Skip to main content

Compliance and Inspection Overview

Biotechnology Regulatory Services (BRS) authorizes the importation, interstate movement, and environmental release of organisms developed using genetic engineering by issuing permits and by acknowledging notifications. One goal of BRS’ Regulatory Operations Programs is to assure compliance with all relevant provisions of the regulations, including authorizations under the permitting and notification procedures. 

APHIS inspectors and compliance specialists inspect field test sites and thoroughly evaluate all potential noncompliance incidents. BRS also evaluates facilities, equipment, records, and reports of potential noncompliance incidents. Authorizations under the permitting and notification procedures require that noncompliance incidents be self-reported within designated time frames. 

If an incident occurs, our focus is to quickly restore compliance with regulatory requirements to protect U.S. agriculture and prevent inadvertent commingling within the food supply. Incidents with low potential impacts may require simple remedial actions, such as correcting clerical errors, installing fencing, or improving monitoring procedures. Serious incidents (such as unauthorized or accidental releases) can require destruction of field test sites, quarantine of harvested crops, formal corrective action plans, or other long-term measures. When self-reports occur, authorization holders have typically already started to implement corrective actions. BRS strives for long-term compliance by working to reassess and modify existing procedures to prevent recurrence of incidents. 

BRS may refer a serious incident, or a history of incidents, to APHIS’ Investigative and Enforcement Services (IES) for further investigation. BRS also works closely with State/Territorial Departments of Agriculture and other government agencies, including the Food and Drug Administration, the Environmental Protection Agency and the Department of Justice, to ensure compliance with APHIS regulations. The Plant Protection Act authorizes broad sanctions for noncompliance, including civil penalties up to $1.1 million. 

Persons authorized to engage in regulated activities must submit certain reports and notices to BRS to communicate compliance-related information. Each report and/or notice is associated with a permit or notification, and has specific requirements for due dates and information. A report provides information on activities that already happened, and a notice contains information on planned activities that will occur in the future. Reports and notices are used for initiating a BRS inspection process or verifying the progress of field trials. 

Reports that persons submit to BRS in connection with regulated activities are separate and apart from BRS-prepared inspection reports, which record observations made independently by inspectors to document inspection findings and ensure compliance with the regulations and permit conditions.  

Most persons authorized to engage in regulated activities have a successful history of compliance with APHIS regulations.  From time-to-time, compliance incidents or patterns of noncompliance occur.  When this occurs, BRS assesses the nature and seriousness of the noncompliance and determines appropriate steps to follow up, ranging from issuing regulatory correspondence to requesting an investigation and seeking sanctions for alleged noncompliance.

View noncompliance history

BRS has a comprehensive inspection system that uses science and risk criteria to identify any potential noncompliance. Inspection planning involves many factors, including geographic location, time of year, species, the risk of crop persistence, compliance history, and the type of authorization (permit or notification).

Learn more about the compliance assistance and site inspection process

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.

Report an unauthorized release

BRS provides compliance assistance to those involved in biotechnology research and development, including small businesses and academic researchers, to facilitate compliance with APHIS regulations (7 CFR part 340). Compliance assistance is provided through a variety of mechanisms including learning opportunities, template procedures, and the Biotechnology Quality Management Support (BQMS) Program.

Learn more about the compliance assistance process

 

Complementary Content
${loading}