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SUPPORTING STATEMENT - OMB NO. 0579-0015

PROHIBITED AND RESTRICTED IMPORTATION OF MEATS, ANIMAL AND POULTRY PRODUCTS, AND ORGANISMS AND VECTORS INTO THE UNITED STATES

September 26, 2008

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. authorizes sections 111, 114, 114a, 114-1, 115, 120, 121, 125, 126, 134a, 134c, 134f, and 134g of 21 U.S.C. These authorities permit the Secretary of the U.S. Department of Agriculture (USDA) to prevent, control, and eliminate domestic diseases such as tuberculosis, as well as to take actions to prevent and manage exotic diseases such as foot-and-mouth disease (FMD).

More specifically, 21 U.S.C. 111, 151158 authorizes the Secretary of Agriculture to take such measures as he or she may deem proper to prevent the introduction or dissemination of any contagious or communicable disease of animals or live poultry from a foreign country into the United States or from one State to another.

Disease prevention is the most effective method for maintaining a healthy animal population and for enhancing the ability of the United States to compete in the world market of animals and animal product trade.

In connection with this disease prevention mission, the Veterinary Services’ (VS) program of USDA’s Animal and Plant Health Inspection Service (APHIS) enforces regulations that pertain to both the importation of restricted animal byproducts and controlled materials and the prevention of foreign animal disease incursions into the United States. The regulations under which APHIS conducts these disease prevention activities are contained in title 9, chapter I, subchapter D, parts 94, 95, and 122 of the Code of Federal Regulations (CFR).

To this end, APHIS engages in a number of information collection activities that are necessary to prevent or control the spread of livestock and poultry diseases via the importation of restricted and controlled animal and poultry products and byproducts, organisms, and vectors into the United States

APHIS is asking OMB to approve its use of these information collection activities for an additional 3 years.

2. Indicate how, by whom, how frequently, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.

Foreign Export Health Certificate

Fresh (chilled or frozen) meat of ruminants or swine raised and slaughtered in a region free of FMD and rinderpest, which, during shipment to the United States, enters a port or otherwise transits a region where rinderpest or FMD exists, may be imported if the meat is in a hold compartment or container that was sealed in the region of origin and is accompanied by an original copy of the export health certificate, which is completed by the Foreign Government. Upon arrival in the United States, the certificate must physically accompany the shipment and be presented to an authorized inspector at the port of arrival.

Location and Reason for Breaking Seal, Application of Seal

If any member of the ship’s crew breaks the original seal, then the serial number of the original seal as well as its location and the reason for breaking it must be recorded in the ship’s log. The person responsible for recording information in the ship’s log must also record the serial numbers of the new seals used to seal the hold compartment or container on the export health certificate that accompanies the meat.

Request for Approval of Defrost Facility

Cooked meat from regions where rinderpest or FMD exist may be imported into the United States only under certain conditions. One of these conditions is that the meat be inspected by a Food Safety & Inspection Service (FSIS) inspector at the port of entry, in a defrost facility approved by APHIS, to ensure that the meat has been thoroughly cooked. Operators of defrost facilities must request APHIS approval by submitting a written letter to APHIS requesting such approval.

Termination of Agreement

APHIS will withdraw approval of the facility when the facility’s operator provides APHIS with written notification that the facility is no longer performing the required services.

Request for Hearing

APHIS may deny approval of any defrost facility if it determines that the defrost facility does not meet the conditions for approval. If approval is denied, the operator of the defrost facility may submit a written request to be given an opportunity to respond at a hearing with respect to any disputed issues.

Certificate from Inspector Stating Conveyance Has Been Cleaned

Garbage on or removed from a means of conveyance is considered regulated garbage if the means of conveyance has been in any port outside the United States and Canada within the previous 2 years. However, garbage on or removed from a means of conveyance (other than an aircraft) is exempt from APHIS restrictions if the means of conveyance is accompanied by a certificate from the Foreign Government stating that the means of conveyance was first cleared of all garbage and then cleaned and disinfected in the presence of an inspector. The certificate must physically accompany the shipment.

Application for Report of Inspection of Establishment Handling Restricted Animal Byproducts or Controlled Materials (VS 16-25)

The VS 16-25 is a dual purpose form. It serves here as a report of inspections of establishments to ensure that restricted and controlled imports are being handled in compliance with the regulations and requirements. The VS 16-25 is completed by the U.S. Federal animal health official who acquires this information through the cooperation and communications with establishment operators located within the United States.

Agreement for Handling Restricted Imports of Animal Byproducts and Controlled Materials (VS 16-26) -- signature only

Restricted animal products, byproducts, and controlled materials, including carcasses or parts or products of carcasses of poultry, game birds, and other birds, may be imported for consignment to any museum, educational institution, or other establishment if, among other requirements, the establishment signs the VS 16-26. The VS 16-26 provides APHIS with evidence that the establishment has the equipment, facilities, and capabilities to store, handle, process, or disinfect such articles to prevent the introduction or dissemination of Exotic Newcastle Disease (END), FMD, and rinderpest into the United States, and that the establishment has been approved by APHIS as evidenced by completion and endorsement of the form by APHIS officials. The operator of the establishment is also required to sign this form.

Application for Permit to Import Controlled Material; Import or Transport Organisms or Vectors, Specifically Bird Carcasses or Parts of Carcasses (VS 16-3)

Carcasses or parts or products of carcasses of poultry, game birds, and other birds from regions where END is considered to exist, and that do not otherwise qualify for importation, may be imported only if the importer, using the VS 16-3, applies for and is granted a permit by APHIS authorizing such importation. This information enables APHIS to carefully scrutinize the products and determine what, if any, disease threat they may pose to the U.S. poultry population. If APHIS decides to issue an import permit, information on the VS 16-3 also enables the Agency to determine what safeguard measures are appropriate for this particular importation. APHIS can then provide port and border personnel with appropriate clearance instructions in connection with the impending shipment.

Certificate for Importation of Eggs, Other Than Hatching Eggs

Eggs, other than hatching eggs, from regions where END is considered to exist may be imported into the United States only in accordance with the regulations contained in 9 CFR 94.6. These regulations require that the eggs must be accompanied by a certificate endorsed and completed by the Foreign Government of the region of origin. The certificate must identify the flock of origin and show the region of origin, the port of embarkation, the port of arrival, the name and address of the exporter and importer, the total number of eggs and cases of eggs shipped with the certificate, and the date the certificate was signed. The certificate must physically accompany the shipment.

Application for Import of Eggs, Other Than Hatching Eggs, in Specific Cases for Research or When Cooked or Processed (VS 16-3)

Eggs, other than hatching eggs, from regions where END is considered to exist may be imported into the United States if they are imported for scientific, educational, or research purposes; or if they have been cooked or processed; and if APHIS has determined that the importation can be made under conditions that will prevent the introduction of END into the United States. Importers, (i.e. commercial business operators, researchers etc.) must obtain an APHIS issued import permit prior to importation by completing the import permit application and submitting it to APHIS in writing or on-line. The eggs must be accompanied, moved, and handled as specified on the permit to prevent the introduction of END into the United States.

Trust Fund Agreement (Signature only)

Before APHIS will approve a meat processing establishment for the export of cooked meat from a region where FMD and rinderpest exist, the operator of the establishment must enter into a trust fund agreement with APHIS. In accordance with the terms of the trust fund agreement, and before the APHIS representative’s site inspection, the operator of the processing establishment must deposit with APHIS an amount equal to the approximate cost of one inspection by an APHIS representative, including travel, salary, subsistence, administrative overhead, and other incidental expenses. As funds from that amount are obligated, a bill for costs incurred, based on official accounting records, will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or changes in estimated costs.

Notification of Customs and Border Protection Inspectors (Department of Homeland Security)

Various commodities that are not eligible for importation into the United States may transit the United States if certain conditions are met. An individual transiting such articles through the United States must notify in writing or by telephone the Customs and Border Protection Inspectors at both the place in the United States where the articles will arrive as well as the port of export prior to such transit. This notification must include the U.S. Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors permit number, the time and date of arrival in the United States, the time and date of exportation from the United States, the time schedule and route to be followed through the United States, the mode of transportation, and the serial numbers of the sealed containers.

Application for Importation of Small Amount of Pork or Pork Products for Analysis, Testing, or Examination Purposes (VS 16-3)

Small amounts of pork or pork product from regions where classical swine fever (CSF) exists may, in specific cases, be imported into the United States for examination, testing, or analysis if the importer submits an application in writing to APHIS and receives written approval for such importation from APHIS.

Application for Importation of Small Amount of Milk/Milk Products for Analysis, Testing, or Examination Purposes (VS 16-3)

Small amounts of milk and milk products from regions where FMD or rinderpest is considered to exist may, in specific cases, be imported for examination, testing, or analysis if the importer submits an application in writing to APHIS and receives written approval from APHIS.

Certification for Importation of Pork or Pork Products of a National Government

Restrictions are in place on the importation of pork and pork products from regions where African swine fever (ASF), swine vesicular disease (SVD), and CSF exist. These products must be accompanied by a certification that APHIS regulations concerning the importation of such products have been met. The certification must be issued by the Foreign Government of the region of origin. Upon arrival of the pork or pork products in the United States, the certificate must be presented to an authorized inspector at the port of arrival. The certificate must physically accompany the shipment.

Agreement between Processing Establishments and VS for Processing Procedures for Hams

Prior to receiving products for processing such as dry-cured pork products (specifically ham, pork shoulder, or pork loin) from regions where FMD, rinderpest, ASF, CSF, or SVD exist, operators wishing to export those products to the United States must provide APHIS with a written agreement in the form of a letter stating that the products have been processed whole and in accordance with APHIS regulations.

Hot Iron Brand/Button or Ink Seal, Plastic Tag

Dry-cured pork products, specifically Italian-type whole hams, from regions where FMD, rinderpest, ASF, CSF, or SVD exist must bear a hot iron brand or ink seal, placed on the ham prior to salting, with the identifying number of the slaughtering establishment and the date salting began. The brand or ink seal must be placed on the ham at the slaughtering establishment. Slaughter establishments must also ensure the ham bears on the hock a tamper-proof button seal approved by APHIS that states the month and year the ham entered the processing establishment. Dry-cured pork loins must bear a tamper-proof plastic tag, securely attached to the pork loin, with the identifying number of the slaughtering establishment and the date the pork loin was placed in a pickle preparation under the supervision of personnel from the Foreign Government of the region of origin.

Maintain Records for Processing Origin of Certain Hams

Whole dry-cured ham, pork shoulder, or pork loin imported into the United States from regions where FMD, rinderpest, ASF, CSF, or SVD exist must come from an establishment where personnel from the Foreign Government of the region of origin maintains original records. These records must be kept for a minimum of 2 years. The records must identify the dry-cured ham, pork shoulder, or pork loin by the date it entered the processing establishment; by the slaughtering facility it came from: and by the number of the certificate that accompanied the dry-cured ham, pork shoulder, or pork loin from the slaughtering facility to the processing establishment.

Certification of a National Government that Certain Processed Hams are Free of Rinderpest

Dry-cured ham, pork shoulder, or pork loin imported into the United States from regions where FMD, rinderpest, ASF, CSF, or SVD exist must, at the time of importation, be accompanied by a certificate completed by the Foreign Government of the region of origin. This certificate must state that all APHIS provisions have been met, including the provision that the dry-cured ham, if it is an Italian-type ham, was processed in a region determined by APHIS to be free of rinderpest. The certificate must physically accompany the shipment.

Certification of a National Government for Importation of Hams (required by FSIS)

FSIS requires certain public health certification statements to accompany imported hams. When hams are imported into the United States from regions where swine diseases of concern (i.e. CSF, SVD, FMD, etc.) exist, APHIS also requires certain disease risk mitigations. These disease risk mitigations are usually written on the back of the FSIS certificate and contain language regarding disease mitigation treatments such as curing and or cooking. Foreign Governments are required to certify to these mitigation treatments on the back of the FSIS certificate or supplied by the foreign national government as an “annex”. The certificate must physically accompany the shipment.

Certification of a National Government for Gelatin from Non-BSE Countries or from Non-Bovine Species

Gelatin derived from horses or swine, or from ruminants that have not been in any BSE-affected region, must, at the time of importation into the United States, be accompanied by an official certificate issued by the Foreign Government of the region of origin. The official certificate must state the species of animal the gelatin is derived from or, if the gelatin is derived from ruminants, certify that those ruminants have not been in any BSE-affected region. The certificate must physically accompany the shipment.

Application for Import of Small Amounts of Pork or Pork Product for Analysis, Testing, or Examination (VS 16-3)

Small amounts of pork or pork product from regions where SVD is considered to exist may, in specific cases, be imported for examination, testing, or analysis if the importer submits a written application to APHIS and receives written approval from APHIS.

Place Placards on Vehicles and Statement on Manifest, Bills of Lading, or Waybills

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

Certificate of Origin for Milk and Milk Products from Regions Free of FMD and Rinderpest

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

Certificate to Accompany Products (Dry-Cured Pork Products)

Each lot of dry-cured pork products, specifically ham, pork shoulder, or pork loins, from regions where FMD, rinderpest, ASF, CSF, or SVD exist, must be inspected at the slicing/packaging facility by personnel of the Foreign Government of the region of origin. This inspection must occur before the product is sliced. The Foreign Government must certify, in English, that the lot has been handled, processed, and packaged according to APHIS regulations and is therefore eligible for importation into the United States. The certificate must physically accompany the shipment.

Maintain Records (Dry-Cured Pork Products)

Facilities that slice and package dry-cured pork products for export to the United States must maintain, for a minimum of 2 years, original records on each lot of whole, dry-cured hams, pork shoulders, and pork loins entering the facility for slicing and packaging. These records must include the approval number of the facility where the whole ham, shoulder, or loin was dry-cured; the date the product started dry-curing; the date it completed dry-curing; the date it was sliced and packaged; and a copy of all required certifications.

Cooperative Agreement (Dry-Cured Pork Products) (SF 424, SF 424A, SF 424B,SF 424C, SF LLL)

Owner-operators of facilities that slice and package dry-cured pork products for export to the United States must enter into a cooperative service agreement with APHIS, prior to receiving the whole dry-cured hams, pork shoulders, or pork loins for slicing and packaging. This agreement must state that all hams, pork shoulders, or pork loins sliced and packaged at the facility for importation into the United States will be processed in accordance with APHIS regulations.

Certification (Dry-Cured Pork Products)

Either personnel of the Foreign Government of the region of origin, or a consortium (if the National Government of the region of origin recognizes a local consortium) must certify in English that he or she personally supervised the entire process of slicing and packaging each lot of dry-cured hams, pork shoulders, and pork loins. The certificate must also state that each lot of dry-cured hams, pork shoulders, and pork loins was sliced and packaged in accordance with APHIS requirements. The certificate must physically accompany the shipment.

Labeling (Dry-Cured Pork Products)

Exporters of sliced and packaged dry-cured pork ham, pork shoulder, or pork loin must label these products with the date that processing of the meat began, and with the date the meat was sliced and packaged.

Certificate of a National Government for Importation of Hides and Skins

Foreign Governments must complete a certificate bearing the seal of the proper department of the relevant National Government. The purpose of the certificate is to ensure that abattoir hides or skins taken from animals slaughtered under the National Government were taken from animals slaughtered in the specified abattoir and found free from anthrax, FMD, and rinderpest. The certificate must physically accompany the shipment.

Certificate of a National Government for Import of Wool, Hair, Bristles

Foreign Governments must complete a certificate bearing the seal of the proper department of the relevant National Government. The purpose of the certificate is to ensure that the described wool, hair, or bristles were taken from animals slaughtered in the specified abattoir and found free from anthrax, FMD, and rinderpest. The certificate must physically accompany the shipment.

Certificate of a National Government for Import of Glue Stock

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

Permission to Import (VS 16-3) (Stomachs of Ruminants or Swine)

Importers must submit a written application to APHIS to receive stomachs or portions of the stomachs of ruminants or swine, other than those imported for food purposes under the meat-inspection regulations of the USDA. Importations permitted will be subject to any restrictions that APHIS deems necessary in each instance.

Permission to Import (VS 16-3) (Animal Manure)

Importers must submit a written application to APHIS to receive manure of horses, cattle, sheep, other ruminants, and swine. Importations permitted will be subject to any restrictions that APHIS deems necessary in each instance. Manure produced by animals while in transit to the United States will be subject only to the requirements of the USDA regulations governing the importation of domestic livestock and other animals.

Report of Telegraph of Emergency Unloading of Restricted Import Products

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

Certificate of a National Government for Importation of Foreign Animal Casings

No animal casings can be imported into the United States from any foreign region unless they are accompanied by a certificate completed and signed by the Foreign Government where the animals were slaughtered and the casings collected. The certificate must physically accompany the shipment.

Application for Permit to Import or Transport Organisms or Vectors (VS 16-3)

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

Compliance Agreement For Handling/Disposing of Regulated Garbage (signature only)

Any person engaged in the business of handling or disposing of regulated garbage must first enter into a compliance agreement with APHIS in which the person agrees to comply with all APHIS provisions in connection with this activity. The purpose of the compliance agreement is to help APHIS ensure that regulated garbage is handled and disposed of in such as way as to prevent the dissemination of livestock or poultry diseases into or within the United States.

Recordkeeping Requirements for Certificates (cured or cooked meat from regions with FMD or rinderpest)

Restrictions are in place in connection with the importation of cured or cooked meat from regions where FMD or rinderpest exists. Meat processing establishments that process cooked meat for export to the United States must adhere to APHIS provisions in order to receive APHIS approval. Original certification, including temperature recording charts and graphs, must be kept for all cooked meat by Foreign Governments of the exporting region assigned to the meat processing establishment. These certificates must be retained for 2 years.

Marking Requirements

Eggs, other than hatching eggs from regions where END is considered to exist may enter the United States only if they are imported in cases marked with the identity of the flock of origin. Foreign Governments must mark the cases of eggs which identifies the flock of origin.

Application for Permit to Import Certain Ruminant Products, Veterinary Vaccines, and Certain Pet Products and Feed Ingredients from Canada (VS 16-3)

Importers of certain ruminant products from Canada such as boneless sheep, goat, or bovine meat; boneless veal; fresh or frozen bovine liver; vaccines for veterinary medicine for non-ruminant use; and pet products and feed ingredients containing processed animal protein and tallow from non-ruminant sources, must submit an application in writing to APHIS. The permit application process allows APHIS to assess the risks associated with such importations. APHIS instituted this permitting process for these items to protect the United States against an incursion of BSE.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

The VS Form 16-3 can be submitted through USDA’s new e-permitting system, which expedites the completion process. This form can be found on the Internet at https://epermits.aphis.usda.gov/epermits.

Currently, the VS Form 16-25 and VS Form 16-26, are not available through the Internet; however, they have been incorporated into the Veterinary Services Process Streamlining (VSPS) initiative currently under development. Within VSPS will be the capability to complete the VS Form 16-25 and 16-26 electronically.

The remaining information collection activities that follow do not involve the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology:

The Foreign Export Health Certificate cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Location, and Reason for Breaking Seal, Application of Seal cannot be recorded electronically because it is recorded in the ship’s log by the person responsible for recording information in the ship’s log, on the vessel that is carrying the container holding the product and physically remains on the ship. Therefore, electronic submission is not a suitable candidate.

Request for Approval of Defrost Facility and the Termination of Agreement cannot be recorded electronically because the application to become an approved defrost facility is a letter written by the operator. APHIS to date has not denied any defrost facilities, therefore, we can also say there are too few respondents to make electronic accessibility feasible.

The Request for Hearing cannot be recorded electronically because APHIS has not had any requests for a hearing, therefore, there are too few respondents to make electronic accessibility feasible. (need more information on this to answer appropriately.) This is an acceptable response.

The Certificate from Inspector Stating Conveyance has been Cleaned cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Certificate for Importation of Eggs, Other Than Hatching Eggs cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Trust Fund Agreement cannot be recorded electronically because it requires an original signature to be valid. Therefore, electronic submission is not a suitable candidate.

The Notification of Customs and Border Protection Inspectors (Department of Homeland Security) cannot be recorded electronically because this notification is given in writing or by phone to DHS, CBP by the importer.

BSE Questionnaire and Site Inspection Requirements For Restricted Animal Materials cannot be recorded electronically because facility owners and foreign governments complete the “BSE Questionnaire” in writing, and the Foreign Government official must sign the document. VS has the capability to e-mail the questionnaire to the respondents and receive the completed questionnaire as an attachment to replied e-mails

The Certification for Importation of Pork or Pork Products of a National Government cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Agreement between Processing Establishments and VS for Processing Procedures for Hams cannot be recorded electronically because the operator writes a letter stating their desire to become a processing establishment and that they agree to abide by APHIS regulations. Currently there is not a letter template or electronic format available.

The Hot Iron Brand/Button or Ink Seal, Plastic Tag cannot be recorded electronically because it requires that these products physically bear a hot iron brand or ink seal with identifying number, a tamper-proof button seal approved by APHIS, or a tamper-proof plastic tag with an identifying number and date. Therefore, electronic submission is not a suitable candidate.

The Certification of a National Government that Certain Processed Hams are Free of Rinderpest cannot be recorded electronically because it is a (hard) certificate completed and issued by the foreign government. The certificate must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Certification of a National Government for Importation of Hams (required by FSIS) cannot be recorded electronically because FSIS requires certain public health certification statements to physically accompany imported hams. Therefore, electronic submission is not a suitable candidate.

The Certification of a National Government for Gelatin from Non-BSE Countries or from Non-Bovine Species cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Certificate of Origin for Milk and Milk Products from Regions Free of FMD and Rinderpest cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Certificate to Accompany Dry-Cured Pork Products cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Certification for Dry-Cured Pork Products cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Labeling of Dry-Cured Pork Products cannot be recorded electronically because it must be physically present on these products; therefore, electronic submission is not a suitable candidate.

The Certificate of a National Government for Importation of Hides and Skins cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Certificate of a National Government for Import of Wool, Hair, or Bristles cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Certificate of a National Government for Import of Glue Stock cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Report of Telegraph of Emergency Unloading of Restricted Import Products cannot be recorded electronically because the carrier must report the unloading incident by telegraph to APHIS. Therefore, electronic submission is not a suitable candidate.

The Certificate of a National Government for Importation of Foreign Animal Casings cannot be recorded electronically because the information must physically accompany the shipment; therefore, electronic submission is not a suitable candidate.

The Marking Requirements for eggs from regions with END cannot be recorded electronically because it requires the eggs be imported in cases physically marked with the identity of the flock of origin. Therefore, electronic submission is not a suitable candidate.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purpose described in item 2 above.

The information that APHIS collects is not available from any other source. APHIS is the only Federal Agency responsible for preventing communicable diseases of livestock or poultry from entering the United States.

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

The information APHIS is collecting in connection with this program is the minimum needed to protect the United States from an introduction to animal diseases as a result of importing foreign animal and poultry products and byproducts, organisms, and vectors.

APHIS has no small entities involved with this information collection.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

Failing to collect this information would increase the chances of rinderpest, FMD, ASF, CSF, SVD, or END being introduced into the United States. Even if the incursion is detected relatively early, an enormous amount of money and human resources would be needed to contain the outbreak and prevent the disease from successfully establishing itself in the United States. Additionally, whether an incursion is detected early or late, it would still have a significant negative impact on U.S. export markets. If the incursion is not detected soon enough, the disease would have an opportunity to establish itself with the livestock or poultry population of the United States. An adverse event of this magnitude would require millions of dollars and years of effort to resolve. Such an effort would divert money and other resources from other vital disease prevention activities for which the Agency is responsible.

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 concerning the information collection activities associated with this program:

C. Matthias Rebmann

Lipoid LLC

744 Broad Street, 16^th Floor

Newark, NJ 07102

(973) 735-2692

[email protected]

Albert Pish

Atalanta Corporation

Atalanta Plaza

Elizabeth, NJ 07206

(908) 351-8000

[email protected]

Lisa Gossett

Ben Venue Laboratories, Inc.

300 Northfield Road

Bedford, OH 44145

(440) 201-3518

[email protected]

On Friday, April 11, 2008, pages 19803-19805, APHIS published in the Federal Register, a 60-day notice seeking public comments on its plans to request a 3-year renewal of this collection of information. No comments from the public were received.

9. Explain any decision to provide any payment or gift to respondents, other than reenumeration of contractors or grantees.

This information collection activity involves no payments or gifts to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

No additional assurance of confidentiality is provided with this information collection. 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 the following entities:

1. Mexican government officials estimate that the average hourly wage for foreign government officials, animal health officials, and inspectors to be $10.77

2. The estimated hourly wage of full-time salaried veterinarian employed by the region of export is $18.81. This figure was arrived at by the average of the following contacts: The Canadian Food Inspection Agency ($43.75); the APHIS contact in the South Africa ($3.31); and the Mexican government ($9.37).

3. Merchant marines provided the hourly wage of a ship’s crewmember responsible for recording information in the ship’s log to be $42.19.

4. Industry contacts provided the hourly wage of managers of foreign facilities that process restricted animal materials to be $46.86.

5. FSIS provided the average hourly wage of operators or owner/operators (of defrost facilities, meat processing establishments, processing establishments that process dry-cured pork products from regions where specific diseases exist, and facilities that slice and package dry-cured pork products) to be $42.32.

6. Michigan State University, Iowa State University, and Johns Hopkins University’s (which are common importers with APHIS) Web sites indicate the average hourly wage of $19.79 for officials at museums, educational institutions, or other establishments importing restricted animal byproducts and controlled materials these are not-for-profit importers i.e. researchers.

7. The Department of Labor’s (DOL) Web site indicates the average hourly wage of importers to be $7.55.

8. The Laborsta International Web site indicates the average hourly wage for exporters for agriculture, meat, and foods to be $8.95.

9. The DOL Web site indicates the average hourly wage of individuals transiting various commodities not eligible for importation into the United States to be $7.56.

10. The DOL Web site indicates the average hourly wage of transportation companies, carriers, or operators of cars, trucks, or other vehicles to be $13.28.

11. Industry contacts provided the average hourly wage of persons engaged in the business of handling or disposing of regulated garbage to be $23.44.

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

APHIS estimates the total annual cost to these respondents to be $507,364. APHIS arrived at this figure by multiplying the hours of estimated response time (23,104) by the estimated average hourly wage of the above respondents ($21.96). The hourly rates for respondents of foreign countries were derived from the following source: Laborsta Internet Web site and consultations with foreign industry contacts The hourly rates for U.S. respondents were derived from the DOL, Bureau of Labor Statistics June 2003 Report - National Compensation Survey: Occupational Wages in the United States, July 2002. See http://www.bls.gov/ncs/ocs/sp/ncbl0539.pdf .

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 $1,071,232. (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.

As a result of disease outbreaks, there was a decrease in the number of foreign facilities approved to ship meat products to the United States. Also, the number of import permits for ruminant materials from Canada has decreased as a result of Canada's change in disease status with regard to BSE and highly pathogenic avian influenza.

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.

Form VS 16-3 is used in 5 collections; therefore, it is not practical to include an OMB expiration date because of the various expiration dates for each collection. APHIS is seeking approval to not display the OMB expiration date on this form.

APHIS has no plans to seek approval for not displaying the OMB expiration date on VS Forms 16-25 and 16-26.

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

APHIS can certify compliance with all provisions under the Act.

B. Collections of Information Employing Statistical Methods

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