0230 SS 2017 Final

July 11, 2017

SUPPORTING STATEMENT

IMPORTATION OF LIVE SWINE, PORK, AND PORK PRODUCTS

FROM CERTAIN REGIONS FREE OF

CLASSICAL SWINE FEVER (CSF) IN

CHILE, MEXICO, AND BRAZIL

OMB NO. 0579-0230

Introduction

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 (ARPA) 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.

Disease prevention is the most effective method for maintaining a healthy animal population and for enhancing the Animal and Plant Health Inspection Service’ (APHIS’) ability to compete globally in animal and animal product trade.

As part of this mission, the U.S. Department of Agriculture (USDA), APHIS, regulates the importation of animals and animal products to prevent the introduction of animal diseases such as classical swine fever (CSF). To that end, APHIS’ animal import regulations in Title 9, Code of Federal Regulations (9 CFR), chapter 1, subchapter D, part 94, place certain restrictions on the importation of swine, pork, and pork products into the United States.

Chile: Importing these commodities from Chile continues to pose an undue risk of introducing CSF into the United States, for several reasons. First, Chile supplements its pork supplies by importing fresh (chilled or frozen) pork from CSF-affected regions. Second, Chile shares a common land border with CSF-affected regions. Third, Chile imports swine from CSF-affected regions under less restrictive conditions than the United States considers acceptable for importation.

Mexico: The Mexican States of Baja California, Baja California Sur, Campeche, Chihuahua, Nayarit, Quintana Roo, Sinaloa, Sonora, and Yucatan are on the list of regions in 9 CFR 94.9 (a)(1) and 9 CFR 94.10 (a)(1), considered free of CSF and allowed to export live swine, pork, and pork products into the United States. Importation of these commodities continues to pose the risk of disease introduction as these States supplement their pork supplies by importing fresh (chilled or frozen) pork from regions affected with CSF, from regions with a common land border with such regions, or import swine from such regions under less restrictive conditions considered acceptable for importation into the United States.

Brazil: The Brazilian State of Santa Catarina has been added to the list of regions in 9 CFR 94.9(a)(1) and 9 CFR 94.10(a)(1) considered free of CSF and allowed to export live swine, pork, and pork products into the United States. Importation of these commodities continues to pose the risk of disease introduction as this State supplements their pork supplies by importing fresh (chilled or frozen) pork from regions affected with CSF, share a common land border with such regions, or import swine from such regions under less restrictive conditions considered acceptable for importation into the United States.

APHIS is asking OMB to approve, for an additional 3 years, its use of these information collection activities to ensure swine, pork, and pork products from Chile, the Brazilian State of Santa Catarina, and the Mexican States of Baja California, Baja California Sur, Campeche, Chihuahua, Nayarit, Quintana Roo, Sinaloa, Sonora, and Yucatan pose a negligible risk of introducing CSF into the United States.

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 collection activities to ensure swine, pork, and pork products from Chile, the Brazilian State of Santa Catarina, and the Mexican States of Baja California, Baja California Sur, Campeche, Chihuahua, Nayarit, Quintana Roo, Sinaloa, Sonora, and Yucatan pose a negligible risk of introducing CSF into the United States.

(9 CFR 94.9, 9 CFR 94.10, and 9 CFR 94.32) - Certification for Live Swine, Pork, and Pork Products (Foreign Government – Mexico, Chile, and Brazil) - This information collection provides data to ensure regulatory compliance for mitigation of CSF from imports of swine, pork, and pork products into the United States. One requirement is completion of a certificate issued by a salaried veterinary officer of the Governments of Mexico, Chile, and/or Brazil to accompany swine, pork, and pork products from their respective regions. The certificate must identify both the exporting region and the region of origin as designated in 9 CFR 94.9, 9 CFR 94.10, and 9 CFR 94.32 as free of CSF at the time the swine, pork, or pork products were in the region. This certificate gives APHIS essential information regarding the origin and history of the commodities presented for import into the United States.

In the case of live swine, the certificate must state: (1) the swine have not lived in a region designated in sections 94.9 and 94.10 as affected with CSF; (2) the swine have never been commingled with swine that have been in a region that is designated in sections 94.9 and 94.10 as affected with CSF; (3) the swine have not transited through a region designated in sections 94.9 and 94.10 as affected with CSF unless moved directly through the region to their destination in a sealed conveyance with the seal intact upon arrival at the point of destination; and (4) the equipment or materials used in transporting the swine, if previously used for transporting swine, have been cleaned and disinfected in accordance with the requirements of part 93.

Regarding pork and pork products, the certificate must state: (1) the pork or pork products were derived from swine born and raised in a region designated in 9 CFR 94.32 as free of CSF, and were slaughtered in such a region at a federally-inspected slaughter plant under the direct supervision of a full-time salaried veterinarian of the Governments of Mexico, Chile, or Brazil, and the region is eligible to have its products imported into the United States under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.); (2) the pork or pork products have never been commingled with pork or pork products having been in a region designated in 9 CFR 94.9 and 9 CFR 94.l0 as affected with CSF; (3) the pork or pork products have not transited through a region designated in sections 94.9 and 94.10 as affected with CSF unless moved directly through the region to their destination in a sealed means of conveyance with the seal intact upon arrival at the point of destination; and (4) if processed, the pork or pork products were processed in a region designated in sections 94.9 and 94.10 as free of CSF in a federally inspected processing plant that is under the direct supervision of a full-time salaried veterinary official of the Government of Mexico, Chile, or Brazil.

(9 CFR 94.9) - Compliance Agreement (Business) - A compliance agreement is required by the operators of the processing establishment located in a non-CSF free region processing pork products from CSF free regions. The operator must sign a compliance agreement stating all meat processed for importation to the United States will be processed in accordance with the requirements of APHIS.

(9 CFR 94.9) - Cooperative Service Agreement (Business) - A cooperative service agreement is required by the processing establishment located in a non-CSF free region that processes pork products from CSF free regions, or a party on its behalf, must enter into a cooperative service agreement with APHIS to pay all expenses incurred by APHIS for the initial evaluation of the processing establishment and periodically thereafter.

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 certificate of certification for live swine, port, and pork products must physically accompany the shipment and requires an original signature from the authorizing veterinarian to be valid. The certificate is therefore not a candidate for electronic submission at this time.

The compliance agreement and the cooperative service agreement also require original signatures and are therefore not eligible for electronic submission at this time.

However, APHIS is involved with the Government-wide utilization of the International Trade Data System (ITDS) via the Automated Commercial Environment (ACE) to improve business operations and further Agency missions.  This will allow respondents to submit the data required by U.S. Customs and Border Protection and its Partner Government Agencies (PGAs), such as APHIS, to import and export through a Single Window concept.  APHIS is also establishing a system known as e-File for CARPOL (Certification, Accreditation, Registration, Permitting, and Other Licensing) activities.  This new system will strive to automate some of these information collection activities.  The system is still being developed and business processes continue to be identified and mapped.

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 introduction of exotic animal 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 is the absolute minimum needed to effectively evaluate the CSF risk associated with Mexican, Chilean, and Brazilian swine, pork, and pork product imports. The veterinarians who complete the required forms are considered foreign entities and thus are not "small entities" for purposes of Executive Order 12866 or the Regulatory Flexibility Act.

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, APHIS would be unable to establish an effective defense against the entry and spread of CSF from Mexican, Chilean, and Brazilian swine, pork, and pork product imports. This would cause serious health consequences for U.S. swine and economic consequences for the U.S. pork 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:

• requiring respondents to report informa­tion to the agency more often than quarterly;

• 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.

APHIS held consultations with the following individuals concerning the information collection activities associated with this program:

Laurie L. Bryant, Executive Director

Meat Importers Council of America, Inc.

1901 North Fort Myer Drive

Arlington, VA 22309

703-522-1910

Ms. Courtney Knupp

Deputy Director of International Trade Policy,

Sanitary and Technical Issues

National Pork Producers Council

122 C Street, N.W., Suite 875

Washington, D.C. 20001

202-347-3600

Lisa Frohn

Topigs Norsvin USA

12750 Nicollet Ave. S. Suite 300

Burnsville, Minnesota 55337

507-273-1316

On Tuesday, March 28, 2017, pages 15319-15320, 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. 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 bow 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 13of OMB Form 83-I.

See APHIS Form 71. Burden estimates were developed from discussions with Federal animal health authorities in Mexico and Chile who complete the certificates necessary to export swine, pork, and pork products 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.

Respondents are full-time, salaried veterinary officers employed by the Governments of Mexico, Chile, or Brazil. APHIS estimates the total annualized cost to these respondents to be $173,769.75. APHIS arrived at this figure by multiplying the total burden hours (3,009) by the estimated average hourly wage of the above respondents ($57.75).

The hourly rate for Chilean, Mexican, and Brazilian Federal veterinarians was determined through consultations with APHIS animal health specialists based in Chile, Mexico, and Brazil.

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 $202,345 (see APHIS Form 79).

15. Explain the reasons for any program changes or adjustments reported in Items 13 or14 of the OMB Form 83-1.

	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	3,009	0	0	2,241	0	768
Annual Time Burden (Hr)	3,009	0	0	2,241	0	768

In this renewal, the number of respondents stayed the same at 11, the annual responses increased from 768 to 3,009, and the burden hours increased from 786 to 3,009. The demand for imported pork and pork products has increased since the last renewal and thus the number of certificates issued by foreign veterinarians has increased. As a result, there is an adjustment increase of 2,241 responses resulting in an increase of 2,241 burden 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 the 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.

There are no APHIS forms associated with this information collection.

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

Statistical methods are not employed in this information collection activity.