U.S. Department of Agriculture February 2006

Animal and Plant Health Inspection Service

APHIS Biotechnology:

Compliance and

Inspections 

The U.S. Department of

Agriculture’s (USDA)

Animal and Plant Health

Inspection Service (APHIS),

through its Biotechnology

Regulatory Services (BRS)

program, 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, or could be, a plant

pest. 

Through a strong regulatory

framework, BRS works to

ensure the safe and confined

introduction of GE organisms.

This is accomplished in large

part through BRS’ Compliance

and Inspection Branch (CIB),

which was established as part

of BRS’ commitment to

strengthen and improve compliance and inspection

actions. BRS’ CIB is dedicated to ensuring that developers of GE organisms maintain

and adhere to all permit conditions and Federal regulations by providing consistent

quality inspections, comprehensive document tracking

and reporting, and prompt

and uniform enforcement

actions. Compliance is

accomplished through a variety of measures, including

inspections, strong 

educational and outreach

efforts, and comprehensive

investigations and audits.

BRS understands that public

confidence in the regulatory

system is critical. To that end,

our policies are science

based, measurable, and communicated to the public.

BRS CIB’s primary office is

located at APHIS

Headquarters in Riverdale,

MD. Additional CIB staff,

including Regional

Biotechnologists (RBTs), are

stationed in two regional

offices, one in Fort Collins,

CO, and another in Raleigh,

NC. 

The RBTs coordinate inspections in their respective

regions, provide technical

assistance and training to

inspectors, and conduct higher risk investigations.

Designated compliance officers at headquarters are

assigned to developers of GE

organisms to facilitate clear

communications about fieldtest conditions and requirements to ensure continuity.

This work is supported by

onsite inspections conducted

by experts from APHIS’ Plant

Protection and Quarantine

(PPQ) program. 

BRS works closely with PPQ,

the State departments of agriculture, and with other

Federal agencies, including

the Food and Drug

Administration and the

Environmental Protection

Agency, to monitor compliance with regulations. 

GE Field-Test Inspections 

A developer wishing to introduce a GE organism must

obtain the necessary authorization from BRS before proceeding. Depending on the

nature of the GE organism, an

applicant files either a notification or a permit application

for APHIS review. Most

plants are field-tested under

notification, a streamlined

approval process that is often

used for plants that are

altered with common agronomic traits. The permitting

process involves a more comprehensive review and is

used for GE organisms that

could pose an elevated risk,

such as plants that produce

pharmaceutical or industrial

compounds. 

BRS inspects field trials using

the relative risk of each type

of trial to determine the frequency and number of

inspections performed.

Notifications are considered

somewhat safer trials than

permit authorizations. While

each permitted field test is

inspected at least once, the

BRS compliance staff uses a

system with definitive selection criteria to identify the

notifications that may represent the greatest risk. 

Several parameters are used

to select notifications for

inspections, such as a regulatBRS understands

that public 

confidence in the

regulatory system is

critical. To that end,

our policies are

science based,

measurable, and

communicated to

the public.
ed article’s traits and characteristics, applicant tenure, and

acreage planted. Each notification receives a total score

based on all factors. A computer program generates the

scores, and those notifications with the highest scores

are assigned to APHIS’ field

force for inspection. 

APHIS inspectors perform targeted, risk-based inspections

of field tests grown under

notification. Inspection manuals contain notification inspection checklists that inspectors

use to record their observations during inspections.

Items on the checklist correspond with BRS’ performance

standards. Performance standards are comprised of guidelines that BRS expects all

developers to comply with,

including isolation distances,

confinement measures, and

harvesting procedures. The

checklist also contains extensive guidance indicating what

an inspector must look for to

determine if the inspected

party is complying with the

performance standards. This

guidance contributes to the

uniformity of inspection

results among all inspectors.

BRS ensures compliance with

its permit conditions by performing frequent and thorough inspections and audits.

Permitted field tests are

inspected at least once, and

plants engineered to produce

pharmaceutical and industrial

proteins are inspected up to

seven times before, during,

and after the field trial to verify that developers are carefully following the conditions set

forth by BRS. These inspections are performed at critical

times during field testing,

including preplanting, flowering, harvesting, and postharvest. BRS maintains a comprehensive database that captures and tracks inspectionrelated information to assure

that all required inspections

are accomplished.

After every inspection, inspectors prepare detailed reports.

The BRS compliance staff

also issues feedback correspondence to the developer

based on findings documented in the inspection report.

The correspondence falls into

one of the following three categories:

• No deviations—The 

inspection revealed no 

deviations from the 

regulations or permit 

conditions.

• Guidance—The inspection 

revealed minor deviations 

from the regulations or 

permit conditions. BRS

requests voluntary 

corrective action.

• Warning—The inspection 

revealed serious 

deviations from the 

regulations or permit 

conditions. BRS requires 

a prompt written response

and immediate corrective 

action.

Noncompliance Incidents

Most developers comply with

BRS regulations. However,

when a developer does not

adhere to APHIS’ regulations

and permit conditions, BRS

refers to these events as

“noncompliance incidents.”

Noncompliance incidents can

include a number of issues.

For example, some incidents

involve administrative issues,

such as the wrong name on a

permit. Others include failing

to notify APHIS in the event

of vandalism or destruction of

a field test; failing to obtain a

permit; and failing to follow

performance standards, such

as isolation distances. 

Planting at a field-test site

before a permit becomes

effective and planting after it

expires also qualify as noncompliance incidents.

In such cases, BRS seeks

immediate corrective actions

from developers so they can

become compliant with regulations. An example of this

would be requiring the developer to implement a mandatory compliance training program for their staff.

Depending on the seriousness of the incident, BRS

may refer the case to APHIS’

Investigative and Enforcement

Services (IES) for further

investigation. In addition to

identifying noncompliance

incidents during inspections,

developers conducting field

tests must identify and selfreport potential noncompliance incidents to BRS. The

regulations require that selfreports be made immediately

following the incident and be

followed up by a written

report within 24 hours. Many

developers have compliance

reporting programs as part of

their operating procedures to

comply with BRS regulations

and ensure safe field testing.

For the fiscal year ending

September 30, 2005, developers self-reported 76 percent

of all noncompliance incidents.
Investigative and

Enforcement Services

BRS’ compliance staff works

closely with IES to initiate formal investigations of developers who may not be adhering

to regulations, permit or notification conditions, or requirements. 

Events that lead to a formal

IES investigation include

• Failure to respond to a 

warning letter,

• Repeated violations,

• Failure to carry out 

promised corrective 

actions,

• Violations of regulations or

permit conditions,

• Suspected fraud,

• Risks to the food 

and/or feed supply,

• Risks to the environment, 

and

• Inability to conduct safe 

field trials.

The findings may lead to an

offer to enter into a stipulation

settlement agreement that

could include the payment of

monetary civil penalties.

Cases that are not resolved

by a settlement agreement or

involve repeat violators are

referred to USDA’s Office of

General Counsel (OGC). OGC

may file a complaint seeking

civil penalties against the violator or, where appropriate,

may refer the case to the U.S.

Department of Justice for the

initiation of civil or criminal

proceedings.

All cases referred to IES are

posted on the APHIS BRS

Web site,

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

brs>, when the investigations

are complete.

Inspector Training

BRS assures that its inspection personnel are trained and

highly skilled. BRS provides

technical assistance and thorough training to its inspectors, the majority of which are 

APHIS’ own seasoned professionals from its PPQ program. 

BRS also works closely with

the State departments of agriculture on compliance initiatives. A pilot training and certification program is being

evaluated to determine if

State inspectors can supplement PPQ inspectors for

inspection of field tests

grown under notification. 

Through its core curriculum

for PPQ and State inspectors,

BRS ensures that its inspection personnel are equipped

with the necessary training to

get the job done, get it done

right, and get it done safely

and economically.

BRS inspectors courses cover

• Introduction to genetic 

engineering and 

transgenic organisms,

• Regulatory authority,

• Handling confidential 

business information,

• Conducting inspections,

• Gathering information and 

making preparations,

• Reporting findings, and

• Inspecting farm 

equipment.

BRS developed a comprehensive database to track completion of inspection assignments issued to PPQ; this

database allows efficient

inspection tracking and followup. BRS recently produced a revised inspection

manual, including detailed

inspection checklists, checklist

guidance, and procedures for

completing an inspection

report. Additional guidance is

provided in monthly, quarterly,

and annual meetings between

BRS and PPQ. 

As science progresses, BRS

will continue to evaluate the 

implications of new technologies, enhance compliance

procedures, and develop

appropriate regulations to

meet the science’s challenges

while continuing to safeguard

American agriculture, the

Nation’s food supply, and the

environment.

Additional Information

For more information about

compliance with APHIS’

biotechnology regulation and

inspection of GE field tests,

or to report compliance incidents, please call 

(301) 734–5690 or contact

USDA–APHIS–BRS

Regulatory Operations 

Program

Compliance and 

Inspections Branch

4700 River Road, Unit 147

Riverdale, MD 

20737–1236

Telephone (301) 734–5690 

or visit the BRS Web site 

at

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

brs>.
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.

COMPLIANCE AND INSPECTION BRANCH 

hief

ompliance and Inspection

ompliance Officer

Western Region Senior

Biotechnologist 

Program Assistant

astern Region Senior

Biotechnologis

Data support Data suppo

Western Region

Biotechnologist 

ield Operation nd 

Investigations Team eader ompliance Officer