Second Regular Session Seventy-fourth General Assembly STATE OF COLORADO INTRODUCED LLS NO. 24-0476.01 Yelana Love x2295 SENATE BILL 24-067 Senate Committees House Committees Health & Human Services A BILL FOR AN ACT C ONCERNING STANDARDS FOR FACILITIES THAT USE TEST SUBJECTS IN101 HEALTH-RELATED RESEARCH .102 Bill Summary (Note: This summary applies to this bill as introduced and does not reflect any amendments that may be subsequently adopted. If this bill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov .) The bill requires a facility that uses animals for health-related research to: ! Submit annual reports to the department of public health and environment regarding the use of animals in the facility; and ! Transfer dogs and cats owned by the facility to animal SENATE SPONSORSHIP Jaquez Lewis, HOUSE SPONSORSHIP Garcia and Rutinel, Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment. Capital letters or bold & italic numbers indicate new material to be added to existing law. Dashes through the words or numbers indicate deletions from existing law. shelters and pet animal rescues before euthanizing the animal. Be it enacted by the General Assembly of the State of Colorado:1 SECTION 1. In Colorado Revised Statutes, add article 5.7 to title2 25 as follows:3 ARTICLE 5.74 Animals in Health-related Research Facilities5 25-5.7-101. Definitions. A S USED IN THIS ARTICLE 5.7, UNLESS6 THE CONTEXT OTHERWISE REQUIRES :7 (1) "A LTERNATIVE TEST METHOD OR STRATEGY " MEANS A TEST8 METHOD, INCLUDING A NEW OR REVISED METHOD , THAT DOES NOT USE9 ANIMALS.10 (2) "A NIMAL" MEANS A LIVE VERTEBRATE, NONHUMAN ANIMAL.11 (3) "A NIMAL SHELTER" HAS THE MEANING SET FORTH IN SECTION12 35-80-102 (1).13 (4) "C AT" MEANS A SMALL, DOMESTICATED, CARNIVOROUS14 MAMMAL THAT IS A MEMBER OF THE FAMILY FELIDAE, ORDER CARNIVORA.15 (5) "C HEMICAL SUBSTANCE" MEANS ANY ORGANIC OR INORGANIC16 SUBSTANCE, INCLUDING:17 (a) A DRUG, AS DEFINED IN 21 U.S.C. SEC. 321 (g)(1);18 (b) A PESTICIDE, AS DEFINED IN 7 U.S.C. SEC. 136 (u);19 (c) A CHEMICAL SUBSTANCE, AS DEFINED IN 15 U.S.C. SEC. 260220 (2); AND21 (d) A FOOD ADDITIVE, AS DEFINED IN 21 U.S.C. SEC. 321 (s).22 (6) "D EPARTMENT" MEANS THE DEPARTMENT OF PUBLIC HEALTH23 AND ENVIRONMENT.24 (7) "D OG" MEANS ANY MEMBER OF THE SPECIES CANIS FAMILIARIS.25 SB24-067-2- (8) (a) "HEALTH-RELATED RESEARCH" MEANS RESEARCH:1 (I) R ELATED TO THE CAUSES , PROGRESSION, DIAGNOSIS,2 TREATMENT, CONTROL, OR PREVENTION OF PHYSICAL OR MENTAL3 DISEASES AND IMPAIRMENTS OR CHRONIC CONDITIONS OF HUMANS OR4 ANIMALS;5 (II) R ELATED TO THE DEVELOPMENT OF BIOMEDICAL PRODUCTS OR6 DEVICES, AS DEFINED IN 21 U.S.C. SEC. 321 (h); OR7 (III) T O TEST THE HEALTH EFFECTS OF CHEMICAL SUBSTANCES ,8 INGREDIENTS, MEDICAL DEVICES, VACCINES, PRODUCTS, OR PRODUCT9 FORMULATIONS.10 (b) "H EALTH-RELATED RESEARCH" DOES NOT INCLUDE RESEARCH11 RELATED TO THE DEVELOPMENT OF DRUGS , AS DEFINED IN 21 U.S.C. SEC.12 321 (g)(1).13 (9) (a) "H EALTH-RELATED RESEARCH FACILITY" MEANS AN ENTITY14 THAT USES ANIMALS FOR HEALTH -RELATED RESEARCH.15 (b) "H EALTH-RELATED RESEARCH FACILITY" DOES NOT INCLUDE16 AN ENTITY THAT PROVIDES BENEFICIAL SERVICE TO AN ANIMAL , SUCH AS17 SPAYING OR NEUTERING.18 (10) "P ET ANIMAL RESCUE" HAS THE MEANING SET FORTH IN19 SECTION 35-80-102 (11.2).20 (11) "W AIVER" MEANS GUIDANCE ISSUED BY A FEDERAL AGENCY21 OR A PROGRAM WITHIN A FEDERAL AGENCY RESPONSIBLE FOR REGULATING22 A SPECIFIC PRODUCT BEING STUDIED THAT ALLOWS A HEALTH -RELATED23 RESEARCH FACILITY TO FOREGO THE USE OF AN ANIMAL TEST .24 25-5.7-102. Health-related research facilities - use of animals25 - mandatory reporting. (1) O N OR BEFORE JANUARY 31 OF EACH YEAR,26 A HEALTH-RELATED RESEARCH FACILITY SHALL SUBMIT TO THE27 SB24-067 -3- DEPARTMENT, ON A FORM APPROVED BY THE DEPARTMENT , THE1 FOLLOWING INFORMATION FOR THE PREVIOUS CALENDAR YEAR :2 (a) T HE SPECIES OF ANIMALS USED OR KEPT BY THE3 HEALTH-RELATED RESEARCH FACILITY;4 (b) T HE TOTAL NUMBER OF ANIMALS PER SPECIES IN EACH OF THE5 FOLLOWING CATEGORIES OF PAIN OR DISTRESS :6 (I) A NIMALS UPON WHICH HEALTH -RELATED RESEARCH WAS7 CONDUCTED INVOLVING NO PAIN , DISTRESS, OR USE OF PAIN-RELIEVING8 DRUGS, INCLUDING ROUTINE PROCEDURES SUCH AS INJECTIONS ,9 TATTOOING, OR BLOOD SAMPLING;10 (II) A NIMALS UPON WHICH HEALTH -RELATED RESEARCH WAS11 CONDUCTED INVOLVING ACCOMPANYING PAIN OR DISTRESS TO THE12 ANIMALS AND FOR WHICH APPROPRIATE ANESTHETIC , ANALGESIC, OR13 TRANQUILIZING DRUGS WERE USED ;14 (III) A NIMALS UPON WHICH HEALTH -RELATED RESEARCH WAS15 CONDUCTED INVOLVING ACCOMPANYING PAIN OR DISTRESS TO THE16 ANIMALS AND FOR WHICH THE USE OF APPROPRIATE ANESTHETIC ,17 ANALGESIC, OR TRANQUILIZING DRUGS WOULD HAVE ADVERSELY18 AFFECTED THE HEALTH-RELATED RESEARCH; AND19 (IV) A NIMALS THAT WERE BRED, CONDITIONED, OR HELD FOR USE20 IN HEALTH-RELATED RESEARCH BUT NOT USED FOR SUCH PURPOSES ;21 (c) T HE TOTAL NUMBER OF ANIMALS PER SPECIES USED FOR EACH22 OF THE FOLLOWING PURPOSES:23 (I) S CIENTIFIC STUDIES RELATING TO ESSENTIAL STRUCTURES ,24 FUNCTIONS, OR DISEASE PROCESSES;25 (II) R ESEARCH, DEVELOPMENT, AND EFFICACY TESTING OF26 TREATMENTS, PRODUCTS, OR DEVICES FOR HUMAN MEDICINE , HUMAN27 SB24-067 -4- DENTISTRY, AND VETERINARY MEDICINE , EXCLUDING TOXICOLOGICAL AND1 OTHER SAFETY EVALUATIONS DESCRIBED IN SUBSECTION (1)(c)(III) OF2 THIS SECTION;3 (III) T OXICOLOGICAL AND OTHER SAFETY EVALUATIONS ,4 INCLUDING SAFETY EVALUATIONS OF CHEMICAL SUBSTANCES AND5 DEVICES USED FOR HUMAN MEDICINE , HUMAN DENTISTRY , AND6 VETERINARY MEDICINE;7 (IV) Q UALITY CONTROL OF PRODUCTS AND DEVICES FOR HUMAN8 OR VETERINARY MEDICINE;9 (V) E DUCATION AND TRAINING OF SCIENTISTS OR HEALTH -CARE10 PROVIDERS; AND11 (VI) A NY OTHER PURPOSE NOT DESCRIBED IN THIS SUBSECTION12 (1)(c), TO BE SPECIFIED BY THE PERSON PROVIDING THE INFORMATION13 REQUIRED BY THIS SECTION;14 (d) T HE FOLLOWING INFORMATION ON THE USE AND PURPOSE OF15 AN ALTERNATIVE TEST METHOD OR STRATEGY :16 (I) T HE TYPE AND NUMBER OF ALTERNATIVE TEST METHODS OR17 STRATEGIES USED;18 (II) T HE NUMBER OF WAIVERS USED , IF ANY;19 (III) T HE PURPOSE OF THE ALTERNATIVE TEST METHODS OR20 STRATEGIES;21 (IV) T HE PERCENTAGE OF FUNDS EXPENDED BY THE22 HEALTH-RELATED RESEARCH FACILITY ON RESEARCH AND TESTING THAT23 INVOLVED THE USE OF ANIMALS AND THE PERCENTAGE SPENT ON24 RESEARCH AND TESTING THAT DID NOT INVOLVE THE USE OF ANIMALS ;25 AND26 (V) I F THE HEALTH-RELATED RESEARCH FACILITY INTENDS TO27 SB24-067 -5- REDUCE THE USE OF ANIMALS IN THE FACILITY 'S HEALTH-RELATED1 RESEARCH, A PLAN THAT INCLUDES AN ESTIMATE OF THE PERCENTAGE2 REDUCTION OF SUCH USE OVER THE FOLLOWING YEAR ; AND3 (e) A DETAILED METHODOLOGY FOR OBTAINING THE INFORMATION4 REQUIRED BY THIS SECTION.5 25-5.7-103. Health-related research - dogs and cats - adoption6 - reporting. (1) (a) B EFORE EUTHANIZING A DOG OR CAT , A7 HEALTH-RELATED RESEARCH FACILITY SHALL OFFER THE DOG OR CAT TO8 AN ANIMAL SHELTER OR A PET ANIMAL RESCUE FOR THE PURPOSE OF9 OFFERING THE DOG OR CAT FOR ADOPTION .10 (b) S UBSECTION (1)(a) OF THIS SECTION DOES NOT APPLY IF A11 HEALTH-RELATED RESEARCH FACILITY EUTHANIZES A DOG OR CAT FOR12 HEALTH OR SAFETY REASONS.13 (2) A HEALTH-RELATED RESEARCH FACILITY MAY ENTER INTO A14 COLLABORATIVE AGREEMENT WITH AN ANIMAL SHELTER OR PET ANIMAL15 RESCUE TO SATISFY THE REQUIREMENTS OF THIS SECTION .16 (3) A HEALTH-RELATED RESEARCH FACILITY THAT ACTS IN GOOD17 FAITH TO TRANSFER A DOG OR CAT TO AN ANIMAL SHELTER OR PET ANIMAL18 RESCUE PURSUANT TO SUBSECTION (1) OF THIS SECTION IS IMMUNE FROM19 CIVIL LIABILITY FOR OR RESULTING FROM THE TRANSFER OF THE DOG OR20 CAT.21 (4) B Y JANUARY 31, 2025, AND BY JANUARY 1 EACH YEAR22 THEREAFTER, A HEALTH-RELATED RESEARCH FACILITY SHALL SUBMIT TO23 THE DEPARTMENT, ON A FORM APPROVED BY THE DEPARTMENT , A REPORT24 THAT INCLUDES THE FOLLOWING INFORMATION FOR THE PREVIOUS25 CALENDAR YEAR:26 (a) T HE TOTAL NUMBER OF DOGS AND CATS OWNED BY THE27 SB24-067 -6- HEALTH-RELATED RESEARCH FACILITY;1 (b) T HE TOTAL NUMBER OF DOGS AND CATS THAT ARE USED FOR2 HEALTH-RELATED RESEARCH CONDUCTED AT THE HEALTH -RELATED3 RESEARCH FACILITY;4 (c) T HE TOTAL NUMBER OF DOGS AND CATS THAT THE5 HEALTH-RELATED RESEARCH FACILITY TRANSFERRED TO AN ANIMAL6 SHELTER OR PET ANIMAL RESCUE FOR THE PURPOSE OF ADOPTION ; AND7 (d) T HE NAME AND ADDRESS OF EACH ANIMAL SHELTER OR PET8 ANIMAL RESCUE TO WHICH THE HEALTH -RELATED RESEARCH FACILITY9 TRANSFERRED A DOG OR CAT FOR THE PURPOSE OF ADOPTION .10 SECTION 2. Act subject to petition - effective date. This act11 takes effect at 12:01 a.m. on the day following the expiration of the12 ninety-day period after final adjournment of the general assembly; except13 that, if a referendum petition is filed pursuant to section 1 (3) of article V14 of the state constitution against this act or an item, section, or part of this15 act within such period, then the act, item, section, or part will not take16 effect unless approved by the people at the general election to be held in17 November 2024 and, in such case, will take effect on the date of the18 official declaration of the vote thereon by the governor.19 SB24-067 -7-