[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]


 ========================================================================
 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.
 
 ========================================================================
 

  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.

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

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \2\ To view the 1986 framework, go to https://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \6\ To view the 2017 update to the Coordinated Framework, go to: 
https://www.aphis.usda.gov/biotechnology/downloads/2017_coordinated_framework_update.pdf.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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:
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

     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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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