Ss 0040

Importation of Animals and Poultry, Animal and Poultry Products, Certain Animal Embryos, and Zoological Animals

OMB NO. 0579-0040

August 2, 2007

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.

Title 21, U.S.C. 117, Animal Industry Act of 1884, authorizes the Secretary to prevent, control, and eliminate domestic diseases such as brucellosis and tuberculosis (TB), as well as to take actions to prevent and to manage exotic diseases such as foot-and-mouth disease (FMD) and rinderpest.

Disease prevention is the most effective method for maintaining a healthy animal population and enhancing APHIS’ ability to compete in exporting animals and animal products. The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) is responsible for, among other things, preventing the introduction of exotic animal diseases in to the United States and for rapidly identifying, containing, and eradicating such diseases when feasible. In connection with this mission, APHIS collects pertinent information from those individuals who import animals or poultry, animal or poultry products, or animal germplasm into the United States.

This information includes data such as 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, and whether the animals or animal products were temporarily offloaded in another country during their transit to the United States. APHIS needs this information to help ensure that these imports do not introduce exotic animal diseases into the United States.

APHIS uses a variety of information collection procedures, devices, and forms including, but not limited to health certificates, import permits, eartags, leg bands, specimen submission forms, inspection reports, cooperative and trust fund agreements, and certification statements.

APHIS is asking OMB to approve, for an additional 3 years, the information collection activities associated with its efforts to safeguard the health of our U.S. livestock and poultry populations.

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.

90-day written Bird Possession Statement - Canada

The owner of a pet bird, before bringing the bird into the United States from Canada, must state in writing that the bird has been in his/her possession for a minimum of 90 days preceding the date of importation, and that during this time the bird did not come in contact with any poultry or other birds. This is APHIS’ way of attempting to ensure that pet birds brought in from Canada are healthy and do not pose a disease risk to the poultry population of the United States.

Marking

Animals entering the United States must be free of disease. A leg band, eartag, bangle tag, or tattoo placed on an animal by the producer serves as proof that the animal has been inspected and determined to be eligible for entry into the United States. For example, markings include leg bands and tattoos for pet birds, leg bands for psittacine birds, blue metal eartag or approved eartag for cattle, eartag or bangle tag for sheep and goats, and eartag or tattoos for ruminants and swine. If these markings were not used to identify these animals, APHIS would have no way of verifying that the animals have met APHIS requirements for entering the United States. Also, if an animal should show signs of disease after entering the United States, the identification on the animal enables APHIS to trace its movements and conduct a successful epidemiological investigation.

Recordkeeping – Identification Marks on Imported Animals

The identification records are kept by the producer and by the official veterinary medical officer issuing the health certificate. Tattoo and brands are a permanent identification that is recorded in the foreign government’s brand registry. However, the CN, M, or MX brands are used to identify country of origin. The foreign government determines the length of tme necessary to maintain the records.

Agreement of Confinement in Personal Possession Declaration and Affirmation Under Oath, VS 17-8

When bird owners return to the United States with a U.S. origin bird with the original health certificate, APHIS requires them to agree, in writing, that they will keep the bird in their home for 30 days (a home quarantine.) This ensures that the bird, if it is carrying a disease acquired in a foreign country, will not pose a disease threat to the U.S. poultry population.

Request for Space at a USDA Operated Quarantine Facility (Pet Birds), VS 17-23

Birds that are not of U.S. origin are required to undergo 30-day quarantine at a USDA-quarantine facility. APHIS requires the owner to request space (in writing) at the quarantine facility. This written request alerts APHIS that a foreign bird is entering the country and allows APHIS to make arrangements for its quarantine. Having this procedure in place helps APHIS in its effort to prevent foreign poultry diseases from entering the United States.

Import Permit to Transit Poultry, Hatching Eggs, or Birds, VS 17-135A

When poultry, hatching eggs, or birds are transiting Anchorage, Alaska, the importer must apply for a transit permit. APHIS requires this so that APHIS can have a veterinarian on hand in Anchorage to supervise the transit. If APHIS did not have this requirement, APHIS would have no way of knowing when foreign poultry was transiting Alaska. This would compromise our ability to prevent foreign poultry diseases from entering the United States.

Application and Space Reservation Request for Ratites and Ratite Hatching Eggs and Site Inspection, VS 17-128

If an importer wishes to reserve quarantine space in order to import ratites or ratite eggs into the United States, or wishes to request that APHIS inspect a ratite farm in a foreign country, APHIS requires the importer to submit this application. (The foreign health certificate is printed on the reverse side of this form.) This enables APHIS to make appropriate arrangements to conduct these activities (quarantines and farm inspections). Not conducting these activities would compromise APHIS ability to prevent foreign poultry diseases from entering the United States.

Identification of Ratites

APHIS requires the operator of a foreign ratite farm to implant a microchip into the ratites as a means of identifying them as originating from that specific farm. This identification is an attempt to prevent smuggling of ratites. This microchip ID provides APHIS with more control in ensuring that only healthy ratites are imported into the United States.

Recordkeeping - Daily Register for Owner or Manager for Ratites and Hatching Eggs,

VS 17-129

This is another anti-smuggling measure. APHIS requires the operator of a foreign ratite farm to record his/her inventory of eggs and ratites on the farm so that APHIS knows exactly how many ratites and eggs are on the farm. This information is used by the national veterinary services of the region of export to maintain a registry of premises. The foreign government determines the length of time necessary to maintain the records.

Arrival Declaration for Birds or Animals for Retention and Other Documents or Certificates for Animals, Animal Semen, and Embryos, VS 17-29

By filling out this form, the importer is simply declaring what he/she is importing: animals, animal semen, or animal embryos into the United States. This alerts APHIS that certain animals or germplasm will be entering the country, and thus assists APHIS in its mission to prevent foreign animal diseases from entering the United States.

Owner or Manager and Country of Export Quarterly Submission of Registers

APHIS requires the operator of a foreign ratite farm to submit his/her daily register to the appropriate government office in that country, which then submits the register to APHIS. This provides APHIS with information concerning the inventory status of the farm. If this register was not submitted to APHIS, APHIS would have no way of knowing if ratites or ratite eggs were being smuggled onto the farm.

Recordkeeping - National Exporting Country Registers and Maintenance of Current Production Records, Additions to Such Premises, and Ceiling Limitations

APHIS requires appropriate foreign veterinary officials to receive and maintain the registers that are kept by the operators of ratite farms. This provides APHIS with yet another safeguard that each farm is keeping accurate records concerning its inventory and the identification of its ratites (via the matching of ID numbers). This also provides APHIS with current information concerning the facility's adherence to ceiling limitation requirements, and whether any additions to the facility are being planned. All of this information provides APHIS with another mechanism for ensuring that smuggled ratites or eggs are not finding their way on to these farms.

Request for Hearing for Withdrawal of an Import Permit for Ratites or Ratite Hatching Eggs

If APHIS withdraws an importer’s permit to import ratites or ratite hatching eggs, the importer has the right to request, in writing, that a hearing be held to determine if just cause exists for the permit’s withdrawal. This procedure allows the importer to challenge APHIS decision to withdraw his/her permit.

Recordkeeping - Horses for Association and Trainer

The trainer or horse owner (overseas) must keep a daily record of the horse's activities and submit this to a recordkeeping association which has been approved by the Department. This serves as a record that the horse has not been on breeding premises, and has been involved only in training activities. If this record was not kept, APHIS would have no evidence that the animal was not used for breeding purposes overseas. (If the animal is used for breeding purposes before entering the United State, the possibility exists that it will contract contagious equine Metritis (CEM) and therefore presents a disease threat to the U.S. equine population.) This information is verified on the import health certificate issued by a salaried veterinary officer of the national government of the region of origin.

Written Request to Change Horse's Itinerary or Method of Transport

A horse of foreign origin that enters the United States must have a definite itinerary and undergo close monitoring if it has not completed all of APHIS required CEM testing. If the horse's itinerary needs to be changed for any reason, APHIS needs to be aware of it in order to make a determination that the horse will not present a disease risk to the U.S. equine population as a result of the itinerary change. If APHIS is not aware of the itinerary change, APHIS has no way of knowing where the horse is, and APHIS personnel will not be able to monitor the horse during its travel within the United States.

Appeal or Hearing of Import Permit Withdrawal

Random Inspections of Ratite Farms per Breeding Season of Premises for Required ID and Recording on Quarterly Report of Registers

APHIS requires appropriate foreign veterinarians to inspect ratite farms to see that they are complying with APHIS recordkeeping and identification guidelines. These veterinarians also record on this quarterly report whether all ratites and hatching eggs are being properly identified. This provides APHIS with one more safeguard that each farm is keeping accurate records concerning its inventory and that smuggled ratites and eggs are not finding their way on to these farms.

Application - Import or In Transit Permits (Request Space at USDA Operated Quarantine Facilities and Includes Mailing Copies), VS 17-129:

Before APHIS can quarantine animals at a USDA operated quarantine facility, the importer must reserve space at the facility by completing the VS 17-129. types of animals include horses, ruminants, swine, wild ruminants and wild swine intended for exhibition in a zoological park, elephants, hippopotami, rhinoceroses, tapirs, poultry, animal and poultry semen, cattle embryos, embryos from all ruminants and swine from FMD-affected countries, sheep and goat germplasm from Scrapie-affected countries, hedgehogs and tenrecs from FMD-free countries, and animals and animal products imported via the regionalization process. If this were not done, APHIS’ quarantine facilities would operate on a first come, first served basis, and there would be no means by which APHIS could guarantee space for anyone. This form also tells APHIS from which country or region the animals originate. The information supplied on the application also enables APHIS to inform the importer concerning the necessary import requirements that must be met based on the disease status of the country or region from which the animals originate.

Foreign Health Certificates

APHIS wants to ensure that animals, eggs, or germplasm destined for the United States have been examined and, if necessary, serologically tested to ensure that they are not carrying disease. Foreign health certificates are required for the following:

Equine semen and embryos

Horses from countries affected with CEM

Porcine semen from Peoples Republic of China

Horses from foreign regions

Canadian certificate for ruminants

Canadian certificate for swine

Canadian certificate for horses for immediate slaughter

Ruminants from Central America & West Indies

Cattle, sheep, and goats from foreign regions

Sheep and goat germplasm from all regions

Elephant, hippopotamus, rhinoceros, or tapir

Cattle embryos and semen

Semen and embryos from all ruminants and swine from FMD-affected regions

Ratites other than hatching eggs

Hatching eggs of ratites

Hedgehogs and tenrecs from FMD-free regions

Animals and animal products imported via the regionalization process

Wild ruminants and swine from FMD affected regions

The foreign health certificate is filled out by veterinary authorities overseas and is written testimony that the animals, eggs, or germplasm have been examined or tested and meet the import requirements of the United States. If APHIS did not require this form, APHIS would have no proof or record that the animals were examined or tested by competent veterinary authorities overseas.

Letter of Credit, Cashiers Check, Certified Check, or Money Order

These financial instruments are necessary to reserve space at USDA-operated quarantine facilities. If an importer did not provide APHIS with these financial instruments, the importer would not be able to use APHIS facilities. The financial instruments can be provided in person, through the mail, or by courier.

Marking Hatching Eggs

The producer marks the eggs in indelible ink with the date of production and with identification, assigned by the national government of the region of export. This is an attempt to ensure that only farm-produced eggs, not eggs from the wild, are imported into the United States.

Written Notice of Cancellation from Importer

If an importer reserves space at a quarantine facility and then decides to cancel, APHIS needs to know about it in order to make the space available for someone else. If an importer failed to provide APHIS with written notice of his/her intent to cancel, APHIS’ ability to effectively manage its quarantine facilities would be severely comprised.

Written Agreement with State for CEM (Monitoring by State)

States perform CEM quarantines under Federal guidelines. This agreement is filled out by State veterinary authorities, and serves as the State’s promise that it will abide by APHIS guidelines when quarantining horses for CEM. If APHIS did not require this agreement, APHIS would have no written evidence that Federal guidelines were being adhered to in the CEM quarantining of horses. Consequently, APHIS’ ability to prevent the outbreak and spread of CEM would be compromised.

Marking Letter “T” for Testing

The “T” brand is applied by the State or Federal inspector or by an accredited veterinarian before the mares are used to test stallions for CEM. This brand is used to permanently identify mares that are to be used for breeding with imported stallions as a means of testing the stallions for CEM. If the stallion has CEM, he will pass it on to the mare. It is easier to test the mare for CEM than it is to test the stallion for CEM. If the T brand were not used, APHIS would have no accurate means of identifying the mare as a CEM test mare, and APHIS CEM prevention efforts would be compromised.

Opportunity to Present View on Suspension

If APHIS opts to suspend a State’s approval to receive horses for CEM quarantine, the State veterinary authorities have the right to appeal the suspension. The appeal must be in writing. If this process were not in place, States would have no way of challenging APHIS’ decision.

Submission of Specimens, VS 10-4 (Burden cleared under OMB No. 0579-0090)

Zoological Park Inspection Report, VS 17-65A

Semi-annually APHIS inspects USDA-approved zoos to ensure they are maintaining specific standards relative to the housing and care of imported swine and ruminants. In connection with this monitoring effort, APHIS requires the zoo operator to have the services of a veterinarian available. This veterinarian must make periodic inspections of the swine or ruminants to ascertain their health status. This veterinarian is required to alert APHIS, in writing, of any suspected illness that he/she detects in the animals. APHIS has this requirement because APHIS people are only physically present at the zoo perhaps twice a year; the presence of an on-site veterinarian provides for continuous monitoring of the animals and their health status.

Agreement for the Importation, Quarantine, and Exhibition of Certain Wild Ruminants and Wild Swine, VS 17-65B

This agreement is completed by zoo authorities who import wild ruminants and swine. In it, they promise to abide by APHIS guidelines when handling these animals. This is APHIS’ way of attempting to ensure that these animals do not pose a disease risk to the ruminant and swine populations of the United States.

Report of Zoo Animals with Suspected Cases of Contagious or Communicable Diseases,

VS 17-65C

If a zoo animal gets sick, zoo authorities need to inform APHIS of the situation so that APHIS can determine whether the animal has a disease that could possibly represent a threat to the U.S. livestock, equine, or poultry population. If zoo authorities did not alert APHIS via this form, APHIS’ ability to protect the United States from disease incursion could be compromised.

Transfer of Wild Animals, VS 17-65D

This form is filled out by zoo authorities when they transfer a wild animal to another location. APHIS needs to know about such transfers, since zoo animals represent a possible disease threat to the U.S. animal population.

Foreign Test Certificate for TB, Brucellosis, Bluetongue, Akabane, Epizootic Hemorrhagic Disease (Burden cleared under Foreign Health Certificates.)

Application for Approval of Quarantine or Holding Facility: (Letter)

Horses

Sheep and goats

Ruminants

Swine

Occasionally foreign animals that are transiting the United States must be temporarily offloaded (from a plane or truck) before they reach their final destination. Or, if these animals are entering the United States, they may be quarantined at a private quarantine facility. In either case, the transporter must request, in writing, that APHIS approves the facility that will be used to temporarily house or quarantine these animals. If APHIS does not require this application for approval, APHIS would have no way of knowing when, where, or for how long these animals were being housed, and no way of determining if or how much of a disease risk they present to the United States.

Opportunity for Hearing to Present Views on Facility Withdrawal and Written Withdrawal by Facility Operator

If APHIS opts to withdraw approval of a facility (such as a laboratory), then the facility operator has the right to appeal APHIS’ decision. The appeal must be in writing. If this process were not in place, facility operators would have no way of challenging APHIS’ decision. The facility operator must also alert APHIS, in writing, if he/she intends to cease operations and voluntarily relinquish operating approval. This allows APHIS to keep accurate records concerning the status of these facilities.

Cooperative Agreement and Trust Fund for Birds (includes: providing a list of current employees to port veterinarian, signed statement from each designated employee, written instructions to monitoring agency, telephone numbers of cooperators, written request for accounting of funds, and written termination)

If a bird quarantine facility changes location or changes ownership, the operator of that facility completes this documentation and sends it to APHIS. This alerts APHIS that the facility has undergone some kind of significant change, and allows APHIS to adjust its records accordingly. In order to prevent the introduction of poultry diseases into the United States, APHIS needs to keep close tabs on these facilities in terms of monitoring, supervision, and inspection. Requiring the above documentation to help APHIS do this.

Trust Fund or Compliance Agreement for Horses

An importer of horses must sign this agreement in which he/she promises to allow USDA personnel to inspect and monitor the horses, and to pay USDA for these services. APHIS needs to do this to ensure the horses are healthy and do not pose a disease risk to the U.S. equine population. If APHIS did not require this agreement, APHIS would have no way of locating and monitoring these animals, and no way of ensuring that they were not being bred (and possibly transmitting CEM) to U.S. horses.

Application/Permit to Import Birds (request space for commercial lots of birds at USDA operated or approved quarantine facilities), VS 17-20

This is the importer's way of reserving space for his/her foreign birds at a USDA - operated or - approved quarantine facility. If APHIS did not require this form, APHIS would not be able to guarantee quarantine space for anyone. This would severely compromise APHIS’ ability to effectively manage APHIS bird quarantine facilities, and could have an adverse impact on APHIS’ capacity to protect the U.S. poultry population from foreign poultry disease.

Recordkeeping – Daily Log of Privately Operated Quarantine Facility for Ruminants, Swine, and Equine

When ruminants, swine, or equine are in quarantine, APHIS needs to ensure that only specified individuals are allowed entry into the quarantine facility. The daily log that these individuals must sign allows APHIS to enforce this. If this daily log were not used, it would compromise APHIS’ ability to maintain the integrity of the quarantine. Unauthorized visitors entering and leaving the quarantine could pose a disease risk to the U.S. livestock population. APHIS requires the facility operator to keep the log for 12 months after the animals leave the quarantine. If some of these animals become sick after leaving quarantine, the log would be of tremendous assistance to APHIS in conducting the necessary investigations into the incident.

Recordkeeping – Daily Log and Identification Record for Birds, VS 17-12

The operator keeps this daily log and identification record to keep APHIS informed of which birds are entering the facility. Only birds that are pre-approved for quarantine can enter these facilities, and this is APHIS’ way of making sure that ineligible (and possibly disease suspect) birds are not being quarantined at these establishments. If this log and identification record were not kept, APHIS’ ability to protect the U.S. poultry population from foreign disease would be compromised.

Additional Requirements for the Quarantine of Birds

APHIS reserves the right to impose additional requirements concerning the quarantining of birds if APHIS determines that it is necessary to prevent the escape of poultry disease agents from quarantine facilities. Imposing such requirements (such as additional sanitation requirements, for example) may require the facility operator to submit (or at least sign) various kinds of documents in connection with the additional requirements.

Application for Approval of Quarantine Facilities and Request for Transfer of Operations to Another Facility for Birds, VS 17-11

If an individual wants to open a bird quarantine facility, or switch a bird quarantine facility to another location, he/she must submit this application to APHIS to have the facility approved. These facilities must meet strict biosecurity standards. This application is APHIS’ way of making sure all bird quarantine facilities meet APHIS standards and do not pose a disease risk to the poultry population of the United States.

Written Request for Inspection, Other Services, and Dipping, VS 17-32

When an importer wishes to import ruminants, horses, or poultry into the United States, he/she must submit this application requesting USDA personnel to inspect the animals at the border. APHIS inspects the animals to ensure they are healthy and do not pose a disease risk to U.S. animal populations. If APHIS did not require this application, APHIS would have no way of knowing when a group of animals might arrive at the border, and APHIS might not have personnel available to inspect them. This would create extraordinary delays for the importer and compromise its ability to conduct inspections in a timely and efficient manner.

Accredited Veterinarians (Burden cleared under OMB No. 0579-0032)

Canadian Port Veterinary Certification on Back of U.S. Health Certificate, VS 17-140 (Burden cleared under OMB 0579-0020)

Affidavit or Certificate from Owner or Importer Stating Animals Have Been in the Country for 60 days Prior to Shipment (Burden cleared under Foreign Health Certificates.)

Importer or Agent Certification Free of Fever Tick (Letter)

This is a letter written to APHIS by a Mexican veterinary official certifying that the cattle destined for importation into the United States have been inspected, found free of fever ticks, and dipped. This helps APHIS to ensure that cattle from Mexico are free of ticks and tick nymphs before entering the United States. Not requiring this certification would lessen our ability to prevent ticks (and the diseases they carry) from entering the United States.

Branding the Letter “M” for Steers from Mexico

APHIS requires an importer to M brand his/her feeder cattle before bringing them from Mexico to the United States. The M alerts APHIS that the animals are from Mexico and therefore may be infected with TB. Not requiring this M brand would significantly compromise our TB prevention and eradication efforts.

72-Hour Prior Arrival Notice (Hedgehogs and Tenrecs)

An APHIS inspector at an appropriate port of entry must be alerted to an impending importation of hedgehogs or tenrecs at least 72 hours before the animals arrive in the United States. The 72-hour notice can be made in writing or via telephone or fax, and must be done for each shipment of animals intended for importation. The 72-hour notice will allow us sufficient time to plan for the animals’ arrival and to arrange to have them inspected.

Written Agreement; Application for Permit and Herd ID (Scrapie Flock Certification) - (Burden cleared under OMB No. 0579-0101)

Owner Affidavit for Sheep and Goats from Scrapie Regions

When sheep or goats are being imported from countries or regions known to be affected with Scrapie, the importer must --along with a standard import application-- supply APHIS with an affidavit stating that these animals originated from a flock or herd in the region of origin that participate in a program determined by APHIS to be equivalent to the Voluntary Scrapie Flock Certification Program, and the flock or herd has been determined by APHIS to be at a level equivalent to “Certified” in the Voluntary Scrapie Flock Certification Program.

Request for Recognition of a Region and Approval to Export Animal or Animal Products

When a region’s veterinary authorities wish to apply for a certain risk class status, or have the status of their region reclassified, they must communicate this desire to APHIS via a letter. This letter of application need follow no particular format. It has no set length, and may contain as little or as much information as the sender feels necessary.

Application for Classification and Reclassification for Risk Classes – Includes Formal Disease Questionnaire and Region’s Agricultural Laws and Regulations Translated into English

Upon receiving this letter, APHIS will send the region an application package for classification or reclassification. This package must be completed by the region’s veterinary authorities and returned to APHIS. It will consist of two parts: a generic questionnaire and a disease specific questionnaire.

1. Request for Recognition of a Region: Generic Questionnaire

The generic questionnaire contains questions designed to provide APHIS with specific information concerning the veterinary infrastructure, demographics, and monitoring/surveillance procedures of the region. This information is critical; without it, APHIS cannot accurately determine the correct risk class of the region. Below is a summary of the kind of information APHIS will be seeking via the generic questionnaire:

• The authority, organization, and infrastructure of the region’s veterinary services, including copies of relevant regulation, policies, and procedures to regulate animal health and veterinary public health. The human and material resources available to the region for protecting animal health, including the number of veterinarians in private practice, by activity (large animal practice, small animal practice, bovine practice, etc.); the number of veterinarians working in fields other than private practice (such as regulatory, preventive medicine, or research); the number of animal health technical personnel associated with the region’s veterinarians, and the names and locations of the region’s diagnostic laboratories including the number and type of personnel working there (veterinarians, microbiologists, etc.) and the number and kinds of procedures performed there.

• Specific demographic information, including detailed border information such as the kilometers of seacoast, the number of seaports with controlled entry, the kilometers of river borders, and the number of controlled river crossing points; the kilometers of mountainous borders and the number of mountain passes with controlled entry; the kilometers of fenced or protected borders, the kilometers of unprotected borders; and the types of locations of points of entry into the region (airports, seaports) and an explanation of how contraband and garbage is handled when it arrives at these entry points.

• Specific information concerning the region’s agriculture demographics, including the amount of cultivated land, forest land, urbanized land areas, savannahs, pastures, prairies, and grazing land.

• Specific information concerning the region’s agriculture infrastructure, including the number of swine, cattle, goats, sheep, poultry, horses. And other animals living within the region.

• Information concerning the region’s agricultural marketing infrastructure, such as the number, names, and locations of the region’s livestock markets, stockyards, assembly points, and slaughter facilities, including the kinds and numbers each of these facilities process.

• Detailed descriptions of the region’s disease surveillance system and animal identification procedures, including a description of the surveillance procedures used for World Organization for Animal Health (OIE) reportable diseases and other diseases, and a description of surveillance procedures used in adjacent areas; the types of animal identification in use (permanent, semi permanent, temporary); an explanation of who is responsible for reporting OIE reportable diseases (owners, veterinarians, market operators); an explanation of how diseases are reported to Veterinary Services, to the OIE and to international trading partners; the penalties in place for failing to report diseases, the number of disease surveys conducted in the past year and the past 5 years, and a description of any continuously operating active surveillance programs in place.

The generic questionnaire will also request regional authorities to produce, for APHIS’ review, a copy of the region’s agricultural laws and regulations. These documents already exist, and therefore no generation of written material is involved. However, the burden is incurred when the respondents must translate this information into English.

2. Request for Recognition of a Region: Disease Specific Questionnaire

The disease specific questionnaire contains questions designed to provide APHIS with specific information concerning the procedures that the region has in place for controlling a specific animal disease. Regional authorities would need to complete a separate disease specific questionnaire for each disease they wish APHIS to consider in their application package. This information is critical; without it, APHIS cannot accurately determine the correct risk class of the region. Below is a summary of the kind of information APHIS will be seeking via the disease specific questionnaire:

• The region’s import controls for animals and animal products, including the number and type of animals imported during a specified period of time and from what countries the animals originated and a description of the inspection procedures used at ports of entry and the certification procedures required before entry.

• The region’s export controls, including the number and type of animals exported from the region during a specified period of time and to what countries the animals were exported and a description of the inspection procedures used at ports of embarkation and the certification procedures required before embarkation.

• The vaccination practices used within the region for a specific animal disease, including when vaccines were last used; the number and location of laboratories in the region and the types of vaccines they produce; and whether vaccination is permitted in areas adjacent to the region and if so, the type of vaccine and doses used.

• Detailed information concerning whether garbage feeding of swine is allowed in the region and if so, the number of commercial garbage-fed swine premises in the region, whether cooking of the garbage is required, and whether garbage feeders are inspected regularly.

• A history of disease prevalence in the region, including the number of premises infected; a list of identified sources of infection, the number of premises completely depopulated, and how cases were detected (postmortem inspection, serological surveillance, ante mortem inspection); estimates of undetected disease; and descriptions of ongoing serological surveys.

• The authority, organization, and infrastructure the region has in place for controlling and eradicating a specific animal disease, including a description of the emergency powers the region has in place for controlling disease outbreaks, the compensation provisions in place for animal owners affected by the region’s control measures, registration and use of vaccines, and budgeted allocations for disease eradication during a specified period of time.

• The human and material resources at the region’s disposal for combating a specific animal disease, including the names and locations of the region’s laboratories that possess the diagnostic capability for a specific disease, including the number and type of personnel working there (veterinarians, microbiologists, etc.) and the number and kinds of procedures performed there. APHIS would also need to know the number of veterinarians and technical personnel in the region who have specialized training in the diagnosis of a specific disease. This would include the number of such veterinarians in private practice, by activity (large animal practice, small animal practice, bovine practice, etc.); the number of such veterinarians working in fields other than private practice (such as regulatory, preventive medicine, or research); and the number of animal health technical personnel associated with the region’s veterinarians.

Request for Additional Information About the Region

In some instances APHIS may determine that the initial application/questionnaire package is incomplete, or that APHIS needs more information than was originally requested in the initial package. If this is the case, APHIS will request the region to send APHIS additional information concerning their animal health status. No form is involved in this information collection; in many cases the information already exists and will simply need to be sent to APHIS.

Veterinary authorities in regions that have already been recognized by APHIS as having achieved an acceptable animal health status with respect to foot-and-mouth disease, BSE, avian influenza, hog cholera --or any other disease of concern -- may be asked to submit additional information regarding their current animal health status if it is determined that time or circumstances may have altered that status. APHIS would use this information to reevaluate, if necessary, the region’s animal health status with respect to a given disease or diseases.

Certification for Horses that Spend Less than 60 Days in a Region

If a horse is presented for importation from a region where it has been for less than 60 days, the national veterinary official in the country of origin must ensure that horse be accompanied by a certification from each region in which the horse has been during the 60 days immediately preceding its shipment to the United States. This helps assure that the horse has not been exposed to a communicable disease such as CEM.

Appeal of Denial of Risk Class

If APHIS denies a region's request to be assigned to a certain Risk Class Level, the region has a right to appeal that decision by sending APHIS any other additional information, or new information that might cause APHIS to reevaluate our decision. No official form is involved in this information collection.

Written Recommendations have been Implemented by the Region

In many cases APHIS will provide a region with written recommendations that will assist the region in attaining the Risk Class Level it desires. Before evaluating the region's request for a Risk Class Level designation, APHIS will need documentation from the region that APHIS recommendations have been implemented. No official form is involved in this information collection.

Notification that a Restricted Agent has been Discovered in the Region

When a region that has been assigned to a certain Risk Class Level discovers a restricted disease agent within its borders, that region is obligated to advise APHIS of the situation. This notification system, which involves no official form, is critical to the success of APHIS’ regionalization program. It will enable APHIS to have accurate, up-to-date information concerning the health status of a given region.

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 data acquired through the information collection activities associated with APHIS import and regionalization programs can be transmitted to APHIS electronically. APHIS is implementing an electronic (Web base) import permit system (e-permits) that will streamline the import permit application and issuance of import permits. This system will also enhance data collection.

APHIS is currently evaluating the information collection activities relating to Mexican cattle imported into the United States to find ways to streamline those activities.

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.

APHIS is the only Federal agency responsible for preventing the interstate spread of poultry diseases. The information APHIS is collecting is APHIS’s only source for the information.

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

The information APHIS collects in connection with its import programs is the minimum needed to ensure that animals, poultry, animal and poultry products, zoological animals, and animal germplasm imported into the United States pose a negligible risk of introducing exotic diseases into the U.S. livestock and poultry populations.

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 cripple APHIS’ ability to protect the United States from exotic animal disease incursions. The U.S. livestock and poultry populations would suffer repeated disease outbreaks, and billions of dollars would need to be spent on containment and eradication efforts. In addition, the U.S. livestock and poultry industries would suffer billions of dollars in losses, since the value of their 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.

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.

In 2007 APHIS engaged in productive consultations with the following individuals in connection with the information collection activities associated with our programs:

Bob Montgomery

American Dairy Exporter

Platteville, CO 80651

(970) 785-2751

Beth Watson

National Pork Producers Council

International Trade Issues

122 C St., Suite 875

Washington, DC 20001

(202) 347-3600

Nancy Robinson

Livestock Marketing Association

10510 NW Ambassador Drive

Kansas City, MO 64153

(800) 821-2048; (816) 891-0502

On Friday, May 18, 2007, pages 28020-28021, APHIS published in the Federal Register, a 60-day notice seeking public comments on our plans to request a three year renewal of this collection of information. No comments from the public were received. A copy of the Federal Register notice is attached.

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. 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 entities involved in the importation of animals and poultry, animal and poultry products, zoological animals, and animal germplasm into the United States; with foreign exporters of these items, with foreign animal health authorities, and also with 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 seeking to engage in the regionalization process; as well as U.S. importers, foreign exporters, veterinarians and animal health technicians in other countries, State animal health authorities, shippers, owners/operators of foreign processing plants and farms, USDA-approved zoos, laboratories, and feedlots; private quarantine facilities, and other entities involved (directly or indirectly) in the importation of animals and poultry, animal and poultry products, zoological animals, and animal germplasm into the United States.

APHIS estimated the total annualized cost to these respondents at $14,675,625. APHIS arrived at this figure by multiplying the total burden hours (326,125 hours) by the estimated average hourly wage of the above respondents ($45.00).

•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.

There is zero annual cost burden associated with capital and start-up costs, operation and maintenance expenditures, and purchase of services.

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.

There is zero annual cost burden associated with capital and start-up costs, operation and maintenance expenditures, and purchase of services.

14. Provide estimates of annualized cost to the Federal government. Provide a description of the method used to estimate cost and any other expense that would not have been incurred without this collection of information.

The annualized cost to the Federal government is estimated at $35,204,962. (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.

The estimated annual burden hours has increased. More regions and countries in the developing world are continuously entering the global arena of animal and animal product trade. However, the number of respondents has decreased because in the previous collection some of the respondents were counted more than once. In addition, APHIS adjusted the burden hours in several activities to more accurately reflect the estimated time required to complete the activity resulting in an adjusted increase of 261,255 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.

If forms were to be discarded because of an outdated OMB expiration date, but otherwise usable, higher printing costs would be incurred by the Federal Government. Therefore, APHIS is seeking approval to not display the OMB expiration date on its forms.

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

Statistical methods are not employed in this information collection activity.