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Compliance and the Inspection Process |
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APHIS verifies compliance with the conditions imposed in permits and notifications by inspecting fields, equipment and other facilities. The BRS Compliance and Inspection Branch (CIB) initiates and manages inspections. A field force of trained officers within APHIS' Plant Protection and Quarantine (PPQ) program conducts inspections for BRS CIB.
BRS determines the frequency and number of field trial inspections to be performed by assessing the relative risk of each type of trial and by other criteria described below. While at least one inspection is conducted for every permit, the BRS compliance staff uses a system with defined selection criteria to identify those notifications that may represent the greatest risk. A percentage of notifications—which represent the types of genetically engineered crops with which APHIS has the most familiarity— are inspected annually.
Inspections for Notifications |
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Several parameters are used to select notifications for inspections, such as a regulated article’s traits and characteristics, applicant history, 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 instructions and forms that inspectors use to record their observations during inspections. Items on the forms correspond with performance standards in federal regulations. BRS expects developers to comply with all performance standards, and these may include observing isolation distances, confinement measures, and harvesting procedures. The instructions also specify what an inspector must assess to determine if the inspected party is complying with the performance standards. APHIS BRS’ written guidance, along with training provided by BRS, contribute to the uniformity of inspection procedures among inspectors.
Inspections for Permits |
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Permits require technology developers to follow procedures described in their applications, the design protocols (e.g., standard operating procedures) they have submitted, and the standard and supplemental permit conditions assigned by BRS. BRS ensures compliance with its permit requirements by performing thorough inspections. All permits receive at least one inspection within each permitted state. Plants engineered to produce pharmaceutical or industrial proteins are inspected up to seven times before, during, and after the field trial to verify that developers are carefully following the conditions that BRS set forth. These inspections are performed at critical times during field testing, including preplanting, flowering, harvesting, and after harvest. BRS maintains a comprehensive database that captures and tracks inspection-related information to assure that all required inspections are accomplished.
View Inspection Overview and Example Inspection Questions
Inspection Results |
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After every inspection, inspectors prepare detailed reports. The CIB staff then issues feedback correspondence to the developer based on findings documented in the inspection report. The correspondence falls into one of the following three categories:
- Notice of Compliance - the inspection revealed no deviations from the regulations or permit conditions, including conditions described on the permit application.
- Notice of Noncompliance - the inspection revealed deviations from the regulation or permit conditions. BRS requests corrective action, usually within a given time frame, and often requests documentation of the action taken.
- Warning Letter - the inspection revealed one or more serious deviations from the regulations or permit conditions. BRS requires a prompt written response, immediate corrective action, and evidence of action taken within a given time frame.
Compliance Incidents |
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Most developers comply with federal regulations. However, when a developer does not adhere to federal 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 printing the wrong name on a permit. Others include failing to notify APHIS in the event of unintended 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. For example, APHIS would require 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. The results of such investigations could include fines, criminal prosecution, and other corrective measures.
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