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Regulatory Status Review

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Developers have the option of requesting a regulatory status review of a plant

developed using genetic engineering to determine whether the plant requires

regulatory oversight.
When a developer requests a regulatory status review, APHIS evaluates whether the

plant requires oversight based on the characteristics of the plant itself rather than

on the use of a plant pest in its development. If a plant developed using genetic

engineering is found to be unlikely to pose a plant pest risk, APHIS will not require

regulation under 7 CFR part 340. If APHIS is unable to reach such a finding, it will

regulate the plant and it would be allowed to move only under permit. Once APHIS

determines that a plant is not regulated, subsequent transformation events using

the same plant-trait-mechanism of action combination would not be regulated.

This process replaces the petition process in the preexisting regulations. Under the

legacy rule, developers could submit a petition requesting an agency determination

that a plant developed using a plant pest is unlikely to pose a plant pest risk, and

therefore, is no longer subject to APHIS’ biotechnology regulations. The petition

process was discontinued on October 1, 2021. See below for links to the petition

table and petition resources.

Regulatory Status Review

Under the revised regulations, developers have the option of requesting a permit

and/or a regulatory status review of a plant developed using genetic engineering

that has not been previously evaluated and determined to be nonregulated. This

process replaces the petition process in the preexisting regulations. When a

developer requests a regulatory status review, APHIS evaluates whether the plant

requires oversight based on the characteristics of the plant itself rather than on the

use of a plant pest in its development. If a plant developed using genetic

engineering is found to be unlikely to pose a plant pest risk, APHIS will not require

regulation under 7 CFR part 340. If APHIS is unable to reach such a finding, it will

regulate the plant and it would be allowed to move only under permit. Once APHIS

determines that a plant is not regulated, subsequent transformation events using

the same plant-trait-mechanism of action combination would not be regulated. 

RSR Evaluations

RSR evaluates plant pest risk based on: 

the biological properties of the plant,
the trait (or new characteristic), and

the mechanism of action (or how the genetic modification causes the new trait

to occur).

RSR will include one or two steps, depending upon the plant.

STEP 1 (APHIS will complete Step 1 in 180 days)

Evaluate the characteristics of the plant developed using genetic engineering

relative to an appropriate comparator plant to identify whether a plausible pathway

to increased plant pest risk exists and the corresponding factors of concern.

If APHIS does not identify a plausible pathway to increased plant pest risk, the

plant is not subject to regulation.

If APHIS does identify a plausible pathway to increased plant pest risk, the

developer may:

elect to take no further action   

request a permit to move the plant and/or perform field trials

request that APHIS complete the second step in the process 

NOTE:  A developer can request both a permit and that APHIS complete the second

step in the process. 

STEP 2 (APHIS will complete its entire evaluation within 15 months)

Evaluate the identified factors of concern involving the plant developed using

genetic engineering to determine the likelihood and consequence of the plausible

increased plant pest risk.

Publish the results of the evaluation in the Federal Register

Solicit and review comments from the public

If APHIS finds the plant is unlikely to pose an increased plant pest risk, the plant

is not subject to the regulations

If APHIS does not make such a finding, the plant will remain regulated 

Ver mas Ver Menos

RSR Guidance and Resources
Final RSR Guide (548.41 KB)

Response to Comments: RSR Guide (209.28 KB)

Table of RSR Requests and APHIS Responses

Guide for Submitting Confidential Business Information (492.34 KB)

Contact us about submitting a Regulatory Status Review

Additional Resources

Learn more about the Revised Regulations

Learn more about the Legacy Petition Process

Learn More About the RSR Process in APHIS Biotechnology Regulations 340.4