U.S. Department of Agriculture February 2006

Animal and Plant Health Inspection Service

National Environmental

Policy Act and Its Role in

USDA’s Regulation of

Biotechnology

Through its

Biotechnology

Regulatory Services

(BRS) program, the U.S.

Department of Agriculture’s

(USDA) Animal and Plant

Health Inspection Service

(APHIS) is responsible for regulating the importation, movement, and field release of

genetically engineered (GE)

plants, insects, and microorganisms that may pose a

plant pest risk.

As the complexity and scope

of biotechnology in the United

States grow and new GE

organisms continue to be

developed, the Federal

Government must continue to

ensure that biotechnology

products are developed and

field-tested safely. Consistent

with the Coordinated

Framework (51 FR 233302,

June 26, 1986), USDA works

with the Environmental

Protection Agency and the

Food and Drug Administration

to ensure the safe development of GE products.

USDA first implemented regulations for biotechnology (Title

7 Code of Federal

Regulations, Part 340) in 1987

under the authorities of the

Federal Plant Pest Act and the

Plant Quarantine Act. Under

these regulations, transgenic

plants, micro-organisms,

insects, and mollusks were

subject to regulation if they

had the potential to pose a

plant pest risk. These regulations provided broad authority

over the introduction of such

organisms and used a permitting system to authorize

importation, interstate movements, and field releases of

GE organisms. The major

actions of all Federal agencies

that significantly affect the

human environment are subject to the National

Environmental Policy Act

(NEPA), and APHIS considers

impacts on the human environment in its decisionmaking, not just the potential for

plant pest risk.

NEPA—the environmental

charter for the U.S.

Government—mandates a

process for evaluating environmental impacts resulting

from agency actions. NEPA

establishes a national policy

for the protection of the environment through an informed

decisionmaking process for

implementing projects and

programs that have potential

impacts on the environment.

NEPA applies to almost all

Federal agencies, which

means that BRS must weigh

environmental impacts prior

to undertaking any major

Federal action with the potential to significantly affect the

environment, including rulemaking. Section 102 (2) of

NEPA declares that this policy

is to be implemented through

the regulations established by

the President’s Council on

Environmental Quality.

Unless an agency action is

categorically excluded from a

NEPA-mandated environmental analysis, the agency must

analyze the action through the

preparation of an

Environmental Assessment

(EA) or an Environmental

Impact Statement (EIS).

Categorical Exclusions

An action that would result in

less-than-significant or no

environmental impacts may

be categorically excluded

from the requirement to prepare an EA or EIS. For example, a categorical exclusion

would apply to the permitting

of the confined release of a

GE organism involving a wellknown species that does not

raise any new issues. A categorical exclusion is not an

exemption from NEPA but a

determination that an EA or

EIS is not necessary. 

Environmental Assessment

An EA is prepared by BRS to

determine whether a proposed action may have significant impacts on the quality of

the human environment. The

EA discusses the need for the

proposed action, possible

alternatives including the noaction alternative, the potential impacts of the proposed

action and alternatives, and

information regarding any

consultation or agency coordiNEPA establishes a

national policy for

the protection of the

environment through

an informed decisionmaking process for

implementing projects and programs

that have potential

impacts on the environment.
nation. The EA, which is a

public document, briefly provides sufficient evidence and

analysis for determining

whether to prepare an EIS. If

the proposed action does not

have a significant impact on

the environment, APHIS will

issue a Finding of No

Significant Impact (FONSI). If

BRS determines that any

aspect of the quality of the

human environment may be

significantly affected by the

proposed action, then it will

prepare an EIS, which

involves a more in-depth

inquiry into the proposal and

any reasonable alternatives to

it. 

BRS writes an EA before

granting permits for introductions of GE organisms that

are considered new or novel

(either the crop species, the

trait, or both), and it is BRS’s

current practice to give the

public the opportunity to comment on an EA before the

permit is granted. APHIS also

prepares an EA when it

decides that a GE plant or

micro-organism will no longer

be regulated. 

The environmental assessment preparation process

includes:

• Consultation and 

coordination with other 

Federal, Tribal, State, or 

local agencies;

• Public scoping;

• Federal Register Notices;

• Public comments on a 

draft EA;

• Public meetings on a draft 

EA;

• Publication of final EA and 

FONSI; and

• Supplements to a previous

EA.

Environmental Impact

Statement

An EIS is the most detailed

and comprehensive environmental analysis specified

under NEPA and must be prepared if the preceding EA is

not resolved with a FONSI.

The EIS evaluates the environmental impacts of broad

agency actions, such as rulemaking, adopting strategic or

long-range plans, and developing major programs with

extensive commitments of

resources. APHIS may also 

decide to use the NEPA

process to better inform the

decisionmaking behind projects of a more narrow scope,

such as the deregulation of a

specific GE crop. The evaluation includes a discussion of

direct, indirect, and cumulative impacts resulting from

the adoption of one of several

reasonable alternatives,

including the no-action alternative. Additionally, BRS may

also specify and discuss

actions that would mitigate

any impact of the biotechnology product. An EIS is developed by a multidisciplinary

team and can take between 

1 and 6 years to complete.

The environmental impact

statement preparation

process includes:

• Consultation and 

coordination with other 

Federal, Tribal, State, or 

local agencies when 

appropriate;

• Scoping;

• Federal Register notices;

• Public comment on draft 

EIS;

• Public meetings on draft 

EIS when appropriate;

• Publication of a final EIS; 

and

• Supplements to an 

inadequate EIS when 

necessary.

BRS is committed to the use

of NEPA to strengthen its

approach to regulating the

field-testing of GE crops to

ensure that these tests neither pose plant pest risks nor

pose significant impacts to

the human environment. 

Additional Information

For more information about

the NEPA process as it

relates to the introduction of

GE 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>.

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