USDA is an equal opportunity provider, employer, and lender.

This publication supersedes Program Aid No. 1841, “Biotechnology Regulatory

Services: Ensuring Safety in the Development of Genetically Engineered Organisms,”

which was published in October 2005.

For More Information

To find out more, please visit APHIS’ biotechnology Web site at

www.aphis.usda.gov/biotechnology. If you have additional questions about permitting or regulatory activities, please call BRS at

(301) 851-3886.

Issued September 2012

Slightly revised May 2016

APHIS’ authority for the regulation of

biotechnology is derived from

the Plant Protection Act of 2000.

If you are interested in APHIS’ biotechnology program initiatives

and current activities, please join our stakeholder registry to

receive automatic updates and other useful information. Register

at https://public.govdelivery.com/accounts/USDAAPHIS/

subscriber/new.

APHIS and Biotechnology

APHIS and

Biotechnology

Protecting Plant HealthThrough

Rigorous Regulation of Genetically

Engineered Organisms

United States Department of Agriculture

Animal and Plant Health Inspection Service

Program Aid No. 2120
APHIS’ BIOTECHNOLOGY MISSION

To protect and enhance America’s agricultural

and natural resources using a dynamic,

science-based regulatory framework to ensure

the safe importation, interstate movement,

and environmental release of genetically

engineered organisms.

We Protect Plant Health

Through our science-based regulatoryframework, the Animal and Plant Health

Inspection Service (APHIS) protects against risks to

U.S. plant health by providing for the safe importation, interstate movement, and environmental

release/field testing of certain genetically engineered

(GE) organisms. APHIS is part of the U.S.

Department of Agriculture (USDA) and has

regulated GE organisms since 1987.

APHIS regularly inspects GE field tests to monitor compliance with confinement

conditions. Here, an APHIS employee inspects GE cotton.

APHIS personnel inspecting GE corn at a field test site. 2 3
We’re Part of the Coordinated Framework

Established as a formal policy in 1986, the Coordinated

Framework for the Regulation of Biotechnology

describes the Federal system for evaluating products

developed using modern biotechnology. The three main

Federal agencies responsible for regulating the safe use of

genetically engineered organisms are APHIS, the U.S.

Environmental Protection Agency (EPA), and the U.S.

Department of Health and Human Services’ Food and

Drug Administration (FDA).

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.

EPA regulates pesticides, including plants with plantincorporated protectants (pesticides intended to be

produced and used in a living plant), to ensure public

safety. That agency also regulates pesticide residue on

food and animal feed. APHIS, through its Biotechnology

Regulatory Services (BRS) program, regulates the introduction of certain GE organisms that may pose a risk to

plant health.

We’re Science-Based

APHIS uses science as the foundation for sound decisions on policy, rulemaking, and regulatory approvals.

Experts in scientific fields (e.g., plant pathology, botany,

entomology, virology, ecology, environmental science,

molecular biology, and biochemistry) assess plant pest

risk and analyze environmental effects while considering

the most current peer-reviewed scientific findings. APHIS

bases its decisions and actions on the best science available.

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Current peer-reviewed scientific data is analyzed as part of the regulatory review process.
We’re Transparent

APHIS makes it a priority to be transparent in all of our

procedures, decisions, and activities. On our Web site,

we publish relevant environmental and regulatory documents for the GE crops we regulate. We announce regulatory actions and the availability of related documents

in the Federal Register. The public may provide comments regarding proposed actions online at www.regulations.gov, through conventional mail, and at various

public meetings. 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.

The APHIS Biotechnology Regulatory System

Developers seeking to field test, move interstate, or

import a GE organism must first submit detailed information to APHIS for review and receive regulatory

approval. During its review, APHIS 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.

The Notification Process

GE plants that meet six specific criteria (see sidebar above)

undergo an administratively streamlined alternative to

the permit process, known as “notification.”

As part of the notification process, applicants must provide information on the nature of the plant and introduced genes, descriptions of genetic modifications, size

of the introduction, and origin and destination for

movement or the location of a field test. Upon approval,

notifications are valid for 1 year from the date of issue.

If a plant does not meet the eligibility criteria for notification, the applicant must follow the permitting process.

APHIS personnel working in the ePermits system, used to electronically process permits

and notifications of regulated GE crops.

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Six eligibility criteria for notification:

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.
The Permit Process

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 does. In addition to the

data required in the notification process, field-test permit

applicants must provide a detailed description of how

they will perform the test. This description must include

specific measures to reduce the risk of harm to other

plants, so the organisms being tested remain confined

and do not persist after completion of the field test.

Depending on the characteristics of the GE organism,

APHIS may impose additional measures and supplemental permit conditions. Permits may be valid for 1 year or

more from the date of issue.

APHIS also works closely with State departments of

agriculture and federally recognized tribes to ensure

that they are aware of field tests taking place within

their jurisdictions and have an opportunity to apply

any further safeguards at the State or tribal level.

Compliance With Regulations

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 provides participants with specific tools and

guidance to implement a BQMS tailored to their own

needs, facilitating more effective compliance with

APHIS regulations.

APHIS compliance specialists and 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

and the possibility of criminal prosecution. APHIS works

closely with State departments of agriculture and other

Federal agencies, including the FDA and the EPA, to

ensure compliance with regulations.

8 9

APHIS requires that organizations conducting GE field trials keep detailed records

on all GE seed. Here, the seeds are counted, weighed, and logged.
10 11

Petition for Determining Nonregulated Status

Under the Plant Protection Act and title 7, section 340.6

of the Code of Federal Regulations (CFR), 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 the agency’s

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. 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 comment.

After receiving and considering all comments, APHIS

determines nonregulated status if it concludes that the

GE organism does not pose a plant pest risk. The GE

organism is then no longer subject to the regulations and

may be freely moved and planted without permits or

other regulatory oversight by APHIS. 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.

APHIS personnel inspecting a combine harvester used in a GE corn field test.