Biotechnology Regulatory Services (BRS) authorizes the introduction of genetically engineered (GE) organisms into the United States by issuing permits and acknowledging notifications. One goal of the 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 perform targeted inspections of field tests and thoroughly evaluate all potential noncompliance incidents. BRS also evaluates facilities, equipment, records of developers, and potential incidents reported by permittees. Authorizations under the permitting and notification procedures require that noncompliance incidents be self-reported within designated time frames.
If an incident occurs, BRS requires that compliance with APHIS regulations quickly be restored to protect U.S. agriculture, the food supply, and the environment. 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) may require destruction of research plots, quarantine of harvested crops, formal corrective action plans, or other long-term measures. When the permittee or responsible person self-reports an incident, typically they will have already begun to implement corrective actions. BRS strives for long-term compliance by having permittees reassess and modify their existing procedures to prevent recurrence of incidents.
A serious incident, or a history of lesser incidents, may prompt BRS to refer the situation to APHIS' Investigative and Enforcement Services (IES) for further investigation. BRS also works closely with State Departments of Agriculture and other federal 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 provides for substantial penalties for serious infractions, including fines up to $500,000 and the possibility of criminal prosecution.
Office of Compliance Assistance
The Office of Compliance Assistance provides compliance assistance to organizations involved in biotechnology research and development, including small businesses and academic researchers, to facilitate compliance with APHIS regulations (7 CFR part 340) for the import, interstate movement, and field release of regulated genetically engineered (GE) organisms. Compliance assistance is provided to the regulated community through a variety of mechanisms including education, template procedures and forms, the Biotechnology Quality Management System (BQMS) Program, and collaboration with academia and private and public stakeholders.
Compliance and the Site Inspection Process
BRS has a comprehensive inspection system based on science and risk criteria to identify any potential noncompliance incidents. The type and subject of an inspection are determined by the kind of permit issued or notification acknowledged.
Reports and Notices
Reports and notices enable applicants to communicate compliance-related information about regulated materials covered by BRS permits and notifications. Each report and/or notice is associated with a permit or notification, and has specific requirements regarding due dates, applicability to a specific permit or notification, and required data. Basically, a report has information on activities that already happened, and a notice contains planned activities to be performed in the near future. Reports and notices are used for initiating a BRS inspection process or verifying the progress of an introduction.
Please do not confuse applicant reports and notices with BRS inspection reports, as their purposes are very different. BRS Inspection reports DO NOT replace applicant reports and notices.
Permit and notification holders have a successful history of compliance with APHIS regulations. However, when the responsible person does not adhere to regulations and permit conditions, the result is a noncompliance incident. Some incidents may be serious and result in an IES investigation and subsequent fines.
Report an Unauthorized/Accidental Release of a Regulated Article or Noncompliance Incident
As specified in 7 CFR 340 and any additional permit conditions, responsible persons are required to notify APHIS if there are accidental or unauthorized releases of the regulated articles. Other actions or outcomes, including unauthorized movements, characteristics of the regulated organism that are substantially different from those listed in the application for the permit, or any unusual occurrence (excessive mortality or morbidity, or unanticipated effects on non target organisms) must also be reported. Time frames for the required reporting differ depending upon the type of incident or observation.