U.S. Department of Agriculture February 2006

Animal and Plant Health Inspection Service

Permitting Genetically

Engineered Plants That

Produce Pharmaceutical

Compounds

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 introduction

(importation, interstate movement, and field release) of

genetically engineered (GE)

organisms, such as plants,

insects, micro-organisms, and

any other organisms that are

known to be or could be a

plant pest. Through a strong

regulatory framework, BRS

works to ensure the safe and

confined introduction of new

GE plants, such as trees,

grass, food crops, and crops

grown for use in making pharmaceutical and industrial compounds.

A pharmaceutical or industrial

crop is a plant that has been

genetically engineered to produce a medical or industrial

product, including a human or

veterinary drug, biologic,

industrial or research 

chemical, or enzyme.

Examples of species that

have been used to produce

pharmaceutical and industrial

compounds include: rice,

corn, barley, tobacco, and safflower. These crops are 

grown to produce research

chemicals, vaccines, human

antibodies, and human blood

proteins. Since 1991, more

than 90 permits for the testing of pharmaceutical and 

industrial crops have been

issued. Pharmaceuticals and

industrials fall into a distinct

category, and BRS policy

makes clear that these GE

plants are handled differently

than those being developed

for use as food or feed.

Pharmaceutical and

Industrial Requirements

Developers interested in fieldtesting a pharmaceutical or

industrial crop must obtain 

permission from APHIS

through a permit. APHIS

issues permits for pharmaceuticals and industrials on a

case-by-case basis following a

rigorous review process. 

The developers must submit

all plans for field testing for

BRS’ review. The purpose of

the review is to ensure that

the field tests are conducted

in such a way that there is no

harm to agriculture or the 

environment. A skilled staff

of regulatory scientists conducts the permit reviews to

evaluate the risks of the field

tests or movement of the

crops. The measures to confine the field trial and the

potential environmental

effects are also carefully evaluated. BRS employs a strong

scientific basis for performing 

all aspects of the permitting

process. BRS has experts in

the fields of plant pathology,

botany, entomology, ecology,

virology, animal science, and

molecular biology. These

experts conduct extensive scientific reviews of permit applications, petitions, and potential infractions. 

For field tests of pharmaceutical and industrial plants,

APHIS imposes more stringent confinement measures

than for field tests of conventional GE crops, such as

increased isolation distances

and fallow zones, and

increased inspections and 

oversight. During the growing season, measures must

be taken to achieve reproductive isolation from any sexually compatible plants to prevent cross-pollination with cultivated or wild plants that are

not part of the field test.

Environmental effects considered include impacts on

threatened and endangered

species, toxicity of the GE

plant to nontarget organisms,

and the likelihood of such

organisms to be exposed. In

cases involving new risks,

such as a new species, the

staff prepares an environmental assessment accompanied

by a public comment period.

In 2003, BRS published two

Federal Register notices

announcing the strengthening

of permit conditions for fieldtesting of plants engineered

to produce pharmaceuticals

and industrials. These regulatory changes resulted in

stricter confinement measures and a greater

Government role.

In 2003, BRS 

published two

Federal Register

notices announcing the strengthening of permit 

conditions for fieldtesting of plants

engineered to 

produce pharmaceuticals and

industrials.
Regulation of

Pharmaceutical and

Industrial Field Trials

Permit Conditions

• Pharmaceutical and 

industrial crops must be 

separated from other 

sexually compatible crops 

by a substantial distance. 

For example, the isolation 

distance for openpollinated corn is 1 mile, 

which is eight times 

further than is required 

for foundation seed 

production.

Other permit conditions

include:

• A 50-foot fallow zone must

surround the plot;

• Developers must submit 

for APHIS review their 

procedures for seed 

handling;

• Developers are required to

have an APHIS-approved 

training program for their 

personnel;

• Developers must have 

equipment and storage 

dedicated to the pharmaceutical or industrial field 

trial. The same equipment

and storage cannot be 

reusedfor crops beyond 

the field test;

• Developers may not plant 

food or feed crops on 

the land that was used to 

produce pharmaceutical 

and industrial crops during

the previous season.

Government Role

• APHIS conducts 

inspections up to seven 

times before, during, and 

after production.

• APHIS audits field trial 

records.

• APHIS partners with State 

departments of agriculture 

in the regulatory oversight 

of biotech crops. State 

officials review all proposed

field tests, and APHIS-BRS 

requires both a permit and 

the concurrence of 

individual State departments of agriculture 

or other relevant agencies 

to import or ship any GE 

organisms that have the 

potential to be plant pests.

APHIS has never approved

a field test permit over the 

science-based objections of

State counterparts or with

out accommodating 

additional permit conditions 

recommended by the 

States.

Compliance With APHIS

Regulations

Developers must comply with

APHIS regulations when fieldtesting pharmaceutical and

industrial crops. A new compliance and enforcement unit

was established in October

2003 to ensure adherence to

permit conditions. BRS’ compliance unit is dedicated solely to ensuring that companies

and organizations maintain

compliance through defined

procedures that include violation-prevention efforts, riskbased criteria for quality

inspection, uniform enforcement, and thorough documentation of any compliance

infractions. Compliance specialists and inspectors from

APHIS’ Plant Protection and

Quarantine program perform 

targeted inspections and

audits of field tests and use

set criteria to thoroughly evaluate all potential 

compliance infractions.

Pharmaceutical and industrial

field-test sites are inspected

by APHIS five times during a

single growing season and

twice during the subsequent

growing season to ensure that

the conditions set forth by BRS

are carefully followed.

BRS will continue to strengthen approaches to regulating

the field testing of pharmaceuticals and industrials to

keep pace with emerging

changes in science and 

technology.

Additional Information

For more information about

the permitting process for

pharmaceutical and industrial

crops, contact:

USDA, APHIS, BRS 

4700 River Road, Unit 147

Riverdale, MD 20737–1236

Telephone (301) 734–7324

or visit the APHIS Web site at 

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

brs/index.html>.

The U.S. Department of Agriculture

(USDA) prohibits discrimination in all

its programs and activities on the

basis of race, color, national origin,

age, disability, and where applicable,

sex, marital status, familial status,

parental status, religion, sexual orientation, genetic information, political

beliefs, reprisal, or because all or part

of an individual’s income is derived

from any public assistance program.

(Not all prohibited bases apply to all

programs.) Persons with disabilities

who require alternative means for

communication of program information (Braille, large print, audiotape,

etc.) should contact USDA’s TARGET

Center at (202) 720–2600 (voice and

TDD). To file a complaint of discrimination, write to USDA, Director,

Office of Civil Rights, 1400

Independence Avenue, S.W.,

Washington, D.C. 20250–9410, or call

(800) 795–3272 (voice) or (202)

720–6382 (TDD). USDA is an equal

opportunity provider and employer.