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Compliance and the Inspection

Process

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APHIS verifies compliance with the conditions contained in permits and notifications

by inspecting fields, records and associated facilities. 

Inspections may be done in person or virtually; virtual inspections are referred to as

Monitoring and Evaluation Interviews (MEIs). Trained inspectors (from BRS, APHIS’
Plant Protection and Quarantine (PPQ) program, or a participating state inspection

program), conduct inspections on behalf of BRS. Methods of verification used for

inspection include:  records review, interview, observation, and measurement and

mapping. 

BRS determines the frequency and number of field test site inspections by assessing

the relative risk of each type of trial and by other criteria described below. BRS

conducts least one inspection for every permit resulting in a planted field trial.

Compliance Incidents

Most persons authorized to engage in regulated activities have a successful history

of compliance with APHIS regulations.  From time-to-time, a noncompliance incident

may occur.  Noncompliance incidents can include failing to notify APHIS in the event

of an unauthorized release, failing to follow permit conditions (such as isolation

distances or volunteer monitoring requirements), and planting at a field test site

before an authorization becomes effective or after it expires.  When noncompliance

occurs, BRS assesses the nature and seriousness of the noncompliance and

determines appropriate steps to follow up, ranging from issuing regulatory

correspondence to requesting an investigation and seeking sanctions for alleged

noncompliance.

Inspections for Permits

Permits require responsible persons to follow procedures described in their

applications, the design protocols (e.g., standard operating procedures) they have

submitted, and the standard permit conditions 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 authorized state where a field test site is planted each year. Plants engineered

to produce pharmaceutical or industrial proteins are inspected up to seven times

before, during, and after the planting occurs to verify compliance with permit

conditions. 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 tracks inspection-related information to

assure that all required inspections are accomplished.

Inspection Results
After every inspection, inspectors prepare a detailed inspection report. BRS then

issues feedback correspondence to the responsible person based on findings

documented in the inspection report. The correspondence typically falls into one of

the following categories:

Notice of Compliance – the inspection revealed no deviations from the

regulations or permit conditions, including conditions described on the permit

application.

Note:  If the analysis revealed activities or circumstances that could lead

to a noncompliance incident in the future, the Notice of Compliance will

provide notice of BRS’ concerns and possible solutions to prevent

noncompliance incidents.

Notice of Noncompliance - the inspection revealed deviations from the

regulations or permit conditions. BRS may require corrective action and

indicate documentation that must be provided to BRS once corrective action is

taken, as appropriate, usually within a given time frame.

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.

BRS also uses these and other letters to communicate findings not specifically

related to inspections, such as noncompliance for late submittal of required reports.

Reports and Notices

APHIS requires responsible persons to submit certain reports and notices under the

regulations and as part of the requirements of the authorization.  Reports and

notices provide compliance-related information about regulated materials. Each

report and/or notice is associated with a specific permit or notification, and has

requirements for due dates and information. BRS uses reports and notices for

initiating inspection processes and verifying the status of the authorization and any

actions taken under it, such as planting and volunteer monitoring. A report has

information on activities that already happened, and a notice contains information

on planned activities that will occur in the future.

Access to Reports and Notices User's Guide

Access to ePermits (XML) Instructions for Reports and Notices
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*

Related Links

How to Report an Unauthorized or Accidental Release