U.S. Department of Agriculture February 2006

Animal and Plant Health Inspection Service

USDA's Biotechnology

Deregulation 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 importation,

movement, and field release

of genetically engineered (GE)

plants, insects, micro-organisms, and any other organism

that is known to, or could, be

a plant pest.

APHIS’ biotechnology regulations are designed to ensure

that GE organisms, such as

herbicide-tolerant cotton or

virus-resistant papayas, are

just as safe for agriculture and

the environment as traditionally bred crop varieties. 

In regulating biotechnology,

BRS works in concert with

the Environmental Protection

Agency (EPA) and the Food

and Drug Administration

(FDA), which also play important roles in protecting agriculture, food safety, and the

environment. BRS involvement begins when a person

or organization wishes to

import, move interstate, or

field-test a GE plant, which is

done under the program’s

permitting and notification

system.

After several years of field

testing and data 

collection, a company or

researcher may choose to

begin preparing for commercialization. At this point, an 

applicant typically files a petition for the determination of

nonregulated status with

USDA, which means they

have gathered enough data to

demonstrate the new crop

variety is not a plant pest,

poses no threat to agriculture

or the environment, and

should no longer be regulated

by USDA. Depending on the

product, reviews by FDA and

EPA may also be required.

Petition for Determination

of Nonregulated Status

The petition for deregulation

must include:

• A description of the 

biology and taxonomy of 

the conventional plant 

variety that was used to 

produce the GE version. 

• A detailed description of 

the differences in geno

type between the GE 

plant and the original 

plant. The description 

must include all scientific, 

common, or trade names, 

and all designations 

necessary to identify the 

donor organism (where 

the new genetic material 

came from), the nature 

of the transformation 

system (how that genetic 

material was inserted), the

inserted genetic material, 

and the GE plant. 

Information about the 

locations of the origin and 

processing of the plant, 

the donor organism, the 

original plant, vector 

organisms (if utilized), and 

any other regulated 

articles must be included.

• A detailed description of 

the phenotype of the GE 

plant. Known and 

potential differences from 

the original plant that 

would substantiate that 

the regulated article is 

unlikely to pose a greater 

plant pest risk than the 

original plant from which 

it was derived must be 

described. This 

description may include 

plant pest risk 

characteristics, disease 

and pest susceptibilities, 

expression of the gene 

product, new enzymes or 

changes to plant 

metabolism, weediness of

the GE plant, impact on 

the weediness of any

other plant with which it 

can interbreed, agricultural

or cultivation practices, 

effects of the regulated 

article on nontarget 

organisms, indirect plant 

pest effects on other 

agricultural products, 

transfer of genetic 

information to organisms 

with which it cannot 

interbreed, and any other 

information that BRS 

requests. Any other 

information known to 

the petitioner that 

indicates that a GE plant 

may pose a greater plant 

pest risk than the original 

APHIS’ biotechnology regulations are

designed to ensure

that GE organisms,

such as herbicidetolerant cotton or

virus-resistant

papayas, are just as

safe for agriculture

and the environment as traditionally bred crop

varieties.
plant must also be 

included.

• Relevant experimental 

data and publications.

• Field-test reports for all 

trials conducted under 

permit or notification 

procedures involving the 

GE plant. These reports 

must include the methods

of observation, resulting 

data, and analysis 

regarding all deleterious 

effects on plants, 

nontarget organisms, and 

the environment. 

APHIS BRS Receives a

Petition

After receiving the petition for

nonregulated status, BRS scientists review it to ensure that

the petition is correct and contains all of the required information. If any information is

missing or BRS determines

more information is needed, a

letter will be sent to the petitioner. The requested information must be submitted, and

the petition deemed complete,

before the review of the petition can be finalized. Before

BRS makes a determination 

on a petition for deregulation,

an applicant may supplement, 

amend, or withdraw their

application in writing at any

time without prior approval of

BRS and without affecting

resubmission.

As part of the review process,

BRS conducts an in-depth

environmental assessment

(EA), which fully evaluates the

organism for deregulation and

determines whether it can

safely be released in the environment. The review is then

published in the Federal

Register along with a notice

seeking public comments on

the environmental assessment

and the petition for a period of

60 days. All comments are

welcome and will be considered in the final decision.

Once the completed petition is

received, BRS is required to

process the petition for deregulation within 180 days.

Based on the findings of the

EA and the comments

received from the public, BRS

will either approve (in whole or

in part) or deny the petition. 

Post Market Authority

After a petition for deregulated

status has been approved,

BRS no longer has authority

over the item as it has been

judged to pose no risk to

plants. However, in the unlikely event that the item becomes

a plant–pest risk in the future,

BRS can reregulate it and take

any necessary action to protect America’s agricultural and

natural resources.

Additional Information

For more information about

the deregulation process contact: 

USDA, APHIS, BRS

4700 River Road, Unit 98

Riverdale, MD 20737

or visit the APHIS Web site at 

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

/index.html

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