First Year Implementation Plan
- 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.
- 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.
- 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.
- 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.
- Fees Rule – EPA is developing a rule to collect fees from certain chemical manufacturers, importers and processors, as authorized under the recent amendments to TSCA. This fee collection authority allows EPA to defray a portion of the costs for EPA to carry out its new responsibilities under TSCA.
- 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.
- Published an annual report on risk evaluations that identifies the chemicals that will undergo risk evaluation this year, their status and schedule, and the resources necessary to complete these activities.
Reporting and Recordkeeping
- Negotiated Rulemaking on Chemical Data Reporting Requirements for Inorganic Byproducts – EPA is establishing 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.
- Standards for Small Manufacturers and Processors for Reporting and Recordkeeping
- Read the Federal Register notice requesting public comment on the standards for small manufacturers and processors used in connection with reporting regulations under TSCA section 8(a).
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.