ss

SUPPORTING STATEMENT - OMB NO. 0579-0214

IMPORTATION OF PORK-FILLED PASTA

December 2008

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.

Disease prevention is the most effective method for maintaining a healthy animal population and enhancing the ability of the United States to compete in the world market of animal and animal product trade.

The agency charged with carrying out this disease prevention mission is the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture. This agency regulates the importation of animals and animal products into the United States to guard against the introduction of exotic animal diseases.

The regulations under which APHIS conducts these disease prevention activities are contained in title 9, chapter 1, subchapter D, part 94 of the Code of Federal Regulations. These regulations 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. Section 94.12 deals specifically with the importation of pork and pork products from regions where swine vesicular disease (SVD) exists.

APHIS is asking OMB to approve, for an additional 3 years, its use of this information collection activity in connection with its efforts to ensure that pork-filled pasta from certain regions will pose a negligible risk of introducing SVD into the United States.

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.

Official Certificate

Pork-filled pasta arriving in the United States from regions affected with SVD must be accompanied by a certificate-issued by an official of the National Government of the region in which the pasta product was processed-stating that the product has been handled and processed according to APHIS requirements. This certificate must be completed and signed by the issuing official, and contains such information as 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 health 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 would provide important information in any trace-back investigation that may need to be conducted by officials of the region of origin, or by officials from the U.S. Department of Agriculture.

Cooperative Service Agreement (signature only)

Prior to 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 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 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 official 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.

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 exotic 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 effectively to ensure that pork-filled pasta from certain regions will pose a negligible risk of introducing SVD into the United States. APHIS has no small entities involved with 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 cripple 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 affects 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.

This 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 2008, APHIS engaged in productive consultations with the following individuals:

Weizhi Chen

Barilla America, Inc.

1200 Lakeside Drive

Bannockburn, IL 60015

847-405-7575

wchen@barilla-usa.com

Francesco Panto

Barilla G. e. R. Fratelli - s.p.A

43100 Parma PR - Italy

f.panto@barilla.it

Sebastiano Brancoli

Consultants International Group

1616 H Street, NW

Suite 400

Washington, DC 20006

t. 202.783.7000

f. 202.393.4655

sbrancoli@cig-dc.com

On Monday, July 28, 2008, pages 43675-43676, 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. No comments from the public were received.

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. However, the confidentiality of information is protected under 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 product is processed. APHIS estimates the total annualized cost to these respondents to be $85. APHIS arrived at this figure by multiplying the hours of estimated response time (2 hours) by the estimated average hourly wage of the above respondents ($42.50). APHIS determined the estimated hourly wage from discussions with its International contacts.

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 $50. (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.

Currently, there are no pork-filled pasta shipments being imported into the United States. Consequently, the burden for this collection has decreased to 3 burden hours. Italy, however, wants to maintain the opportunity to ship pork-filled pasta to the United States; therefore, APHIS is keeping its existing regulations to regulate these imports.

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.