Compliance and the Inspection Process

Compliance and the Inspection Process

Permit Inspection Overview
APHIS performs physical inspections of approved field trial sites as part of its efforts to ensure compliance with biotechnology regulations. BRS utilizes APHIS' Plant Protection and Quarantine (PPQ) staff, which has officers in every state, to conduct many inspections for BRS. BRS provides annual biotechnology inspection training to PPQ officers, preparing them to perform the field inspections for BRS.

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 necessarily pose these specific questions to the permittee's site cooperator, but she or he will derive answers to them through a multi-faceted inspection. The inspector will often need to ask the on-site responsible person a number of initial questions, review records, and make field observations in order to answer the questions BRS is posing. Inspectors may also report other observations as part of a summary of findings in the inspection report.

To assist the inspector in preparing for an inspection, BRS provides information about the specific authorization, such as a copy of the permit and the regulatory conditions BRS placed on the trial, as well as a copy of the applicant's design protocols and/or standard operating procedures.

BRS initially reviews completed inspection reports for quality to ensure that inspectors have submitted all the appropriate information. Following the quality review, BRS evaluates the inspection report for compliance with federal regulations. If BRS identifies infractions, the program implements the appropriate enforcement action. BRS reports inspection outcomes to the permit holder.

Example Permit Inspection Questions

  • Does the responsible party have a copy of the current design procedures or protocols for the field trial?
  • Do the shipping and packing containers used for this field trial meet the specifications in the Release Permit?
  • Were packing and shipping materials used for this field trial cleaned out and disposed of to meet the Release Permit?
  • Were transport and storage containers employed so as to fully contain the regulated article at the field trial location?
  • Are seed bags, packages, pots or other containers used for the regulated article clearly and durably marked so that each article under this permit can be distinguished and identified by the responsible party throughout the field trial process?
  • Did the permit holder provide you with an up-to-date map of sufficient detail showing the field site(s) for regulated articles under this permit?
  • Is the total area of the field site(s) at or below the total amount of acreage approved in the Release Permit?
  • Are the type(s) of regulated article(s) in the field trials at this location (organism/trait) exactly and only those stated in the Release Permit?
  • If border rows are present in the field trial site, are they grown to meet Permit Conditions?
  • Is the design and management of the outermost boundary of the field site(s) sufficient to assure segregation and confinement during all field operations and growth stages?
  • Is the field trial planted to achieve the isolation distance that is specified in the Release Permit?
  • Are measures being taken to minimize or prevent expected human or animal incursions onto the field trial?
  • Do records show that equipment used in this field trial meets the specifications for the frequency and type of cleaning required in the Permit Conditions and design procedures/protocols?
  • If flower removal was used to control reproduction, was the technique employed successfully and recorded?
  • If flower bagging was used to control reproduction, was the technique employed successfully and recorded?
  • If border rows were used to control reproduction, was the technique employed successfully and recorded?
  • If temporal isolation (flowering time) was used to control reproduction, was the technique employed successfully and recorded?
  • Does the responsible party have monitoring and removal records for sexually compatible plants within the isolation area of the field trial?
  • Were field operations to manage growth of the regulated article fully employed?
  • Do descriptions or records demonstrate that the responsible party is monitoring for deleterious/negative effects expressed by the regulated crop on itself, other plants, non-target species, or the environment?
  • Does the responsible party have a schedule and plan to monitor for volunteers?
  • Were operations to dispose and devitalize the regulated article (including field trial borders) fully employed?
  • Did your inspection find that this field trial is free of any potential non-compliance incidents?



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