Maryland 2025 Regular Session

Maryland Senate Bill SB536 Compare Versions

Only one version of the bill is available at this time.
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33 EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
44 [Brackets] indicate matter deleted from existing law.
55 *sb0536*
66
77 SENATE BILL 536
88 M4 5lr1395
99 SB 761/24 – EEE
1010 By: Senator Kramer
1111 Introduced and read first time: January 23, 2025
1212 Assigned to: Education, Energy, and the Environment
1313
1414 A BILL ENTITLED
1515
1616 AN ACT concerning 1
1717
1818 Research Facilities and Testing Facilities That Use Animals – Regulation 2
1919
2020 FOR the purpose of establishing requirements for the use and treatment of dogs or cats by 3
2121 a research facility or testing facility; prohibiting a research facility and testing 4
2222 facility from using certain dogs and cats for research or testing purposes and 5
2323 performing certain procedures on dogs or cats; prohibiting a research facility and 6
2424 testing facility from using traditional animal test methods under certain 7
2525 circumstances; prohibiting a research facility and testing facility from conducting a 8
2626 canine or feline toxicological experiment under certain circumstances; applying 9
2727 certain provisions of law regarding the adoption of dogs and cats used for scientific 10
2828 research purposes to testing facilities; and generally relating to research facilities 11
2929 and testing facilities that use animals in research, education, or testing. 12
3030
3131 BY adding to 13
3232 Article – Agriculture 14
3333 Section 15–101 through 15–103 and 15–105 through 15–107 15
3434 Annotated Code of Maryland 16
3535 (2016 Replacement Volume and 2024 Supplement) 17
3636
3737 BY repealing and reenacting, with amendments, 18
3838 Article – Agriculture 19
3939 Section 15–101 to be under the amended title “Title 15. Research Facilities and 20
4040 Testing Facilities That Use Animals” 21
4141 Annotated Code of Maryland 22
4242 (2016 Replacement Volume and 2024 Supplement) 23
4343
4444 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 24
4545 That the Laws of Maryland read as follows: 25
4646
4747 Article – Agriculture 26
4848 2 SENATE BILL 536
4949
5050
5151 Title 15. Research Facilities [that] AND TESTING FACILITIES THAT Use [Dogs or Cats] 1
5252 ANIMALS. 2
5353
5454 15–101. 3
5555
5656 (A) IN THIS TITLE THE FOL LOWING WORDS HAVE TH E MEANINGS 4
5757 INDICATED. 5
5858
5959 (B) (1) “ALTERNATIVE TEST METH OD” MEANS A TEST METHOD , 6
6060 INCLUDING A NEW OR R EVISED METHOD , THAT: 7
6161
6262 (I) DOES NOT USE ANIMALS ; 8
6363
6464 (II) PRODUCES INFORMATION OF EQUIVALENT OR BET TER 9
6565 SCIENTIFIC QUALITY A ND RELEVANCE COMPARE D TO TRADITIONAL ANI MAL TEST 10
6666 METHODS; AND 11
6767
6868 (III) HAS BEEN IDENTIFIED A ND ACCEPTED FOR USE BY THE 12
6969 FEDERAL AGENCY OR PR OGRAM WITHIN THE FEDERAL A GENCY RESPONSIBLE FO R 13
7070 REGULATING THE SPECI FIC PRODUCT OR ACTIV ITY FOR WHICH THE TE ST IS BEING 14
7171 CONDUCTED . 15
7272
7373 (2) “ALTERNATIVE TEST METH OD” INCLUDES: 16
7474
7575 (I) COMPUTATIONAL TOXICOL OGY AND BIOINFORMATI CS; 17
7676
7777 (II) HIGH–THROUGHPUT SCREENING METHODS; 18
7878
7979 (III) TESTING CATEGORIES OF CHEMICAL SUBSTANCES ; 19
8080
8181 (IV) TIERED TESTING METHOD S; 20
8282
8383 (V) IN VITRO STUDIES; AND 21
8484
8585 (VI) SYSTEMS BIOLOGY . 22
8686
8787 (C) (1) “BIOMEDICAL RESEARCH ” MEANS: 23
8888
8989 (I) THE INVESTIGATION OF THE BIOLOGICAL PROCE SSES AND 24
9090 CAUSES OF DISEASE; OR 25
9191 SENATE BILL 536 3
9292
9393
9494 (II) RESEARCH CONDUCTED TO INCREASE FUNDAMENTAL 1
9595 SCIENTIFIC KNOWLEDGE AND EXPAND THE UNDER STANDING OF HOW PROC ESSES IN 2
9696 LIVING ORGANISMS DEV ELOP AND FUNCTION . 3
9797
9898 (2) “BIOMEDICAL RESEARCH ” DOES NOT INCLUDE TES TING DONE TO 4
9999 ASSESS THE SAFETY O R EFFICACY OF: 5
100100
101101 (I) CHEMICAL SUBSTANCES ; 6
102102
103103 (II) INGREDIENTS ; 7
104104
105105 (III) DRUGS; 8
106106
107107 (IV) VACCINES; 9
108108
109109 (V) PRODUCTS; OR 10
110110
111111 (VI) PRODUCT FORMULATIONS . 11
112112
113113 (D) “CANINE OR FELINE TOXI COLOGICAL EXPERIMENT ” MEANS A TEST OR 12
114114 STUDY USED TO DETERM INE THE EFFECT OF THE APPLICATION O R EXPOSURE , 13
115115 WHETHER INTERNAL OR EXTERNAL AND INCLUDI NG ORAL INGESTION , SKIN OR EYE 14
116116 CONTACT, AND INHALATION , OF ANY AMOUNT OF A C HEMICAL SUBSTANCE ON A DOG 15
117117 OR CAT. 16
118118
119119 (E) “CHEMICAL SUBSTANCE ” MEANS ANY ORGANIC OR INORGANIC 17
120120 SUBSTANCE INCLU DING: 18
121121
122122 (1) A DRUG AS DEFINED IN 21 U.S.C. § 321(G); 19
123123
124124 (2) A PESTICIDE AS DEFINED IN 7 U.S.C. § 136(U); 20
125125
126126 (3) A CHEMICAL SUBSTANCE A S DEFINED IN 15 U.S.C. § 2602(2); AND 21
127127
128128 (4) A FOOD ADDITIVE AS DEF INED IN 21 U.S.C. § 321(S). 22
129129
130130 (F) (1) “RESEARCH FACILI TY” MEANS ANY FACILITY I N THE STATE THAT 23
131131 USES ANIMALS FOR RESEARCH , EDUCATION, OR EXPERIMENTATION . 24
132132
133133 (2) “RESEARCH FACILITY ” DOES NOT INCLUDE : 25
134134
135135 (I) A PARTNERSHIP , A CORPORATION , AN ASSOCIATION , AN 26
136136 INSTITUTION, AN ORGANIZATION , OR ANY OTHER ENTITY IN THE STATE THAT 27 4 SENATE BILL 536
137137
138138
139139 PROVIDES ONLY BENEFI CIAL SERVICES TO AN ANIMAL SUCH AS SPAYI NG AND 1
140140 NEUTERING; OR 2
141141
142142 (II) A SCHOOL OR AN INSTITU TION OF HIGHER EDUCA TION. 3
143143
144144 (G) (1) “TESTING FACILITY ” MEANS A PUBLIC OR PR IVATE 4
145145 PARTNERSHIP , CORPORATION , ASSOCIATION, ORGANIZATION , OR ANY OTHER 5
146146 ENTITY IN THE STATE THAT USES ANIMA LS FOR THE TESTING O F: 6
147147
148148 (I) CHEMICAL SUBSTANCES ; 7
149149
150150 (II) INGREDIENTS ; 8
151151
152152 (III) DRUGS; 9
153153
154154 (IV) VACCINES; 10
155155
156156 (V) PRODUCTS; OR 11
157157
158158 (VI) PRODUCT FORMULATIONS . 12
159159
160160 (2) “TESTING FACILITY ” INCLUDES A PARTNERSH IP, A 13
161161 CORPORATION , AN ASSOCIATION , AN ORGANIZATION , OR ANY OTHER ENTITY IN THE 14
162162 STATE THAT IS OWNED , LEASED, OR OPERATED BY A PUB LIC OR PRIVATE ENTIT Y. 15
163163
164164 (3) “TESTING FACILITY” DOES NOT INCLUDE : 16
165165
166166 (I) A PARTNERSHIP , A CORPORATION , AN ASSOCIATION , AN 17
167167 INSTITUTION, AN ORGANIZATION , OR ANY OTHER ENTITY IN THE STATE THAT 18
168168 PROVIDES ONLY BENEFI CIAL SERVICES TO AN ANIMAL SUCH AS SPAYI NG AND 19
169169 NEUTERING; OR 20
170170
171171 (II) A SCHOOL OR AN INSTITU TION OF HIGHER EDUCA TION. 21
172172
173173 (H) “TRADITIONAL ANIMAL TE ST METHOD ” MEANS A PROCESS , AN 22
174174 EXPERIMENT , OR A PROCEDURE THAT : 23
175175
176176 (1) USES ANIMALS TO OBTAI N INFORMATION ON THE 24
177177 CHARACTERISTICS OF A CHEMICAL SUBSTANCE , AN INGREDIENT , A DRUG, A 25
178178 VACCINE, A PRODUCT FORMULATIO N, OR A PRODUCT ; AND 26
179179
180180 (2) GENERATES INFORMATION REGARDING THE ABILIT Y OF THE 27
181181 CHEMICAL SUBSTANCE , INGREDIENT, DRUG, VACCINE, PRODUCT FORMULATION , OR 28 SENATE BILL 536 5
182182
183183
184184 PRODUCT TO PRODUCE A SPECIFIC BIOLOGICAL EFFECT UNDER SPECIFI ED 1
185185 CONDITIONS. 2
186186
187187 15–102. 3
188188
189189 (A) EACH RESEARCH FACILITY AND TESTING FACILITY SHA LL ENSURE THAT 4
190190 THE NUMBER OF DOGS A ND CATS USED FOR RES EARCH OR TESTING PUR POSES NOT 5
191191 OTHERWISE PROHIBITED UNDER THIS TITLE IS REDUCED TO THE SMALL EST 6
192192 NUMBER POSSIBLE BY U SING SCIENTIFICAL LY RELIABLE AND RELE VANT METHODS 7
193193 THAT DO NOT INVOLVE THE USE OF DOGS OR C ATS. 8
194194
195195 (B) A RESEARCH FACILITY OR TESTING FACILITY MAY NOT USE FOR 9
196196 RESEARCH OR TESTING PURPOSES: 10
197197
198198 (1) A DOG SOLD BY A CLASS B DEALER LICENSED UNDE R THE 11
199199 FEDERAL ANIMAL WELFARE ACT; 12
200200
201201 (2) A DOG OR CAT OBTAINED FROM A PERSON THAT D ID NOT BREED 13
202202 AND RAISE THE DOG OR CAT, INCLUDING A DOG OR C AT OBTAINED FROM AN 14
203203 AUCTION, A FLEA MARKET , OR AN ANIMAL SHELTER ; OR 15
204204
205205 (3) A DOG OR CAT THAT HAS UNDERGONE A DEVOCALI ZATION 16
206206 SURGERY. 17
207207
208208 (C) A RESEARCH FACILITY OR TESTING FACILITY MAY NOT PERFORM A 18
209209 DEVOCALIZATION SURGE RY ON A DOG OR CAT . 19
210210
211211 (D) A DOG OR CAT AT A RESEARCH FACILITY OR TESTING FACILITY MAY BE 20
212212 EUTHANIZED ONLY BY A LETHAL INJECTION OF SODIUM PENTOBARBITAL 21
213213 ADMINISTERED : 22
214214
215215 (1) BY A VETERINARI AN LICENSED IN THE STATE; OR 23
216216
217217 (2) UNDER THE DIRECT SUPE RVISION OF A VETERIN ARIAN LICENSED 24
218218 IN THE STATE. 25
219219
220220 15–103. 26
221221
222222 (A) (1) SUBJECT TO PARAGRAPH (3) OF THIS SUBSECTION , A RESEARCH 27
223223 FACILITY OR TESTING FACILITY MAY NOT USE A TRADITIONA L ANIMAL TEST 28
224224 METHOD IF THE AGENCY RESPON SIBLE FOR REGULATING THE SPECIFIC PRODUCT 29
225225 OR ACTIVITY FOR WHIC H A TEST METHOD IS B EING USED HAS: 30
226226 6 SENATE BILL 536
227227
228228
229229 (I) APPROVED AN ALTERNATI VE TEST METHOD ; OR 1
230230
231231 (II) GRANTED THE RESEARCH FACILITY OR TESTING FACILITY 2
232232 A WAIVER FROM USING A TRADITIONA L ANIMAL TEST METHOD . 3
233233
234234 (2) IF THERE IS NO ALTERN ATIVE TEST METHOD AV AILABLE OR 4
235235 WAIVER GRANTED , A RESEARCH FACILITY OR TESTING FACILITY MAY USE A 5
236236 TRADITIONAL ANIMAL T EST METHOD IF THE RESEARCH FACILITY OR TESTING 6
237237 FACILITY USES THE FE WEST NUMBER OF ANIMA LS POSSIBLE AND MINIMIZ ES THE 7
238238 LEVEL OF PAIN, SUFFERING, AND STRESS OF AN ANI MAL USED FOR TESTING . 8
239239
240240 (3) NOTHING IN THIS SUBSE CTION MAY BE CONSTRU ED TO PROHIBIT 9
241241 THE USE OF A TRADITI ONAL ANIMAL TEST MET HOD TO COMPLY WITH F EDERAL OR 10
242242 STATE REQUIREMENTS IF THE APPROPRIATE FEDERAL O R STATE AGENCY HAS 11
243243 APPROVED THE USE OF AN ALTERNATIVE TEST METHOD BUT DETERMINE D THAT 12
244244 THE ALTERNATIVE TEST METHOD DOES NOT ENSU RE THE HEALTH OR SAF ETY OF 13
245245 THE PUBLIC OR THE EN VIRONMENT. 14
246246
247247 (B) (1) THIS SUBSECTION DOES NOT APPLY TO BIOMEDI CAL RESEARCH . 15
248248
249249 (2) A RESEARCH FACILITY OR TESTING FACILITY MAY NOT CONDUCT 16
250250 A CANINE OR FELINE T OXICOLOGICAL EXPERIM ENT IN THE STATE FOR DISCOVERY , 17
251251 APPROVAL, MAINTENANCE OF APPRO VAL, NOTIFICATION, REGISTRATION , OR 18
252252 MAINTENANCE OF A CHE MICAL SUBSTANCE UNLE SS THE CANINE OR FELI NE 19
253253 TOXICOLOGICAL EXPERI MENT IS CONDUCTED TO : 20
254254
255255 (I) SATISFY AN EXPRESS RE QUIREMENT IMPOSED BY THE U.S. 21
256256 ENVIRONMENTAL PROTECTION AGENCY UNDER THE AUTH ORITY OF THE FEDERAL 22
257257 INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT OR THE FEDERAL TOXIC 23
258258 SUBSTANCES CONTROL ACT; 24
259259
260260 (II) SATISFY AN EXPRESS RE QUIREMENT IMPOSED BY THE U.S. 25
261261 FOOD AND DRUG ADMINISTRATION UNDER THE AUTHORITY OF THE FEDERAL 26
262262 FOOD, DRUG, AND COSMETIC ACT IF THE RESEARCH FACILITY OR TESTING 27
263263 FACILITY: 28
264264
265265 1. SUBMITS A PRE –INVESTIGATIONAL NEW DRUG 29
266266 APPLICATION MEETING REQUEST TO THE U.S. FOOD AND DRUG ADMINISTRATION 30
267267 TO RECEIVE GUIDANCE ON WHETHER ALL PROPO SED CANINE OR FELINE 31
268268 TOXICOLOGICAL EXPERI MENTS ARE NECESSARY TO SUPPORT THE RESEARCH 32
269269 FACILITY’S OR TESTING FACILITY ’S PLANNED CLINICAL TRIALS; AND 33
270270 SENATE BILL 536 7
271271
272272
273273 2. IS NOT EXPRESSLY DIRE CTED BY THE U.S. FOOD AND 1
274274 DRUG ADMINISTRATION TO USE AN ALTERNATIVE TEST METHOD; 2
275275
276276 (III) SUPPORT AN APPLICATIO N TO THE U.S. ENVIRONMENTAL 3
277277 PROTECTION AGENCY FOR A WAIVER F ROM THE USE OF A CAN INE OR FELINE 4
278278 TOXICOLOGICAL EXPERI MENT IF THE EXPERIME NT IS CONDUCTED SOLE LY FOR THE 5
279279 PURPOSE OF REDUCING THE TOTAL NUMBER OF ANIMALS NEEDED FOR 6
280280 EXPERIMENTS TO ACHIE VE DISCOVERY , APPROVAL, MAINTENANCE OF APPRO VAL, 7
281281 NOTIFICATION, REGISTRATION , OR MAINTENANCE OF A CHEMICAL SUBSTANCE; OR 8
282282
283283 (IV) DEVELOP, MANUFACTURE , OR MARKET A PRODUCT 9
284284 INTENDED FOR THE BEN EFICIAL USE OF DOGS OR CATS. 10
285285
286286 [15–101.] 15–104. 11
287287
288288 (a) (1) In this section the following words have the meanings indicated. 12
289289
290290 (2) “Animal rescue organization” includes: 13
291291
292292 (i) A nonprofit organization incorporated for the purpose of rescuing 14
293293 animals in need and finding permanent adoptive homes for the animals; and 15
294294
295295 (ii) A government–operated animal control unit that provides 16
296296 animals for adoption. 17
297297
298298 (3) [“Research facility” includes: 18
299299
300300 (i) A higher education research facility; 19
301301
302302 (ii) A scientific research facility; 20
303303
304304 (iii) A medical research facility; and 21
305305
306306 (iv) A product testing facility. 22
307307
308308 (4)] “Scientific research purposes” includes: 23
309309
310310 (i) Investigation; 24
311311
312312 (ii) Experimentation; 25
313313
314314 (iii) Instruction; and 26
315315
316316 (iv) Testing. 27
317317 8 SENATE BILL 536
318318
319319
320320 (b) This section applies to a dog or cat that, in the determination of an attending 1
321321 veterinarian, is suitable for adoption. 2
322322
323323 (c) A research facility OR TESTING FACILITY located in the State in which dogs 3
324324 or cats are used for scientific research purposes shall take reasonable steps to provide for 4
325325 the adoption of a dog or cat that, in the determination of the research facility OR TESTING 5
326326 FACILITY, is no longer needed for scientific research purposes by: 6
327327
328328 (1) Establishing a private placement process to provide for the adoption of 7
329329 a dog or cat; 8
330330
331331 (2) Establishing a list of animal rescue organizations that are approved by 9
332332 the research facility OR TESTING FACILITY and are willing to take a dog or cat from the 10
333333 research facility OR TESTING FACILITY ; and 11
334334
335335 (3) Offering the dog or cat to the animal rescue organizations identified in 12
336336 the list established under item (2) of this subsection if the research facility OR TESTING 13
337337 FACILITY is unable to place the dog or cat through its private placement process. 14
338338
339339 (d) A research facility OR TESTING FACILITY may enter into a collaborative 15
340340 agreement with an animal rescue organization for the purpose of carrying out the 16
341341 provisions of this section. 17
342342
343343 15–105. 18
344344
345345 (A) ON OR BEFORE JANUARY 31 EACH YEAR, EACH RESEARCH FACILITY 19
346346 AND TESTING FACILITY SHA LL SUBMIT TO THE SECRETARY THE FOLLOWI NG 20
347347 INFORMATION REGARDIN G THE IMMEDIATELY PR ECEDING 12–MONTH PERIOD : 21
348348
349349 (1) THE NUMBER OF EACH SP ECIES OF ANIMALS OWN ED AND USED BY 22
350350 THE RESEARCH FACILITY OR TESTING FACILITY ; 23
351351
352352 (2) THE NUMBER OF DOGS OR CATS RELEASED TO ANI MAL RESCUE 24
353353 ORGANIZATIONS UNDER § 15–104 OF THIS TITLE AND TH E NAMES OF THE ANIMA L 25
354354 RESCUE ORGANIZATIONS TO WHICH THE DOGS OR CATS WERE RELEASED ; 26
355355
356356 (3) THE TYPE AND NUMBER O F ALTERNATIVE TEST M ETHODS AND 27
357357 TRADITIONAL ANIMAL T EST METHODS USED ; 28
358358
359359 (4) THE NUMBER OF TRADITI ONAL ANIMAL TEST MET HOD WAIVERS 29
360360 AND CANINE OR FELINE TOXICOLOGICAL EXPERI MENT WAIVERS USED ; AND 30
361361
362362 (5) THE PURPOSE OF ANY TE STS CONDUC TED USING ALTERNATIV E 31
363363 TEST METHODS OR TRAD ITIONAL ANIMAL TEST METHODS. 32 SENATE BILL 536 9
364364
365365
366366
367367 (B) THE SECRETARY SHALL : 1
368368
369369 (1) PREPARE AN ANNUAL REP ORT AGGREGATING THE INFORMATION 2
370370 SUBMITTED UNDER SUBS ECTION (A) OF THIS SECTION; AND 3
371371
372372 (2) POST THE ANNUAL REPOR T ON THE DEPARTMENT ’S WEBSITE. 4
373373
374374 15–106. 5
375375
376376 A RESEARCH FACILITY OR TESTING FACILITY THA T VIOLATES THIS TITL E IS 6
377377 SUBJECT TO: 7
378378
379379 (1) FOR A FIRST OFFENSE , A FINE NOT EXCEEDING $1,000; AND 8
380380
381381 (2) FOR A SECOND OR SUBSE QUENT OFFENSE , A FINE NOT 9
382382 EXCEEDING $5,000. 10
383383
384384 15–107. 11
385385
386386 THE DEPARTMENT SHALL ADOP T REGULATIONS TO : 12
387387
388388 (1) CARRY OUT THIS TITLE ; AND 13
389389
390390 (2) ENSURE THE HUMANE TRE ATMENT AND CARE OF D OGS AND CATS 14
391391 THAT ARE USED FOR RE SEARCH, EDUCATION, OR TESTING CONSISTEN T WITH THE 15
392392 FEDERAL ANIMAL WELFARE ACT AND CORRESPONDING REGULATIONS. 16
393393
394394 SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 17
395395 October 1, 2025. 18
396396