2012 Ss 0219

2012 SS 0219.docx

Requirements for Recognizing the Animal Health Status of Foreign Regions

OMB: 0579-0219

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SUPPORTING STATEMENT - OMB NO. 0579-0219

REQUIREMENTS FOR RECOGNIZING THE ANIMAL

HEALTH STATUS OF FOREIGN REGIONS

June 2012

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 such 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.


The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture is responsible for, among other things, protecting the health of the Nation’s livestock and poultry populations by preventing the introduction and spread of serious diseases and pests of livestock and poultry and for eradicating such diseases and pests from the United States when feasible.


The regulations in title 9 of the Code of Federal Regulations (9 CFR), part 92, “Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions,” set out the process by which a foreign government may request recognition of the animal health status of a region or approval to export animals or animal products to the United States. The process is based on the risk associated with animals or animal products from that region. APHIS’ recognition of a region’s animal health status makes exports of animals and animal products from that region subject to a certain set of import requirements. These requirements are designed to ensure that animals and animal products imported from that region will not introduce animal diseases—such as foot-and-mouth disease (FMD), bovine spongiform encephalopathy (BSE), or classical swine fever (CSF)—into the United States.


Under 9 CFR 92.2(g), APHIS may conduct information collection activities to verify that the assigned import conditions remain appropriate over time. Specific information collection activities, if determined necessary, will vary based on the information required to assess the animal health status. For example, APHIS may request information to confirm that the import requirements of the region have not changed. Similarly, if a region with recognized health status borders a region that reports an animal disease outbreak, APHIS may request information regarding security along that border. Verification is necessary to ensure continued protection from the introduction of foreign animal diseases into the United States.


APHIS is asking the Office of Management and Budget to approve, for an additional 3 years, its use of these information collection activities.



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 animals and animal products imported from foreign regions will not introduce animal diseases—such as foot-and-mouth disease (FMD), bovine spongiform encephalopathy (BSE), or classical swine fever (CSF)—into the United States.


Animal Health Status Information Request

Veterinary authorities in foreign regions that have already been recognized by APHIS as having achieved an acceptable animal health status with respect to FMD, BSE, avian influenza, CSF, or any other disease of concern may be asked to submit additional information about the regions’ animal health status if it is determined that time or circumstances may have altered that status. APHIS would use this information to reevaluate, if necessary, the region’s animal health status with respect to a given disease or diseases.


Information regarding the animal health status of a region could involve assembling an extensive amount of data (such as, reports, charts, and graphs). This information might include:


  1. The authority, organization, and infrastructure of the veterinary services organization in the region

  2. Disease status

  3. The status of adjacent regions with respect to the disease agent

  4. The extent of an active disease control program, if any, if the agent is known to exist in the region

  5. The vaccination status of the region, when was the last vaccination, what is the extent of vaccination if it is currently used, and what vaccine is being used

  6. The degree to which the region is separated from adjacent regions of higher risk through physical or other barriers

  7. The extent to which movement of animals and animal products is controlled from regions of higher risk and the level of biosecurity regarding such movements

  8. Livestock demographics and marketing practices in the region

  9. The type and extent of surveillance in the region (e.g., passive, active, or both and what is the quantity and quality of sampling and testing)

  10. Diagnostic laboratory capabilities

  11. Policies and infrastructure for animal disease control in the region (i.e., emergency response capacity)



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 information APHIS requests can be submitted to APHIS via faxes, e‑mails, computer-generated reports, and letters. The information is not a candidate for electronic submission. APHIS has not developed a database to do so because the number of yearly submissions is low.


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 program is not available from any other source. APHIS is the only 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.


No small businesses or other small entities will be affected by 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.


If the information was collected less frequently or not collected at all, it would cripple APHIS’ ability to monitor the animal health status of various regions, making an animal disease incursion more likely. The U.S. livestock and poultry industries could suffer serious economic losses as the result of an incursion, as the value of their products would be diminished both domestically and internationally.



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 three 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.


The 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 2010 and 2011, APHIS engaged in productive consultations with the following individuals in connection with the information collection activities associated with this program:


Dr. Shiro Yoshimura

Ministry of Agriculture, Forestry and Fisheries

1-2-1 Kasumigaseki, Chiyoda-ku

Tokyo 100-8950, Japan

+81-3-3502-8295


Dr. Daisuke Tsukamoto

Ministry of Agriculture, Forestry and Fisheries

1-2-1 Kasumigaseki, Chiyoda-ku

Tokyo 100-8950, Japan

+81-3-3502-8111 (x4582)


Dr. Don Franco

National Renderers Association

801 Fairfax Street, Suite 205

Alexandria, VA 22314

(703) 683-0155


On Tuesday, February 7, 2012, page 6056, 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. During that time, APHIS received no comments.



9. Explain any decision to provide any payment or gift to respondents, other than remuneration 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 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 animal health authorities in certain foreign regions that have already been granted a particular animal health status for a specified animal disease.


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


Respondents are foreign animal health authorities. APHIS estimates the total annualized cost to these respondents to be $5,304. APHIS arrived at this figure by multiplying the hours of estimated response time (120 hours) by the estimated average hourly wage of the above respondents ($44.20). APHIS determined the estimated hourly wage from discussions with its international contacts.



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, or 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 $9,473.63. (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-I.


The burden for this 3-year renewal information collection has not changed.



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.


No forms are used in this information collection.



18. Explain each exception to the certification statement identified in "Certification for Paperwork Reduction Act."


APHIS can certify compliance with all provisions of the Act.



B. Collections of Information Employing Statistical Methods


Statistical methods are not employed in this information collection activity.

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