• LCSA added section 4(h) to TSCA to require EPA to develop a strategic plan to minimize the use of vertebrate animals when requiring the development of new information pertaining to a chemical.

Generally, the development of new information on chemicals relies on animal testing, unless an alternative approach is shown to reliably produce information suitable for evaluating risks. Stakeholders have disagreed about whether animal testing is necessary to develop new information on chemicals, particularly with respect to the usefulness of any new information and whether alternative testing methods can reliably produce information that traditionally has been produced through animal testing.

Lautenberg Act made specifications for minimize animal testing

However, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) of 2016 added section 4(h) to the Toxic Substances Control Act (TSCA) to require the Environmental Protection Agency (EPA) to develop a strategic plan to minimize, to the extent practicable, the use of vertebrate animals when requiring the development of new information pertaining to a chemical. EPA published the strategic plan in June 2018. The Strategic Plan has three core components:

• Identifying, developing, and integrating New Approach Methodologies (NAMs) for TSCA decisions;
• Building confidence that the NAMs are scientifically reliable and relevant for TSCA decisions; and
• Implementing the reliable and relevant NAMs for TSCA decisions.

TSCA as amended by LCSA, directs EPA to:

• Reduce and replace, to the extent practicable and scientifically justified, the use of vertebrate animals in the testing of chemical substances or mixtures; and
• Promote the development and timely incorporation of alternative test methods or strategies that do not require new vertebrate animal testing.

TSCA section 4(h) also requires EPA to take specified steps to reduce and replace vertebrate animal testing to the extent practicable, scientifically justified, and consistent with policies of Title I of TSCA. Voluntary testing developed for submission under Title I of TSCA, and not pursuant to a request or requirement by EPA, must first be attempted by means of an alternative test method or strategy identified by EPA pursuant to TSCA section 4(h)(2)(C) and for the development of such information before conducting new vertebrate animal testing.