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.

• Status of new chemicals cases currently under review by EPA
• Interim and final determinations for TSCA section 5 PMN and SNUN submissions
• Chemicals determined not likely to present unreasonable risk after PMN review
• Points to Consider When Preparing TSCA New Chemical Notifications
• Meeting materials from the December 6, 2017 public meeting held on implementation of the New Chemicals Review program
• Meeting materials from the December 14, 2016 public meeting held to update the public on changes to the New Chemicals Review program
• More informatin on EPA's new chemicals review program

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

• Alternative test methods and strategies to reduce 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.

• Guidance on requesting accessing CBI
• More information on requesting access to CBI under TSCA

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.

• CBI unique ID requirements and list of unique IDs
• Policy for assigning and applying unique identifiers

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

• Guidance on generic names

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.

• Federal Register Notice announcing EPA’s interpretation of revised TSCA requiring upfront substantiation for CBI claims

Section 6 Rulemakings

Learn about the following rules under section 6 of TSCA.

• Proposed rule to reduce exposure to certain persistent, bioaccumulative, and toxic chemicals
• Final rule to prohibit the manufacture, processing, and distribution of methylene chloride paint removers for consumer use

Framework Actions

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

• List of the first 10 chemicals and links to documents related to their risk evaluations, including the scope and problem formulation 

Fees Rule – 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. 

• Text of the final fees rule
• More information about TSCA administration 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. 

• Text of the final prioritization process rule
• Chemicals undergoing prioritization, including proposed high and low priority chemicals
• Approach for identifying potential chemicals for prioritization
• Submit information on which chemicals should be prioritized for risk evaluation
• More information about the prioritization process under amended TSCA

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.

• Text of the final risk evaluation process rule 
• More information about the risk evaluation process under amended TSCA

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. 

• Guidance for external parties interested in submitting draft risk evaluations to EPA for consideration

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. 

• Text of the final inventory rule
• Latest version of the TSCA inventory, include chemicals designated as active in commerce
• More information on the TSCA inventory rule

Advisory Panel

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.

• SACC panel members
• SACC meetings, including peer reviews of draft risk evaluations for the first 10 chemicals undergoing risk evaluation under amended TSCA

Mercury

Issued additions to the Mercury Export Ban, which is intended to reduce the availability of elemental (metallic) mercury in domestic and international markets.

• Federal Register notice on a list of five mercury compounds prohibited from export after January 1, 2020

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.

• Federal Register notice on the initial inventory of the supply, use, and trade of mercury
• Initial inventory report

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.

• Text of the final mercury inventory reporting rule
• More information about the mercury inventory reporting rule

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. 

• Read past reports.

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 reports 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.  

• October 2022 Report to Congress on EPA’s Capacity to Implement Certain Provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (pdf) (274.25 KB, 10/31/2022)
• Initial Report to Congress on EPA’s Capacity to Implement Certain Provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act