ICRApplicationsupportingstatementforALcontactupdatesheet111213

SUPPORTING STATEMENT JUSTIFICATION FOR

ACCREDITED LABORATORY PROGRAM ANNUAL CONTACT UPDATE

1. Circumstances Making Collection Of Information Necessary:

This is a new information collection application for accredited laboratories related to meat, poultry, and egg products inspection.

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, poultry, and egg products are wholesome, not adulterated, and properly labeled and packaged.

FSIS requires FSIS accredited non-Federal analytical laboratories to maintain certain paperwork and records. The Agency uses this collected information to ensure that all meat and poultry establishments produce safe, wholesome, and unadulterated product, and that non-federal laboratories accord with FSIS regulations.

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

FSIS will use the Annual Contact Update to maintain necessary information for responsibly connected personnel at the laboratories (see 9 CFR 439.20 (e) and 9 CFR 439.1 (w)). The completed Annual Contact Update form will also inform the Agency if a laboratory, or responsibly connected person or entity, has been charged, indicted, or convicted or any crime listed in 9 CFR 439.52. If a laboratory, or responsibly connected person or entity, has been convicted of such a crime, FSIS will revoke the laboratory’s accreditation (9 CFR 439.53).

3. Use Of Improved Information Technology:

Under the Government Paperwork Elimination Act, FSIS is offering electronic versions of FSIS Form 10,000-11. Records may be maintained electronically provided that appropriate controls are implemented to ensure the integrity of the electronic data. The Agency estimates that 100% of the paperwork and recordkeeping will be done electronically.

4. Efforts To Identify Duplication:

No USDA agency, or any other Government agency, requires information regarding application for inspections, registration, exemptions, or accreditation of laboratories relating to meat, poultry, and egg 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. There are 60 small businesses.

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;

To maintain food safety, certain forms and recordkeeping requirements in this information collection will be done more 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.

There are no additional exceptions to the certification.

8. Consultation With Persons Outside The Agency:

In accordance with the Paperwork Reduction Act, FSIS published a 60-day notice in the Federal Register (78 FR 23898) on April 23, 2013, requesting comments regarding this information collection request. FSIS received no comments.

FSIS did contact three laboratory participants for input on the amount of time that would be required for use of the form. One laboratory (Chantilly Reddmann; 225-342-5812) stated that it would take less than 30 minutes to complete and return the form. Another laboratory (Cindy Pownell; 317- 564-3680 x 7234) stated it took 15 minutes to complete and return the form. A third laboratory partipant (Stephen Ramsey; 229-336-7216) stated it would take 15 minutes.

In response to these comments, the Agency changed its estimate of how long it takes to complete an Annual Contact Update from 30 to 15 minutes. And FSIS changed its annual estimate of burden from 30 hours to 15 hours.

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 30 hours.

FSIS estimates that 60 respondents will spend 15 minutes completing this form once a year for a total of 60 responses and 15 hours.

The annualized cost to the above respondents ($344.85) was calculated by multiplying their estimated average hourly wage ($22.99) (laboratory technicians) by the number of hours (15). The hourly rate is derived from the U.S. Department of Labor; Bureau of Statistics May 2012 Report - Occupational Employment and Wages in the United States. See http://www.bls.gov/news.release/pdf/ocwage.pdf .

ACCREDITED LABORATORY PROGRAM ANNUAL CONTACT UPDATE

(9 CFR 439.20 and 9 CFR 439.1/FSIS Form 10,000-11)

Type of Establishment	No. of Respondents	No. of Re- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Accredited Labs	60	1	60	15	15

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 ­­­­$111.00 annually. The costs arise primarily from the review duties necessary to verify that laboratories comply with the information collection responsibilities. The Agency estimates a cost of $37 per hour for inspector time.

15. Reasons For Changes In Burden:

This is a new information collection of 15 burden hours.

16. Tabulation, Analyses And Publication Plans:

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

17. OMB Approval Number Display:

The OMB approval number will appear on required FSIS Forms.

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.

Page 6