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USDA/APHIS RIN: 0579-AE47 Publication ID: Fall 2018 
Title: ●Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms 

APHIS is proposing to revise its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to update the regulations in response to advances in genetic engineering and APHIS' understanding of the plant health risk posed by genetically engineered organisms, thereby reducing the burden for regulated entities whose organisms pose no plant health risks.

Agency: Department of Agriculture(USDA)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 7 CFR 340   
Legal Authority: 7 U.S.C. 7701 to 7772    7 U.S.C. 7781- to 786   
Legal Deadline:  None

Statement of Need:

This rule is necessary in order to respond to advances in genetic engineering and APHIS’ understanding of the pest risks posed by genetically engineered (GE) organisms, to assess such organisms for plant pest risks in light of those advances and establish a process to determine whether APHIS has jurisdiction under the Plant Protection Act to regulate specific GE organisms under Part 340, and to respond to two Office of Inspector General audits regarding APHIS’ regulation of genetically engineered organisms, as well as the requirements of the 2008 Farm Bill.

Summary of the Legal Basis:

The Plant Protection Act, as amended (7 U.S.C. 7701 et seq.).


Alternatives that we considered were (1) to leave the regulations unchanged and (2) to regulate all GE organisms as presenting a possible plant pest or noxious weed risk, without exception, and with no means of granting nonregulated status.

Anticipated Costs and Benefits:

Not yet determined.


Unless we issue this proposal, we will not be able to respond to the products of future technologies and not be able to provide appropriate oversight of GE organisms that pose a plant pest risk. Additionally, as noted above, the current regulations do not incorporate recommendations of two OIG audits, and do not respond to the requirements of the 2008 Farm Bill, particularly regarding APHIS oversight of field trials and environmental releases of genetically engineered organisms.

Action Date FR Cite
NPRM  04/00/2019 
Additional Information: Additional information about APHIS and its programs is available on the Internet at
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal, State 
Federalism: No 
Included in the Regulatory Plan: Yes 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Gwendolyn Burnett
Agriculturalist, BRS
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 147,
Riverdale, MD 20737-1236
Phone:301 851-3893