ICRModPltrySlghtr2014

SUPPORTING STATEMENT JUSTIFICATION FOR

MODERNIZATION OF POULTRY SLAUGHTER INSPECTION

1. Circumstances Making Collection of Information Necessary:

This information collection requests a new information collection related to the Modernization for Poultry Slaughter Inspection rule.

The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the functions of the Secretary as provided in the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.). This statute mandates that FSIS protect the public by ensuring that poultry products are safe, wholesome, unadulterated, and properly labeled and packaged.

FSIS is requiring that all poultry slaughter establishments develop, implement, and, maintain, as part of their HACCP plans, or Sanitation SOPs, or other prerequisite programs written procedures to prevent contamination of carcasses and parts by enteric pathogens, e.g., Salmonella and Campylobacter, and fecal material throughout the entire slaughter and dressing operation. FSIS is requiring that these procedures must include sampling for microbial organisms at the pre-chill and post-chill points in the process to monitor establshments’ process control for enteric pathogens, except low volume poultry establishments would only be required to test at post-chill.

Poultry establishments would also need to record the results of their microbial sampling and maintain the records of the results as supporting documentation as required by their HACCP, Sanitation SOP, or prerequisite program.

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 is requiring that all poultry slaughter establishments develop, implement, and, maintain, as part of their HACCP plans, or Sanitation SOPs, or other prerequisite programs written procedures to prevent contamination of carcasses and parts by enteric pathogens, e.g., Salmonella and Campylobacter, and fecal material throughout the entire slaughter and dressing operation. FSIS is requiring that these procedures must include sampling for microbial organisms at the pre-chill and post-chill points in the process to monitor establshments’ process control for enteric pathogens, except for low volume establishments that would be required to test only at post-chill.

Poultry establishments would also need to record the results of their microbial sampling and maintain the records of the results as supporting documentation as required by their HACCP, Sanitation SOP, or prerequisite program.

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 poultry 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 poultry establishments. FSIS estimates that 138 small establishments will be 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 poultry 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.

Establishments will be 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 January 27, 2012, requesting comments regarding this information collection. FSIS received one comment related to the information collection.

Center for Science in the Public Interest commented that the estimate that the Agency gave to the frequency of sampling among large, small, and very small establishments in the Paperwork Reduction Act section of the proposed rule did not contain information about how FSIS developed these estimates. These estimates were based on the frequency with which establishments operating under a SIP waiver conduct sampling. Under SIP, FSIS grants establishments a waiver of regulations under the condition that the establishment provides collects and analyzes samples for microbial organisms and shares the results with FSIS. The Agency is revising the rule to prescribe a minimum frequency with which all establishments that slaughter poultry will need to conduct testing for microbial organism to monitor their process control procedures. Thus, FSIS has updated its paperwork burden estimates to reflect these changes.

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 191,204.27 hours.

FSIS estimates that a total of 289 establishments would conduct a micro test 764,594 times annually for a total of 159,338 hours.

MICROBIAL TESTING

(9 CFR 381.36(c))

Type of Establish- Ment	No. of Respon-dents	No. of Res- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Large	151	4,322.7	652,734	12.5	135,986
Small	84	1,318	110,711	12.5	23,065
V. Small	54	21.3	1,150	15	288
Total	289		764,594		159,339

FSIS estimates that a total of 289 establishments would record the results of a micro test 764,594 times annually for a total of 31,858 hours.

MICROBIAL TESTING DATA RECORDKEEPING

(9 CFR 381.36 (c))

Type of Establish- Ment	No. of Respon-dents	No. of Res- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Large	151	4,322.7	652,773	2.5	27,197
Small	84	1,318	110,712	2.5	4,613
V. Small	54	21.3	1,134	2.5	48
Total	289		764,594	2.5	31,858

FSIS estimates that 219 establishments would record the attestation of work-related conditions 219 times annually, for a total of 7.27 hours.

ATTESTATION OF WORK-RELATED CONDITIONS

Respondents: Establishments Operating under the NPIS		Estimated No. of Re-spondents	Average Annual No. of Re-sponses per Respondent	Total Annual Re-sponses	Time per Re-sponse in Minutes	Total Annual Burden Hours
Large establishments	Attestation on Work-Related Conditions	149	1	149	2	4.97
Small establishments	Attestation on Work-Related Conditions	70	1	70	2	2.3
Very small establishments		0	0	0		0
	Total Reporting Burden	219	1	219		7.27

The cost to the respondents is estimated at $7,265,762 million annually. The Agency estimates that it will cost respondents $38 an hour in fulfilling these paperwork and recordkeeping requirements. Respondents will spend an annual total of 191,204.27 hours and $7,265,762

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 $380,000 annually. The Agency estimates a cost of $38 per hour.

15. Reasons for Changes in Burden:

This is a new information collection. Between the proposed rule and the final rule, the burden hours and responses have decreased hours due to a reduction in sampling.

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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