(Washington, D.C. – June 22, 2017) The Environmental Protection Agency (EPA) issued the final “framework” rules for implementation of the Toxic Substances Control Act (TSCA), as well as the “scopes” for the first 10 risk evaluations to be conducted, and guidance for third parties who wish to submit their own draft risk evaluations.
“EDF’s initial assessment is that changes have been made that significantly weaken the proposed rules, in some cases in ways that are contrary to the new law. Given that this is taking place in the most anti-environmental Administration we’ve faced in decades, the changes heighten our concern that the law will not be implemented in the coming years in a way that protects the public’s health,” said Dr. Richard Denison, EDF’s lead senior scientist.
Background on EDF’s initial concerns on the final Risk Evaluation, Prioritization, and Inventory Notification Rules:
Risk Evaluation Rule
EPA’s final risk evaluation rule raises concerns as to whether human health will be protected. In some instances, provisions appear to be contrary to the law.
- Narrowing of conditions of use – Unlike the proposed rule, EPA is now indicating that it may not and does not need to include all conditions of use in the scope of a chemical risk evaluation, and provides no explanation as to how these use exclusions will be determined. EPA indicates, for example, that it intends generally to exclude legacy uses and associated exposures. Further, the rule indicates that the agency can make risk determinations for individual conditions of use, and that these determinations can be staggered. The statute does not permit such separations — a determination that a chemical does not present unreasonable risk is to be made on the chemical as a whole, not individual uses. EPA’s approach complicates and undermines the clear intent of Congress that EPA examine the full range of exposures to a chemical.
- Allowance for narrow manufacturer-requested risk evaluations – In contrast to the proposed rule, manufacturers may limit their requests for EPA to conduct risk evaluations to specific conditions of use instead of all conditions of use. Manufacturers only need to provide information to the agency on the specified uses, and not on the other conditions of use that the agency will need to evaluate. This shifts a large burden to the agency whenever it grants such a request (a minimum number of which it must do under the law).
EPA’s final prioritization rule omits important elements that had been included in the proposed rule, hampering EPA’s ability to make sound decisions about chemicals. Among these omissions:
- Elimination of pre-prioritization – Pre-prioritization is no longer included in the rule as it was in the proposed rule. Instead, the agency intends to rely on a future process (potentially a rulemaking) to develop what is likely to be an unnecessarily prescriptive pre-prioritization process that may limit EPA’s ability to use its information-gathering authorities and be burdensome to the agency.
- Information-gathering constraints – In addition to the removal of the pre-prioritization process, the preamble to the rule describes an information-gathering process that seeks to minimize and undermine EPA’s use of the new testing authorities available to the agency under section 4.
- Elimination of default to high priority where information is insufficient – Given the constraints noted above on information gathering, it seems implausible that EPA will always have sufficient information before or during the prioritization stage to determine whether a chemical meets the statutory definition of high or low priority. Yet the final rule no longer explicitly indicates that insufficient information (after efforts to obtain it have been followed) results in a high-priority designation, as required under the law.
Inventory Notification Rule
The rule creates loopholes for companies that will limit the public’s ability to know what chemicals are on the market.
- Questionable activation of inactive chemicals – A company can notify EPA it is “activating” an inactive chemical and then never do it, yet the chemical still is designated as active, which means other companies can manufacture or process it without having to first notify EPA.
- “Transferable” CBI claims for chemical identity – One company can rely on another company’s prior confidential business information (CBI) claim for the identity of the chemical, despite the fact that the justification for such a claim is company-specific. This effectively allows companies to assert new CBI claims for a chemical identity using a process designed to ensure the validity of claims asserted previously.