2013 Ss 0065

Revised February 2014

SUPPORTING STATEMENT

SWINE HEALTH PROTECTION

OMB NO. 0579-0065

TERMS OF CLEARANCE: In accordance with the terms of 5 CFR 1320, OMB approves this collection of information for a period of two years. Before resubmitting this collection for an extension of the approval, USDA should make this collection available electronically.

There are five forms in this Information Collection, and one of the forms is currently available electronically.  The Animal and Plant Health Inspection Service (APHIS), Veterinary Services’ (VS), recent reorganization impacted the updating and consolidating of the remaining forms into VS’s electronic data collection process. Now that the reorganization and the revamping of the electronic data collection are complete, VS is making every effort to make the remainder of the forms electronic. APHIS will submit a Non-substantive Change Request upon completion of making each form available electronically.

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.

VS, a program within the United States Department of Agriculture's (USDA), APHIS, is responsible for administering regulations intended to prevent the dissemination of animal diseases within the United States. These regulations are found in Title 9, Code of Federal Regulations (CFR).

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

The regulations under which APHIS conducts its disease prevention activities are contained in title 9, chapter 1, subchapter D, parts 91 through 99 of the CFR. These regulations govern the importation of animals, birds, and poultry; certain animal and poultry products; and animal germplasm.

Garbage is one of the primary media through which numerous infections or communicable diseases of swine are transmitted. African swine fever, which is potentially the most dangerous and destructive of all communicable swine diseases, is periodically confirmed in a number of regions that are relatively close to the United States. Classical swine fever, another serious disease of swine that was officially declared eradicated from the United States in 1978, is also present in several nearby regions.

Because of this serious threat to the U.S. swine industry, Congress passed Public Law 96-468, the Swine Health Protection Act, on October 17, 1980. This law requires USDA to ensure that all garbage is treated before being fed to swine intended for interstate or foreign commerce or that substantially affect such commerce. The regulations that implement this legislation are found in

9 CFR, part 166.

The Act and the regulations allow only operators of garbage treatment facilities that meet certain specifications to use garbage for swine feeding. Noncompliance with the regulations constitutes grounds for enforcement action and could include suspension or revocation of the license to operate the garbage treatment facility. The Act and regulations ensure that all garbage, before being fed to swine, is treated to destroy all potential animal disease agents.

Implementing these regulations requires the use of a number of information collection activities, including the creation of Food Waste Reports, the completion of applications to operate garbage treatment facilities, the completion of a notification process when certain events occur at regulated facilities, the creation of Swine Health Protection Program Inspection Summaries, and recordkeeping.

APHIS is asking OMB to renew, for an additional 3 years, its use of the various information collections listed below.

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 to ensure that garbage fed to swine does not pose a threat of spreading animal diseases within the United States.

VS Form 13-17, Food Waste Report

This form is used by Federal and State public health officials. These officials contact food establishments (grocery stores, restaurants, etc.) and inquire about the disposition of the establishment's food waste. The form is forwarded to VS’ Area Office or the State animal health office only when the results of the inspection reveal that the destination of the food waste is potentially a garbage feeder.

Upon receipt of the information from the public health officials, Federal or State animal health personnel use the information to determine if the waste collector is feeding garbage to swine, if the garbage is being treated, and if the feeder is licensed or needs to be licensed.

VS Form 13-15, Application for Licensing of Garbage Treatment Facility

This application process provides a system to license and regulate individuals who wish to operate a garbage treatment facility to use garbage for swine feeding. Persons desiring to obtain a permit (license) to operate a facility to treat garbage must apply to USDA or the State agency.

Acknowledgement of Act and Regulations

When an applicant is given a licensing application to operate a garbage treatment facility, he or she also receives a copy of the Swine Health Protection Act and the related regulations. At the time of the pre-licensing inspection, the applicant is required to sign a statement that he or she has received a copy of the Act and regulations, understands them, and agrees to comply with them.

VS Form 13-16, Garbage Treatment Facility Inspection

This form is used by Veterinary Services or State inspectors during routine and repeat visits to garbage treatment facilities for the purpose of inspection, and for pre-licensing inspection activity at premises before licensing a garbage treatment facility. This form guides the inspector through the inspection process at the facility and allows the inspector to record satisfactory or unsatisfactory findings at the facility. This form enables review of the sanitation, cooking procedures, cooked product storage, and raw product storage at the facility. This information is obtained via direct observation on the farm and interview with the owner.

Request for Hearing

A license will be canceled if a licensee fails to treat garbage for a consecutive 4-month period. This regulation reduces the number of periodic inspections of facilities that are not treating garbage after receipt of a license under the Act. A licensee who has been notified of a proposed cancellation of license may request a hearing to retain his or her license. The licensee requests this hearing in writing, to APHIS.

Cancellation of License by Licensee

Any licensee who no longer wishes to treat garbage under the Act may request cancellation of his or her license by writing to the Area Veterinarian in Charge (AVIC) or to the State animal health official in a State that issues licenses under a cooperative agreement. Once received, the State animal health official will cancel the license.

Notification by Licensee of Sick or Dead Animals

A licensee must immediately notify a Federal or State inspector on detecting, in any animal, illness or death not normally associated with the licensee's operation of the facility. The licensee must also notify APHIS of any change in the name, address, management, or ownership of the facility within 30 days of the change. This information enables APHIS to carefully monitor events at the facility. On request, the licensee must also give APHIS information concerning the sources of garbage at the facility. This information includes the dates of supply and the names and addresses of the suppliers.

VS Form 13-2, Swine Health Protection Program Inspection Summary

This document is used by the AVIC and State animal health officials in evaluating the progress of the swine health protection program in each State. The reports include data from the first day of each month to the last day of each month and are sent by the State or Federal epidemiologist to APHIS to be entered and tabulated in a spreadsheet.

Recordkeeping

Each licensee must record the destination and date of removal of all garbage removed from the premises. These records must be kept for 1 year. The records are reviewed annually by supervising Federal officials to determine compliance with the Swine Health Protection Act and regulations. In the case of a disease outbreak, this information is essential for disease-tracing actions taken by Federal and State animal health officials.

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.

Currently only the VS Form 13-2 is available for electronic collection of data. It is available on APHIS’ web site at http://inside.aphis.usda.gov/vs/downloads/vs-form13-2.pdf

VS’ recent reorganization impacted the updating and consolidating of the remaining forms into VS’ electronic data collection process. Now that the reorganization and the revamping of the electronic data collection are complete, VS is making every effort to make the remainder of the forms electronic. APHIS will submit a Non-substantive Change Request upon completion of making each form available electronically.

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 collected is the absolute minimum needed to conduct effective monitoring of garbage treatment facilities in the United States. The information that APHIS collects is not available from any other source. APHIS is the only Federal agency responsible for controlling and eliminating domestic diseases of animals and poultry.

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

All of the respondents to this information collection are small entities. This collection represents APHIS’ efforts to ensure that garbage fed to swine does not pose a threat of spreading animal diseases within the United States. Burden is reduced by only asking for the information needed to ensure the Swine Health Protection Act is being followed and by having State or APHIS personnel available to assist with questions on the needed records.

6. Describe the consequences 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 prevent the spread of contagious animal diseases within the United States. If this information were not collected, the incidence of animal disease outbreaks would begin to rise, and the United States would lose its favored status for the export of livestock.

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 prepare a written response to a collection of information in fewer than 30 days after receipt of it;

Notification by Licensee of Sick or Dead Animals - A licensee must immediately notify a Federal or State inspector on detecting, in any animal, illness or death not normally associated with the licensee's operation of the facility. The licensee must also notify APHIS of any change in the name, address, management, or ownership of the facility within 30 days of the change. This information lets APHIS monitor the facility and helps with disease investigation tracebacks.

No other 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 record keeping, 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 2013, APHIS engaged in productive consultations with the following individuals concerning the information collection activities associated with this program:

Dr. Liz Wagstrom

Chief Veterinarian

National Pork Producers Council

122 C Street NW

Washington, DC 20001

(202) 347-3600

[email protected]

Dr. Paul Sundberg

Vice President of Science and Technology

National Pork Board

1776 Northwest 114th Street

Clive, IA 50325

(515) 223-2600

[email protected]

Dr. Tom Burkgren

Executive Director

American Association of Swine Veterinarians

830 26th Street

Perry, IA 50220

(515) 465-5255

[email protected]

On Thursday, September 5, 2013, pages 54618-54619, APHIS published in the Federal Register, a 60-day notice seeking public comments on its plans to request continuation of a 3-year renewal for this information collection. During that time, APHIS received three comments from the public. Two of these comments were from a concerned citizen about her perception of the general disregard of the environment by USDA. Those two comments have no relevance to the purpose of the collection. The final comment praised APHIS for monitoring for non-licensed facilities, APHIS-issued violations for the noncompliant facilities, and all activities supported by this collection of information which are essential for protecting swine health.

9. Explain any decision to provide any payment or gift to respondents, other than re-numeration 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 and attitudes, religious beliefs, and others that are 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 bow 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 APHIS headquarters and field personnel, State veterinary authorities, herd owners, and owners/operators (licensees) of garbage treatment facilities.

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

Respondents are owners/operators (licensees) of garbage treatment facilities, owners/operators of facilities that have food waste, herd owners, and State animal health authorities. APHIS estimates the multiplying the total burden hours (11,333) by the estimated average hourly wage of the above respondents ($31.20).

Owners/Operators of Food Waste Facilities: $25.30 [Food Service Managers]

Owners/Operators of herds: $ 33.66 [Farm, Ranch, and Other Agricultural Managers]

Licensees: $21.97 [First-Line Supervisors of Farm Workers]

State Animal Health Authorities: $43.87 [Veterinarians]

The average hourly rate is derived from the U.S. Department of Labor; Bureau of Labor Statistics – National Occupational Employment and Wage Estimates at http://www.bls.gov/oes/#tables

13. Provide estimates of the total annual cost burden to respondents or record keepers 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 startup 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.

Administrative and overhead costs for this certification program are estimated to cost $186,387 (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.

ICR Summary of Burden:

	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	12,897	0	0	176	0	13,073
Annual Time Burden (Hr)	11,333	0	0	9	0	11,324
Annual Cost Burden ($)	0	0	0	0	0

In the previous renewal package there were 2,105 respondents, and in this current collection there are 2,110 respondents; an adjusted increase of 5 respondents from the previous collection. The minor increase in respondents also caused an increase of 176 responses, and an increase of 9 burden hours, as reflected in the chart above. This slight change occurred because five garbage treatment facilities were added to the program in the past two years. APHIS also continues to improve at counting inspected garbage treatment facilities more accurately.

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 collected 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.

APHIS has no plans to seek approval for not displaying 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 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.

11