0579-AE47 201810 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0579 Animal and Plant Health Inspection Service APHIS 0500 Department of Agriculture USDA 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.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 7 CFR 340 7 U.S.C. 7701 to 7772 7 U.S.C. 7781- to 786 Yes

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.

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

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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.

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Not yet determined.

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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.

]]> NPRM 04/00/2019 Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. Undetermined Federal State No No Yes Gwendolyn Burnett Agriculturalist, BRS 0579 Animal and Plant Health Inspection Service APHIS 301 851-3893 4700 River Road, Unit 147, Riverdale MD 20737-1236