0015 Ss 20191115

SUPPORTING STATEMENT - OMB NO. 0579-0015

RESTRICTED, Prohibited, AND CONTROLLED IMPORTATION OF ANIMAL AND POULTRY PRODUCTS AND BYPRODUCTS INTO THE UNITED STATES

May 2019

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 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 Animal Health Inspection Service’s (APHIS’) ability to compete globally in animal and animal product trade. In connection with this mission, APHIS enforces regulations regarding both the importation of controlled materials and the prevention of foreign animal disease incursions into the United States. These regulations can be found at title 9, chapter I, subchapter D, parts 94, 95, 96, and 122 of the Code of Federal Regulations (CFR). APHIS engages in a number of information collection activities to prevent or control the spread of livestock diseases via the importation of restricted and controlled animal products into the United States.

APHIS is asking the Office of Management and Budget (OMB) to approve, for 3 years, its use of these information collection activities in connection with APHIS’ efforts to prevent or control the spread of livestock diseases via the importation of restricted and controlled animal products 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 activities to enforce regulations regarding both the importation of controlled materials and the prevention of animal disease incursions into the United States:

Certificate from Inspector Stating Conveyance Has Been Cleaned (Federal Government)

9 CFR 94.5(c)(2)(ii)

During pre-clearance at foreign ports of exit, garbage on or removed from a vehicle is considered regulated garbage if the vehicle has been in any port outside the United States and Canada within the previous 2 years. However, garbage on or removed from a vehicle (other than an aircraft) is exempt from APHIS restrictions if the vehicle is accompanied by a certificate from an inspector of the foreign government stating that the vehicle was cleared of all garbage, cleaned, and disinfected in the presence of said inspector. This is performed to provide USDA assurances that there will be no introduction of exotic animal and plant pests. The certificate must physically accompany the shipment.

Approved Warehouse Request and Agreement to Handle Restricted Animal Byproducts (Hunting Trophies & Museum Specimens) (VS 16-28) (Business/Not For Profit)

9 CFR 94.6(b)(2), 95.17(c), 95.24(c)
Restricted animal products, byproducts, and controlled materials, including carcasses or parts or products of carcasses of poultry, game birds, and other birds (for both nonprofit and business uses) may be imported for consignment to any museum, educational institution, or other establishment if, among other requirements, the establishment is inspected and approved by USDA using the VS Form 16-28. The VS 16-28 serves as an inspection report to help ensure that USDA-approved establishments are handling restricted and controlled imports in compliance with APHIS regulations. The VS 16-28 is completed by a United States Federal animal health official who acquires this information from United States establishment operators.

Approved Establishment Request and Agreement to Handle Restricted Animal Byproducts (Hunting Trophies & Museum Specimens) (VS 16-29 (Business) - 9 CFR 94.6(b)(2), 95.17(c), 95.24(c)

Restricted animal products, byproducts, and controlled materials, including carcasses or parts or products of carcasses of poultry, game birds, and other birds, may be imported for consignment to any not-for-profit museum, educational institution, or other establishment if, among other requirements, the establishment officer signs the VS 16-29. The VS 16-29 gives APHIS evidence that the establishment officer has the equipment, facilities, and capabilities to store, handle, process, or disinfect such articles to prevent the introduction or dissemination of Newcastle disease (ND), foot-and-mouth disease (FMD), African swine fever (ASF), highly pathogenic avian influenza (HPAI), classical swine fever (CSF), and rinderpest into the United States. The form also shows, by completion and endorsement of the form by APHIS officials, that APHIS has approved the establishment.

Application for Permit to Import Controlled Bird Carcasses (VS 16-3) (Business/Not For Profit) - 9 CFR 94.6(b)(2)

Carcasses or parts or products of carcasses of poultry, game birds, and other birds from regions where ND and HPAI is considered to exist, and that do not otherwise qualify for importation, may be imported (for nonprofit and business uses) only if the importer, using the VS 16-3, applies for and is granted a permit by APHIS authorizing such importation. The products must be moved and handled as specified on the permit. The applicant must state the mode of transportation; any U.S. ports of entry; the name, organization, complete address, and telephone/fax number of both the shipper and receiver; fully describe the material to be imported and the expected use; the quantity and frequency of importation; any treatment of the material before importation; and proposed disposition. This information enables APHIS to carefully scrutinize the products and determine what, if any, disease threat they may pose to the U.S. poultry population. If APHIS decides to issue an import permit, information on the VS 16-3 also enables APHIS to determine the appropriate safeguard measures. APHIS can then provide port and border personnel with appropriate clearance instructions for the impending shipment.

Application for Import of Eggs, Other than Hatching Eggs, in Specific Cases for Research or When Cooked or Processed (VS 16-3) (Business/Not For Profit) - 9 CFR 94.6(c)(3)

Before leaving the premises of origin, the cases in which the eggs are packed must be sealed with the seal of the national government by the accredited veterinarian who signed the certificate. The seal is documented on the Certificate for Importation of Eggs and requires no other paperwork. Hatching eggs, from regions where ND and HPAI is considered to exist, may be imported into the United States if they are to be used for scientific, educational, or research purposes; or if they have been cooked or processed; and if APHIS has determined that the eggs can be imported under conditions that will prevent the introduction of ND and HPAI into the United States. Not for profit importers must obtain an APHIS-issued import permit before importation by completing the permit application and submitting it to APHIS in writing or electronically.

Application for Permit to Import or Transport Controlled Material or Organisms or Vectors (Eggs) (VS 16-3) - (Business/Not For Profit) - 9 CFR 94.6(c)(3)&(4)

Eggs, other than hatching eggs, from regions where ND or HPAI has been determined to exist, may be imported into the United States if they are to be used by not for profit entities for scientific, educational, or research purposes, or if they have been cooked or processed, and if APHIS has determined that the eggs can be imported under conditions that will prevent the introduction of ND or HPAI into the United States. Importers must obtain an APHIS-issued import permit before importation by completing the permit application and submitting it to APHIS in writing or electronically. The eggs must be moved and handled as specified on the permit. The applicant must state the mode of transportation; any U.S. ports of entry; the name, organization, complete address, and telephone or fax number of both the shipper and receiver; fully describe the material to be imported and the expected use; the quantity and frequency of importation; any treatment of the material before importation; and proposed disposition.

Application for Permit to Import or Transport Controlled Material or Organisms or Vectors (Milk) (VS 16-3) - (Business/Not For Profit) - 9 CFR 94.6(c)(3)

Small amounts of milk and milk products from regions where FMD or rinderpest has been determined to exist may under certain circumstances be imported for examination, testing, or analysis. The business or not for profit importer must be granted a permit through the VS 16-3 application after which APHIS will authorize such importation. The applicant must state the mode of transportation; any U.S. ports of entry; the name, organization, complete address, and telephone/fax number of both the shipper and receiver; fully describe the material to be imported and the expected use; the quantity and frequency of importation; any treatment of the material before importation; and proposed disposition.

Place Placards on Vehicles and Statements on Manifest, Bills of Lading, or Waybills (Business) - 9 CFR 95.36(a)

Transportation companies or operators of cars, trucks, or other vehicles carrying import products or materials moving under restriction, other than those in tight cases or casks, must affix to and maintain on both sides of all such vehicles, durable placards not less than 5 ½ by 6 inches in size, on which must be printed with permanent black ink and in boldface letters not less than 1½ inch in height, the words: “Restricted Import Product, Clean and Disinfect Car or Truck.” Each of the waybills, conductors’ manifests, memoranda, and bills of lading for such shipments must have the words: “Restricted import product, clean and disinfect car or truck,” plainly written or stamped on its face.

Certification of a National Government for Gelatin from Non-Bovine Spongiform Encephalopathy (BSE) Countries or from Non-bovine Species (Federal Government)

9 CFR 94.24(a)

Gelatin derived from horses or swine, or from ruminants that have not been in any region listed in

9 CFR 94.24(a), must, at the time of entry into the United States, be accompanied by an official certificate issued by the government of the region of origin. The certificate must state the species of animal the gelatin is derived from, or if the gelatin is derived from ovines or caprines, certify that the gelatin is not derived from ovines or caprines that have been in any region listed in 9 CFR 94.24(a).

Certificate of Importation of Eggs, other than Hatching Eggs (Foreign Government)

9 CFR 94.6(c)(1)

Eggs, other than hatching eggs, from regions where ND has been determined to exist, may be imported into the United States only in accordance with 9 CFR 94.6(c). This regulation requires that the eggs be accompanied by a certificate endorsed by the government of the region of origin, or, if from Mexico, by a certificate issued by a veterinarian accredited by the national government of Mexico and endorsed by a full-time salaried veterinary officer of the national government of Mexico. The endorsement indicates that the veterinarian was authorized to issue the certificate.

The salaried veterinary officer of the national government of the region of origin must identify on the certificate the flock of origin, the region of origin, the port of embarkation, the port of arrival, the name and address of the exporter and importer, the total number of eggs (and cases of eggs) shipped with the certificate, and the date the certificate was signed. The eggs qualify for importation in accordance with 9 CFR 94.6(c) if, no more than 90 days before the certificate was signed, a salaried veterinarian accredited by the national government inspected the flock of origin and found no evidence of communicable diseases of poultry; no ND or highly pathogenic avian influenza (HPAI) occurred on the premises of origin or on adjoining premises during the 90 days before the certificate was signed; there is no evidence that the flock of origin was exposed to ND or HPAI during the 90 days before the certificate was signed; the eggs are from a flock of origin found free of ND; and egg drop syndrome (EDS) is notifiable in the region of origin and there have been no reports of EDS in the flocks of origin of the eggs, or within a 50-kilometer radius of the flock of origin, for the 90 days before issuance of the certificate. The certificate must physically accompany the shipment.

Certificate Issued by a National Government for Importation of Hides and Skins (Foreign Government) - 9 CFR 95.16(a)

Governments of the regions of origin must complete a certificate bearing the seal of the proper department. The certificate ensures that abattoir hides or skins taken from animals slaughtered under government supervision were taken from animals slaughtered in the specified abattoir and found free from anthrax, FMD, and rinderpest. The certificate must physically accompany the shipment.

Certificate of a National Government for Import of Wool, Hair, Bristles (Foreign Government) - 9 CFR 95.18(c)

Governments of the regions of origin must complete a certificate bearing the seal of the proper department. The certificate ensures that the described wool, hair, or bristles were taken from animals slaughtered in the specified abattoir and found free from anthrax, FMD, and rinderpest. The certificate must physically accompany the shipment.

Certificate of a National Government for Import of Glue Stock (Federal Government)

9 CFR 95.20(a), (b), & (c)

Glue stock originating in and shipped directly from a region recognized by APHIS as free of FMD or rinderpest may be imported into the United States without other restrictions, if, in addition to compliance with other APHIS regulations, the government of the region of origin provides a certificate bearing the seal of the proper department and signed by an official veterinary inspector. The certificate must show that the glue stock was taken from animals slaughtered in the specified abattoir and found free from anthrax, FMD, and rinderpest. The certificate must physically accompany the shipment.

Permission to Permit to Import Stomachs of Ruminants or Swine (Business/Not For Profit)

9 CFR 95.30

Importers, both nonprofits and businesses, must submit a written VS import permit application to APHIS to receive stomachs or portions of the stomachs of ruminants or swine, other than those imported for food purposes under USDA meat-inspection regulations. The import permit application asks for the exporter, a description of the permitted material, the proposed use of the imported material, final disposition of the permitted material, and any treatments to the imported material that may inactivate diseases of APHIS concern. Permitted imports will be subject to any restrictions that APHIS deems necessary.

Permission to Import Animal Manure (VS 16-3) (Business/Not For Profit) - 9 CFR 95.31

Importers, both nonprofits and businesses, must submit a written VS import permit application to APHIS to receive manure of horses, cattle, sheep, other ruminants, and swine. The import permit application asks for the exporter, a description of the permitted material, the proposed use of the imported material, final disposition of the permitted material, and any treatments to the imported material that may inactivate diseases of APHIS concern. Permitted imports will be subject to any restrictions that APHIS deems necessary. Manure produced by animals transiting to the United States will be subject only to the USDA regulations governing the import of domestic livestock and other animals.

Report of Telegraph Emergency Unloading of Restricted Import Products (Business)

9 CFR 95.36(b)

If it is necessary to unload, en route, any restricted material or products transported in a placarded car, truck, or other vehicle, the carrier must then clean and disinfect the vehicle and any part of a premises that may have had contact with the material or product during unloading or reloading. The carrier must report the unloading incident to the VS Deputy Administrator. This report must include such information as the nature of the emergency, the place where the material was unloaded, the original points of shipment and destination, the number and materials of the original vehicle, and the number and initials of the vehicle into which the material was reloaded in case the original vehicle was not used.

Certificate from a National Government for Importation of Foreign Animal Casings (Foreign Government) - 9 CFR 96.3

No animal casings can be imported into the United States from any foreign region unless they are accompanied by a certificate completed and signed by the government of the region where the animals were slaughtered and the casings collected, or by a non-government veterinarian authorized by the national government stating that the casings meet the criteria described in the Foreign Official Certificate for Animal Casings. A certificate issued by a non-government veterinarian is valid only if the certificate is endorsed by a veterinarian salaried by the national government of the region in which the animals were slaughtered and the casings were collected. This document certifies that the animals from which casings were derived were healthy and underwent veterinary inspection. It also certifies that the casings were clean, sound, and handled in a sanitary manner, and describes the kind of casings, their weight, and their packaging. The certificate must physically accompany the shipment.

Compliance Agreement (Handling/Disposing of Regulated Garbage) (PPQ Form 519) (Business) - 9 CFR 94.5(e)

Any business engaged in handling or disposing of regulated garbage must first enter into a compliance agreement stating that the person agrees to comply with all APHIS regulations regarding this activity. Specifically, the business agrees to:

• Allow inspectors access to all records maintained by the person regarding handling or disposal of garbage, and to all areas where handling or disposal of garbage occurs;

• If the garbage is regulated under 9 CFR 94.5(c) (garbage generated onboard a conveyance), remove garbage from a means of conveyance only in tight, covered, leakproof receptacles;

• If the garbage is regulated under 9 CFR 94.5(d) (garbage generated in Hawaii), transport garbage interstate in sealed, leak proof packaging approved by the Administrator;

• Move the garbage only to a facility approved by the Administrator; and

• At the approved facility, dispose of the garbage in a manner approved by the Administrator and described in the compliance agreement.

The compliance agreement helps APHIS ensure that regulated garbage is handled and disposed of in such a way as to prevent the dissemination of livestock or poultry diseases into or within the United States. Although APHIS requires the compliance agreement to be completed, the Agency does not complete, review, or receive these documents; Customs Border Patrol receives them.

Application for Permit to Import or Transport Controlled Material or Organisms or Vectors

(VS 16-3) (Business) - 9 CFR 122

United States importers, both nonprofits and businesses, must submit an application in writing to APHIS for permission to import organisms or vectors into the United States, or transported from one State, Territory, or the District of Columbia to another State, Territory, or the District of Columbia. The application contains the importer’s name, address, telephone number, fax number, a description of the products to be imported, the quantity and frequency of importation, the proposed use of the material, a description of the applicant’s facilities for handling the material, the qualifications of the technical personnel who will be working with the material, and a description of any processing the material may have undergone before entering the United States. This information enables APHIS to scrutinize the products and determine what, if any, disease threat they may pose to the U.S. livestock population. If APHIS decides to issue an import permit, information on the VS 16-3 enables officials to determine the appropriate safeguarding measures for the importation. APHIS can then provide port and border personnel with appropriate clearance instructions.

Appeal of Denial or Cancellation of Compliance Agreement or Request for a Hearing (Business) - 9 CFR 94.5

APHIS may initiate denial or cancellation of a compliance agreement at any time if APHIS determines the requirements set forth in the agreement are not being met. The owner or operator of the facility whose agreement has been canceled may appeal APHIS’ decision, in writing, within 10 days of receiving written notification of the cancellation. The appeal must state all of the facts and reasons on which the person relies to show that the compliance agreement was wrongfully canceled.

Certificate of Origin for Milk and Milk Products from Regions Free of FMD and Rinderpest (Business) - 9 CFR 94.16(d)

Except for milk and milk products imported from Canada, milk or milk products imported from a region listed as free of rinderpest and FMD must be accompanied by a certificate endorsed by a full-time salaried veterinarian employed by the region of export. The certificate, which is completed by the foreign government, must state that the milk was produced and processed in a region recognized as free of rinderpest and FMD or that the milk product was processed in a rinderpest and FMD-free region from milk produced in a rinderpest and FMD-free region. The certificate must name the region where the milk was produced and the region where it was processed. Further, the certificate must state—except for movement that occurs under seal—that the milk or milk product has never been in any region where rinderpest or FMD exist.

Marking Requirements (for eggs from regions with ND) (Foreign Government)

9 CFR 94.6(c)(1)(i)

Eggs, other than hatching eggs from regions where ND has been determined to exist, may be imported into the United States only if they are in cases marked by an official of the government of the region of origin with the identity of the flock of origin.

Government Seals (Foreign Government) - 9 CFR 94.6

Before leaving the premises of origin, the cases in which the eggs are packed must be sealed with the seal of the national government by the accredited veterinarian who signed the certificate. The seal is documented on the Certificate for Importation of Eggs and requires no other paperwork.

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 16-28 is obtained from the VS District Office. The form requires original signatures and cannot currently be submitted electronically. However, APHIS continues to work to make the form available for submission via its Veterinary Services Processes Streamlining system.

The VS 16-29 requires an original signature and therefore is not a candidate for electronic submission at this time. However, APHIS continues to work to make the form available for submission via its Veterinary Services Processes Streamlining system. This system is currently used at headquarters and APHIS is working to extend its availability to the field.

The VS 16-3 is available to the public electronically at: http://www.aphis.usda.gov/forms/vs16-3.pdf or at http://www.aphis.usda.gov/animal_health/permits/downloads/vs16_3.pdf.

In addition to faxing and mailing respondents may submit the VS 16-3 electronically through the e-Permits at https://epermits.aphis.usda.gov/epermits.

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), 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.

The Compliance Agreement PPQ Form 519 is available electronically on the APHIS website https://www.aphis.usda.gov/library/forms/pdf/ppq519.pdf.

The Certificate from Inspector Stating Conveyance is Clean must physically accompany the conveyance; therefore, it is not a candidate for electronic submission.

The Certification of a National Government for Gelatin from Non-BSE Countries or from Non-Bovine Species must physically accompany the shipment; therefore, it is not a candidate for electronic submission.

The Certificate of a National Government for Importation of Hides and Skins must physically accompany the shipment; therefore, it is not a candidate for electronic submission.

The Certificate of a National Government for Import of Wool, Hair, or Bristles must physically accompany the shipment; therefore, it is not a candidate for electronic submission.

The Certificate of a National Government for Import of Glue Stock must physically accompany the shipment; therefore, it is not a candidate for electronic submission.

The Report of Emergency Unloading of Restricted Import Products could be recorded electronically but APHIS does not currently have the capability for electronic submission of such reports.

The Certificate of a National Government for Importation of Foreign Animal Casings must physically accompany the shipment; therefore, it is not a candidate for electronic submission.

The Certificate of Importation of Eggs, other than Hatching Eggs must physically accompany the shipment; therefore, it is not a candidate for electronic submission.

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 that APHIS collects in connection with this effort is not available from any other source. APHIS is the only Federal Agency responsible for preventing diseases of animal, poultry products, and byproducts 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.

The information APHIS collects is the absolute minimum needed to protect the United States from the introduction and spread of animal diseases by importing foreign animal and poultry byproducts, organisms, and vectors. APHIS estimates that no business respondents are small entities involved with 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 this information were collected less frequently or not collected, the United States would be at increased risk for the introduction of rinderpest, FMD, ASF, CSF, SVD, ND, or HPAI. This would cause serious economic consequences to several United States livestock industries and potentially serious health consequences for United States livestock.

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;

Appeal of Denial or Cancellation of Compliance Agreement or Request for a Hearing - The owner or operator of the facility whose agreement has been canceled may appeal APHIS’ decision, in writing, within 10 days of receiving written notification of the cancellation.

• 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 3 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 other 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 engaged in productive consultations with the following individuals concerning the information collection activities associated with this program. We discussed with them how we and they obtain the necessary data and how frequently; how much data is available; the convenience and clarity of reporting formats and other collection instruments. The respondents stated via email or phone that they had no concerns with any of these items and had no further recommendations.

Ellen Paul

The Ornithological Council

5107 Sentinel Drive

Bethesda, MD 20816

301-986-8568

[email protected]

C. Matthias Rebmann

Lipoid LLC

744 Broad Street, 16^th Floor

Newark, NJ 07102

973-735-2692

[email protected]

Catherine Kerr

IDEXX Laboratories

One IDEXX Drive

Westbrook, ME 04092

207-556-0300

[email protected]

On Thursday, December 27, 2018, pages 66672-66673, Volume 83, No. 247, 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 this time, APHIS received 2 comments from the public. The first comment from a concerned citizen regarding meat processing and contamination risk. APHIS governs the protection of animal health by detecting, controlling, and eradicating pest and disease of livestock and poultry. Meat processing and safeguarding against contamination is governed by USDA Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA); therefore it is irrelevant to this APHIS information collection. The other comment was from a concerned citizen, who expressed her opinion that the importation of all animal products from foreign countries should be shut down. It had 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. 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.

• 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 annual cost to these respondents to be $13,456,511.64. APHIS arrived at this figure by multiplying the hours of estimated total burden (427,734 hours) by the sum of estimated average hourly wage + benefits of the above respondents ($21.49+9.95=31.46).

1. Mexican government officials estimate the average hourly wage for foreign government officials, animal health officials, and inspectors to be $14.25.

2. The estimated hourly wage of full-time salaried veterinarians employed by the region of export is $24.87. This figure was arrived at by the average of the following contacts: The Canadian Food Inspection Agency ($57.86); the APHIS contact in the South Africa ($4.38); and the Mexican government ($12.39).

3. Industry contacts provided the hourly wage of managers of foreign facilities that process restricted animal materials to be $61.97.

4. The Department of Labor’s (DOL) Web site indicates the average hourly wage of importers (adjusted for inflation 15 percent) to be $9.98.

5. The Laborsta International Web site indicates the average hourly wage for exporters for agriculture, meat, and foods, adjusted for inflation to be $11.83.

6. The DOL Web site indicates the average hourly wage (adjusted for inflation 15 percent) of individuals transiting various commodities not eligible for importation into the United States to be $9.99.

7. The DOL Web site indicates the average hourly wage of transportation companies, carriers, or operators of cars, trucks, or other vehicles (adjusted for inflation 15 percent) to be $17.56.

The hourly rates for respondents of foreign countries were derived from the following source: Laborsta International Web site and consultations with foreign industry contacts The hourly rates for U.S. respondents were derived from the is the hourly rate derived from the U.S. Department of Labor, Bureau of Labor Statistics May 2018 Report - Occupational Employment and Wages in the United States. See http://www.bls.gov/news.release/pdf/ocwage.pdf.

Benefits = wages X 46.4% (21.49 X 0.464 = $9.97)

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, 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 $36,126,479.38. (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	216,399	0	0	0	216,399	0
Annual Time Burden (Hr)	427,734	0	0	0	427,734	0
Annual Cost Burden ($)	0	0	0	0	0	0

This is a reinstatement of a previously approved information collection resulting in a program change of + 3,437 respondents and 216,399 annual responses and 427,734 annual burden hours.

APHIS included the burden from discontinued information collection 0579-0397 “Prohibited and Restricted importation of Animal and Poultry products (Milk, Eggs), into the United States” which is being reported as a Change Due to Potential Violation of the PRA.

From 0579-0015 there were 3,209 Respondent, 12,082 Responses and 19,451 Burden Hours

From 0579-0397 there were 228 Respondents, 204,317 Responses and 408,283 Burden Hours

Note: Since the previous approval, VS Form 16-25 was replaced with VS Form 16-28 and VS Form 16-26 was replaced with VS 16-29. In addition, this information collection reinstatement request includes information formally approved under 0579-0397.

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.

Forms VS 16-3, VS 16-28, and VS 16-29 are used in multiple information collections; therefore, it is not practical to include an OMB expiration date because of the various information collection expiration dates. APHIS is seeking approval to not display the OMB expiration date on these forms; however, APHIS is considering making these forms into common forms.

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

APHIS can certify compliance with all provisions under the Act.

B. Collections of Information Employing Statistical Methods

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

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