0338 Ss 20201014

October 2020

SUPPORTING STATEMENT

JOHNE’S DISEASE IN DOMESTIC ANIMALS

OMB NO. 0579-0338

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 for enhancing APHIS’ ability to compete in the world market of animal and animal product trade.

Johne’s disease affects cattle, sheep, goats, and other ruminants. It is an incurable and contagious disease that results in progressive wasting and eventual death. The disease is nearly always introduced into a healthy herd by an infected animal that is not showing symptoms of the disease.

APHIS regulations provide that cattle and other domestic animals suspected of having Johne’s disease can be moved interstate for purposes other than slaughter if certain procedures are strictly followed. For example, sexually intact animals that are positive to an official Johne’s disease test (as defined at title 9, Code of Federal Regulations (9 CFR) 80.1) may be moved interstate for the collection of germplasm. Moving Johne’s-positive livestock interstate for slaughter or for other purposes without increasing the risk of disease spread requires the use of information collection activities.

APHIS is asking OMB to approve, for 3 additional years, the use of information collection activities associated with its efforts to control Johne’s disease in 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.

APHIS uses the following information activities associated with its efforts to control Johne’s disease in the United States.

9 CFR 80.3(a)(2) - Permit for Movement of Restricted Animals (VS 1-27)/Owner-Shipper Statement (Business and Accredited Veterinarians)

The animals’ owner or shipper completes the permit (an owner-shipper statement can also be used). Use of the form enables these individuals to ship animals sooner than they could if they had to wait for government personnel to issue a certificate or movement permit. (This, in turn, hastens the removal of sick animals from the farm, reducing the opportunity for disease to spread to healthy animals.)

The 1-27 or owner-shipper statement contains the following information: (1) The number of animals to be moved, (2) the species of the animals, (3) the points of origin and destination, and (4) the names and addresses of the consignor and the consignee. The owner-shipper statement provides written documentation alerting APHIS that affected animals are being moved interstate. This, in turn, enables APHIS to track the movement of these animals for disease control purposes.

9 CFR 80.3(a)(3) - Official Ear Tags (Business)

APHIS’ current regulations require that domestic animals positive to an official Johne’s disease test that are being moved interstate be identified with an official ear tag as described at 9 CFR 80.1. APHIS believes that such ear tags are more than sufficient to properly identify these cattle. Accredited veterinarians typically apply the official ear tag, which is used to trace these animals to their herd of origin even if they become separated from their accompanying documentation.

9 CFR 80.3(b) - Request for Permission to Move (Business)

Owners or shippers may ask the APHIS Administrator to allow domestic animals positive to an official Johne's disease test to be moved interstate in a manner other than as provided in 9 CFR 80.1(a). The request must be made in writing and must specify the conditions under which the animals are to be moved. The Administrator may also prescribe in each case conditions designed to prevent the spread of Johne's disease. The Administrator will promptly notify the State animal health officials of the States involved of any such action.

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) and/or owner-shipper statement, requires an original signature, and is serially numbered; therefore, not conducive to an electronic format. Also, too few are used in connection with this disease prevention effort to justify electronic use.

Ear tags and other animal identification move with the animals, being physically attached, and therefore are not candidates for electronic submission.

The Request for Permission to Move is usually submitted as a letter, which may be emailed to APHIS.

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 effort is not available from any other source. APHIS is the only agency responsible for detecting and controlling contagious animal diseases such as Johne’s disease in 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 is the absolute minimum needed to assess the disease status of animals and premises, assist and track disease control efforts at the State and premises level, and track vaccination history. APHIS estimates that all respondents are small entities.

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 were collected less frequently or not collected, the ability of APHIS to control Johne’s disease would be greatly hindered. APHIS needs to be able to identify and protect non-affected herds as well as other healthy animals to help reduce the national prevalence of the disease to prevent serious economic and health effects for the U.S. livestock industry. This disease is contagious and fatal, and affects many different kinds of ruminants.

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 3 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.

No special circumstances exist that would require this collection to be conducted in a manner inconsistent with the general information collection guidelines 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.

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

Kate Lott, DVM

Director, Farm Engagement

Tillamook Creamery

4165 Highway 101 North

Tillamook, OR 97141

Office: (503) 815-6745

Mobile: (503) 812-4855

Fax: (503) 815-1368

[email protected]

Elisabeth Patton, DVM, PhD, Diplomate ACVIM

Veterinary Program Manager - Division of Animal Health

Wisconsin Department of Agriculture

Trade and Consumer Protection

Phone: (608) 224-4891

Fax: (608) 224-4871

[email protected]

Karen Jordan, DVM

Health and Well-Being Committee

National Milk Producers Federation

2107 Wilson Blvd., Suite 600

Arlington, VA 22201

Phone: 336-260-6534

[email protected]

APHIS contacted these respondents by email and phone to discuss the information APHIS collects to administer its Johnes disease surveillance and response requirements. We discussed with them how we and they obtain the necessary data and how frequently; how much data is available; the convenience and clarity of reporting formats and other collection instruments; and the clarity of, and necessity for, any recordkeeping requirements. The respondents stated via email or phone that they had no concerns with any of these items and had no further recommendations. They did observe, uniformly, that the producers and veterinarians they work with seldom have need to implement the surveillance instruments.

On Wednesday, July 15, 2020, APHIS published a 60-day notice on pages 42820-428-21 of the Federal Register (85 FR 42820) seeking public comment on its plans to request renewal of this collection of information. There were zero (0) comments 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. 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 asks 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 herd owners, accredited veterinarians, and livestock shippers.

•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 these respondents to be $474.22. APHIS arrived at this figure by multiplying the hours of estimated response time (9 hours) by the estimated average hourly wage of the above respondents ($35.83) and then multiplying the result ($322.47) by 1.4706 to capture benefit costs. According to DOL BLS news release USDL-20-0451, dated March 2020 (see https://www.bls.gov/news.release/pdf/ecec.htm), benefits account for 32 percent of employee costs, and wages account for the remaining 68 percent. Mathematically, total costs can be calculated as a function of wages using a multiplier of 1.4706.”

Animal shippers: $32.47 (buyers and purchasing agents)

Animal producers: $24.42 (first-line supervisors of farming, fishing, and forestry workers)

Veterinarians: $50.59

The average hourly rate is derived from the U.S Department of Labor; Bureau of Labor Statistics

Report – National Compensation Survey: Occupational Employment and Wages. See https://www.bls.gov/oes/current/oes_stru.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.

No annual cost burden is associated with capital and startup 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 $270.55. (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.

	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	13	0	0	0	0	13
Annual Time Burden (Hr)	9	0	0	0	0	9
Annual Cost Burden ($)	0	0	0	0	0	0

There are no changes to the renewal request.

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.

The VS Form 1-27 is used in multiple collections; therefore, it is not practical to include an OMB expiration date because of the various expiration dates for each collection. APHIS is seeking approval to not display the OMB expiration date on the VS Form 1-27.

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.

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