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Working together to improve EPA’s proposed rules for chemical prioritization and risk evaluation under the Lautenberg Act

As efforts continue in earnest to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), ACC sees two areas in particular where industry and the Environmental Protection Agency (EPA) can work together closely to put the program on a solid footing – prioritizing chemicals for review and conducting efficient risk evaluations.

EPA must complete new rules governing these processes by June 2017.

To support this important work, ACC filed comments this week on EPA’s proposed rules for Procedures for Prioritization of Chemicals and Risk Evaluation, as required by the new law.

Strong footing: Prioritization of chemicals

Prioritization of chemicals for review is a key provision of the LCSA’s framework. It is the foundation for a more efficient EPA process to evaluate the risks of high priority substances.

However, EPA’s proposed prioritization process for designating chemicals as low or high priority for risk evaluations raises several concerns.

EPA suggested a “pre-prioritization” step to identify candidate chemicals for prioritization but provided very little detail about the operation of this step. ACC strongly urges EPA to clarify the criteria, methods, authority and limitations on this step in its final rule. Greater clarity is essential to ensure consistency in, and credibility of, EPA’s prioritization designations.

The prioritization process rule’s treatment of low priority chemicals is also problematic. EPA suggests that it would be unlikely to designate chemicals as low priorities because the Agency proposes that ALL conditions of use of the chemical meet the low priority criteria to be designated as such.

Congress intended low priority designations to be one way EPA could make more efficient progress in reviewing chemicals, to assure the public about chemical safety, and to conserve resources by focusing its attention on chemicals that may pose a risk to human health and the environment. EPA has authority to designate low priorities more often than it has suggested.

It is critical that EPA get prioritization right.

Next step forward: Risk evaluations

At the core of the LSCA is effective and efficient risk evaluation of prioritized chemicals and uses.

ACC and our members have called for EPA to focus on the most relevant, greatest potential risk conditions of use that warrant risk evaluations — taking into account a substance’s hazards and its exposure potential, using the best available science and the full weight-of-the-scientific-evidence. The process should consist of a tiered approach that includes an initial screening-level evaluation; when necessary, a more detailed evaluation to quantify potential risks would then be conducted.

Unfortunately, the Agency’s proposed rule on risk evaluation does not incorporate the key scientific criteria and weight-of-the-evidence provisions that were required by the LCSA.

We believe revisions to the rule are necessary so that all stakeholders can understand exactly how EPA will evaluate the quality, reliability, and relevance of the scientific evidence it examines to achieve final risk evaluations.

Not to be overlooked: Data and information sharing

Embedded in each of these components of the LCSA is the need for data and information sharing.

Industry has a lot to offer in this regard – from our deep knowledge base and expertise both in the U.S. and abroad, to the robust chemical safety information we’ve developed over the years on chemicals in commerce.

That’s why we are committed to working closely with EPA to provide or identify the information that can help the Agency make quick, accurate risk evaluations.

Why it matters

Steady and consistent progress to review chemicals in commerce will only be possible if EPA, industry and other stakeholders commit to it; view each other as partners with shared goals; and cooperate to reach milestones.

The Lautenberg Chemical Safety Act is our opportunity to demonstrate:

  1. how a state-of-the-art, risk-based chemical safety program truly works in practice;
  2. how it can protect both public health and the environment without unnecessarily stifling innovation; and
  3. how key elements of such a risk-based program can be implemented around the globe today, especially in developing countries where governments and communities could most benefit from the innovation and economic growth that chemistry makes possible.

That is why ACC and our members are committed to implementing the Lautenberg Act successfully.

It’s important to note that Administrator Pruitt has committed to making sound science the foundation of all regulation – a principle that ACC, its members and their customers have long supported.

Administrator Pruitt’s leadership and commitment to science will be instrumental to ensuring that the Lautenberg Chemical Safety Act is implemented in the way that lawmakers intended.

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