Animal testing

(a)

In general

Except as otherwise provided by this section, it shall be unlawful for any entity to submit to a covered agency, with respect to a product or substance, data that has been derived using an animal test method if— (1)a non-animal test method is available to meet the information requirement concerned, as determined by the covered agency; or (2)the covered agency has issued a waiver exempting the entity from a requirement for data derived from an animal test method. (b)

Exceptions

Subsection (a) shall not apply with respect to— (1)data generated before the date of enactment of this Act; (2)data generated from an animal test method conducted outside the United States in order to comply with a requirement from a foreign regulatory authority; (3)data requested by a covered agency following a determination by the covered agency that— (A)existing data is insufficient for satisfying the information requirement concerned; and (B)no scientifically satisfactory non-animal test method was practicably available when the testing was conducted despite reasonable efforts to access a non-animal test method; and (4)data generated from specified animal test methods requested in writing by a covered agency, which request shall include a clear justification by the covered agency that available non-animal test methods (if any) are not appropriate for the product or substance concerned. (c)

Limiting harm to animals

In a case in which no appropriate non-animal test method is available and a waiver has not been granted by the covered agency concerned, the regulated entity shall— (1)ensure that the number of animals used in any animal test method is reduced to the minimum number possible without compromising the objectives of the test; and (2)reduce to a minimum any possible pain, suffering, distress, or lasting harm to the animals used. (d)

Penalties

(1)

Refusals to accept data

A covered agency may refuse to accept animal testing data generated in violation of this section. (2)

Civil penalties

In addition to any other penalties under applicable law, a covered agency may impose on any person who violates this section a civil penalty in an amount of not more than $10,000 for each such violation, as determined by the regulatory authority of the covered agency. (e)

Guidance; regulations

A covered agency shall— (1)not later than one year after the date of enactment of this Act, issue guidance on the acceptability and use of non-animal test methods for products and substances regulated by the covered agency; and (2)to the extent the covered agency determines appropriate— (A)revise regulations to reflect the acceptability of non-animal test methods; and (B)eliminate requirements for the corresponding animal test data. (f)

Reporting

(1)

Publication

Not later than one year after the date of enactment of this Act, and annually thereafter, each covered agency shall publish a progress report on the use of non-animal test methods by the covered agency and the entities regulated by the covered agency. (2)

Contents

A report published by a covered agency under paragraph (1) shall specify for all research that is conducted or supported by the covered agency or is submitted to the covered agencies by regulated entities— (A)the number of animals used; (B)the species of animals used; (C)the types of testing for which the animals were used; (D)the number of waivers issued; and (E)the purpose of animal test methods, non-animal test methods, and waivers accepted or issued by the covered agency. (3)

Public availability

(A)

In general

The information collected by a covered agency for purposes of this subsection shall be made publicly available, as soon as practicable, on an internet website of the covered agency. (B)

Personally identifiable or proprietary information

Before making such information publicly available, the covered agency shall omit personally identifiable information and proprietary information. (g)

Definitions

In this section: (1)

Animal

The term animal means a live vertebrate non-human animal or cephalopod. (2)

Animal test method

The term animal test method means a test method that involves the use of live animals. (3)

Covered agency

The term covered agency means— (A)the Consumer Product Safety Commission; (B)the Department of Agriculture; (C)the Environmental Protection Agency; and (D)the Food and Drug Administration. (4)

Non-animal test method

The term non-animal test method means a test method that— (A)does not involve the use of live animals; and (B)has been identified and accepted for use by the covered agency concerned. (5)

Test method

The term test method means a process, procedure, or approach used to obtain information on the properties of a product or its ingredients.