DAR File No. 43185

Health, Disease Control and Prevention, Laboratory Services

Rule R438-13

Rules for the Certification of Institutions to Obtain Impounded Animals in the State of Utah

Notice of Proposed Rule

(Amendment)

DAR File No.: 43185
Filed: 09/12/2018 08:49:10 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The reason for these amendments is to clarify process and committee membership.

Summary of the rule or change:

These changes are made to section headings and numbering systems. Instructions are rearranged to make it easier for the reader to understand their responsibilities in carrying out this rule. These changes also update references and changes are made to clarify committee membership. No changes are made to the process or the intent of this rule.

Statutory or constitutional authorization for this rule:

• Section 26-21-1 et seq.

This rule or change incorporates by reference the following material:

• Updates Guide for the Care and Use of Laboratory Animals, published by National Institute of Health, 12/27/2010

Anticipated cost or savings to:

the state budget:

These proposed rule changes are not expected to have any fiscal impact on state government revenues or expenditures because these changes do not affect the implementation of this rule; they simply clarify the process.

local governments:

These proposed rule changes are not expected to have any fiscal impact on local governments' revenues or expenditures because these changes do not affect the implementation of this rule. These changes simply clarify the process.

small businesses:

These proposed rule changes are not expected to have any fiscal impact on small businesses' revenues or expenditures because these changes do not affect the implementation of this rule. These changes simply clarify the process.

persons other than small businesses, businesses, or local governmental entities:

These proposed rule change are not expected to have any fiscal impact on other person�s revenues or expenditures because these changes do not affect the implementation of this rule. These changes simply clarify the process.

Compliance costs for affected persons:

These proposed rule change are not expected to have any fiscal impact on any person�s revenues or expenditures because these changes do not affect the implementation of this rule. These changes simply clarify the process.

Comments by the department head on the fiscal impact the rule may have on businesses:

Most of these changes are nonsubstantive for reorganization and clarification of existing requirements. The only substantive change was to remove the term of appointment for membership on the Impound Animals Advisory Committee. There is no fiscal impact to businesses.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Disease Control and Prevention, Laboratory Services
4431 S 2700 W
TAYLORSVILLE, UT 84119

Direct questions regarding this rule to:

• Robyn Atkinson at the above address, by phone at 801-965-2424, by FAX at 801-969-3704, or by Internet E-mail at [email protected]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

10/31/2018

This rule may become effective on:

11/07/2018

Authorized by:

Joseph Miner, Executive Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2019	FY 2020	FY 2021
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Person	$0	$0	$0
Total Fiscal Costs:	$0	$0	$0
Fiscal Benefits
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Persons	$0	$0	$0
Total Fiscal Benefits:	$0	$0	$0
Net Fiscal Benefits:	$0	$0	$0

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

These proposed rule changes are not expected to have any fiscal impacts on non-small business revenues or expenditures because the changes do not affect the implementation of the rule; they simply clarify the process.

 

The Executive Director of the Department of Health, Joseph Miner, has reviewed and approved this fiscal analysis.

 

 

R438. Health, Disease Control and Prevention, Laboratory Services.

R438-13. Rules for the Certification of Institutions to Obtain Impounded Animals in the State of Utah.

R438-13-1. Introduction.

The purpose of [these rules]this rule is to enable the proper execution of Section 26-26 -1 et seq., for controlling the humane use of animals obtained from impound establishments for the diagnosis and treatment of human and animal diseases; the advancement of veterinary, dental, medical, and biological sciences; and the testing, improvement, and standardization of laboratory specimens, biologic products, pharmaceuticals and drugs.

 

R438-13-2. Definitions.

(1) "ADMINISTRATOR" means a Department of Health staff member appointed by the Director to administer this rule[these rules].

(2) "ANIMAL" means any unredeemed, abandoned or stray dog or cat impounded and requested by an institution for purposes specified in Section 26-26- 1 et seq.[(1-7)], as amended, and this rule[these rules]. Animals obtained from any source other than an establishment are not covered by this rule[these rules]. Owners of voluntarily released animals may elect , by signature , whether the animal may or may not be used in research.

(3) "ANIMAL FACILITY" means an area of the institution where [impounded ]animals are housed or kept .[for recovery].

(4) "COMMITTEE" means a body of seven individuals appointed by the Administrator with the Director 's approval for carrying out the purpose of this rule[purposes of these rules].

(5) "DEPARTMENT" means the Utah Department of Health (DOH).

(6) "DIRECTOR" means the Executive Director of the Department of Health.

(7) "ESTABLISHMENT" means any [public ]place maintained for the impounding, care, and disposal of animals seized by lawful authority.

(8) "INSPECTION TEAM" means [an]one animal control officer , recommended by the Utah Animal Control Officers' Association (UACO ,) and one licensed veterinarian, both approved by the institution being inspected and appointed by the Administrator.

(9) "INSPECTOR" means a representative of the United States Department of Agriculture (USDA) or a qualified person acceptable to the Director or Administrator.

(10) "INSTITUTION" means any school or college of agriculture, veterinary medicine, medicine, pharmacy, dentistry, or other educational, hospital or scientific establishment, as determined by the committee and approved by the Director, which is properly concerned with the investigation of or instruction concerning the structure or functions of living organisms, or the cause, prevention, control, or cure of diseases or abnormal conditions of human beings or animals.

(11) "PHYSICIAN" means any person who is licensed by the Utah Department of Commerce under either the Utah Medical Practice Act or the Utah Osteopathic Medicine Licensing Act to practice medicine and /or surgery in all its branches, or a physician in the employment of the government of the United States who is similarly qualified.

(12) "VETERINARIAN" means any person who is licensed by the Department of Commerce under the Veterinary Practice Act to practice veterinary medicine, surgery, and dentistry or a veterinarian in the employment of the government of the United States who is similarly qualified.

 

R438-13-3. Department of Health - Power to Certify Institutions.

The Department, under the powers and duties conferred upon it by Section 26-26-2, may issue a certificate to obtain impounded animals to any institution requesting such certification upon being assured that the institution meets the requirements of Section 26-26-1 et seq., and has satisfied the requirements for certification[as detailed in these rules], as determined after an inspection.

 

R438-13-4. Committee -- Responsibilities and Membership. [ Responsibilities, Membership, and Term of Appointment. ]

(1) There is created an Impounded Animals Advisory Committee pursuant to Section 26-1-20[Utah].

[A. Responsibilities

] (2) The committee shall review and evaluate all applications of institutions requesting certification under this rule[these rules], or applications for renewal of certification[, as well as cause to be investigated]. The committee shall investigate any complaints of violation of Section 26-26-1 et seq. and/or this rule[these rules] by any individual, institution, or establishment, and shall inform the Director of its findings . [and] The committee shall make recommendations for or against certification or enforcement of the law and this rule[these rules].

[B. Membership

] (3) The committee shall include not less than one representative from the following: institutions directly involved with the use of laboratory animals, a physician, a representative of establishments, a veterinarian, a representative of animal welfare advocates, and two other members to be appointed by the Director, one of which must represent the public. The committee shall elect a chairman and a vice chairman from its membership[for terms not to exceed one year]. The committee shall be convened when an application or violation complaint is received by the Administrator or the Director[meet a minimum of two times annually].

[C. Terms of Appointment

Appointments shall be made for a period of three years. Any member may be appointed to a second consecutive term; however, no more than two consecutive terms may be served. A former committee member may return after an absence of one term.]

 

R438-13-5. Administrator - Duties and Responsibilities.

The Director may appoint a member of the Department staff to be responsible for the administration of this rule[these rules]. The [a]Administrator shall be a nonvoting member of the committee and shall issue certificates, receive and review all applications and records, conduct investigations, and receive and review reports of an inspector, consistent with the requirements of Section 26-26-1 et seq. and shall advise the committee of all findings.

 

R438-13-6. Requirements [ for Institutions ]for Certification.

(1) Any institution requesting certification under this rule[act] shall be found to have the proper personnel and facilities for the care and humane treatment of any animal procured under this rule[act], and so shown by the application and by an inspection of the institution's animal facility[facilities] by an inspector.

[A. Personnel]

(2) The care and management of animals shall be performed by qualified personnel.

[1.](3) The institution's animal facilities shall be under the direct supervision of a diplomate of the American College of Laboratory Animal Medicine, a physician, veterinarian, or dentist, or a person formally trained in the biological sciences and having no less than three years of pertinent training and experience in animal care, or a person qualified by specialized education, training and experience essentially equivalent to the above categories.

[2.](4) Animal care personnel shall be qualified by training and experience in the care of animals as determined by the institution's animal facility supervisor.

[3.](5) Apprentice personnel shall be under the direct and immediate supervision of regular animal care personnel.

[4.](6) The size of the animal care staff shall be adequate to assure daily attention to the needs of the animals.

[5.](7) Provision shall be made for the emergency care of animals whenever needed.

[B. Physical Facilities and Animal Care]

[1.](8) Sanitary practices and humane care of animals shall conform to standards as described in the National Institutes of Health Publication , [No. 86-23 ]revised 2011[1985], "Guide for the Care and Use of Laboratory Animals , 8 ^th ed" and the Animal Welfare Act , [9 CFR parts 1, 2, 3 1990 edition ]which are incorporated by reference.

[2. At the conclusion of an experiment which does not require euthanasia for the collection of samples, the institution may, providing the establishment agrees and for the purpose of adoption, return to the establishment any healthy animal posing no contagious threat to humans. If the establishment does not agree to accept the animal, the institution shall euthanize the animal.

C. Inspections]

(9) Institutions seeking initial certification must submit evidence of a successful on-site inspection of their impounded animal facilities by the United States Department of Agriculture (USDA). Institutions unable to be inspected by USDA are subject to inspection by a Department of Health inspection team. After initial certification, institutions wishing to maintain certified status shall be inspected at least annually by the USDA, an inspection team or both.

[D. Fees

Fees for certification will be set and administered by the Department, with approval of the State Legislature.

E. Animal Care and Use Committee]

(10) Each institution shall appoint an animal care and use committee. This committee should include a scientist from the institution, a doctor of veterinary medicine, and a person who is not affiliated with the institution in any way other than a member of the committee.

(11) This committee should be responsible for evaluating the animal care and use program. Its duties should include those described in the National Institutes of Health Publication, revised 2011, "Guide for the Care and Use of Laboratory Animals, 8 ^th ed."[NIH publication No. 86-23, Guide for the Care and Use of Laboratory Animals.]

 

R438-13-7. Application for Certification.

(1) Application for certification shall be initiated by the institution wishing to obtain unredeemed impounded animals. The application shall be made on a form furnished by the Department, and shall include:

[A.](a) the name and address of the institution;

[B.](b) the name of the person [who will be ]responsible for the supervision of procurement and handling of the animal (s).[The Administrator must be notified within ten days of personnel changes;]

[C.](c) an estimate of the maximum number and species of animals to be obtained by the institution during the calendar year[.];

[D.](d) the names of members of the institution's animal care and use committee.

(2) Fees for certification will be set and administered by the Department, with approval of the State Legislature.

 

R438-13-8. Issuance of Certificate.

[A.](1) Upon receipt of an application, an inspector shall review the animal facility of the institution and shall submit a report of the review to the committee , unless an inspection report is submitted at the same time as the application. [The inspector's report shall be attached to the application and the]The committee will review the application and the inspection report. The committee will review submit written recommendations [made by the committee and submitted ]to the Director. It shall be the prerogative of the Director to determine if the institution meets the requirements of Section 26-26-1 et seq. and this rule[these rules].

[B. A certificate, once granted, cannot be transferred.]

[C.](2) Any certificate is[shall be] valid only for the [calendar year]time frame for which it is issued , not to exceed 12 months. Any institution wishing to renew a certificate shall do so on a form furnished by the Department, and shall state any changes made or contemplated since the most recent application was submitted.

[D.](3) The certificate of approval or duplicate thereof, as supplied by the Department, shall be displayed in a prominent place in the approved institution's animal facility.[quarters or approved laboratory.]

(4) A certificate cannot be transferred.

 

R438-13-9. [Records.]Requirements for Certified Institutions.

(1) Each institution shall appoint a person to be responsible for the procurement of and maintenance of records on all animals obtained from establishments.

(2) Records shall be kept by the institution of all animals procured under certification .[on forms provided by the Department. Information for the purpose of record keeping shall be provided on the "Record of Transfer and Receipt of Impounded Animal" form and the "Requisition of Impounded Animals" form.]

[A.](3) Records shall include:

[1.](a) a description of the animal, including breed, if known;

[2.](b) the date and place where the animal was procured;

[3.](c) the physical condition of the animal when received by the institution;

[4.](d) the cage or pen number or other identification;

[5.](e) the experimental or scientific use of the animal, including information as to whether anesthesia was or was not used;

[6.](f) name and address of person who adopted animal, if adopted at the end of the study period;

[7.](g) the method of euthanasia of the animal, if euthanasia is performed.

[B.](4) The institution is to provide a copy of the information in 438-13-9(3)[the "Record of Transfer and Receipt of Impounded Animals" form, with parts A and B completed,] to an establishment for each animal received.

[C.](5) After the final disposition of the animal, a copy of the completed record[form] shall be mailed or delivered to the [a]Administrator by the institution.

(6) The completed records[form] shall be maintained by the institution for not less than two years and shall be made available for inspection at any time deemed necessary by the Director or his authorized representative.

 

[R438-13-10. Requisitions.

An establishment may require ]

(7) Written[written] requisitions [for animals]may be required by an establishment prior to the[ir] release of an animal to an institution.[The requisition shall be executed in duplicate on forms provided by the Department.] The institution[original] shall [be ]furnish[ed] one copy of the requisition to the establishment and one copy shall be retained by the institution.

(8) The requisition shall include:

[A.](a) name and address of the institution;

[B.](b) name and address of the establishment;

[C.](c) number, species, size and sex of the animals desired;

[D.](d) number of certificate;

[E.](e) date requisition was issued.

(9) The institution shall accept the available animals and provide for the their transportation to the institution.

(10) The institution shall compensate the establishment for the actual expense for holding animals beyond the time of the notice to the institution of their availability until they have been obtained by the institution.

(11) At any time after a requisition has been issued to an establishment and before notice of the availability of the animals requisitioned has been made to the institution, the institution may cancel all or any unfilled part of the requisition.

(12) Whenever unredeemed animals are received by an institution, the institution shall furnish the establishment a receipt. Receipts shall be issued in triplicate and shall be countersigned by a representative of the establishment. A copy shall be mailed or delivered to the Administrator by the institution and one copy shall be retained by the institution. A receipt shall be issued for each animal obtained. The receipt shall show the date that the animal was delivered to the agent of the institution by the establishment and the signature of the person to who it was delivered.

(13) At the conclusion of an experiment which does not require euthanasia for the collection of samples, the institution's animal facility may, providing the establishment agrees and for the purposes of adoption, return to the establishment any healthy animal posing no contagious threat to humans. If the establishment does not agree to accept the animal, the institution's animal facility shall euthanize the animals.

(14) The Administrator must be notified within ten days of personnel changes.

 

R438-13-[11]10 . [Duties of Establishments.]Requirements of an Establishment.

[A.](1) Each establishment shall keep a public record of all animals received and disposed.

[B.](2) Whenever a requisition[request] for impounded animals is submitted to [a supervisor of ]an establishment, it shall be [his]its duty to make available to the institution the number of animals of the species, size, and sex specified in the requisition, from the unredeemed animals in [his]their charge. The establishment shall then withhold from the destruction all unredeemed animals of the species, size, and sex specified by the requisition until the number of animals is sufficient to complete the requisition.

(3) If the number of animals specified by the requisition is not available, the [supervisor]establishment shall immediately make available all unredeemed animals [as are then ]in the establishment under his supervision.[The supervisor shall then withhold from destruction all unredeemed animals of the species, size, and sex specified by the requisition until the number of animals is sufficient to complete the requisition. The institution shall accept the available animals and provide for their transportation to the institution.

C. The institution shall compensate the establishment for the actual expense for holding animals beyond the time of notice to the institution of their availability until they have been obtained by the institution.

D. At any time after a requisition has been issued to an establishment and before notice of the availability of the animals requisitioned has been made to the institution, the institution may cancel all or any unfilled part of the requisition.]

[E.](4) It shall be unlawful for any establishment to release any animal to an institution not holding a valid certificate issued under this rule[these rules].

 

[R438-13-12. Receipts.

Whenever unredeemed animals are received by an institution, the institution shall furnish the establishment a receipt therefor. Receipts shall be issued in triplicate and shall be countersigned by a representative of the establishment. A copy shall be mailed or delivered to the administrator by the institution and one copy shall be retained by the institution. A receipt shall be issued for each animal obtained. The receipt shall show the date that the animal was delivered to the agent of the institution by the establishment, and the signature of the person to whom it was delivered.]

 

R438-13-[ 13 ]11 . Maintenance and Release of Animals by the Institution.

[A.](1) No animal obtained by an institution on requisition as herein provided shall be sold or given into the possession of any other person or organization unless released to its previous owner or adopted after the experiment to a private citizen for possession as a pet. All animals shall be transported immediately from the establishment to the institution in a humane manner and maintained by the institution for the remainder of the life of the animal unless adopted under the provision of this rule[these rules]. Nothing shall prohibit the institution from releasing an animal to its previous owner if satisfactory proof of ownership is provided to the institution. The institution may require the owner to reimburse the institution for actual expenses for maintaining the animal from the time it was received by the institution until it was delivered to the previous owner.

[B.](2) Any animal procured by an institution under this rule[these rules] shall be handled, transported and disposed of in a humane manner.

 

R438-13-[14]12. Revocation of Certification.

(1) Violation of Section 26-26-1 et seq. or this rule[these rules] violates Section 26-23-6 and is cause to consider the cancellation of any certificate issued under this rule[these rules].

[A.](2) Notification of Intent To Revoke

Upon receipt of evidence of a violation, the Director shall issue written notice, pursuant to Section [63-46b-3]63G-4-2, of intent to revoke the certificate of the institution 30 days following receipt of notice.

[B.](3) Notice of Hearing

The institution shall have 15 days from receipt of notice to file a written response to show why the certificate should not be revoked, and to request an informal hearing under [Sections 63-46b-4 and 63-46b-5]Section 63G-4-2. If requested by the institution, the Director shall grant an informal hearing upon 15 days written notice.

[C.](4) Action On Hearing

If after the hearing the Director decides the certificate shall be revoked, copies of the revocation shall be sent to the institution and all establishments providing animals for the institution. Institutions may seek review of agency action as outlined in Section [63-46b-12]63G-4-2.

 

R438-13-[15]13. Renewal of [Canceled]Revoked Certificate.

An institution may submit an application for the renewal of a certificate canceled by reason of violation of the law or this rule[these rules] not less than 30 days after final action was taken. The application shall be accompanied by documented evidence that the reason for cancellation has been removed. Upon being assured that the institution is acting in good faith and upon receipt of a favorable recommendation from the committee, the Director may issue a new certificate.

 

R438-13-[16]14. Complaint.

Anyone who files a complaint with the Department against an individual, institution or establishment violating any part of R438-13 et seq., shall supply in writing specific information regarding the alleged violation or violations. The complaint shall include the time, date, place, individual or persons involved and the names of witnesses who may be called upon to testify. This statement must be in the form of a sworn affidavit and must be notarized. Preliminary investigations of complaints may be conducted at the discretion of the Director or a designated representative without the filing of a notarized sworn affidavit.

 

KEY: animals, laboratories, laboratory animals

Date of Enactment or Last Substantive Amendment: [1989]2018

Notice of Continuation: July 12, 2013

Authorizing, and Implemented or Interpreted Law: 26-26-1 to 7