Icr Amr2014

ICR AMR2014.doc

Advanced Meat Recovery Systems

OMB: 0583-0130

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SUPPORTING STATEMENT JUSTIFICATION FOR

ADVANCED MEAT RECOVERY SYSTEMS


1. Circumstances Making Collection Of Information Necessary:


This information collection requests an extension of the information collection of burden hours which addresses the regulatory requirements in production of meat from Advanced Meat Recovery systems.

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.). This statute mandates that FSIS protect the public by ensuring that meat products are safe, wholesome, unadulterated, and properly labeled and packaged.


FSIS requires that official establishments that produce meat from AMR systems ensure that bones used for AMR systems do not contain brain, trigeminal ganglia, or spinal cord; to test for calcium (at a different level than previously required), iron, spinal cord, and dorsal root ganglia (DRG); to document their testing protocols, to assess the age of cattle product used in the AMR system, and to document their procedures for handling product in a manner that does not cause product to be misbranded or adulterated; and to maintain records of their documentation and test results (9 CFR 318.24).


2. How, By Whom and Purpose Information Is To Be Used:


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


Official establishments that produce meat from AMR systems must ensure that bones used for AMR systems do not contain brain, trigeminal ganglia, or spinal cord; test for calcium (at a different level than previously required), iron, spinal cord, and dorsal root ganglia (DRG); document their testing protocols, to assess the age of cattle product used in the AMR system; and document their procedures for handling product in a manner that does not cause product to be misbranded or adulterated, and to maintain records of their documentation and test results. This testing and recordkeeping is necessary for establishments to ensure (and for FSIS to verify) that the meat product produced by the use of AMR systems is free from Bovine Spongiform Encephalopathy (BSE).



There are a total of 25,209 burden hours for the information collection requests relating to AMR systems for meat products.


3. Use Of Improved Information Technology:


Under the Government Paperwork Elimination Act, 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 USDA agency, or any other Government agency, requires information regarding exportation, transportation and importation of meat and poultry products. 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 establishments producing meat product using AMR systems. FSIS estimates that there are 56 small establishments affected by this information collection.


6. Consequences If Information Were Collected Less Frequently:


To conduct the information collections less frequently will reduce the effectiveness of the meat and poultry 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.


To ensure that meat produced under AMR systems is free of BSE, testing must be conducted at least daily. 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 (79 FR 4321; January 27, 2014). There was one comment received not relevant to the information collection. The Agency also contacted a trade association (Lloyd Hontz, 202/639-5924) that solicited comments from a few of its members on this information collection. None had any comments to make.



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 25,209 hours. The burden estimates are described in the pages that follow.


Total 25,209 hours


It will take establishments an average of 180 minutes to develop written procedures, including testing protocols. FSIS estimates that 3 new establishments will respond one time for a total of 3 times and 9 hours.



DEVELOP WRITTEN PROCEDURES

(9 CFR 318.24)



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


AMR Ests.


3


1


3


180


9


The Agency estimates that it takes 30 minutes to test for calcium and iron. Approximately 56 establishments a year will respond 300 times for a total of 16,800 responses and 8,400 hours.



TEST FOR CALCIUM & IRON

(9 CFR 318.24)


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


AMR Ests.


56


300


16,800


30


8,400



The Agency estimates that it takes 30 minutes to test for spinal cord and dorsal root ganglia (DRG). Approximately 56 establishments a year will respond 300 times for a total of 16,800 responses and 8,400 hours.


TEST FOR SPINAL CORD & DRG

(9 CFR 318.24)


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


AMR Ests.


56


300


16,800


30


8,400







FSIS estimates that 56 establishments will respond 300 times a year in recording procedures in handling AMR livestock for a total of 16,800 responses. It will 30 minutes per response for a total of 8,400 hours.



PROCEDURES RECORDKEEPING

(9 CFR 318.24)


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


AMR Ests.


56


300


16,800


30


8,400



The cost to the respondents is estimated at $957,942 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 25,209 hours and $957,942.


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 $114,000 annually. The costs arise primarily from the inspection review duties necessary to verify that establishments comply with the information collection responsibilities. The cost estimate includes records review time of FSIS inspection personnel (GS 7/9/11) and staff officers (GS 11/12). The Agency estimates a cost of $38 per hour for inspector time.


15. Reasons For Changes In Burden:


There is no change in the burden of 25,209 hours; this is a request for an extension of the currently approved information collection.


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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File Modified2014-03-28
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