2013 Ss 0218

SUPPORTING STATEMENT

IMPORTATION OF LIVE SWINE, PORK AND PORK PRODUCTS, AND

SWINE SEMEN FROM THE EUROPEAN UNION

OMB NO. 0579-0218

NOTE: The information collected in IC 0579-0265 is a duplicate of what is being collected in IC 0579-0218. IC 0579-0265 was started because it was tied to a proposed rule in 2005. When Veterinary Services evaluated the burden for this

3-year renewal of 0218, they realized that the same information was being collected in 0265. This merger will reduce redundancy in reporting the same activities twice for the Importation of Swine Pork Products, and Swine Semen from the European Union. Collection 0579-0265 will retire once this collection is approved.

1. JUSTIFICATION February 2013

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, dated May 13, 2002, the Farm Security and Rural Investment Act of 2002.

Disease prevention is the most effective method to maintain a healthy animal population and for enhancing the United States' ability to compete in the world market animal and animal product trade.

In connection with this disease prevention mission, the Animal and Plant Health Inspection Service (APHIS) regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases not currently present or prevalent in this country. The regulation in title 9 of the Code of Federal Regulations (9 CFR), part 94, prohibit or restrict the importation of specified animals and animal products to prevent the introduction into the United States of various animal diseases, including Classical Swine Fever (CSF), rinderpest, Foot and Mouth Disease (FMD), swine vesicular disease (SVD), and African Swine Fever (ASF). Section 94.24 deals specifically with the importation of pork and pork products from regions where CSF exists.

To help ensure that CSF is not introduced into the United States, the regulations allow, under specified conditions, the importation of pork, pork products, and swine from the APHIS-defined European Union (EU) CSF region. These requirements necessitate the use of several information collection activities, including certification statements for the importation of pork, pork products, and swine.

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

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 regulate the importation of live swine, pork and pork products, and swine semen into the United States to guard against the introduction of animal diseases not currently present or prevalent in this country.

Certificate for Pork and Pork Products – Foreign Government (also accounted for in

0579-0265 previously)

In addition to meeting all other applicable APHIS provisions, fresh pork and pork products imported from the APHIS-defined EU CSF region must be accompanied by a certificate stating that the applicable provisions have been met. This certificate must be issued by an official of the competent veterinary authority of the APHIS-defined EU CSF region Member State who is authorized to issue the foreign meat inspection certificate.

Application for Import or Transit Permit (Certificate for Live Swine) (VS 17-129) – Foreign Government (also accounted for in 0579-0265 previously))

In addition to meeting all other applicable APHIS provisions, live swine imported from regions listed as low-risk regions for CSF must be accompanied by a certificate issued by an official of the national government of the region of origin. This certificate must state, among other things, that:

• The swine are breeding swine

• They have not lived in any CSF-affected region or zone or transited a CSF affected region or zone

• They have been inspected and found free of clinical evidence of contagious or communicable disease

• They have not been exposed to contagious or communicable disease during the preceding 60 days they spent in isolation

• They originate in an EU Member State recognized as low-risk for CSF and free of FMD, rinderpest, ASF, and SVD

• All hay, straw, forage, feed and bedding aboard the transporting aircraft or vessel originated in an EU Member State designated as be free of FMD, rinderpest, ASF, and SVD

• The equipment or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected.

Application for Import or Transit Permit (Certificate for Swine Semen) (VS 17-129) – Foreign Government (also accounted for in collection 0579-0265 previously)

In addition to meeting all other applicable APHIS provisions, swine semen imported from regions listed as low-risk regions for CSF must be accompanied by a certificate issued by an official of the national government of the region of origin. This certificate must state, among other things, that:

• The semen originated from a semen collection center approved for export by the veterinary services of the national government of the country of origin

• The donor boar

• Did not live in any CSF-affected zone or region

• Was held in isolation for 30 days prior to entering the semen collection center

• Tested negative for CSF using a test approved by the World Organization for

Animal Health (OIE)

• Equipment or materials used in transporting the donor boar from the farm or origin to the semen collection center was cleaned and disinfected

Declaration of Importation (VS 17-29) (APHIS Inspectors)

This form was previously completed by businesses and presented to the U.S. Collector of Customs for use by the veterinary inspector. The declaration lists the port of entry, the name and address of the importer, the name and address of the broker, the origin of the swine, the number, breed, species, and purpose of the importation, the name of the person to whom the swine will be delivered, and the location of the place to which such delivery will be made. The information requested on this form facilitates the oversight necessary to ensure that all APHIS import requirements are met to mitigate the introduction of foreign and other animal diseases regulated by APHIS and is completed by the APHIS inspector from information retrieved on the

VS 17-129. APHIS is no longer accounting for public burden for use of this form.

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 certification statements employed in this program for pork and pork products are not APHIS Veterinary Services forms, but are documents manufactured, completed, and signed by veterinary authorities in the exporting country. The certification statements employed in this program for live swine and swine semen is VS Form 17-129. All of these certifications must physically accompany the shipment to the United States, and must contain an original signature from both the collection center's veterinarian and the official veterinarian to be valid; therefore, electronic submission is not an available option.

APHIS and the private sector are working to develop electronic forms and certificates. These efforts have been further driven by the need for traceability, both in the animal health and trade arenas. There is not a current USDA-wide plan or solution for including e-signatures or

e-certificates or forms. Furthermore, VS regulations that govern international trade currently require “original certificates,” which implies an original signature from the issuing official and must physically accompany the shipment to the United States. APHIS is currently working to begin using e-certificates and forms and e-signatures and has identified program areas that could

provide a simple model for testing the implementation of e-certificates and forms and

e-signatures. APHIS anticipates this to occur in 2015.

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 communicable diseases of livestock from entering the United States.

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

Respondents are foreign Federal government officials and therefore are not considered small entities. The information APHIS is collecting in connection with this program is the minimum needed to ensure that CSF is not introduced into the United States via the importation of certain pork and pork products.

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 increase the chances of CSF being introduced into the United States. Even if the incursion was detected relatively early, an enormous amount of money and human resources would be needed to contain the outbreak and prevent the disease from successfully establishing itself in the United States. Such an effort would divert money and other resources from other vital disease prevention activities for which the Agency is responsible.

If the incursion was not detected soon enough, the disease would have an opportunity to establish itself in the swine population of the United States. An adverse event of this magnitude would require millions of dollars and years of effort to resolve.

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.

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.

In 2012, APHIS engaged in productive consultations with the following individuals concerning the information collection activities associated with this program:

Scott Dodson

Traffic Administrator

The Semex Alliance

130 Stone Road West

Guelph, Ontario NIG 3Z2

Canada

(519) 821-5060, ext. 222

David Preisler

Minnesota Pork Producers Association

151 Saint Andrews Court, Suite 810

Mankato, MN 56001

(507) 345-8814

Jeff Schnell

Agribusiness Association of Iowa

900 Des Moines Street

Des Moines, IA 50309

[email protected]

(515) 262-8323

On Wednesday, October 31, 2012, page 65953, 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. APHIS received one comment from an interested member of the public. This comment did not deal with paperwork burden. It was about the importation of live pigs into the United States and how they would be in immense pain from being slaughtered.

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 for hour burden estimates. Burden estimates were developed from discussions with Foreign Federal animal health authorities in the EU who will be completing the certificates necessary to export swine, pork and pork products, and swine semen to the United States.

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

The cost to the public was determined by multiplying the total number of burden hours, 7,504 times the wage per hour rate, $22.81. ($22.81 x 7,504 = $171,166.24). APHIS determined the estimated hourly wage of respondents through discussions with its International contacts, and by averaging the known salary of both junior and senior Government officials.

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 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 $401,220. (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	7,504	0	-6	-735	0	8,245
Annual Time Burden (Hr)	7,504	0	--3	-735	0	8,242
Annual Cost Burden ($)	0	0	0	0	0	0

When Veterinary Services evaluated the burden for the 3-year renewal of 0218, they realized that the same information is also being collected in 0579-0265. IC 0579-0265 was started because it was tied to a proposed rule in 2005. This merger will reduce redundancy in reporting the same activities twice for the Importation of Swine Pork Products, and Swine Semen from the European Union. No burden was added by merging 0265 with 0218. The annual responses and burden hours that were accounted for in 0579-0265 are part of the same 7,504 annual responses and 7,504 burden hours requested for this renewal.

There is a program change of -6 annual responses and -3 burden hours for the removal of VS Form 17-29. This form is completed by APHIS inspectors from information derived from the VS Form 12-129 so should not be counted as public burden.

There is an adjusted decrease of -9 respondents, resulting in a decrease of -735 annual responses and -735 burden hours. This decrease is a result of fewer companies importing swine semen due to a downturn in the economy.

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 01/18 approval of the information collection, explain the reasons that display would be inappropriate.

VS 17-129 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 this form.

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

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