supporting statement A swine slaughter final rule 01012020

SUPPORTING STATEMENT JUSTIFICATION FOR

MODERNIZATION OF SWINE SLAUGHTER INSPECTION

1. Circumstances Making Collection of Information Necessary:

This is a request for a new information collection related to the proposed rule for Modernization of Swine Slaughter Inspection.

The Food Safety and Inspection Service (FSIS) FSIS has been delegated the authority to exercise the functions of the Secretary (7 CFR 2.18, 2.53) as specified in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq.). This statute mandates that FSIS protect the public by ensuring that meat products are safe, wholesome, unadulterated, and properly labeled and packaged.

FSIS amended the Federal meat inspection regulations to establish a new inspection system for market hog slaughter establishments that has been demonstrated to provide equivalent or greater public health protection than the existing inspection system. The Agency also made several changes to the regulations that would affect all establishments that slaughter any swine, regardless of the inspection system under which they operate or the age, size, or class of swine. These changes allow all swine slaughter establishments to develop sampling plans that are more tailored to their specific operations, and thus be more effective in monitoring their specific process control. These changes also ensure that before the start of slaughter operations, food-contact surfaces are sanitary and free of enteric pathogens.

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.

FSIS requires that all swine slaughter establishments develop sampling plans that are more tailored to their specific operations. All establishments operating under the New Swine Slaughter Inspection System (NSIS) must monitor their systems through microbial testing and recordkeeping. For each sample on which a microbiological test is conducted, there are two “responses” for the establishment: one response for the actual collecting of the sample and sending it to the laboratory for analysis, and the other for recording the sample result. Under the final rule, large establishments must test and record microbiological results for enteric pathogens, at both pre-evisceration and post-chill, 13 times a day; small high-volume establishments, one-time a day; and small low-volume and very small establishments, 13 times a year. FSIS estimates that large establishments would test and record microbial results for the pre-operational environment weekly; small establishments, biweekly; small low-volume and very small establishments, monthly. Furthermore, all swine slaughter establishments operating must maintain records that document that the products resulting from its slaughter operations meet the definition of RTC pork products.

FSIS also requires that each establishment operating under the NSIS submit on an annual basis an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a program to monitor and document any work-related conditions of establishment workers.

3. Use of Improved Information Technology:

Under the E-Gov Act, firms may keep records electronically provided that appropriate controls are implemented to ensure the integrity of the electronic data.

4. Efforts to Identify Duplication:

No other Government agency requires information regarding enteric pathogens in official swine slaughter establishments. 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 official swine slaughter establishments. FSIS estimates that 57 small establishments are subject to this information collection.

6. Consequences If Information Were Collected Less Frequently:

To conduct the information collections less frequently will reduce the effectiveness of the swine slaughter 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.

Establishments are required to collect and record data more frequently that quarterly. There are no other circumstances that would cause the guidelines above not to be met by this information collection.

8. Consultation with Persons Outside the Agency:

In accordance with the Paperwork Reduction Act, FSIS embedded a 60-day notice in the proposed rule that published in the Federal Register on February 1, 2018, requesting comments regarding this information collection. FSIS reviewed all relevant comments and is making the necessary changes to propose a revision to this information collection. FSIS published an additional 60-day notice with this final rule on October 1, 2019 (84 FR 52300) and plans to request a revision to this information collection once the public comment period closes.

9. Payment or Gifts to Respondents:

Respondents will not receive any gifts or payments.

10. Confidentiality Provided to Respondents:

No additional assurance of confidentiality is provided with this information collection. Any and all information obtained in this collection shall not be disclosed except in accordance with 5 U.S.C.552a.

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 4,347.3 hours.

FSIS estimates that a total of 74 establishments would record the results of a micro test an average of 1,051 times annually for a total of 3,240 hours.

MICROBIAL TESTING DATA RECORDKEEPING

(9 CFR 310.18)

Type of Establish- Ment	No. of Respon-dents	Average No. of Res- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Large	17	3,869	65,773	2.5	2,741
Small (high vol)	51	229	11,679	2.5	487
V. Small (high vol)	6	52	312	2.5	13
Total	74	1,051	77,764	2.5	3,240

FSIS estimates that a total of 40 respondents would provide attestations on work-related conditions 40 times annually for a total of 1.33 hours.

ATTESTATION OF WORK-RELATED CONDITIONS

	Estimated No. of Respon-dents	No. of Res- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Large	27	1	27	2	.90
Small (high vol)	13	1	13	2	.43
Total	40	1	40	2	1.33

FSIS estimates that a total of 40 respondents would complete FSIS Form 6200-2, 13,274 times annually for a total of 1,106 hours.

FSIS FORM 6200-2

ESTABLISHMENT SORTING RECORD

	Estimated No. of Respon-dents	No. of Res- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Large	27	352	9504	5	792
Small (high vol)	13	290	3770	5	314
Total	40	332	13,274	5	1,106

The cost to the respondents is estimated at $192,803 annually. The Agency estimates that it will cost respondents $44.35 an hour, including fringe benefits, in fulfilling these reporting and recordkeeping requirements. Respondents will spend an annual total of 4,347.3hours and $192,803. 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 $73,622 annually.

15. Reasons for Changes in Burden:

There is a reduction in the burden estimate for this information collection from 610 respondents to 84 respondents, 452,207 responses to 91,078 responses, and 57,077 hours to 4,348 hours. The reduction is due to the procedures for sampling and analysis for microbial organisms being removed because it is already covered in an approved information collection for HACCP systems (0583-0103).

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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