Biotechn

Regulato

Ensuring Safety 

of Genetically E

p

Program Aid No. 1841
Here, GE cotton is surrounded by other types of crops to ensure

that confinement measures are achieved. 

BRS MISSION

To protect America’s agriculture and environment

using a dynamic and science-based regulatory

framework that allows for the safe development

and use of genetically engineered organisms

Through its strong regulatory framework,Biotechnology Regulatory Services (BRS)

protects America’s agriculture and the environment

by allowing for the safe development and introduction (importation, interstate movement, and field

testing) of genetically engineered (GE) organisms.

Under the authority of the Plant Protection Act, the

U.S. Department of Agriculture’s (USDA) Animal

and Plant Health Inspection Service (APHIS) has

regulated GE organisms since 1987. In 2002,

APHIS established BRS to take over this role. The

agency has authorized more than 10,000 permits

and notifications for the introduction of GE organisms and deregulated more than 60 products for

use, establishing itself as an international leader in

the safe regulation of GE products.

BIOTECHNOLOGY REGULATORY SERVICES

APHIS regularly inspects GE field tests to ensure that companies are complying with 

BRS’ confinement conditions. Here, an APHIS employee inspects GE cotton.

One of BRS’ permit conditions for GE plants that produce pharmaceutical and 

industrial compounds is the maintenance of a fallow zone of at least 50 feet.

2 3
Here, an APHIS inspector is checking farm equipment for the

presence of regulated material.

It is the vision of BRS to work openly and cooperatively

to provide a clear, timely, and strategic regulatory system

that responds to the rapidly evolving field of biotechnology and fosters public confidence. Fulfilling this vision

requires many things, among them the flexibility to

respond. APHIS writes its biotechnology regulations

with flexibility such that measures imposed on permits

can vary based on case-by-case assessments. BRS regulations may also be revised and strengthened as needed,

based on new trends in biotechnology, changes in the

field, and experience gained. 

Also as part of its vision, BRS makes it a priority to

ensure that its processes, decisions, and activities are

transparent to the public and to its stakeholders. As part

of this initiative, BRS makes available on its Web site all

environmental assessments for GE crops that produce

pharmaceutical and industrial compounds; it announces

the findings in the Federal Register and allows for a

comment period. The BRS Web site also provides accessibility to permits and decisions and news and upcoming

events. In addition, BRS has a stakeholder registry that

allows interested parties to receive updates and other

information relevant to selected topics of interest, such

as regulation activities, communication and outreach,

capacity building, and compliance issues. 

Science Guiding BRS

BRS performs all aspects of its regulatory role with science as its basis. A diversified collection of scientific

expertise enables BRS to make sound, science-based 

decisions that ensure the safe development of new GE

organisms that are themselves as safe as their non-GE

counterparts. BRS has experts in scientific fields (e.g.,

plant pathology, botany, animal science, entomology,

virology, ecology, environmental science, molecular biology, and biochemistry) who conduct extensive scientific

review of permit applications, petitions for deregulation,

potential permit infractions, and proposed regulatory

changes. To keep pace with the ever-evolving technology, BRS staff and scientists attend and host scientific

meetings and workshops, read literature, and interact

with outside scientists, stakeholders, and the public.

BRS also plays an active role in international standards

setting and regulatory capacity building. In fulfilling

these functions, along with other international activities,

BRS supports other USDA agencies and Federal departments that are directly involved in trade activities by providing the technical and scientific expertise of its staff.

BRS works with key international organizations to develop international biotechnology standards that are science

based and consistent with U.S. regulatory policy and

standards. BRS also works with developing countries to

establish their own regulatory framework.

The BRS Permit System

APHIS regulations are mandatory, and developers

must seek APHIS approval through its permit system

before introducing a GE organism. Developers must

also comply with the regulations and permit conditions throughout the duration of the approved permit.

Applicants must submit all plans for movement,

importation, or field testing for thorough review by

regulatory scientists, who evaluate the risks and the

procedures that the developer will use. Depending on

the nature of the GE crop, an applicant files either a

notification or a permit application for APHIS review.

BRS also works closely with State departments of agriculture to ensure that they are aware of events taking

place within their jurisdiction and to allow them to

apply any additional safeguards they may require. 

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Most plants are field-tested under notification, a streamlined approval process that is often used for plants that

are altered with common agronomic traits, such as pest

resistance or herbicide tolerance. Applicants may use

the notification process only for plants that meet all six

of the following eligibility criteria, based on their plant

pest potential:

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 genetic material 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.

they will conduct the test in a manner that meets the per

formance standards listed in APHIS biotechnology regulations. For example, one performance standard states

that the field trial must be conducted in such a way that

the regulated article will not persist in the environment

and no offspring can be produced that could persist in

the environment. 

As part of the notification process, BRS requires that

applicants provide detailed data, such as information

about the plant; descriptions of genetic modifications;

the source and identity of any genes introduced; and the

size, duration, and location of the field test. If a plant

does not meet the criteria for notification, the applicant

must follow the full permitting process.

The Permit Process

The permitting process involves a more comprehensive

review and is used for GE plants that could pose an

elevated risk, such as plants that produce pharmaceutical or industrial compounds, as well as for any GE

organism other than plants. As part of the permit

application process, applicants must provide the same

data as required in the notification process and, in

addition, must provide a detailed description of how

the developer will perform the test. When applying

for a permit, applicants must include specific measures

to reduce the risk of harm to other organisms to

ensure that the plants being tested do not pose a significant plant pest risk. BRS often works with applicants

on design protocols and may impose additional measures and supplemental permit conditions. 

Corn followed by soybeans,

potatoes, cotton, and tomatoes are the most common

crops for which developers

request permits. In 2003, roughly 81 percent of the soybeans grown in the United States 

were genetically engineered, nearly all for herbicide tolerance. 6 7
Corn followed by tomatoes, cotton, rapeseed,

potatoes, and soybeans

are the most commonly

deregulated products.

BRS requires that 

organizations conducting 

GE field tests keep detailed

records on all GE seed.

Here, the seeds are counted, weighed, and logged.

Workers are sprayed with compressed air to remove any 

regulated material from their clothing.

al compounds for humans or animals fall into a distinct

category, and APHIS policy makes clear that these GE

plants are handled differently from those being developed

for use as food or feed. APHIS issues permits for GE

plants that produce pharmaceutical and industrial compounds on a case-by-case basis after BRS experts complete

an extensive scientific review or an environmental assessment. In addition, APHIS imposes more stringent confinement measures, such as increased isolation distances

and fallow zones and restrictions against using the same

land to produce pharmaceutical and industrial crops for

the production of food or feed crops. BRS also requires

developers of pharmaceutical and industrial crops to have

dedicated equipment and storage facilities for those crops.

BRS inspects every field test site with GE crops that produce pharmaceutical and industrial compounds up to

seven times before, during, and after production.

Petition for Deregulation

After a GE plant has been field-tested and the developers

have demonstrated that the product is as safe as its nonGE counterpart and should be removed from BRS oversight, they may file a petition for deregulation, or nonregulatory status. As part of the deregulation process,

petitioners must submit detailed data, such as a description of the biology of the plant before it was genetically

engineered, extensive data from tests designed to detect

differences between the GE plant and the original plant,

characterization of genetic changes, plant pest-risk characteristics, disease and pest susceptibilities, expression of

gene products, new enzymes, effects on nontarget organ8 9
BRS requires that researchers field-testing plant-made pharmaceuticals or 

industrials use farm equipment dedicated only to that use.

APHIS inspectors utilize global positioning systems to document the 

exact location of GE field tests.

plant, impact on the weediness of relatives of the GE

plant, and impacts on agricultural practices or on other

agricultural products.

After review of the data, BRS prepares an environmental

assessment to analyze the potential impacts the GE plant

may have on the environment and then seeks public

comment. BRS approves a petition only when it determines that the organism does not pose a plant pest risk.

Once BRS has granted a petition for nonregulatory status, the product may be freely moved and planted without the permits or other regulatory oversight by BRS.

Developers will seek to obtain nonregulated status for

their products, along with completion of applicable

reviews at other agencies, as a practical step toward

commercialization. BRS has the authority to bring any

deregulated item back under regulation if new information becomes available that demonstrates unanticipated

effects or plant health risks. This authority, however, has

never been used because deregulated products have an

established history of safe development.

Since 1987, APHIS has overseen the deregulation of

more than 60 GE products. Of these approved products, 40 percent were engineered for herbicide tolerance

and 25 percent for insect resistance.

Compliance With BRS Regulations

Failure to adhere to the regulations, permit conditions,

and requirements can result in serious penalties, including fines up to $500,000 per adjudication. BRS’ compliance unit is dedicated exclusively to ensuring that companies and organizations maintain compliance through

defined procedures that include violation-prevention

efforts, risk-based criteria for quality inspection, uniform

enforcement, and thorough documentation of any compliance infractions. 

Compliance specialists and APHIS inspectors perform

targeted inspections and audits of field tests and use set

criteria to thoroughly evaluate all potential compliance

infractions. In the case of an infraction, BRS immediately implements procedures to bring the developer back

into compliance with all necessary measures to protect

U.S. agriculture, the food supply, and the environment.

Depending on the seriousness of the infraction, BRS may

refer the case to APHIS’ Investigative and Enforcement

Services for further investigation. BRS also works closely with State departments of agriculture and other

Federal agencies, including the Food and Drug

Administration and the U.S. Environmental Protection

Agency, to ensure compliance with regulations.

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BIOTECHNOLOGY 

The U.S. Department of Agriculture (U

and activities on the basis of race, co

applicable, sex, marital status, familia

tion, genetic information, political bel

ual’s income is derived from any publ

apply to all programs.) Persons with 

communication of program informatio

contact USDA’s TARGET Center at (20

of discrimination, write to USDA, Dire

Avenue, S.W., Washington, D.C. 20250

720–6382 (TDD). USDA is an equal op

For More Informa

To find out more about BRS, 

<http://www.aphis.usda.gov/b

on permitting or regulatory act

Photo credits: The soybean shots on 

by USDA–Agricultural Research Serv

images were taken by APHIS photog

Issued October 2005