On June 22, 2017, the U.S. Environmental Protection Agency (EPA) released a prioritization rule, inventory update rule, risk evaluation rule, external risk evaluation guidance, and notice on scoping documents for the first ten chemical substances, all designed to implement statutory changes under the amended Toxic Substances Control Act (TSCA). These rules have yet to be published in the Federal Register, but as soon as they are published we will post the links.
Below we provide short summaries of the rules.
The EPA’s prioritization rule establishes the process and criteria for identifying “high priority” chemicals for risk evaluation and “low priority” chemicals for which such an evaluation is not necessary. By December 22, 2019, EPA must have designated at least 20 chemical substances as either low or high-priority substances. Some of the key takeaways from the prioritization rule include:
- Candidate selection/review- TSCA requires 50% of all high-priority designations be drawn from the 2014 Update of the TSCA Work Planand EPA prioritize: chemicals with persistence and bioaccumulation scores of three, known human carcinogens, and chemicals with high acute or chronic toxicity. To support a designation, EPA will screen the substance under its conditions of use against specific criteria in TSCA section 6(b)(1)(A).
- Pre-Prioritization- The entire pre-prioritization process (which would have facilitated candidate identification and information gathering before formal prioritization) has been removed from the final rule. However, in the fall of 2017 EPA will begin another stakeholder process to receive more comments regarding pre-prioritization.
- Scope of Priority Designations- EPA will issue priority designations to entire chemical substances as opposed to limiting designations to specific uses.
- Chemicals Subject to Prioritization- “Inactive” chemicals can still be subject to prioritization, but may be less likely to be selected for early prioritization than “active” chemicals. Whether a chemical is “active” will not be dispositive, but will be weighed heavily in regards to exposure judgments during the prioritization process.
- Designations Defined- The high priority standard can be met by identifying one or more conditions of use that meet the standard, while the low priority standard requires that no conditions of use meet the high priority standard.
- “New Chemicals”- Chemicals recently added to the TSCA inventory following PMN review are not likely to be selected as high priority candidates.
Inventory “Reset” Rule
The Inventory “reset” rule requires industry to report chemicals manufactured (including imported) for non-exempt commercial purposes in a ten-year period (“lookback period”), ending on June 21, 2016. The goal of this requirement is to designate chemicals on the TSCA inventory as either “active” or “inactive” in U.S. commerce. Top-level takeaways from the final inventory reset rule include:
- Reporting format stays the same from proposed rule- Reporting will be on CDX (EPA’s Central Data Exchange) using Form A for retrospective reporting (“reset” reporting) and Form B for prospective reporting (to move substances from the inactive to the active list). If a substance is not reported, it will be considered “inactive” and a notification will need to be submitted 90 days before actual manufacturing or processing begins.
- Processors- Processors can voluntarily report using Form A
- “One and Done” alternative- If a manufacturer obtains a CDX receipt of a Form A submitted by another manufacturer for the same chemical, it does not have to submit its own Form A for that specific chemical.
- No more date range- Manufacturers will not have to specify dates of manufacture or commercial activity with Form A submissions.
- Timing- Manufacturers and importers must complete their reporting within 180 days from publication of the final rule. Note: the final rule has not yet been published in the Federal Register.
Risk Evaluation Rule
The risk evaluation rule establishes the guidelines to determine whether a chemical presents an unreasonable risk to health or the environment, under the conditions of use, including an unreasonable risk to potentially exposed or susceptible populations. EPA must evaluate hazard and exposure while excluding cost considerations, and ensure that decisions are based on the weight-of-scientific-evidence. Some key findings from the risk evaluation rule include:
- EPA initiated risk evaluations- EPA will conduct risk evaluations on chemical substances designated as high-priority substances throughout the prioritization process. For each risk evaluation completed on a high-priority substance, a new one must begin. By the end of 2019, EPA must have at least 20 high-priority evaluations going at any one time.
- Conditions of use- Conditions of use will be identified on a case-by-case basis. When conducting a risk evaluation, EPA is not required to evaluate all possible conditions of use. For example, uses that result in a de minimis exposure would be excluded. Overall, a condition of use is more likely to be found where the facts suggest that the activity is probable as opposed to possible.
- Manufacturer-requested evaluations- Chemicals can be evaluated at a manufacturer’s request using CDX, but EPA will conduct a full risk evaluation, as if the substance received a high-priority designation.
- Components of a risk evaluation- A risk evaluation will include a scope (hazards, exposures, conditions of use, and potentially exposed populations), hazard assessment (adverse health or environmental effects), exposure assessment (duration, intensity, frequency and number of exposures), risk characterization, and risk determination (does the substance under conditions of use present an unreasonable risk to health or the environment).
Guidance to External Parties for Submitting Draft Risk Evaluations
This guidance document describes the science, standards, and processes that should be followed when an interested party is drafting and submitting a risk evaluation for EPA. EPA’s general expectation is that interested party draft risk evaluations will be of the same quality as those developed by EPA.
- Non-binding- This guidance is not binding on third parties, or the Agency itself.
- Standards- EPA expects draft evaluations to adhere to the statutory requirements of section 6 of TSCA, and the scientific standards of section 26 of TSCA. EPA also recommends third parties consider using a data quality system to ensure a high standard for data quality.
- Moving forward- EPA indicates that they are interested in receiving public comments to strengthen the document, and commit to reviewing this guidance document every 5 years.
Scoping Documents for the First Ten Chemical Substances
On December 19, 2016, EPA published a list of 10 substances that are the subject of the Agency’s initial chemical risk evaluations, as required by TSCA § 6(b)(2)(A). The scoping documents that correspond to these first 10 chemicals outline the risk evaluations, hazards, exposures, conditions of use, and potentially susceptible populations that the Agency expects to consider under TSCA. EPA will be accepting public comments on a problem formulation document that will refine the current scope, which document is expected to be released within approximately six months of publication of the scoping documents. The scoping documents for each of the chemical substances can be found below: