Ss 0235-1

SUPPORTING STATEMENT - OMB NO. 0579-0235

CLASSICAL SWINE FEVER STATUS OF CHILE

November 27, 2006

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.

Title 21, U.S.C. authorizes sections 111, 114, 114a, 114-1, 115, 120, 121, 125, 126, 134a, 134c, 134f, and 134g of 21 U.S.C. These authorities permit the Secretary of the United States Department of Agriculture (USDA) to prevent, control and eliminate domestic diseases such as brucellosis, as well as to take actions to prevent and to manage exotic diseases such as classical swine fever and other foreign animal diseases.

More specifically, 21 U.S.C. 111, 151-158 authorizes the Secretary of Agriculture to take such measures as he/she may deem proper to prevent the introduction or dissemination of contagious or communicable diseases of animals or live poultry from a foreign country into the United States or from one State to another.

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

Veterinary Services, a program within USDA’s Animal and Plant Health Inspection Service (APHIS), is responsible for carrying out this disease prevention mission. This agency regulates the importation of animals and animal products into the U.S. to guard against the introduction of exotic animal diseases such as classical swine fever.

The regulations under which APHIS conducts these disease prevention activities are contained in Title 9, Chapter 1, Subchapter D, and Part 91 through 99 of the Code of Federal Regulations. These regulations govern the importation of animals, birds, and poultry, certain animal and poultry products, and animal germplasm.

To this end, these regulations place certain restrictions on the importation of swine, pork and pork products in order to prevent an incursion of classical swine fever or other exotic swine diseases into the U.S.

The importation of these commodities into the U.S., however, continues to pose an undue risk of introducing classical swine fever. This is because Chile supplements its pork supplies via the importation of fresh (chilled or frozen) pork from regions that are affected with classical swine fever, shares a common land border with such regions, or imports swine from such regions under conditions less restrictive than would be acceptable for importation into the U.S.

APHIS is asking OMB to approve, for 3 years, its use of this information collection activity in connection with APHIS’ efforts to ensure that swine, pork, and pork products from Chile pose a negligible risk of introducing classical swine fever into the U.S.

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.

Certificate for Live Swine, Pork and Pork Products from Chile

Swine, pork, and pork products from specified regions must be accompanied by a certificate issued by a salaried veterinary officer of the Government of Chile. The certificate must identify both the exporting region and the region of origin as a region designated in Sections 94.9 and 94.10 (Title 9, Code of federal Regulations) as free of classical swine fever at the time the swine, pork, or pork products were in the region.

In the case of live swine, the certificate must also state that (1) the swine have not lived in a region designated in Sections 94.9 and 94.10 as affected with classical swine fever; (2) the swine have never been commingled with swine that have been in a region that is designated in Sections 94.9 and 94.10 as affected with classical swine fever; (3) the swine have not transited a region designated in Sections 94.9 and 94.10 as affected with classical swine fever unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and (4) the equipment or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected in accordance with the requirements of Part 93.

In the case of pork and pork products, the certificate must identify the exporting region and the region of origin of the pork or pork products as a region designated in Sections 94.9 and 94.10 as free of classical swine fever at the time the pork or pork products were in the region.

This certification must also state that (1) the pork or pork products were derived from swine that were born and raised in a region designated in Sections 94.9 and 94.10 as free of classical swine fever and were slaughtered in such a region at a Federally inspected slaughter plant that is under the direct supervision of a full-time salaried veterinarian of the Government of Chile, and that the region id eligible to have its products imported into the U.S. under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the regulations of the USDA’s Food Safety Inspection Service in 9 CFR 327.2; (2) the pork or pork products were derived from swine that have not lived in a region that is designated in Sections 94.9 or 94.10 as affected with classical swine fever; (3) the pork or pork products have never been commingled with pork or pork products that have been in a region that is designated in Sections 94.9 and 94.10 as affected with classical swine fever; (4) the pork or pork products have not transited a region designated in Sections 94.9 and 94.10 as affected with classical swine fever unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the port of destination; and (5) if processed, the pork or pork products were processed in a region designated in Sections 94.9 and 94.10 as free of classical swine fever in a Federally inspected processing plant that is under the direct supervision of a full-time salaried veterinarian of Chile.

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 certification statements employed in this program must physically accompany the shipment to the U.S., and must contain an original signature from the authorizing veterinarian to be valid. Since the number of respondents and annual responses is so small, there are no plans to automate the completion of the certificate.

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 that APHIS collects is not available from any other source. APHIS is the only Federal Agency responsible for the introduction of exotic animal diseases into the U.S.

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

The information that APHIS is requiring on the certificate must be recorded and certified by Federal animal health authorities in Chile, not by individual exporters, shippers, or other entities involved with the exportation of swine, pork, and pork products into the U.S.

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 swine, pork, and pork products from Chile pose a minimal risk of introducing classical swine fever and other exotic animal diseases into the U.S. This would make a disease incursion event much more likely, with potentially devastating affects on the U.S. swine 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.

During 2006, APHIS engaged in productive consultations with the following individuals concerning the information collection activities associated with this program:

Jeff Schnell

Iowa Pork Producers Association

1636 NW 114 Street

Clive, IA 50325

(515) 225-7675

Beth Lautner

National Pork Board

1776 Northwest 114^th Street

Clive, IA 50325

515-223-2600

Paul Clayton

U.S. Meat Export Federation

1050 17^th Street, Suite 2200

Denver, CO 80265

303-623-6328

On Wednesday, November 8, 2006, pages 65451-65452, 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 Federal animal health authorities in Chile who will be completing the certificates necessary to export swine, pork and pork products to the U.S.

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

Respondents are full-time salaried veterinary officers employed by the Government of Chile. APHIS estimates the total annualized cost to these respondents to be $1657.00 APHIS arrived at this figure by multiplying the hours of estimated response time (50 hours) by the estimated average hourly wage of the above respondents ($33.14).

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 $1952.25. (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.

There is an adjustment of 25 hours due to the number of respondents increasing from 5 to 10 due to an increasing number of imports from Chile.

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.

There are no forms associated with this information collection.

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

APHIS can certify compliance with all provisions under the Act.

B. Collections of Information Employing Statistical Methods

There are no statistical methods associated with the information collection activities used in this program.