15 July 2016
EPA Issues Plan to Implement Chemical Reform Legislation
The Environmental Protection Agency has laid out the steps it plans to take over the next year to implement some of the key provisions of the recently enacted Frank R. Lautenberg Chemical Safety for the 21st Century Act, which represents the first significant overhaul of the Toxic Substances Control Act since its enactment 40 years ago. The new law imposes a number of new responsibilities on the EPA subject to comparatively short deadlines. Accordingly, the agency believes that it must engage partners and stakeholders early in the process and be as transparent as possible to be able to comply with its obligations in a timely and effective fashion.
The implementation plan recently released by the EPA is meant to be a roadmap of major activities during the initial year of implementation and is organised by the statutory timeframes during which the required activities must be completed. The agency observes that the plan is a living document that will be further developed over time and does not include all requirements of the new law.
Immediate actions beginning on day one of implementation include the following.
- New Chemicals
The law requires the EPA to review and make an affirmative determination on all pre-manufacture notices and significant new use notices before manufacturing can commence. For companies that submitted PMNs prior to enactment and are currently undergoing review, the 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.
- Confidential Business Information
The EPA intends to meet the 90-day deadline for incoming confidential business information claims and create a plan to link associated information by mid-July. The agency will also develop by mid-July an approach for the routine review of at least 25 percent of new confidentiality claims for other types of information. Moreover, the agency will provide stakeholders also by mid-July additional information on statement and certification.
- On-going Section 6 Rulemakings
For chemicals with risk assessments completed prior to the date of enactment, 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. Accordingly, the agency will continue work to address identified risks from trichloroethylene (TCE), methylene chloride (MC) and N-methylpyrrolidone (NMP). A proposed rule for TCE use in spot cleaning and aerosol degreasing is expected by early October 2016 and a final rule is anticipated by early October 2017. A proposed rule for TCE use in vapour degreasing is expected by early December 2016 and a final rule by early December 2017, while a proposed rule for MC and NMP use in paint removers is anticipated by early December 2016 and a final rule by early December 2017.
Long-term actions that the EPA plans to initiate during the first year of implementation are described below.
- Initial Risk Evaluations
The EPA will publish a list of 10 Work Plan chemicals by mid-December 2016 and publish the scope of each assessment by mid-June 2017.
- Prioritisation Process Rule
The agency expects to issue a final procedural rule by mid-June 2017 to establish the process and criteria for identifying high-priority chemicals for risk evaluation as well as low-priority chemicals. A proposed rule is expected to be issued by mid-December 2016.
- Risk Evaluation Process Rule
The agency expects to issue a final procedural rule by mid-June 2017 to establish the process for evaluating the risk of high-priority chemicals, with a proposed rule expected by mid-December 2016.
- Fees Rule
The EPA is authorised to collect fees to help defray the cost of implementing certain provisions and to fully defray the cost of industry-requested risk evaluations but must issue a rule to require such fees. There is no deadline in the bill, but authority to require fees will be needed as soon as possible. Accordingly, the agency plans to (i) consult and meet with parties potentially subject to the fees, (ii) issue a proposed rule by mid-December 2016, and (iii) issue a final rule by mid-June 2017.
- Inventory Rule
A rule to require industry reporting of chemicals manufactured/processed in the previous ten years will be issued by mid-June 2017, with a proposed rule expected by mid-December 2016. The results will be used to designate active and inactive chemicals on the TSCA inventory of existing chemicals.
- Science Advisory Committee on Chemicals
The EPA must establish a committee to provide independent advice and expert consultation with respect to the scientific and technical aspects of issues related to the implementation of the statute. While the legislation requires the committee to be established one year after enactment, the EPA is working to have it in place by mid-December 2016. A notice is expected to be published in the Federal Register in early September 2016 and parties will be able to submit comments through early November 2016.
- Annual Plans for Risk Evaluations
The required plan must identify chemicals for which evaluations are expected to be initiated or completed that year and the resources needed, the status of other chemicals under evaluation and updated schedules as appropriate. The first plan is due in early January 2017.
- Additions to Mercury Export Ban
Mercury compounds are now banned from export, in addition to elemental mercury which was previously banned under the Mercury Export Ban Act of 2008. The EPA will publish an initial list of mercury compounds prohibited from export by mid-September 2016.
- Mercury Inventory
The EPA will publish by 1 April 2017 an inventory of mercury supply, use and trade in the United States. The inventory will be updated every three years.
- Small Business Definitions
The legislation requires the EPA to review the adequacy of standards for identifying small manufacturers and processors and revise them as warranted. The agency will determine whether such revision is warranted within 180 days of enactment and will plan and schedule any revisions accordingly.
- Report to Congress
The EPA must report to Congress on its capacity and the resources needed to conduct risk evaluations and to issue rules to address unreasonable risks. It must also report on its capacity to conduct industry-requested risk evaluations, the likely demand for such requests, and the anticipated schedule for accommodating the demand. The first report will be submitted by mid-December 2016 and updates will be provided every five years thereafter.
Other mandatory actions that must be completed within the first few years of implementation are summarised below.
- Mercury Use / Product Reporting Rule
A final rule will be issued within two years of enactment, or by mid-June 2018.
- CBI Review / Substantiation Rule
A final rule will be issued one year after publication of the active list of chemicals.
- Generic Names for CBI Chemicals
Guidance will be issued within two years of enactment, or by mid-June 2018.
- Negotiated Rulemaking on By-Products Reporting for CDR
A proposed rule will be issued within three years of enactment, or by mid-June 2019.
- Alternative Testing Methods Strategy
The strategy will be issued by mid-June 2018.