examples of conventional breeding and a working definition of the term
genetic engineering later in this document, beneath the heading
``Contemplated Regulatory Framework.'') The AHPA also establishes broad
definitions of ``import,'' ``interstate commerce,'' and how animals and
products ``move'' in commerce. (7 U.S.C. 8302(7), (9), (12)). The
statute provides that the term ``disease'' has the meaning given the
term by the Secretary of Agriculture (7 U.S.C. 8302(3)), although that
term has remained undefined to date, and provides that the Secretary
may promulgate such regulations and issue such orders as the Secretary
determines necessary to carry out the responsibilities under the AHPA.
(7 U.S.C. 8315). Collectively, these provisions provide ample authority
for the Secretary of Agriculture to promulgate regulations for the pre-
market review and oversight of animals modified or developed using
genetic engineering and intended for importation, interstate movement,
or environmental release if there is reason to believe that such
movement may present a pest or disease risk to livestock.
USDA's Food Safety and Inspection Service (FSIS) has been delegated
the authority to exercise the functions of the Secretary (7 CFR 2.18,
2.53) as specified in 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.). Specifically, FSIS protects the public by verifying that
meat and poultry products are safe, wholesome, unadulterated, and
properly labeled and packaged. FSIS verification programs include ante-
mortem and post-mortem inspection of livestock and poultry intended for
use as human food, as well as the inspection of meat and poultry
products for processing. Livestock subject to FSIS jurisdiction under
the FMIA (defined as ``amenable species'' at 21 U.S.C. 601(w)) are
cattle, sheep, swine, goats, horses, mules, or other equines, and fish
of the order Siluriformes. Poultry subject to FSIS jurisdiction under
the PPIA (defined as ``any domesticated bird,
[[Page 84270]]
whether live or dead'' at 21 U.S.C. 453(3)) are chickens, turkeys,
ducks, geese, guineas, ratites, and squabs, as listed in the
regulations at 9 CFR 381.1. Under both statutes, FSIS prevents
adulterated or misbranded meat and poultry products from entering
commerce, working with the Food and Drug Administration (FDA), which
determines the safety of food additives and animal drug residues.
``Adulterated'' is defined in the FMIA and PPIA (21 U.S.C. 601(m) and
453(g), respectively) as a number of conditions that may render meat or
poultry to be injurious to human health, otherwise cause meat or
poultry to be unfit for human food, or make a meat or poultry product
appear better or of greater value than it is. ``Misbranded'' is defined
in the FMIA and PPIA (21 U.S.C. 601(n) and 453(h), respectively) as
several types of product labeling or representation of a meat or
poultry product that are false or misleading.
USDA acknowledges that the number of species subject to APHIS'
purview under the AHPA is significantly greater than the number of
species subject to FSIS' purview under the FMIA and PPIA. For purposes
of this document and the contemplated regulatory framework discussed in
it, USDA limits its discussion to species subject to both APHIS and
FSIS purview.\1\ This is not intended to infer any limitations or
restrictions regarding APHIS' statutory authority in this matter.
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\1\ For example, although APHIS has authority over all farmed
aquaculture under the AHPA, the contemplated regulatory framework
would pertain only to farmed Siluriformes intended for human food
because this is the only aquaculture subject to FSIS authority under
the FMIA.
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Coordinated Framework for the Regulation of Biotechnology
Along with the Environmental Protection Agency (EPA) and FDA, USDA
(APHIS and FSIS) is responsible for the oversight and review of
organisms modified or developed using genetic engineering and the foods
derived from them. In 1986, the Coordinated Framework for the
Regulation of Biotechnology (Coordinated Framework) \2\ was published
by the Office of Science and Technology Policy (OSTP). The Coordinated
Framework explains the regulatory roles for USDA (APHIS and FSIS), EPA,
and the FDA, and how Federal agencies use existing Federal statutes to
ensure public health and environmental safety while maintaining
regulatory flexibility to avoid impeding the growth of the
biotechnology industry. The Coordinated Framework was subsequently
updated in 1992 (see 57 FR 6753). A 2016 document issued by OSTP,
discussed immediately below, led to a third update to the Coordinated
Framework in 2017.
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\2\ To view the 1986 framework, go to https://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf.
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In 2016, OSTP issued the National Strategy for Modernizing the
Regulatory System for Biotechnology Products (National Strategy).\3\
Recognizing that rapid scientific advances would result in novel types
of products, the National Strategy stated that EPA, FDA, and USDA
should continue to examine their regulatory structures with the goal of
clarifying how the Federal Government will regulate genetically
engineered insects and noted that the agencies are working to better
align their responsibilities over genetically engineered insects with
their traditional oversight roles. (For example, the 2016 National
Strategy highlighted the agencies' work to consider mechanisms that
would enable EPA to regulate mosquitoes under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136, et seq.) as a pesticide,
when the developer claims the mosquitoes are intended for population
control, FDA to regulate them when a developer makes a disease
claim,\4\ and USDA to regulate them using its authorities \5\ to
control of certain plant or animal pest insects.
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\3\ To view, go to https://www.epa.gov/sites/production/files/2016-12/documents/biotech_national_strategy_final.pdf.
\4\ Under the Federal Food, Drug, and Cosmetic Act (FD&C Act, 21
U.S.C. 301, et seq.; see 21 U.S.C. 321(g)).
\5\ Plant Protection Act of 2000; (PPA, 7 U.S.C. 7701 et seq.)
and Animal Health Protection Act (7 U.S.C. 8301, et seq.).
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As a result of the National Strategy, the Coordinated Framework was
then updated in 2017,\6\ taking into account advances that had occurred
in the field of biotechnology. The 2017 update pointed out that the
complexities of the regulatory systems make it difficult for the public
to understand how the safety of biotechnology products is evaluated and
create challenges for small and mid-sized businesses navigating the
regulatory process for the products.
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\6\ To view the 2017 update to the Coordinated Framework, go to:
https://www.aphis.usda.gov/biotechnology/downloads/2017_coordinated_framework_update.pdf.
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Further, on June 11, 2019, the President signed an Executive Order
on Modernizing the Regulatory Framework for Agriculture Biotechnology
products in order to conduct improved Federal oversight of agricultural
biotechnology products that is science-based, timely, efficient, and
transparent. The Executive Order pointed out that for many national
imperatives for food production and rural prosperity to be realized,
the Federal biotechnology regulatory system must both foster public
confidence in the technology and avoid undue regulatory burdens.
Current Federal Regulatory Approach for Animals Modified or Developed
Through Genetic Engineering
Currently, FDA regulates intentional genomic alterations in animals
as animal drugs under the FD&C Act; Institute for Fisheries Resources
v. Hahn, 424 F. Supp. 3d 740, 751 (N.D. Cal. 2019), except for mosquito
products as described in the 2017 FDA Guidance for Industry #236
entitled ``Clarification of FDA and EPA Jurisdiction Over Mosquito-
Related Products,'' \7\ and genetically engineered plant pests, which
are subject to APHIS regulation under the Plant Protection Act (7
U.S.C. 7701, et seq.).\8\ FDA's oversight of intentional genomic
alterations in animals includes an evaluation of food safety, safety to
the animal, and effectiveness. Although sponsors are generally required
to have an approved new animal drug application for intentional genomic
alterations in animals prior to marketing, FDA has exercised
enforcement discretion for certain low-risk alterations, such as
intentional genomic alterations in aquarium fish intended to cause the
fish to fluoresce or intentional genomic alterations in animals of
food-producing species intended for use as models of disease.
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\7\ To view GFI #236, go to: https://www.fda.gov/media/102158/download.
\8\ FDA has exercised enforcement discretion over certain
intentional genomic alterations in animals of non-food-species that
are regulated by other government agencies or entities, such as
plant or animal pest insects modified or developed using genetic
engineering for plant pest control or animal health protection,
which are under APHIS oversight.
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Contemplated Regulatory Framework
In consultation with FDA, USDA is contemplating regulations that
would establish a flexible, risk- and science-based regulatory
framework for the regulation of certain animals modified or developed
using genetic engineering that are intended for agricultural purposes.
(For purposes of our contemplated regulatory framework, we envision
genetic engineering to mean ``techniques that use recombinant,
synthesized, or amplified nucleic acids to modify or create a genome''
(see 7 CFR 340.3). Thus, it would not include conventional breeding
methods such as directed breeding, artificial insemination, embryo
transfer, selective breeding, cross breeding, genetic
[[Page 84271]]
backgrounding for purposes of studding, or other practices commonly
available to and employed by producers.) Under this contemplated
regulatory framework, USDA would in most instances provide end-to-end
regulatory oversight from pre-market reviews through post-market food
safety monitoring for animals modified or developed using genetic
engineering intended for use as human food that are subject to the FMIA
or the PPIA (cattle, sheep, goats, swine, horses, mules, or other
equines,\9\ and fish of the order Siluriformes, domesticated chickens,
turkeys, ducks, geese, guineas, ratites, and squabs). Instances where
this would not be the case are discussed later in this document. USDA
also would provide pre-market animal health regulatory oversight for
cattle, sheep, goats, swine, horses, mules, other equines, fish of the
order Siluriformes, domesticated chickens, turkeys, ducks, geese,
guineas, ratites, and squabs modified or developed using genetic
engineering intended for agricultural purposes other than human or
animal food (e.g., fiber or labor). For ease of reading, we refer to
the animals listed in this paragraph that are modified or developed
using genetic engineering and intended for agricultural purposes as
``amenable species modified or developed using genetic engineering.''
As discussed above, ``amenable species'' is a statutorily defined
phrase under the FMIA and used generally by FSIS to refer to livestock
and poultry species subject to the FMIA or PPIA. Since the contemplated
regulatory framework would apply to certain foods only from those
species, we use this phrase for the rest of the document, except where
context dictates otherwise (e.g., when the use of the phrase could be
misconstrued to suggest that a USDA determination that would apply only
to a particular animal would instead apply to the entire species).
USDA's safety reviews would focus on risks to animal health and human
health, by:
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\9\ Horses, mules, and other equines are subject to FSIS
jurisdiction under the FMIA, but there are no USDA-inspected horse
slaughter establishments in the United States, and USDA is currently
prohibited from spending funds to perform ante-mortem inspection of
horses for human consumption.
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Ensuring that the animal of the amenable species that has
been modified or developed using genetic engineering and that is
subject to the review is not more susceptible to pests or disease of
livestock (infectious and non-infectious), or more likely to spread
pests or infectious diseases of livestock, including zoonotic diseases,
than animals from the same species that were not modified or developed
using genetic engineering.
Regulating the importation, interstate movement, and
environmental release of the animal of the amenable species that has
been modified or developed using genetic engineering accordingly.
Ensuring that animals of the amenable species modified or
developed using genetic engineering that are intended to enter the food
supply are safe for human consumption by ensuring such animals would
not result in a meat or poultry product that is adulterated or
misbranded, using the same statutory criteria used for meat and poultry
products made from animals produced without genetic engineering.
Providing permits for the import, interstate movement, or
environmental release (i.e., controlled field trials to evaluate the
animals) of amenable species modified or developed using genetic
engineering.
Having clear mechanisms for APHIS deregulation when the
animal under review is found to pose no greater risk to animal health
than the animal from which it was derived.
The contemplated regulatory framework for amenable species modified
or developed using genetic engineering is intended to operate under a
Memorandum of Understanding (MOU) with FDA consistent with each
agency's authorities and statutory obligations and informed by the
comments received in response to this advance notice of proposed
rulemaking and request for comments. A MOU would facilitate an orderly
transition of the oversight of amenable species modified or developed
using genetic engineering for certain intended uses from FDA to USDA
once USDA's regulatory program is established. A MOU would set clear
roles, responsibilities, and timeframes for the interaction between FDA
and USDA.
As described, under the contemplated regulatory framework, USDA
would in most instances serve as a single point of entry for amenable
species modified or developed using genetic engineering that are
intended for agricultural purposes and would provide coordinated end-
to-end regulatory oversight from pre-market animal pest and disease
risk and human food safety reviews through post-market human food
safety reviews for amenable species modified or developed using genetic
engineering intended for use as human food. USDA also would provide
pre-market animal health regulatory oversight of amenable species
modified or developed using genetic engineering intended for
agricultural purposes other than human food (e.g., fiber or labor).
Under the contemplated regulatory framework, USDA would not regulate
amenable species modified or developed using genetic engineering
intended for non-agricultural purposes, including medical and
pharmaceutical purposes (other than veterinary biologics), and gene
therapies. FDA would continue its review of intentional genomic
alterations in these amenable species as well as the regulation of
dairy products, table and shell eggs, and animal food (feed) that are
derived from amenable species. In addition, FDA would continue its
review of intentional genomic alterations in animals and the animal
food products derived from them that are not subject to the FMIA or
PPIA and not previously determined by FDA to be low risk.
The regulatory framework that USDA is considering would be
conceptually similar to the recently updated USDA regulations for the
movement of organisms, notably plants, modified or developed using
genetic engineering, which are found in 7 CFR part 340. However, due to
the differences in experience, biology, and breeding practices of
animals as compared to plants, there would be some differences between
these regulatory frameworks. For example, although 7 CFR part 340
includes up-front exemptions from the regulations for certain types of
modifications, we envision that all amenable species modified or
developed using genetic engineering and intended for agricultural
purposes would be subject to permitting requirements for their import,
interstate movement, or environmental release until they have undergone
an expedited safety review or an animal health risk assessment and been
determined not to pose an increased risk to animal health. We do seek
comment on this issue.
Under the contemplated regulatory framework, developers could
request that USDA conduct a risk-based and science-based safety review
focused on animal health; if the animal of an amenable species has been
modified or developed using genetic engineering and is intended for use
as human food, then the risk-based and science-based safety review
would also be focused on food safety. Depending on the conclusions of
the review, the animal subject to the safety review could be determined
to not require a permit for import, interstate movement, or
environmental release under regulations issued pursuant to this
framework, and, if such animal is intended for use as human food, it
could be eligible for inspection and to be marked ``Inspected
[[Page 84272]]
and Passed,'' as free from adulteration, at any USDA-inspected meat
packing facility.
We envision a two-tiered system for such reviews. First, USDA is
considering an expedited safety review for any genetic modification
made that is already known to occur in the gene pool of the species,
except in cases where an animal health claim is made for the animal or
the modification is known to adversely affect animal health.\10\ The
purpose of the review would be to verify, through a molecular
characterization of the modification and an understanding of the
process by which it was introduced, that the intended change was made
and that there were no unintended disruptions of endogenous genes,\11\
unintended DNA insertions, or off-target changes if the genome was
modified without inserting DNA. The expedited safety review would
assess whether the modification made using genetic engineering is
equivalent to what can be accomplished through conventional breeding
practices to ensure that the animal presents no increased risk relative
to the animal from which it was derived, including the verification
process described above. If USDA finds that the modification made using
genetic engineering is equivalent to what can be accomplished through
conventional breeding practices, the animal would not be subject to
further regulation under the contemplated regulatory framework, and
USDA would issue a notice in the Federal Register that the animal of
the amenable species modified or developed using genetic engineering
poses no increased risk to animal health or human health relative to
the animal from which it was derived.
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\10\ When an animal health claim is made or a modification is
known to adversely affect animal health and the animal otherwise
qualifies for an expedited safety review, USDA would undertake
additional review that focuses on the animal health modification,
including validation of any animal health claim.
\11\ Endogenous genes are pre-existing genes in the genome of
the animal being modified or developed using genetic engineering.
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If, as part of the expedited safety review, USDA finds that the
animal of the amenable species modified or developed using genetic
engineering has one of the aforementioned unintended changes, the
submitter will be informed. A permit would be required for import,
interstate movement, or environmental release of such animal until USDA
completes a full animal health risk assessment, and, if the animal of
the amenable species modified or developed using genetic engineering is
intended for use as human food, a food safety assessment, as described
below. For all other types of modifications that are not eligible for
expedited safety review, a permit would likewise be required for the
importation, interstate movement, or environmental release of the
animal of the amenable species that had been modified or developed
using genetic engineering, until USDA conducted an animal health risk
assessment of the animal and, if the animal is intended for use as
human food, a food safety assessment, and determined that there was no
additional animal health risk relative to an appropriate comparator.
Review Under the AHPA
The animal health risk assessment would identify any plausible
increased risks to animal health or to human health, relative to the
risk posed by animals from the same species that were not modified or
developed using genetic engineering. In particular, the risk assessment
would examine whether the animal could plausibly exhibit increased
susceptibility to pests, non-infectious diseases, or infectious
diseases of livestock, including zoonotic diseases, or increased
ability to transmit such pests or diseases. If a plausible increased
risk is identified, USDA would evaluate the scientific data submitted
by the developer to ensure that the animal of the amenable species
modified or developed using genetic engineering would not pose an
increased risk to animal health as compared with animals from the same
species that were not modified or developed using genetic engineering.
If the risk assessment concludes that the animal is unlikely to
pose an increased risk to animal health relative to the animal from
which it was derived, USDA would make the risk assessment available for
public comment through a notice published in the Federal Register. If
no new information emerges that changes USDA's conclusion, USDA would
determine that the animal of the amenable species that had been
modified or developed using genetic engineering is not regulated under
the contemplated regulatory framework. If the risk assessment is unable
to reach such conclusion, the animals of the amenable species that had
been modified or developed using genetic engineering would remain
regulated, and a permit would be needed for importation, interstate
movement, or environmental release. APHIS and FSIS would coordinate in
these situations to determine whether such animals would be eligible
for slaughter. A developer could request a re-review at any time and
would be able to provide additional information. USDA would keep the
developer apprised of the review's progress.
Additionally, when USDA is unable to reach a conclusion that the
animal is unlikely to pose an increased risk to animal health relative
to the animal from which it was derived, the developer could request
that USDA seek public comment on its risk assessment. Where appropriate
when conducting this review, USDA would consult with FDA as described
in a MOU.
At a minimum, the animal health risk assessment would include an
evaluation of the following issues:
Molecular Characterization: What is the genetic
modification(s) in the animal, how was the genetic modification(s)
introduced, and how does the genetic modification(s) alter protein or
ribonucleic acid (RNA expression)?
Animal Health: Is there scientific evidence that the
modified animal could plausibly, either directly or indirectly,
increase susceptibility of livestock, including of the animal itself,
to pests, non-infectious diseases, or infectious diseases of livestock,
including zoonotic diseases? Is there scientific evidence that the
modified animal could plausibly increase the spread of pests or
infectious diseases of livestock, including zoonotic diseases? When a
plausible pathway to such an increased risk is identified, further
analysis would be conducted to evaluate the pathway. When an animal
health claim is made or a modification is known to adversely affect
animal health, the review would assess the animal health claim.
Environmental Factors: Is there scientific evidence that
introduction of the modified animal into the environment may result in
environmental impacts that would warrant review pursuant to the
National Environmental Policy Act (NEPA) or other statutes?
Review Under the FMIA and PPIA
Under the contemplated regulatory framework, FSIS would require
food safety assessments of animals of amenable species modified or
developed using genetic engineering pursuant to its authorities under
the FMIA and PPIA, primarily using its authority to conduct ante-mortem
inspections of livestock and poultry presented for slaughter. A
discussion of these authorities and how they might be applied within
the contemplated regulatory framework for amenable species modified or
developed using genetic engineering follows.
[[Page 84273]]
As discussed above, under FMIA, FSIS has authority to prevent
adulterated meat and meat food products derived from amenable livestock
and intended for human consumption from entering commerce. Currently,
the amenable livestock eligible for inspection include cattle, sheep,
swine, goats, horses, mules, and other equines, and fish of the order
Siluriformes. The statute defines ``meat food product'' as ``any
product capable of use as human food which is made wholly or in part
from any meat or other portion of the carcass of any cattle, sheep,
swine, or goats, excepting products which contain meat or other
portions of such carcasses only in a relatively small proportion or
historically have not been considered by consumers as products of the
meat food industry, and which are exempted from definition as a meat
food product by the Secretary under such conditions as he may prescribe
to assure that the meat or other portions of such carcasses contained
in such product are not adulterated and that such products are not
represented as meat food products'' (21 U.S.C. 601(j)). The statute
provides that ``this term as applied to food products of equines shall
have a meaning comparable to that provided . . . with respect to
cattle, sheep, swine, and goats.'' Id.
The FMIA requires that, ``for the purpose of preventing the use in
commerce of meat or meat food products which are adulterated, the
Secretary shall cause to be made, by inspectors appointed for that
purpose, an examination and inspection of all amenable species before
they shall be allowed to enter into any slaughtering, packing, meat-
canning, rendering, or similar establishment, in which they are to be
slaughtered and the meat and meat food products thereof are to be used
in commerce . . . '' (21 U.S.C. 603(a)) (emphasis added). The FMIA also
provides for the post-mortem inspection of meat and meat food products.
Specifically, the statute provides that ``[t]he Secretary shall cause
to be made, by inspectors appointed for that purpose, an examination
and inspection of all meat food products prepared for commerce in any
slaughtering, meat-canning, salting, packing, rendering, or similar
establishment, and for the purposes of any examination and inspection
and inspectors shall have access at all times, by day or night, whether
the establishment be operated or not, to every part of said
establishment; and said inspectors shall mark, stamp, tag, or label as
`Inspected and passed' all such products found to be not adulterated;
and said inspectors shall label, mark, stamp, or tag as `Inspected and
condemned' all such products found adulterated; and all such condemned
meat food products shall be destroyed for food purposes, as
hereinbefore provided and the Secretary may remove inspectors from any
establishment which fails to so destroy such condemned meat food
products'' (21 U.S.C. 606) (emphasis added).
Similarly, the PPIA provides FSIS with authority to prevent
adulterated poultry and poultry products for human consumption from
entering commerce (21 U.S.C. 451, et seq.). The statute defines
``poultry'' as ``any domesticated bird, whether live or dead'' (21
U.S.C. 451(e)). Regulations promulgated under the Act define the
domesticated poultry species to include chickens, turkeys, ducks,
geese, guineas, ratites and squabs (9 CFR 381.1(b)). The statute
defines ``poultry product'' as ``any poultry carcass, or part thereof;
or any product which is made wholly or in part from any poultry carcass
or part thereof, excepting products which contain poultry ingredients
only in a relatively small proportion or historically have not been
considered by consumers as products of the poultry food industry, and
which are exempted by the Secretary from definition as a poultry
product under such conditions as the Secretary may prescribe to assure
that the poultry ingredients in such products are not adulterated and
that such products are not represented as poultry products'' (21 U.S.C.
451(f)).
The PPIA permits the Secretary to conduct an ante-mortem inspection
of every live animal before slaughter. Specifically, the statute
provides: ``For the purpose of preventing the entry into or flow or
movement in commerce of, or the burdening of commerce by, any poultry
product which is capable of use as human food and is adulterated, the
Secretary shall, where and to the extent considered by him necessary,
cause to be made by inspectors ante-mortem inspection of poultry . .
.'' (21 U.S.C. 455(a)) (emphasis added). Like the FMIA, the PPIA
contemplates an inspection of live animals in order to exclude animals
from the slaughter process that could result in the production of
adulterated product. The PPIA also requires the Secretary to conduct a
post-mortem inspection of every carcass and to inspect processed
products as the Secretary deems necessary (21 U.S.C. 455(b)): ``The
Secretary, whenever processing operations are being conducted, shall
cause to be made by inspectors post-mortem inspection of the carcass of
each bird processed, and at any time such quarantine, segregation and
reinspection as he deems necessary of poultry and poultry products
capable of use as human food in each official establishment processing
such poultry or poultry products for commerce or otherwise subject to
inspection under this Act'' (21 U.S.C. 455(b)). Further, ``[a]ll
poultry carcasses and parts thereof and other poultry products found to
be adulterated shall be condemned and shall, if no appeal be taken from
such determination of condemnation, be destroyed for human food
purposes under the supervision of an inspector; Provided, That
carcasses, parts, and products, which may by reprocessing be made not
adulterated, need not be so condemned and destroyed if so reprocessed
under the supervision of an inspector and thereafter found to be not
adulterated'' (21 U.S.C. 455(c)) (emphasis added).
Both the FMIA and PPIA contain definitions of the term
``adulterated'' (21 U.S.C. 601(m) and 453(g), respectively) that
describe a number of conditions that may render meat or poultry to be
injurious to human health, otherwise cause meat or poultry to be unfit
for human food, or make a meat or poultry product appear better or of
greater value than it is. As previously noted, meat, meat food
products, poultry, and poultry products cannot be sold or distributed
in commerce for use in human food until an inspector makes an
affirmative determination that the product is not adulterated. Both
statutes also define ``misbranded'' as several types of product
labeling or representation of a meat or poultry product that are false
or misleading (21 U.S.C. 453(h) and 601(n)). Under the approach
contemplated in this document, USDA would conduct a pre-slaughter food
safety assessment utilizing the ante-mortem and adulteration provisions
of the FMIA and PPIA cited above to ensure that an animal of the
amenable species modified or developed using genetic engineering would
not result in a product that is adulterated or misbranded.
An issue to be addressed would be the timing of the pre-slaughter
food safety assessment for animals modified or developed using genetic
engineering. As discussed above, both statutes provide for ante-mortem
inspection of live animals in order to prevent adulterated product from
being sold or distributed in commerce (21 U.S.C. 455(a), 603(a)).
Neither statute specifies how far in advance examinations or reviews
relative to this inspection can occur. Thus, on their face, these
statutes would appear to authorize USDA to
[[Page 84274]]
promulgate a regulation requiring a food safety review of animals of
amenable species modified or developed using genetic engineering before
arrival at the slaughter facility in order to ensure that the meat or
poultry derived from such animals would not be adulterated under the
FMIA and PPIA.
Such a conclusion would appear to be consistent with the text of
these statutory provisions and the purposes that the statutory text was
enacted to further. Providing for review before arrival at the
slaughter facility would further the purposes of the provisions of the
FMIA and the PPIA that provide for ante-mortem inspection of live
animals and, more generally, of the inspection regimes established by
the FMIA and the PPIA. Historically, inspectors assigned to work in
slaughtering and processing facilities have used a variety of tools,
including sensory examination and available laboratory testing, to
determine whether meat or poultry products are adulterated within the
meaning of the statutes at the time of slaughter or processing. Because
certain laboratory tests can take days to finalize, the inspectors
require sampled carcasses and products to be held at the establishment
until the laboratory tests are completed. For animals of the amenable
species modified or developed using genetic engineering, however, a
FSIS inspector would likely be unable to make an ``on the spot''
determination about whether the live animal should be segregated, or
whether the meat or poultry product is adulterated at the time the
animal is presented for inspection at the slaughter facility using
currently available testing methodologies and inspection techniques.
Live animals of the amenable species modified or developed using
genetic engineering and their carcasses typically will not be
distinguishable from conventionally produced animals based on their
physical appearance. Also, there currently is no generally applicable
test that could be administered in the slaughter facility to determine
whether the animal was modified or developed using genetic engineering
or whether the genetic modification would render the resulting meat or
poultry product adulterated within the meaning of the statutes.
Therefore, as a practical matter, unless there is a pre-slaughter (or
pre-market) safety review, FSIS inspectors would be unable to determine
that meat or poultry products derived from animals modified or
developed using genetic engineering are not adulterated. By operation
of the statutes and regulations, such a product would be precluded from
being marked as ``Inspected and Passed,'' and thus could not be sold or
distributed in commerce for human food, until a food safety assessment
was completed and the meat was determined to not be adulterated.
FSIS Review
For the food safety assessment, FSIS would evaluate the scientific
data submitted by the developer to ensure that the animal of amenable
species modified or developed using genetic engineering would not
result in products that are adulterated as defined under the Acts. FSIS
would also examine whether genetic engineering may result in meat and
poultry products being misbranded, i.e., labeled in a false or
misleading manner, which is prohibited by both the FMIA and PPIA. At a
minimum, the FSIS assessment would include an evaluation of the
following issues:
Evaluation of expressed substances: Is there scientific
evidence that the genetic modification could result, directly or
indirectly, in toxins, chemical residues, or other potentially
deleterious substances in meat or poultry products?
Allergenicity: Is there scientific evidence that the
genetic modification would directly or indirectly alter the allergenic
potential of meat or poultry products derived from the animal?
Food storage and processing: Is there scientific evidence
that meat or poultry products derived from the modified animal could
mislead consumers regarding wholesomeness or the need for appropriate
storage (e.g., meat that maintains a red appearance even when spoiled)?
Compositional analyses of key components: Is there
scientific evidence that meat or poultry products from the modified
animal are compositionally (e.g., nutritionally or functionally) no
different than meat from conventional animals, such that it meets any
regulatory definition, standard of identity or other labeling
requirement, and consumer expectations for the applicable product?
Request for Comments
We are soliciting public comments on all aspects of this document,
including the contemplated regulatory framework as described herein,
with particular attention on the following questions:
Scope of Regulations and Review
The contemplated regulatory framework would apply to
animals of the ``amenable species'' (cattle, sheep, goats, swine,
horses, mules, other equines, fish of the order Siluriformes, chickens,
turkeys, ducks, geese, guineas, ratites, and squabs) modified or
developed using genetic engineering that are ``intended for
agricultural purposes'' such as human or animal food, fiber, and labor.
What are the agricultural uses for ``amenable species'' other than use
as human or animal food? Should the contemplated regulatory framework
define ``agricultural purposes other than food''? If so, how should it
be defined?
Is the safety review process described above (see
``Contemplated Regulatory Framework'') appropriate to protect human
health, including for both human consumption and disease transmission?
Why or why not?
Is the safety review process described above (see
``Contemplated Regulatory Framework'') appropriate to protect livestock
health of both the target animal and its herd or flock? Why or why not?
Are there types of modifications that should make an
animal of an amenable species modified or developed using genetic
engineering eligible or ineligible for the expedited safety review
process outlined above?
How should USDA define ``off-target changes'' for the
purposes of expedited review of animals in which modifications already
known to occur in the gene pool of the species are made without the
insertion of DNA?
Should USDA exempt certain types of genetic modifications
of amenable species intended for agricultural use from regulation? If
so, what types of modifications and why?
Which types of genetic modifications should not be
exempted from regulation? Why?
Should any entities or activities be exempt from
regulation? If so, what types of entities and why? If not, why not?
Are there any statutory or regulatory constraints and/or
advantages that need to be considered?
Risk Assessment Process
How should USDA assess risks to animal health? Which pest
or disease risks should be considered? Should any other adverse effects
(e.g., specific adverse effects on the biology of the animal modified
or developed using genetic engineering) be considered? Please be
specific and include examples when possible.
Under what circumstances would a controlled animal safety
study be needed versus general surveillance over the health of the
herd?
What information, beyond that described in the
``Contemplated Regulatory Framework'' section of the
[[Page 84275]]
document, would USDA need to consider in order to properly review and
assess risks associated with amenable species modified or developed
using genetic engineering that are intended for agricultural purposes?
Are there limitations to the types of information that could be
gathered or technologies that could be used to inform the evaluation of
animal health claims? If so, please describe the limitations.
What is the minimal information would need to consider to
evaluate animal disease claims made for the animals of the amenable
species modified or developed using genetic engineering? What are the
limitations of current technologies that exist to evaluate animal
disease claims?
What other animal health claims, aside from disease
resistance, should USDA require developers to validate? Why?
Under the current proposal, USDA is not performing a post-
market evaluation of animal health. Should USDA require developers to
submit information in order to monitor risks to animal health post-
market? Why?
Are there any gaps in the contemplated framework with
respect to animal and human health, and if so, how might they be
addressed?
Regulatory Authority and Framework
Does the contemplated regulatory framework provide
adequate scope and flexibility to regulate current and future advances
in agricultural animals developed using genetic engineering?
What, if any, terms related to the regulation of animals
of the amenable species modified or developed using genetic engineering
would need to be defined under the contemplated regulatory framework?
Should animals of the amenable species modified or
developed using genetic engineering with multiple uses (such as an
amenable species modified or developed using genetic engineering and
intended for both biomedical/pharmaceutical purposes and agricultural
purposes) receive any different treatment than other amenable species
during USDA's review processes? What steps should USDA take to ensure
efficient review of these products? What steps should USDA take to
account for existing regulatory burden when a product must be reviewed
both by USDA and by another agency?
Do you have any other specific concerns or recommendations
for appropriately reducing regulatory burdens involving the regulation
of amenable species modified or developed using genetic engineering by
USDA as described in this document?
Genetic Engineering and Conventional Breeding
What are the known current limits of conventional breeding
in animals in terms of generating and/or selecting for a specific
trait, or multiple traits?
What problems are entities currently attempting to solve
using animals modified or developed using genetic engineering?
FSIS Assessment
Would the pre-slaughter assessment ever require physical
examination or testing by FSIS of amenable species modified or
developed using genetic engineering, specifically examination or
testing in regard to their genetic modifications, prior to arrival at
the slaughter facility? If so, under what circumstances?
What documentation, if any, should accompany amenable
species modified or developed using genetic engineering destined for
slaughter, certifying that their modifications have been assessed by
USDA (APHIS and FSIS)?
Economic Considerations
What classes of entities are currently engaged in the
modification, production, breeding, distribution, commercialization or
any related activities involving animals modified or developed using
genetic engineering? How many of these entities fall within or below
the threshold for ``small entity'' size standards according to the
Small Business Administration?
What markets are there where animals for agricultural use
modified or developed using genetic engineering have been produced and
commercialized? What challenges and opportunities (regulatory,
economic, or otherwise) have been encountered by the relevant
authorities?
How often does a start-up company or not-for-profit
university or research organization modify or develop an animal using
genetic engineering?
Could the contemplated regulatory framework have adverse
impacts on international trade (imports or exports)? If so, what?
Should USDA assess user fees in connection with conducting
reviews for animals modified or developed using genetic engineering? If
so, how should USDA structure the fees? What factors should USDA
consider in assessing fees?
We welcome all comments on the questions outlined above and on all
aspects of this document.
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Done in Washington, DC, this 18th day of December 2020.
Lorren Walker,
Acting Under Secretary for Marketing and Regulatory Programs.
Paul Kiecker,
Administrator, Food Safety and Inspection Service.
[FR Doc. 2020-28534 Filed 12-23-20; 8:45 am]
BILLING CODE 3410-34-P