2017 SS 0065 updated

SUPPORTING STATEMENT

SWINE HEALTH PROTECTION

OMB NO. 0579-0065

May 2017

Information collection 0579-0137 is being merged into this information collection because both information collections are related to swine health protection. Once this information collection is approved, APHIS will discontinue 0579-0137.

A. Justification

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict import or export of any animal or related material if necessary to prevent the spread of any livestock or poultry pest or disease. The AHPA is contained in Title 7, Chapter 109, Sections 8301-8321 of the U.S. Code.

Veterinary Services (VS), a program within the United States Department of Agriculture's (USDA), Animal and Plant Health Inspection Services (APHIS), is responsible for administering regulations intended to prevent the dissemination of animal diseases within the United States. These regulations are found in Title 9, Code of Federal Regulations (CFR).

The regulations under which APHIS conducts its disease prevention activities are contained in title 9, chapter 1, subchapter D, parts 91 through 99 of the CFR. These regulations govern the importation of animals, birds, and poultry; certain animal and poultry products; and animal germplasm.

Additionally, the Swine Health Protection Act (Title 7, Chapter 69, Sections 3801-3813) was enacted because garbage is one of the primary media through which numerous infections or communicable diseases of swine are transmitted. African swine fever, which is potentially the most dangerous and destructive of all communicable swine diseases, is periodically confirmed in a number of regions that are relatively close to the United States. Classical swine fever, another serious disease of swine that was officially declared eradicated from the United States in 1978, is also present in several nearby regions.

The Swine Health Protection Act requires USDA to ensure that all garbage is treated before being fed to swine intended for interstate or foreign commerce or that substantially affect such commerce. The regulations that implement this legislation are found in 9 CFR, part 166.

The Act and the regulations allow only operators of garbage treatment facilities that meet certain specifications to use garbage for swine feeding. Noncompliance with the regulations constitutesgrounds for enforcement action and could include suspension or revocation of the license to operate the garbage treatment facility. The Act and regulations ensure that all garbage, before being fed to swine, is treated to destroy all potential animal disease agents.

APHIS VS also conducts a pseudorabies (PRV) eradication program in cooperation with State governments, swine producers, swine shippers, herd owners, and accredited veterinarians. The program identifies PRV-affected swine, provides herd management techniques, and has eliminated PRV in commercial production herds. However, APHIS periodically finds infected swine when swine are exposed to feral swine or other swine that have had exposure to feral swine.

APHIS regulations in title 9, Code of Federal Regulations (9 CFR) parts 71 and 85 facilitate the PRV eradication program and general swine health by providing requirements for moving swine interstate within a swine production system. (A production system consists of separate farms that each specialize in a different phase of swine production such as sow herds, nursery herds, and finishing herds. These separate farms, all members of the same production system, may be located in more than one State.)

Implementing these regulations requires the use of a number of information collection activities, including:

• the creation of food waste reports;

• the completion of applications to operate garbage treatment facilities;

• an acknowledgement of Act and regulations;

• garbage treatment facility inspection;

• cancellation of license by State animal health officials;

• request for a hearing;

• cancellation of license by licensee;

• notification by licensee of sick or dead animals;

• notification by licensee of changes to name, address, or management;

• swine health protection program inspection summary;

• permit to move restricted animals;

• owner-shipper statement;

• certificate of veterinary inspection;

• accredited veterinarian's statement: embryo and semen shipments;

• identification for swine moving interstate;

• swine production system health plan;

• interstate movement report and notification;

• cancellation or withdrawal of a swine production system health plan;

• appeal of cancellation of a swine production system health plan;

• shipment to slaughter seal;

• appraisal and indemnity claim form; report of net salvage proceeds;

• herd management plans;

• and recordkeeping.

APHIS is asking OMB to renew, for an additional 3 years, its use of the various information collection activities listed below.

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

APHIS uses the following information activities to ensure that garbage fed to swine does not pose a threat of spreading animal diseases within the United States.

VS Form 13-17, Food Waste Report (Business and State) - 9 CFR 116.2

This form is used by Federal and State public health officials. These officials contact food establishments (grocery stores, restaurants, etc.) and inquire about the disposition of the establishment's food waste. The form is forwarded to VS’ Area Office or the State animal health office only when the results of the inspection reveal that the destination of the food waste is potentially a garbage feeder.

Upon receipt of the information from the public health officials, Federal or State animal health personnel use the information to determine if the waste collector is feeding garbage to swine, if the garbage is being treated, and if the feeder is licensed or needs to be licensed.

VS Form 13-15, Application for Licensing of Garbage Treatment Facility (Business)

9 CFR 166.10 (a)

This application process provides a system to license and regulate individuals who wish to operate a garbage treatment facility to use garbage for swine feeding. Persons desiring to obtain a permit (license) to operate a facility to treat garbage must apply to USDA or the State agency.

Acknowledgement of Act and Regulations (Business) - 9 CFR 166.10 (b)

When an applicant is given a licensing application to operate a garbage treatment facility, he or she also receives a copy of the Swine Health Protection Act and the related regulations. At the time of the pre-licensing inspection, the applicant is required to sign a statement that he or she has received a copy of the Act and regulations, understands them, and agrees to comply with them.

VS Form 13-16, Garbage Treatment Facility Inspection (Business and State) - 9 CFR 166.13

This form is used by Veterinary Services or State inspectors during routine and repeat visits to garbage treatment facilities for the purpose of inspection, and for pre-licensing inspection activity at premises before licensing a garbage treatment facility. This form guides the inspector through the inspection process at the facility and allows the inspector to record satisfactory or unsatisfactory findings at the facility. This form enables review of the sanitation, cooking procedures, cooked product storage, and raw product storage at the facility. This information is obtained via direct observation on the farm and interview with the owner.

Request for Hearing (Business) - 9 CFR 166.11 (a)

A license will be canceled if a licensee fails to treat garbage for a consecutive 4-month period. This regulation reduces the number of periodic inspections of facilities that are not treating garbage after receipt of a license under the Act. A licensee who has been notified of a proposed cancellation of license may request a hearing to retain his or her license. The licensee requests this hearing in writing, to APHIS.

Cancellation of License by State Animal Health Official (State) - 9 CFR 166.12 (a)

A license will be canceled if a licensee fails to treat garbage for a consecutive 4-month period. This regulation reduces the number of periodic inspections of facilities that are not treating garbage after receipt of a license under the Act. If a State animal health official cancels a license, the licensee must be informed in writing.

Cancellation of License by Licensee (Business) - 9 CFR 166.12 (b)

Any licensee who no longer wishes to treat garbage under the Act may request cancellation of his or her license by writing to the Assistant District Director (AD) or to the State animal health official in a State that issues licenses under a cooperative agreement. Once received, the State animal health official will cancel the license.

Notification by Licensee of Sick or Dead Animals (Business) - 9 CFR 166.13 (b)

A licensee must immediately notify a Federal or State inspector on detecting, in any animal, illness or death not normally associated with the licensee's operation of the facility. The licensee must also notify APHIS of any change in the name, address, management, or ownership of the facility within 30 days of the change. This information enables APHIS to carefully monitor events at the facility. On request, the licensee must also give APHIS information concerning the sources of garbage at the facility. This information includes the dates of supply and the names and addresses of the suppliers.

VS Form 13-2, Swine Health Protection Program Inspection Summary (State) - 9 CFR 166.15

This document is used by the AVIC and State animal health officials in evaluating the progress of the swine health protection program in each State. The reports include data from the first day of each month to the last day of each month and are sent by the State or Federal epidemiologist to APHIS to be entered and tabulated in a spreadsheet.

Recordkeeping (Business) - 9 CFR 166.9

Each licensee must record the destination and date of removal of all garbage removed from the premises. These records must be kept for 1 year. The records are reviewed annually by supervising Federal officials to determine compliance with the Swine Health Protection Act and regulations. In the case of a disease outbreak, this information is essential for disease-tracing actions taken by Federal and State animal health officials.

From Information Collection 0579-0137

VS Form 1-27, Permit to Move Restricted Animals (Business, Accredited Veterinarians, and State) - 9 CFR 71.19, 85.1, 85.5, 85.6, 85.11

Herd owners and producers with PRV-infected, exposed animals who wish to have their swine transported to another facility for slaughter, salvage, or disposal must obtain a permit for movement. The application for the permit is filled out by the owner’s accredited veterinarian. The swine must also be identified as described in 9 CFR 71.19.

The permit alerts APHIS that infected or exposed animals are being shipped, and allows APHIS to carefully monitor this activity. This permit must be sent to the destination State animal health office within three days of movement (9 CFR 85.11). For all movements of PRV-infected or exposed swine the permit must include (9 CFR 85.1, 85.5):

1. The number of swine to be moved;

2. The purpose for which the swine are to be moved;

3. The shipment's points of origin and destination; and

4. The names and addresses of the consignor and consignee.

To move PRV-infected or exposed to a quarantined herd or feedlot, the permit must include the 4 items above and (9 CFR 85.5 (b)):

• Indicate the PRV quarantine status of the farm of origin;

• The date of the official PRV serological test;

• The name of the laboratory providing the test;

• The date of official PRV vaccination; and

• Approval from a State animal health official of the destination State.

To move PRV vaccinate swine, except swine from a qualified negative gene-altered vaccinate herds, not known to be infected with or exposed to PRV, the permit must include the four items above and (9 CFR 85.6(a)(b)):

• Indicate the PRV status of the herd of origin;

• Date of vaccination; and

• Approval from the State animal health official of the destination State.

To move PRV vaccinated swine, except from qualified negative gene-altered vaccinate herds, the permit or owner-shipper statement must include the four items above and certify that the swine are being moved to their destination with no stops (9 CFR 85.6 (a)).

Owner-Shipper Statement (Business) - 9 CFR 85.6, 85.7

Exposed or infected swine, or those vaccinated with other than a gene-deleted vaccine, can be moved interstate to slaughter, to a quarantined feedlot, or to an approved livestock market if accompanied by an owner-shipper statement. The statement is also used to accompany swine that are non-vaccinated, non-infected, and non-exposed to PRV that are moving to a feedlot, quarantined feedlot, quarantined herd, or approved livestock market (9 CFR 85.7(b)). The owner-shipper statement is not an official form and can be written on any piece of paper as long as it contains the necessary information. Not all owner-shipper statements are collected or inspected. They are usually inspected on a spot-check basis or during an actual outbreak.

The statement is completed by the owner or shipper of swine and lists:

(1) The number of swine to be moved,

(2) The shipment's points of origin and destination, and

(3) The names and addresses of the consignor and consignee.

To move PRV vaccinated swine, except from qualified negative gene-altered vaccinate herds, the permit or owner-shipper statement must include the three items above and certify that the swine are being moved to their destination with no stops (9 CFR 85.6 (a)).

Certificate of Veterinary Inspection (Business, Accredited Veterinarians, and State) - 9 CFR 85.1, 85.6, 85.7, 85.8

Producers and State officials desiring to move swine interstate that are not within a production system, that are not known to be infected with or exposed to PRV, and are not PRV-vaccinated or are vaccinated with a gene-deleted vaccine, must obtain a State-issued certificate to do so.

The certificate (filled out by the herd’s accredited veterinarian) contains (9 CFR 85.1):

(1) The number and description of the swine to be moved;

(2) A statement that the animals are not showing signs of infectious, contagious, or communicable diseases;

(3) The purpose for which the swine are to be moved;

(4) The shipment's points of origin and destination, and

(5) The names and addresses of the consignor and consignee.

For swine vaccinated for pseudorabies with a glycoprotein I (gpI) deleted gene-altered pseudorabies vaccine and not known to be infected with or exposed to pseudorabies, but that are not from a qualified negative gene-altered vaccinated herd, the certificate must also certify (9 CFR 85.6 (c)):

• That each animal to be moved was vaccinated for pseudorabies with a gpI-deleted gene-altered pseudorabies vaccine;

• That each animal to be moved was subjected to a gpI enzyme-linked immunosorbent assay (ELISA) or a gpI Particle Concentration Fluorescence Immunoassay (PCFIA) approved differential pseudorabies test no more than 30 days prior to the interstate movement and was found negative;

• The date of the gpI ELISA or the gpI PCFIA approved differential pseudorabies test; and

• The name of the laboratory that conducted the gpI ELISA or the gpI PCFIA approved differential pseudorabies test.

Swine not vaccinated for PRV and not known to be infected with or exposed to PRV may be moved interstate if the accompanying certificate includes the 5 items above and certifies that the swine (9 CFR 85.7(c)):

• Were subjected to an official pseudorabies serologic test within 30 days prior to the interstate movement and was found negative, the test date and the name of the laboratory conducting the test; or

• Are part of a currently recognized qualified pseudorabies negative herd and the date of the last qualifying test; or,

• Are part of a pseudorabies controlled vaccinated herd and is one of the off-spring that was subjected to the official pseudorabies serologic test to achieve or maintain the status of the herd as a pseudorabies controlled vaccinated herd, and the date of the last test to maintain said status.

For swine from a qualified negative gene-altered vaccinated herd, the certificate must also certify (9 CFR 85.8(b)):

• That the swine are from a qualified negative gene-altered vaccinated herd;

• The date of the herd's last qualifying test;

• The identification for the swine to be moved interstate, in accordance with 9 CFR 71.19; and

• If the swine to be moved are official gene-altered pseudorabies vaccinates, the official gene-altered pseudorabies vaccine used in the herd.

The veterinarian collects this information via conversations with the producer or State official. The accredited veterinarian must mail or deliver the certificate to the State animal health official of the destination State within 3 days of the date the animals are moved interstate (9 CFR 85.11).

Accredited Veterinarian's Statement: Embryo and Semen Shipments (Accredited Vets) - 9 CFR 85.10, 85.11

Swine semen and swine embryos moved interstate for insemination of swine or implantation into swine shall be accompanied by a document issued by an accredited veterinarian stating that the donor swine are not known to be infected with or exposed to PRV, were negative to an official PRV serologic test within 30 days prior to the collection of the semen or embryos or were members of a qualified PRV negative herd, and had not been exposed to PRV within 30 days prior to the collection of the semen or embryos (9 CFR 85.10). The accredited veterinarian bases the statement on his or her knowledge of the herd and test results gained through his or her relationship with the livestock owner.

The veterinarian must send the statement to the State animal health official of the destination State within 3 days of the date the animals are moved interstate (9 CFR 85.11).

Swine Production System Health Plan (Business and State) - 9 CFR 71.19(g)

The swine production health plan is an individualized document developed between the participating swine producer, the origin State, and the destination State which requires all farms within a given swine production system to maintain the health of their swine and remain vigilant for any signs of communicable disease. The plan identifies all the farms participating in the swine production system, provides for an accredited veterinarian to perform inspections at these sites, authorizes APHIS and State animal health officials to inspect animals and review records, documents any specific animal health requirements of a State that is a signatory to the plan, describes the recordkeeping system being used by the swine production system, and acknowledges that failure to abide by the provisions of the plan is a basis to cancel the plan. The plan also allows interstate movement within a production system for other than slaughter or to a livestock market. In this case, it is an agreement among the shipping State, the receiving State, and the producer that outlines the shipment's points of origin and destination as well as any additional information or actions agreed on by the States.

The swine production health plan is not valid until it is signed by all participants, including the producers in the production system and the State animal health officials from each State involved.

Swine Production System Health Plan – Recordkeeping (Business) - 9 CFR 71.19(g)

Each premises must maintain, for 3 years after their date of creation, records that will allow an APHIS representative or State animal health official to trace any animal on the premises back to its previous premises, and must maintain copies of each swine production health plan signed by the producer, all interstate swine movement reports issued by the producer, and all reports the swine production system accredited veterinarian(s) issue documenting the health status of the swine on the premises.

Interstate Movement Report and Notification (Business) - 9 CFR 71.19(g)

The Interstate Swine Movement Report is a paper or electronic (email) document initiated by swine producers to notify their accredited veterinarians, APHIS, and State regulatory officials in the States of origin and destination that a group of animals is being moved across State lines in a swine production system. This report must contain the name of the swine production system; the name, location, and farm identification number of the farm the swine are leaving and the farm to which the swine are going; the date of the movement; the number, age, and type of swine to be moved; the health status of the herd from which the swine are moving; the name of the accredited veterinarian who regularly inspects the swine on the farm; and a statement that the swine have been inspected and found free from signs of communicable disease by the accredited veterinarian.

Producers moving animals within swine health production systems must complete a report each month for all animals moved within the month. This report must be sent to APHIS officials each month. The report can be a simple spreadsheet indicating the number of animals moved, identification numbers, or any additional information requested in the herd plan. This report is not an official form but must meet the agreed-on criteria of the State veterinarians as specified in the herd health plan.

VS Form 7-1 Annual Report of Pseudorabies Control/Eradication Activities and Recordkeeping (State) 9 CFR 71.19

APHIS recommends this report be completed annually by each State receiving Federal PRV funding. The report assists States in ensuring surveillance performance criteria are properly tracked and analyzed. It provides both State and Federal program administrators with program data such as the number of PRV-infected herds in each State, the number of herds vaccinated for PRV, and the total number of animals tested. States completing this form are required to keep the form for 3 years.

VS Form 1-23, Appraisal and Indemnity Claim Form (Business and State) - 9 CFR 52.3, 52.4

Herds of swine and individual breeding sows to be destroyed because they are known to be infected with PRV will be appraised by an APHIS employee and a representative of the State jointly, a representative of the State alone, or, if the State authorities approve, by an APHIS employee alone.

Appraisals of swine must be reported on a VS 1-23 and signed by the owner of the swine. The form is then signed by the veterinary medical officer, who completes and sends it to the Assistant District Director (AD) for the applicable State. The AD sends the original form to the District Director (DD) for approval. The DD then sends the form to APHIS headquarters staff; once headquarters staff approves the indemnity amount, the form is returned, through the DD, to the AD with appropriate funds to depopulate the animals. The AD retains the original form.

For all claims for indemnity, the owner of the swine must certify on the claim form that the swine covered are, or are not, subject to any mortgage as defined in this part. If the owner states there is a mortgage, the owner and each person holding a mortgage on the swine must sign, consenting to the payment of indemnity to the person specified on the form.

Herd Management Plan (Business and State) - 9 CFR 52.5

On a written herd management plan and before depopulation, removal, or payment of indemnity to any swine herd owner or producer, the producer must agree with either an APHIS official or a State veterinary medical officer to specified terms to receive indemnity. All producers are considered herd owners for purposes of depopulation and indemnity. The herd plan is an agreement between APHIS and the herd owner. It outlines biosecurity measures that the producer must comply with to prevent PRV from reentering the herd. This plan also allows APHIS to depopulate without indemnity if the herd becomes reinfected and it is found that the herd plan was not followed. The agreements are written specifically for each herd. Producers must sign the document after agreement to specified terms to receive indemnity. The document accompanies the VS 1-23 to APHIS headquarters and, after indemnity is approved, is kept by the DD.

VS Form 1-24, Proceeds from Animals/Animal Products/Materials Sold for Slaughter (Business)

9 CFR 52.5

Producers with PRV-infected, exposed animals who have had their infected swine transported to a slaughter facility for disposal must report to APHIS the value received for the depopulation. The owner reports the value minus the trucking expense to APHIS. APHIS pays the herd owner the difference between the indemnity price and his or her net salvage proceeds. The herd owner must provide documentation of this amount to APHIS by fax, mail, or in person once the herd has been disposed of to receive compensation.

New

VS Form 1-26 Appraisal Request for Affected Premises Using Contract Growers - (Business)

In the event of a foreign animal outbreak, producers uses this form as an Application for permit to move slaughter swine from the originating slaughter facilities to approved destination facilities.

The State Official or Tribal Official and APHIS Official have determined that animals/animal products on this premises are affected with a disease. Animals on this premises will be depopulated by State and/or APHIS and/or industry personnel; the State-Federal-Industry goal is to complete depopulation within 24 hours of detection. Indemnity for destroyed animals/animal products affected by disease will be based on their fair market value, as determined by the current USDA APHIS indemnity calculators. In cases where the destroyed animals and/or animal products were produced by a Contract Grower, the appraised value of the animals and animal products will be split between the Owner and Contract Grower based on the terms of the contract currently in place for the growing or care of the affected animals and animal products. In the event that determination of indemnity as described above is deemed to be impractical or inappropriate, APHIS may use any other method for split payments that the Administrator deems appropriate. If Federal indemnity is approved for the destroyed animals and animal products, the Animal Owner will receive the difference between the total indemnity shown on the VS Form 1-23, Appraisal and Indemnity Claim, and the total indemnity paid to the Contract Grower.

Notification by Licensee of Changes to Name, Address, or Management (Business) - 9 CFR 166.13 (b)

A licensee must immediately notify Federal or State animal health officials of any changes to the name or address of the facility as well as any substantial changes in the control or ownership of the facility.

Recordkeeping Required for Buyers/Sellers of Swine Moved Interstate (Business) - 9 CFR 71.19(e))

Each person who buys or sells, for his or her own account or as the agent of the buyer or seller, transports, receives for transportation, offers for sale or transportation, or otherwise handles swine in interstate commerce, must keep records for two years relating to the transfer of ownership, shipment, or handling of the swine, such as yarding receipts, sale tickets, invoices, and waybills upon which is recorded:

• All serial numbers and other approved means of identification appearing on the swine that are necessary to identify it to the person from whom it was purchased or otherwise obtained; and

• The street address, including city and state, or the township, county, and State, and the telephone number, if available, of the person from whom the swine were purchased or otherwise obtained.

Identification for Swine Moving Interstate (Business, Accredited Vets, and State) - 9 CFR 71.19(d)

Serial numbers of United States Department of Agriculture (USDA) approved backtag and official swine tattoos will be assigned to each person who applies to the State animal health official or the area veterinarian in charge for the State in which that person maintains his/her or its place of business. Serial numbers of official eartags will be assigned to each accredited veterinarian or State or Federal representative who requests official eartags from the State animal health official or the area veterinarian in charge, whoever is responsible for issuing official eartags in that State. Persons assigned serial numbers of United States Department of Agriculture (USDA) approved backtag, official swine tattoos, and official eartags must record the following information on a document (9 CFR 71.19(d)):

• All serial numbers applied to the swine;

• Any other serial numbers and approved identification appearing on the swine that are needed to identify the swine to its previous owner and location;

• The street address, including the city and state, or the township, county, and state, of the premises where the approved means of identification were applied; and

• The telephone number, if available, of the person who owns or possesses the swine.

Identification for Swine Moving Interstate – Recordkeeping (Business) - 9 CFR 71.19(d)

Persons assigned serial numbers of United States Department of Agriculture (USDA) approved backtag, official swine tattoos, and official eartags must maintain these records at the person's place of business for 2 years and make these records available for inspection and copying during ordinary business hours upon request by any authorized employee of the USDA, upon that employee's request and presentation of his or her official credentials.

Cancellation or Withdrawal of a Swine Production System Health Plan (Business and State)

9 CFR 71.19(h)

The following procedures apply to cancellation of, or withdrawal from, a swine production health plan:

• A State animal health official may cancel his or her State's participation in a swine production health plan by giving written notice to all swine producers, APHIS representatives, accredited veterinarians, and other State animal health officials listed in the plan.

• A swine production system may withdraw one or more of its premises from participation in the plan upon giving written notice to the Administrator, the accredited veterinarian(s), all swine producers listed in the plan, and State animal health officials listed in the plan.

Appeal of Cancellation of a Swine Production System Health Plan (Business) - 9 CFR 71.19(h)

The Administrator may cancel a swine production health plan by giving written notice to all swine producers, accredited veterinarians, and State animal health officials listed in the plan. Before a swine health production plan is canceled, an APHIS representative will inform a representative of the swine production system of the reasons for the proposed cancellation. The swine production system may appeal the proposed cancellation in writing to the Administrator within 10 days after being informed of the reasons for the proposed cancellation. The appeal must include all of the facts and reasons upon which the swine production system relies to show that the reasons for the proposed cancellation are incorrect or do not support the cancellation

VS 1-38 Application for Permit to Move Slaughter Swine from Originating Slaughter Facilities to Approved Destination Facilities (Business and State) - 9 CFR 71.21(a)

Any business entity wishing to re-transport swine from slaughter facility lairage areas must apply for a permit from the office of the Assistant Director (AD) in the State of origin. The AD and the State veterinarian will jointly review and approve (or disapprove) the permit application. Each business entity wishing to transport swine must acquire a separate approved permit application for each originating slaughter establishment. Animals may only be transported to locations listed on the permit. The permit application will list all eligible facilities for possible swine reshipment within one State. If swine are to be re-transported across state lines a separate application must be filed for each State in which potential reshipment receiving facilities are located.

Shipment to Slaughter Seal (Accredited Vets, and State) - 9 CFR 52.2

Swine to be destroyed because they are from a herd known to be infected with PRV or individual breeding sows known to be infected with PRV must be sent directly to slaughter under permit in a conveyance closed with an official seal applied and removed by either an APHIS employee, a State representative, an accredited veterinarian, or an individual authorized for this purpose by an APHIS employee.

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.

Currently only the VS Form 13-2 is available for electronic collection of data. It is available on APHIS’ web site at http://inside.aphis.usda.gov/vs/downloads/vs-form13-2.pdf VS’ recent reorganization impacted the updating and consolidating of the remaining forms into VS’ electronic data collection process. Now that the reorganization and the revamping of the electronic data collection are complete, VS is making every effort to make the remainder of the forms electronic. APHIS will submit a Non-substantive Change Request upon completion of making each form available electronically. Most forms in widespread use have been converted to fillable PDF format to allow completion and electronic filing as e-mail attachments.

The Permit for Movement of Restricted Animals (VS 1-27) is not available in an electronic format. Use of this form requires individuals to seal vehicles. Additionally, original documents with signatures must accompany the animal shipment. Therefore, APHIS has no plans to produce this form in an electronic format.

An electronic Certificate of Veterinary Inspection is available. The electronic version can be completed by accredited veterinarians by accessing www.globalvetlink.com or through the USDA Veterinary Services Processes Streamlining System located at https://vsps.aphis.usda.gov/vsps. It includes the accredited veterinarian's statement concerning embryos for implantation and semen shipments. Accredited veterinarians can access, complete, and submit all parts of the form electronically. Once completed, the form is automatically tracked in a data management system. An increasing number of swine veterinarians in multiple States now use the electronic form.

The owner-shipper statement cannot be submitted electronically. Owner-shipper statements are not official APHIS forms. These forms are created as needed by the swine herd owner or shipper, and are usually collected or inspected on a spot-check basis or during an actual outbreak.

The swine production health plan, while required by APHIS regulations, is not an official report. Rather, it is an agreement among the shipping State, the receiving State, and the producer regarding movement of swine. It also requires original signatures and thus does not lend itself to an electronic format.

The interstate movement reports can be submitted electronically to State veterinarians in receiving and shipping States, based on individual state requirements. This is not an official report but is created by producers to inform accredited veterinarians, State veterinarians, and ADs of animal movements. These records are collected by States and periodically reviewed for accuracy. They can be transmitted via email to accredited veterinarians, APHIS, or appropriate State offices.

The Appraisal and Indemnity Claim Form (VS 1-23) is available in an electronic PDF format. The form is located on the VS intranet site http://inside.aphis.usda.gov/vs/downloads/vs-form1-23.pdf. However, since this form requires original signatures, the electronic version has to be printed, signed, and submitted to all offices manually by mail or in person.

The herd plan is a producer-specific document, not an official APHIS form. This document is written in cooperation with the producer to prevent reentry of disease. Because this document is different for every producer, a standard electronic form is not available. This document accompanies the VS 1-23; as such, it is generally submitted via mail or in person.

The Report of Net Salvage is not an official form and cannot be created electronically as it differs from case to case. For this report, producers provide proof of sales and payment receipts for animals sold for salvage value to government officials by fax, mail, or in person.

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 collected is the absolute minimum needed to conduct effective monitoring of garbage treatment facilities in the United States. The information that APHIS collects is not available from any other source. APHIS is the only Federal agency responsible for controlling and eliminating domestic diseases of animals and poultry.

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

Over 80 percent of all respondents in the information collection are considered small entities. This information collection represents APHIS’ efforts to ensure that garbage fed to swine does not pose a threat of spreading animal diseases within the United States. Burden is reduced by only asking for the information needed to ensure the Swine Health Protection Act is being followed and by having State or APHIS personnel available to assist with questions on the needed records.

6. Describe the consequences 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 severely cripple APHIS’ ability to prevent the spread of contagious animal diseases within the United States. If this information were not collected, the incidence of animal disease outbreaks would begin to rise, and the United States would lose its favored status for the export of livestock.

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

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

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

Certificate of Veterinary Inspection - Producers and State officials desiring to move swine interstate that are not within a production system, that are not known to be infected with or exposed to PRV, and are not PRV-vaccinated or are vaccinated with a gene-deleted vaccine, must obtain a State-issued certificate to do so. The veterinarian collects this information via conversations with the producer or State official. The accredited veterinarian must mail or deliver the certificate to the State animal health official of the destination state within 3 days of the date the animals are moved interstate

Notification by Licensee of Sick or Dead Animals - A licensee must immediately notify a Federal or State inspector on detecting, in any animal, illness or death not normally associated with the licensee's operation of the facility. The licensee must also notify APHIS of any change in the name, address, management, or ownership of the facility within 30 days of the change. This information lets APHIS monitor the facility and helps with disease investigation tracebacks.

Accredited Veterinarian's Statement: Embryo and Semen Shipments - Swine semen and swine embryos moved interstate for insemination of swine or implantation into swine shall be accompanied by a document issued by an accredited veterinarian stating that the donor swine are not known to be infected with or exposed to PRV, were negative to an official PRV serologic test within 30 days prior to the collection of the semen or embryos or were members of a qualified PRV negative herd, and had not been exposed to PRV within 30 days prior to the collection of the semen or embryos. The accredited veterinarian bases the statement on his or her knowledge of the herd and test results gained through his or her relationship with the livestock owner. The veterinarian must send the statement to the State animal health official of the Destination State within 3 days of the date the animals are moved interstate.

Appraisal Request for Affected Premises Using Contract Growers (VS 1-26) – If it is determined that animals/animal products on this premises are affected with a disease. The animals/animal products on this premises will be depopulated. The goal is to complete depopulation within 24 hours of detection. Indemnity for destroyed animals/animal products affected by disease will be based on their fair market value, as determined by the current USDA APHIS indemnity calculators.

• requiring respondents to submit more than an original and two copies of any document;

• requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;

• in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

• requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

• that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

No other special circumstances exist that would require this collection to be conducted in a manner inconsistent with the general information collection guidelines in 5 CFR 1320.5.

8. Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and record keeping, disclosure, or reporting form, and on the data elements to be recorded, disclosed, or reported. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, soliciting comments on the information collection prior to submission to OMB.

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

Dr. Dave Pyburn

Vice President of Science and Technology

National Pork Board

1776 NW 114th St.

Clive, IA 50325

Phone: 515-223-2634

Cell: 515-330-5431

Fax: 515-309-5715

Email: [email protected]

Dr. Dan  Kovich

Assistant Director of Science and Technology

National Pork Producers Council

122 C Street NW
Suite 875
Washington, DC 20001

202-347-3600

[email protected]

Dr. Patrick Webb

National Pork Board

1776 Northwest 114th Street

Clive, IA 50325

(515) 223-2600

[email protected]

On Tuesday, March 28, 2017, pages 15321-15322, APHIS published in the Federal Register, a 60-day notice seeking public comments on its plans to request a 3-year renewal of this collection of information. During that time, APHIS received 3 comments from a concerned citizen about her perception of the general maltreatment of animals. All comments were the same but, received to APHIS via different mediums. The comment had no relevance to the purpose of the collection.

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

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

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

No additional assurance of confidentiality is provided with this information collection. Any and all information obtained in this collection shall not be disclosed except in accordance with 5 U.S.C.552a.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and others that are 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 asks 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 bow 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 APHIS headquarters and field personnel, State veterinary authorities, herd owners, and owners/operators (licensees) of garbage treatment facilities.

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

Respondents are owners/operators (licensees) of garbage treatment facilities, owners/operators of facilities that have food waste, herd owners, and State animal health authorities. APHIS estimates the total cost to respondents to be $53,616,640.50 by multiplying the total burden hours (1,687,650) by the estimated average hourly wage of the above respondents ($31.77).

Owners/Operators of Food Waste Facilities: $25.79 [Food Service Managers]

Owners/Operators of herds: $ 33.60 [Farm, Ranch, and Other Agricultural Managers]

Licensees: $23.22 [First-Line Supervisors of Farm Workers]

State Animal Health Authorities: $44.47 [Veterinarians]

The average hourly rate is derived from the U.S. Department of Labor; Bureau of Labor Statistics – National Occupational Employment and Wage Estimates at https://www.bls.gov/oes/current/oes_stru.htm.

13. Provide estimates of the total annual cost burden to respondents or record keepers resulting from the collection of information, (do not include the cost of any hour burden shown in items 12 and 14) .The cost estimates should be split into two components: (a) a total capital and startup cost component annualized over its expected useful life; and (b) a total operation and maintenance and purchase of services component.

No annual cost burden is associated with capital and startup costs, operation and maintenance expenditures, and purchase of services.

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

Administrative and overhead costs for this certification program are estimated to cost $1,334,978 (see APHIS Form 79).

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB Form 83-1.

ICR Summary of Burden:

	Requested	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses	1,147,789	0	1,134,904	-12	0	12,897
Annual Time Burden (Hr)	1,687,650	0	1,676,304	13	0	11,333
Annual Cost Burden ($)	0	0	0	0	0	0

There is in adjustment decrease of -1 respondent and -12 responses and there was an increase of +13 burden hours. There is an increase of +25 burden hours as a result of an increase in the time to complete the Acknowledgment of Acts and Regulations (Business). There is a decrease of

-1 respondent and -12 responses resulting in a decrease of -12 burden hours for the Swine Health Protection Program Summary (State).

There is a program change resulting in an increase of + 1,134,904 responses and in an increase of +1,676,304 due to merging information collection 0579-0137 into this collection, 0579-0065.

There is a program change of + 296,156 responses and +73,647 total burden hours with the addition of the Following activities:

The program increase is due to the inclusion of all burden reporting from information collection 0579-0137 and the addition of the following burden items, which had previously been overlooked will be reported as violation by APHIS:

• VS 1-27 - Permit to Move Restricted Animals

• Owner-Shipper Statement

• Certificate of Veterinary Inspection

• Swine Production System Health Plan

• Swine Production System Health Plan -- Recordkeeping

• VS 7-1 - Annual Report of PRV Control and Eradication Activities

• Annual Report of PRV Control and Eradication Activities Recordkeeping

• VS 1-23 - Appraisal and Indemnity Claim Form

• Herd Management Plan

• VS 1-24 - Proceeds from Animals/Animal Products/Materials Sold for Slaughter

There is a program change of + 838,748 responses and + 1,602,657 total burden hours with the addition of the Following activities:

• VS 1-26 - Appraisal Request for Affected Premises Using Contract Growers

• Notification by Licensee of Changes to Name, Address, or Management

• Recordkeeping for Buyers and Sellers of Swine Moved Interstate

• Identification of Swine Moving Interstate

• Identification of Swine Moving Interstate -- Recordkeeping

• Cancellation of Withdrawal of a Swine Production System Health Plan

• Appeal of Cancellation of a Swine Production System Health Plan

• VS 1-38 - Application for Permit To Move Slaughter Swine from Originating Slaughter Facilities to Approved Destination Facilities

• Shipment to Slaughter Seal

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 collected in connection with this program.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

VS 1-23, VS 1-24, and VS 1-27 are used in multiple information collections; therefore, it is not practical to include OMB expiration dates because of the various expiration dates for each collection. APHIS is seeking approval to not display OMB expiration dates on these forms.

APHIS has no plans to seek approval for not displaying the OMB expiration date on the remaining forms in this information collection.

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

APHIS can certify compliance with all provisions under the Act.

B. Collections of Information Employing Statistical Methods

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

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