Title: Primate Protection and Research Modernization Act of 2018
Policy area: Science, Technology, Communications

Summary:
Primate Protection and Research Modernization Act of 2018
This bill establishes limitations regarding research on nonhuman primates.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 3773 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
                                S. 3773

    To require review and approval for future research on nonhuman 
                   primates, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 18, 2018

  Mr. Booker introduced the following bill; which was read twice and 
   referred to the Committee on Commerce, Science, and Transportation

_______________________________________________________________________

                                 A BILL


 
    To require review and approval for future research on nonhuman 
                   primates, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Primate Protection and Research 
Modernization Act of 2018''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) numerous recent high-profile research studies involving 
        nonhuman primates, both in private and government facilities, 
        raise serious concerns about animal welfare, government waste, 
        and the scientific validity of the studies;
            (2) most nonhuman primates used in research are owned or 
        financially supported by the Federal Government;
            (3) nonhuman primates are highly intelligent and social 
        animals, and most research laboratory environments do not meet 
        the complex physical, social, and psychological needs of 
        nonhuman primates;
            (4) the Institute of Medicine and National Research Council 
        report entitled ``Chimpanzees in Biomedical and Behavioral 
        Research'' concluded that while the chimpanzee has been a 
        valuable research model in the past, most current uses of 
        chimpanzees are unnecessary;
            (5) the concerns relating to the scientific validity of 
        using chimpanzees to model human disease are magnified in the 
        case of research involving other nonhuman primates, with whom 
        humans are even less genetically and morphologically similar;
            (6) nonhuman primate research is very often not effective 
        in leading to treatments for humans, as demonstrated by high 
        failure rates for new drugs and the nonreproducibility of 
        preclinical research results;
            (7) alternatives to nonhuman primate research such as 
        organs-on-chips technology and computer modeling are now 
        available; and
            (8) nonhuman primates should only be used in research to 
        fulfill an important public health objective and if no 
        alternative research method exists.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Active protocol.--The term ``active protocol'' means a 
        valid, non-expired experimental plan approved by the animal use 
        committee of a research institution.
            (2) Ethologically appropriate environment.--The term 
        ``ethologically appropriate environment'' means a set of 
        species-specific standards for the living conditions for 
        captive nonhuman primates that--
                    (A) is informed by scientific evidence and 
                expertise from animal behaviorists;
                    (B) promotes the full range of the natural 
                cognitive abilities of the nonhuman primate, including 
                healthy outlets to fulfill needs for inquisitiveness 
                and inventiveness;
                    (C) comports with the natural social arrangements 
                of the nonhuman primate as observed in the wild, 
                including the preservation of healthy maternal 
                relationships, familial groups, colonies, and pair-
                bonds;
                    (D) consists of a secure, contained physical 
                habitat that, at a minimum--
                            (i) is sufficiently complex and 
                        appropriately sized so that the inhabitants can 
                        establish and maintain stable dominance 
                        hierarchies, including the provision of 
                        secluded areas for submissive individuals to 
                        escape or hide from aggressors;
                            (ii) has access to the outdoors with 
                        complex, natural features and substrates, such 
                        as grass, dirt, mulch, and vegetation;
                            (iii) provides foraging opportunities and 
                        diets that are varied, nutritious, and 
                        challenging to obtain; and
                            (iv) includes not fewer than 1 climbing 
                        structure of sufficient height and complexity 
                        such that multiple individuals can climb or 
                        descend at the same time, with the ability to 
                        rest on separate tiers; and
                    (E) offers frequently changed enrichment that 
                provides ample opportunities for interaction, choice, 
                and self-determination.
            (3) Nonhuman primate.--The term ``nonhuman primate'' means 
        any living animal of the taxonomic order Primates except for 
        individuals who belong to the genus Homo.
            (4) Nonhuman primate research.--The term ``nonhuman primate 
        research'' means any research performed involving a nonhuman 
        primate, including basic research, translational or applied 
        research, observational research of nonhuman primates in 
        captivity, testing, or other scientific procedures.
            (5) Person.--The term ``person'' means--
                    (A) an individual, corporation, partnership, trust, 
                association, or any other private or nonprofit entity;
                    (B) any officer, employee, agent, department, or 
                instrumentality of the Federal Government, a State, a 
                political subdivision of a State, or a unit of local 
                government; or
                    (C) any other entity subject to the jurisdiction of 
                the United States.
            (6) Standing committee.--The term ``standing committee'' 
        means the committee established under section 6(a).
            (7) Suitable sanctuary.--The term ``suitable sanctuary'' 
        means a nonprofit organization that--
                    (A) operates a place of refuge where abused, 
                neglected, unwanted, impounded, abandoned, orphaned, 
                displaced, or retired animals are provided care for the 
                lifetime of the animal;
                    (B) does not conduct research on the animals that 
                involves accompanying pain or distress;
                    (C) does not conduct any commercial activity with 
                respect to the animals, including, at a minimum--
                            (i) the sale, trade, auction, lease, or 
                        loan of animals or animal parts; or
                            (ii) the use of animals in any manner in a 
                        for-profit business or operation;
                    (D) does not use the animals for entertainment 
                purposes or in a traveling exhibit;
                    (E) does not breed any animals, whether 
                intentionally or by failing to use adequate birth 
                control methods;
                    (F) does not allow members of the public the 
                opportunity to come into physical contact with the 
                animals; and
                    (G) provides an ethologically appropriate 
                environment.
            (8) Systematic review.--The term ``systematic review'' 
        means an analysis of evidence that is conducted based on a 
        predetermined, comprehensive search strategy, which is 
        designed--
                    (A) to capture all appropriate studies; and
                    (B) to reduce bias in analyzing the data gleaned 
                from those studies.

SEC. 4. SYSTEMATIC REVIEWS BY THE NATIONAL ACADEMY OF SCIENCES.

    (a) Preexisting Fields of Research.--
            (1) In general.--Not later than 180 days after the date of 
        enactment of this Act, the National Academy of Sciences shall 
        conduct a systematic review for each preexisting field of 
        research in which the field of research has conducted nonhuman 
        primate research to determine whether the nonhuman primate 
        research has, with respect to the field of research--
                    (A) an established history of advancing that field 
                of research; and
                    (B) resulted in meaningful clinical interventions.
            (2) Continued review.--For any preexisting field of 
        research for which a systematic review under paragraph (1) has 
        concluded that the use of nonhuman primates meets the 
        requirements described in subparagraphs (A) and (B) of 
        paragraph (1), a systematic review shall be reconducted every 5 
        years.
    (b) New Fields of Research.--For any new field of research in which 
the standing committee approves the use of nonhuman primates, the 
National Academy of Sciences shall, on request of the standing 
committee, conduct a systematic review to determine whether the 
nonhuman primate research has--
            (1) advanced that field of research; and
            (2) resulted in meaningful clinical interventions.

SEC. 5. PROHIBITIONS.

    (a) Prohibited Nonhuman Primate Research.--
            (1) In general.--Subject to paragraph (2), no person shall 
        perform any nonhuman primate research unless that person has 
        received prior approval for the nonhuman primate research from 
        the standing committee.
            (2) Exception.--During the period ending on the date that 
        is 2 years after the date of enactment of this Act, the 
        prohibition under paragraph (1)--
                    (A) shall not apply to any active protocol 
                commenced prior to the date of enactment of this Act; 
                but
                    (B) shall apply to any renewal of an active 
                protocol.
    (b) Prohibition on Foreign Grants.--No Federal funds may be awarded 
to a foreign organization or entity--
            (1) to support nonhuman primate research; or
            (2) to support an entity conducting nonhuman primate 
        research.
    (c) Restriction on Domestic Awards.--
            (1) In general.--No Federal funds may be awarded to any 
        domestic organization to support nonhuman primate research 
        unless the nonhuman primate research has received prior 
        approval from the standing committee.
            (2) Exception.--The prohibition under paragraph (1)--
                    (A) shall not apply to any awards or funds 
                allocated prior to the date of enactment of this Act; 
                but
                    (B) shall apply to any renewal of a nonhuman 
                primate research project funded prior to the date of 
                enactment of this Act.
    (d) Consumer Products.--Nonhuman primate research for consumer 
goods and products, including nonhuman primate research to compare 1 
consumer product with another consumer product for marketing purposes, 
is prohibited.
    (e) Transfer of Ownership Prohibited.--No Federal agency may 
transfer ownership of a nonhuman primate to a non-Federal entity unless 
the non-Federal entity is a suitable sanctuary.
    (f) Exemptions.--Nothing in this section limits or prevents--
            (1) individualized medical care performed on a nonhuman 
        primate by a licensed veterinarian or physician conducted for 
        the well-being of the individual nonhuman primate, including a 
        surgical procedure or a chemical treatment for birth control; 
        or
            (2) the collection of biological samples to further the 
        well-being of an individual nonhuman primate or a social group 
        of nonhuman primates.

SEC. 6. STANDING COMMITTEE.

    (a) Establishment.--Not later than 1 year after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
convene a standing committee to assess proposals for new nonhuman 
primate research, in accordance with the criteria described in 
subsection (c).
    (b) Composition.--
            (1) Definition of advanced expertise in nonanimal research 
        methods.--In this subsection, the term ``advanced expertise in 
        nonanimal research methods'', with respect to an individual, 
        means that not less than 50 percent of the body of work of the 
        individual is completed using nonanimal research methodologies.
            (2) Requirements.--With respect to the membership of the 
        standing committee--
                    (A) \1/4\ shall be Federal employees of the 
                Department of Health and Human Services, the Department 
                of Veterans Affairs, or the Department of Defense;
                    (B) \1/4\ shall be ethologists or other individuals 
                who have expertise in the behavioral and psychological 
                needs of nonhuman primates, but do not use or directly 
                benefit from the use of nonhuman primates in invasive 
                experimentation;
                    (C) \1/4\ shall be individuals who have advanced 
                expertise in nonanimal research methods;
                    (D) \1/8\ shall be clinicians actively treating 
                human patients; and
                    (E) \1/8\ shall be individuals who represent the 
                interests of the nonhuman primates.
    (c) Criteria for Approval of Research.--The standing committee may 
not approve any nonhuman primate research unless--
            (1) the standing committee determines that--
                    (A) the research is for the prevention, diagnosis, 
                or treatment of debilitating or life-threatening 
                clinical conditions in human beings;
                    (B) no alternative research method exists; and
                    (C) the nonhuman primates will be housed in an 
                ethologically appropriate environment; and
            (2) if the National Academy of Sciences has commenced a 
        systematic review under section 4 for the field of research in 
        which the use of a nonhuman primate is being proposed, the 
        systematic review concluded that the use of nonhuman primates 
        meets the requirements described in subparagraphs (A) and (B) 
        of section 4(a)(1).

SEC. 7. FUNDING CONSIDERATIONS.

    All Federal funding for nonhuman primate research provided after 
the date of enactment of this Act shall include funding for the 
eventual retirement of the nonhuman primates used in the funded 
projects to a suitable sanctuary.

SEC. 8. PENALTIES AND ENFORCEMENT.

    (a) Civil Fines.--Any person who violates this Act may be assessed 
a civil penalty of up to $10,000 per nonhuman primate, per violation, 
per day.
    (b) Ineligibility for Federal Funds.--Any person who violates this 
Act shall be permanently precluded from receiving Federal research 
funds.
    (c) District Court Jurisdiction.--The district courts of the United 
States shall have jurisdiction over any actions arising under this Act.
    (d) Rewards and Certain Incidental Expenses.--
            (1) In general.--The Attorney General shall pay, from sums 
        received as fines for any violation of this Act, a reward to 
        any person who furnishes information that leads to a civil 
        fine.
            (2) Amount.--The amount of the reward is to be determined 
        by the Attorney General.
    (e) Enforcement.--
            (1) In general.--This Act shall be enforced by the Attorney 
        General.
            (2) Warrants.--The judges of the district courts of the 
        United States and the magistrate judges may, within their 
        respective jurisdictions, on proper oath or affirmation showing 
        probable cause, issue any warrants or other process as may be 
        required for enforcement of this Act.
            (3) Forfeiture.--
                    (A) Nonhuman primates.--Any nonhuman primates used 
                or held contrary to the provisions of this Act shall be 
                subject to forfeiture to the United States and shall be 
                placed in a suitable sanctuary.
                    (B) Equipment.--Any equipment or other materials 
                used in the course of holding or using nonhuman 
                primates contrary to the provisions of this Act shall 
                be subject to forfeiture to the United States.
    (f) Citizen Suits.--
            (1) Civil action on own behalf.--Except as provided in 
        paragraph (3), any person may commence a civil action on his or 
        her own behalf to enjoin any person, including the United 
        States and any other governmental instrumentality or agency, 
        who is alleged to be in violation of any provision of this Act.
            (2) Civil action on behalf of federal government.--
                    (A) In general.--Except as provided in paragraph 
                (3), any person may commence a civil action in the name 
                of the Federal Government against any person, except 
                for the United States and any other governmental 
                instrumentality or agency, who is alleged to be in 
                violation of any provision of this Act, and may seek 
                injunctive relief and civil fines under that civil 
                action.
                    (B) Fines.--
                            (i) In general.--A court may award a person 
                        bringing a civil action under subparagraph (A) 
                        an amount that the court decides is reasonable 
                        for collecting the civil fine under subsection 
                        (a).
                            (ii) Limitation.--The amount under clause 
                        (i) shall be not less than 25 percent and not 
                        more than 30 percent of the proceeds of the 
                        action or settlement and shall be paid out of 
                        those proceeds.
            (3) Exceptions.--No civil action may be commenced under 
        paragraphs (1) or (2)--
                    (A) earlier than the date that is 60 days after the 
                date on which written notice of the violation has been 
                given to--
                            (i) the Attorney General; and
                            (ii) the alleged violator; or
                    (B) if the Department of Justice has commenced 
                action to impose a civil fine under subsection (a).
            (4) Intervention.--In any suit under this subsection in 
        which the United States is not a party, the Attorney General 
        may intervene on behalf of the United States as a matter of 
        right.
            (5) Costs of litigation.--The court, in issuing any final 
        order in any suit brought under this subsection, may award 
        costs of litigation (including reasonable attorney and expert 
        witness fees) to any party, if the court determines the award 
        is appropriate.
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