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.

Proposed Rules Federal Register

84269 

Vol. 85, No. 248 

Monday, December 28, 2020 

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/#!docket

Detail;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; Alan.Pearson@

usda.gov. 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; 

Kis.Robertson1@usda.gov. 

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 premarket 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 antemortem 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, 


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1For 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. 

2To view the 1986 framework, go to https://

www.aphis.usda.gov/brs/fedregister/coordinated_

framework.pdf. 

3To view, go to https://www.epa.gov/sites/ 

production/files/2016-12/documents/biotech_

national_strategy_final.pdf. 

4Under the Federal Food, Drug, and Cosmetic Act 

(FD&C Act, 21 U.S.C. 301, et seq.; see 21 U.S.C. 

321(g)). 

5Plant Protection Act of 2000; (PPA, 7 U.S.C. 

7701 et seq.) and Animal Health Protection Act (7 

U.S.C. 8301, et seq.). 

6To view the 2017 update to the Coordinated 

Framework, go to: https://www.aphis.usda.gov/ 

biotechnology/downloads/2017_coordinated_

framework_update.pdf. 

7To view GFI #236, go to: https://www.fda.gov/ 

media/102158/download. 8FDA 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. 

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. 

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. 

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. 

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 midsized businesses navigating the 

regulatory process for the products. 

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. 

Contemplated Regulatory Framework 

In consultation with FDA, USDA is 

contemplating regulations that would 

establish a flexible, risk- and sciencebased 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 


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9Horses, 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. 

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: 

• 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 premarket 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 


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10When 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. 

11Endogenous genes are pre-existing genes in the 

genome of the animal being modified or developed 

using genetic engineering. 

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. 

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, noninfectious 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. 


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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, meatcanning, 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 postmortem 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 preslaughter 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 


tkelley on DSKBCP9HB2PROD with PROPOSALS
84274 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Proposed Rules 

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 premarket) 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 ‘‘offtarget 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 


tkelley on DSKBCP9HB2PROD with PROPOSALS
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Proposed Rules 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 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2020–1165; Project 

Identifier 2019–SW–027–AD] 

RIN 2120–AA64 

Airworthiness Directives; Airbus 

Helicopters 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: The FAA proposes to adopt a 

new airworthiness directive (AD) for 

certain Airbus Helicopters Model 

SA341G and SA342J helicopters. This 

proposed AD was prompted by the 

determination that a new life limit was 

necessary for certain tail rotor blades 

(TRBs). This proposed AD would 

require replacing certain TRBs, reidentifying certain TRBs, and repairing 

certain other TRBs, as specified in a 

European Union Aviation Safety Agency 

(EASA) AD, which is proposed for 

incorporation by reference. The FAA is 

proposing this AD to address the unsafe 

condition on these products. 

DATES: The FAA must receive comments 

on this proposed AD by February 11, 

2021. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590. 

• Hand Delivery: Deliver to Mail 

address above between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 


tkelley on DSKBCP9HB2PROD with PROPOSALS