2015 Ss 0228

SUPPORTING STATEMENT - OMB NO. 0579-0228

RESTRICTIONS ON IMPORTATION OF LIVE POULTRY, POULTRY MEAT, AND OTHER POULTRY PRODUCTS FROM SPECIFIED REGIONS

May 2016

NOTE: This is a reinstatement of a previously approved information collection with changes.

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 also may 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 Services (APHIS) ability to compete in the world market of animal and animal product trade. Veterinary Services (VS), a program within USDA APHIS, is responsible for administering regulations intended to prevent the introduction of animal diseases into the United States. Regulations in title 9, Code of Federal Regulations (9 CFR), parts 93 and 94, place certain restrictions on the export of live poultry, poultry meat, and other poultry products to prevent an incursion of highly pathogenic avian influenza (HPAI), Newcastle disease (ND), or other exotic poultry diseases into the United States.

The regulations in 9 CFR parts 93 and 94 allow the export of live poultry, poultry meat, and other poultry products from Argentina and the Mexican States of Campeche, Quintana Roo, and Yucatan under certain conditions. To ensure live poultry, poultry meat, and other poultry products from these areas do not pose a risk of bringing ND or other exotic poultry diseases into the United States, APHIS requires the following:

(1) An application for import or in-transit permit (VS 17-129)

(2) Completion of an import or in-transit permit customs declaration (VS 17-29)

(3) A report that the poultry have been offered for importation (VS 17-30)

(4) An additional health certificate issued by a full-time, salaried veterinary officer of the national governments of Argentina or Mexico.

Four information collection activities are required to allow poultry meat that originates in the United States to be shipped, for processing purposes, to a region where ND exists, and then returned to the United States. APHIS has determined that these items, imported in accordance with its requirements, pose a negligible risk of introducing ND into the United States. Importing these commodities from regions affected with ND requires the use of four information collection activities:

1. A certificate of origin that must be issued, including serial numbers that must be recorded,

2. Records that must be maintained,

3. Cooperative service agreements that must be signed, and

4. Certificates for shipment back to the United States.

The information provided by the documents is critical to APHIS' ability to prevent the spread of diseases capable of causing significant economic harm to the United States poultry industry.

APHIS is asking the Office of Management and Budget (OMB) to approve its use of these information collection activities for 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 collection activities to prevent the spread of HPAI, ND, and/or other exotic poultry diseases capable of causing significant economic harm to the U.S. poultry industry.

Application for Import or In-Transit Permit (for Live Animals, Animal Semen, Animal

Embryos, Birds, Poultry, and Hatching Eggs) (VS Form 17-129) (Business) - 9 CFR 93.101 & 93.201

Businesses or importers seeking to import poultry into the United States must complete an application (VS 17-129) to attain the permit (VS 17-29) allowing import of these commodities. The importer must provide his/her name, address, and telephone number as well as the name and address of the shipper in the country of origin. The importer must list the port of embarkation, the country from which the poultry or poultry products are to be shipped, and the mode of transportation. He/she must also describe the type, number, and identification of the animals or products to be exported. The importer must further list the origin, intended date and location of arrival, routes of travel, and destination of the animals or products. APHIS uses the permit applications to track, identify, and monitor animals and products entering the United States.

Import or In-Transit Permit (for Live Animals, Animal Semen, Animal Embryos, Birds,

Poultry, and Hatching Eggs), Customs Declaration (VS Form 17-29) (Business) - 9 CFR 93.101 & 93.201

Live poultry imported into the United States must be accompanied by this document under APHIS' import requirements. This form is completed by importers and is submitted at the time of import. These forms accompany each shipment imported and provide the following information:

• The date and port of arrival

• Import permit numbers

• The port of embarkation

• The name and address of the importer

• The name and address of the broker

• Carrier and vessel or flight number

• The name, number, and sex of each kind of live animal, poultry, or source of semen, embryos, or hatching eggs

• The purpose of importation

• The name and address of destination after release

Report of Animals, Poultry, or Hatching Eggs Offered for Importation (VS 17-30) (Business) -

9 CFR 93.206

This report is completed by port veterinary inspectors and given to the custodian to accompany the live poultry or hatching eggs being exported to the United States. The report documents poultry or hatching eggs sent into quarantine by number, breed, species, and purpose of importation. The form lists the port of entry, the country of origin, the importer, and the anticipated delivery site. It can also be used by VS when submitting specimens for testing at an approved laboratory. The form is further used by VS to document the release of quarantined poultry or eggs into the United States.

Health Certificate for Live Poultry, Poultry Meat, and Poultry Products (Foreign Government and Business) - 9 CFR 94.6 and 94.33

Live poultry, poultry meat, and other poultry products from Argentina and the Mexican States of Campeche, Quintana Roo, and Yucatan must be accompanied by a certificate issued by a full-time, salaried veterinary officer of the national governments of Argentina or Mexico. The certificate is prepared by veterinarians approved by their countries' national animal health service using information provided by exporters and other poultry industry personnel.

The health certificates include information regarding the identification and health certifications for animals being exported to the United States. APHIS uses it to evaluate health status and health compliance. The health certificate must accompany each shipment of poultry and be issued no more than 30 days before import.

In the case of live poultry, the health certificate must state that no poultry were vaccinated against any H5 or H7 subtype of avian influenza and that the shipment will not transit through any regions where APHIS considers HPAI to exist, as listed at http://www.aphis.usda.gov/import_export/animals/animal_import/animal_imports_hpai.shtml. The certificate must also state that the flocks of origin were vaccinated against ND at least 21 days before export, using vaccines that do not contain any velogenic strains of Newcastle disease virus. If the flocks of origin have not been vaccinated against ND, the health certificate should indicate this.

In the case of poultry meat or other poultry products, the certificate must state that (1) the poultry meat or other poultry products are derived from poultry that meet all requirements of 9 CFR 94.26 and have been slaughtered in a region designated in 9 CFR 94.6 as free of ND at a federally inspected slaughter plant under the direct supervision of a full-time salaried veterinarian of the national governments of Argentina or Mexico, and which is approved by the Food Safety and Inspection Service to export poultry meat and other poultry products to the United States in accordance with 9 CFR 381.196; (2) the poultry meat or other poultry products have not been in contact with poultry meat or other poultry products from any region where ND is considered to exist; (3) the poultry meat or other poultry products have not transited through a region where ND is considered to exist unless moved directly through the region in a sealed means of conveyance with the seal intact on arrival at the point of destination (the seal number is on the health certificate); and (4) if processed, the poultry meat or other poultry products were processed in a region designated in 9 CFR 94.6 as free of ND in a federally inspected processing plant under the direct supervision of a full-time salaried veterinarian of the national governments of Argentina or Mexico.

Certificate of Origin from the National Government (Foreign Government) 9 CFR 94.6(b)(5)(i) (new)

A Federal official from the ND-free exporting region must complete a certificate to accompany every shipment of poultry carcasses. The certificate must attest to the origin of the carcasses, identify the foreign processing establishment for which the carcasses are destined, and list the serial numbers from the seals applied to the shipping containers. When the shipment arrives at the foreign processing establishment, a Federal official for that region must sign the certificate, attesting that the seals on the containers were intact when the containers arrived at the establishment. The shipment may then be opened at the processing establishment.

Recordkeeping (Foreign Government) - 9 CFR 94.6(b)(5)(ii) (new)

The foreign government officials must maintain the signed certificates (Certificate of Origin from the National Government and the Certificate for Shipment Back to the United States) on file for at least 2 years after the carcasses are sent back to the United States. The certificates must be made available to USDA inspectors on request.

Cooperative Service Agreement (Foreign Government) - 9 CFR 94.6(b)(5)(iii) (new)

Before receiving and processing poultry carcasses for export to the United States, the operator of the foreign establishment must first enter into a cooperative service agreement with APHIS. Under this agreement, the operator agrees to 1) handle and process poultry in accordance with APHIS regulations; 2) allow APHIS representatives to enter the establishment unannounced to inspect its facilities, operations, and records; and 3) pay for the costs associated with these inspections. A copy of the cooperative service agreement is attached to this collection.

Certificate for Shipment Back to the United States (Foreign Government) - 9 CPR 94.6(b)(5)(iv) (new)

Poultry carcasses and parts of poultry carcasses to be imported to the United States must be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by a Federal official for that region. The shipments must be accompanied by a certificate, signed by a government official in the region where the poultry was processed, list the number of seals applied, and state that the shipment meets all APHIS conditions.

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 17-129 can be completed online and can be submitted electronically through the ePermits system at https://epermits.aphis.usda.gov/ePermits. The OMB statement is included on the form once the permit is printed.

The VS 17-29 is available electronically at http://www.aphis.usda.gov/library/forms and can be sent by facsimile once completed.

Form VS 17-30 is a five-part form requiring original signatures that includes a copy for Customs and Border Protection, a copy for the importer, a copy for the veterinarian at the destination, a copy for the quarantine station, and a final copy for the State of destination. A copy is also given to the importer to document the end of quarantine for imports of live animals; however, this form is available in VSPS at https://vsapps.aphis.usda.gov/vsps. The OMB statement is included on the form once the permit is printed.

The health certificate for live poultry, poultry meat, and poultry products must physically accompany the shipment is therefore not a candidate for electronic transmission.

The health certificates and VS17-30 listed in this information collection have been identified as part of the ITDS ACE project and APHIS is working with CBP to streamline the process. In addition, APHIS will publish a notice in the Federal Register removing the original signature requirement from the regulations.

The certificates used to allow poultry meat that originates in the United States to be shipped, for processing purposes, to a region where ND exists, and then returned to the United States are documents manufactured, completed, and signed by veterinary authorities in the exporting countries. The certificates must physically accompany shipments to the United States and must include an original signature from the authorizing veterinarians for validation. Therefore, they are not candidates for electronic transmission. The cooperative service agreement also requires an original signature.

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 Federal agency responsible for preventing the introduction of foreign 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 ND risk associated with poultry and poultry product imports from ND-affected regions. Approximately 88 percent of U.S. importers are considered small entities. The exporters and veterinarians preparing the required health certificate are foreign individuals 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 at all, APHIS would be unable to establish an effective defense against the incursion of HPAI and ND from import poultry and poultry products. This could have serious health consequences for United States poultry and economic consequences for the United States 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.

• 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.

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.

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

Dr. Shelly McKee

Director of Technical Services

USA Poultry & Egg Export Council

2300 West Park Place Blvd., Suite 100

Stone Mountain, GA 30087

Phone: 334-750-2827

Email: [email protected]

Ashley Peterson, Vice President of Scientific and Regulatory Affairs

National Chicken Council

1152 15th Street NW, Suite 430

Washington, DC, 20005

Phone: 202-296-2622

Email: [email protected]

Lisa Wallenda Picard, Vice President

Scientific and Regulatory Affairs

National Turkey Federation

1225 New York Ave. NW, Suite 400

Washington, DC 20005

Phone: 202-898-0100

Email: [email protected]

On Thursday, March 24, 2016, pages 15677-15678, 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 remuneration of contractors or grantees.

Per the cooperative service agreement there is a pay for the costs associated with inspections.

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 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 Argentinean and Mexican Federal animal health authorities, industry representatives (mainly exporters), and importers who complete the documents necessary to export poultry, poultry meat, and other poultry 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.

APHIS estimates the total annualized cost to these respondents to be $5,572.42. APHIS arrived at this figure by multiplying the total burden hours (222 hours) by the estimated average hourly wage of the above respondents ($25.11). Respondents are full-time, salaried veterinary officers employed by the governments of Argentina and Mexico, industry representatives, and United States importers. (Veterinary officer respondents ($36.10), United States importer respondents ($22.11), and exporters

($17.11) derived from the United States Department of Labor; Bureau of Labor Statistics May 2015 Report - Occupational Employment and Wages in the United States. See http://www.bls.gov/oes/current/oes_stru.htm

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.

Per the cooperative service agreement there is a pay for the costs associated with inspections. There is a cost associated with the use of the ePermits system.

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 $13,180. (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.

	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	222	0	222	0	0	0
Annual Time Burden (Hr)	224	0	224	0	0	0
Annual Cost Burden ($)	0	0	0	0	0	0

This reinstatement is a program change resulting in increase of +22 respondent and +222 responses resulting in an increase of +224 burden hours.

APHIS has added the following reporting activities to information collection 0579-0288:

• Certificate of Origin from the National Government

• Recordkeeping

• Cooperative Service Agreement

• Certificate for Shipment Back to the United States

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.

VS Forms 17-29 and 17-129 are used in multiple OMB-approved collections; therefore

APHIS is seeking approval to not display the OMB expiration date on these forms. VS Form 17-30 will display the expiration date.

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

APHIS is able to certify compliance with all the provisions under the Act.

B. Collections of Information Employing Statistical Methods

Statistical methods will not be used in this information collection.