Compliance Inspection Overview
APHIS performs in-person inspections of authorized field trial sites and facilities to ensure compliance with the regulations. Inspections also verify compliance with permit conditions or notification performance standards. APHIS may also perform virtual inspections. Inspectors use various methods to assess compliance during inspections including records review, interview, observation, measurements, and mapping.
BRS ensures all inspectors are trained to understand applicable regulatory requirements before they conduct BRS inspections.
BRS has designed the inspection process to be objective by having inspectors use a series of questions that they can answer with “yes”, “no”, or “not applicable.” An inspector will not pose these specific questions during the inspection, but they will derive answers through a multi-faceted inspection. To ensure thoroughness, inspectors also include a written description of observations to provide clarification and additional details that are not covered by “yes”, “no”, or “not applicable” responses. The inspector will often need to ask multiple initial questions, review records, and make field observations to answer the questions. Inspectors can report other observations as part of a summary of findings in the inspection report.
An inspector prepares for an inspection by reviewing information about the specific authorization, such as a copy of the permit, including supplemental permit conditions or the notification and associated design protocols.
BRS reviews completed inspection reports for quality to ensure inspectors submit all the relevant information and uses the information captured in the inspection report to evaluate compliance with the regulations. If BRS identifies noncompliance, BRS will specify the necessary corrective action, and may take additional follow up steps, as appropriate. BRS provides correspondence to convey inspection outcomes to the responsible person for each authorization inspected.
- How was the inspection conducted in person or virtual?
- Did the responsible person/agent allow physical access to all locations?
- Were all requested records made available to the inspector?
- Do the BRS Standard Permit Conditions match those held by the cooperator on site?
- Have all shipments (importation, mailing, shipping, transport between states, transport to/from trial location and storage facilities) been moved while maintaining containment?
- Did the cooperator supply an up-to-date map of the field trial site/plots?
- Is the total trial acreage at or below the approved acreage in permit and within the authorized release site location?
- Were spatial/reproductive confinement measures implemented according to the permit conditions?
- Are efforts being made to prevent unwanted human or animal incursions onto the field?
- Are all viable regulated plant materials and plant products labeled or otherwise identified as regulated and kept segregated from nonregulated plant materials?
- Do records indicate that all in-season monitoring and removal of sexually compatible species, including volunteers of the same species and/or sexually compatible relatives, found within the separation distance as described in the permit conditions?
- Have volunteer plants or sexually compatible species been found? If so, describe the approximate number, location/spatial distribution, and methods used for devitalization.
- Do records indicate that equipment used at this field trial was cleaned using methods sufficient to assure segregation from nonregulated material and to prevent loss or dissemination of viable regulated material before being moved?
- Was viable regulated material recovered during cleaning and properly devitalized?
- Do records demonstrate that the cooperator is monitoring for deleterious/negative effects?
- Does the responsible person have a plan for devitalization and disposal of the regulated material?
- Did your inspection find that this field trial is free of any potential non-compliance incidents?
- How was the inspection conducted in person or virtual?
- Did the responsible person/agent allow physical access to all locations?
- Were records that are necessary to evaluate compliance made available to the inspector?
- Do the notification and any design protocols you received from BRS match those held by the cooperator on site?
- Were equipment cleaning methods sufficient to assure segregation from nonregulated material, and to prevent loss of viable regulated material?
- Was viable regulated material recovered from equipment properly devitalized?
- Is the total trial site at or below the total amount of acreage approved in the notification?
- If other regulated articles are present, are they covered under other authorizations?
- Did the cooperator maintain identity of the regulated material at all times?
- Are efforts being made to prevent unwanted human or animal incursions onto the field?
- Is physical separation the only method being used for reproductive control?
- Is the area within the separation distance of the regulated material free of sexually compatible species?
- Are other reproductive control methods, such as border rows, flower bagging, flower removal, or temporal isolation, being used?
- If border rows are present, does the cooperator plan to treat them as regulated material?
- Does the cooperator have a plan for removing volunteer plants and volunteers monitoring?
- Do records demonstrate that the cooperator is monitoring for deleterious/negative effects?
- Does the cooperator have an anticipated harvest date(s) for this trial?