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SUPPORTING STATEMENT - OMB NO. 0579-0192

ISA PAYMENT OF INDEMNITY

August 2008

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 to prevent, control, and eliminate contagious, infectious, and communicable diseases. Disease prevention is the most effective method of maintaining a healthy animal population, continuing a safe food supply and enhancing APHIS' ability to compete in marketing its animal and animal product worldwide.

Veterinary Services, a program within the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS), is responsible for administering regulations intended to prevent the introduction of animal diseases, such as END, into the United States. These regulations are found in title 9, chapter 1, subchapter D.

Animal health regulations promulgated by the U.S. Department of Agriculture (USDA) under this authority include those specifically addressing control programs and indemnity payments. Part 53 provides for the payment of indemnity for claims made by Infectious Salmon Anemia (ISA) control program participants arising out of the destruction of fish due to ISA under certain conditions.

ISA poses a substantial threat to the economic viability and sustainability of salmon aquaculture in the United States and abroad. Salmon production in Maine exceeds 36.2 million pounds annually, with a value of $101 million. Because of outbreaks of ISA in Maine, that State’s salmonid industry had already depopulated approximately 900,000 salmon worth nearly $11 million by the time of the Secretary’s declaration of emergency. (ISA is the clinical disease resulting from infection with the ISA virus; signs include hemorrhaging, anemia, and lethargy.)

This indemnity program will entail the use of several information collection activities, including the completion of a Program Enrollment Form, an Appraisal and Indemnity Claim Form, the development of biosecurity protocols, the creation of site-specific ISA action plans, and the compilation of fish inventories and mortality reports. Program participants (who may include certain aquaculture industry business owners, managers, site employees, or accredited veterinarians) and designated laboratories must also assist the Animal and Plant Health Inspection Service (APHIS).

APHIS is asking OMB to approve, for an additional 3 years, its use of these information collection activities in connection with its efforts to control ISA and prevent its spread.

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.

VS Form 1-22 - ISA Program Enrollment Form (Signature Only)

As a condition of receiving indemnity, program participants must sign an ISA Program Enrollment Form in which they agree to participate fully in USDA’s and the State of Maine’s ISA Program. By signing this document, program participants agree to (1) establish and maintain a veterinary client-patient relationship with an APHIS accredited veterinarian; (2) cooperate and assist with on-site disease surveillance, testing, and reporting activities; (3) develop and implement biosecurity protocols; (4) develop a site specific ISA Action Plan for the prevention, control, and management of ISA; (5) participate in Maine’s integrated pest management of sea lice on salmonids; (6) submit complete and current fish inventory information to the ISA Program Veterinarian; (7) maintain mortality data and make it available, upon request, to the ISA Program Veterinarian; and (8) cooperate and assist APHIS in the completion of biosecurity audits.

VS Form 1-23 - All Species Appraisal & Indemnity Claim Form

Appraisals of salmon must be reported on the VS Form 1-23 and signed by both the appraiser (a Federal employee) and the program participant. The VS Form 1-23 is completed by the appraiser with input from the program participant, and contains such information as the owner's name and address, the number of fish for which the participant is seeking payment, and the appraised value of each fish. The participant’s signature on this form indicates agreement with the appraised value. On this form the participant must also certify as to whether the fish are subject to a mortgage. If the participant states that there is a mortgage, the form must be signed not only by the participant, but also by each person holding a mortgage. By signing the form, each mortgage holder is consenting to the payment of indemnity to the participant or lien holder.

Biosecurity Protocols

As a condition of receiving indemnity, program participants must develop and implement biosecurity protocols for use at their salmonid aquaculture operations throughout Maine. Program participants must submit a copy of these protocols to APHIS. The implementation of effective biosecurity protocols reduces the risk of ISA introduction and spread via the movement of farmed fish, equipment, and people among marine sites.

Biosecurity Audits

As a condition of receiving indemnity, program participants must cooperate with and assist APHIS in the completion of biosecurity audits at their salmonid aquaculture operations throughout Maine. These audits will be performed to assess the efficacy of the biosecurity protocols.

ISA Action Plan

As a condition of receiving indemnity, program participants must develop an ISA action plan for the control and management of ISA at each of the operation’s marine sites. A copy of this action plan must be submitted to APHIS. The action plan is a document developed to define the response contingencies for ISA (activities to be undertaken upon disease detection) should the disease emerge at any given site.

Fish Inventory

As a condition of receiving indemnity, program participants must compile and submit to APHIS a complete and current fish inventory. Fish inventory information must include the numbers, age, date of saltwater transfer, vaccination status, and previous therapeutant history for all fish in a particular unit. (This information can be complied using existing industry records systems and log sheets.) This information will provide APHIS with the data necessary to establish disease control actions and complete epidemiological assessments. Moreover, the information will increase APHIS’ ability to effectively monitor fish populations.

Mortality Data (and Recordkeeping)

As a condition of receiving indemnity, program participants must compile, maintain, and make available to APHIS upon request, mortality data for their salmonid aquaculture operations throughout Maine. (This information can be complied utilizing existing industry records systems and log sheets.) Mortality data will be used by APHIS, in conjunction with the fish inventory, to establish disease control actions and complete epidemiological assessments. Moreover, the information will increase APHIS’ ability to effectively monitor fish populations. These records are to be retained by the originating office for a period not less than 10 years; however, records for infected populations of fish should be kept for no less than 15 years.

Disease Surveillance

As a condition of receiving indemnity, program participants and designated laboratory personnel must cooperate with and assist in on-site monthly disease surveillance, testing, and reporting activities for ISA, which will be conducted by their staff APHIS accredited veterinarian or Federal official. Surveillance ensures that resources and producers’ attention will be directed at routine and regularly scheduled inspections and health assessments of fish so that ISA can be diagnosed quickly.

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 Form 1-23 must be completed on site and also requires an original signature from both the appraiser and the program participant; therefore, the document is not a practical candidate for electronic transmission. All other information gathering activities associated with this program can be created and transmitted 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 that APHIS collects is not available from any other source. APHIS is the only Federal Agency responsible for preventing, detecting, controlling, and eradicating contagious animal diseases 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 is collecting in connection with this program is the minimum needed to protect Maine salmon from ISA. APHIS has no small entities involved with this information collection.

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.

Collecting this information less frequently or failing to collect it would make it impossible for APHIS to continue implementing its current program to contain and prevent ISA outbreaks in the United States.

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 2008, APHIS engaged in productive consultations with the following individuals concerning the information collection activities associated with this program:

Dr. Leighanne Hawkins- Fish health manager and company veterinarian

Cooke Aquaculture Co.

59 Beach Road

Beaver Harbor, New Brunswick

E5H 1M4 Canada

506-456-6637

Jennifer Robinson, Compliance Officer

Phoenix Salmon/Cooke Aquaculture Co.

PO Box 263, Estes Head

Eastport, ME 04631

207-853-6081

Mr. David Miller, Maine Production Manager

Atlantic Salmon of Maine/Cooke Aquaculture

HCR 70 Box 325, Smalls Point Road

Machiasport, ME 04655

207-255-6714

On Tuesday, March 4, 2008, pages 11612-11613, 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 program participants (such as certain aquaculture industry business owners, managers, site employees, or accredited veterinarians) and Federal animal health officials.

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

The annualized cost to the public is $13,942.60. APHIS arrived at this figure by multiplying the hours of estimated response time (644 hours) by the estimated average hourly wage of the respondents ($21.65). To determine the average hourly wage, APHIS multiplied the hourly wage of an aquaculture industry employee ($17.94) by the average hourly wage of the accredited veterinarian ($25.36). The hourly rate for an aquaculture industry employee was derived from the following Web site: http://www.careerccc.org/Careerdirections/eng/e_oc_dwn.asp?ID=15&Alpha=No. The hourly rate for the accredited veterinarian was derived from the following Web site: http://www.payscale.com/research/CA/Job=Veterinarian/Salary/show_all

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 $2,487 (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 are currently no outbreaks of ISA; therefore, the total burden has decreased from 5,600 hours to 644 hours.

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 in the Act.

B. Collections of Information Employing Statistical Methods

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