ACC files comments to inform EPA’s development of rules under the LCSA
The U.S. Environmental Protection Agency (EPA) is already moving quickly to implement the Lautenberg Chemical Safety Act (LCSA), and here at ACC we have been actively engaged with the Agency in the implementation process.
In early August, EPA held a series of public meetings on the LCSA to discuss the first rules the Agency is to develop under the new law. The first stakeholder meetings were important in that they allowed input prior to the drafting of regulations. Stakeholders like ACC were able to engage with the Agency to discuss the importance of properly implementing the new law in an objective and transparent way and using the best available and highest quality science to draw conclusions about a chemical’s safety.
We believe these rules are critical to ensure that the law is meeting its goal of reassuring Americans that chemicals in the marketplace have undergone a safety review.
During the stakeholder meetings ACC outlined:
- how EPA should systematically prioritize chemicals for purposes of risk evaluations;
- the necessary elements of high-quality risk evaluations that reflect the LCSA requirements that decisions be based on the best available science and weight-of-the-evidence; and
- issues the Agency should address in establishing a fee system that supports EPA administration of the new law.
As a follow-up to these meetings, ACC submitted written comments that clarify and extend our remarks. In particular, ACC’s written comments clarify our views on how the Agency should develop the rules, especially for addressing the scientific provisions of LCSA in adequate detail in the regulations.
ACC’s written comments are summarized below.
Risk-Based Prioritization of Chemicals
- The rule must address both procedural requirements of the prioritization process and the application of the best-science provisions.
- EPA must include the basic elements outlined by the statute in the rule for the development of a “risk based screening process” to designate substances as high or low priority.
- EPA’s implementation of the prioritization sections of the LCSA should incorporate the law’s provisions on testing, reporting of information and confidential business information.
- If EPA’s prioritization process is based on the Agency’s Work Plan Chemical methodology to identify priorities, it should incorporate several near- and long-term improvements.
Risk Evaluations
- The LCSA outlines substantive elements that are core to the risk evaluation process, including:
- a reasonable, efficient process to determine whether a substance presents and unreasonable risk to human health or the environment;
- a process to identify potentially exposed subpopulations relevant to the evaluation under the conditions of use; and
- incorporating the specific LCSA science requirements, including best available science, weight-of-the-evidence and transparency requirements.
- EPA should engage stakeholders early and often in the risk evaluation process.
Fees for EPA to Administer the LCSA
- EPA must be clear about its current and anticipated costs and realistic in its expectation for fee revenue. EPA must assure that fees are not set at a level that would adversely impact innovation and competition.
- EPA should not assess fees for the submission of data under testing requirements.
- Fees for submissions and Agency actions should reflect the level of effort required by the Agency.
- EPA should establish a single fee per substance for risk evaluations and allow flexibility for industry groups to determine how those fees should be allocated.
The development of these rules in collaboration with stakeholders is vital to the success of the new law. Proper implementation will incorporate the key science provisions of the LCSA, promote transparency and stakeholder input and ensure that Americans can trust that the products of chemistry are safe for their intended uses.
Stakeholders can expect EPA to propose rules on these issues by mid-December 2016 and make them final by June 2017.
