Notice of Request To Renew an Approved Information Collection: Procedures for the Notification of New Technology and Requests for Waivers

AGENCY:

Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA).

ACTION:

Notice and request for comments.

SUMMARY:

In accordance with the Paperwork Reduction Act of 1995 and the Office of Management and Budget (OMB) regulations, FSIS is announcing its intention to request renewal of the approved information collection regarding the procedures for notifying the Agency about new technology and requests for waivers. There are no changes to the existing information collection. The approval for this information collection will expire on June 30, 2023.

DATES:

Submit comments on or before May 8, 2023.

ADDRESSES:

FSIS invites interested persons to submit comments on this Federal Register notice. Comments may be submitted by one of the following methods:

• Federal eRulemaking Portal: This website provides commenters the ability to type short comments directly into the comment field on the web page or to attach a file for lengthier comments. Go to https://www.regulations.gov . Follow the on-line instructions at that site for submitting comments.

• Mail: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, DC 20250-3700.

• Hand- or Courier-Delivered Submittals: Deliver to 1400 Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, DC 20250-3700.

Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2023-0003. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to https://www.regulations.gov .

Docket: For access to background documents or comments received, call (202) 205-0495 to schedule a time to visit the FSIS Docket Room at 1400 Independence Avenue SW, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT:

Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 20250-3700; (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Title: Procedures for the Notification of New Technology and Requests for Waivers.

Expiration Date of Approval: June 30, 2023.

OMB Number: 0583-0127.

Type of Request: Renewal of an approved information collection.

Abstract: FSIS has been delegated the authority to exercise the functions of the Secretary (7 CFR 2.18 and 2.53), as specified in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031, et seq.). These statutes mandate that FSIS protect the public by verifying that meat, poultry, and egg products are safe, wholesome, and properly labeled and packaged.

FSIS is announcing its intention to request renewal of the approved information collection regarding the procedures for notifying the Agency about new technology and requests for waivers. There are no changes to the existing information collection. The approval for this information collection will expire on June 30, 2023.

FSIS has procedures for official meat, poultry, and egg products establishments to request temporary waivers from regulatory requirements in the event of a public health emergency or to permit experimentation (see 9 CFR 303.1 (h), 381.3 (b), and 590.10). FSIS also has procedures for official establishments and companies that manufacture and sell technology to official establishments, to notify the Agency of any new technology intended for use in official establishments, so that the Agency has an opportunity to decide whether the new technology requires a pre-use review. (68 FR 6873). To follow the procedures, official establishments and firms that manufacture and sell technology to official establishments notify the Agency by submitting documents describing the operation and purpose of the new technology or waiver request. The documents should explain why the new technology or waiver request will not (1) adversely affect the safety of the product, (2) jeopardize the safety of Federal inspection personnel, or (3) interfere with inspection procedures. If use of the new technology will also require a waiver of any Agency regulation, the notice must identify the regulation and explain why a waiver would be appropriate (9 CFR 303.1(h), 381.3(b), and 590.10). If the new technology could affect FSIS regulations, product safety, inspection procedures, or the safety of inspection program personnel, the establishment or plant would need to submit a written protocol for an in-plant trial as part of a pre-use review. The submitter of a written protocol should provide data to the Agency throughout the duration of the in-plant trial.

FSIS has made the following estimates based upon an information collection assessment:

Estimate of Burden: FSIS estimates that it will take respondents an average of 8 hours to complete a notification of intent to use new technology if no in-plant trial is necessary. If an in-plant trial is necessary, FSIS estimates that it will take an average of 80 hours to develop a protocol and an average of 80 additional hours to collect data and keep records during the in-plant trial. FSIS estimates it will take respondents an average of 120 hours to collect data and conduct recordkeeping under a waiver.

Respondents: Official meat and poultry establishments and egg product plants; firms that manufacture or sell technology to official establishments and plants.

Estimated Number of Respondents: 75 respondents will submit notifications of intent to use new technology. 50 respondents will develop a protocol for and conduct an in-plant trial. 50 respondents will collect data and conduct recordkeeping for the duration of the in-plant trial. 35 respondents will collect data and conduct recordkeeping under the waiver.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 12,800 hours. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 20250-3700; (202) 205-0495.

Comments are invited on: (a)whether the proposed collection of information is necessary for the proper performance of FSIS' functions, including whether the information will have practical utility; (b) the accuracy of FSIS' estimate of the burden of the proposed collection of information, including the validity of the method and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20253.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: https://www.fsis.usda.gov/federal-register .

FSIS will also announce and provide a link to this Federal Register publication through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS can provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe . Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

USDA Non-Discrimination Statement

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(1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410;

(2) Fax: (833) 256-1665 or (202) 690-7442; or (3) Email: program.intake@usda.gov.

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