2021-04716. Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

AGENCY:

Animal and Plant Health Inspection Service, Department of Agriculture (USDA); Food Safety and Inspection Service, USDA.

ACTION:

Advance notice of proposed rulemaking; reopening of comment period.

SUMMARY:

We are reopening the comment period for our advance notice of proposed rulemaking on establishing regulations for the movement of certain animals modified or developed by genetic engineering. This action will allow interested persons additional time to prepare and submit comments.

DATES:

The comment period for the advance notice of proposed rulemaking published on December 28, 2020 (85 FR 84269) is reopened. We will consider all comments that we receive on or before May 7, 2021.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to www.regulations.gov. Enter APHIS-2020-0079 in the Search field. Select the Documents tab, then select the Comment button in the list of documents.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2020-0079, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.

Supporting documents and any comments we receive on this docket may be viewed at regulations.gov or in our reading room, which is located in Room 1620 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call [phone] before coming.

FOR FURTHER INFORMATION CONTACT:

Dr. Alan Pearson, Assistant Deputy Administrator, Biotechnology Regulatory Services; APHIS, 4700 River Road, Unit 98, Riverdale, MD 20737-1238; [phone]; [e-mail]. Dr. Kis Robertson Hale, Deputy Assistant Administrator, Office of Public Health Science, USDA Food Safety and Inspection Service, 1400 Independence Avenue SW, Room 341-E. Whitten Building; [phone]; [e-mail].

SUPPLEMENTARY INFORMATION:

On December 28, 2020, we published in the Federal Register (85 FR 84269-84275, Docket No. APHIS-2020-0079) an advance notice of proposed rulemaking (ANPR) on establishing regulations for the movement of certain animals modified or developed by genetic engineering. As outlined in the ANPR, the United States Department of Agriculture would promulgate regulations using the authorities granted to the Department through the Animal Health Protection Act, the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA). Pursuant to these authorities, the Animal and Plant Health Inspection Service would conduct a safety assessment of animals subject to the FMIA or PPIA that have been modified or developed using genetic engineering that may increase the animal's susceptibility to pests or diseases of livestock, including zoonotic diseases, or ability to transmit the same. The Food Safety and Inspection Service would conduct a pre-slaughter food safety assessment to ensure that the slaughter and processing of certain animals modified or developed using genetic engineering would not result in a product that is adulterated or misbranded.

Comments on the ANPR were required to be received on or before February 26, 2021. We are reopening the comment period on Docket No. APHIS-2020-0079 for an additional 60 days. The comment period will now close on May 7, 2021. This action will allow interested persons additional time to prepare and submit comments.

Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.

Done in Washington, DC, this 2nd day of March 2021 .

Heather Pichelman,

Acting Deputy Under Secretary for Marketing and Regulatory Programs.

Paul Kiecker,

Acting Deputy Under Secretary, Office for Food Safety.