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Response to Comments

Regulatory Status Review Guide

December 20, 2022

On August 25, 2021, APHIS-BRS published a draft Guide for Submitting Regulatory Status 

Review (RSR) Requests for public comment. We received comments from 11 individuals and 

organizations. After considering the comments, we revised and finalized the RSR Guide. This 

document summarizes and responds to the comments we received related to the RSR Guide, 

including indicating whether we revised the Guide based on the comment.

We received comments on a range of different issues and grouped the comments into the 

following categories:

• Procedures, generally

• Initial Review and Plant Pest Risk Assessment (PPRA) processes

• Information and data requirements and submissions 

• Treatment of Plant Incorporated Protectants (PIPs)

• Examples provided in the RSR Guide

• Confidential Business Information (CBI)

• National Environmental Policy Act (NEPA)

• Confirmations of Exemption from Regulation in relation to RSRs

We also received comments related to permits, permit reviews, and permit requirements. These 

comments are out of scope for the RSR Guide and will be considered as we revise our Permit 

Guide. Comments about exemptions and the confirmation of exemption process, and general 

comments about communication, outreach, and the BRS website that address issues unrelated to 

the RSR process are also out of scope and will not be addressed here.

Comments about procedures, generally

1. Commenters requested we consider interim findings that a modified plant poses a plausible 

pathway to increased plant pest risk at the conclusion of step 1 or initial review, to be 

confidential communications between the Agency and the developer that APHIS would not 

publish. They asked APHIS to clarify whether we would publish findings that products are 

subject to the part 340 regulations if we are unable to conclude in a PPRA that the plant is 

unlikely to pose an increased plant pest risk.

Response: We have revised the RSR Guide to clarify that if we identify a plausible 

pathway to increased plant pest risk (initial review), we will not publish our response 

letter to the requestor. Similarly, we have revised the RSR Guide to indicate that if, while 

conducting a PPRA, we believe we may be unable to conclude the plant is unlikely to 

pose an increased plant pest risk, we will notify the requestor, and the requestor will have 

the option to withdraw the RSR request prior to APHIS completing and publishing a draft 

PPRA for public comment. If the requestor withdraws the RSR, APHIS will not publish 

the draft PPRA.
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2. Commenters requested clarification on timelines for the technical review and completeness 

check of an initial review submission, and on whether developers may request an RSR for 

products in the early development stage.

Response: We have revised the RSR Guide to clarify timelines and that we will accept 

RSR requests for modified plants early in the product development. However, if APHIS 

has a large number of RSR requests, it intends to prioritize products that have been 

developed over products that are conceptual in nature.

3. One commenter asked that when APHIS receives an RSR request for a plant with a 

phenotype or mechanism of action (MOA) observed in the species or its sexually compatible 

relatives, that APHIS expedite the review and issue a decision on regulatory status in less 

than 180 days.

Response: APHIS agrees that initial reviews may often take less than 180 days when 

there is familiarity with the plant-trait-MOA; in the preamble APHIS states that in such 

situations we can likely complete the initial review in less than 180 days.

4. Commenters requested that, when APHIS determines a modified plant is not subject to 

regulation, our response letter succinctly summarize our findings and make clear our 

determination that the modified plant is not regulated also applies to progeny of the modified 

plant. 

Response: Our response letters succinctly summarize the basis for our finding, and we 

will make clear our determination extends to progeny of the modified plant when bred 

with itself or other plants not subject to 7 CFR part 340. We have revised the RSR Guide 

to clarify this point.

5. Commenters sought clarification on whether the re-review process allows for requests to be 

submitted by anyone other than the original requestor and, if so, whether and how the 

original requestor would have an opportunity to provide input on the re-review process. 

Response: We have revised the RSR Guide to clarify the regulations do allow requests 

for re-review to be submitted by any person. If the original requestor does not submit the 

request for re-review, we will make the original requestor aware of the request. The 

requestor will be able to provide input if we determine a PPRA or a new PPRA is 

required.

Comments about the Initial Review and PPRA processes

1. We received several comments asking we provide additional information regarding our 

evaluation in the initial review of whether a plant poses a plausible pathway to increased 

plant pest risk, regarding the Plant Reference Documents (PRDs) we prepare to inform the 

initial review, and regarding the PPRA, the types of information we would typically request 

to support a PPRA, and the basis of decision-making. Commenters stated such information 

would help developers better understand the kinds of information used by APHIS to 

complete either stage of the RSR process and could help prevent potential delays in the RSR 

process that could result if developers have to wait to receive an initial review outcome 
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before preparing additional information to support a PPRA. Commenters also stated APHIS 

should retain the authority to choose a different comparator plant than the requestor, and 

asked we make PRDs publicly available.

Response: We have revised the RSR guide to provide additional information on the 

factors we consider during the RSR process, and the information we document in the 

PRDs and in the Mechanisms of Action Descriptions (MOADs). Both PRDs and MOADs 

are internal reference materials that we do not intend to post on our website. We also 

clarify information about the PPRA and basis of decision-making. With no prior 

knowledge of the plant-trait-MOA combinations we will receive, it is difficult to predict 

the information we might request if a PPRA is required. As examples of PPRAs become 

available in the Federal Register when posted for public review and comment, requestors 

will gain knowledge of the types of information APHIS considers in the PPRA process 

for particular categories of plant-trait-MOA combinations. PRDs are prepared at the 

species level considering the genetic variation present in the cultivated gene pool. APHIS 

will choose the most appropriate comparator plant for a given RSR and will provide an 

opportunity for developers to discuss with the Agency the most appropriate 

comparator(s) for any agronomic and ecological investigations they undertake to inform a 

PPRA.

2. Commenters recommended the Initial Review should limit its consideration of plant pest risk 

to the context of unmanaged, non-agricultural ecosystems, because in a typical or anticipated 

agricultural environment, modified plants will not present a reasonable hypothesis of 

increased plant pest risk due to practices that a grower will likely take as part of crop 

production. Another commenter recommended we assess the modified plant in the context of 

its agricultural landscape and associated cultivation practices.

Response: In the initial review we do not limit our consideration of plant pest risk to 

unmanaged ecosystems. We do include knowledge about standard agronomic practices 

for the crop when considering whether there is a plausible pathway to increased plant pest 

risk. For example, increased plant pest abundance in fields of a modified plant may or 

may not lead to an increase in plant pest risk, depending on the ability of existing 

management practices to prevent an increase in pest pressure on comparator plants not 

subject to regulation.

3. A commenter noted the plant pest risk potential of a plant is not merely dependent on 

exposure, and even when there is a change in occurrence pattern relative to the 

comparator(s), the overall risk may remain unchanged. The commenter also recommended

only changes in characteristics beyond the range of what has previously been observed in the 

plant species’ gene pool should be considered for any possible change in occurrence pattern, 

and when a change in occurrence pattern of a modified plant provides a new route of 

exposure, the RSR process should progress to the PPRA only for those modified plants 

where the expected changes in occurrence pattern would be outside the observed range in the 

plant species’ gene pool and there is a plausible pathway to increased plant pest risk as 

compared to the comparator(s). 

Response: APHIS agrees the plant pest risk potential of a plant is not merely dependent 

on exposure, and there may not be an increased plant pest risk simply because of a 
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change in occurrence pattern. However, we do not agree with the commenter that the 

identification of plausible pathways to increased plant pest risk should consider whether a 

change in a characteristic, or a resulting change in an occurrence pattern, is within the 

range observed in the plant species gene pool. Nor do we agree we should only progress

to a PPRA when the expected changes in a characteristic or occurrence pattern are 

outside the range found in the plant species’ gene pool. For RSR, APHIS considers 

genetic variation present in the species cultivated gene pool and the occurrence pattern in

managed and unmanaged ecosystems. If the modified trait and MOA results in a 

plausible change in a characteristic or occurrence pattern within the range of genetic 

variation commonly found in cultivated comparator plants, then the RSR will not 

progress to step 2. However, if the gene pool of the plant being assessed includes other 

species that do not contain the introduced trait and/or MOA, potentially including wild 

and weedy relatives or distant species that are rarely cultivated, we will consider effects 

that could change the characteristics or occurrence patterns of the other species if the 

introduced or modified genetic sequence were to introgress.

4. A commenter recommended our consideration of whether an introduced trait and MOA could 

lead to the production, creation, or enhancement of a plant pest or a reservoir for a plant pest 

should be focused on modified plants with a new trait or characteristic that is intended to 

alter the plant’s relationship with plant pests. The commenter similarly recommended 

evaluation of harm to non-target organisms should be limited to modified plants where the 

intended trait or characteristic targets a pest via a toxic mechanism of action. In both cases, 

the commenter recommended that consideration be limited to changes in phenotype that are

outside the range observed in the plant species’ gene pool.

Response: APHIS does not agree with the commenter. While knowing the intent of the 

modification can facilitate our review in the RSR, the RSR must evaluate whether the 

trait and/or mechanism of action could have plausible yet unintended effects that could 

result in a plausible pathway to increased plant pest risk regardless of intent. Similarly, 

APHIS reviews all products subject to the RSR process to assess whether there are any 

plausible pathways to increased plant pest risk via harm to a beneficial non-target 

organism, regardless of the toxicity of the MOA. We also do not agree our consideration 

should be limited to changes in phenotype that are outside the range observed in the 

species’ gene pool for the reasons stated above.

5. A commenter recommended APHIS limit its evaluation of the weedy impacts of the modified 

plant and its sexually compatible relatives to instances where each of four criteria are met: 

(1) the modified plants or its wild relative(s) inherently has invasive characteristics, (2) the 

modification of these characteristics is outside the range observed in the plant species’ gene

pool, (3) where gene introgression may be likely to occur to the wild relative(s), and (4) 

where there is exposure to wild relatives in unmanaged ecosystems. 

Response: APHIS does not agree with the commenter. Adopting the commenter’s 

approach would limit the evaluation to only those plants with sexually compatible 

relatives that already have invasive characteristics, and then only when gene flow to the 

sexually compatible relative is likely to occur in unmanaged ecosystems. If we identify a 

plausible pathway to increased plant pest risk via gene introgression to a sexually 

compatible relative, the PPRA will evaluate, and the findings will reflect, the likelihood 
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and consequence of gene introgression. Since sexually compatible relatives can occur in 

both managed and unmanaged ecosystems, as well as on the borders of managed 

ecosystems, this assessment must include the likelihood of introgression whether that 

occurs within unmanaged ecosystems, within managed ecosystems, or from a managed to 

an unmanaged ecosystem. Additionally, limiting the evaluation to those plants which are 

already invasive would prevent the identification of plausible pathways to increased plant 

pest risk that could occur due to increasing the range of the modified plant or its sexually 

compatible relative.

6. A commenter stated our requirement that RSR requests include information on the intended 

trait and intended phenotype implies our review will be limited to the consideration of the 

intended change, but that a plant modified for one intended purpose will often exhibit 

unintended changes that require assessment in the initial review and PPRA. The commenter 

also recommended APHIS consult available databases and the scientific literature to 

determine whether a MOA may have multiple functions that could result in unintended 

phenotypes.

Response: APHIS requests information on the intended trait and the intended phenotype 

to inform the initial review. However, the initial review is not limited to the intended 

changes in the plant. The initial review also considers whether there are plausible 

pathways to increased plant pest risk based on the plant, the trait, and the function(s) and 

plausible effects of the mechanism(s) of action on the plant, regardless of whether the 

plausible effects are intended or unintended. APHIS consults both information provided 

by the requestor and information APHIS obtains from databases and scientific literature.

If one or more plausible pathways to increased plant pest risk are identified, they will be 

evaluated in the PPRA regardless of whether they are due to intended or unintended 

changes in the plant. We have revised the RSR Guide to clarify this point.

7. A commenter raised several concerns that the scope of the PPRA is too narrow, especially 

regarding herbicide resistant crops. 

Response: The comments raise issues outside the scope of the RSR process.

Comments about information and data requirements and submissions

1. A commenter suggested the Guide would be more useful if we described how each of the 

required pieces of information is used in the initial review to evaluate the regulatory status of 

a plant.

Response: We have revised the Guide to provide a brief description of how each piece of 

requested information will be used.

2. Some commenters did not agree nucleotide sequence information is relevant to evaluation of 

plant pest risk and should not be required. Commenters also noted if such information is 

required, the FASTA format for submitting sequence information does not support 

annotation or redaction of such information as CBI and requested allowing the submission of 

sequence information in other formats. Another commenter noted that full sequence 
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information of the inserted or modified DNA, and/or the sequence that bridges gene 

deletions, would help the agency assess the effects of the genetic modification.

Response: APHIS uses nucleotide sequence information to confirm the intended trait(s) 

at the molecular/genetic level; to understand the MOA for purposes of assessing the plant 

pest impact(s), if any, of the modification(s); and to assess similarity with previously 

reviewed plants. We have revised the RSR Guide to indicate other formats that may be

used to submit sequence information.

3. A commenter stated many questions that need answers in the initial review and the PPRA 

will require empirical data, and APHIS should make clear that no finding regarding plant 

pest risk will be made until all needed data are collected.

Response: As described in the RSR Guide, empirical data is generally not necessary to 

conduct an initial review. When the initial review identifies a plausible pathway to plant 

pest risk, empirical data may be necessary for APHIS to reach a finding. In such 

instances, APHIS would inform the submitter of the types of data that would be useful. If 

APHIS has insufficient information to reach a finding that a plant is unlikely to pose an 

increased plant pest risk, the plant will remain subject to the regulations.

Comments about the treatment of Plant Incorporated Protectants (PIPs)

1. Commenters requested APHIS coordinate with EPA when conducting RSRs on plants 

modified to contain plant incorporated protectants (PIPs) so that the agencies’ assessments 

and conclusions are consistent and do not result in unnecessary duplication, while noting the 

two agencies have different assessment endpoints, and thus may have different information 

and data needs. Commenters also requested clarification about whether plants containing 

PIPs are required to undergo an RSR if PIP-containing products are registered or exempted 

under FIFRA.

Response: APHIS agrees with the commenter that the overall assessment endpoints for 

the two agencies differ and thus the agencies may have related but distinct data needs. 

APHIS will continue to discuss our analyses of plants containing PIPs with EPA when 

both agencies receive the same product for review. Commenters correctly noted that 

plants modified solely to contain PIPs registered with EPA are exempt from the permit 

requirements under part 340 and thus do not need to undergo an RSR to be moved or 

planted without a permit. This exemption applies whether the plant is modified to contain 

a single registered PIP or multiple registered PIPs. A developer may nonetheless request 

an RSR if they wish to have clarification whether the agency considers the PIP unlikely 

to pose a plant pest risk, or to add the plant containing the PIP to APHIS’ list of planttrait-MOA combinations that are exempt from the part 340 regulations. If an EPA 

registration expires or is rescinded, the developer would have to apply for a BRS permit 

to engage in regulated activities or submit an RSR request to learn whether the modified 

plant is subject to 7 CFR part 340. APHIS will clarify the status under 7 CFR part 340 of 

plants containing PIPs exempt from registration requirements once EPA completes 

rulemaking regarding such PIPs.

Comments about the examples provided in the RSR Guide
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1. Commenters requested we indicate the drought tolerance and insect resistance examples 

provided in the RSR Guide are simply examples and do not necessarily represent conclusions 

that will apply to all drought tolerant or insect resistant plants.

Response: The RSR Guide makes clear these are examples only.

2. A commenter requested we clarify the PPRA for the drought tolerance example would focus 

on whether the drought tolerance is modified so as to result in a plausible pathway to 

increased plant pest risk in an unmanaged ecosystem, and, if so, whether the trait may 

increase plant pest risk to such a degree that other species or ecotypes are displaced, or the 

plant becomes unmanageable.

Response: As indicated above, we consider both managed and unmanaged ecosystems in 

the RSR process, including knowledge about standard agricultural production and 

management practices for the crop, when considering whether there is a plausible 

pathway to increased plant pest risk. We also consider such practices when conducting a 

PPRA if we identify a plausible pathway to increased plant pest risk during the initial 

review. Additionally, the focus of both the initial review and PPRA is on plausible plant 

pest risks to other plants, not to the plant under review, although other plants may include 

plants of the same species that are not the plant under review. We have revised the RSR 

Guide to clarify these points. APHIS does not agree the PPRA should focus solely on 

whether the increase in plant pest risk is to such a degree that other species or ecotypes 

are displaced or the plant becomes unmanageable. There could be plant pest impacts that 

have major consequences for other species yet remain short of displacing those species.

3. Commenters requested examples of plant-trait-MOA combinations that would not lead to a 

plausible pathway to increased plant pest risk relative to the comparator(s) and thus would 

complete the RSR process after the initial review.

Response: APHIS posts RSR requests, response letters, and plant-trait-MOA 

combinations on its website that provide examples where no plausible pathways to plant 

pest risk were identified. These examples will continue to grow over time. 

Comments about Confidential Business Information (CBI)

1. Commenters requested APHIS consider the possibility that RSR requests may be submitted 

much earlier in the commercial development of a product than when petitions for 

nonregulated status had historically been submitted and will be more likely to contain CBI 

that could not be disclosed until a product is closer to commercialization. Commenters also 

requested we withdraw any suggestions the protection of CBI is subject to a time limitation.

Response: We understand there may be more CBI claims in RSRs than in petitions 

submitted under the legacy regulations. BRS will evaluate any CBI claims in accordance 

with applicable laws and procedures before releasing information in submissions to the 

public. Our goal is to undertake this CBI review as close in time as possible to any public 

release of information. The review will include communication with the requestor about 

any CBI claims. In our experience, minimizing CBI claims in published materials fosters 
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public acceptance of plant products of biotechnology and is important to enable informed 

public comment on PPRAs. Regarding time limitations, per 7 CFR 1.8(c), CBI 

designations expire 10 years after the date of the submission unless the submitter requests 

and provides justification for a longer designation period. We revised the RSR Guide to 

clarify these points. 

Comments about the National Environmental Policy Act (NEPA)

1. Commenters requested we describe APHIS’ expected processes for conducting analyses 

under NEPA when reviewing an RSR request, clarify whether requestors could provide 

supplemental information to APHIS which may not relate directly to plant pest risk but could 

assist in APHIS’ preparation of appropriate analyses under NEPA, and develop a mechanism 

that allows requestors to submit such supplemental information if they wish. 

Response: When APHIS is reviewing an RSR request, it is determining whether a 

modified plant is unlikely to pose an increased plant pest risk relative to an appropriate 

comparator (and, thus, is not a plant pest or a plant that requires regulation to prevent 

introducing or disseminating a plant pest). If APHIS determines the modified plant is 

unlikely to pose an increased plant pest risk relative to the comparator plant, APHIS has 

no authority to regulate the modified plant under 7 CFR part 340. In these instances, 

APHIS is not required to undergo NEPA analysis as it “lacks the power to act on 

whatever information might be contained in the [NEPA analysis].” Dep't of Transp. v. 

Pub. Citizen, 541 U.S.. 

Comments about Confirmations of exemption in relation to RSRs 

We received multiple comments discussing the regulatory exemptions in 7 CFR 340.1(b). Most 

of these comments were not directly relevant to the RSR process or the RSR Guide and are not 

discussed here. Please see our recently updated Guide for Submitting Confirmation Requests, 

which provides clarity on some of the issues in these comments.