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Assessing and Managing Chemicals under TSCA

The Frank R. Lautenberg Chemical Safety for the 21st Century Act Implementation Activities

First Year Implementation Plan

New Chemicals

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.

Issued a Strategic Plan to promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing.

Confidential Business Information

Finalized guidance outlining the circumstances under which TSCA allows the Agency to disclose CBI and how state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders can request disclosure.

Issued Agency policy 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 guidance on developing structurally descriptive generic names for chemical identities being claimed as CBI.

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.

Section 6 Rulemakings

Learn about the following rules under section 6 of TSCA.

Framework Actions

Initial Risk Evaluations 每 EPA selected and is reviewing the first 10 chemicals to undergo risk evaluation under amended TSCA.

Fees Rule 每finalized a rule to collect fees from certain chemical manufacturers, including importers, to provide a sustainable source of funding to a portion of TSCA implementation costs.

Prioritization Process Rule 每 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每 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 每 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 每 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.

Advisory Panel

Science Advisory Committee on Chemicals (SACC) 每 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.

Mercury

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.

Finalized 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 rule supports future, triennial publications of the mercury inventory.

Annual Report

Published 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.

Reporting and Recordkeeping

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.

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.