APHIS Factsheet

Biotechnology Regulatory Services March 2007

Low-Level Presence

Agricultural Genetic Engineering 

 Genetic engineering (GE) is a precise and predictable method used to introduce new traits into plants 

and animals by moving genes and other genetic 

elements from one or more organisms into another 

organism. 

• GE crops are being produced that have a wide 

variety of traits that benefit farmers and consumers. For example, GE crops can tolerate drought 

conditions and herbicides, resist insects and 

viruses, and provide enhanced quality and nutrition for consumers. GE crops are being developed 

by private companies, universities, and other 

researchers. 

• GE crops that are currently consumed for food, 

fiber or feed include corn, soybeans, cotton, 

canola, and squash.

• USDA’s National Agricultural Statistics Service 

estimates that in 2006, 61 percent of the corn, 83 

percent of the cotton and 89 percent of the 

 soybeans planted in the United States were 

 biotech varieties. 

Biotechnology Regulatory Authority 

 Under a coordinated regulatory framework, 

USDA’s Animal and Plant Health Inspection Service 

(APHIS), the Food and Drug Administration (FDA), 

and the U.S. Environmental Protection Agency (EPA) 

share responsibility for regulating biotechnology products to ensure that approved biotechnology products 

developed in the U.S. pose no risk to human health or 

the environment. 

 APHIS, through its Biotechnology Regulatory Services (BRS) program, oversees the development and 

introduction (importation, interstate movement and 

environmental release) of GE organisms. The Agency 

is committed to ensuring that this technology moves 

forward safely through our rigorous regulatory system. 

Developers must adhere to certain performance standards or conditions that ensure that the regulated GE 

organisms do not persist in the environment or enter 

the food or feed supply. Depending on the field test, 

these conditions could include stringent confinement 

measures, such as isolation distances, to prevent 

pollen flow; clean equipment and containers to prevent cross-contamination; and labeling of all regulated 

articles to prevent accidental use or incorporation with 

other crops. At the end of all field tests, developers 

must destroy or properly handle or contain any viable 

plant material in the field and ensure that no regulated 

materials persist in the environment beyond the 

duration of the trial.

APHIS Policy On Responding To The Low-Level 

Presence Of Regulated Genetically Engineered 

Plant Materials

 APHIS is clarifying the Agency’s existing approach 

for handling detections of regulated GE plant material 

in commercial seeds and grain. 

• APHIS’ policy is to respond to these occurrences 

with actions appropriate to the level of risk and 

warranted by the facts in each case. 

• APHIS will always initiate an inquiry whenever 

regulated materials are detected in commercial 

seeds and grain to evaluate any risk, to determine 

the circumstances surrounding the release and 

to determine what remedial and/or enforcement 

actions may be required.

• If APHIS determines that an occurrence involving 

regulated GE plant material could pose a risk to 

plant health or the environment, APHIS will take 

appropriate steps to mitigate that risk using its 

authority under the Plant Protection Act (PPA). 

• In cases in which APHIS determines that action 

may not be necessary to mitigate the low-level 

presence of the regulated GE plant material to 

protect plant health and the environment, APHIS 

is not precluded from taking enforcement action 

against a company or individual for violations of 

APHIS regulations. 

• APHIS considers six safety-related criteria when 

determining a GE plant material’s potential to pose 

a risk to plant health or the environment. The 

criteria are:

1. The plant is not a Federal noxious weed or 

considered a weed in the area of introduction.

2. The introduced genetic material must remain 

inside the living cell and replicate only with the 

plant DNA.

3. The introduced genetic material’s function is 

known and does not create a plant disease. 

4. The introduced genetic material does not create an infectious entity or unintended toxins, or 

produce products intended for pharmaceutical 

or industrial use.

5. The introduced genetic material does not 

cause the creation of a new plant virus. 

6. The plant does not contain genes from animal or human pathogens, or contain coding 

sequences whose products are known agents 

of diseases in humans or nontarget animals.
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. 

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

Glossary Of Terminology 

Agricultural Biotechnology: A range of tools, including traditional breeding techniques, that alter living 

organisms, or parts of organisms, to make or modify 

products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic 

engineering.

Deregulated: If a GE crop has gone through the regulatory process for USDA to determine that it can be 

safely commercialized, it is commonly referred to as 

being a deregulated crop. This is necessary before it is 

sold and produced commercially. It allows the product 

to be moved and planted freely without the need for 

notification or permits. A developer may file a petition 

for deregulation only after a GE crop has been tested 

extensively and the developer can show that the 

product does not pose a plant pest risk. 

Gene: The fundamental physical and functional unit 

of heredity. A gene is typically a specific segment of a 

chromosome and encodes a specific functional product 

(such as a protein or RNA molecule). 

Genetic engineering: Manipulation of an organism’s 

genes by introducing, eliminating or rearranging specific genes using the methods of modern molecular 

biology, particularly those techniques referred to as 

recombinant DNA techniques. 

Herbicide-tolerant crops: Crops that have been developed to survive application(s) of particular herbicides 

by the incorporation of certain gene(s) either through 

genetic engineering or traditional breeding methods. 

The genes allow the herbicides to be applied to the 

crop to provide effective weed control without 

damaging the crop itself. 

Low-level presence: The low-level mixing of genes and 

gene products from unintended plant sources. This 

can occur with both conventionally bred plants as well 

as biotechnology-derived plants. These occurrences 

can result from natural processes such as the movement of seeds or pollen, or human-mediated processes 

associated with field testing, plant breeding, or seed 

production. 

Protein: A molecule composed of one or more chains 

of amino acids in a specific order. Proteins are required 

for the structure, function, and regulation of the body’s 

cells, tissues, and organs, and each protein has a 

unique function. 

Regulated: If a GE crop has not gone through the regulatory process for USDA to determine if it can be safely 

commercialized, it is commonly referred to as being in 

regulated status or a regulated crop. 

Remedial measures: APHIS has authority under the 

PPA to take or order remedial measures which include 

the authority to hold, seize, quarantine, treat, apply 

other remedial measures to, destroy, or otherwise dispose of regulated materials if it is determined that such 

measures are necessary to prevent the dissemination 

of a plant pest within or throughout the United States.