2009 Ss 0245

SUPPORTING STATEMENT 0579-0245

HIGHLY PATHOGENIC AVIAN INFLUENZA (HPAI) Subtype H5N1

November 23, 2009

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 10401-1 8 of P.L. 107-171, May 13, 2002, the Farm Security and Rural Investment Act of 2002.

The agency charged with carrying out this disease prevention mission is the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), through its Veterinary Services (VS) program. VS Regulations for preventing the introduction of foreign animal diseases into the United States are contained in title 9 of the Code of Federal Regulations (9 CFR), subchapter D - Exportation and Importation of Animals and Animal Products. Parts 93 through 96 of this subchapter govern importing into the United States certain live animals, birds, poultry (including hatching eggs), meat, other animal products and byproducts, hay, and straw to prevent introducing various animal diseases.

Highly pathogenic avian influenza (HPAI) is an extremely infectious and often fatal viral disease affecting all types of birds and poultry. HPAI can strike poultry quickly, without infection warning signs. Once established, the disease can spread rapidly from flock to flock. This form of influenza, when caused by certain viral subtypes such as H5N I, can also adversely affect humans and other animals, such as pigs. HPAI caused by subtype H5NI does not currently exist in birds or poultry in the United States.

To protect the United States against an incursion of HPAI, APHIS requires the use of several information collection activities, including an Application to Import Controlled Materials or Transport Organisms and Vectors (VS Form 16-3); an Import Permit (VS Form 16-6A); an Application for Import or In-Transit Permit (VS Form 17-129); a notarized declaration or affirmation; and a Pet Bird Owner Agreement

(VS Form 17-8).

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.

Application to Import Controlled Materials or Transport Organisms and Vectors (VS Form 16-3)

Bird and poultry carcasses, parts, and products may be imported from a region where HPAI H5N1 exists only if accompanied by an import permit (VS Form 16-6A) and if these items are research materials destined for a museum, educational institution, or research institution. Products and byproducts of birds and poultry (including feathers, nests, and trophies) may be imported from a region where H5N1 exists only if accompanied by an import permit, and only if VS determines that the importation can be made under conditions that will prevent introducing HPA1 into the United States.

Importers can obtain this permit by completing a permit application, VS Form 16-3, which is available on the APHIS Web site. The application asks for the importer's name and address, the name and address of the individual exporting the material or product, the type and amount of material or product being shipped, the material or product’s intended use, and the material or product’s origin and destination points.

This information enables VS to determine whether the shipment qualifies for import into the United States, and what risk-mitigating action VS may need to take to ensure the shipment does not pose a disease threat to the United States.

Import Permit for Controlled Materials or Transport Organisms and Vectors (VS Form 16-6A) Signature Only

If an importer fills out the VS 16-3 application and VS determines that a shipment qualifies for import, VS will issue the importer an import permit, VS Form 16-6A, which he/she must sign. The importer's signature provides acknowledgment that the importer agrees to abide by all the restrictions and precautions outlined on the import permit. The original hard copy import permit then accompanies the product.

Application for Import Permit (VS Form 17-129)

U.S. origin pet birds and performing or theatrical birds and poultry returning to the United States from any region, except those returning from Canada or Mexico via a land border port, must be accompanied by an APHIS-issued import permit. The owner of the birds or poultry can obtain this permit by completing a permit application, VS Form 17-129, which is available on the APHIS Web site.

The application asks for the owner's name, telephone number, address; the number, breed, and species of birds or poultry returning to the United States; a description of the birds or poultry including sex, age, registered name, tattoo, tag number, or other markings; the country the birds or poultry have come from; the proposed shipping and arrival dates; and the U.S. port of entry.

This information allows VS to determine the level of risk associated with the shipment, and the appropriate risk-mitigating measures to take, if necessary, to ensure that it does not pose a risk of introducing HPAI into the United States.

Notarized Declaration or Affirmation

In addition to VS Form 17-129, these owners must also provide VS with a notarized declaration, affirmation, or statement signed by the owner and witnessed by a USDA inspector that states that the birds or poultry were not exposed to other birds or poultry while out of the United States. This document is specifically referred to in 9 CFR 93.101(c)(e), which lists obtaining a notarized statement, and provides VS with another means of ensuring that U.S. origin pet birds or theatrical birds or poultry returning to the United States were not exposed to foreign bird populations of unknown health status.

Agreement of Pet Bird Owner (VS Form 17-8)

Owners of pet birds or performing birds or poultry that have been out of the country for more than 60 days must sign an additional agreement stipulating that the owner will quarantine the birds or poultry for 30 days following importation, and immediately alert Federal officials if the owners note signs of disease. Owners can obtain this agreement from a Federal inspector at the U.S. port of entry or from the APHIS Web site.

This agreement includes the owner's name and address, the number and kind of birds or poultry the owner is bringing into the United States, the location where they will be held in quarantine, and the port of entry through which they will enter the United States. The form also asks for signatures from the owner, the detaining official at the port of entry, the releasing official, and the final releasing official.

Notification of Signs of Disease in a Recently Imported Bird

Owners of pet birds or performing birds or poultry that have been out of the country for more than 60 days must immediately alert Federal officials if the owners note signs of disease. To do this, owners would call their local VS Area Office and inform them of their bird’s signs of disease. This call would last 5 minutes or less. The Area Office would then send out a veterinarian to assess the bird's condition. This is an informal process involving a small number of respondents. The VS Area Offices do not keep records on whether respondents call them regarding symptoms in recently imported birds, therefore, there is no way to determine how often this occurs.

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.

VS Form 16-3: the Application for a Permit to Import Controlled Material or Transport Organisms or Vectors (found at www.aphis.usda.gov/import_export/animals/downloads/vs16_3.pdf) can be submitted electronically if the importer has applied for and received e-Authentication and can log in through that system (found at www.eauth.egov.usda.gov). However, some importers may not choose to become

e-Authenticated. Those importers must submit the VS 16-3 by fax or mail.

VS Form 17-129: the Application for an Import or In-Transit Permit (found at

www.aphis.usda.gov/import_export/animals/downloads/vs17_129.pdf), is available to the public electronically at www.aphis.usda.gov/import_export/forms.shtml, but must be submitted by fax or mail. There are currently no plans to produce an electronic version of the form for submission.

VS Form 17-8: the Pet Bird Owner Agreement (found at www.aphis.usda.gov/import_export/animals/downloads/vs17_8.pdf) is available to the public electronically at www.aphis.usda.gov/import_export/forms.shtml. The department is currently working to produce a VS 17-18 form that can be submitted electronically; however, at this time the form must be mailed or faxed. The VS Form 17-8 is also available through Federal inspectors at U.S. ports of entry. To be valid, it requires original signatures from the pet bird owner, the detaining official, the releasing official, and the final releasing official.

The VS Form 16-6A is a hard copy permit generated through e-permits, that is only produced after the VS 16-3 application is accepted by VS. This hard copy permit must be signed by the importer and accompanies the imported product. It cannot be produced electronically.

The notarized declaration is not a VS Form, but a document generated by pet bird owners; therefore, VS cannot provide a means to submit this form electronically, other than by faxing.

If an owner notifies a VS Area Office regarding signs of disease in a recently imported bird, he/she does so by phone. There is no form involved.

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 is not available from any other source. APHIS is the only Federal Agency responsible for preventing the incursion of exotic animal and poultry diseases into 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 HPAI is not introduced into the United States via imports of certain birds, poultry, and related products and byproducts. Of the respondents importing pet birds or theatrical and performing birds and poultry, 100 percent 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.

Collecting this information less frequently or failing to collect it would make it impossible for APHIS to establish an effective line of defense against an introduction of HPAI. The incursion and spread of this disease within the United States could have serious economic consequences for the U.S. poultry industry.

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 2009, APHIS engaged in productive consultations with the following individuals concerning the information collection activities associated with this program:

Ellen Paul

The Ornithological Council

5107 Sentinel Drive

Bethesda, MD 20816

(301) 986-8568

Valerie Penergraph

Private Citizen who has imported pet birds

11211 County Rd. 110

Kiowa, CO 80117

(303) 648·0083

Ronda Hefner

Private Citizen who has imported pet birds

3812 Sedgefield Drive

Conover, NC. 28613

(919) 967-1402

On Tuesday, March 30, 2010, pages 15672-15673, 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. One comment from the public was received.

The comment was received from Jean Public of New Jersey. She stated that the US should stop importing any birds, live or dead, into the country. This comment has no relevance to the purpose of the collection.

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. APHIS developed burden estimates from discussions with owners of U.S. origin pet birds and performing or theatrical birds or poultry; with U.S. importers of bird and poultry carcasses, parts, products, and byproducts (including feathers. nests, and trophies) from certain regions; and with Federal personnel engaged in import-related activities at U.S. ports of entry.

• 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 respondents to be $3,916.66. APHIS arrived at this figure by multiplying the hours of estimated response time (165.26 hours) by the estimated average hourly wage of the above respondents ($23.70).

$23.70 hourly rate is derived from the U.S. Department of Labor; Bureau of Labor Statistics May 2008 Report - Occupational Employment and Wages in the United States. See www.bls.gov/news.release/ocwage.t03.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 $8,350.42. (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 is a program change of +8 burden hours with the addition of VS Form 16-6A to this information collection. This permit is generated through e-permits once the VS Form 16-3 has been submitted and approved. This form was not previously included in this collection. Correcting the collection by including this form increased the number of responses by 248 caused a burden increase of +8 hours.

The number of respondents decreased from 5,180 to 270 causing the number of responses to decrease from 23,520 to 563. There was a decrease in burden hours from 11,760 hours to 165 hours with an adjustment of -11,595 burden hours. The decrease is a result of the U.S. ban on the trade of live birds from countries with HPAI, which became comprehensive in 2005 and since that time only live birds of U.S. origin could be imported. From 2007 through 2009, there has been a sharp decline in the live bird trade due to this ban, with the exception of one classification of bird. This decline is reflected in the total numbers: in 2007, a total of 73 birds were imported from countries under the avian influenza ban; in 2008, a total of 49 birds fitting the criteria were imported. In 2009, to date, only 22 birds have been imported.

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.

APIHS 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 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.