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Compliance Permit Inspection

Overview

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APHIS performs physical inspections (in person) of authorized field trial sites to

ensure compliance with the regulations and permit conditions. APHIS also performs

inspections virtually: virtual inspections are referred to as Monitoring and Evaluation

Interviews or MEIs. 

Trained inspectors (from BRS, APHIS’ Plant Protection and Quarantine (PPQ) program

and with a participating state inspection program), conduct inspections. Methods

used to assess compliance during inspections include: records review, interview,

observation, and measurement and mapping.  BRS ensures all inspectors are

specifically trained to 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 to them 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 the on-site responsible person a

number of 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.

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 associated with the trial, as well as a copy of the design protocols and/or

standard operating procedures submitted with the application for permit. 

BRS initially reviews completed inspection reports for quality to ensure inspectors

submit all the appropriate information. Following the quality review, BRS evaluates

the inspection report for compliance with the regulations. If BRS identifies

noncompliance, BRS will specify the necessary corrective action, and take additional

follow up steps, as appropriate. BRS provides the inspection outcomes to the

responsible person to whom the permit is issued. 

Example Permit Inspection Questions

Does the responsible person have a copy of the 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 person 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 person 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 person is

monitoring for deleterious/negative effects expressed by the regulated crop on

itself, other plants, non-target species, or the environment?

Does the responsible person 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 noncompliance incidents?

Overview of noncompliance history.

Notices of inspection findings are subsumed in the table.
ROP has guidance documents here for submitting reports via email or mail; no

changes anticipated at this time

More Information

View Noncompliance History   

View Table of Pharma Inspection Findings

Related Links

How to Report an Unauthorized or Accidental Release