EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
*sb0536*
SENATE BILL 536
M4 5lr1395
SB 761/24 – EEE
By: Senator Kramer
Introduced and read first time: January 23, 2025
Assigned to: Education, Energy, and the Environment
A BILL ENTITLED
AN ACT concerning 1
Research Facilities and Testing Facilities That Use Animals – Regulation 2
FOR the purpose of establishing requirements for the use and treatment of dogs or cats by 3
a research facility or testing facility; prohibiting a research facility and testing 4
facility from using certain dogs and cats for research or testing purposes and 5
performing certain procedures on dogs or cats; prohibiting a research facility and 6
testing facility from using traditional animal test methods under certain 7
circumstances; prohibiting a research facility and testing facility from conducting a 8
canine or feline toxicological experiment under certain circumstances; applying 9
certain provisions of law regarding the adoption of dogs and cats used for scientific 10
research purposes to testing facilities; and generally relating to research facilities 11
and testing facilities that use animals in research, education, or testing. 12
BY adding to 13
Article – Agriculture 14
Section 15–101 through 15–103 and 15–105 through 15–107 15
Annotated Code of Maryland 16
(2016 Replacement Volume and 2024 Supplement) 17
BY repealing and reenacting, with amendments, 18
Article – Agriculture 19
Section 15–101 to be under the amended title “Title 15. Research Facilities and 20
Testing Facilities That Use Animals” 21
Annotated Code of Maryland 22
(2016 Replacement Volume and 2024 Supplement) 23
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 24
That the Laws of Maryland read as follows: 25
Article – Agriculture 26
2 SENATE BILL 536
Title 15. Research Facilities [that] AND TESTING FACILITIES THAT Use [Dogs or Cats] 1
ANIMALS. 2
15–101. 3
(A) IN THIS TITLE THE FOL LOWING WORDS HAVE TH E MEANINGS 4
INDICATED. 5
(B) (1) “ALTERNATIVE TEST METH OD” MEANS A TEST METHOD , 6
INCLUDING A NEW OR R EVISED METHOD , THAT: 7
(I) DOES NOT USE ANIMALS ; 8
(II) PRODUCES INFORMATION OF EQUIVALENT OR BET TER 9
SCIENTIFIC QUALITY A ND RELEVANCE COMPARE D TO TRADITIONAL ANI MAL TEST 10
METHODS; AND 11
(III) HAS BEEN IDENTIFIED A ND ACCEPTED FOR USE BY THE 12
FEDERAL AGENCY OR PR OGRAM WITHIN THE FEDERAL A GENCY RESPONSIBLE FO R 13
REGULATING THE SPECI FIC PRODUCT OR ACTIV ITY FOR WHICH THE TE ST IS BEING 14
CONDUCTED . 15
(2) “ALTERNATIVE TEST METH OD” INCLUDES: 16
(I) COMPUTATIONAL TOXICOL OGY AND BIOINFORMATI CS; 17
(II) HIGH–THROUGHPUT SCREENING METHODS; 18
(III) TESTING CATEGORIES OF CHEMICAL SUBSTANCES ; 19
(IV) TIERED TESTING METHOD S; 20
(V) IN VITRO STUDIES; AND 21
(VI) SYSTEMS BIOLOGY . 22
(C) (1) “BIOMEDICAL RESEARCH ” MEANS: 23
(I) THE INVESTIGATION OF THE BIOLOGICAL PROCE SSES AND 24
CAUSES OF DISEASE; OR 25
SENATE BILL 536 3
(II) RESEARCH CONDUCTED TO INCREASE FUNDAMENTAL 1
SCIENTIFIC KNOWLEDGE AND EXPAND THE UNDER STANDING OF HOW PROC ESSES IN 2
LIVING ORGANISMS DEV ELOP AND FUNCTION . 3
(2) “BIOMEDICAL RESEARCH ” DOES NOT INCLUDE TES TING DONE TO 4
ASSESS THE SAFETY O R EFFICACY OF: 5
(I) CHEMICAL SUBSTANCES ; 6
(II) INGREDIENTS ; 7
(III) DRUGS; 8
(IV) VACCINES; 9
(V) PRODUCTS; OR 10
(VI) PRODUCT FORMULATIONS . 11
(D) “CANINE OR FELINE TOXI COLOGICAL EXPERIMENT ” MEANS A TEST OR 12
STUDY USED TO DETERM INE THE EFFECT OF THE APPLICATION O R EXPOSURE , 13
WHETHER INTERNAL OR EXTERNAL AND INCLUDI NG ORAL INGESTION , SKIN OR EYE 14
CONTACT, AND INHALATION , OF ANY AMOUNT OF A C HEMICAL SUBSTANCE ON A DOG 15
OR CAT. 16
(E) “CHEMICAL SUBSTANCE ” MEANS ANY ORGANIC OR INORGANIC 17
SUBSTANCE INCLU DING: 18
(1) A DRUG AS DEFINED IN 21 U.S.C. § 321(G); 19
(2) A PESTICIDE AS DEFINED IN 7 U.S.C. § 136(U); 20
(3) A CHEMICAL SUBSTANCE A S DEFINED IN 15 U.S.C. § 2602(2); AND 21
(4) A FOOD ADDITIVE AS DEF INED IN 21 U.S.C. § 321(S). 22
(F) (1) “RESEARCH FACILI TY” MEANS ANY FACILITY I N THE STATE THAT 23
USES ANIMALS FOR RESEARCH , EDUCATION, OR EXPERIMENTATION . 24
(2) “RESEARCH FACILITY ” DOES NOT INCLUDE : 25
(I) A PARTNERSHIP , A CORPORATION , AN ASSOCIATION , AN 26
INSTITUTION, AN ORGANIZATION , OR ANY OTHER ENTITY IN THE STATE THAT 27 4 SENATE BILL 536
PROVIDES ONLY BENEFI CIAL SERVICES TO AN ANIMAL SUCH AS SPAYI NG AND 1
NEUTERING; OR 2
(II) A SCHOOL OR AN INSTITU TION OF HIGHER EDUCA TION. 3
(G) (1) “TESTING FACILITY ” MEANS A PUBLIC OR PR IVATE 4
PARTNERSHIP , CORPORATION , ASSOCIATION, ORGANIZATION , OR ANY OTHER 5
ENTITY IN THE STATE THAT USES ANIMA LS FOR THE TESTING O F: 6
(I) CHEMICAL SUBSTANCES ; 7
(II) INGREDIENTS ; 8
(III) DRUGS; 9
(IV) VACCINES; 10
(V) PRODUCTS; OR 11
(VI) PRODUCT FORMULATIONS . 12
(2) “TESTING FACILITY ” INCLUDES A PARTNERSH IP, A 13
CORPORATION , AN ASSOCIATION , AN ORGANIZATION , OR ANY OTHER ENTITY IN THE 14
STATE THAT IS OWNED , LEASED, OR OPERATED BY A PUB LIC OR PRIVATE ENTIT Y. 15
(3) “TESTING FACILITY” DOES NOT INCLUDE : 16
(I) A PARTNERSHIP , A CORPORATION , AN ASSOCIATION , AN 17
INSTITUTION, AN ORGANIZATION , OR ANY OTHER ENTITY IN THE STATE THAT 18
PROVIDES ONLY BENEFI CIAL SERVICES TO AN ANIMAL SUCH AS SPAYI NG AND 19
NEUTERING; OR 20
(II) A SCHOOL OR AN INSTITU TION OF HIGHER EDUCA TION. 21
(H) “TRADITIONAL ANIMAL TE ST METHOD ” MEANS A PROCESS , AN 22
EXPERIMENT , OR A PROCEDURE THAT : 23
(1) USES ANIMALS TO OBTAI N INFORMATION ON THE 24
CHARACTERISTICS OF A CHEMICAL SUBSTANCE , AN INGREDIENT , A DRUG, A 25
VACCINE, A PRODUCT FORMULATIO N, OR A PRODUCT ; AND 26
(2) GENERATES INFORMATION REGARDING THE ABILIT Y OF THE 27
CHEMICAL SUBSTANCE , INGREDIENT, DRUG, VACCINE, PRODUCT FORMULATION , OR 28 SENATE BILL 536 5
PRODUCT TO PRODUCE A SPECIFIC BIOLOGICAL EFFECT UNDER SPECIFI ED 1
CONDITIONS. 2
15–102. 3
(A) EACH RESEARCH FACILITY AND TESTING FACILITY SHA LL ENSURE THAT 4
THE NUMBER OF DOGS A ND CATS USED FOR RES EARCH OR TESTING PUR POSES NOT 5
OTHERWISE PROHIBITED UNDER THIS TITLE IS REDUCED TO THE SMALL EST 6
NUMBER POSSIBLE BY U SING SCIENTIFICAL LY RELIABLE AND RELE VANT METHODS 7
THAT DO NOT INVOLVE THE USE OF DOGS OR C ATS. 8
(B) A RESEARCH FACILITY OR TESTING FACILITY MAY NOT USE FOR 9
RESEARCH OR TESTING PURPOSES: 10
(1) A DOG SOLD BY A CLASS B DEALER LICENSED UNDE R THE 11
FEDERAL ANIMAL WELFARE ACT; 12
(2) A DOG OR CAT OBTAINED FROM A PERSON THAT D ID NOT BREED 13
AND RAISE THE DOG OR CAT, INCLUDING A DOG OR C AT OBTAINED FROM AN 14
AUCTION, A FLEA MARKET , OR AN ANIMAL SHELTER ; OR 15
(3) A DOG OR CAT THAT HAS UNDERGONE A DEVOCALI ZATION 16
SURGERY. 17
(C) A RESEARCH FACILITY OR TESTING FACILITY MAY NOT PERFORM A 18
DEVOCALIZATION SURGE RY ON A DOG OR CAT . 19
(D) A DOG OR CAT AT A RESEARCH FACILITY OR TESTING FACILITY MAY BE 20
EUTHANIZED ONLY BY A LETHAL INJECTION OF SODIUM PENTOBARBITAL 21
ADMINISTERED : 22
(1) BY A VETERINARI AN LICENSED IN THE STATE; OR 23
(2) UNDER THE DIRECT SUPE RVISION OF A VETERIN ARIAN LICENSED 24
IN THE STATE. 25
15–103. 26
(A) (1) SUBJECT TO PARAGRAPH (3) OF THIS SUBSECTION , A RESEARCH 27
FACILITY OR TESTING FACILITY MAY NOT USE A TRADITIONA L ANIMAL TEST 28
METHOD IF THE AGENCY RESPON SIBLE FOR REGULATING THE SPECIFIC PRODUCT 29
OR ACTIVITY FOR WHIC H A TEST METHOD IS B EING USED HAS: 30
6 SENATE BILL 536
(I) APPROVED AN ALTERNATI VE TEST METHOD ; OR 1
(II) GRANTED THE RESEARCH FACILITY OR TESTING FACILITY 2
A WAIVER FROM USING A TRADITIONA L ANIMAL TEST METHOD . 3
(2) IF THERE IS NO ALTERN ATIVE TEST METHOD AV AILABLE OR 4
WAIVER GRANTED , A RESEARCH FACILITY OR TESTING FACILITY MAY USE A 5
TRADITIONAL ANIMAL T EST METHOD IF THE RESEARCH FACILITY OR TESTING 6
FACILITY USES THE FE WEST NUMBER OF ANIMA LS POSSIBLE AND MINIMIZ ES THE 7
LEVEL OF PAIN, SUFFERING, AND STRESS OF AN ANI MAL USED FOR TESTING . 8
(3) NOTHING IN THIS SUBSE CTION MAY BE CONSTRU ED TO PROHIBIT 9
THE USE OF A TRADITI ONAL ANIMAL TEST MET HOD TO COMPLY WITH F EDERAL OR 10
STATE REQUIREMENTS IF THE APPROPRIATE FEDERAL O R STATE AGENCY HAS 11
APPROVED THE USE OF AN ALTERNATIVE TEST METHOD BUT DETERMINE D THAT 12
THE ALTERNATIVE TEST METHOD DOES NOT ENSU RE THE HEALTH OR SAF ETY OF 13
THE PUBLIC OR THE EN VIRONMENT. 14
(B) (1) THIS SUBSECTION DOES NOT APPLY TO BIOMEDI CAL RESEARCH . 15
(2) A RESEARCH FACILITY OR TESTING FACILITY MAY NOT CONDUCT 16
A CANINE OR FELINE T OXICOLOGICAL EXPERIM ENT IN THE STATE FOR DISCOVERY , 17
APPROVAL, MAINTENANCE OF APPRO VAL, NOTIFICATION, REGISTRATION , OR 18
MAINTENANCE OF A CHE MICAL SUBSTANCE UNLE SS THE CANINE OR FELI NE 19
TOXICOLOGICAL EXPERI MENT IS CONDUCTED TO : 20
(I) SATISFY AN EXPRESS RE QUIREMENT IMPOSED BY THE U.S. 21
ENVIRONMENTAL PROTECTION AGENCY UNDER THE AUTH ORITY OF THE FEDERAL 22
INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT OR THE FEDERAL TOXIC 23
SUBSTANCES CONTROL ACT; 24
(II) SATISFY AN EXPRESS RE QUIREMENT IMPOSED BY THE U.S. 25
FOOD AND DRUG ADMINISTRATION UNDER THE AUTHORITY OF THE FEDERAL 26
FOOD, DRUG, AND COSMETIC ACT IF THE RESEARCH FACILITY OR TESTING 27
FACILITY: 28
1. SUBMITS A PRE –INVESTIGATIONAL NEW DRUG 29
APPLICATION MEETING REQUEST TO THE U.S. FOOD AND DRUG ADMINISTRATION 30
TO RECEIVE GUIDANCE ON WHETHER ALL PROPO SED CANINE OR FELINE 31
TOXICOLOGICAL EXPERI MENTS ARE NECESSARY TO SUPPORT THE RESEARCH 32
FACILITY’S OR TESTING FACILITY ’S PLANNED CLINICAL TRIALS; AND 33
SENATE BILL 536 7
2. IS NOT EXPRESSLY DIRE CTED BY THE U.S. FOOD AND 1
DRUG ADMINISTRATION TO USE AN ALTERNATIVE TEST METHOD; 2
(III) SUPPORT AN APPLICATIO N TO THE U.S. ENVIRONMENTAL 3
PROTECTION AGENCY FOR A WAIVER F ROM THE USE OF A CAN INE OR FELINE 4
TOXICOLOGICAL EXPERI MENT IF THE EXPERIME NT IS CONDUCTED SOLE LY FOR THE 5
PURPOSE OF REDUCING THE TOTAL NUMBER OF ANIMALS NEEDED FOR 6
EXPERIMENTS TO ACHIE VE DISCOVERY , APPROVAL, MAINTENANCE OF APPRO VAL, 7
NOTIFICATION, REGISTRATION , OR MAINTENANCE OF A CHEMICAL SUBSTANCE; OR 8
(IV) DEVELOP, MANUFACTURE , OR MARKET A PRODUCT 9
INTENDED FOR THE BEN EFICIAL USE OF DOGS OR CATS. 10
[15–101.] 15–104. 11
(a) (1) In this section the following words have the meanings indicated. 12
(2) “Animal rescue organization” includes: 13
(i) A nonprofit organization incorporated for the purpose of rescuing 14
animals in need and finding permanent adoptive homes for the animals; and 15
(ii) A government–operated animal control unit that provides 16
animals for adoption. 17
(3) [“Research facility” includes: 18
(i) A higher education research facility; 19
(ii) A scientific research facility; 20
(iii) A medical research facility; and 21
(iv) A product testing facility. 22
(4)] “Scientific research purposes” includes: 23
(i) Investigation; 24
(ii) Experimentation; 25
(iii) Instruction; and 26
(iv) Testing. 27
8 SENATE BILL 536
(b) This section applies to a dog or cat that, in the determination of an attending 1
veterinarian, is suitable for adoption. 2
(c) A research facility OR TESTING FACILITY located in the State in which dogs 3
or cats are used for scientific research purposes shall take reasonable steps to provide for 4
the adoption of a dog or cat that, in the determination of the research facility OR TESTING 5
FACILITY, is no longer needed for scientific research purposes by: 6
(1) Establishing a private placement process to provide for the adoption of 7
a dog or cat; 8
(2) Establishing a list of animal rescue organizations that are approved by 9
the research facility OR TESTING FACILITY and are willing to take a dog or cat from the 10
research facility OR TESTING FACILITY ; and 11
(3) Offering the dog or cat to the animal rescue organizations identified in 12
the list established under item (2) of this subsection if the research facility OR TESTING 13
FACILITY is unable to place the dog or cat through its private placement process. 14
(d) A research facility OR TESTING FACILITY may enter into a collaborative 15
agreement with an animal rescue organization for the purpose of carrying out the 16
provisions of this section. 17
15–105. 18
(A) ON OR BEFORE JANUARY 31 EACH YEAR, EACH RESEARCH FACILITY 19
AND TESTING FACILITY SHA LL SUBMIT TO THE SECRETARY THE FOLLOWI NG 20
INFORMATION REGARDIN G THE IMMEDIATELY PR ECEDING 12–MONTH PERIOD : 21
(1) THE NUMBER OF EACH SP ECIES OF ANIMALS OWN ED AND USED BY 22
THE RESEARCH FACILITY OR TESTING FACILITY ; 23
(2) THE NUMBER OF DOGS OR CATS RELEASED TO ANI MAL RESCUE 24
ORGANIZATIONS UNDER § 15–104 OF THIS TITLE AND TH E NAMES OF THE ANIMA L 25
RESCUE ORGANIZATIONS TO WHICH THE DOGS OR CATS WERE RELEASED ; 26
(3) THE TYPE AND NUMBER O F ALTERNATIVE TEST M ETHODS AND 27
TRADITIONAL ANIMAL T EST METHODS USED ; 28
(4) THE NUMBER OF TRADITI ONAL ANIMAL TEST MET HOD WAIVERS 29
AND CANINE OR FELINE TOXICOLOGICAL EXPERI MENT WAIVERS USED ; AND 30
(5) THE PURPOSE OF ANY TE STS CONDUC TED USING ALTERNATIV E 31
TEST METHODS OR TRAD ITIONAL ANIMAL TEST METHODS. 32 SENATE BILL 536 9
(B) THE SECRETARY SHALL : 1
(1) PREPARE AN ANNUAL REP ORT AGGREGATING THE INFORMATION 2
SUBMITTED UNDER SUBS ECTION (A) OF THIS SECTION; AND 3
(2) POST THE ANNUAL REPOR T ON THE DEPARTMENT ’S WEBSITE. 4
15–106. 5
A RESEARCH FACILITY OR TESTING FACILITY THA T VIOLATES THIS TITL E IS 6
SUBJECT TO: 7
(1) FOR A FIRST OFFENSE , A FINE NOT EXCEEDING $1,000; AND 8
(2) FOR A SECOND OR SUBSE QUENT OFFENSE , A FINE NOT 9
EXCEEDING $5,000. 10
15–107. 11
THE DEPARTMENT SHALL ADOP T REGULATIONS TO : 12
(1) CARRY OUT THIS TITLE ; AND 13
(2) ENSURE THE HUMANE TRE ATMENT AND CARE OF D OGS AND CATS 14
THAT ARE USED FOR RE SEARCH, EDUCATION, OR TESTING CONSISTEN T WITH THE 15
FEDERAL ANIMAL WELFARE ACT AND CORRESPONDING REGULATIONS. 16
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 17
October 1, 2025. 18