0047 2022 Ss (20220712)

0047 2022 SS (20220712).docx

Cooperative State-Federal Brucellosis Eradication Program

OMB: 0579-0047

Document [docx]
Download: docx | pdf

July 2022


SUPPORTING STATEMENT

Cooperative State-Federal Brucellosis Eradication Program

OMB NO. 0579-0047



TERMS OF CLEARANCE: “Before this ICR is renewed, USDA should convert VS Forms 1-23, 1-23A, 1-24, 1-26, and 1-27 to common forms or consolidate ICR packages to eliminate the multiple control numbers on each of these forms.” These forms are currently associated with multiple information collections, each with different OMB approval expiration dates. APHIS and OIRA are currently developing procedures for creating and maintaining a consolidated intra-Agency common form ICR. Upon the forms’ inclusion in the common form ICR upon its approval, the forms will be updated with the appropriate PRA banners, ICR control numbers, and OMB approval expiration dates.


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.33


The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the protection of animal health. The law gives the Secretary of Agriculture broad authority to detect, control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or restrict import or export of any animal or related material if necessary, to prevent the spread of any livestock or poultry pest or disease. The AHPA is contained in Title X, Subtitle E, Sections 10401-18 of P.L. 107-171, May 13, 2002, the Farm Security and Rural Investment Act of 2002 [7 U.S.C. 8301 et. seq.].


Disease prevention and disease surveillance are the most effective methods for maintaining a healthy animal population and for enhancing the United States’ ability to compete in the world market of animal and animal product trade. The Veterinary Services (VS) unit of the USDA’s Animal and Plant Health Inspection Service (APHIS) is responsible for administering regulations intended to protect the health of U.S. livestock populations.


Brucellosis is an infectious disease of animals and humans caused by bacteria of the genus Brucella. The disease is characterized by abortions and impaired fertility in its principal animal hosts. The disease infects humans through contact with infected animals or with certain body fluids of infected animals. Usually Brucella abortus is associated with the disease in cattle or bison, Brucella suis with the disease in swine, and Brucella melitensis with the disease in sheep and goats. The continued presence of brucellosis in a herd seriously threatens the health, welfare, and economic viability of the livestock industry. There is no economically feasible treatment for brucellosis in livestock.

The Cooperative State-Federal Brucellosis Eradication Program is a national program to eliminate this serious disease of livestock. The program is conducted under the authority of the various States, supplemented by Federal authorities regulating interstate movement of infected animals. Regulations in title 9, Code of Federal Regulations, (9 CFR) part 78 outline the Cooperative State-Federal Brucellosis Eradication Program. These rules stipulate the necessary surveillance, epidemiological investigation, annual reporting, and interstate movement activities that must be documented.


Minimum program standards known as the Brucellosis Eradication Uniform Methods and Rules (UM&R) have been developed cooperatively by organizations representing the livestock industry, State animal health agencies, and USDA. State and Federal officials in charge of program activities in each State are responsible for continuously evaluating the efficiency of local procedures in locating and eliminating infected livestock. The minimum standards in the UM&R must be met or exceeded throughout the certification period to maintain continuous status.


In addition, the APHIS bovine brucellosis program regulations in 9 CFR part 78 provide a system for classifying States or portions of States according to the rate of Brucella abortus infection present and the general effectiveness of a brucellosis control and eradication program. The program also provides for the creation of brucellosis management areas within a State and for testing and movement mitigation activities before regulated animals are permitted to move interstate. This system enhances the ability of States to move healthy, brucellosis-free cattle and bison interstate and internationally. This management area and testing system also enhances the effectiveness of the Brucellosis Eradication Program by decreasing the likelihood that infected animals will be moved interstate or internationally.


The creation of brucellosis management areas allows States that have found B. abortus in wildlife (which are nonregulated animals) to mitigate the risk of transmission and spread of disease while maintaining the State’s disease-free status in regulated domestic livestock. The State must sign a memorandum of understanding (MOU) with the Administrator that describes its brucellosis management plan. The brucellosis management plan developed by the State must define the geographic brucellosis management area and describe the surveillance and mitigation activities that the State will conduct to identify occurrence of B. abortus in domestic livestock and wildlife and potential risks for spread of the disease. The use of brucellosis management areas necessitates the use of information collection activities including 1) the brucellosis management plan, and 2) the MOU. The information provided by these documents is critical to APHIS’ mission to prevent the introduction or spread of brucellosis.


APHIS is asking the Office of Management and Budget (OMB) to approve, for 3 years, its use of these information collection activities in connection with APHIS’ efforts to eradicate brucellosis from the United States.



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


APHIS uses the following information collection activities to demonstrate that program requirements are being met for State and herd status and to demonstrate that program-allowed activities, such as testing, vaccinating, and movement, are being conducted in accordance with program rules.


Application for Brucellosis Classification or Reclassification of State or Area (VS Form 4-1 or equivalent); (9 CFR 78.1, 78.40, and 78.42); (State)

This form documents State or Area status for bovine brucellosis. States are classified annually. This form is prepared by the Area Epidemiology Officer (AEO), using data gathered from APHIS databases and reports compiled and provided by other State and Federal personnel. The completed VS Form 4-1 is then reviewed and signed by the State veterinarian and Area Veterinarian in Charge (AVIC) and submitted for review and approval by Cattle Health Center (CHC) staff and Director.


The form requires the following information so that the State can be classified appropriately:

  • The name of the State or the Area.

  • Type of request (advancement or continuation of status) and regulation reference.

  • General information regarding herd and cattle population statistics and the reporting period dates.

  • Brucellosis field blood testing summary information for Market Cattle Identification (MCI) reactor and brucellosis ring test epidemiological investigations, including numbers of herds and cattle tested and results of these blood tests, including number of reactor animals and infected herds identified.

    • Brucellosis surveillance testing summary information for brucellosis ring testing and MCI surveillance, including numbers of herds and cattle eligible for surveillance testing.

    • Summary information and statistics by case closure categories for reactor animals.

    • Summary information for other species of domestic animals blood tested.


Application for Validation of a Brucellosis-Free Area (VS Form 4-1D or equivalent); (9 CFR 78.1 and 78.32); (State)

This form documents State or Area brucellosis status for swine brucellosis. States or areas are validated every 3 years. It is prepared by the District Epidemiologist (DE), reviewed and signed by the State veterinarian and AVIC, and reviewed by the AEO and the brucellosis program manager for a recommendation to approve or disapprove the application. The form requires the following information so that the Area can be approved as a validated brucellosis-free Area:

  • The name of the State, status applied for, and qualifying method.

  • Complete herd (area) testing summary information, including numbers of herds and swine tested and number of validated swine brucellosis-free herds.

  • Market swine testing summary information, including numbers of samples tested from collection at first points of concentration and slaughter, and numbers of breeding swine slaughtered.

  • Summary information for blood samples collected and tested for diagnostic, sale, and other purposes.

  • Summary information for combined surveillance.

  • Summary information for Market Swine Test (MST) reactors, including total number of MST reactors, number traced, and number not traced.

  • Range of dates of testing for the application period.

  • Brief narrative of swine brucellosis status of the State, including identification and disposition of last infected animal.


Certified Herd – Cooperative Brucellosis Eradication (VS Form 4-13 or equivalent); (9 CFR 78.1); (State; Business)

This form documents brucellosis herd status for cattle and bison. Certified herds are recertified annually. This form is prepared by the DE and reviewed and signed by the State veterinarian and Area Veterinarian in Charge (AVIC). The form includes the following information:

  • Name of State and owner’s name and address.

  • Number and description (type) of animals in the herd.

  • Herd certification period ending date.


Quarterly Report of Swine Brucellosis Eradication Activities (VS Form 4-59 or equivalent); (9 CFR 78.1); (State)

This form is used for swine brucellosis program planning and in preparing national statistics and reports regarding the progress of the national swine brucellosis program. This form is prepared by the DE, using data gathered from APHIS databases and reports compiled and provided by other State and Federal personnel. The completed form is then reviewed and signed by the State veterinarian and AVIC and submitted for review and approval by the AEO and the swine health program manager. The form requires the following information to be submitted on a quarterly basis:

  • Name of State, stage of program, and date (month/year).

  • Summary data for samples collected at markets and slaughter establishments to include number of sows and boars tested and number of reactors and suspects, for farm of origin samples collected in the reporting State, and for farm of origin samples collected in other States.

  • Summary data for traceback of MST reactors and suspects, reported by numbers traced to known infected herds, traced and complete herd tests required, traced and complete herd test not required, traced to dealers, traced to other States, unable to trace, and test results pending.

  • Summary data for on-farm testing as broken out by reason for test (tracebacks, diagnostic, epidemiology, surveillance, validated herd, and change of ownership) and to include numbers of herds tested and number of swine tested when no infection was found and when infection was found.

  • Summary data for sources of new herd infections; data reflects number of new herds infected by purchased swine, exposure to feral swine, community spread, unknown source, or other source.

  • Summary data for swine brucellosis infected herds in the State to include numbers of herds under quarantine, new infected herds, and herds released from quarantine.

  • Summary data for herds depopulated and indemnified.

  • Summary information regarding each swine brucellosis-infected herd, to include name and address of herd owner, method of determination and source of infection, results of all testing in the herd since the last report, herd inventory, and plans for eliminating swine brucellosis from the herd.


Cooperative State-Federal Brucellosis Eradication Program, Brucellosis Test Record (VS  Form 4-33 or equivalent) and Brucellosis Test Record Continuation Sheet (VS Form 4-33A or equivalent); (9 CFR 78.1); (State; Business)

The forms are prepared by the veterinarian (an accredited veterinarian or State or Federal veterinarian) doing the testing. The VS-approved brucellosis laboratory records the test results on the form. The AEO reviews the form and classifies the animals tested. The form is prepared as needed to document brucellosis testing of animals for movement, private sale, show, or exhibition; herd certification; and brucellosis epidemiological investigations. These forms are used to document on-farm or on-ranch brucellosis testing. They include:

  • The herd owner’s name, address, county, herd number, premises ID number, and GPS coordinates.

  • The reasons for the tests, the type of herd tested, and whether the tests are complete herd tests of all eligible animals.

  • The individual animal identification and description of each animal tested and the test results.


Brucellosis Test Record Market Cattle Testing Program (VS Form 4-54 or equivalent); (9 CFR 78.1); (State; Business)

This form documents brucellosis testing at slaughter facilities and livestock markets. The form lists the name and address of the location where samples were drawn. The form is prepared by the individual at the slaughter facility contracted to collect the blood samples or by the veterinarian (accredited veterinarian or State or Federal veterinarian) at the livestock market doing the testing. The VS-approved brucellosis laboratory (identified by name and address on the form) identifies the names and addresses of the animals’ owners and records the test results on the form. The AEO reviews the form and classifies the animals tested. The form is prepared daily at the slaughter facilities and whenever it is required at the livestock markets.


Report of Backtags Applied (VS Form 4-52 or equivalent) and Report of Backtags Applied, Continuation Sheet (VS Form 4-52A or equivalent); (9 CFR 78.1); (Business)

These forms document the application of MCI backtags at slaughter facilities and livestock markets. They are prepared by a designated slaughter facility individual, a designated livestock market individual, or a State or Federal market inspector. The following information is collected on these forms:

  • The name, address, and type of the location where the tags were applied.

  • The name and job responsibility of the person applying the tags.

  • Inventory of the tag applied, to include the tag number, date applied, corresponding sales tag number, any brand information, and the herd owner’s name, address, and county.

The completed forms are submitted to the appropriate program manager in the State or VS District office on a daily to monthly basis depending on the number of backtags applied. A data entry clerk enters the date into the appropriate database and files the report for use in brucellosis epidemiologic investigations.


Calfhood Vaccination Record (VS Form 4-26 or equivalent); (9 CFR 78.1, 9 CFR 78.10); (State; Business)

This form documents brucellosis vaccination or reapplication of a brucellosis tattoo. The forms record:

  • The name and address of the herd owner; herd number and owner number.

  • The kind of herd (beef, dairy, or mixed).

  • The vaccine used, including serial number and expiration date, and dosage used.

  • The date of vaccination and vaccination tattoo applied.

  • Information identifying the cattle vaccinated, including the age, breed, sex, and grade.

  • Information identifying the veterinarian performing the vaccination.

  • Information if re-establishing the vaccination status, including the date of re-establishment, when a vaccination tattoo is reapplied.

The accredited veterinarian or the State or Federal veterinarian performing the vaccination prepares the form whenever brucellosis vaccination occurs. The form is submitted to the appropriate brucellosis program personnel in the State where the vaccination is performed. The data is entered in the appropriate database and is used in preparing the VS Form 4-1 and in epidemiological investigations.


Recordkeeping; (9 CFR 78.1); (State; Business)

Records are maintained by producers, State and Federal animal health agencies, livestock markets, livestock dealers, slaughter establishments, dairy plants, laboratories, animal agriculture agencies, breed registries, and private veterinary practitioners. The information primarily encompasses animal identification, animal location, animal movement, and animal health management activities. In addition, diagnostic testing information is maintained as part of routine surveillance activities as well as disease investigation activities.


Various documents are kept for various lengths of time depending on their purpose. Record retention periods range from 2 years to 10 years. The recordkeeping requirement documents compliance with program regulations and enables APHIS to trace animals for disease epidemiological investigations.


Current animal identification requirements for cattle and swine provide a means for all cattle and swine in interstate commerce to be traced through marketing channels. The regulations require that cattle and swine be identified while in interstate commerce, and that records be maintained showing ownership of the cattle and swine. The types of records normally kept (waybills, bills of lading, dock receipts, and tagging tickets) are records normally kept by the business to properly pay for the livestock after sale. APHIS uses this same information for disease tracebacks.


Field Investigation of Brucellosis Market Test Reactors (VS Form 4-106 or equivalent); (9 CFR 78.1); (State; Business)

The AEO, appointed State or Federal brucellosis program person, or investigating regulatory veterinarian prepares the form as needed and uses the data in preparing the VS 4-1. This form documents the findings of brucellosis epidemiological investigations conducted after finding a brucellosis reactor animal. Information recorded on this form includes:

  • Summary information regarding initiation of the investigation, the origin of the test sample, laboratory testing information, and animal backtagging information.

  • Reactor animal identification information.

  • Information for tracing to herd of origin.

  • Herd information.

  • Summary information for tracing exposed animals.


Log for Market Cattle Test Reactors (VS Form 4-100 or equivalent); (9 CFR 78.1); (State)

This form is used to summarize the VS 4-106 (Field Investigation of Brucellosis Market Test Reactors). The AEO prepares or updates the form as needed and uses the data in preparing the VS 4-1. The information recorded on the form includes:

  • MCI blood sample ID, sample test results, animal identification accompanying the sample, and name of the laboratory where the sample was tested.

  • The name and address of the consignor of the animal from which the MCI blood sample was collected and total number of cattle in the consignment.

  • The destination of the reactor cattle in the consignment.

  • The date of the field investigation, including the date the herd of origin was tested and the result of that herd test.


Epidemiological Investigation of Brucellosis Reactor Herd (VS Form 4-108 or equivalent); (9 CFR 78.1); (State; Business)

This form documents information of epidemiological importance when a herd is found to be infected with brucellosis. (VS Forms 4-108A, VS 4-108B, and VS 4-108C, described below, are supplements to this form. These forms are all completed at the same time.) Information recorded on this form is collected by the AEO or assigned State or Federal field veterinarian and includes:

  • Name and address of the herd owner and the herd number.

  • The reason for testing the herd.

  • Summary herd status information including clinical signs present, vaccination status of the herd, and number and location of other herds under the same ownership or management.

  • Type of operations, cattle census on the premises, number of susceptible species on the premises, and herd breeding program.

  • Traceback and contact herd information including possible and probable sources of infection, origins, movement, and sales of animals in the herd, and accompanying documents.

  • Quarantine and permits information, including names of six nearest herd owners, quarantine, quarantine release, and movement permit requirements.

  • Documentation of communication with the herd owner regarding herd plan and test schedule and documentation of completing other forms in the 4-108 series and remarks.


Origin of Reactors/Herd Additions (VS Form 4-108A or equivalent); (9 CFR 78.1); (State; Business)

This form documents the origin of reactor animals and herd additions. Information recorded on this form is collected from the herd owner by the AEO or assigned State or Federal field veterinarian and includes:

  • The name and address of the current herd owner, county location, and herd number.

  • Information identifying the origin of reactors and herd additions, including sources, animal identification and description, and test results.


Animals Removed from Infected Herds (VS Form 4-108B or equivalent); (9 CFR 78.1); (State; Business)

This form documents animals removed from the infected herd. Information recorded on this form is collected from the herd owner by the AEO or assigned State or Federal field veterinarian and includes:

  • The name and address of the current herd owner, county of location, and herd number.

  • Information identifying the list of animals sold or otherwise removed from the herd, including sources, animal identification and description, and test status.


Epidemiological Report – Area Herds (VS Form 4-108C or equivalent); (9 CFR 78.1); (State; Business)

This form lets APHIS evaluate whether animals have been mingled, and to determine whether other herds in the area need to be evaluated to detect disease spread. It identifies premises with cattle in the vicinity of the infected herd. Information recorded on this from is collected by the AEO or assigned State or Federal field veterinarian and includes a diagram showing the location of infected and other herds in the same vicinity and the following information for each of those herds:

  • The name and address of the herd owner, county of location, and the herd number.

  • Diagram showing location of infected and other herds in the same locality.

  • The names and addresses of owners of herds in the same vicinity, dates these owners were contacted, and dates herds are scheduled for test or an explanation if no test is required.


Permit for Movement of Animals (VS Form 1-27 or equivalent); (9 CFR 78.1, 78.9, 78.11, 78.20, 78.25, 78.30, and 78.34); (State; Business)

This form documents the movement of brucellosis reactor, exposed, or suspect animals to provide assurance that the animals are not diverted in shipment. This document is prepared, as needed, by an accredited veterinarian or State or Federal veterinarian before the animals are moved. A copy of the form accompanies the animals to their destination. Personnel at the destination acknowledge receipt of the animals. Information recorded on this form includes:

  • Name and address of the shipper or consignor, consignee, and owner at the time the disease condition was diagnosed.

  • State where the VS 1-27 is issued, location of the premises the animals are moved from, the type and purpose of the movement, and the number and species of animals in the shipment.

  • Disease and classification status of the animals, the herd of origin and of the area of origin.

  • Transportation vehicle identification, seal number, and vehicle cleaning and disinfection instructions.

  • Breed, sex, disease brand, and complete identification tag information for each individual animal to be moved in the shipment.

  • Signature of issuing individual, date and time issued, and expiration date and time.

  • Owner, shipper, or trucker identification and title.

  • Location and date animals received, number of animals received, and date slaughtered or quarantined.

  • Documentation of date and time seals broken and identification of authorized individual.

  • Documentation of cleaning and disinfection of conveyance vehicle if required.


Appraisal and Indemnity Claim for Animals Destroyed, Materials Destroyed, or Services Provided (VS Form 1-23 or equivalent); Appraisal and Indemnity Claim for Animals Destroyed, Materials Destroyed, or Services Provided Continuation Sheet (VS Form 1-23A or equivalent); Proceeds From Animals/Animal Products/Materials Sold for Salvage (VS Form 1-24 or equivalent); and Appraisal and Indemnity Request for Affected Premises Using Contract Growers (VS Form 1-26 or equivalent); (9 CFR 51.1, 51.10, 51.30, and 51.33); (Business)

These forms document appraisal values of the animals and approval of payment to the owners-claimants (including contract growers). They are prepared by the AVIC. The AVIC submits the completed forms to the CHC staff, or the Swine Health staff for review and approval, then to the District Director for processing of the request to transfer funds. Information recorded on these forms includes:

  • Date animals or materials to be destroyed are appraised, dates destroyed, and date of cleaning and disinfection.

  • The disease for which the action is being taken.

  • The name and address of the owner-claimant, the name of all partners if joint ownership, and the location of the premises where the appraisal is made.

  • The number, species, age, sex, breed, and identification of each animal appraised.

  • The appraisal value per unit, unit type, and weight or number of units appraised.

  • The total appraisal value of grade and purebred animals or materials appraised.

  • Amount due from either or both Federal and State agencies, once adjusted for salvage value.


The two information collection activities described below are needed to provide indemnity to owners of goats, sheep, or horses destroyed because of brucellosis. These animals rarely contract brucellosis; APHIS has this indemnity program as a safeguard if brucellosis is detected in a band, flock, or herd of these animals. This program fosters cooperation with producers and enables APHIS to purchase infected or exposed animals in a timely manner, thus preventing the possibility of disease spread.


Proof of Destruction

Before receiving indemnity for animals destroyed because of brucellosis, the owner must submit documentation of destruction to the District Director. These documents may include a postmortem report; a meat inspection certification of slaughter; a written statement by a State representative, APHIS representative, or accredited veterinarian attesting to the destruction of the animals; a written, sworn statement by the owner or caretaker of the animal attesting to the destruction of the animals; or a permit (VS Form 1-27) consigning the animal from a farm or livestock market directly to a recognized slaughter establishment.


Extension Request

Ear tags or other forms of animal identification must be applied within 15 days after the animals are condemned. The District Director may extend this time limit to 30 days if he or she receives a request for extension from the owner (either verbally or in writing). After the condemned animals are removed from their holding location, all structures, holding facilities, conveyances, and materials contaminated due to the presence of these animals must be properly cleaned and disinfected within 15 days from the date the animals are removed. The District Director may extend this time limit to 30 days if he or she receives a request for extension from the owner (either verbally or in writing).


Justification for Brucellosis Herd Depopulation (VS Form 4-6 or equivalent); (9 CFR 78.1, 51.1, 51.10, 51.30, and 51.33); (State)

This form is used to obtain approval for the destruction of infected herds. It is prepared as needed by the AEO, approved by the District Director, and submitted to the CHC staff. It is also used to assist with appraisal and indemnity activities.


Agreement for Complete Herd Depopulation – Brucellosis (VS Form 4-7 or equivalent); (9 CFR 78.1, 51.1, 51.10, 51.30, and 51.33); (Business)

This form is prepared as needed by the AEO, approved by the District Director, and submitted to the CHC staff. It is also used to assist with appraisal and indemnity activities. The form lists the name and address of the herd owner, the species and number of animals in the herd, the number of exposed nonreactors to be destroyed, and a description of the nonreactor animals.


Certificate of Veterinary Inspection (CVI); (9 CFR part 71, 78.1, 78.9, 78.11, 78.20, 78.25, 78.30, and 78.34); (State; Business)

These certificates (State-issued forms) are prepared as needed by accredited veterinarians to document interstate movement of animals. The certificates contain:

  • The number and description of animals to be moved.

  • A statement that the animals are not showing signs of infectious, contagious, or communicable diseases.

  • The purpose for which the animals are to be moved.

  • The shipment’s points of origin and destination.

  • The names and addresses of the consignor and consignee.

These certificates are used in brucellosis epidemiological investigations if brucellosis is detected in an animal or herd.


Quarantine and Quarantine Release Forms; (9 CFR 78.1, 78.9, 78.11, 78.20, 78.25, 78.30, and 78.34); (State; Business)

These State-issued forms are prepared as needed by State animal health officials to document the quarantine of brucellosis-affected animals or herds and release from quarantine of animals or herds. These State-issued forms also document that the appropriate procedures have been used to prevent transmission of brucellosis to other animals or herds.


Brucellosis Management Plans (no form); (9 CFR 78.1); (State)

Any State in which APHIS has determined wildlife are infected with B. abortus must develop and implement a brucellosis management plan approved by APHIS. APHIS may also require a Class Free State or Area to develop and implement a brucellosis management plan under any other circumstances if APHIS determines it is necessary to prevent the spread of brucellosis. APHIS may reclassify to a lower status any State or Area that has not implemented an approved brucellosis management plan within 6 months of being required to develop one. The brucellosis management plan, which is written by State animal health and (if necessary) wildlife officials, must:

  • Define and explain the basis for the geographic area in which a disease risk exists from B. abortus and to which the brucellosis management plan activities apply.

  • Describe epidemiological assessment and surveillance activities to identify occurrence of B. abortus in domestic livestock and wildlife and potential risks for spread of disease.

  • Describe mitigation activities to prevent the spread of B. abortus from domestic livestock and/or wildlife, as applicable, within or from the brucellosis management area.

The State officials submit the plan for review to APHIS. The plan is reviewed by APHIS VS officials at the District and Headquarters levels before being signed by State animal health (and, if necessary) wildlife officials as well as APHIS officials. APHIS retains the original plan. States generally keep a copy for their records but are not required to by APHIS.


Memorandum of Understanding (MOU) for Brucellosis Management Plans (no form); (9 CFR 78.1); (State)

As part of the process for developing and implementing a brucellosis management plan, the State must enter into an MOU with APHIS which describes the brucellosis management plan the State will administer. The MOU is prepared by APHIS and State animal health and wildlife (as appropriate) officials and signed by all parties. The MOU must be updated annually.



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.


Automated and electronic information technology is available and used by States to submit their annual and monthly reports (VS Form 4-1 and VS Form 4-1D) directly into the program’s SharePoint site) via Web access, reducing the burden of accessing data. In addition, the State’s animal health agency may enter data from VS Forms 4-26, 4-33, 4-33A, and 4-54 directly into a database of the State’s choice.


The SharePoint site replaced the program’s disease database (SCS) as the State’s repository for transmitting information to APHIS VS. The change has made it easier for the States, which are now handling most of the direct data entry instead of sending data to APHIS VS and having them key in the data.


APHIS developed electronic versions of VS Forms 4-26 and 4-33 to be used in the Mobile Information Management (MIM) system. These electronic forms can be used in the field and incorporate use of electronic animal identification information being applied and read onsite to populate the appropriate information collection fields on these forms. Use of these automated forms can significantly decrease the time and collection burden on producers, private veterinary practitioners, and State and Federal animal health officials.


The following forms are available as fillable fileable Adobe PDFs, either from the APHIS VS Forms Web site (https://www.aphis.usda.gov/aphis/resources/forms/ct_vs_forms) or sent to respondents: VS Forms 1-23, 1-23A, 1-24, 1-26, 1-27, 4-1, 4-1D, 4-26, 4-33, 4-33A, 4-52, 4‑52A, and 4-54.

The brucellosis management plan and MOU are each unique to each situation; however, the documents may be drafted and submitted to APHIS via email.


Documents used for proof of destruction associated with appraisals and indemnity claims may be submitted by any convenient means, including email and other electronic means, at the discretion of the receiving APHIS official.


Requests for extending certain deadlines associated with this program can be made via phone, fax, or electronically, as well as by hard copy.


The CVI forms and Quarantine and Quarantine Release forms are State-issued forms. Some, but not all, States use and accept electronic CVIs.


APHIS strives for continual improvement and thus will continue efforts to further streamline and automate its collection instruments and methods.



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


The information that APHIS collects in connection with this program is not available from any other source. APHIS is the only Federal agency responsible for preventing, detecting, controlling, and eliminating brucellosis and other domestic diseases of animals and poultry from the United States.



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


APHIS estimates that 90 percent of business respondents are considered small entities. The information collected is the absolute minimum needed to conduct effective brucellosis surveillance, control, and eradication efforts.



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


If the information were collected less frequently or not at all, APHIS would be unable to conduct an effective brucellosis surveillance and eradication program. Consequently, brucellosis would likely spread to areas of the United States that are currently classified free of the disease, which could have a potentially devastating effect on U.S. livestock markets and trade.



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, such as:


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

VS Form 4-52 Report of Back Tags Applied: The form is submitted on a daily to monthly basis depending on the number of back tags applied.

VS Form 4-54 Brucellosis Test Record Market Cattle Testing Program: The form is prepared daily at the slaughter facilities and whenever it is required at the livestock markets.

APHIS requires reporting and collection of information at frequent intervals to ensure that program activities are being carried out as regulations require. Moreover, frequent testing and rapid review of results allows APHIS and States to respond promptly and appropriately to the brucellosis situation in the State or District.

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

Ear tags or other forms of animal identification must be applied within 15 days after the animals are condemned. The District Director may extend this time limit to 30 days if he or she receives a request for extension from the owner (either verbally or in writing).


After the condemned animals are removed from their holding location, all structures, holding facilities, conveyances, and materials contaminated due to the presence of these animals must be properly cleaned and disinfected within 15 days from the date the animals are removed. The District Director may extend this time limit to 30 days if he or she receives a request for extension from the owner (either verbally or in writing).

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

  • requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than 3 years;

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

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

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

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


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



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


APHIS engaged in productive consultations with the following stakeholder organizations by email and phone to discuss the information APHIS collects to administer its brucellosis management program. APHIS discussed with them how we obtain the necessary data and how frequently; how much data is available; the convenience and clarity of reporting formats and other collection instruments; and the clarity of, and necessity for, any recordkeeping requirements. The respondents stated via email or phone that they had no concerns with any of these items and had no further recommendations.


Dr. Patrick Webb, Director, Swine Health

National Pork Board

1776 N.W. 114th Street

Des Moines, IA 50325

Phone: (515) 223-3441

Fax: (515) 223-2646



Dr. Eric Liska, Brucellosis Program Veterinarian

Animal Health Division, Montana Department of Livestock

P.O. Box 202001

Helena, MT 59620-2001

Phone: (406) 444-3374

Email: [email protected]


Dr. Brad DeGroot, Assistant State Veterinarian

Wyoming Livestock Board

1934 Wyott Drive

Cheyenne, WY 8200

Phone: (307) 777-6440

Email: [email protected]


On Monday, December 27, 2021, APHIS published in the Federal Register (86 FR 78239) 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. Any
and all information obtained in this information collection shall not be disclosed except in accordance with
5 U.S.C. 552a (https://www.govinfo.gov/app/details/USCODE-2010-title5/
USCODE-2010-title5-partI-chap5-subchapII-sec552a) and APHIS-15, APHIS Animal Health, Disease, and Pest Surveillance and Management System (https://www.aphis.usda.gov/aphis/
resources/lawsandregs/privacy-act/pta-pia-sorn/pta-pia-sorn).



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.


Questions of a personal nature are not found in this information collection.



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 based on real-time use and discussions with commercial livestock farm owners and managers; animal agriculture-related business owners and managers; private veterinarians; animal agriculture-related agencies and organizations; breed registry agencies; agriculture extension agents; fair and exhibition officials; owners, operators, and managers of livestock markets; owners, operators, and managers of slaughter establishments and dairy plants; and State animal health officials and laboratory personnel (including wildlife biologists).


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 annualized cost to these respondents to be $10,890,984. APHIS arrived at this figure by multiplying the estimated total burden hours (247,325 hours) by the estimated average hourly wage of the above respondents ($30.39), and then multiplying the result by 1.449 to capture benefit costs.


APHIS derived the estimated wage by averaging the following figures from the U.S. Department of Labor; Bureau of Labor Statistics website https://www.bls.gov/oes/current/oes_stru.htm in the table below. The estimate for the previous submission was high and is being corrected.


SOCC

Title

Hourly Wage

11-9010

Farmers, Ranchers, and Other Agricultural Managers

$37.71

19-1011

Animal Scientists

$38.65

19-4012

Agricultural Technicians

$21.56

29-1131

Veterinarians

$52.84

45-2021

Animal Breeders

$20.81

45-2093

Ranch Farmworkers

$14.93

45-2011

Agricultural Inspectors

$22.80

19-1023

Wildlife Biologists

$33.80


Average Hourly Wage

$30.39


According to DOL BLS news release USDL-22-0469 dated March 18, 2022 (https://www.bls.
gov/news.release/pdf/ecec.pdf), benefits account for 31 percent of employee costs, and wages account for the remaining 69 percent. Mathematically, total costs can be calculated as a function of wages, resulting in a multiplier of 1.449.

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


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



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


See APHIS 79. The annualized cost to the Federal government is estimated at $10,413,433.



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



Requested

Program Change Due to New Statute

Program Change Due to Agency Discretion

Change Due to Adjustment in Agency Estimate

Change Due to Potential Violation of the PRA

Previously Approved

Annual Number of Responses

957,102

0

0

0

0

957,102

Annual Time Burden (Hr)

247,325

0

0

4

0

247,321


This request for renewal is for 957,102 estimated responses and 247,325 estimated burden hours, reflecting an increase of 4 hours of estimated burden from the previous request. This increase is due to previous improper rounding calculations following activities: Calfhood Vaccination Record, Justification for Brucellosis Herd Depopulation, and the Agreement for Complete Herd Depopulation. There were no discretionary changes.



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.


APHIS will display the OMB expiration date on VS Forms 4-1, 4-1D, 4-6, 4-7, 4-13, 4-26, 4-33, 4-33A, 4-52, 4-52A, 4-54, 4-100, 4-106, 4-108, 4-108A, 4-108B, and 4-108C.


VS Forms 1-23, 1-23A, 1-24, 1-26, and 1-27 are in multiple APHIS information collections, each with different OMB approval expiration dates. It would not be practical to add an expiration date to the forms at this time. APHIS and OIRA are currently developing procedures for creating and maintaining a consolidated intra-Agency common form ICR. Upon the forms’ inclusion in the common form ICR upon its approval, the forms will be updated with the appropriate PRA banners, ICR control numbers, and OMB approval expiration dates.



18. Explain each exception to the certification Statement 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.

19

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorGovernment User
File Modified0000-00-00
File Created2022-07-29

© 2024 OMB.report | Privacy Policy