U.S. Department of Agriculture August 2006

Animal and Plant Health Inspection Service

Questions and

Answers About

Biotechnology and

the USDA 

Q. What is the difference

between biotechnology and

genetic engineering? 

A. Though the terms

“biotechnology” and “genetic

engineering” are sometimes

used synonymously, it is

more accurate to regard

genetic engineering as a modern advancement in biotechnology. Biotechnology began

centuries ago when people

began using yeasts and bacteria to leaven bread and ferment cheeses. In 1917, the

word biotechnology was given

to traditional techniques, such

as selective breeding, used

by farmers to improve the

quality of their plants and 

animals.

Genetic engineering is a

recent, precise, and predictable method used to introduce new traits into plants

and animals by moving genes

and other genetic elements

from one or more organism(s)

into a second organism. In its

regulations for genetically

engineered organisms, the

U.S. Department of

Agriculture’s (USDA) Animal

and Plant Health Inspection

Service (APHIS), defines

genetic engineering as the

genetic modification of organisms by recombinant DNA

techniques. 

Q. What are genetically

engineered (GE) crops

designed to do? 

A. GE crops are being produced that have a wide variety of traits that can benefit

farmers and consumers. For

example, GE crops that can

tolerate drought conditions

and herbicides, resist insects

and viruses, and provide

enhanced quality and nutrition

for consumers are being 

tested and grown under controlled conditions by private

companies, universities, and

other researchers. Genetic

engineering can also be used

to create plants that produce

pharmaceutical and industrial

compounds. To ensure 

safety, plants engineered to

produce pharmaceutical and

industrial compounds are 

handled differently from those

being developed for use as

food or feed.

Q. Who is responsible for

regulating GE crops?

A. In 1986, the Federal

Government published a policy document known as the

Coordinated Framework for

the Regulation of

Biotechnology, which

described the Government’s

plan to regulate biotechnology. According to this document, USDA’s APHIS, the U.S

Department of Health and

Human Services’ Food and

Drug Administration (FDA),

and the Environmental

Protection Agency (EPA)

share responsibility for regulating biotechnology in the

United States based on various laws for protecting

human health, agriculture, and

the environment. 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.

Q. How do USDA, EPA, and

FDA ensure the safety of

agriculture, the environment, and the food supply? 

A. USDA and EPA are

responsible for ensuring the

safety of agriculture and the

environment. Through APHIS’

Biotechnology Regulatory

Service (BRS), USDA ensures

the safe introduction (confined field testing, interstate

movement, and importation)

of new GE plants with significant safeguards to prevent

the accidental release of any

GE material. EPA is responsible for ensuring that pesticides engineered and used in

living plants can be safely

consumed and safely used in

the environment. FDA has

primary responsibility for

ensuring the safety of the

food supply and any food

ingredients derived from

genetic engineering.
Following the principles of the

coordinated framework,

USDA, EPA, and FDA focus

on safety based on the biological characteristics of the

product, not the process

employed to create the product. USDA imposes stringent

safeguards throughout the

development phase to ensure

that GE products remain confined until they are deemed

as safe as their conventional

counterparts. 

Q. How are developers of

GE organisms regulated by

APHIS? 

A. Companies and organizations that wish to introduce a

GE organism must obtain

APHIS’ permission.

Depending on the nature of

the GE organism, an applicant

files either a notification or a

permit application. With either

application, the developer

must adhere to APHIS regulations and, in some cases, to

conditions imposed specifically for that permit to ensure

adequate confinement of the

organism. Under the authority of the Plant Protection Act,

BRS further ensures the safety of field tests and the strict

adherence to regulations and

permit conditions through targeted inspections and audits. 

Q. What is a notification?

A. Most GE plants are regulated under the notification

process. The notification

process is streamlined and

may be used only for familiar

plants and traits that meet

certain safety-based criteria.

For example, the gene used

must not create plant diseases, viruses, or unintended

toxic substances; the plant

must not contain genes from

animal or human pathogens;

and the plant must not produce pharmaceutical or industrial compounds. To ensure

confinement, the developer

must perform the test in a

way that meets performance

standards that are specified in

APHIS’ regulations. If a plant

does not meet the criteria for

notification, the applicant

must follow the full permitting

process.

Q. What is a permit?

A. Permits are required for

any GE introductions that are

not covered under notifications. Permits are generally

more restrictive than notifications and are used for any GE

organism that is not a plant,

as well as for GE plants that

could pose an elevated plant

pest risk, such as plants engineered to produce pharmaceutical or industrial compounds. 

A list of standard permit conditions is available in the Code

of Federal Regulations, at Title

7, Part 340.4(f), and can be

accessed through the BRS

Web site at

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

brs/usergd.html>.

Supplemental conditions that

are tailored to fit the specific

circumstances of each field

test may also be imposed

before a permit is granted. 

Applicants must provide the

same detailed data for permits as required in the notification process, including the

size, duration, and location of

field tests; plant information;

and descriptions of any genes

used and the genetic modifications. In addition, the

developer must provide

detailed descriptions of how

field tests will be performed,

including specific measures

for reducing the risk of harm

to other organisms. If portions of the application 

contain trade secrets or confidential business information

(CBI), applicants must submit

two versions of the application: one with CBI marked

and included and one with

CBI marked and redacted.

The CBI-redacted version is

the edited version that is circulated for review by officials

outside APHIS, such as State

departments of agriculture.

Field-test permits are issued

on a case-by-case basis after

scientific experts complete an

extensive environmental

assessment (EA), which analyzes possible impacts on the

environment.

Q. What are crops that produce pharmaceutical and

industrial compounds, and

how are they regulated?

A. Crops that produce pharmaceutical compounds are

specifically engineered to produce compounds for medicinal drugs, such as vaccines,

for humans or animals. Crops

that produce industrial compounds are specifically engineered to produce chemicals

for industrial purposes, such

as enzymes used in detergent

manufacturing. Crops 

engineered to produce 

pharmaceutical and industrial

compounds fall into a distinct

category and are handled 

differently from those plants

being developed for use as
food or feed. BRS issues permits for field tests for crops

that produce pharmaceutical

and industrial compounds on

a case-by-case basis and

addresses any new issues

raised by such crops in EAs. 

Developers must apply for a

permit rather than a notification to field test crops that

produce pharmaceutical and

industrial compounds. When

applying for a permit, applicants must include specific

measures to reduce the risk

of harm to other organisms.

APHIS also imposes morestringent confinement measures on these field tests. This

includes increased isolation

distances and fallow zones

(areas that are not in production), restrictions on growing

crops that produce pharmaceutical and industrial compounds on the same land

used to produce food or feed

crops, and dedicated equipment and storage facilities for

those crops. BRS inspects

these test sites seven times,

with inspections corresponding to critical times in production. 

Q. What is an EA?

A. An EA is a public document that analyzes possible

impacts of certain

Government actions on the

environment as required

under the National

Environmental Policy Act

(NEPA). It is prepared by BRS

before granting petitions for

deregulation and before

approving permits when the

plant species, the trait, or

both are considered new or

novel. If a proposed action

does not have the potential to

significantly impact the environment, BRS will prepare a

finding of no significant

impact. If BRS determines

that the proposed action has

the potential to significantly

impact the environment, then

it will prepare an environmental impact statement (EIS),

which involves a more comprehensive environmental

analysis of the proposal and

reasonable alternatives. 

Q. What is an EIS? 

A. An EIS is a detailed and

comprehensive environmental

analysis that must be prepared when proposed

Government actions are broad

in scope or have the potential

to significantly impact the

environment. As with an EA,

the EIS is required for certain

Government actions in order

to comply with NEPA. An EIS

evaluates the environmental

impacts of GE organisms, and

as part of this document, BRS

must present and assess

alternative courses of action

for these potential impacts.

BRS may also specify actions

that would mitigate any

impacts of the biotechnology

product. 

Q. What is CBI, and how

does deleted CBI affect BRS’

and the States’ ability to

judge permit applications?

A. Certain qualifying financial

or commercial information

that the developer does not

want disclosed for competitive reasons can be claimed

as CBI. BRS sees and

reviews all confidential and

nonconfidential information

and is able to make sound,

science-based decisions

when reviewing all notifications applications, permit

applications, and petitions for

deregulation. Although BRS

cannot provide CBI data to

the States or any other outside parties, State agricultural

officials may contact the companies directly to request any

CBI-deleted information that

may be needed to make decisions about the environmental

safety of a GE organism.

BRS posts CBI-deleted versions of petitions online, and

all nonconfidential data submitted in support of a petition

are available for public inspection. 

Q. How does BRS ensure

compliance with regulations and permit conditions?

A. BRS maintains a rigorous

regulatory process that

includes strict compliance and

inspection practices. When it

issues a permit for movement, importation, or field

testing of a GE organism,

BRS imposes certain conditions to which the developer

must adhere. To ensure that

the conditions set forth by

APHIS are carefully followed,

compliance specialists and

inspectors from APHIS’ Plant

Protection and Quarantine

(PPQ) program perform targeted inspections and audits

of field tests. Depending on

the GE crop being tested, a

site may be inspected for

compliance seven times.

BRS also works closely with

other Federal agencies,

including FDA and EPA, to

monitor compliance with regulations. These agencies,

along with State departments

of agriculture, can submit
external incident reports of

any potential compliance

infractions to BRS. As a

result of these rigorous standards, overall compliance

rates with BRS regulations

are very high.

Additionally, APHIS regulations require permit holders

to notify BRS immediately

upon discovery of potential

compliance issues and follow

up with a written report within 24 hours of the incident.

Developers who do not follow

these guidelines face the

potential for fines and other

penalties.

Q. Are all field tests

inspected, and how often?

A. All permitted field tests

are inspected, with the number of inspections based on

the relative risk of each trial.

Field-test sites for crops that

produce pharmaceutical and

industrial compounds, for

example, are inspected seven

times before, during, and

after the growing season. 

Notification field tests have

been extensively regulated in

the past and have a low plant

pest potential. These field

tests are given a computergenerated score based on

several parameters, including

the regulated article’s traits

and characteristics, acreage

planted, and the length of

time an applicant has been in

business. Field tests are

selected for inspection based

on this score, as well as by

random sample. 

BRS maintains a comprehensive database that captures

and tracks inspection-related

information to ensure that all

required inspections are

accomplished.

Q. What are compliance

infractions, and how does

BRS resolve incidents of

noncompliance? 

A. Compliance infractions

can include a wide range of

incidents from administrative

issues, such as the wrong

name on a permit, to more

serious infractions, such as

failure to observe isolation

distances. Unforeseen

events, such as the accidental

release of a regulated article

or the destruction of a field

test by livestock, wild animals, or strong winds can

also be considered compliance infractions when they

cause the developer to be in

noncompliance with permit

conditions. While developers

have no control over these

events, immediate notification

of BRS is important in order

to implement any necessary

mitigation measures quickly.

Developers are required to

notify BRS of all possible

compliance infractions, and

failure to do so immediately is

itself a compliance infraction. 

When a developer fails to

adhere to BRS’ regulations

and permit conditions,

employees in the compliance

and inspection branch ensure

that corrective measures are

taken. In these cases, the

developer must immediately

take remedial measures to

protect agriculture, the food

supply, and the environment.

These measures include, but

are not limited to, safeguarding the field-test site and regulated articles, returning to

compliance with permit conditions or notification performance standards, and supplying

all necessary information to

BRS and the State. In some

cases, the field test may need

to be terminated and the crop

destroyed.

Intentional violation of any

biotechnology regulations can

bring high monetary fines and

other punitive criminal actions

to the offender(s) by any or all

of the three biotechnology

regulating agencies. 

Q. What role does BRS play

in ensuring commercial

food and feed is free of

field-test materials?

A. Under the Coordinated

Framework for the Regulation

of Biotechnology, USDA, EPA,

and FDA work together to

regulate biotechnology. FDA

has primary responsibility for

ensuring the safety of the

food supply and any food

ingredients derived from

genetic engineering. When

BRS issues a permit for

movement, importation, or

field testing of a GE organism, the developer must

adhere to certain conditions

that ensure that the regulated

GE organism does not persist

in the environment or enter

the food or feed supply.

These conditions include

stringent confinement measures, such as isolation distances, to prevent pollen

flow; clean equipment and

containers, in good working

order, to prevent cross-contamination; and labeling of all

regulated articles to prevent
accidental use or incorporation with other crops. In the

event that a regulated GE

organism does become intermingled with unregulated GE

food or feed, Government

agencies have the authority to

seize the food or feed and

require its destruction, thereby preventing it from entering

the food supply. 

At the end of all field tests,

developers must destroy or

properly dispose of any viable

plant material and ensure that

no regulated articles persist in

the environment beyond the

duration of the trial.

Q. What process does a GE

crop go through before

USDA determines that it

can be safely commercialized? 

A. In a practical sense, being

granted nonregulated status

is usually necessary before a

GE crop is sold and produced

commercially. Nonregulated

status allows the product to

be moved and planted freely

without the need for notifications or permits. A developer

may file a petition for deregulation or nonregulatory status

only after a GE crop has been

field tested extensively and

the developer can show that

the product does not pose a

plant pest risk. 

After an intensive review of

the data, BRS prepares an EA

to analyze the potential

impacts the crop may have on

the environment and seeks

public comment on the findings. BRS approves a petition

for deregulation only after 

determining that the organism

does not pose a plant pest

risk.

Before being made commercially available, the crop may

also be subject to regulatory

review by other agencies. For

example, crops to be used as

food or feed are reviewed by

FDA and are declared equal to

conventional food crops only

when deemed as safe as

their conventional counterparts. 

Once BRS has granted a

product nonregulatory status,

the product may be freely

moved and planted without

the need of permits or other

regulatory oversight by BRS.

Since 1987, APHIS has deregulated more than 60 GE products. BRS has the authority

to bring any of the deregulated items back under regulation if new information

demonstrates that they are

plant pests. This authority,

however, has never been

used, and deregulated products have an established history of safe use in U.S. agriculture. 

Q. What GE crops are available commercially, and are

these products labeled? 

A. Deregulated GE crops,

such as corn, soybean, cotton, rapeseed (canola), flax,

alfalfa, sugar beet, squash,

and papaya, have been made

commercially available.

Soybeans, corn, cotton, and

canola that are herbicide tolerant or insect resistant are the

most popular items. GE products that are commercially

available today are not

required to be labeled just

because genetic engineering

was used in producing the

plants. These products have 

been reviewed for safety by

the relevant agencies and

have been found to be as safe

as traditional varieties. 

Q. How do APHIS regulations keep pace with the

science of biotechnology? 

A. APHIS revised its regulations in 1993 and 1997 to

increase agency regulatory

efficiency and keep pace with

new technologies. In 2003,

BRS published two Federal

Register notices announcing

more-stringent permit conditions for field tests of plants

engineered to produce pharmaceutical and industrial compounds. These regulatory policy changes resulted in

stricter confinement measures and greater oversight. 

Driven by recent technological

trends, such as the increased

interest in GE organisms as a

means to produce pharmaceutical compounds, BRS is

planning to revise its current

regulations. The first step in

this process is the development of a programmatic EIS

to provide a detailed environmental analysis of the proposed revisions and allow for

public input and comment.

This EIS will identify the

range of actions, alternatives,

and impacts that need to be

considered when evaluating

APHIS’ biotechnology regulations and possible regulation

changes, such as multitiered,

risk-based permitting to

replace the current

permit/notification system.

Using the information and

alternatives contained in the
EIS, BRS will be able to make 

informed decisions on policy

changes and clearly lay out

the rationale for these recommended changes.

BRS established an Office of

Science to ensure that APHIS’

biotechnology-related regulations are grounded in the latest science. The Office of

Science helps BRS remain

informed about the latest scientific knowledge useful for

the development of regulatory

policies and decisions and

allows BRS to pass on this

knowledge to the research,

regulatory, and stakeholder

communities. One of the primary responsibilities of the

Office of Science is to oversee the peer-review process

for the scientific information

used as the basis of APHIS’

regulatory policies and decisions. Peer review can be

used when BRS produces an

EIS, including BRS’ programmatic EIS.

Q. How does BRS involve

the public and stakeholders

in important policy discussions and decisions?

A. BRS makes it a priority to

ensure that our processes,

decisions, and activities are

transparent to the public and

our stakeholders. The United

States Regulatory Agencies

Unified Biotechnology Web

site

<http://usbiotechreg.nbii.gov>

contains a searchable database of biotechnology products that have completed

reviews for use in the United

States. BRS’ Web site provides accessibility to permits,

decisions, and information on

the regulatory process, including the deregulation process.

EAs for field tests of crops

engineered to produce pharmaceutical and industrial compounds are posted for viewing and for a 30-day comment

period, allowing stakeholders

and the public to be part of

the decisionmaking process.

An online stakeholder registry

system lets stakeholders sign

up to receive information

based on selected topics of

interest. Interested individuals can sign up for the registry by visiting the BRS Web

site at

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

and clicking on Stakeholder

Registration. In addition to its

Web site, BRS regularly provides briefings and information to the media and

Congress and holds open

public meetings to gain feedback directly from the public

on issues of importance. 

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(Not all prohibited bases apply to all

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Office of Civil Rights, 1400

Independence Avenue, S.W.,

Washington, D.C. 20250–9410, or call

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