Guidance for Requesting a Confirmation of 

Exemption from Regulation under

7 CFR part 340

The contents of this presentation do not have the force 

and effect of law and are not meant to bind the public in 

any way. This presentation is intended only to provide 

clarity to the public regarding existing requirements under 

the law or agency regulations. 

June 24, 2020
Introduction to the 

Confirmation of Exemption Process

 7 CFR part 340 governs the movement of certain organisms 

that are modified or produced through genetic engineering.

 Certain plants are exempt from the regulations (§ 340.1).

 Developers may request confirmation that their plant is 

exempt 

• Not mandatory

• Responses generally within 120 days

• Posted on the APHIS-BRS website

 Consult prior to your first submission, if possible.
Exemptions

 There are four exemptions defined in § 340.1. 

 The first three exemptions cover modified plants that could 

otherwise have been developed through conventional 

breeding techniques (§ 340.1(b)(1-3)). 
The First Three Exemptions

These exemptions cover plants modified to contain a single 

targeted genetic modification of one of the three types listed:

 Exemption 1

 A change resulting from cellular repair of a targeted DNA break in the 

absence of an externally provided repair template (§ 340.1(b)(1)).

 Exemption 2

 Is a targeted single base pair substitution (§ 340.1(b)(2)).

 Exemption 3

 Introduces a gene known to occur in the plant’s gene pool or makes 

changes in a targeted sequence to correspond to a known allele of such 

a gene or to a known structural variation present in the gene pool 

(§ 340.1(b)(3)).
The Fourth Exemption

This exemption (§ 340.1(c)) covers plants modified to contain 

a plant-trait-MOA combination that is the same as that in 

another plant of the same species previously reviewed and 

determined by APHIS not to be regulated under either the:

 Current petition process; or,

 Future Regulatory Status Review process
Your Letter Must Include

 Requestor’s name and contact information, including email 

address; AND

 A description of the plant’s genus, species, and, if relevant, 

subspecies or ecotypes; AND

 A citation to the claimed regulatory exemption for the plant, a 

clear statement of why the plant qualifies for that exemption; 

AND

 A description of the trait (it is helpful to also include a description 

of the phenotype of the plant).
Your Letter Must Include

For modified plants that could otherwise have been developed through conventional breeding techniques 

provide: 

 A description of the intended and/or actual genetic 

modification sufficient to enable APHIS to confirm the final 

plant is eligible for the exemption, AND

 The type of genetic modification (e.g., insertion, deletion, single base pair substitution, allele replacement or 

alteration), AND

 The targeted gene or genetic element, and the method 

used to produce the modification (§ 340.1(b)(1) or (b)(2)), 

OR

 The gene or genetic or structural element, the donor 

organism or the organism on which the modification is 

based, and the method used to produce the modification 

(§ 340.1(b)(3)).
Your Letter Must Include

For previously reviewed plant/trait/MOA 

combinations under § 340.1(c) provide: 

 A description of the intended and/or actual genetic 

modification sufficient to enable APHIS to confirm the 

final plant is eligible for the exemption, AND

 The trait(s) and associated MOA(s), including a molecular 

description of the inserted genetic material, and the 

method used to produce the modification. 
Your Letter Must Include

 Describe the scientific methodology you used, or 

intend to use, to verify the plant qualifies for the 

requested exemption. 

 Provide sufficient information to enable APHIS to 

assess the efficacy of the methodology.
Your Letter May Include 

Supporting Information and Data

 Function of the modified gene or genetic element

 Molecular characterization data (e.g., Southerns)

 DNA sequence data

 Sequence data should encompass the modification.

 Any sequencing strategy and methodology should be 

clearly presented.
Off-Target Mutations

 APHIS will not review off-target mutations that occur during 

development of an exempt plant.

(1) The rate of off-target mutation is low relative to the 

background mutation rate that occurs in conventional breeding, 

which raises no plant pest risk concern, and

(2) Deleterious off-target mutations are likely to be lost unless 

they are closely genetically linked to the targeted modification.

 APHIS will focus review on the targeted modification.

 APHIS does not consider the unintended retention of exogenous 

DNA that was inserted as part of the modification process to be an 

off-target mutation.
Request for Confirmation of Exemption

If you are seeking confirmation that your plant is exempt 

from the regulations in 7 CFR part 340, electronically 

submit your confirmation request as a letter to: 

Bernadette Juarez 

APHIS Deputy Administrator 

Biotechnology Regulatory Services 

ConfirmationRequests@usda.gov
APHIS’ Reply

Will vary slightly depending on:

 Whether the modification to the plant is actual or 

intended;

 Whether the requestor provides a description of both 

the confirmatory methods and the results;

 Whether the requestor provides a description of the 

confirmatory methods and supporting data for the 

results.
Confidential Business Information

 If your confirmation request, as well as any follow-up 

documentation you provide, does not contain 

Confidential Business Information (CBI), it must be 

marked “No CBI.” 

 If your confirmation request, or any documentation you 

provide, contains CBI, you must correctly mark and 

submit: 

 a CBI copy;

 a CBI-deleted copy; and,

 a detailed justification for each CBI claim.

 Refer to CBI Submission Guidance on BRS’ website 
Questions?

Future questions --

ConfirmationRequests@usda.gov

Thank you!