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Compliance and the Inspection Process

APHIS verifies compliance with the conditions imposed in permits and notifications by inspecting fields, records and associated facilities. The BRS Compliance Assurance Branches (CABs) initiate and manage inspections. Trained officers within APHIS' Plant Protection and Quarantine (PPQ) program, or with a participating state inspection program, conduct inspections on behalf of APHIS BRS CABs. Methods of verification used for inspection include: records review, interview, observation, and measure and mapping.

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 planted,  a percentage of notifications—which represent the types of genetically engineered crops with which APHIS has the most familiarity— are randomly selected for inspection annually.

Inspections for Permits
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 Permit conditions (7 CFR 340.4 (f)(1-11)) 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 where a field release is planted each year. 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 pre-release, release, reproductive control, harvest post-harvest and two volunteer monitoring inspections. BRS maintains a comprehensive database that captures and tracks inspection-related information to assure that all required inspections are accomplished.

Inspections for Notifications
Notification inspections are selected on a statistically valid random sampling basis.  As planting reports arrive, spreadsheets are populated with planting information and random selection of notifications for inspection is performed using a computer model. The BRS Inspection Manual contains instructions and worksheets that inspectors use to record their observations during inspections. Items on the forms correspond with the Performance standards in federal regulations (7 CFR § 340.3(c)(1-6)). Regulated entities also submit Design Protocols specifying what methods will be used to meet the Performance standards. BRS expects regulated entities to comply with all Design Protocols and the Performance standards, which may include observing isolation distances, confinement measures, harvesting procedures, and devitalization and disposal. 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.

View Inspection Overview and Example Inspection Questions

Inspection Selection and Frequency Table
 

Authorization Type

Selection Frequency Additional Inspections
Pharma-Industrial Permit (perennial) Non-random 2 in-season inspections of each site the year of planting, at least one each subsequent year 1 inspections the following growing season, 1 the next growing season**
Pharma-Industrial Permit (annual) Non-random 5 in-season inspections of each site in each state where planted 2 inspections the following growing season
Permit (perennial) Non-random At least one site inspected in each state where growing each year Post-harvest inspections as needed
Permit (annual) Non-random At least one site inspected in each state where planted Higher frequency for large-scale trials
Notification Randomly selected by computer model If selected, at least one site inspected in one state* As needed*


Inspection Results
After every inspection, inspectors prepare detailed reports. BRS then issues feedback correspondence to the developer based on findings documented in the inspection report. The correspondence falls into one of the following four potential categories:

  • Standard Notice of Compliance – the inspection revealed no deviations from the regulations or permit conditions, including conditions described on the permit application.
  • Notice of Compliance with Comments – the inspection revealed no deviations from the regulations or permit conditions, including conditions described on the permit application, but the analysis revealed activities or circumstances that could lead to a non-compliance incident in the future and/or there are specific compliance concerns that need to be communicated back to the responsible party. This letter contains the same information as the NOCS, but also uses customized test to address BRS’ specific concerns and possible solutions in order to prevent similar future incidents.
  • 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.


Reports and Notices
APHIS requires permittees to submit certain reports and notices as part of the permit/notification conditions.  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. Reports and notices also are used for initiating a BRS inspection process or verifying the progress of an introduction. Basically, a report has information on activities that already happened, and a notice contains planned activities to be performed in the near future.


Compliance Incidents
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 can include Warning Letters, fines, criminal prosecution, and/or other corrective measures.



Additional Information