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Summarizing the “New TSCA” Implementation
Posted on August 2nd, 2016 by Christina Valimaki in New Materials & Applications
The Environmental Protection Agency (EPA) has published a roadmap of its plans to implement the recent legislative amendments to the Toxic Substances Control Act (TSCA). Every company in the chemical industry should review this implementation plan to prepare for the potential short-term and long-term business impacts.
Here are the highlights of the EPA plan:
The EPA initiated several actions on June 22, 2016, the day that the Frank R. Lautenberg Chemical Safety of the 21st Century Act became law.
For new chemicals, the EPA set a requirement to review and approve all premanufacture notices (PMNs) and significant new use notices before manufacturing can begin. For PMNs undergoing review before June 22, the agency will attempt to complete its review and make a determination within the original deadline.
For confidential business information, the agency will conduct, within 90 days, a review of —and a determination on — all new confidentiality claims for chemical identity of chemicals offered for commercial distribution. Its goal is to meet the 90-day deadline for incoming CBI claims soon, by mid-July 2016.
For chemicals with risk assessments completed prior to the date of enactment, the EPA may publish both the proposed and the final rules, consistent with the scope of those earlier risk assessments.
The agency announced six processes to guide its longer-term program:
- Initial risk evaluations: The EPA will publish a list of 10 Work Plan chemicals and formally initiate risk evaluation on those chemicals. It will publish the list by mid-December 2016 and each scope of assessment by mid-June 2017.
- Prioritization process rule: The agency will publish a procedural rule to establish its process for prioritizing chemicals, along with criteria for identifying both high-priority and low-priority chemicals for risk evaluation by mid-June 2017.
- Risk evaluation process rule: The EPA will publish a procedural rule to establish its process for evaluating the risk of high-priority chemicals. The agency will publish its proposed rule by mid-December 2016 and its final rule by mid-June 2017.
- Fees rule: The agency’s goal is to consult with affected parties, publish its proposed fee rule by mid-December 2016, and publish the final rule by mid-July 2017.
- Inventory rule: The EPA will publish a rule to require industry reporting of chemicals manufactured or processed in the previous 10 years. It will use the results to designate active and inactive chemicals on the TSCA inventory of existing chemicals. The agency will publish its proposed rule by mid-December 2016 and its final rule by mid-June 2017.
- Science advisory committee: The new law requires the EPA to establish a committee to provide independent advice and expert consultation on the scientific and technical aspects of issues related to implementing the new legislation. The legislation sets a deadline of one year after enactment, but the agency’s goal is to establish the committee earlier, by mid-December 2016.
Early Mandatory Actions
The EPA announced six early mandatory actions to be completed within the next 12 months:
- Scope of initial risk evaluations: The agency plans to publish its scope of the evaluation of the first 10 chemicals by mid-June 2017.
- Annual plan for risk evaluations: The EPA’s deadline for its annual risk-evaluation plan is the beginning of each calendar year, with the first plan due early January 2017.
- Additions to mercury export ban: The agency will publish its initial list of mercury compounds prohibited from export by September 2016.
- Mercury inventory: The EPA will publish its first mandatory inventory of mercury supply, use, and trade in the U.S. by April 1, 2017, and update it every three years.
- Small business definitions: The agency will determine by mid-December 2016 whether revisions to its standards for identifying small manufacturers and processors are needed.
- Report to Congress: The EPA will submit its first report by mid-December 2016 and every five years thereafter.
Later Mandatory Actions
The agency also announced five actions to be completed within the first few years of implementation:
- Mercury use/product reporting rule: The EPA will publish a final rule by mid-June 2018.
- CBI review/substantiation rule: The agency will publish a final rule one year after publishing its list of active chemicals.
- Generic names for CBI chemicals: The EPA will publish its guidance by mid-June 2018.
- Negotiated rulemaking on byproducts reporting for Chemical Data Reporting: The agency expects to publish a proposed rule by mid-June 2019
- Alternative testing methods strategy: The EPA will publish its strategy by mid-June 2018.
All opinions shared in this post are the author’s own.
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