The Frank R. Lautenberg Chemical Safety for the 21st Century Act Implementation Activities
- Review and make an affirmative determination on all pre-manufacture notices (PMNs), Microbial Commercial Activity Notice (MCAN), and significant new use notices (SNUNs) before manufacturing can commence.
Confidential Business Information
- Requested public comment on approaches for assigning and applying unique identifiers under TSCA § 14(g)(4). When a CBI claim for chemical identity is approved, EPA is required to assign a unique identifier to that chemical identity.
- Read the May 2017 Federal Register notice explaining the new provisions and requesting comment on three potential approaches for assigning and applying unique identifiers
- Read the February 2018 Federal Register notice requesting comment on an additional potential approach to assigning and applying unique identifiers
- Issued Agency interpretation of revised TSCA § 14(c)(3) as requiring that chemical manufacturers and other entities who submit information to EPA under TSCA provide support for non-exempt CBI claims at the time the information claimed as CBI is submitted to EPA.
Ongoing Section 6 Rulemakings
- EPA published proposed risk management requirements for three chemicals with risk assessments completed prior to the date of enactment.
- Learn more about TCE and view proposed rules for TCE use in spot cleaning and aerosol degreasing and in vapor degreasing
- Learn more about methylene chloride and view the proposed rule for its use in paint removers
- Learn more about N-methylpyrrolidone (NMP) and view the proposed rule for its use in paint removers
- Initial Risk Evaluations – EPA selected the initial 10 chemicals to undergo risk evaluation under amended TSCA and released scope documents providing information on the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations EPA expects to consider in its risk evaluations.
- View the scope documents for the initial 10 chemicals to undergo risk evaluation under amended TSCA
- Read the Federal Register Notice announcing the availability of the scope documents for the initial 10 chemicals
- View press release announcing the first 10 chemicals
- Read the Federal Register Notice announcing the February 14, 2017 Public Meeting held to receive input to assist the Agency in its efforts to establish the scope of the risk evaluations
- Fees Rule – EPA proposed a fees rule under amended TSCA. The proposed fees on certain chemical manufacturers, including importers, would provide a sustainable source of funding to defray the costs of implementation of new responsibilities under the amended law.
- Read the Federal Register Notice extending the comment period to May 24, 2018
- View the supplemental analysis on alternative small business size definitions and their effect on the TSCA user fee collection
- Read the proposed fees rule Federal Register notice
- View the presentation from the August 2016 industry consultation meeting on fees
- Prioritization Process Rule – Finalized a rule to establish EPA’s process and criteria for identifying high-priority chemicals for risk evaluation and low-priority chemicals for which risk evaluation is not warranted at this time.
- Risk Evaluation Process Rule – Finalized a rule to establish EPA’s process for evaluating high priority chemicals to determine whether or not they present an unreasonable risk to health or the environment.
- Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations – Published guidance to assist interested persons in developing and submitting draft risk evaluations to EPA. The guidance describes the science standards, data quality considerations, and the steps of the risk evaluation process that external parties should follow when developing draft TSCA risk evaluations.
- Inventory Rule – Finalized a rule to require industry reporting of chemicals manufactured, imported, or processed in the U.S. over the past 10 years. This reporting will be used to identify which chemical substances on the TSCA Inventory are active in U.S. commerce and will help inform the chemicals EPA prioritizes for risk evaluation.
- Science Advisory Committee on Chemicals (SACC) – Established a committee to provide independent advice and expert consultation with respect to the scientific and technical aspects of issues related to implementation of the statute.
- Issued additions to the Mercury Export Ban, which is intended to reduce the availability of elemental (metallic) mercury in domestic and international markets.
- Issued an initial inventory of mercury supply, use, and trade in the United States. This inventory report is a compilation of publicly available data on the supply, use, and trade of elemental mercury and mercury compounds.
- Proposed a rule to require reporting from persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process. The proposed rule, when finalized, would support future, triennial publications of the mercury inventory.
- View the Federal Register notice on the Mercury Reporting Rule.
- Read the Federal Register notice extending the end of the comment period from December 26, 2017 to January 11, 2018.
- Publish annual reports on risk evaluations that identify the chemicals that will undergo risk evaluation in the coming year, their status and schedule, and the resources necessary to complete these activities.
- Established a Negotiated Rulemaking Committee under section 8(a)(6) of TSCA to develop a proposed rule for limiting chemical data reporting requirements for manufacturers of any inorganic byproducts, when such byproducts are subsequently recycled, reused, or reprocessed. In October 2017, the Committee determined that it was not able to reach consensus on regulatory approaches and concluded its negotiations.Learn more about the Negotiated Rulemaking Committee.
- Standards for Small Manufacturers and Processors for Reporting and Recordkeeping
- EPA announced that changes need to be made to the size standards used to determine which small manufacturers and processors are exempt from TSCA Section 8(a) reporting. Read the Federal Register notice.
Report to Congress
- Provided a report to Congress on EPA’s capacity, and the resources needed, to conduct risk evaluations and to issue regulations to address unreasonable risks. The Agency also reported on capacity to conduct industry-requested risk evaluations, the likely demand for such requests, and the anticipated schedule for accommodating the demand.