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How to Report an Unauthorized or

Accidental Release

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As specified in regulations and permit conditions, persons engaging in regulated

activities must notify APHIS of any possible or actual unauthorized movements or

releases of the regulated material. 
This includes accidental releases or those caused by flooding or other weather

events. Time frames for reporting differ depending upon the type of incident or

observation and the conditions associated with the authorization. It is important to

carefully read the applicable regulations and conditions associated with an

authorization to ensure full compliance at all times.

HOW to Report an Incident

By Phone

Describe the incident, date, location (county and state/territory), crop or organism,

developer’s name and contact information, APHIS permit/notification number, and

initial corrective actions.  Please call one of the following numbers at BRS

headquarters:

The dedicated reporting line of Biotechnology Regulatory Services: 301-851-

3935.

If you cannot get through to the dedicated reporting line, call the main line of

BRS: 301-851-3877. Please state that you wish to report an incident to the

Compliance Evaluation and Enforcement Branch.

IN CASE OF AN EMERGENCY AND YOU ARE UNABLE TO REACH

HEADQUARTERS CONTACT: 

Eastern Region Biotechnologist (states east of Mississippi River, plus Minnesota,

Puerto Rico, and the American Virgin Islands): 919-855-7622 or 919-855-7624.

Western Region Biotechnologist (states west of Mississippi River including

Alaska, Hawaii, and Pacific Territories (Guam, Northern Marianas, American

Samoa), except Minnesota): 970-494-7513 or 970-494-7573.

In Writing

Describe the incident in detail, and provide the date, location (county and

state/territory), crop or organism, developer's name and contact information, APHIS

permit/notification number, and initial corrective actions by one of the following

methods:
Sending an email to the dedicated reporting address: 

BRSCompliance@usda.gov

Sending a letter to the BRS Compliance, Evaluation and Enforcement Branch

using the address below. (BRS encourages using an overnight carrier service,

but it is not required.)

USDA APHIS BRS

ATTN: Compliance Evaluation and Enforcement Branch

4700 River Road, Unit 91

Riverdale, MD 20737 

The written report should provide incident information regarding who was involved,

what occurred, where, when, how, and why it occurred. The report should indicate

whether an unauthorized release resulted in loss of containment. It should include

any corrective actions, preventive actions, and/or mitigating actions already taken.

When applicable, it should include a statement regarding who can provide

information to APHIS about the incident, and who can receive information from

APHIS about it. It should also include any necessary authorization statement for such

discussions to occur.  For example, an responsible person may designate a site

researcher or regulatory compliance lead as the point-of-contact for APHIS.

WHAT and WHEN You Need to Report

APHIS regulations require responsible persons to report the following: 

1. Unauthorized Release: If a regulated article is accidentally released into the

environment, or is released without authorization. The responsible person must 

orally report the incident immediately upon discovery AND in writing

 within 24 hours. Note: Unauthorized releases include releases made before

the effective date, or after the expiration date, of a permit or notification. They

also include importations and interstate movements made without valid

permits or notifications. Planting at or moving regulated material to sites other

than those described on the permit or notification qualify as noncompliance.

These are only examples of possible incidents, and other similar incidents

qualify.

2. Substantially Different Characteristics: When the regulated article or host

organism (such as a microbial organism, and the host organism is substantially

different) shows features substantially different from those listed in the permit

or notification. The responsible person must report the occurrence in
writing as soon as possible but no later than 5 working days after

discovery. BRS also encourages reporting orally before sending the written

report, but it is not required. 

3. Any Unusual Occurrence: When any unexpected result or event (excessive

mortality or morbidity, or unanticipated effects on non-target organisms)

affects the regulated article or host, or its controlled release into the

environment.  The responsible person must report the occurrence in writing

 as soon as possible but no later than 5 working days after discovery.

BRS also encourages reporting orally before sending the written report, but it is

not required.

WHO Should Report

Responsible persons who possess permits or acknowledged notifications

are required by regulations to report certain incidents to BRS (see your

authorization and WHAT and WHEN You Need to Report - below).

Third parties, including members of the public, who have knowledge or

evidence of biotechnology-related noncompliance incidents are encouraged to

voluntarily report them to BRS. Third parties do not need to have all of the

requested information (see How to Report tab below) to report an incident.