United States Department of Agriculture

Questions and

Answers:

Biotechnology

and the USDA

Biotechnology

Q. What is agricultural

biotechnology?

A. Agricultural biotechnology

is a range of tools—including

both genetic engineering and

traditional breeding techniques—that alter living

organisms or parts of organisms to make or modify products, improve plants or animals,

or develop micro-organisms

for specific agricultural uses.

Q. What is genetic engineering?

A. Genetic engineering is a

precise and predictable

method used to introduce

new traits into plants and 

animals by moving genes and

other genetic elements from

one or more organism(s) into

a second organism. In its

regulations for genetically

engineered (GE) organisms,

the U.S. Department of

Agriculture (USDA) defines

genetic engineering as the

genetic modification of organisms by recombinant DNA

(rDNA) techniques. 

Q. What are GE crops

designed to do?

A. GE crops have a wide variety of traits that can benefit

farmers, consumers, and the

environment. For example,

GE crops can tolerate drought

conditions and herbicides,

resist insects and viruses, and

provide enhanced quality and

nutrition for consumers. 

Regulating

Biotechnology

Q. Who is responsible for

regulating GE crops?

A. The three main Federal

agencies responsible for 

regulating the safe use of

organisms derived from modern biotechnology are the

USDA’s Animal and Plant

Health Inspection Service

(APHIS), the U.S.

Environmental Protection

Agency (EPA), and the U.S.

Department of Health and

Human Services’ Food and

Drug Administration (FDA).

These agencies work together

in what is commonly referred

to as the Coordinated

Framework for the Regulation

of Biotechnology. The White

House Office of Science and

Technology Policy established

this Federal framework as a

formal policy in 1986.

APHIS regulates the introduction (meaning the importation,

interstate movement, and

environmental release/field

testing) of certain GE organisms that may pose a risk to

plant health. EPA regulates

pesticides, including plants

with plant-incorporated protectants (pesticides intended

to be produced and used in a

living plant), to ensure public

safety. EPA also sets limits

on pesticide residues on food

and animal feed. FDA has primary responsibility for ensuring the safety of human food

and animal feed, as well as

proper labeling and safety of

all plant-derived foods and

feeds. 

Q. How do I know what is

regulated by APHIS? 

A. The Federal regulations for

biotechnology explain what

items and processes APHIS

regulates and how they may

be regulated (e.g., timeframes,

permitting procedures, penalties for regulatory violations).

These regulations are published in title 7, part 340 of

the Code of Federal

Regulations (CFR). You can

download a copy of the regulations online at

www.gpo.gov/fdsys/pkg/CFR2008-title7-vol1/contentdetail.html. More information

is also available on APHIS’

Web site at

www.aphis.usda.gov/biotechnology.

Compliance 

Q. What is the regulatory

process for GE organisms?

A. Developers seeking to

field-test, move interstate, or

import a GE organism must

first submit detailed information to APHIS’ Biotechnology

Regulatory Services (BRS) for

review and receive regulatory

approval. During its review,

BRS assesses the information

for potential plant health risks

before the introduction can be

approved. Depending on the

characteristics of the GE

organism, a developer either

files a notification letter or

applies for a permit.

APHIS regulates the

introduction (meaning the importation,

interstate movement, and environmental release/field

testing) of certain

GE organisms that

may pose a risk to

plant health. 

Animal and Plant Health Inspection Service

Biotechnology Regulatory Services
Q. When would a developer

be eligible to use the notification process?

A. GE plants that meet the

six specific criteria listed

below (per 7 CFR 340.3) are

eligible for an administratively

streamlined alternative to the

permit process, known as

“notification.” Upon approval,

notifications are valid for 

1 year from the date of issue.

The eligibility criteria are:

1. The GE plant is not listed

as a Federal noxious weed

and is not considered a weed

in the area of introduction.

2. The genetic material must

be “stably integrated” into

the plant genome.

3. The newly introduced

gene’s function must be

known and not result in plant

disease. 

4. The newly introduced

gene’s function must not

cause production of a plant

pest, cause the plant to 

produce substances that are

toxic to nontarget organisms,

or be genetically engineered

for the purpose of producing

compounds intended for pharmaceutical or industrial use.

5. The newly introduced

gene must not cause the 

creation of a new plant virus.

6. The plant must not have

been modified to contain

genes from animal or human

pathogens.

Q. When is the permit

process applicable?

A. The permit process

applies to GE plants that do

not meet all six criteria for

notification and to GE organisms other than plants (e.g.,

insects, microbes) that fall

under APHIS regulation. This

process involves a more comprehensive review than notification. Applicants must provide the same data required

for notification plus a detailed

description of how they will

perform a field test, including

specific measures to reduce

the risk of harm to other

plants. Depending on the

characteristics of the GE

organism, APHIS may impose

additional measures and supplemental permit conditions.

Permits are valid for up to 

3 years from the date of issue. 

Q. What system does

APHIS have in place to

ensure compliance with

biotechnology regulations

and permit conditions? 

A. APHIS has a comprehensive program of proactive

measures in place to ensure

that biotechnology organizations maintain compliance

with all relevant provisions of

the agency’s regulations,

including authorizations under

the permitting and notification

processes. APHIS officials

perform inspections tailored

to the specific requirements

of the notification or permit.

In addition, APHIS provides

continuous education and 

outreach to the regulated

community, including the

Biotechnology Quality

Management System (BQMS)

Program. This program, in 

particular, provides participants with specific tools and

guidance to develop a BQMS 

tailored to their own needs,

which helps them to better

maintain compliance with

APHIS regulations. 

Q. How does APHIS address

regulatory violations?

A. BRS compliance specialists and APHIS inspectors

perform targeted inspections

and audits to thoroughly evaluate suspected or reported

compliance infractions. The

Plant Protection Act of 2000

allows substantial penalties

for serious infractions, including fines of up to $500,000,

the possibility of criminal

prosecution, and other corrective measures. APHIS also

works closely with State

departments of agriculture

and other Federal agencies,

including the FDA and the

EPA, to ensure compliance

with regulations. 

Q. Are all release authorizations (i.e., field tests)

inspected? 

A. Releases under notification are randomly selected for

inspection by APHIS. All

releases under permit are

inspected once in each State

each year. 

Q. What are common 

compliance infractions? 

A. Compliance infractions

can range from administrative

issues, such as the wrong

name on a permit, to more

serious infractions, such as

failure to observe separation

distances. Unforeseen

events such as the accidental

release of a regulated article

or the destruction of a field

test by livestock, wild animals, or strong winds can

also be considered infractions

when they result in violations

of permit conditions. Even

though developers have no

control over these events, it is

important to notify APHIS

immediately so that mitigation

measures can be implement-
ed quickly. Developers must

notify APHIS of all possible

compliance infractions, and

failure to do so immediately is

itself a compliance infraction.

Q. What role does APHIS

play to ensure commercial

food and feed is free of

field-test materials?

A. When APHIS issues an

authorization for the movement, importation, or field

testing of a GE organism, the

developer must adhere to certain conditions to ensure that

the regulated GE organism

does not enter the food or

feed supply. These conditions

include confinement measures, such as separation distances, to prevent pollen

flow; regularly cleaning all

equipment and containers

and keeping them in good

working order; and labeling all

regulated articles to prevent

accidental use or incorporation with other crops. If a

regulated GE organism

becomes intermingled with

unregulated GE food or feed,

government agencies have

the authority to seize the food

or feed and require its

destruction to prevent it from

entering the food supply. At

the end of all field tests,

developers must destroy or

properly dispose of any viable

plant material and ensure that

no regulated articles persist in

the environment beyond the

duration of the trial.

Determining

Nonregulated Status

Q. How is nonregulated

status determined?

A. Under the Plant Protection

Act of 2000 and 7 CFR 340.6,

if developers (applicants) can

demonstrate that a GE organism is not a plant pest, they

can submit a petition

(request) to APHIS for a

determination of nonregulated

status; this status means that

the GE organism is no longer

subject to regulatory oversight under 7 CFR part 340.

The petitioner must provide

data, often gathered through

confined field tests regulated

by APHIS, to help inform

APHIS’ decision. APHIS analyzes data from the petitioner,

researches current scientific

findings, and prepares a plant

pest risk assessment (PPRA)

in accordance with the Act. 

APHIS also prepares documentation required by the

National Environmental Policy

Act of 1969 (NEPA). Under

NEPA, all Federal agencies

must take a close look at the

potential environmental

impacts of their proposed

actions prior to making decisions and provide opportunities for public comment during that process. Therefore,

at the same time as it develops a PPRA, APHIS prepares

either an environmental

assessment (EA) or an environmental impact statement

(EIS) to analyze potential environmental impacts the GE

plant may have. Once complete, APHIS makes the document available to the public

for comment. Overall, the

petition process allows for

two, and in some cases

three, opportunities for public 

input. After receiving and

considering all comments,

APHIS determines nonregulated status if it concludes

that the GE organism does

not pose a plant pest risk. 

Q. What is an environmental assessment (EA)?

A. An EA is a concise public

document that provides sufficient evidence and analysis

for determining whether a

proposed Federal action will

have a significant impact on

the environment. If the

agency finds no significant

impact during the assessment

process, it issues a finding of

no significant impact (FONSI),

a public document explaining

the agency’s reasons for this

conclusion. 

Q. What is an environmental impact statement (EIS)?

A. An EIS is a more detailed

document required by NEPA if

the agency is proposing a

major Federal action that 

significantly affects the quality

of the human environment.

Specifically, this document

informs the decisionmaker

and the public of potential

environmental impacts, if any,

and what steps may be taken

to minimize those impacts. It

describes the positive and

negative environmental

impacts of a proposed action

and lists at least two alternative actions. 
Q. When can a GE crop be

safely commercialized?

A. Once APHIS has made a

determination of nonregulated

status, the GE organism is no

longer subject to APHIS 

regulations and may be freely

moved and planted without

authorizations or other regulatory oversight. Most developers will seek to obtain nonregulated status for their

organism, along with completing applicable reviews at

other agencies, as a practical

step toward commercialization. 

Q. Where can I find a list of

GE crops that have nonregulated status?

A. The United States

Regulatory Agencies Unified

Biotechnology Web site

(https://usbiotechreg.epa.gov/)

contains a searchable database of biotechnology products that have completed

reviews for use in the United

States. The APHIS biotechnology Web site also provides

access to permits, decisions,

and information on the

biotechnology regulatory

process, including deregulation. A list of petitions for

determination of nonregulated

status is available on APHIS’

Web site at

www.aphis.usda.gov/biotechnology/petitions.

Q. Does APHIS involve the

public in important policy

decisions?

A. APHIS makes it a priority

to be transparent in all of its

procedures, decisions, and

activities. On its Web site,

APHIS publishes all relevant

environmental and regulatory

documents for the GE crops it

regulates, and it announces

regulatory actions and the

availability of related documents in the Federal

Register. APHIS also provides opportunities for public

comment on proposed

actions through an online system, conventional mail, and at

various public meetings. 

Q. Where can I go for more

information?

A. The APHIS biotechnology

Web site

(www.aphis.usda.gov/biotechnology) offers access to a

wide range of information,

including official documents,

guidance for GE developers,

application status, news, and

upcoming events. APHIS also

encourages people who are

interested in program initiatives

and current activities to join its

biotechnology stakeholder

registry. To receive automatic

updates and other useful

information, register at

https://public.govdelivery.com/

accounts/USDAAPHIS/

subscriber/new.

USDA is an equal opportunity

provider, employer, and lender.

Program Aid No. 2121

Issued September 2012

Slightly revised July 2016