EPA’s new Collaborative Research Program – A step toward improving new chemical reviews under TSCA

Maria Doa, Ph.D., Senior Director, Chemicals Policy; Lauren Ellis, MPH, Research Analyst; and Lariah Edwards, Ph.D., Post-Doctoral Fellow 

The Environmental Defense Fund (EDF) recently filed comments on EPA’s Toxic Substances Control Act (TSCA) Collaborative Research Program to Support New Chemical Reviews (Collaborative Research Program). The Collaborative Research Program is a multi-year scientific partnership between the agency’s Office of Pollution Prevention and Toxics (OPPT) and Office of Research and Development (ORD) aimed at modernizing the methods, approaches, and tools used to evaluate new chemicals under TSCA.  

We strongly support OPPT’s collaboration with ORD, which has a breadth of scientific expertise across EPA’s different research programs. As such, ORD will help OPPT implement the best available science in its new chemical assessments, which should ultimately prevent risky chemicals from entering the marketplace. We urge OPPT to use this opportunity – and ORD’s expertise – to improve and expand its consideration of new chemical impacts to frontline communities, the risks new chemicals may pose throughout their entire life cycle, as well as cumulative risks from chemicals that may cause similar health effects. 

Below we outline the five proposed research areas for new chemicals under the Collaborative Research Program and our comments on each. All five can have an important impact on EPA’s new chemical assessments and consequently on EPA’s determination on whether a new chemical is expected to present an unreasonable risk. 

Research Area 1: Update and Refine Chemical Categories

There is typically very little health and safety data included in most new chemical submissions. Where there is little or no data for a new chemical, EPA typically relies on data it has on members of a category of structurally similar chemicals. We appreciate EPA’s commitment to improve this approach and hope it will be rigorously and transparently updated and expanded. 

Research Area 2: Develop and Expand Databases Containing TSCA Chemical Information 

It is encouraging that the agency plans to consolidate information from different databases and digitize confidential new chemical information currently available only in hard copy. We believe this will increase the efficiency of new chemical reviews and ensure that OPPT staff have more complete information when assessing risk. However, notably missing from the plan is a commitment to make data transparent and publicly accessible. We hope EPA will also use this opportunity to ensure that data claimed as confidential business information (CBI) are in fact eligible for CBI protections under TSCA. 

Research Area 3: Develop and Refine QSAR and Predictive Models 

EPA also relies on models for its new chemical assessments. EPA uses these to estimate physical-chemical properties, the persistence and transport of a chemical in the environment and exposures to workers, consumers and the general population. In updating the models used in its new chemical assessments, EPA should use the best available science and more transparently document the applicability and uncertainty of its models. This is particularly important for new chemical assessments given the paucity of data that often accompanies new chemical submissions. As part of this effort, we encourage EPA to consider exposures throughout the entire life cycle of the chemical and fully consider the impacts of new chemicals on all stakeholders, including but not limited to workers and fence-line communities near emitting facilities or contaminated bodies of water. 

Research Area 4: Explore Ways to Integrate and Apply NAMs in New Chemical Assessments 

EPA is increasingly using new approach methods (NAMs) to generate mechanistic, toxicity, and toxicokinetic data to inform the toxicity assessment of new chemicals without the use of animal testing. Indeed, the legal, financial, and ethical concerns around animal testing make NAMs an attractive option. We generally support the use of NAMs, so long as they are utilized in a manner that prioritizes public health. We are concerned that some NAMs may be insufficient for identifying complex endpoints such as neurodevelopmental toxicity. We also are concerned about a potential over-reliance on modeled or predicted toxicity and exposure data in which the agency limits or halts use of its TSCA authorities to fill data gaps where new chemical submissions lack sufficient health and safety information. We hope that subsequent drafts of this Collaborative Research Program include more details on how NAMs will be used and how their use will impact the agency’s evaluation of information sufficiency in new chemical reviews, as required under TSCA. 

Research Area 5: Develop a TSCA New Chemicals Decision Support Tool to Modernize the Process 

We support EPA’s decision to build a “decision support tool that will efficiently integrate all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made.” In doing so, we urge EPA to prioritize making the underlying data, assumptions, and decisions easily accessible to the public to help restore public confidence in the agency’s new chemical program. 

We look forward to providing further input as EPA works to update, refine, and implement its Collaborative Research Program. 

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