SS 0127 Communicable Diseases in Horses (EIA)

SUPPORTING STATEMENT – OMB NO. 0579-0127

COMMUNICABLE DISEASES IN HORSES

August 2, 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 21, U.S.C. 117 Animal Industry Act of 1884 authorizes the Secretary to prevent, control and eliminate domestic diseases such as equine infectious anemia, as well as to take actions to prevent and to manage exotic diseases such as contagious equine metritis and other foreign animal diseases.

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.

United States Department of Agriculture (USDA) regulations for governing the interstate movement of animals for the purpose of preventing the dissemination of equine infectious anemia and other animal diseases within the United States are contained in Title 9 of the Code of Federal Regulations, Subchapter C --”Interstate Transportation of Animals (Including Poultry) and Animal Products.”

APHIS’ regulations at 9 CFR 75.4 deals specifically with regulating the interstate movement of horses affected with equine infectious anemia (EIA).

Veterinary Services, a program within USDA's Animal and Plant Health Inspection Service (APHIS), is responsible for administering these and other regulations intended to ensure that horses affected with EIA are moved interstate in a way that does not endanger the health of the U.S. equine population.

Ensuring the safe movement of these horses requires APHIS to engage in a number of information collection activities (including the completion of official tests) that are described below.

APHIS is asking OMB to approve, for an additional 3 years, its use of these information collection activities in connection with its program to prevent the spread of EIA within the U.S. equine population.

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 for the Movement of Restricted Animals (VS Form 1-27)

At the time, animals are loaded and ready for transport; information is obtained from the animal owner by appropriate State of Federal personnel, who complete certain section of the VS 1-27. This information includes the owner’s name and address, the points of origin and destination of the animals, the number of animals being moved, the purpose of the movement, and various pieces of animal identification data so that each animal in the shipment can be identified. A copy of this form then accompanies the shipment. This form has been cleared under 0579-0051.

Equine Infectious Anemia Laboratory Test (VS Form 10-11)

This form is completed by an accredited veterinarian who has been called to a farm to conduct an EIA test on a horse. (The horse's owner –who assists the accredited veterinarian in completing certain sections of the form-- may have any number of reasons for wanting the horse tested, but a primary reason would be that the owner wants to move the horse across State lines.) The accredited veterinarian takes a blood sample from the horse, then sends this sample (along with Form VS Form 10-11) to an approved laboratory for analysis. The VS Form 10-11 provides a physical description of the horse, the date the sample was taken, the owner's name and address, and the name of the veterinarian who took the sample. If laboratory personnel received a blood sample for processing that was not accompanied by VS Form 10-11, they would have no way of identifying from which horse (of the millions of horses in the United States) the sample was drawn.

Equine Infectious Anemia Supplemental Investigation (VS Form 10-12)

If a sample taken from a given horse is positive for EIA, then a full investigation must be done of the farm where the horse resides. State veterinary medical officers will conduct this investigation, using VS Form 10-12 to record their findings. The VS Form 10-12 –which is completed by State personnel with input from the animal owner-- contains such information as the vaccination history of the horses on the farm, the number of horses with which the positive horse shares a pasture, and a site sketch of the farm. Receiving this vital information from the State allows Veterinary Services to effectively coordinate an EIA investigation and make critical decisions concerning which areas to quarantine.

State Participation

State personnel play an important role in APHIS’ program to ensure that horses affected with EIA are moved interstate in a way that does not endanger the health of the U.S. equine population. This participation includes State inspection of slaughtering establishments that process certain reactors, receiving and reviewing official test results from approved laboratories, ensuring that reactors are moved interstate through no more than one approved stockyard, reviewing schedules of sales days submitted by stockyards, and monitoring the quarantine of EIA reactors that have been moved interstate to diagnostic or research facilities.

Request for hearing

If APHIS opts to deny or withdraw approval from a stockyard, laboratory, or diagnostic/research facility, the owner/operator of that establishment may request a hearing on the matter. During the hearing, the owner/operator can present arguments concerning why approval should not be denied or withdrawn. The request for this hearing must be made in writing by the owner/operator.

Cooperative Agreement (Signature Only)

The owner/operator of a participating stockyard, laboratory, or diagnostic or research facility must promise to adhere to APHIS’ guidelines and regulations when carrying out EIA-related activities. These requirements are spelled out in a cooperative agreement that the owner/operator must sign.

Written Notification of Approval Withdrawal

Approval of a diagnostic or research facility to receive EIA reactors moved interstate will be automatically withdrawn by APHIS when the facility’s operator notifies APHIS, in writing, that the facility no longer receives reactors moved interstate.

Recordkeeping

If a sample taken from a given horse is positive for EIA, then a full investigation must be done of the farm where the horse resides. State veterinary medical officers will conduct this investigation, using VS Form 10-12 to record their findings. The VS Form 10-12, which is completed by State personnel with input from the animal owner -- contains such information as the vaccination history of the horses on the farm, the number of horses with which the positive horse shares a pasture, and a site sketch of the farm. Receiving this vital information from the State allows Veterinary Services to effectively coordinate an EIA investigation and make critical decisions concerning which areas to quarantine. This important information collected by State veterinary medical officers is maintained by the States, since such records could be of value in future EIA investigations. State personnel also play an important role in the Federal EIA Program by ensuring that horses affected with EIA are moved interstate in a way that does not endanger the health of the U.S. equine population. These efforts include State inspection of slaughtering establishments that process certain reactors, receiving and reviewing official test results from approved laboratories, ensuring that reactors are moved interstate through no more than one approved stockyard, reviewing schedules of sales days submitted by stockyards, and monitoring the quarantine of EIA reactors that have been moved interstate to diagnostic or research facilities. Records of these activities are maintained by the States, since such records could be of value in any future EIA investigation. Records are to be kept 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 VS 1-27 must physically accompany the shipment of animals from the farm of origin to the slaughtering establishment. To be valid, the form requires original signatures from authorized personnel at both the farm of origin and slaughtering establishment.

The VS Form 10-11 must physically accompany samples sent to the laboratory for analysis.

A hard copy of the VS Form 10-12 must be used in lieu of electronic submission, since this form includes a sketch of the affected premises.

The request for hearing and notification of approval withdrawal may be made via a telephone call or e-mail to APHIS. For legal purposes, however, this communication must be followed up with hard copies containing original signatures.

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 preventing, detecting, controlling, and eradicating EIA from 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 collects in connection with this program is the minimum needed to ensure that horses moving interstate do not pose a health threat to the U.S. equine population.

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, it would be impossible for APHIS to effectively regulate the interstate movement of horses infected with EIA, a situation that would eventually result in the spread of this disease to healthy horses.

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:

Robin Lohnes

American Horse Protection Association

1000 29^th Street NW Suite T-100

Washington, DC

202-965-0500

Peter Timoney

University of Kentucky, College of Agriculture

108 Gluck Equine Research Center

Lexington, Kentucky 40546

859-257-4757, Ext. 81085

Amy Mann

American Horse Council

1700 K Street, NW., Suite 300

Washington, DC 20006

(202) 296-1970

On Friday, April 13, 2007, pages 18620-18621, APHIS published in the Federal Register, a 60-day notice seeking public comments on its plans to request a three-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 accredited and State veterinarians who participate in our program; laboratory/diagnostic/research facility personnel; stockyard personnel, and owners and shippers of horses.

•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 $4,358,250. APHIS arrived at this figure by multiplying the hours of estimated total burden (174,330 hours) by the estimated average hourly wage of the above respondents ($25.00).

This 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/oes/current/oes_nat.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 $8,290,960 (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.

APHIS previously estimated the total annual burden as 195,410 hours. After re-evaluating the information collection activities associated with this program, APHIS has determined that:

1. The burden hour amounts on the previous collection for completing VS Form 10-11 did not coincide with the OMB-approved designated time allotment as indicated on the

VS 10-11 form; this error has been adjusted;

2. The use of the VS Form 10-12 has been reserved for reactors at approximately 200 per year; therefore, there is a decrease in the number of respondents using the VS Form 10-12 from 5,000 to 200;

3. Because of the decrease in VS 10-12 forms being used, there is also a reduction in the estimated annual records kept from 5,000 to 200;

4. Operators at NVSL-approved laboratories have experienced a failure to pass the annual check tests on an average of two per year; in almost all cases, the operators submitted a written appeal; and as a result of these changes, APHIS adjusted its estimated annual burden hours from 195,410 to 174,330.

As a result of these changes, APHIS adjusted its estimated annual burden hours from 195,410 to 174,330.

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 the "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.