EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
Underlining indicates amendments to bill.
Strike out indicates matter stricken from the bill by amendment or deleted from the law by
amendment.
*sb0560*
SENATE BILL 560
J1, C2 3lr0607
CF HB 626
By: Senator Guzzone
Introduced and read first time: February 6, 2023
Assigned to: Finance
Committee Report: Favorable with amendments
Senate action: Adopted
Read second time: March 5, 2023
CHAPTER ______
AN ACT concerning 1
Animal Testing and Research – Human–Relevant Research Funding and Animal 2
Testing and Research Licensure Contributions 3
FOR the purpose of establishing the Human –Relevant Research Fund under the 4
administration of the Maryland Technology Development Corporation as a special, 5
nonlapsing fund; requiring that the interest earnings of the Fund be credited to the 6
Fund; requiring the Corporation to establish a grant and loan program to provide 7
grants and loans for State–funded, human–relevant animal testing alternatives 8
research; requiring a person, on or after a certain date, to be issued a license by 9
certain research facilities who engage in animal testing or research to pay a certain 10
contribution to the Secretary of Health before the person may use nonhuman 11
animals to conduct medical or product testing or research in the State; and generally 12
relating to the Human–Relevant Research Fund. 13
BY repealing and reenacting, without amendments, 14
Article – Economic Development 15
Section 10–401(a) and (c) and 10–429(a) and (g) 16
Annotated Code of Maryland 17
(2018 Replacement Volume and 2022 Supplement) 18
BY adding to 19
Article – Economic Development 20
Section 10–4D–01 through 10–4D–06 to be under the new subtitle “Subtitle 4D. 21
Human–Relevant Research Fund and Program” 22
Annotated Code of Maryland 23 2 SENATE BILL 560
(2018 Replacement Volume and 2022 Supplement) 1
BY adding to 2
Article – Health – General 3
Section 24–2201 through 24–2205 24–2203 to be under the new subtitle “Subtitle 22. 4
Animal Testing and Research License Contribution” 5
Annotated Code of Maryland 6
(2019 Replacement Volume and 2022 Supplement) 7
BY repealing and reenacting, without amendments, 8
Article – State Finance and Procurement 9
Section 6–226(a)(1) and (2)(i) 10
Annotated Code of Maryland 11
(2021 Replacement Volume and 2022 Supplement) 12
BY repealing and reenacting, with amendments, 13
Article – State Finance and Procurement 14
Section 6–226(a)(2)(ii)170. and 171. 15
Annotated Code of Maryland 16
(2021 Replacement Volume and 2022 Supplement) 17
BY adding to 18
Article – State Finance and Procurement 19
Section 6–226(a)(2)(ii)172. 20
Annotated Code of Maryland 21
(2021 Replacement Volume and 2022 Supplement) 22
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 23
That the Laws of Maryland read as follows: 24
Article – Economic Development 25
10–401. 26
(a) In this subtitle the following words have the meanings indicated. 27
(c) “Corporation” means the Maryland Technology Development Corporation. 28
10–429. 29
(a) In this part the following words have the meanings indicated. 30
(g) “Institutional review board” has the meaning stated in the federal regulations 31
on the protection of human subjects. 32
SUBTITLE 4D. HUMAN–RELEVANT RESEARCH FUND AND PROGRAM. 33
SENATE BILL 560 3
10–4D–01. 1
(A) IN THIS SUBTITLE THE FOLLOWING TERMS HAVE THE MEANINGS 2
INDICATED. 3
(B) “BOARD” MEANS THE HUMAN–RELEVANT RESEARCH REVIEW BOARD 4
ESTABLISHED UNDER § 10–4D–04 OF THIS SUBTITLE. 5
(C) “CORPORATION ” HAS THE MEANING STATED IN § 10–401 OF THIS TITLE. 6
(D) “FUND” MEANS THE HUMAN–RELEVANT RESEARCH FUND. 7
(E) “INSTITUTIONAL REVIEW BOARD” HAS THE MEANING STAT ED IN § 8
10–429 OF THIS TITLE. 9
10–4D–02. 10
(A) THERE IS A HUMAN–RELEVANT RESEARCH FUND. 11
(B) THE PURPOSE OF THE FUND IS TO PROMOTE STATE–FUNDED 12
RESEARCH INTENDED TO DEVELOP HUMAN –RELEVANT ALTERNATIVE S TO USING 13
NONHUMAN ANIMALS IN MEDICAL AND PRODUCT TESTING AND RESEARCH 14
THROUGH GRANTS AND L OANS TO PUBLIC AND P RIVATE ENTITIES IN T HE STATE. 15
(C) THE CORPORATIO N SHALL ADMINISTER T HE FUND. 16
(D) (1) THE FUND IS A SPECIAL , NONLAPSING FUND THAT IS NOT 17
SUBJECT TO § 7–302 OF THE STATE FINANCE AND PROCUREMENT ARTICLE. 18
(2) THE STATE TREASURER SHALL HOLD THE FUND SEPARATELY , 19
AND THE COMPTROLLER SHALL ACC OUNT FOR THE FUND. 20
(E) THE FUND CONSISTS OF : 21
(1) REVENUE DISTRIBUTED TO THE FUND UNDER § 24–2203 § 22
24–2202 OF THE HEALTH – GENERAL ARTICLE; 23
(2) MONEY APPROPRIATED I N THE STATE BUDGET TO THE FUND; 24
(3) INTEREST EARNINGS OF THE FUND; AND 25
(4) ANY OTHER MONEY FROM ANY OTHER SOURC E ACCEPTED FOR 26
THE BENEFIT OF THE FUND. 27
(F) MONEY IN THE FUND MAY BE USED ONLY TO: 28 4 SENATE BILL 560
(1) AWARD GRANTS AND LOA NS FOR STATE–FUNDED, 1
HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH IN ACCORDANCE 2
WITH THE RECOMMENDAT IONS OF THE BOARD; AND 3
(2) PAY THE COSTS NECESS ARY TO ADMINISTER TH E FUND. 4
(G) (1) THE STATE TREASURER SHALL INVES T THE MONEY IN THE FUND 5
IN THE SAME MANNER A S OTHER STATE MONEY MAY BE IN VESTED. 6
(2) ANY INTEREST EARNINGS OF THE FUND SHALL BE CREDITE D TO 7
THE FUND. 8
(H) (1) THE GOVERNOR MAY INCLUDE IN THE STATE BUDGET BILL EAC H 9
FISCAL YEAR AN APPRO PRIATION TO THE FUND. 10
(2) EXPENDITURES FROM THE FUND MAY BE MADE ONLY IN 11
ACCORDANCE WITH THE STATE BUDGET . 12
10–4D–03. 13
(A) SUBJECT TO THE PROVIS IONS OF THIS SUBTIT LE, THE CORPORATION 14
SHALL ESTABLISH A GR ANT AND LOAN PROGRAM TO PROVIDE GRANTS AN D LOANS 15
FOR STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES 16
RESEARCH. 17
(B) A GRANT OR LOAN AWARDE D UNDER THIS SUBTITL E IS CONTINGENT ON 18
THE RECIPIENT: 19
(1) SUBMITTING TO THE BOARD APPROVAL FROM A N INSTITUTIONAL 20
REVIEW BOARD ; AND 21
(2) ENTERING INTO A MEMO RANDUM OF UNDERSTAND ING WITH THE 22
CORPORATION THAT : 23
(I) (1) ESTABLISHES THE SCOP E OF THE STATE’S 24
OWNERSHIP OR OTHER F INANCIAL INTEREST IN THE COMMERCIALIZATIO N AND 25
OTHER BENEFITS OF TH E RESULTS, PRODUCTS, INVENTIONS, AND DISCOVERIES 26
RESULTING FROM STATE–FUNDED, HUMAN–RELEVANT RESEARCH ; AND 27
(II) (2) TO THE EXTEN T CONSISTENT WITH FE DERAL AND 28
STATE LAW , REFLECTS THE INTELLE CTUAL PROPERTY POLIC IES OF THE 29
CORPORATION . 30
SENATE BILL 560 5
(C) A RECIPIENT SHALL SUBM IT THE APPROVAL REQU IRED UNDER 1
SUBSECTION (B)(1) OF THIS SECTION WITH IN 6 MONTHS AFTER THE AWA RD OF THE 2
GRANT OR LOAN . 3
(D) THE CORPORATION MAY NOT D ISBURSE GRANT OR LOA N MONEY TO A 4
RECIPIENT UNTIL THE RECIPIENT MEETS THE REQUIREMENTS OF SUBS ECTION (B) 5
OF THIS SECTION. 6
10–4D–04. 7
(A) THE CORPORATION SHALL CON TRACT WITH AN INDEPE NDENT 8
SCIENTIFIC REVIEW BO ARD COMPOSED OF RECOGNIZED SCIENTIFI C EXPERTS IN 9
THE FIELD OF HUMAN –RELEVANT ANIMAL TEST ING ALTERNATIVES TO ACT AS THE 10
HUMAN–RELEVANT RESEARCH REVIEW BOARD. 11
(B) THE BOARD SHALL: 12
(1) REVIEW, EVALUATE, RANK, AND RATE RESEARCH PR OPOSALS FOR 13
STATE–FUNDED, HUMAN–RELEVANT ANIMAL TESTING ALTER NATIVES RESEARCH : 14
(I) BASED ON THE PROCEDU RES AND GUIDELINES 15
ESTABLISHED BY THE CORPORATION ; AND 16
(II) IN A MANNER THAT GIV ES DUE CONSIDERATION TO THE 17
SCIENTIFIC, MEDICAL, AND ETHICAL IMPLICAT IONS OF THE RESEARCH ; AND 18
(2) BASED ON THE RANKINGS AN D RATINGS AWARDED TO THE 19
RESEARCH PROPOSALS B Y THE BOARD, MAKE RECOMMENDATIONS TO THE 20
CORPORATION FOR THE A WARD AND DISBURSEMEN T OF GRANTS AND LOAN S. 21
(C) A MEMBER OF THE BOARD: 22
(1) IS NOT ELIGIBLE TO R ECEIVE A GRANT OR LO AN FOR 23
STATE–FUNDED, HUMAN–RELEVANT RESEARCH FR OM THE FUND; AND 24
(2) SHALL BE SUBJECT TO CONFLICT OF INTEREST STANDARDS THAT 25
ARE AT LEAST AS STRI NGENT AS THE STANDAR DS ON CONFLICT OF IN TEREST 26
ADOPTED BY THE FEDER AL NATIONAL INSTITUTES OF HEALTH. 27
10–4D–05. 28
THE CORPORATION , IN CONSULTATION WITH THE BOARD, SHALL ADOPT 29
REGULATIONS TO ESTAB LISH PROCEDURES FOR AWARDING AND MAKING THE 30
DISBURSEMENT OF A GR ANT OR LOAN. 31 6 SENATE BILL 560
10–4D–06. 1
(A) ON OR BEFORE JANUARY 1 EACH YEAR, THE CORPORATION AND THE 2
BOARD SHALL REPORT TO THE GOVERNOR AND , IN ACCORDANCE WITH § 2–1257 OF 3
THE STATE GOVERNMENT ARTICLE, THE GENERAL ASSEMBLY ON THE PROGR ESS 4
OF THE HUMAN –RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH 5
CONDUCTED WITH MONEY FROM GRANTS OR LOANS AWARDED UNDER THIS 6
SUBTITLE. 7
(B) THE REPORT SHALL IDENTIFY : 8
(1) EACH RECIPIENT OF MO NEY FROM THE FUND; 9
(2) THE AMOUNT OF MONEY AWARDED TO EACH RECI PIENT; AND 10
(3) A DESCRIPTION OF THE T YPE OF STATE–FUNDED, 11
HUMAN–RELEVANT RESEARCH PE RFORMED BY THE RECIP IENT AND THE ANIMAL 12
TESTS THE RESEARC H IS INTENDED TO REP LACE. 13
Article – Health – General 14
SUBTITLE 22. ANIMAL TESTING AND RESEARCH LICENSE CONTRIBUTION . 15
24–2201. 16
(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS 17
INDICATED. 18
(B) “LICENSE” MEANS A LICENSE TO C ONDUCT MEDICAL OR PRODUCT 19
TESTING OR RESEARCH USING ANIMALS . 20
(C) “LICENSEE” MEANS A PERSON WHO H OLDS A LICENSE ISSUE D UNDER 21
THIS SUBTITLE, “ANIMAL AND PLANT HEALTH INSPECTION SERVICE FORM 7023” 22
MEANS THE FORM REQUI RED TO BE SUBMITTED TO THE FEDERAL DEPARTMENT OF 23
AGRICULTURE UNDER 7 U.S.C. § 2143 AND 9 C.F.R. § 2.36. 24
24–2202. 25
(A) ON OR AFTER BEFORE JANUARY 1, 15 EACH YEAR, BEGINNING IN 2024, 26
A PERSON EACH RESEARCH FACILI TY THAT IS LOCATED I N THE STATE AND IS 27
REQUIRED TO SUBMIT A N ANIMAL AND PLANT HEALTH INSPECTION SERVICE FORM 28
7023 SHALL BE LICENSED BY THE SECRETARY BEFORE THE PERSON MAY USE 29 SENATE BILL 560 7
NONHUMAN ANIMALS TO CONDUCT MEDICAL OR PRODUCT T ESTING OR RESEARCH 1
IN THE STATE. 2
24–2203. 3
(A) (1) AN APPLICANT FOR A LICE NSE SHALL SUBMIT AN APPLICATION 4
TO THE SECRETARY ON THE FORM THAT THE SECRETARY REQUIRES . 5
(2) AN INITIAL APPLICATIO N SHALL REQUIRE AN A PPLICANT TO 6
INCLUDE: 7
(I) THE NUMBER OF ANIMALS THAT WILL BE USED TO CONDUCT 8
THE MEDICAL OR P RODUCT TESTING OR RE SEARCH; 9
(II) A LIST OF THE SPECIE S OF ANIMALS THAT WI LL BE USED TO 10
CONDUCT THE MEDICAL OR PRODUCT TESTING O R RESEARCH; AND 11
(III) ANY OTHER INFORMATION REQUIRED BY THE SECRETARY. 12
(B) (1) THE ANNUAL LICENSE FE E IS PAY TO THE DEPARTMENT A 13
CONTRIBUTION IN THE AMOUNT OF: 14
(I) (1) $5,000 FOR UP TO 500 100 ANIMALS; 15
(II) (2) $10,000 FOR MORE THAN 500 100 BUT NOT MORE 16
THAN 1,000 500 ANIMALS; 17
(III) (3) $25,000 $55,000 FOR MORE THAN 1,000 500 BUT NOT 18
MORE THAN 5,000 ANIMALS; 19
(IV) $35,000 FOR MORE THAN 5,000 BUT NOT MORE THAN 10,000 20
ANIMALS; AND 21
(V) (4) $50,000 $75,000 FOR MORE THAN 10,000 5,000 22
ANIMALS. 23
(2) THE ANNUAL LICENSE FE E MAY BE PAID IN QUA RTERLY 24
INSTALLMENTS . 25
(B) THE AMOUNT OF THE FEE TO BE PAID UNDER SUBSECTION (A) OF THIS 26
SECTION SHALL BE BAS ED ON THE TOTAL NUMB ER OF ANIMALS REPORT ED IN 27
COLUMN F ON THE MOST RECENTLY SUBMITTED ANIMAL AND PLANT HEALTH 28
INSPECTION SERVICE FORM 7023. 29
8 SENATE BILL 560
(C) THE SECRETARY SHALL : 1
(1) DISTRIBUTE THE AMOUNT OF LICENSING FEES NECESSARY TO 2
ADMINISTER THE LICEN SING PROGRAM TO AN A DMINISTRATIVE COST A CCOUNT; 3
AND 4
(2) DISTRIBUTE DISTRIBUTE THE REMAINING FEES FUNDS PAID 5
UNDER SUBSECTION (A) OF THIS SECTION TO THE HUMAN–RELEVANT RESEARCH 6
FUND ESTABLISHED UNDE R § 10–4D–02 OF THE ECONOMIC DEVELOPMENT 7
ARTICLE AFTER MAKING THE DIS TRIBUTION REQUIRED U NDER ITEM (1) OF THIS 8
SUBSECTION. 9
24–2204. 10
(A) (1) THE SECRETARY SHALL ISSUE A LICENSE TO AN APPL ICANT WHO 11
SUBMITS THE INFORMAT ION REQUIRED UNDER § 24–2203(A) OF THIS SUBTITLE AND 12
ON PAYMENT OF : 13
(I) THE TOTAL ANNUAL LICE NSE FEE; OR 14
(II) THE FIRST QUARTERLY I NSTALLMENT OF THE TO TAL 15
ANNUAL LICENSE FEE . 16
(2) THE TERM OF A LICENSE IS 1 YEAR. 17
(B) THE SECRETARY MAY DENY A LICENSE TO AN APPLIC ANT OR MAY 18
SUSPEND OR REVOKE A LICENSE IF THE APPLI CANT OR LICENSEE : 19
(1) FRAUDULENTLY OR DECEP TIVELY MAKES A STATE MENT ON AN 20
APPLICATION FOR A LI CENSE; 21
(2) FAILS TO MAKE A QUART ERLY INSTALLMENT PAY MENT OF THE 22
ANNUAL LICENSE FEE ; OR 23
(3) COMMITS FREQUENT OR N UMEROUS VIOLATIONS O F THIS 24
SUBTITLE OR THE REGU LATIONS ADOPTED UNDE R THIS SUBTITLE. 25
(C) EACH LICENSEE SHALL : 26
(1) MAINTAIN A RECORD OF ALL ANIMALS USED AND DISPOSED OF TO 27
CONDUCT MEDICAL OR P RODUCT TESTING OR RE SEARCH, INCLUDING THE NUMBER 28
AND TYPES OF ANIMALS USED; AND 29
SENATE BILL 560 9
(2) SUBMIT TO THE SECRETARY A QUARTERLY REPORT INCLUDING 1
THE INFORMATION REQU IRED UNDER ITEM (1) OF THIS SUBSECTION . 2
(D) ON OR BEFORE JANUARY 1 EACH YEAR, BEGINNING IN 2024, THE 3
SECRETARY SHALL REPOR T TO THE GENERAL ASSEMBLY, IN ACCORDANCE WITH § 4
2–1257 OF THE STATE GOVERNMENT ARTICLE, THE AGGREGATE NUMBER OF EACH 5
SPECIES OF ANIMAL US ED IN MEDICAL OR PRO DUCT TESTING OR RESE ARCH BY 6
LICENSEES IN THE STATE. 7
24–2205. 8
(A) (1) A PERSON MAY NOT USE N ONHUMAN ANIMALS TO C ONDUCT 9
MEDICAL OR PRODUCT T ESTING OR RESEARCH IN THE STATE UNLESS LICENSED BY 10
THE SECRETARY. 11
(2) A PERSON MAY NOT AID O R ABET THE UNAUTHORI ZED USE OF 12
NONHUMAN ANIMALS TO CONDUCT MEDICAL OR P RODUCT TESTING OR RE SEARCH 13
IN THE STATE. 14
(B) A PERSON IN VIOLATION OF SUBSECTION (A) OF THIS SECTION IS 15
GUILTY OF A FELONY A ND ON CONVICTION IS SUBJECT TO: 16
(1) FOR A FIRST OFFENSE , A FINE NOT EXCEEDING $5,000; OR 17
(2) FOR EACH SUBSEQUENT O FFENSE, A FINE NOT EXCEEDING 18
$20,000. 19
24–2203. 20
A RESEARCH FACILITY TH AT FAILS TO PAY THE CONTRIBUTION REQUIRED 21
UNDER § 24–2202(A) OF THIS SUBTITLE MAY BE SUBJECT TO A CIVI L PENALTY OF 22
NOT MORE THAN $1,000 PER DAY. 23
Article – State Finance and Procurement 24
6–226. 25
(a) (1) Except as otherwise specifically provided by law or by regulation of the 26
Treasurer, the Treasurer shall credit to the General Fund any interest on or other income 27
from State money that the Treasurer invests. 28
(2) (i) Notwithstanding any other provision of law, and unless 29
inconsistent with a federal law, grant agreement, or other federal requirement or with the 30
terms of a gift or settlement agreement, net interest on all State money allocated by the 31
State Treasurer under this section to special funds or accounts, and otherwise entitled to 32 10 SENATE BILL 560
receive interest earnings, as accounted for by the Comptroller, shall accrue to the General 1
Fund of the State. 2
(ii) The provisions of subparagraph (i) of this paragraph do not apply 3
to the following funds: 4
170. the Cannabis Public Health Fund; [and] 5
171. the Community Reinvestment and Repair Fund; AND 6
172. THE HUMAN–RELEVANT RESEARCH FUND. 7
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect July 8
1, 2023. 9
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
President of the Senate.
________________________________________________________________________________
Speaker of the House of Delegates.