supporting statement ICRNewTechnology0583_0127 April 2020

SUPPORTING STATEMENT JUSTIFICATION FOR

PROCEDURES FOR THE NOTIFICATION OF NEW TECHNOLOGY AND REQUESTS FOR WAIVERS

1. Circumstances Making Collection of Information Necessary:

This is a request for an extension of the previously approved information collection which addresses the regulatory requirements for meat, poultry, and egg products establishments and plants in implementing new technologies and requests for waivers.

The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the functions of the Secretary as provided 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 ensuring that meat and poultry products are safe, wholesome, unadulterated, and properly labeled and packaged.

FSIS established flexible procedures to actively encourage the development and use of new technologies in meat and poultry establishments and egg products plants (68 FR 6873). These procedures facilitate notification to the Agency of any new technology that is intended for use in meat and poultry establishments and egg products plants so that the Agency can decide whether the new technology requires a pre-use review.

If a new technology could affect product safety, FSIS regulations, inspection procedures, or the safety of Federal inspection program personnel, or requires a waiver of a regulation, FSIS will advise the firm that a pre-use review is necessary. A pre-use review often includes an in-plant trial. If an in-plant trial is necessary, FSIS will request that the firm submit a protocol that is designed to collect relevant data to support the use of the new technology.

2. How, By Whom and Purpose For Which Information is to be Used:

The following is a discussion of the required information collection and recordkeeping activities.

Notification

Before introducing new technology into an official establishment or plant, firms should submit notification and documentation of the new technology to FSIS describing the operation and purpose of the new technology (68 FR 6873). The document should explain why the new technology will not:

• adversely affect the safety of the product,

• jeopardize the safety of Federal inspection program personnel,

• interfere with inspection procedures.

FSIS will make every effort to review the documentation and notify the firm within 60 days whether it has no objection to the use of the new technology or if it needs a pre-use review.

Development of Protocols

If FSIS determines that the proposed use of the new technology could adversely affect product safety, interfere with FSIS inspection procedures, jeopardize the safety of inspection program personnel, or require a waiver of a regulation, then a pre-use review is needed. Title 9 CFR 303.1(h), 381.3(b), and 590.10 authorize the Administrator to waive for limited periods any provision of the regulations to permit experimentation so that new procedures, equipment, and processing techniques may be tested to facilitate definite improvements. Typically, when a pre-use review is needed, the firm will develop a protocol for an in-plant trial of the new technology. The firm then must submit a protocol that is designed to collect relevant data to support the use of the new technology.

In-plant Trials Data Collection and Recordkeeping

Firms that conduct in-plant trials must collect and record the data on a regular, on-going basis.

In-plant Monthly Data Collection and Recordkeeping

Firms that operate under a waiver must collect and record data on a regular, on-going basis.

There are a total of 12,800 burden hours for the information collection requests relating to the notification of new technology procedures.

3. Use of Improved Information Technology:

Under the E-Gov Act, firms may submit notification and protocols electronically. Records may be maintained electronically provided that appropriate controls are implemented to ensure the integrity of the electronic data.

4. Efforts to Identify Duplication:

No FSIS office, USDA agency, or any other Government agency requires information regarding the use of new technology in meat, poultry, and egg products establishments and plants. There is no available information that can be used or modified.

5. Methods to Minimize Burden on Small Business Entities:

Data collected from small businesses are the same as for large ones. The information collections must apply to all meat, poultry, and egg products establishments and plants under FSIS inspection implementing new technology or requesting waivers. There are no small businesses.

6. Consequences If Information Were Collected Less Frequently:

To conduct the information collections less frequently will reduce the effectiveness of the meat, poultry, and egg products inspection program.

7. Circumstances that Would Cause the Information Collection to be Conducted in a Manner:

• requiring respondents to report informa­tion to the agency more often than quarterly;

• requiring respondents to prepare a writ­ten response to a collection of infor­ma­tion in fewer than 30 days after receipt of it;

• requiring respondents to submit more than an original and two copies of any docu­ment;

• requiring respondents to retain re­cords, other than health, medical, governm­ent contract, grant-in-aid, or tax records for more than three years;

• in connection with a statisti­cal sur­vey, that is not de­signed to produce valid and reli­able results that can be general­ized to the uni­verse of study;

• requiring the use of a statis­tical data classi­fication that has not been re­vie­wed and approved by OMB;

• that includes a pledge of confiden­tiali­ty that is not supported by au­thority estab­lished in statute or regu­la­tion, that is not sup­ported by dis­closure and data security policies that are consistent with the pledge, or which unneces­sarily impedes shar­ing of data with other agencies for com­patible confiden­tial use; or

• requiring respondents to submit propri­etary trade secret, or other confidential information unless the agency can demon­strate that it has instituted procedures to protect the information's confidentiality to the extent permit­ted by law.

During the protocol establishments and plants may be required to report data gained from their study of the new technology more frequently than quarterly. All information collection and recordkeeping activities in this submission are consistent with the guidelines in 5 CFR 1320.6. No other circumstances exist that would cause the Agency to conduct this information collection in a manner differently than described above.

8. Consultation with Persons Outside the Agency:

In accordance with the Paperwork Reduction Act, FSIS published a 60-day notice in the Federal Register (85 FR 10648; February 25, 2020). FSIS received two public comments that were not relevant to the information collection. The Agency also consulted with three outside persons regarding the information collection: Mark Berrang (706-546-3551); Manpreet Singh (706-542-9971); and Rachel Morissette (240-402-1212), to request input on the FSIS burden estimates. The three individuals agreed the FSIS burden estimate for the information collection requirements related to Procedures for the Notification of New Technology and Requests for Waivers­­ remains accurate.

9. Payment or Gifts to Respondents:

Respondents will not receive any gifts or payments.

10. Confidentiality Provided to Respondents:

No assurances other than routine protection provided under the Freedom of Information Act have been provided to respondents.

11. Questions of a Sensitive Nature:

The applicants are not asked to furnish any information of a sensitive nature.

12. Estimate of Burden

The total burden estimate for the reporting and recordkeeping requirements associated with this information collection is 12,800 hours. The burden estimates are broken down into three categories described in the pages that follow.

Notification 600

Development of Protocol 4,000

In-plant Trials 760

In-plant Monthly Data 7,440

Total 12,800 hours

Notification

FSIS estimates that it will take 8 hours for firms to complete a notification of intent to use new technology. 75 firms will annually respond once for a total of 600 hours.

NOTIFICATION OF NEW TECHNOLOGY

(68 FR 6873)

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Firms	75	1	75	480	600

Development of Protocols

The Agency estimates that it will take 80 hours to develop a protocol. Approximately, 50 firms once a year will develop a protocol for submission for a total of 4,000 hours.

DEVELOPMENT OF PROTOCOLS

(68 FR 6873)

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Firms	50	1	50	4,800	4,000

In-plant Trial Data Collection and Recordkeeping

The Agency estimates that 23 firms once a year will spend 33 hours collecting data and recordkeeping during the duration of the in-plant trial for a total of 760 hours.

In-Plant Trials

(68 FR 6873)

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Firms	23	1	23	1,983	760

In-plant Monthly Data Collection and Recordkeeping

The Agency estimates that 62 firms will spend 120 hours collecting data and recordkeeping annually for the duration of the waiver for a total of 7,440 hours.

In-Plant Monthly Data

(68 FR 6873)

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Firms	62	1	62	7,200	7,440

The cost to the respondents is estimated at $1,031,680 annually. The Agency estimates that it will cost respondents $80.60 an hour, including fringe benefits in fulfilling these information collection requirements. Respondents will spend an annual total of 12,800 hours and $1,031,680. The hourly rate for the respondents was attained from the Department of Labor Bureau of Labor and Statistics wage data, May, 2018.

13. Capital and Start-up Cost and Subsequent Maintenance

There are no capital and start-up costs and subsequent maintenance burdens.

14. Annual Cost to Federal Government and Respondents:

The cost to the Federal Government for these information collection requirements is $350,921 annually. The costs arise primarily from the time spent by FSIS staff reviewing notifications, protocol submissions, and in-plant data. The Agency estimates a cost of $45.35 per hour, including fringe benefits, for Agency personnel time.

15. Reasons for Changes in Burden:

There is no change in burden requested for this information collection renewal. Annually, there are 12,800 hours, 210 respondents, and 210 responses.

16. Tabulation, Analyses and Publication Plans:

There are no plans to publish the data for statistical use.

17. OMB Approval Number Display:

FSIS will display the OMB approval number on any instructions it publishes relating to recordkeeping activities.

18. Exceptions to the Certification:

There are no exceptions to the certification. This information collection accords with the certification in item 19 of the OMB 83-I.

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