Reporting and Unauthorized/Accidental Release of a Regulated Article or Compliance Issue |
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- Responsible persons who possess permits or acknowledged notifications are required by federal regulations to report certain incidents to APHIS’ Biotechnology Regulatory Services (see What and When You Need to Report).
- Third parties, including members of the general public, who have knowledge or evidence of biotechnology-related noncompliance incidents are encouraged to voluntarily report them to APHIS’ BRS. Third parties do not need to have all of the requested information (see How to Report) to report an incident.
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APHIS regulations (340.4(f)(10)) require responsible persons who have permits or acknowledged notifications to report the following incidents to APHIS:
- Environmental Release: If a regulated article is accidentally released into the environment, or is released without authorization:
Verbally report the incident immediately upon discovery AND in writing within 24 hours.
Note: Unauthorized environmental releases include releases made before the effective date, or after the termination date, of a permit or notification. They also include importations and movements (e.g., interstate shipments) made without valid permits or notifications. Planting at sites other than those described on the permit qualify as noncompliance. These are only examples of possible incidents, and other similar incidents may qualify.
- 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:
Report the occurrence in writing as soon as possible but no later than 5 working days after discovery. BRS also recommends reporting verbally before sending the written report.
- 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:
Report the occurrence in writing as soon as possible but no later than 5 working days after discovery. BRS also recommends reporting verbally before sending the written report.
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Verbally: Describe the incident, date, location (county & state), crop or organism, developer’s name & contact information, APHIS permit/notification number, and initial corrective actions by telephoning one of the following numbers at BRS headquarters:
- The dedicated reporting line of Biotechnology Regulatory Services: (301) 734-5690
- A Regulatory Specialist in the Compliance & Inspection Branch of Biotechnology Regulatory Services
- The central line of BRS: (301) 734-7324. Please state that you wish to report an incident to the Compliance and Inspection Branch.
IN CASE OF AN EMERGENCY AND YOU ARE UNABLE TO REACH HEADQUARTERS CONTACT:
- Eastern Region Biotechnologist (east of Mississippi River, plus Minnesota and Puerto Rico): 919-855-7622 or 919-855-7624.
- Western Region Biotechnologist (west of Mississippi River including Alaska and Hawaii, except Minnesota): 970-494-7513 or 970-494-7573.
In Writing: Describe in detail the incident, date, location (county & state), crop or organism, developer’s name & 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@aphis.usda.gov
- Sending an email to a Regulatory Specialist in the BRS Compliance and Inspection Branch.
- Sending a letter to a Regulatory Specialist in the BRS Compliance and Inspection Branch at the address below. BRS suggests using an overnight carrier service.
Mail your report to:
[Name of Regulatory Specialist], USDA APHIS BRS
Compliance and Inspection Branch
4700 River Road, Unit 91
Riverdale, MD 20737
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ISO 9001:2000
FM 535173