ss 2016 2 proposed

Importation of Sheep, Goats, and Certain Other Ruminants

0579-00XXX

July 2016

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 of 2002 (7 U.S.C. 8301–8317) 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. Disease prevention is the most effective method for maintaining healthy animal populations in the United States and for enhancing the ability to compete in the world market of animal and animal product trade.

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. The regulations in Title 9, Code of Federal Regulations (9 CFR) parts 91, 93, 94, 95, and 96 govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States to prevent the introduction of diseases such as bovine spongiform encephalopathy (BSE), a chronic degenerative disease that affects the central nervous system of cattle. The regulations also help prevent the spread of diseases currently in the United States, such as scrapie.

APHIS uses a variety of information collection procedures and forms to gather data in its effort to prevent the introduction or spread of disease. Information collected via these procedures and forms includes, but is not limited to, the names of the exporter and importer of the animal commodities; the origins of the animals or animal products to be imported; the health status of the animals or the processing methods used to produce animal products to be imported; the destination of delivery in the United States; and whether the animals or animal products were temporarily offloaded in another country during transit to the United States.

APHIS is asking OMB to approve, for 3 years, the information collection activities listed below that are associated with its efforts to safeguard the health of the U.S. livestock and poultry populations from diseases that might be introduced or spread by the importation of small and exotic ruminants.

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 will use the following information collection activities to safeguard the health of the U.S. livestock and poultry populations from diseases that might be introduced or spread by the importation of small and exotic ruminants.

9 CFR 3.404, 98.5, and 98.35 -Application for Import or In-Transit Permit (for Live Animals, Animal Semen, Animal Embryos, Birds, Poultry, or Hatching Eggs), VS Form 17-129 (Business)

Anyone required by APHIS to have an import or in-transit permit must submit a VS 17-129, Application for Import or In-Transit Permit (Animals, Animal Semen, Animal Embryos, Birds, Poultry, and Hatching Eggs), to APHIS. The applicant must describe the type, number, and identification of the animals to be exported. The applicant must also list the origin, intended date and location of arrival, routes of travel, and destination of the animals. APHIS will use the permit applications to carefully evaluate each import request. For the import of sheep and goats under 9 CFR 93.402(a)(2), APHIS will now begin requiring additional information for this form:

• Whether the animals are intended for immediate slaughter or restricted feeding before slaughter, and if so, the name and address of the receiving slaughter establishment or designated feedlot.

• If the animals are intended for purposes other than immediate slaughter or restricted feeding for slaughter, the following information as appropriate:

• The flock identification (ID) number, if the animals are imported to a flock;

• The premises/location ID number as listed in Scrapie National Database;

• If the animals originate in a region not free of classical scrapie, documentation that the animals reached and maintained certified status in a scrapie flock certification program acceptable to the APHIS Administrator:

• Address or other means of ID of premises and flock of birth;

• Other flocks in which animal has resided.

If the permit will cover sheep of certain classical scrapie-resistant genotypes (only either of scrapie-resistant genotype AARR or AAQR; see 93.404(a)(6) of proposed rule), the importer must so specify. The importer must also specifically request issuance of a permit for ruminants that would otherwise be prohibited importation due to TSEs. APHIS must be able to determine that the disease risk posed by the animals can be adequately mitigated through pre-entry or post-entry mitigation measures, or through combinations of such measures. These measures will be specified in the permit.

9 CFR 93.404, 93.407, 98.5, and 98.35 - Declaration of Importation of Animals, Animal Semen, Embryos, Birds, Poultry, and Eggs for Hatching, VS 17-29 (Business)

By filling out this form, which is collected by (or provided from APHIS to) U.S. Customs officials, importers declare what they are importing into the United States; namely, animals or animal germplasm. This alerts APHIS that certain animals or germplasm will be entering the United States and assists APHIS in preventing the entry of foreign animal diseases. In the case of sheep and goat embryos, the regulations at 9 CFR 98.5 allow import of in vivo-derived sheep and goat embryos and oocytes if collected from donors in or originating from regions not free of classical scrapie. APHIS will now require that the certificate accompanying sheep embryos not of resistant genotypes (i.e, only either of scrapie-resistant genotype AARR or AAQR), in vitro derived or processed, and all goat embryos include statements that in the region where the embryos originated:

• TSEs of sheep and goats are compulsorily notifiable;

• A classical scrapie awareness, surveillance, monitoring, and control system is in place;

• TSE-affected sheep and goats are killed and completely destroyed; and

• The feeding of meat-and-bone meal of ruminant origin has been banned and effectively enforced in the whole country.

The certificate would also have to state that the donor animals:

• Have been kept since birth in flocks in which no case of classical scrapie had been confirmed during their residency;

• Are permanently identified to enable traceback to their flock of birth or herd of origin, and the identification is recorded on the certificate accompanying the embryos and linked to the embryo container identification;

• Showed no clinical sign of classical scrapie at the time of embryo or oocyte collection; and

• Have not tested positive for, and are not suspect for, a TSE.

9 CFR 93.404 - Service Center Contact (Business)

Sheep/goat embryos and oocytes from regions not free of classical scrapie are to be imported only for transfer to females in flocks listed in the National Scrapie Database. To be listed in the National Scrapie Database, a flock owner must contact the local VS Service Center or cooperating State Veterinarian’s office and ask to be listed, providing location of flock and owner’s contact information.

9 CFR 93.404 and 98.10 - Embryo/Oocyte Recipient Flock – Identification and Recordkeeping (Business)

The importer, owner of a recipient flock, or owner of an APHIS-approved embryo or oocyte storage facility must identify the animals and maintain records of the disposition of imported or stored items for 5 years after transfer or destruction.

9 CFR 93.405 - Health Certificates for Sheep (Business)

APHIS is expanding the information requirements for health certificates for sheep to include the following:

• The name and address of the importer;

• The number or quantity of sheep or goats to be imported;

• The purpose of the importation;

• The official individual sheep or goat identification applied to the animals;

• When required by 9 CFR 93.435, the permanent country mark and other identification present on the animal, including registration number, if any;

• A description of each sheep or goat linked to the official ID number, including age, sex, breed, color, and markings, if any;

• The flock of residence; the address (including street, city, State, and ZIP code) of the destination where the sheep or goats are to be physically located after importation, including the premises or location identification number assigned in the APHIS National Scrapie Database and when applicable, the flock identification number;

• The name and address of the exporter;

• The port of embarkation in the region of export;

• The mode of transportation, route of travel, and port of entry in the United States;

• For sheep or goats imported for purposes other than immediate slaughter or restricted feeding for slaughter, the certificate must specify the region of origin and the address or other identification of the premises and flock of birth, and any other flock in which the animals have resided;

• The results of any testing required in the import permit; and

• Any other information required in the import permit.

The certificate accompanying sheep or goats from any part of the world, except for certain sheep or goats imported for immediate slaughter and certain sheep or goats for restricted feeding for slaughter, must also state:

• That the sheep or goats originated from a country APHIS recognizes as free of classical scrapie; or that the animals have reached and maintained certified status in a scrapie flock certification program APHIS recognizes as acceptable for this purpose;

• That the sheep or goats for export have not commingled with sheep or goats of a lower health status, or resided on the premises of a flock or herd of lower health status, after leaving the flock of residence and before arrival in the United States;

• That any enclosure, container, or conveyance in which the sheep or goats had been placed during the export process, and which had previously held sheep or goats, was cleaned and disinfected in accordance with 9 CFR 54.7(e)(2) before being used for the sheep or goats for export;

• That none of the female sheep or goats is carrying an implanted embryo from a lower health status flock; or that any implanted embryo met the requirements for import into the United States when implanted and documentation as required in 9 CFR Part 98 is attached;

• That the veterinarian issuing the certificate has inspected the sheep or goats for export, and their flocks of residence, within 30 days of consignment for export, and found the animals for export and the flocks or herds of residence to be free of any evidence of infectious or contagious disease;

• That as far as it is possible for the veterinarian who inspects the animals to determine, none of the sheep or goats in the flocks or herds of residence has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States; and

• The animals’ movement is not restricted within the country of origin due to animal health reasons.

For sheep or goats imported for immediate slaughter, the certificate must state that:

• APHIS recognizes the country as free of classical scrapie ; or

• APHIS does not recognize the country as free of classical scrapie but the country meets the following criteria:

• Transmissible spongiform encephalopathies (TSEs) in sheep and goats are compulsorily notifiable;

• An effective classical scrapie awareness, surveillance, monitoring, and control system is in place;

• TSE-affected sheep and goats are killed and completely destroyed;

• The sheep and goats selected for export showed no clinical sign of scrapie on the day of shipment and are fit for travel;

• The sheep and goats have not tested positive for, and are not suspect for, a TSE; and

• The animals' movement is not restricted within the country of origin due to animal health reasons.

For sheep or goats imported for restricted feeding for slaughter, the certificate must also include statements that:

• Female sheep and goats are not known to be pregnant, are not visibly pregnant, and female animals have not been exposed:

• To a sexually intact male at over 5 months of age; or

• To a sexually intact male within 5 months of shipment;

• That the veterinarian issuing the certificate has inspected the sheep or goats for export, and their flocks of residence, within 30 days of consignment for export, and found the animals for export and the flocks or herds of residence to be free of any evidence of infectious or contagious disease; and

• That as far as it is possible for the veterinarian who inspects the animals to determine, none of the sheep or goats has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States.

In the case of sheep and goat embryos, the regulations at 9 CFR 98.5 allow import of in vivo-derived sheep and goat embryos and oocytes if collected from donors in or originating from regions not free of classical scrapie and if accompanied by a health certificate. APHIS will amend the health certificate requirements to require that in vivo-derived sheep embryos only either of scrapie-resistant genotype AARR or AAQR based on official testing were collected, processed, and stored in accordance with the requirements of 9 CFR 98.3.

All health certificate language must be in English. This is not a new requirement, but APHIS is now attempting to assess additional burden this may impose on the foreign government issuing the health certificate. Health certificates are also negotiated between the importing and exporting countries before documentation is completed.

9 CFR 93.435 - Permanent Country Mark, Seals, and Recordkeeping (Business)

Sheep and goats imported for purposes other than immediate slaughter must bear a permanent official country mark for the country of origin, while sheep and goats imported for immediate slaughter must be moved with seals on the vehicle of transport. APHIS will also now require importers to maintain records of the sale, death, or other disposition of all imported animals, including the official ID numbers and country marks on the animals at the time of import; a record of the replacement of any lost ID devices linking the new official identification number to the lost device number; the date and manner of disposition of the animals; and the name and address of the new owner. These records must be maintained for 5 years after the sale or death of the animal. The records must be available for APHIS to view and copy during normal business hours.

Seals are removed at the slaughterhouse by a designated official; this activity is tracked on the VS 1-27 or VS 17-130 as appropriate.

9 CFR 93.419 -Animals Imported for Immediate Slaughter, VS Form 17-33 (Business) and Recordkeeping (Business)

APHIS allows certain animals to be imported into the United States if they are moved from the U.S. port of entry directly to a slaughtering establishment. These animals must be accompanied from the U.S. port of entry by VS Form 17-33, “Animals Imported for Immediate Slaughter.” These animals include sheep or goats of any age.

The VS 17-33 is used exclusively to ensure that regulated animals are moved directly to slaughter after entering the United States, and not to any other destination. At the time animals are loaded and ready for transport, information is obtained from documents (such as the VS 17-29 and 17-129) completed by the animal owner (or the owner’s representative) after review by appropriate Federal personnel such as port veterinary medical officers. These officers complete the first section of the VS 17-33. The information compiled includes the owner’s name and address, the points of origin and destination of the animals, the number of animals being moved, the purpose of the movement, and various pieces of animal identification data so that each animal in the shipment can be identified. This form then accompanies the shipment to its destination.

When the animals arrive at the slaughtering facility, authorized slaughter plant personnel complete the second section of the VS 17-33, certifying that all the animals have been received at the facility, and that the animals were held in pens until slaughter to prevent contact with animals not scheduled for immediate slaughter. This section includes the name and address of the slaughter establishment, the date the animals were slaughtered, and the signature and title of the slaughter establishment official completing the VS 17-33.

A third section of the VS 17-33 is completed by a Federal veterinarian at the slaughtering facility who signs and dates the form. In this section, the veterinarian certifies that the slaughtered animals—following a postmortem examination—did not show lesions suggestive of tuberculosis, the only reportable disease of interest that can be observed via postmortem lesions.

9 CFR 93.419 - Sheep and Goats Imported to Designated/Approved Feedlots, VS 17-130 (Business)

This form must be completed at the feedlot by an accredited veterinarian or other designated individual. The form must include the name, address, phone number, and ZIP code of that individual; the number of animals consigned to the feedlot; the species of animals consigned to the feedlot; the license number of the truck or trailer carrying the animals to the feedlot; the seal numbers on the truck; the names and addresses of the consignor and the consignee (including ZIP code and phone number); the name and address of the feedlot; and the name and address of the port veterinarian to whom the form is returned. The form must be returned to the port veterinarian within 14 days of consignment.

9 CFR 404 - Feedlot Compliance Agreement (deviation may be requested) (Business and State)

Feedlots used for importation of sheep and goats not imported for immediate slaughter must be approved for this use; APHIS does this for the benefit of the hosting State. The operator must sign a compliance agreement providing that the operator:

• Will monitor all imported feeder animals to ensure that they have the required official ID at the time of arrival to the feedlot; and will not remove official ID from animals unless medically necessary, in which case new official ID will be applied and cross referenced in the records. Any lost official ID will be replaced with eartags provided by APHIS for the purpose and will be linked to new official ID with the lost identification. If more than one animal loses its official ID at the same time, the new official identification will be linked with all possible original ID numbers;

• Will monitor all incoming imported feeder animals to ensure they have the required country mark, or will maintain all imported animals in separate pens from U.S.-origin animals, and that all sheep and goats that enter the feedlot are moved only for slaughter;

• Will maintain records of the acquisition and disposition of all imported sheep and goats entering the feedlot, including the official ID number and all other identifying information, the age of each animal, the date each animal was acquired and the date each animal was shipped to slaughter, and the name and location of the plant where each animal was slaughtered. For imported animals that die in the feedlot, the feedlot will remove the official ID device if affixed to the animal, or will record any other official identification on the animal and place the official identification device or record of official ID in a file with a record of the disposition of the carcass;

• Will maintain copies of the APHIS Forms VS 17-130 and VS 1-27 or other movement documentation deemed acceptable by the Administrator issued for incoming animals and for animals moved to slaughter and listing the official identification of each animal;

• Will allow State and Federal animal health officials access to inspect and approve its premises and animals and to review inventory records and other required files on request;

• Will keep required records for at least 5 years;

• Will designate either the entire feedlot or pens within the feedlot as terminal for sheep and goats to be moved only directly to slaughter. The agreement will specify how that is to be done, as it will vary between facilities owing to handling of different species and performance of different functions;

• Agrees that if inventory cannot be reconciled or if animals are not moved to slaughter as required, the approval of the feedlot to receive additional animals will be immediately withdrawn and any imported animals remaining in the feedlot will be disposed of as directed by the Administrator;

• Agrees that if an imported animal gives birth in the feedlot, the offspring will be humanely euthanized and the birth tissues and soiled bedding disposed of in a sanitary landfill or by another means approved by the Administrator; and

• Agrees to maintain sexually intact animals of different genders over 5 months of age in separate enclosures.

For a feedlot to be approved to receive sheep or goats imported for feeding but which do not have a country mark, the compliance agreement must also provide that the feedlot will maintain all imported animals in separate pens from U.S.-origin animals and that all sheep and goats that enter the feedlot are moved only for slaughter.

9 CFR 93.404 - Request for Deviation (Business)

For any item where an alternative approved by the Administrator is specified, the applicant must submit, in writing, a description of an alternate method or procedure with results as efficacious as those anticipated by the procedure set forth in APHIS’ regulations and policies. APHIS will consider the proposal and return a response.

9 CFR 93.419 - Permit for Movement of Restricted Animals, VS Form 1-27 and Recordkeeping (Business)

This permit identifies restricted animals moved for quarantine or slaughter purposes. The information is needed to identify infected or exposed animals moved to specific locations to control and prevent spread of disease. The form must include the name, address, and ZIP code of the owner or shipper and of the recipient/destination; an indication whether the animals are moved for quarantine or slaughter; the animals’ disease status and the status of their area of origin; the number, species, and identification information of the animals moved; the license number of the transport vehicle; the seal number; and signatures and dates from the inspector, owner or shipper, and the recipient of the animals.

9 CFR 93.428 - Written Request for Inspection, Other Services, and Dipping, VS 17-32 (Application for Inspection and Dipping) (Business)

When importers wish to import ruminants into the United States, they must submit this application requesting USDA personnel to inspect the animals at the border. Ruminants imported from Mexico are required to have an ectoparasite treatment (i.e. ticks, scabies) before entering the United States. APHIS inspects the animals to ensure they are healthy and do not pose a disease risk to U.S. animals. This application lets APHIS know when the animals are expected so personnel will be available to inspect the animals. This avoids delays for the importers and helps APHIS conduct inspections in a timely and efficient manner.

9 CFR 92.2 -Determination of Whether a Country or Region Conducts an Equivalent Classical Scrapie-Free Flock Certification Program (deviation may be requested) (Foreign Government)

To qualify for this determination:

• The country or region must meet the provisions in 9 CFR regarding effective classical scrapie awareness, surveillance, monitoring, and control programs;

• An official scrapie-free accreditation scheme must be in operation under the supervision of the competent authority , and the following conditions must be complied with for at least 7 years before a flock can be classified as classical scrapie free:

• Sheep and goats are permanently identified and records maintained, to enable trace back to their flock of birth;

• Records of movements of sheep and goats in and out of the flock are maintained;

• Introductions of sheep and goats are allowed only from scrapie free flocks or from a flock at an equal or higher stage in the accreditation process;

• The introduction of sheep and goat embryos and oocytes used in artificial inseminations comply with the provisions listed in 9 CFR 98.10a;

• Sheep and goat semen used in artificial inseminations comply with the provisions listed in 9 CFR 98.3;

• An official veterinarian inspects sheep and goats in the flocks and audits the records at least once a year;

• No case of classical scrapie has been reported for at least 7 years;

• Sheep and goats in the flocks should have no direct or indirect contact, including shared grazing, with sheep or goats from flocks of a lower status;

• All culled sheep and goats over 18 months of age are inspected by an official veterinarian, and a proportion of those exhibiting wasting signs and all those exhibiting neurological signs are tested in a laboratory for scrapie. The selection of the sheep and goats to be tested should be made by the official veterinarian. Sheep and goats over 18 months of age that have died or have been killed for reasons other than routine slaughter should also be tested (including “fallen” stock and those sent for emergency slaughter);

• There is a scientifically sound process in place for addressing flocks in the scheme later determined to have received animals exposed to classical scrapie in another flock before acquisition;

• If flocks are permitted to be moved to a new location without loss of status there must be a process for addressing potential premises contamination if sheep or goats had previously resided on the new premises.

• The scheme must include a process that effectively addresses noncompliance with the conditions for scrapie freedom and is consistently enforced so noncompliant flocks lose status or are removed from the program, depending on the severity of the noncompliance.

APHIS may allow deviations to the conditions for scrapie freedom if the basis for the deviation is scientifically sound, such as the deviations described in the U.S. Scrapie Flock Certification Program Standards. In assessing a region's classical scrapie free flock certification program, APHIS will also consider the past performance of the program in successfully classifying flocks as free of classical scrapie, the number of animals that must be tested before a flock reaches certified status, the applicable standards of the World Organization for Animal Health (OIE), and other relevant information obtained through public comments or collected by or submitted to APHIS through other means.

9 CFR 93.435 – Seals (Foreign Government and Business)

Products from imported sheep and goats must meet the following requirements:

• The articles must be sealed in leakproof containers bearing serial numbers during transit. Each container must remain under either Customs seal or foreign government seal during the entire time it is in the United States.

• Before transit, the person moving the articles must notify, in writing, the authorized Customs inspector at both the place in the United States where the articles will arrive and the port of export. The notification must include the:

• Times and dates of arrival in the United States;

• Times and dates of exportation from the United States;

• Mode of transportation; and

• Serial numbers of the sealed containers.

9 CFR 94.15 - Application for United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors, VS 16-3 (Business)

Anyone who imports animal-derived products into the United States must apply for and obtain from APHIS a U.S. Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors (see VS Form 16-6a, below). This permit is obtained by completing a VS Form16-3. The form contains the applicant's name and address, the name and address of the exporter (shipper or manufacturer), the material or product type (including a list of ingredients of animal origin), the approximate amount of material or product being shipped, any treatment the material has undergone before export, and the intended use of the material or product. Information contained in the VS Form 16-3 enables APHIS to determine whether the shipment qualifies for import into the United States.

9 CFR 94.26 -Export Health Certificate: Gelatin (Foreign Government)

Imported gelatin derived from ovines or caprines from APHIS-approved regions must be accompanied by a certificate that indicates the risk classification of the region of export. The certificate must be issued by a full-time salaried veterinary officer of the national government of the region of export, or issued by a veterinarian designated by the national government of the region of export and endorsed by a full-time salaried veterinary officer of the region of export, representing that the veterinarian issuing the certificate was authorized to do so.

9 CFR 94.15 - Import Permit for Controlled Materials or Transport Organisms and Vectors, VS Form 16-6A Signature Only (Business)

If an importer fills out the VS 16-3 application and VS determines that a shipment qualifies for import, VS will issue the importer an import permit, VS Form 16-6A, which he or she must sign. The importer's signature provides acknowledgment that the importer agrees to abide by all the restrictions and precautions outlined on the import permit. The original hard copy import permit then accompanies the product.

9 CFR 94.15 - Foreign Government Sanitary Certificate (products)/Export Health Certificates (Foreign Government)

Foreign veterinary authorities complete any export sanitary certificates required by APHIS as written proof that competent veterinary authorities have examined or tested the products or germplasm and that the commodities meet APHIS’ import requirements. APHIS requires export sanitary certificates to ensure that animal products required by APHIS’ regulations to be accompanied by an export certificate, as well as any animal products imported under any special conditions (permit or protocol), are of an acceptable health status.

9 CFR 93.407 – Report of Animals, Poultry, or Eggs Offered for Importation, VS Form 17-30 (Business)

APHIS uses the VS 17-30 to track imports of live animals into the United States. APHIS employees stationed at ports prepare the form using information from accompanying health certificates, supporting documents, VS forms, and permits. The license number of the vehicle transporting the animals and seal number, if applicable, may also be recorded, as well as the Customs and Border Protection code assigned to the shipment. The bulk of the form records the number of animals or other unit of measure; the form may include additional descriptive information such as species, breed, and type; the animals’ age and sex; and the purpose of importation. The port of entry, country of origin, importer, and destination must also be recorded. Finally, the form contains a certification that the animals were inspected and found free of evidence of communicable disease or exposure to such disease. The form helps APHIS determine that animals entering the country pose minimal risk of introducing communicable disease into the United States and helps track animals in the event of a disease outbreak.

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.

VS Form 17-129 can be submitted electronically, via fax (which APHIS receives as a pdf document), or in hard copy. Electronic submission requires eAuthentication to access the ePermits system (OMB approved). Not all who apply for these permits have internet accessibility or submit applications frequently enough to warrant the process.

VS 17-29 may be submitted via the Veterinary Services Process System (VSPS), and there is a fillable pdf on the USDA Web site. It is still submitted as a paper document at the time of arrival, although it is scheduled to be collected via the Document Imaging System (DIS) in ACE for commercial shipments.

Service Center contacts may be made by phone or in writing. An email is acceptable, as well.

For health certificates, VS relies on foreign veterinary specialists to certify that U.S. import requirements have been met. These government-to-government certificates must accompany each commodity on a per shipment basis. They include formal markings such as official (original) signatures and government seals, stamps and/or watermarks that identify the document as authentic. An APHIS Veterinary Medical Officer must visually review the original paper document to verify the legitimacy of a foreign government-issued certificate and prevent individuals from circumventing APHIS regulations by using fraudulent documents. The original signature also provides APHIS and the foreign country of origin recourse when inaccurate, fraudulent, or incomplete documentation is presented at the port of entry.

Permanent country marks are physically attached to the animals and thus are not candidates for electronic submission.

Seals must physically accompany the shipments and thus are not candidates for electronic submission.

The VS 17-33 must physically accompany the shipment and thus is not a candidate for electronic submission.

The VS 17-130 may be generated by APHIS personnel in an electronic format through the VSPS. It is provided to the importer or broker as a paper document to facilitate transport to the designated/approved feedlot. The paper document (which could be presented to law enforcement if requested) confirms the shipment of animals is being moved legally to its destination.

The Feedlot Compliance Agreement is a paper document. It is not submitted to APHIS, but is a contract between APHIS and the feedlot to ensure restricted animals are properly maintained and transported to minimize potential risk to the domestic livestock population. APHIS has no plans to make this an electronic document.

VS Form 1-27 is currently not collected electronically as it is a carbon-copy form with multiple pages. The carbon copies are used by industry partners including State animal health officials, the transporter, and USDA personnel to verify the contents of a conveyance. The transporter maintains this document as proof that the shipment may move legally to its destination (potentially crossing State lines).

The VS 17-32 is currently collected as a paper document. The importer/broker must sign this form, as it serves as a legal release for the agency to inspect the animals presented for importation. This form is available from the Port Veterinarian in a hard copy format. By December 2016, commercial importers will submit this document via DIS, an electronic PDF format, in ACE. All other importers should continue to use the paper document.

Determination of Whether a Country or Region Conducts and Equivalent Classical Scrapie-Free Flock Certification Program: This is an extended process for which APHIS does not currently have an electronic program.

VS Forms 16-3 and 16-6a will be available online and be submitted manually or online via ePermits if the user chooses to register for eAuthentication.

The Export Health Certificate for Gelatin and foreign sanitary certificates must physically accompany the shipment and are therefore not candidates for electronic submission.

The VS 17-30 may be completed by VS personnel in VSPS.

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 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.

APHIS estimates that 25 percent of the total respondents are small entities. Information can be collected in either a paper or electronic format, both of which are made available to importers at no cost. The information APHIS collects in connection with its import programs is the minimum needed to ensure that animals and animal products, and animal germplasm imported into the United States, pose a negligible risk of introducing foreign animal diseases into the U.S. livestock population.

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 were collected less frequently or not collected at all, it would diminish APHIS’ ability to protect the United States from foreign (and other communicable) animal disease incursions. The U.S. livestock population would suffer repeated disease outbreaks, and many billions of dollars would need to be spent on containment and eradication efforts. In addition, the U.S. livestock industry would suffer many additional billions of dollars in losses, since the value of its products would be diminished both domestically and internationally.

7. Explain any special circumstances that require the collection to be conducted in a manner inconsistent with the general information collection guidelines in 5 CFR 1320.5.

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

• requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

APHIS requires return of the 17-130 within 14 days of consignment because the form helps track animal movements into and out of the United States as well as across State lines. Animals can move sometimes within a day or two; the 14-day deadline ensures that APHIS receives timely notification of animal movements. This information supports APHIS’ disease control, eradication, and surveillance needs.

• 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;

APHIS requires retention of records associated with the import of sheep, goats, and their germplasm for 5 years because of the nature of scrapie. Scrapie is a prion disease with a long incubation period and can take a number of years to detect. Moreover, this requirement is based on the fact that livestock animals typically live to be more than 3 years old. Therefore, information that fully supports disease control, eradication, and surveillance needs to be maintained for longer than 3 years. The 5-year requirement brings consistency throughout APHIS regulations.

• 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.

There are no other special circumstances; this information collection is otherwise 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 has engaged in productive consultations with the following individuals in connection with the information collection activities associated with its programs:

Kristen Parman, Vice President of Membership Services

Livestock Marketing Association

10510 NW Ambassador Drive

Kansas City, MO 64153

Phone: (800) 821-2048

Tom Boyer, Board Member

American Goat Federation

2200 Chalk Creek

Coalville, UT 84017

Phone: (801) 376-4685

Paul Rogers, Deputy Director of Policy

American Sheep Industry Association

Rt. 2, Box 94

Ronceverte, WV 24970

Phone: (304) 647-9981

APHIS’ proposed rule (Docket Number APHIS-2009-0095) publishing in the Federal Register on Monday, July 18, 2016 (page 46619), will describe its information gathering requirements, and also provide a 60-day comment period. During this time, interested members of the public will have the opportunity to provide APHIS with their input concerning the usefulness, legitimacy, and merit of the information collection activities APHIS is proposing.

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.

APHIS assesses a user fee of $132 an hour for inspection and approval of feedlots used for importation of sheep and goats not imported for immediate slaughter; see 9 CFR, 130.30 (OMB approved). No additional assurance of confidentiality is provided with this information collection. However, the confidentiality of information is protected under 5 U.S.C. 552a.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior or attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

This information collection activity will ask no questions of a personal or sensitive nature.

12. Provide estimates of the hour burden of the collection of information. Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated.

•Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens in Item 13 of OMB Form 83-I.

See APHIS Form 71. Burden estimates were developed from discussions with importers of animals, animal products, and animal germplasm into the United States; foreign exporters of these items; foreign animal health authorities; and State animal health authorities.

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

Respondents include foreign animal health authorities; U.S. importers; foreign exporters; veterinarians and animal health technicians in other countries; State animal health authorities; shippers, owners, and operators of foreign processing plants and farms; USDA-approved feedlots; private quarantine facilities; and other individuals involved (directly or indirectly) in importing animals, animal products, and animal germplasm into the United States.

APHIS estimates the total annualized cost to these respondents to be $1,411,760 APHIS arrived at this figure by multiplying the total burden hours (34,408) by the estimated average hourly wage of the above respondents ($41.03). Estimated hourly wages for the respondents were determined from the U.S. Department of Labor; Bureau of Labor Statistics May 2014 Report – National Compensation Survey: Occupational Employment and Wages, April 2015. See http://www.bls.gov/oes/current/oes_stru.htm.

Foreign animal health authorities $52.99 [Management Occupations]

State animal health authorities $52.99 [Management Occupations]

Importers and exporters $29.02 [Buyers and purchasing agents, farm products]

Veterinarians $ 47.23[Veterinarians]

Animal health technicians $15.56 [Veterinary technologists and technicians]

Shippers $12.56 [Laborers and material movers, hand]

Owners and operators of foreign processing plants and farms $52.99 [Managers, all others]

Owners and operators of feedlots $52.99 [Managers, all others]

Owners and operators of private quarantine facilities $52.99 [Managers, all others]

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 $805,272. (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	64,771	0	64,771	0	0	0
Annual Time Burden (Hr)	34,408	0	34,408	0	0	0
Annual Cost Burden ($)	0	0	0	0	0	0

This is a new collection resulting in 34,408 additional 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 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 17-129, 17-29, 17-33, 17-130, 1-27, 17-32, 16-3, and 17-30 are used in multiple information collections; therefore, it is not practical to include an OMB expiration date because of the various expiration dates for each information collection. APHIS is seeking approval to not display the OMB expiration date on these forms.

APHIS will display the expiration date on VS 16-6A.

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

APHIS can certify compliance with all provisions in the Act.

B. Collections of Information Employing Statistical Methods

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

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