Section 1 Short title
This Act may be cited as the “Primate Protection and Research Modernization Act of 2018”.
Primate Protection and Research Modernization Act of 2018
A BILL
To require review and approval for future research on nonhuman primates, and for other purposes.
Sec. 2 Findings
Congress finds that—
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;
most nonhuman primates used in research are owned or financially supported by the Federal Government;
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;
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;
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;
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;
alternatives to nonhuman primate research such as organs-on-chips technology and computer modeling are now available; and
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:
Active protocol— The term active protocol means a valid, non-expired experimental plan approved by the animal use committee of a research institution.
Ethologically appropriate environment— The term ethologically appropriate environment means a set of species-specific standards for the living conditions for captive nonhuman primates that—
is informed by scientific evidence and expertise from animal behaviorists;
promotes the full range of the natural cognitive abilities of the nonhuman primate, including healthy outlets to fulfill needs for inquisitiveness and inventiveness;
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;
consists of a secure, contained physical habitat that, at a minimum—
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;
has access to the outdoors with complex, natural features and substrates, such as grass, dirt, mulch, and vegetation;
provides foraging opportunities and diets that are varied, nutritious, and challenging to obtain; and
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
offers frequently changed enrichment that provides ample opportunities for interaction, choice, and self-determination.
Nonhuman primate— The term nonhuman primate means any living animal of the taxonomic order Primates except for individuals who belong to the genus Homo.
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.
Person— The term person means—
an individual, corporation, partnership, trust, association, or any other private or nonprofit entity;
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
any other entity subject to the jurisdiction of the United States.
Standing committee— The term standing committee means the committee established under section 6(a).
Suitable sanctuary— The term suitable sanctuary means a nonprofit organization that—
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;
does not conduct research on the animals that involves accompanying pain or distress;
does not conduct any commercial activity with respect to the animals, including, at a minimum—
the sale, trade, auction, lease, or loan of animals or animal parts; or
the use of animals in any manner in a for-profit business or operation;
does not use the animals for entertainment purposes or in a traveling exhibit;
does not breed any animals, whether intentionally or by failing to use adequate birth control methods;
does not allow members of the public the opportunity to come into physical contact with the animals; and
provides an ethologically appropriate environment.
Systematic review— The term systematic review means an analysis of evidence that is conducted based on a predetermined, comprehensive search strategy, which is designed—
to capture all appropriate studies; and
to reduce bias in analyzing the data gleaned from those studies.
Sec. 4 Systematic reviews by the National Academy of Sciences
Preexisting fields of research—
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—
an established history of advancing that field of research; and
resulted in meaningful clinical interventions.
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.
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—
advanced that field of research; and
resulted in meaningful clinical interventions.
Sec. 5 Prohibitions
Prohibited nonhuman primate research—
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.
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)—
shall not apply to any active protocol commenced prior to the date of enactment of this Act; but
shall apply to any renewal of an active protocol.
Prohibition on foreign grants— No Federal funds may be awarded to a foreign organization or entity—
to support nonhuman primate research; or
to support an entity conducting nonhuman primate research.
Restriction on domestic awards—
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.
Exception— The prohibition under paragraph (1)—
shall not apply to any awards or funds allocated prior to the date of enactment of this Act; but
shall apply to any renewal of a nonhuman primate research project funded prior to the date of enactment of this Act.
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.
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.
Exemptions— Nothing in this section limits or prevents—
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
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
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).
Composition—
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.
Requirements— With respect to the membership of the standing committee—
1/4 shall be Federal employees of the Department of Health and Human Services, the Department of Veterans Affairs, or the Department of Defense;
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;
1/4 shall be individuals who have advanced expertise in nonanimal research methods;
1/8 shall be clinicians actively treating human patients; and
1/8 shall be individuals who represent the interests of the nonhuman primates.
Criteria for approval of research— The standing committee may not approve any nonhuman primate research unless—
the standing committee determines that—
the research is for the prevention, diagnosis, or treatment of debilitating or life-threatening clinical conditions in human beings;
no alternative research method exists; and
the nonhuman primates will be housed in an ethologically appropriate environment; and
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
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.
Ineligibility for Federal funds— Any person who violates this Act shall be permanently precluded from receiving Federal research funds.
District court jurisdiction— The district courts of the United States shall have jurisdiction over any actions arising under this Act.
Rewards and certain incidental expenses—
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.
Amount— The amount of the reward is to be determined by the Attorney General.
Enforcement—
In general— This Act shall be enforced by the Attorney General.
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.
Forfeiture—
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.
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.
Citizen suits—
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.
Civil action on behalf of Federal Government—
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.
Fines—
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).
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.
Exceptions— No civil action may be commenced under paragraphs (1) or (2)—
earlier than the date that is 60 days after the date on which written notice of the violation has been given to—
the Attorney General; and
the alleged violator; or
if the Department of Justice has commenced action to impose a civil fine under subsection (a).
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.
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.