The many new tasks the EPA was assigned in the 2016 Toxic Substances Control Act (TSCA) reform legislation include development of a strategic plan to promote the reduction and eventual replacement of testing on vertebrate animals when manufacturers are required by TSCA to use testing to determine the risks posed by their chemicals.
Announcing that it has achieved another “milestone” under the reform act, the Agency has released a draft of the required strategic plan and will accept public comments on it for 45 days upon publication of a notice in the Federal Register (FR). An all-day public meeting wherein oral comments may be made will also be held in Washington, D.C., on April 10, 2018.
Reduce and Replace
TSCA Section 4 (Testing of Chemical Substances and Mixtures) gives the EPA the authority to require that health and environmental effects testing be conducted relevant to a determination of an unreasonable risk of injury to health or the environment. When such testing is required, a new subsection directs that the EPA “shall reduce and replace, to the extent practicable, scientifically justified, and consistent with the policies of this title, the use of vertebrate animals in the testing of chemical substances or mixtures.”
The subsection further states that the Agency must develop a strategic plan “to promote the development and implementation of alternative test methods and strategies to meet the non-vertebrate-animal requirement and also provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures.”
NAMs
In the draft, the EPA states that the organizing framework for the strategy relies heavily on new approach methodologies (NAMs). NAMs have been adopted as a broadly descriptive reference to any nonanimal technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment. TSCA-related NAMs generally fall into four categories: chemical characterization, hazard identification and characterization, dosimetry (measurement of the amount or dosage of radiation absorbed by a substance), and in vitro/in vivo extrapolation and exposure.
The Agency notes that while innovation and progress in the development of NAMs are rapidly occurring, few NAMs exist that reliably predict complex end points such as developmental, reproductive, and repeated-dose toxicity studies. In addition, NAMs that do exist often do not provide predictions of points of departure that are needed for risk evaluation.
Near-Term and Midterm Activities
The Strategic Plan has three core components:
- Identifying, developing, and integrating NAMs for TSCA decisions;
- Building confidence that NAMs are scientifically reliable and relevant for TSCA decisions; and
- Implementing the reliable and relevant NAMs for TSCA decisions.
In addition, the strategy identifies seven current/near-term needs and activities (to be completed in less than 3 years); four intermediate-term objectives (to be completed in 3 to 5 years); and the long-term goal of reducing and eventually eliminating vertebrate animal testing for TSCA objectives.
Near-term activities include reviewing existing NAMs and creating and maintaining a list; identifying and maintaining the most requested/needed studies for new and existing chemicals; identifying and curating available existing TSCA information on NAMs (and traditional test data); using NAMs to identify candidates for prioritizing existing chemicals for TSCA risk evaluations; and collaborating with partners and stakeholders to identify NAMs for further development.
The intermediate-term objectives are to progress toward use of NAMs for prioritization and risk evaluation; maintain the continual expansion of the TSCA NAM list; develop and maintain educational and outreach goals for regulatory scientists, end users, and the public; and continue collaboration with partners and stakeholders to identify NAMs for further development.
“The use of NAMs under TSCA does not diminish this mission, rather it is a call to achieve it through new and better science-based methods and approaches,” states the Agency.
The draft strategic plan is here.