On its website, EPA released a first-year implementation plan since the revised law imposes a number of new responsibilities on the agency, accompanied by implementation deadlines. Some of the statute's changes are in effect now and will have immediate impact, while other changes in the law will require EPA to promulgate new rules and policies. EPA's roadmap for implementation includes the following information.
- Pending PMNs and SNUNs Must Be Re-evaluated
Given the new safety standard, EPA must evaluate pending pre-manufacture notices (PMNs) and significant new use notices(SNUNs) according to the new risk-based standard. Furthermore, under the new law, EPA must make an affirmative determination on PMNs and SNUNs before a manufacturer or importer can introduce the new chemical into commerce. As such, EPA will likely review these notices with heightened scrutiny. EPA stated that while it will make every effort to complete its review and make determinations within the remaining time under the notices' original deadlines, the new law has reset the 90-day review period from June 22, 2016. The immediate impact could be that companies that have pending PMNs and SNUNs will have to wait an additional 90 days before hearing back from EPA on whether or not their notices are approved.
- Ongoing Chemical Reviews Must Be Re-evaluated
EPA currently has a number of chemicals that are under review under Section 6 of TSCA, including trichloroethylene (TCE), methylene chloride, and N-Methyl-2-pyrrolidone (NMP). Given the new safety standard, EPA must review the chemicals according to the new risk-based standard and propose rules in accordance with the new TSCA's risk-management provisions. According to EPA, the agency plans to release the proposed regulations for these chemicals on the following schedule:
- Proposed rule for TCE in spot-cleaning and aerosol degreasing: October 2016
- Proposed rule for TCE in vapor degreasing: December 2016
- Proposed rule for methylene chloride and NMP in paint removers: December 2016
- New Confidential Business Information (CBI) Claims Must Be Reviewed
The new TSCA requires EPA to routinely review and determine (within 90 days) all new confidentiality claims for chemical identity of chemicals that have been offered for commercial distribution and, where claim is upheld, apply a unique identifier to the chemical and any associated information. EPA intends to meet the 90-day deadline for incoming CBI claims and create a plan to link associated information by mid-July 2016.
- 2016 CDR Submissions Must Have New Certification Language
EPA states that there are changes in the new law related to CBI submitted under TSCA. For the 2016 CDR submitters — who have until September 30th to submit their data — EPA changed the wording of the CBI certification statement to be consistent with the requirements in the new law. EPA is updating the guidance, instructions, and other information documents to be consistent with the new certification language.
The revised TSCA mandates EPA to commence rulemakings for several significant changes to the statute. Based on the changes to the law, EPA released the following implementation schedule.
- Within Six (6) Months
- Publish the list of 10 TSCA Work Plan chemicals and initiate risk evaluations of those chemicals. EPA must publish the scope of each risk assessment 6 months afterward
- Meet with stakeholders potentially subject to new user fees
- Form Science Advisory Committee on Chemicals
- Publish list of mercury compounds prohibited from export (90 days)
- Determine whether revision to small business definitions is warranted
- Within One (1) Year
- Publish final rule to reset TSCA inventory
- Publish final rule on prioritization process for existing chemicals
- Publish final rule on risk evaluation process for high priority chemicals
- Publish final rule on new user fee structure
- Publish annual plan for which chemical evaluations are expected to be initiated
To read EPA's new resources on TSCA, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act.
For opportunities for input from the public including briefings, webinars, public meetings, comment periods, etc., EPA has also made available this link to sign-up for updates on EPA's stakeholder engagement efforts.