EPA’s quick-draw TSCA implementation plan
The recently enacted sweeping revisions to the Toxic Substances Control Act
(TSCA) have been decades in the making, but the EPA needed to begin
implementing the changes even before the ink of President Obama’s
signature dried. Accordingly, just 1 week after enactment, the Agency
released its First Year Implementation Plan for the new law, including several actions under the heading “Beginning on Day 1.”
“The new law imposes a number of new responsibilities on EPA, with comparatively short deadlines to carry out these actions,” the EPA states.“The Agency takes these responsibilities and deadlines seriously.For implementation to be successful, EPA believes it is important to engage partners and stakeholders early in the process, and to be as transparent as possible.This document is intended to be a roadmap of major activities EPA will focus on during the initial year of implementation.”
The EPA says the implementation plan is a “living document” that will be developed over time and is not intended to be a comprehensive listing of all requirements the Agency must meet under the law.
Information on the implementation plan can be found here.
Respecting transparency
TSCA reform would not have occurred without the encouragement and infusion of ideas from many stakeholders within both government and the private sector. At this juncture, the EPA seems to recognize that that level of support should be reciprocated with transparency from the Agency on how it intends to proceed.“The new law imposes a number of new responsibilities on EPA, with comparatively short deadlines to carry out these actions,” the EPA states.“The Agency takes these responsibilities and deadlines seriously.For implementation to be successful, EPA believes it is important to engage partners and stakeholders early in the process, and to be as transparent as possible.This document is intended to be a roadmap of major activities EPA will focus on during the initial year of implementation.”
Day 1 actions
The implementation plan lists three actions in the Day 1 category:- Review and make an affirmative determination on all premanufacture notices (PMNs) and significant new use notices (SNUNs) before manufacturing of new chemicals can commence.
The Agency says: “For companies that submitted PMNs prior to enactment and are currently undergoing review, EPA will make every effort to complete its review and make a determination within the remaining time under the original deadline. However, as a legal matter, the new law effectively resets the 90-day review period.”
- Conduct routine review of and determination on (within 90 days) all new confidentiality claims for chemical identity of chemicals that have been offered for commercial distribution, and where the claim is upheld, apply a unique identifier to the chemical and any associated information.
- For chemicals with risk assessments completed before the date of
enactment, TSCA Section 26(l)(4) allows the EPA to publish proposed and
final rules consistent with the scope of those risk assessments even if
they do not cover all conditions of use. The Agency lists three of
these “ongoing Section 6 rulemakings” to address identified risks from
trichloroethylene (TCE), methylene chloride (MC) and
N-methylpyrrolidone (NMP) as follows:
- Propose a rule for TCE use in spot cleaning and aerosol degreasing by early October 2016; final rule anticipated early October 2017.
- Propose a rule for TCE use in vapor degreasing by early December 2016; final rule anticipated early December 2017.
- Propose a rule for MC and NMP use in paint removers by early December 2016; final rule anticipated early December 2017.
The EPA says its goal is to meet the 90-day deadline for incoming confidential business information (CBI) claims and create a plan to link associated information in 30 days—by mid-July 2016.
The Agency must also conduct routine reviews of and determinations on (within 90 days) at least 25 percent of new confidentiality claims for other types of information. The goal is to develop an approach for routine review in 30 days—by mid-July 2016.
Longer term
The implementation plan also includes sections on longer-term “Framework Actions” (e.g., publishing a list of 10 work plan chemicals by mid-December 2016 and formally initiating risk evaluations for them); “Early Mandatory Actions” (e.g., by January 2017, issue the first annual plan for risk evaluations for chemicals for which evaluations are expected to be initiated or completed in 2017); and “Later Mandatory Actions” (e.g., publish an alternative testing methods strategy by mid-June 2018).The EPA says the implementation plan is a “living document” that will be developed over time and is not intended to be a comprehensive listing of all requirements the Agency must meet under the law.
Information on the implementation plan can be found here.