WES MOORE, Governor Ch. 447 – 1 – Chapter 447 (House Bill 626) AN ACT concerning Animal Testing and Research – Human–Relevant Research Funding and Animal Testing and Research Licensure Contributions FOR the purpose of establishing the Human –Relevant Research Fund under the administration of the Maryland Technology Development Corporation as a special, nonlapsing fund; requiring that the interest earnings of the Fund be credited to the Fund; requiring the Corporation to establish a grant and loan program to provide grants and loans for State–funded, human–relevant animal testing alternatives research; requiring a person, on or after a certain date, to be issued a license by certain persons research facilities who engage in animal testing or research to pay a certain contribution to the Secretary of Health before the person may use nonhuman animals to conduct medical or product testing or research in the State; and generally relating to the Human–Relevant Research Fund. BY repealing and reenacting, without amendments, Article – Economic Development Section 10–401(a) and (c) and 10–429(a) and (g) Annotated Code of Maryland (2018 Replacement Volume and 2022 Supplement) BY adding to Article – Economic Development Section 10–4D–01 through 10–4D–06 to be under the new subtitle “Subtitle 4D. Human–Relevant Research Fund and Program” Annotated Code of Maryland (2018 Replacement Volume and 2022 Supplement) BY adding to Article – Health – General Section 24–2201 through 24–2205 24–2203 to be under the new subtitle “Subtitle 22. Animal Testing and Research License Contribution” Annotated Code of Maryland (2019 Replacement Volume and 2022 Supplement) BY repealing and reenacting, without amendments, Article – State Finance and Procurement Section 6–226(a)(1) and (2)(i) Annotated Code of Maryland (2021 Replacement Volume and 2022 Supplement) BY repealing and reenacting, with amendments, Ch. 447 2023 LAWS OF MARYLAND – 2 – Article – State Finance and Procurement Section 6–226(a)(2)(ii)170. and 171. Annotated Code of Maryland (2021 Replacement Volume and 2022 Supplement) BY adding to Article – State Finance and Procurement Section 6–226(a)(2)(ii)172. Annotated Code of Maryland (2021 Replacement Volume and 2022 Supplement) SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, That the Laws of Maryland read as follows: Article – Economic Development 10–401. (a) In this subtitle the following words have the meanings indicated. (c) “Corporation” means the Maryland Technology Development Corporation. 10–429. (a) In this part the following words have the meanings indicated. (g) “Institutional review board” has the meaning stated in the federal regulations on the protection of human subjects. SUBTITLE 4D. HUMAN–RELEVANT RESEARCH FUND AND PROGRAM. 10–4D–01. (A) IN THIS SUBTITLE THE FOLLOWING TERMS HAVE THE MEANINGS INDICATED. (B) “BOARD” MEANS THE HUMAN–RELEVANT RESEARCH REVIEW BOARD ESTABLISHED UNDER § 10–4D–04 OF THIS SUBTITLE. (C) “CORPORATION” HAS THE MEANING STAT ED IN § 10–401 OF THIS TITLE. (D) “FUND” MEANS THE HUMAN–RELEVANT RESEARCH FUND. (E) “INSTITUTIONAL REVIEW BOARD” HAS THE MEANING STAT ED IN § 10–429 OF THIS TITLE. WES MOORE, Governor Ch. 447 – 3 – 10–4D–02. (A) THERE IS A HUMAN–RELEVANT RESEARCH FUND. (B) THE PURPOSE OF THE FUND IS TO PROMOTE STATE–FUNDED RESEARCH INTENDED TO DEVELOP HUMAN –RELEVANT ALTERNATIVE S TO USING NONHUMAN ANIMALS IN MEDICAL AND PRODUCT TESTING AND RESEARCH THROUGH GRANTS AND L OANS TO PUBLIC AND P RIVATE ENTITIES IN T HE STATE. (C) THE CORPORATION SHALL ADM INISTER THE FUND. (D) (1) THE FUND IS A SPECIAL , NONLAPSING FUND THAT IS NOT SUBJECT TO § 7–302 OF THE STATE FINANCE AND PROCUREMENT ARTICLE. (2) THE STATE TREASURER SHALL HOLD THE FUND SEPARATELY , AND THE COMPTROLLER SHA LL ACCOUNT FOR THE FUND. (E) THE FUND CONSISTS OF : (1) REVENUE DISTRIBUTED TO THE FUND UNDER § 24–2203 § 24–2202 OF THE HEALTH – GENERAL ARTICLE; (2) MONEY APPROPRIATED I N THE STATE BUDGET TO THE FUND; (3) INTEREST EARNINGS OF THE FUND; AND (4) ANY OTHER MONEY FROM ANY OTHER SOURCE ACC EPTED FOR THE BENEFIT OF THE FUND. (F) MONEY IN THE FUND MAY BE USED ONLY TO: (1) AWARD GRANTS AND LOA NS FOR STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH IN ACCORDANCE WITH THE RECOMME NDATIONS OF THE BOARD; AND (2) PAY THE COSTS NECESS ARY TO ADMINISTER TH E FUND. (G) (1) THE STATE TREASURER SHALL INVES T THE MONEY IN THE FUND IN THE SAME MANNER A S OTHER STATE MONEY MAY BE IN VESTED. (2) ANY INTEREST EARNINGS OF THE FUND SHALL BE CR EDITED TO THE FUND. Ch. 447 2023 LAWS OF MARYLAND – 4 – (H) (1) THE GOVERNOR MAY INCLUDE IN THE STATE BUDGET BILL EAC H FISCAL YEAR AN APPRO PRIATION TO THE FUND. (2) EXPENDITURES FROM THE FUND MAY BE MADE ONLY IN ACCORDANCE WITH THE STATE BUDGET . 10–4D–03. (A) SUBJECT TO THE PROVISIONS OF THIS S UBTITLE, THE CORPORATION SHALL ESTABLISH A GR ANT AND LOAN PROGRAM TO PROVIDE GRANTS AN D LOANS FOR STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RESEARCH. (B) A GRANT OR LOAN AWARDE D UNDER THIS SUBTITL E IS CONTINGENT ON THE RECIPIENT: (1) SUBMITTING TO THE BOARD APPROVAL FROM A N INSTITUTIONAL REVIEW BOARD ; AND (2) ENTERING INTO A MEMO RANDUM OF UNDERSTAND ING WITH THE CORPORATION THAT : (I) (1) ESTABLISHES THE SCOP E OF THE STATE’S OWNERSHIP OR OTHER F INANCIAL INTEREST IN THE COMMERCIALIZA TION AND OTHER BENEFITS OF TH E RESULTS, PRODUCTS, INVENTIONS, AND DISCOVERIES RESULTING FROM STATE–FUNDED, HUMAN–RELEVANT RESEARCH ; AND (II) (2) TO THE EXTENT CONSIS TENT WITH FEDERAL AN D STATE LAW , REFLECTS THE INTELLE CTUAL PROPERT Y POLICIES OF THE CORPORATION . (C) A RECIPIENT SHALL SUBM IT THE APPROVAL REQU IRED UNDER SUBSECTION (B)(1) OF THIS SECTION WITH IN 6 MONTHS AFTER THE AWA RD OF THE GRANT OR LOAN . (D) THE CORPORATION MAY NOT D ISBURSE GRANT OR LOA N MONEY TO A RECIPIENT UNTI L THE RECIPIENT MEET S THE REQUIREMENTS O F SUBSECTION (B) OF THIS SECTION. 10–4D–04. (A) THE CORPORATION SHALL CON TRACT WITH AN INDEPE NDENT SCIENTIFIC REVIEW BO ARD COMPOSED OF RECO GNIZED SCIENTIFIC EX PERTS IN WES MOORE, Governor Ch. 447 – 5 – THE FIELD OF HUMAN –RELEVANT ANIMAL TEST ING ALTERNATIVES TO ACT AS THE HUMAN–RELEVANT RESEARCH REVIEW BOARD. (B) THE BOARD SHALL: (1) REVIEW, EVALUATE, RANK, AND RATE RESEARCH PR OPOSALS FOR STATE–FUNDED, HUMAN–RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH: (I) BASED ON THE PROCEDU RES AND GU IDELINES ESTABLISHED BY THE CORPORATION ; AND (II) IN A MANNER THAT GIV ES DUE CONSIDERATION TO THE SCIENTIFIC, MEDICAL, AND ETHICAL IMPLICAT IONS OF THE RESEARCH ; AND (2) BASED ON THE RANKING S AND RATINGS AWARDE D TO THE RESEARCH PROPOSALS B Y THE BOARD, MAKE RECOMMENDATIONS TO THE CORPORATION FOR THE A WARD AND DISBURSEMEN T OF GRANTS AND LOAN S. (C) A MEMBER OF THE BOARD: (1) IS NOT ELIGIBLE TO R ECEIVE A GRANT OR LO AN FOR STATE–FUNDED, HUMAN–RELEVANT RESEARCH FR OM THE FUND; AND (2) SHALL BE SUBJECT TO CONFLICT OF INTEREST STANDARD S THAT ARE AT LEAST AS STRI NGENT AS THE STANDAR DS ON CONFLICT OF IN TEREST ADOPTED BY THE FEDER AL NATIONAL INSTITUTES OF HEALTH. 10–4D–05. THE CORPORATION , IN CONSULTATION WITH THE BOARD, SHALL ADOPT REGULATIONS TO ESTABLISH PROCEDURES FOR AWARDING AND MAK ING THE DISBURSEMENT OF A GR ANT OR LOAN. 10–4D–06. (A) ON OR BEFORE JANUARY 1 EACH YEAR, THE CORPORATION AND THE BOARD SHALL REPORT TO THE GOVERNOR AND , IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, THE GENERAL ASSEMBLY ON THE PROGR ESS OF THE HUMAN –RELEVANT ANIMAL TEST ING ALTERNATIVES RES EARCH CONDUCTED WITH MONEY FROM GRANTS OR LOANS AWARDED UNDER THIS SUBTITLE. (B) THE REPORT SHALL IDEN TIFY: Ch. 447 2023 LAWS OF MARYLAND – 6 – (1) EACH RECIPIENT OF MO NEY FROM THE FUND; (2) THE AMOUNT OF MONEY AWARDED TO EACH RECI PIENT; AND (3) A DESCRIPTION OF THE TYPE OF STATE–FUNDED, HUMAN–RELEVANT RESEARCH PE RFORMED BY THE RECIP IENT AND THE ANIMAL TESTS THE RESEARCH I S INTENDED TO REPLAC E. Article – Health – General SUBTITLE 22. ANIMAL TESTING AND RESEARCH LICENSE CONTRIBUTION . 24–2201. (A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANINGS INDICATED. (B) “LICENSE” MEANS A LICENSE TO C ONDUCT MEDICAL OR PR ODUCT TESTING OR RESEARCH USING ANIMALS . (C) “LICENSEE” MEANS A PERSON WHO H OLDS A LICENSE ISSUE D UNDER THIS SUBTITLE, “ANIMAL AND PLANT HEALTH INSPECTION SERVICE FORM 7023” MEANS THE FORM REQUI RED TO BE SUBMITTED TO THE FEDERAL DEPARTMENT OF AGRICULTURE UNDER 7 U.S.C. § 2143 AND 9 C.F.R. § 2.36. 24–2202. (A) ON OR AFTER BEFORE JANUARY 1, 15 EACH YEAR, BEGINNING IN 2024, A PERSON EACH RESEARCH FACILI TY THAT IS LOCATED I N THE STATE AND IS REQUIRED TO SUBMIT A N ANIMAL AND PLANT HEALTH INSPECTION SERVICE FORM 7023 SHALL BE LICENSED BY THE SECRETARY BEFORE THE PERSON MAY USE NONHUMAN ANIMALS TO CONDUCT MEDICAL OR PRODUCT T ESTING OR RESEARCH IN THE STATE. 24–2203. (A) (1) AN APPLICANT FOR A LI CENSE SHALL SUBMIT A N APPLICATION TO THE SECRETARY ON THE FORM THAT THE SECRETARY REQUIRES . (2) AN INITIAL APPLICATION SHALL RE QUIRE AN APPLICANT T O INCLUDE: (I) THE NUMBER OF ANIMALS THAT WILL BE USED TO CONDUCT THE MEDICAL OR PRODU CT TESTING OR RESEAR CH; WES MOORE, Governor Ch. 447 – 7 – (II) A LIST OF THE SPECIE S OF ANIMALS THAT WI LL BE USED TO CONDUCT THE MEDICAL OR PRODUCT TESTING OR RESEARCH ; AND (III) ANY OTHER INFORMATION REQUIRED BY THE SECRETARY. (B) (1) THE ANNUAL LICENSE FE E IS PAY TO THE DEPARTMENT A CONTRIBUTION IN THE AMOUNT OF: (I) (1) $5,000 FOR UP TO 500 100 ANIMALS; (II) (2) $10,000 FOR MORE THAN 500 100 BUT NOT MORE THAN 1,000 500 ANIMALS; (III) (3) $25,000 $55,000 FOR MORE THAN 1,000 500 BUT NOT MORE THAN 5,000 ANIMALS; (IV) $35,000 FOR MORE THAN 5,000 BUT NOT MORE THAN 10,000 ANIMALS; AND (V) (4) $50,000 $75,000 FOR MORE THAN 10,000 5,000 ANIMALS. (2) THE ANNUAL LICENSE FE E MAY BE PAID IN QUA RTERLY INSTALLMENTS . (B) THE AMOUNT OF THE CON TRIBUTION TO BE PAID UNDER SUBSECTION (A) OF THIS SECTION SHAL L BE BASED ON THE TO TAL NUMBER OF ANIMAL S REPORTED IN COLUMN F ON THE MOST RECENTLY SUBMITTED ANIMAL AND PLANT HEALTH INSPECTION SERVICE FORM 7023. (C) THE SECRETARY SHALL : (1) DISTRIBUTE THE AMOUNT OF LICENSING FEES NE CESSARY TO ADMINISTER THE LICEN SING PROGRAM TO AN A DMINISTRATIVE COST A CCOUNT; AND (2) DISTRIBUTE DISTRIBUTE THE REMAINING FEES FUNDS PAID UNDER SUBSECTION (A) OF THIS SECTION TO THE HUMAN–RELEVANT RESEARCH FUND ESTABLISHED UNDE R § 10–4D–02 OF THE ECONOMIC DEVELOPMENT ARTICLE AFTER MAKING THE DIS TRIBUTION REQUIRED U NDER ITEM (1) OF THIS SUBSECTION. 24–2204. Ch. 447 2023 LAWS OF MARYLAND – 8 – (A) (1) THE SECRETARY SHALL ISSUE A LICENSE TO AN APPL ICANT WHO SUBMITS THE INFORMAT ION REQUIRED UNDER § 24–2203(A) OF THIS SUBTITLE AND ON PAYMENT OF : (I) THE TOTAL ANNUAL LICE NSE FEE; OR (II) THE FIRST QUARTERLY I NSTALLMENT OF THE TO TAL ANNUAL LICENSE FEE. (2) THE TERM OF A LICENSE IS 1 YEAR. (B) THE SECRETARY MAY DENY A LICENSE TO AN APPLIC ANT OR MAY SUSPEND OR REVOKE A LICENSE IF THE APPLI CANT OR LICENSEE : (1) FRAUDULENTLY OR DECEP TIVELY MAKES A STATE MENT ON AN APPLICATION FOR A LI CENSE; (2) FAILS TO MAKE A QUART ERLY INSTALLMENT PAY MENT OF THE ANNUAL LICENSE FEE ; OR (3) COMMITS FREQUENT OR N UMEROUS VIOLATIONS O F THIS SUBTITLE OR THE REGU LATIONS ADOPTED UNDE R THIS SUBTITLE. (C) EACH LICENSEE SHALL : (1) MAINTAIN A RECORD OF ALL ANIMALS USED AND DISPOSED OF TO CONDUCT MEDICAL OR P RODUCT TESTING OR RE SEARCH, INCLUDING THE NUMBER AND TYPES OF ANIMALS USED; AND (2) SUBMIT TO THE SECRETARY A QUARTERLY REPORT INCLUDING THE INFORMATION REQU IRED UNDER ITEM (1) OF THIS SUBSECTION . (D) ON OR BEFORE JANUARY 1 EACH YEAR, BEGINNING IN 2024, THE SECRETARY SHALL REPOR T TO THE GENERAL ASSEMBLY, IN ACCORDANCE WITH § 2–1257 OF THE STATE GOVERNMENT ARTICLE, THE AGGREGATE NUMBER OF EACH SPECIES OF ANIMAL US ED IN MEDICAL OR PRO DUCT TESTING OR RESEARCH BY LICENSEES IN THE STATE. 24–2205. (A) (1) A PERSON MAY NOT USE N ONHUMAN ANIMALS TO C ONDUCT MEDICAL OR PRODUCT T ESTING OR RESEARCH I N THE STATE UNLESS LICENSED BY THE SECRETARY. WES MOORE, Governor Ch. 447 – 9 – (2) A PERSON MAY NOT AID O R ABET THE UNAUTHORI ZED USE OF NONHUMAN ANIMALS TO CONDUCT MEDICAL OR P RODUCT TESTING OR RE SEARCH IN THE STATE. (B) A PERSON IN VIOLATION OF SUBSECTION (A) OF THIS SECTION IS GUILTY OF A FELONY A ND ON CONVICTION IS SUBJECT TO: (1) FOR A FIRST OFFENSE , A FINE NOT EXCEEDING $5,000; OR (2) FOR EACH SUBSEQUENT O FFENSE, A FINE NOT EXCEEDING $20,000. 24–2203. A RESEARCH FACILITY TH AT FAILS TO PAY THE CONTRIBUTION REQUIRE D UNDER § 24–2202(A) OF THIS SUBTITLE MAY BE SUBJECT TO A CIVI L PENALTY OF NOT MORE THAN $1,000 PER DAY. Article – State Finance and Procurement 6–226. (a) (1) Except as otherwise specifically provided by law or by regulation of the Treasurer, the Treasurer shall credit to the General Fund any interest on or other income from State money that the Treasurer invests. (2) (i) Notwithstanding any other provision of law, and unless inconsistent with a federal law, grant agreement, or other federal requirement or with the terms of a gift or settlement agreement, net interest on all State money allocated by the State Treasurer under this section to special funds or accounts, and otherwise entitled to receive interest earnings, as accounted for by the Comptroller, shall accrue to the General Fund of the State. (ii) The provisions of subparagraph (i) of this paragraph do not apply to the following funds: 170. the Cannabis Public Health Fund; [and] 171. the Community Reinvestment and Repair Fund; AND 172. THE HUMAN–RELEVANT RESEARCH FUND. SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect July 1, 2023. Ch. 447 2023 LAWS OF MARYLAND – 10 – Approved by the Governor, May 8, 2023.