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Program Aid No. 1862
Biotechnology and the 

Need for Federal Regulation

While biotechnology has the potential to provide new

varieties with a wide array of useful characteristics,

government regulatory agencies have the responsibility

to ensure that this science advances safely. In 1986,

the Federal Government’s Office of Science and

Technology Policy (OSTP) published a policy document known as the Coordinated Framework for the

Regulation of Biotechnology. This document specifies

three Federal agencies that are responsible for regulating biotechnology in the United States: the U.S.

Department of Agriculture’s (USDA) Animal and Plant

Health Inspection Service (APHIS), the Environmental

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

of Health and Human Services’ Food and Drug

Administration (FDA). Products are regulated according to their intended use, and some products are regulated by more than one agency.

Together, these agencies ensure that the products of modern biotechnology are safe to grow, safe to eat, and safe

for the environment. USDA, EPA, and FDA apply regulations to biotechnology that are based on the specific

nature of each GE organism. Assessments are based on

the biological characteristics of the new organism.

USDA and EPA are the agencies responsible for ensuring the safety of the agriculture and environment.

FDA has primary responsibility for ensuring the safety

of food and any food ingredient derived from genetic

engineering. EPA is responsible for ensuring that a

type of pesticide engineered and used in living plants—

termed Plant-Incorporated Protectants (PIPs)—can be

safely consumed and safely used in the environment.

People or companies that violate any of these agencies’

laws or regulations are subject to high monetary fines

and other punitive actions.

APHIS–BRS regulates the products of biotechnology 

that are undergoing confined field trials.

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HISTORY OF BIOTECHNOLOGY

For hundreds of years, people have used traditional methods

such as selective breeding to improve plants and animals.

The last century was marked by rapid advances in agriculture, including mechanization, improved breeding techniques, and a vastly expanded knowledge of plant sciences.

Genetic engineering—a precise and predictable method for

introducing new traits into organisms—is one of the most

recent methods for improving plants. Scientists have safely

been using genetic engineering and other tools of modern

biotechnology since the 1980s to develop new plant varieties

and to enhance agriculture. The technology has been readily

adopted by U.S. farmers since becoming commercially available in the mid-1990s—so much so that a significant portion

of the corn, soybeans, cotton, and canola grown in the

United States is now genetically engineered (GE) varieties.
Most of the field trials that

BRS regulates are for crops

genetically engineered

for insect, herbicide, and

drought resistance, such as

this drought-tolerant cotton.

U.S. Department of Agriculture

Within USDA, APHIS is responsible for protecting U.S.

agriculture and the environment from pests, diseases,

and weeds. Under the authority of the Plant Protection

Act, APHIS regulations require that a developer of a GE

organism have authorization in the form of a permit or

an acknowledged notification prior to introducing a regulated article into the United States. Regulated articles

are organisms and products altered or produced through

genetic engineering that may pose a risk as a plant pest.

The act of introducing includes any movement into

(import) or through (interstate) the United States, or

release into the environment, as in a field test.

Biotechnology Regulatory Services (BRS) is the unit in

APHIS responsible for ensuring the safety of these GE

organisms through a comprehensive program of rigorous

regulatory oversight. Applicants seeking permission to

move, import, or field-test a GE organism must submit

detailed information to BRS for thorough review by regulatory scientists before the introduction can be authorized. Depending on the nature of the GE crop, an applicant files a permit application or uses the more expedited

notification process.

Both permits and notifications are subject to APHIS

review by biotechnologists trained in relevant scientific

disciplines. Developers must comply with the regulations and permit conditions throughout the duration of

the authorized action. To ensure that developers do so,

APHIS conducts inspections and audits.

The regulations also provide for a petition process for

the determination of nonregulated status. Developers

can file a petition request after a product has been adequately field-tested and enough data have been collected

to ensure that it is as safe as its traditionally bred counterparts. Once a determination of nonregulated status

has been made, the product and its progeny no longer

require APHIS review for movement or release in the

United States. Developers typically seek nonregulated

status for their products after years of field testing as a

practical step needed to commercialize their products.

APHIS works in coordination with EPA and FDA, which

also play important roles in ensuring the safe advancement of biotechnology.

Environmental Protection Agency

EPA regulates to ensure the safe use of pesticides, no

matter how they are made or their mode of action. The

BioPesticides and Pollution Prevention Division of the

Office of Pesticide Programs uses the authority of the

Federal Insecticide, Fungicide, and Rodenticide Act

(FIFRA) to regulate the distribution, sale, use, and testing of pesticides, including PIPs produced and used in

living plants. Under the Federal Food, Drug, and

Cosmetic Act (FFDCA), EPA sets tolerance limits for

substances used as pesticides on and in food and feed, or

establishes an exemption from the requirement of a tolerance. EPA also establishes tolerances for residues of

herbicides used on novel herbicide-tolerant crops, including those generated through genetic engineering.

FIFRA requires pesticide manufacturers to register pesticidal products prior to their sale and distribution and

makes provisions for issuance of permits for field testing

of pesticides. EPA sets conditions in the registration

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BRS Compliance Specialists use set criteria to thoroughly evaluate all GE field-test 

sites for adherence to rigorous safety standards.
Through a registration process, EPA regulates the sale, distribution, and use of 

pesticides in order to protect human health and the environment, regardless of 

how the pesticide was made or its mode of action.

process for use of the pesticide to minimize environmental impacts and establishes protective limits for pesticide

residue in food, ensuring that both food and animal feed

are safe for consumption.

EPA also regulates “new” micro-organisms—those formed

by combining genetic material from organisms in different

genera. These micro-organisms may express new traits or

new combinations of traits with unknown effects on

humans, wildlife, fish, and plants. EPA uses its authority

under the Toxic Substances Control Act to regulate new

micro-organisms used commercially in the production of

industrial enzymes and other specialty chemicals.

U.S. Department of Health and Human Services’ 

Food and Drug Administration

FDA is responsible for ensuring the safety and proper

labeling of all plant-derived foods and feeds, including

those developed through genetic engineering. All foods

and feeds, whether imported or domestic and whether

derived from crops modified by conventional breeding

techniques or by genetic engineering techniques, must

meet the same rigorous safety standards. Under the

FFDCA, it is the responsibility of food and feed manufacturers to ensure that the products they market are safe and

properly labeled. In addition, any food additive, including

one introduced into food or feed by way of plant breeding, must receive FDA approval before marketing.

FDA ensures that food and feed manufacturers meet

their obligations through its enforcement authority under

the FFDCA. To help sponsors of foods and feeds

derived from genetically engineered crops comply with

their obligations, FDA encourages them to participate in

its voluntary consultation process.

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All foods and feeds—

whether imported or 

domestic and whether

derived from crops modif

by conventional breedin

techniques or by GE 

techniques—must mee

the same rigorous FDA

safety standards.

Who Regulates What

Biotech products are regulated according to their intended use, with some products regulated under more than

one agency. The table below illustrates how the authority of the three agencies of the Coordinated Framework

results in differing regulatory oversight according to the

traits introduced through biotechnology.

Safety for agriculture and the

environment

Safety for the environment and

food and feed safety of PIPs

Safety for food and feed use

Safety for agriculture and the

environment

Safety for food and feed use

Safety for agriculture and the

environment

Safe use of companion 

herbicide

Safety for food and feed use

Safety for agriculture and the

environment

Safe use of companion 

herbicide

Safety for agriculture and the

environment

APHIS

EPA

FDA

APHIS

FDA

APHIS

EPA

FDA

APHIS 

EPA

APHIS

Insect resistance in a

food crop, e.g., Bt corn

Modified oil 

content in a food crop,

e.g., oleic acid in soybean seed

Herbicide tolerance in

a food crop, e.g.,

glyphosate-tolerant

corn

Herbicide tolerance in

an ornamental crop,

e.g., glyphosatetolerant marigold

Modified flower color

in an ornamental crop,

e.g., blue carnation

Regulatory

New trait/organism Reviewed to ensure review by
BIOTECHNOLOGY 

The U.S. Department of Agriculture (USD

activities on the basis of race, color, nati

marital status, familial status, parental st

political beliefs, reprisal, or because all o

public assistance program. (Not all proh

disabilities who require alternative mean

large print, audiotape, etc.) should conta

and TDD). To file a complaint of discrimi

1400 Independence Avenue, S.W., Wash

or (202) 720–6382 (TDD). USDA is an equ

For More Informatio

For information on BRS, plea

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

on permitting or regulatory act

USDA–APHIS

http://www.aphis.usda.gov

U.S. Environmental Protection 

http://www.epa.gov/pesticides/

http://www.epa.gov/oppt/biote

U.S. Department of Health and 

http://www.cfsan.fda.gov/~lrd/

Photo credits: On the cover, the streams

R. Anson Eaglin. The corn shot is a USDA 

photographer Peggy Greb took the pictur

all the photographs except that of the pe

Tarpenning) and the shopper buying grap

Issued April 2006

representatives from each 

Coordinated Framework 

emerging issues. Additio

calls are held monthly w

agencies. At these critica

pending decisions on new 

information, and identifi

The Coordinated Frame

creating an effective syst

agriculture, native ecosy

allowing for the safe fiel

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