Ss 0070

SUPPORTING STATEMENT 0579-0070

PSEUDORABIES

October 1, 2007

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 7, U.S.C. 8301, The Animal Health Protection Act, authorizes the Secretary of the U.S. Department of Agriculture (USDA) to take such measures as deemed proper to prevent the introduction or dissemination of any contagious or communicable disease of animals and/or live poultry from a foreign region into the United States or from one State to another.

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

Veterinary Services, a program within USDA's Animal and Plant Health Inspection Service (APHIS), is responsible for administering regulations intended to prevent the dissemination of pseudorabies within the United States. These regulations are found in Part 85, Title 9, Code of Federal Regulations.

APHIS’ pseudorabies regulations were adopted on February 16, 1979. Their intent is to control and stop the spread of pseudorabies, which is a herpes virus disease that affects many species of animals (although the only known reservoir for the disease is swine).

In swine, pseudorabies has many of the characteristics of herpes infections in other animals, including humans. Older hogs usually survive infection, but they remain latently infected carriers of the virus. Swine that have become infected will remain serologically positive for the remainder of their lives. Their offspring, if managed properly, can grow up to be negative. Vaccine has played a role in managing infected herds, and does give some protection to negative swine. However, vaccination alone will not eradicate the disease.

The most common method of pseudorabies transmission is via the movement of infected swine from one herd to another. APHIS’ pseudorabies regulations in Part 85 are designed to reduce the interstate spread of pseudorabies by ensuring that interstate movement of infected and exposed swine is carefully controlled.

Regulating the interstate movement of swine requires the use of certain information gathering activities (such as permits, certificates, and owner-shipper statements) that enables APHIS to ascertain the health status of the swine being moved, the number of swine being moved in a particular shipment, the shipment's point of origin, the shipment's destination, and the reason for the interstate movement.

These important documents also provide APHIS with critical information concerning a shipment's history, which in turn enables APHIS to engage in swift, successful traceback investigations when infected swine are discovered.

The information provided by these documents is critical to APHIS’ ability to prevent the interstate spread of pseudorabies, which is capable of causing significant economic harm to the U.S. swine industry.

APHIS is therefore asking OMB to renew its approval of these information gathering activities for an additional 3 years.

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.

Permit to Move Restricted Animals (VS Form 1-27)

Persons desiring to move pseudorabies-infected, exposed, or vaccinated swine interstate must apply for a permit to do so. The application for permit must include the following information: (1) the number of swine to be moved, (2) the purpose for which the swine are to be moved, (3) the shipment's point of origin and destination, and the name and address of the consignor and consignee. The permit alerts APHIS that a shipment of infected or exposed animals is occurring, and thus allows APHIS to carefully monitor this activity.

Certificate

Persons desiring to move swine interstate that are not known to be infected with or exposed to pseudorabies, and are not pseudorabies vaccinated, must be issued a certificate that contains the following information: (1) the number and description of the swine to be moved, (2) a statement that the swine are not known to be infected or exposed to pseudorabies, (3) the purpose for which the swine are to be moved, (4) the shipment's point of origin and destination, and (5) the name and address of the consignor and consignee.

Owner-Shipper Statement

Swine not vaccinated for pseudorabies and not known to be infected with or exposed to pseudorabies can be moved interstate if accompanied by an owner-shipper statement and are moved from their farm of origin to an approved livestock market. The owner-shipper statement is signed by the owner or shipper of swine, and contains: (1) the number of swine to be moved, (2) the points of the shipment's origin and destination, and (3) the name and address of the consignor and consignee. The owner-shipper statement is not an official form; the statement can, in fact, be written on any piece of paper as long as it contains the necessary information. It should also be noted that not all owner-shipper statements are collected or inspected. These statements are usually inspected on a spot-check basis only, or during an actual outbreak.

Accredited Veterinarian's Statement Concerning Embryos for Implantation and Semen Shipments

Swine semen and swine embryos moved interstate for insemination of swine or implantation into swine must be accompanied by an accredited veterinarian's statement, written on a State-issued certificate, attesting to the health status and freedom from pseudorabies of donor swine contributing semen or embryos for interstate movement.

Mailing Interstate Movement Documents

A copy of any permits or certificates issued in connection with APHIS’ pseudorabies program must be mailed or delivered to the State animal health official of the State of destination by the individual issuing the document (either an APHIS employee, State animal health official, or accredited veterinarian) within 3 days of the date the animals are moved interstate. This ensures that animal health protection authorities in the State of destination are aware that the shipment is occurring.

Monthly Report of Pseudorabies Control/Eradication Activities (VS Form 7-1)

APHIS requires this report to be completed quarterly by each State receiving Federal pseudorabies funding. This is the basis for the national eradication program management report and provides both State and Federal program administrators with critical program data such as the number of pseudorabies-infected herds in each State, and the number of herds vaccinated for pseudorabies. It is imperative that APHIS have this basic data available in order to report program progress to Congress as well as to leadership within the swine industry.

Additionally, this information is essential to the overall management of APHIS National Pseudorabies Eradication Program. This is the most efficient and reliable means of collecting the data needed. The compiling of this report has been approved and deemed necessary by all major animal health and associated swine industry organizations.

All of the forms described above enable APHIS to collect information showing when, where, and why swine are being moved interstate. This information is not only critical to APHIS’ ability to carefully monitor these movements, but also to APHIS’ ability to trace disease outbreaks to their source. Without the information collected with the assistance of these forms, APHIS’ ability to rapidly locate and eradicate pseudorabies outbreaks would be severely compromised.

Recordkeeping

The records to be retained are the VS Form 7-1, Quarterly Report of Pseudorabies Control/Eradication Activities, completed by each State receiving Federal pseudorabies funding. The records are needed to verify that management of APHIS’ national pseudorabies program is efficient and a reliable source of data reported to Congress. The records must be maintained for 3 years.

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 major information collection component of this program, including the Permit for Movement of Restricted Animals (VS 1-27) are serially numbered and is therefore not conducive to an electronic format. Electronic submission of Certificates of Veterinary Inspection (CVI’s) is being developed by VS and private entities, but is still not in widespread use in the field.

The Monthly Report of Pseudorabies Control/Eradication Activities (VS 7-1) can be submitted electronically through the generic database or via the Automated Web-Based Data System (AWBDS). The two available data submissions systems were developed by State and Federal animal health programs for data collection and management.

The owner-shipper statement is not available electronically. Owner-shipper statements are not official VS forms. These forms are created on an as-needed basis by the swine herd owner or shipper, and are usually collected or inspected on a spot-check basis only, or during an actual outbreak.

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 in connection with the pseudorabies program is exclusive to its mission of regulating the interstate movement of swine to prevent the spread of swine diseases, and is not available from any other source. Both Federal and State personnel work closely together to administer this program. The program has therefore been carefully designed to avoid duplication of information-gathering efforts.

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 is the minimum needed to ensure that pseudorabies is not spread to healthy swine herds via the interstate movement of infected animals. Burden is minimized by the fact that more and more swine are now being moved interstate within swine production systems, and are therefore exempt from certain information collection requirements normally associated with APHIS’ pseudorabies prevention efforts.

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.

Failing to collect this information would severely cripple APHIS’ ability to monitor and control the interstate movement of swine that could potentially spread pseudorabies to healthy animals.

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 2007, APHIS engaged in productive consultations with the following individuals concerning the information collection activities associated with this program:

Paul Sundberg

National Pork Board

1776 Northwest 114th Street

Clive, Iowa 50325

515-223-2600

[email protected]

David Preisler

Minnesota Pork Producers Association

360 Pierce Avenue, Suite 106

North Mankato, Minnesota 56003

(507) 345-8814

[email protected]

Dr. Thomas Burkgren

American Association of Swine Veterinarians

902 1st Street

Perry, Iowa 50220

515-465-5255

[email protected]

On Friday, July 13, 2007, pages 38553 - 38554, APHIS published in the Federal Register, a 60-day notice seeking public comments on its plans to request a 3-year extension of this information collection. There was one comment received it did not pertain to paperwork burden.

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 swine shippers; swine herd owners, State animal health protection authorities, and accredited veterinarians.

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

APHIS estimates the total annualized cost to the above respondents to be $93,750.00 APHIS arrived at this figure by multiplying the hours of estimated response time (3,125 hours) by the estimated average hourly wage of the above respondents ($30.00).

$30.00 hourly rate is derived from the U.S. Department of Labor, Bureau of Labor Statistics June 2003 Report – National Compensation Survey; Occupational Wages in the United States, July 2002. See http://www.bls.gov/ncs/ocs/sp/ncb10539.pdf.

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 $92,961.71. (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.

All States are now in Stage 5 (free status); therefore, owner-shipper statements are no longer used unless special circumstances require its use (e.g., an outbreak of pseudorabies virus in “transitional swine” affecting nearby commercial herd risk). In addition, there is a decrease in accredited veterinary statements concerning embryos and semen as well. There is a decrease of -5442 hours due to a major decrease in owner/shipper statement. This decrease resulted in a decrease in burden on the public; thereby decreasing the cost to the public.

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.

If forms were to be discarded because of an outdated OMB expiration date, but otherwise usable, higher printing costs would be incurred by the Federal Government. Therefore, APHIS is seeking approval to not display the OMB expiration date on its forms.

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

APHIS can certify compliance with all provisions of the Act.

B. Collections of Information Employing Statistical Methods

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