2012 ss 0214

SUPPORTING STATEMENT - OMB NO. 0579-0214

IMPORTATION OF PORK-FILLED PASTA

November 2011

A. Justification

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict import or export of any animal or related material if necessary to prevent the spread of any livestock or poultry pest or disease. The AHPA is contained in Title X, Subtitle E, Sections 10401-18 of P.L. 107-171, May 13, 2002, the Farm Security and Rural Investment Act of 2002.

The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture protects the health of the U.S. livestock and poultry populations by preventing the spread of contagious, infectious, or communicable animal diseases (such as Swine Vesicular Disease (SVD)) and for eradicating such diseases from the United States when feasible. Disease prevention is the most effective method for maintaining a healthy animal population and for enhancing the U.S. ability to compete in the world market of animal and animal product trade.

SVD is a highly contagious disease that resists both environmental factors and common disinfectants. SVD rarely results in mortality in infected swine and does not cause severe production losses. However, the disease can have a major economic impact since eradication is costly and SVD-free regions often prohibit imports of swine, pork, and pork products from affected regions.

APHIS regulations in title 9 of the Code of Federal Regulations (CFR), part 94, prohibit or restrict the importation of specified animals and animal products into the United States to prevent the introduction into the U.S. livestock population of certain contagious animal diseases, including SVD. Section 94.12(c) contains specific requirements for the processing, recordkeeping, and certification procedures for pork-filled pasta products exported to the United States from SVD-affected regions. These regulations are designed to ensure that these products are properly processed, and that no commingling occurs with products that are ineligible to enter the United States.

APHIS is asking the Office of Management and Budget to approve this collection for an additional 3 years. These information activities include an export certificate, recordkeeping, and a cooperative service agreement.

2. Indicate how, by whom, how frequently, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

APHIS uses the following information activities associated with its efforts to prevent an SVD incursion into the United States.

Export Certificate

Pork-filled pasta arriving in the United States from regions affected with SVD must be accompanied by an export certificate. An official of the National Government of the region in which the pasta product was processed completes and signs the certificate. The certificate states that the product has been handled and processed according to APHIS requirements. The official records the origin of the meat used in the product, the name and location of the facility that processed the product, and the product’s intended destination.

Recordkeeping

Pork-filled pasta destined for the United States from a region affected with SVD must be processed in an establishment in which an individual, authorized by Veterinary Services of the region’s National Government, maintains original records (to be kept for a minimum of 2 years) identifying the pork by the date it entered the facility, the lot number, the export certificate that accompanied the pork from the slaughter/processing facility to the meat-filled pasta processing facility; and the date the pork began either dry-curing or cooking. These records will provide important information in any traceback investigation that may need to be conducted by officials of the region of origin, or by APHIS officials.

Cooperative Service Agreement

Before receiving pork intended to be used in pork-filled pasta products destined for the United States, the operator of the foreign processing establishment must first enter into a cooperative service agreement with APHIS. Under this agreement, the establishment agrees to (1) process its pork in accordance with APHIS regulations; (2) allow the unannounced entry into the establishment of APHIS representatives for the purpose of inspecting the facilities, operations, and records of the establishment; and (3) pay for the costs associated with these inspections. A copy of the cooperative service agreement is attached to this collection.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

The export certificate used in this importation program is completed and signed in the country of origin. It is not a Veterinary Services form, but a document issued by a foreign government. This export certificate requires an original signature from the issuing official and must physically accompany the shipment to the United States; therefore, it is not a candidate for electronic submission. Also, the cooperative service agreement requires an original signature and, therefore, cannot be submitted electronically.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purpose described in item 2 above.

The information APHIS collects in connection with this program is not available from any other source. APHIS is the only Agency responsible for preventing the introduction of foreign animal diseases into the United States.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

The information APHIS is collecting in connection with this program is the absolute minimum needed to ensure that pork-filled pasta from certain regions will pose a negligible risk of introducing SVD into the United States. No small businesses or other small entities will be affected by this information collection.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

If the information was collected less frequently or not collected at all, it would significantly hinder APHIS’ ability to ensure that pork-filled pasta from certain regions pose a minimal risk of introducing SVD into the United States. This would make a disease incursion event much more likely, with potentially devastating effects on the U.S. pork industry.

7. Explain any special circumstances that require the collection to be conducted in a manner inconsistent with the general information collection guidelines in 5 CFR 1320.5.

• 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.

The information collection is conducted in a manner consistent with the guidelines established in

5 CFR 1320.5.

8. Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting form, and on the data elements to be recorded, disclosed, or reported. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, soliciting comments on the information collection prior to submission to OMB.

In 2011, APHIS engaged in productive consultations with the following individuals:

David Largey

Barilla America, Inc.

1200 Lakeside Drive

Bannockburn, IL 60015

David.Largey@barilla.com

Telephone: 847-405-7575

Jeff Schnell

Iowa Pork Producers Association

1636 Northwest 114^th Street

Clive, IA 50325

paul.sunberg@porkboard.org

Telephone: 515-223-2600

David Preisler

Minnesota Pork Producers Association

360 Pierce Avenue, Suite 106

North Mankato, MN 56003

davidp@hickorytech.net

Telephone: (507) 345-8814

On Tuesday, March 13, 2012, pages 14724 - 14725, APHIS published in the Federal Register, a

60-day notice seeking public comments on its plans to request a 3-year renewal of this collection of information. During that time, APHIS received no comments.

9. Explain any decision to provide any payment or gift to respondents, other than reenumeration of contractors or grantees.

This information collection activity involves no payments or gifts to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

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. Provide additional justification for any questions of a sensitive nature, such as sexual behavior or attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

This information collection activity will ask no questions of a personal or sensitive nature.

12. Provide estimates of the hour burden of the collection of information. Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated.

•Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13 of OMB Form 83-I.

See APHIS Form 71. Burden estimates were developed from discussions with officials of National Governments of regions in which pork-filled pasta products are processed and intended for import into the United States.

•Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories.

Respondents are officials of the National Government of the region in which the pork-filled pasta is processed and operators of pasta facilities. APHIS estimates the total annualized cost to these respondents to be $116.22. APHIS arrived at this figure by multiplying the hours of estimated response time (3 hours) by the estimated average hourly wage of the above respondents ($38.74).

National Government Officials – $42.50 [Discussions with APHIS international contacts]

Operators of Pasta Facility – $34.97 [http://www.bls.gov/fls/country/italy.htm]

13. Provide estimates of the total annual cost burden to respondents or recordkeepers resulting from the collection of information, (do not include the cost of any hour burden shown in items 12 and 14). The cost estimates should be split into two components: (a) a total capital and start-up cost component annualized over its expected useful life; and (b) a total operation and maintenance and purchase of services component.

There is zero annual cost burden associated with capital and start-up costs, operation and maintenance expenditures, and purchase of services.

14. Provide estimates of annualized cost to the Federal government. Provide a description of the method used to estimate cost and any other expense that would not have been incurred without this collection of information.

The annualized cost to the Federal government is estimated at $116. (See APHIS Form 79.)

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB Form 83-1.

ICR Summary of Burden:

	Requested	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses	3	0	0	0	0	3
Annual Time Burden (Hr)	3	0	0	0	0	3
Annual Cost Burden ($)	0	0	0	0	0	0

There is no change in burden for this 3-year renewal information collection.

16. For collections of information whose results are planned to be published, outline plans for tabulation and publication.

APHIS has no plans to publish information it collects in connection with this program.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

No forms are used in this collection.

18. Explain each exception to the certification statement identified in the "Certification for Paperwork Reduction Act."

APHIS can certify compliance with all provisions of the Act.

B. Collections of Information Employing Statistical Methods

Statistical methods are not employed in this information collection activity.