APHIS Factsheet

Biotechnology Regulatory Services July 2007 

Programmatic 

Environmental 

Impact Statement

Biotechnology Regulatory Services (BRS), a program 

within the U.S. Department of Agriculture’s (USDA) 

Animal and Plant Health Inspection Service (APHIS), 

is responsible for regulating the introduction—meaning 

the importation, interstate movement, and environmental release—of genetically engineered (GE) organisms. The program is considering potential revisions 

to update its existing regulations in light of advances in 

science and technology as well as the knowledge and 

experience BRS’ experts have gained through their 

work. 

 As part of the evaluation of its regulatory program, 

BRS has published a draft Environmental Impact 

Statement (EIS). The draft EIS is a crucial step in 

the regulatory revision process. The purpose of this 

process is to provide a detailed analysis of the regulatory alternatives that BRS is considering and allow for 

public input and comment. The draft EIS evaluates 

the environmental impacts of the current regulations 

and the potential environmental effects of the revisions 

under consideration. The National Environmental 

Policy Act (NEPA) guides Federal agencies on the 

integration of environmental and public considerations 

into their decisionmaking processes. During this process, BRS officials are closely following NEPA requirements, which ensure that environmental impacts of 

proposed actions and reasonable alternatives to those 

actions are considered. 

 In January 2004, BRS publicly announced it was 

beginning a review of its regulations and published a 

notice of intent to prepare an EIS. The notice identified potential issues and alternatives to be studied 

in the EIS and requested public comment to further 

shape the scope of the issues and alternatives. The 

comments received contributed to the issues that BRS 

officials are now considering.

Changes Under Consideration Regulatory 

Authority

BRS currently regulates GE organisms to ensure that 

they are not a plant pest and do not cause damage, 

injury, or disease to plants. BRS’ authority comes 

from the Plant Protection Act (PPA) of 2000, which 

combines the authorities of several previous acts, 

including the Noxious Weed Act, the Federal Plant 

Pest Act, and the Plant Quarantine Act. BRS is 

considering revising its regulations to better utilize the 

broad regulatory authority of the PPA. 

 BRS is considering expanding its regulatory 

oversight to include the oversight of GE organisms 

that have the potential to be noxious weeds. This 

would increase BRS oversight of GE organisms that 

may damage crops and other plants to also include 

GE plants that may pose a broader array of risks to 

agriculture, the environment, and public health.

 In addition, BRS is considering expanding its regulatory oversight to include the use of biological control organisms (organisms genetically engineered to 

control insect pests) and nonviable GE plant material 

originating from field tests. Nonviable materials, like 

plant stems and leaves that cannot propagate successfully, are not currently regulated by BRS because 

they have been regarded as an insignificant risk to 

plant health. In some circumstances, however, they 

may pose other types of environmental risks. 

 BRS is also considering regulating nonviable GE 

material when there is reason to believe that such 

material might be harmful to the environment if it were 

allowed to remain, or when there is a violation of regulations or permit conditions that create the potential for 

the nonviable material to pose a risk. 

Multi-Tiered Permitting System

BRS currently regulates GE organisms through a twotiered system that includes notifications and permits. 

BRS uses notifications as an expedited permitting 

process for GE plants it considers to be lower risk and 

has extensive experience regulating in the past. BRS 

requires permits 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 risk to plant health, 

such as plants engineered to produce pharmaceutical 

or industrial compounds. 

 BRS is considering establishing an expanded, 

tiered permitting system based on potential environmental risk and familiarity. The new tiered system 

would increase transparency with respect to how the 

agency intends to handle various types of GE organisms and would allow for the movement of GE organisms among the tiers as new information becomes 

available. The degree of confinement and oversight 

would be risk-proportionate and vary by tier. For 

instance, BRS would continue to use a system similar 
to the current notification process for more familiar, 

low-risk GE organisms. These organisms would be 

introduced under the least restrictive tier “permit.” BRS 

would require additional confinement and oversight 

measures for less familiar organisms or those with the 

potential to pose elevated risks. Additional tiers could 

be established to accommodate: 

• Plants with higher plant pest or noxious weed potential;

• Plants engineered to express traits with which BRS 

is less familiar, such as plants that produce pharmaceutical or industrial compounds; and

• Plants engineered to express traits that are likely to 

pose a hazard to human health and the environment. 

For example, plants engineered to remove heavy 

metals from contaminated soil could pose a potential 

hazard if metals accumulate in the plant.

 

Nonregulated Status 

Developers of GE organisms can petition BRS for a 

determination of nonregulated status. BRS does not 

currently place any restrictions or requirements on the 

use of GE organisms that have been granted nonregulated status. Organisms are granted nonregulated 

status, or deregulated, if BRS officials determine that 

they do not pose a risk to plant health. 

 As indicated in the draft EIS, BRS is considering developing an alternative process through which 

GE organisms could either be fully deregulated and 

removed from agency oversight, or could be granted 

conditional approval and be retained under some 

degree of oversight. This would accommodate commercialization while continuing, in some cases, to regulate the organisms based on minor unresolved risks to 

plant health.

GE Plants that Produce Pharmaceutical and 

Industrial Compounds

BRS is also considering proposing a more efficient but 

equally rigorous regulatory process for the commercial production of plants that produce pharmaceutical 

or industrial compounds. To date, no GE plants that 

produce pharmaceutical or industrial compounds have 

been deregulated. It is common for GE plants that 

produce pharmaceutical or industrial compounds for 

commercial purposes to be grown under permits, even 

though BRS’ permit process was designed for the introduction—not commercial production—of GE plants. As 

a result, BRS repeatedly reviews full permit applications 

for these crops each year, even when the locations and 

protocols have not changed. 

 The new tiered system would provide continued 

rigorous oversight of GE plants that produce pharmaceutical and industrial compounds through multiyear 

permits, and would incorporate intensive reviews of 

standard operating procedures, audits, and inspections 

to protect the environment. The new system would 

result in BRS increasing the efficiency and transparency of its regulatory efforts. 

 Plants engineered to produce pharmaceutical and 

industrial compounds are presently grown under highly 

stringent conditions and with considerable oversight. 

In 2003, BRS published two Federal Register notices 

announcing more rigorous permit conditions for field 

testing of plants engineered to produce pharmaceutical or industrial compounds. These regulatory policy 

changes resulted in stricter confinement measures and 

greater oversight. 

 As noted in the EIS, BRS is considering maintaining its current strict oversight for the field testing of food 

or feed crops engineered to produce pharmaceutical 

or industrial compounds. BRS would consider the food 

safety of the new substance in determining appropriate 

confinement measures.

Low-Level Presence of Regulated GE Products 

Plant breeding programs frequently work to develop 

and test several plant varieties simultaneously. As 

they develop new varieties, plant breeders go to great 

lengths to prevent them from mixing. Occasionally, 

however, with both conventionally bred plants as well 

as GE plants, low-level mixing may occur due to natural 

processes such as the movement of seeds or plant pollen, or human-mediated processes associated with field 

testing, plant breeding, or seed production. To prevent 

mixing and minimize low-level presence (LLP)—the 

occurrence of low levels of regulated GE products in 

commercial seeds and grain—developers of GE plants 

must comply with all BRS regulations and permit conditions. 

 In 2007, BRS clarified its existing approach for 

handling LLP. Should LLP occur, BRS’ current policy is 

to respond with actions appropriate to the level of risk 

determined by a scientific assessment and warranted 

by the facts in each case. For cases in which LLP 

poses no risk to plant health and the environment, BRS 

may take no remedial action. Such cases could include 

those involving a minimal-risk plant that qualifies for 

APHIS’ notification process or if the GE plant is similar 

to another GE plant that has already been deregulated 

or shown not to be a plant pest. 

 Current regulations do not address or expressly 

allow for LLP. BRS is considering establishing a 

system under which regulated GE products must meet 

pre-established safety criteria in order for APHIS not to 

take remedial action if LLP occurs. A product’s ability 

to meet or not meet the safety criteria would determine 

the requirements under which it must be field tested. 
Products not meeting the safety criteria would require 

more stringent confinement standards and be regulated 

in such a way that makes it highly unlikely that they 

would ever occur in commerce. 

Importation and Movement of GE Organisms

BRS regulates the importation of new GE organisms. 

BRS currently handles requests involving the importation of low-risk GE organisms intended for nonpropagative use—that is, for food, feed, or processing—on a 

case-by-case basis. BRS anticipates that the number 

of importation requests will increase. The current system of permits and notifications does not have a separate process for reviewing (or exempting from review) 

low-risk products. 

 BRS is considering developing a new regulatory 

mechanism to allow for imports of commodities that are 

for nonpropagative use and that have not been deregulated by BRS in the United States. BRS would establish criteria to ensure safety and to allow for additional 

environmental review with the aim of protecting U.S. 

agriculture and human health without creating unnecessary trade barriers. Allowing such imports would 

not preclude the need for importers to comply with the 

requirements of other Federal agencies, such as the 

Food and Drug Administration and the Environmental 

Protection Agency.

 BRS also oversees the interstate movement of 

regulated GE organisms by enforcing interstate movement requirements. Currently, only GE varieties of the 

species Arabidopsis thaliana, a small flowering plant 

related to cabbage and mustard, are exempt from interstate movement requirements because they are well 

understood, extensively used in research, and are not a 

plant pest. 

 As noted in the EIS, BRS is considering similarly 

exempting those GE organisms that are among the 

most well-studied and familiar GE organisms from 

the requirement of a permit for interstate movement. 

Exemptions would apply only to those organisms within 

a tier of organisms meeting specific safety-based 

criteria. Shippers would notify BRS that they plan to 

ship the organisms. No agency response would be 

required. 

 Whether being shipped interstate or arriving as 

import material, all GE material regulated under permits 

must be shipped in specified containers. BRS has a 

list of approved containers and issues variances for the 

use of other suitable containers when appropriate. 

BRS plans to continue regulating the types of containers used to ensure the safe shipping of GE organisms. 

However, as indicated in the EIS, BRS is considering 

proposing the use of performance-based standards 

for all shipping containers for regulated GE material. 

Numerous types of appropriate containers could meet 

United States Department of Agriculture • Animal and Plant Health Inspection Service • Safeguarding American Agriculture

given safety standards, namely that the containers prevent escape, dissemination, or environmental persistence of the GE material.

Next Steps

BRS is committed to ensuring that its regulations will 

be robust enough to meet the demands of biotechnology. BRS is seeking to create rigorous, consistent, 

and easily understood regulations that are based on 

science. These regulations must be effective, flexible, 

and impose a degree of oversight proportionate to the 

potential risks. 

 BRS’ goals are to improve its regulatory system 

through new practices that will enhance environmental 

safety, increase public confidence, and make more 

efficient use of resources while maintaining scientific 

integrity, reducing the regulatory burden, and increasing transparency to the public. 

 A draft EIS is one step in the regulatory revision 

process, forming the basis of any new regulations 

which BRS will propose. The information and proposed changes under consideration in the draft EIS will 

assist BRS in making an informed decision regarding 

regulatory and policy changes and will help define the 

rationale for recommended changes. In addition to the 

draft EIS, BRS will use public comments and the latest 

scientific information to formulate new proposed regulations (a proposed rule). A final EIS will be prepared 

that addresses public comments responding to the draft 

EIS. 

 Any future proposed rule which results from these 

efforts will take into account deliberations recorded in 

the draft EIS, as well as the public responses to the 

draft EIS, and will be reviewed by other Federal agencies. Under the Federal rulemaking process, a notice 

of availability for a proposed rule would also be published in the Federal Register with a public comment 

period to follow.

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.