Overview of the Draft Guide 

for the Regulatory Status 

Review Process

Suma Chakravarthy

Abigail Walter

Biotechnology Regulatory Services (BRS)

Animal and Plant Health Inspection Service (APHIS)

September 28, 2021
Background

 Revised 7 CFR § 340 published in 

May 2020

 The Regulatory Status Review 

(RSR) is described in 7 CFR § 340.4

 RSR began in April 2021 for 6 

plants, available for all plants 

October 2021

 Draft Guidance is open for public 

comment until October 25, 2021
Regulatory Status Review (RSR)

 Evaluation of a modified plant to determine 

whether it falls within the scope of the regulations 

 Not event specific

 Plants found not subject to the 

regulations; the same planttrait-mechanism of action 

combination will qualify for 

regulatory exemption. 

 We encourage consultation 

prior to submission
Regulatory Status Review (RSR)

 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 developer caused 

the new trait to occur).

 The RSR is a two-step process

• Step 1: Initial Review

– Problem formulation to identify whether there are 

plausible pathways to increased plant pest risk

• Step 2: Plant Pest Risk Assessment (PPRA)

– Determines likelihood and consequence of any 

plausible pathways in the initial review
APHIS Conducts 

INITIAL REVIEW of 

Modified Plant

Technically 

Complete 

RSR REQUEST

APHIS Conducts 

PLANT PEST RISK 

ASSESSMENT

NOT 

REGULATED

New 

Scientifically 

Valid Evidence

YES

YES

NOT 

REGULATED

Plausible 

Pathway to 

Increased 

Plant Pest 

Risk?

NO

NO

ReReview

Movement Must 

Be Regulated by 

APHIS Permit 

under § 340.5

The RSR Process

Determined 

Unlikely to Pose 

Increased Plant 

Pest Risk?
The RSR Process

Timelines:

• Initial Review –180 days after complete request received

• PPRA—15 months after complete request received

• Does not count any time process is paused by requestor

Postings:

• Initial Review (no pathway identified): APHIS website

• PPRA: Federal Register (preliminary and final)

• Plant not subject to regulation: Plant-Trait-MOA table
Risk = Exposure x Adverse Consequence

Plant Pest Risk in the RSR

 Initial Review identifies plausible changes in:

• The distribution, density, or development of the plant 

and its sexually compatible relatives;

• The production, creation, or enhancement of a plant 

pest or a reservoir for a plant pest;

• Harm to non-target organisms beneficial to 

agriculture; and

• The weedy impacts of the plant and its sexually 

compatible relatives.
Example—Insect Resistant Corn

REQUESTOR APHIS

RSR Request describing 

transgenic insert to express 

novel pesticidal protein 

Initial Review

Plausible pathway to 

increased plant pest risk 

identified based on 

potential for harm to 

non-target organisms

Pause RSR (Optional)

Tier I safety 

testing data for 

pesticidal protein*

Plant Pest Risk Assessment

Determination of 

whether modified 

plant is subject to 

7 CFR part 340

180 Days

15 Months
RSR Submission Requirements

 Fully described in draft guidance

 Submissions and Questions

• RSRRequests@usda.gov

 Personal Information & Contact Information

 Confidential Business Information (CBI) statement

• CBI Submission Guidance: 

https://www.aphis.usda.gov/brs/pdf/CBI_Submi

ssion_Guidance.pdf

 Scientific name of plant
RSR Submission Requirements

Genotype of the modified plant

 Inserted material

• Sequence of the insert in FASTA format

• Publicly available reference numbers (when available) 

for each component

• Annotation along with function description of inserted 

genetic material (component type, name, genetic donor, 

function, and base pair location)
RSR Submission Requirements

Genotype of the modified plant

 When genetic material is not inserted

• Nature of modification 

• Sequence of modified region in FASTA format

• Sequence alignment of modified region with unmodified 

region 
RSR Submission Requirements

 Description of intended trait(s)

• The observable characteristic that changes

 Description of intended phenotype(s)

• The manifestation of the observable characteristic

 Description of Mechanism(s) of Action (MOA)

• How will the modification affect the plant?

• Include any expected changes in metabolism, 

physiology, and development due to the trait/genetic 

modification

• The requestor may cite references in this section
 When plausible pathway(s) to plant pest risk are identified 

in the Initial Review, the requestor will be informed

 Requestor can choose to ask APHIS to proceed with PPRA 

• Process pauses in the interim

• Consultation with BRS encouraged

 Optional data package should address only the factor(s) of 

concern identified in Initial Review 

• PPRA data package will vary

• The PPRA data package should include the exact 

package, submitted at the initial review stage, followed 

by new information pertinent to the PPRA 

Plant Pest Risk Analysis (PPRA)
For More Information

 RSR site:

https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/perm

its-notifications-petitions/petitions

 View Draft Guidance for RSR:

https://www.aphis.usda.gov/brs/pdf/rsr-guidance.pdf

 Comment on Draft Guidance (open until 10/25/21):

https://www.regulations.gov/docket/APHIS-2021-0062

 APHIS BRS CBI Submission Guidance:

https://www.aphis.usda.gov/brs/pdf/CBI_Submission_Guidance.

pdf

 RSR Inbox:

RSRRequests@usda.gov
Thank you!
Questions?