U.S. Department of Agriculture February 2006

Animal and Plant Health Inspection Service

USDA’s Biotechnology

Notification Process

The U.S. Department of

Agriculture’s (USDA)

Animal and Plant Health

Inspection Service (APHIS),

through its Biotechnology

Regulatory Services (BRS)

program, is responsible for

regulating the introduction

(importation, interstate movement, and field release) of

genetically engineered (GE)

organisms such as plants,

insects, micro-organisms, and

any other organism that is

known to, or could be, a plant

pest. Through a strong regulatory framework, APHIS,

under the authority of the

Plant Protection Act, thoroughly evaluates GE organisms to verify that they are

just as safe for agriculture and

the environment as traditionally bred crop varieties, which

have been the cornerstone of

American agriculture. 

In regulating biotechnology,

APHIS’ BRS works in concert

with the Environmental

Protection Agency (EPA) and

the Food and Drug

Administration (FDA), which

play important roles in protecting food safety and the

environment. BRS is committed to the continual development of a regulatory framework that reflects the latest

science and research, while

continuing to protect

America’s agriculture. 

BRS regulates the introduction of GE organisms through

two processes: permitting

and notification. Notification

is an expedited permitting

process for GE plants that

BRS considers to be lower

risk and has extensive experience regulating in the past.

Examples of these GE plants

include those altered for pest

resistance, herbicide tolerance, and agronomic properties, such as male sterility,

and product quality, such as

delayed fruit ripening. 

To qualify for the notification

process, the GE plant must

meet six eligibility requirements that are related to

safety and primarily centered

on the new variety’s potential

to pose a plant pest risk. The

GE plant must also be introduced in accordance with

BRS’ specified performance

standards to ensure confinement of the regulated material. These eligibility requirements and performance standards are detailed below.

In order to process the notification, BRS requires detailed

information about the plant,

such as the source and identity of any genes introduced;

the method of genetic engineering; and the size, duration, and location of the field

test. BRS must receive notification from an applicant wishing to introduce a GE plant at

least 10 days before the interstate movement of the organism to allow for review and

processing. The program

requires 30 days to review

and process notifications for

field testing or importation of

GE plants. This timeframe is

necessary to allow BRS

employees time to review the

notification and to obtain concurrence from State counterparts. Detailed follow–up

reports are also required for

field testing under notification, just as they are under

the permitting process.

First introduced in 1993, the

notification process covers

only those GE plants that

meet BRS eligibility criteria

and performance standards.

Introductions of GE plants

engineered to express pharmaceuticals or new industrial

compounds not intended for

food or feed are not eligible

for notification. If a GE plant

does not meet notification eligibility criteria, the permit

process must be followed for

movement, importation, or

field testing.

Eligibility Requirements for

Notification

Any GE organism introduced

under the notification process

must meet all six eligibility criteria. BRS designed these

criteria to ensure that the GE

material being introduced is

low risk. The criteria are as

follows: 

• The plant must not be 

listed on the Federal 

Noxious Weed list or be 

Notification is an

expedited permitting

process for GE plants

that BRS considers to

be lower risk and has

extensive experience

regulating in the

past.
considered a weed in the 

area of proposed release. 

• The introduced genetic 

material must be stably 

integrated, which means 

the introduced DNA 

must remain inside the 

cell and replicate only 

with the plant DNA. 

• The function of the 

introduced genetic 

material is known, and its 

presence in the regulated 

article does not result in a 

plant disease.

• The introduced genetic 

material does not cause 

the production of an 

infectious entity, produce 

substances that are 

known to be, or are likely 

to be, toxic to nontarget 

organisms, or produce 

products intended for 

pharmaceutical or 

industrial use. 

• The introduced genetic 

sequences derived from 

plant viruses do not pose 

a significant risk of 

creating a new plant virus.

For information on eligible 

plant virus–derived 

sequences, please 

contact BRS.

• The plant has not been 

modified to contain 

certain genetic material 

derived from an animal 

or human pathogens. In 

addition, plants containing 

coding sequences whose 

products are known 

agents of diseases in 

humans or nontarget 

animals are not eligible.

Performance Standards for

Notification

BRS requires companies or

institutions utilizing the notification process to adhere to

six performance standards

that ensure complete confinement of the GE material. The

goal of these standards is to

manage the regulated article

so that neither it nor its offspring is released into, or persists in, the environment.

The six performance standards are as follows:

• The introduced regulated 

article must be shipped 

to and maintained at the 

destination facility in a 

manner so that there is no

release into the 

environment. There must 

be no inadvertent mixing 

of regulated articles and 

nonregulated articles. 

• The regulated plant 

material should be 

maintained in such a way 

that the identity of all 

material is known. When 

the tests are complete, 

the plant material must be

contained or killed.

• When the transformation 

process uses a live 

microorganism as a vector

to introduce the 

genetic construct, the 

transformed plant should 

be free of the 

micro-organism before 

movement or introduction 

into the environment. 

• The regulated article or its 

offspring cannot persist in 

the environment.

• No viable plant material 

(e.g. seeds or propagules) 

shall remain that is likely 

to germinate and create 

new plants known as 

volunteers. Any 

volunteers that do appear 

must be destroyed to 

prevent persistence in the 

environment. 

Additional Information

For more information about

the notification process for

the introduction of genetically

engineered organisms, contact:

USDA, APHIS, BRS

4700 River Road, Unit 147

Riverdale, MD 20737

Telephone (301) 734–7324 

or visit the APHIS 

Web site at 

http://www.aphis.usda.gov/brs

/index.html.

The U.S. Department of Agriculture

(USDA) prohibits discrimination in all

its programs and activities on the

basis of race, color, national origin,

age, disability, and where applicable,

sex, marital status, familial status,

parental status, religion, sexual orientation, genetic information, political

beliefs, reprisal, or because all or part

of an individual’s income is derived

from any public assistance program.

(Not all prohibited bases apply to all

programs.) Persons with disabilities

who require alternative means for

communication of program information (Braille, large print, audiotape,

etc.) should contact USDA’s TARGET

Center at (202) 720–2600 (voice and

TDD). To file a complaint of discrimination, write to USDA, Director,

Office of Civil Rights, 1400

Independence Avenue, S.W.,

Washington, D.C. 20250–9410, or call

(800) 795–3272 (voice) or (202)

720–6382 (TDD). USDA is an equal

opportunity provider and employer.

BRS requires companies or institutions utilizing the

notification

process to adhere

to six performance

standards that

ensure complete

confinement of

the GE material.