Regulatory Developments

TSCA Reform:  EPA Publishes First Year Implementation Plan

June 29, 2016

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA's plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182, and copies are expected to be available from the U.S. Government Publishing Office (GPO) next week. EPA notes that the new law imposes new responsibilities on EPA, while providing "comparatively short" deadlines to implement them. EPA "takes these responsibilities and deadlines seriously," and intends for the Implementation Plan to be a roadmap of the major activities on which EPA will focus during the initial year of implementation. EPA organizes the Implementation Plan by the statutory timeframes during which the activities must be completed, rather than by what is of importance to EPA. EPA states that the Implementation Plan is a living document, and EPA will further develop it over time. EPA cautions that the Implementation Plan "is NOT intended to be a comprehensive listing of all requirements in the new law."

EPA's Implementation Plan is reproduced below:

SUMMARY OF IMPLEMENTATION PLAN ACTIONS

The Implementation Plan lists the following actions:

Immediate Actions (Beginning on Day One)

New Chemicals

Requirement: Review and make an affirmative determination on all premanufacture notices (PMN) and significant new use notices (SNUN) before manufacturing can commence.
 
Goal: Meet the applicable deadlines. For companies that submitted PMNs prior to enactment and are currently undergoing review, EPA will make every effort to complete its review and make a determination within the remaining time under the original deadline. EPA states that as a legal matter, however, "the new law effectively resets the 90-day review period."

Confidential Business Information (CBI)

Requirement: Routine review of and determination on (within 90 days) all new confidentiality claims for chemical identity of chemicals that have been offered for commercial distribution and, where claim is upheld, apply a unique identifier to the chemical and any associated information.
 
Goal: Meet the 90-day deadline for incoming CBI claims and create a plan to link associated information in 30 days -- mid-July 2016.
 
Requirement: Routine review of and determination on (within 90 days) at least 25 percent of new confidentiality claims for other types of information.
 
Goal: Develop approach for routine review in 30 days -- mid-July 2016.
 
Requirement: Claimants to submit required statement and certification for all asserted CBI claims. (This requirement and the following goal are listed in the PDF of the Implementation Plan, although they are omitted on EPA’s web page.)
 
Goal: Provide stakeholders with additional information on statement and certification by mid-July 2016.

Ongoing Section 6 Rulemakings

Description: For chemicals with risk assessments completed prior to the date of enactment, Section 26(l)(4) allows EPA to publish proposed and final rules consistent with the scope of those risk assessments, even if they do not cover all conditions of use.
 
Goal: Continue work to address identified risks from trichloroethylene (TCE), methylene chloride (MC), and N-methylpyrrolidone (NMP):
  • Proposed rule for TCE use in spot cleaning and aerosol degreasing by early October 2016; final rule anticipated early October 2017;
     
  • Proposed rule for TCE use in vapor degreasing by early December 2016; final rule anticipated early December 2017; and
     
  • Proposed rule for MC and NMP use in paint removers by early December 2016; final rule anticipated early December 2017.

 

Framework Actions (Processes to Guide Longer Term Program)

 

Initial Risk Evaluations

Description: Publish list of ten Work Plan chemicals and formally initiate risk evaluation on those chemicals.
 
Deadlines: Publish list of chemicals within 180 days after enactment -- mid-December 2016; and publish scope of each assessment within six months -- mid-June 2017.

Prioritization Process Rule

Description: Procedural rule to establish EPA's process and criteria for identifying high priority chemicals for risk evaluation and low priority chemicals.
 
Deadline: Final rule one year after enactment -- mid-June 2017.
 
Interim Milestone: Publish proposed rule -- mid-December 2016.

Risk Evaluation Process Rule

Description: Procedural rule to establish EPA's process for evaluating the risk of high priority chemicals.
 
Deadline: Final rule one year after enactment -- mid-June 2017.
 
Interim Milestone: Publish proposed rule mid-December 2016.

Fees Rule

Description: EPA is authorized to collect fees to help defray the cost of implementing certain provisions and to fully defray the cost of industry-requested risk evaluations, but must put a rule in place to require fees. There is no deadline in the bill, but authority to require fees will be needed as soon as possible.
 
Goal: Final rule one year after enactment -- mid-June 2017.
 
Interim Milestones: Consult and meet with parties potentially subject to the fees; and publish proposed rule -- mid-December 2016.

Inventory Rule

Description: Rule to require industry reporting of chemicals manufactured/processed in the previous ten years. Results will be used to designate active and inactive chemicals on the TSCA Inventory of existing chemicals.
 
Deadline: Final rule one year after enactment -- mid-June 2017.
 
Interim Milestones: Publish proposed rule mid-December 2016.

Science Advisory Committee on Chemicals (SACC)

Description: EPA must establish 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.
 
Deadline: Committee established one year after enactment.
 
Goal: Committee established six months after enactment -- mid-December 2016.
 
Interim Milestones: Federal Register notice published early September 2016; and public comment period ending early November 2016.

 

Early Mandatory Actions (To Be Completed During the First Year of Implementation)

 

Scope of Initial Risk Evaluations

Description: EPA must publish the scope of the evaluation of the first ten chemicals.
 
Deadline: Publish six months after initiation -- mid-June 2017.

Annual Plan for Risk Evaluations

Description: Plan must identify chemicals for which evaluations are expected to be initiated or completed that year and the resources needed, status of other chemicals under evaluation, and updated schedules as appropriate.
 
Deadline: The beginning of each calendar year after enactment -- first plan due early January 2017.

Additions to Mercury Export Ban

Description: Mercury compounds are now banned from export, in addition to elemental mercury which was previously banned under the Mercury Export Ban Act; and
 
Deadline: Publish initial list of mercury compounds prohibited from export within 90 days of enactment -- mid-September 2016.

Mercury Inventory

Description: EPA must publish an inventory of mercury supply, use, and trade in the U.S., and update it every three years.
 
Deadline: Publish first inventory April 1, 2017.

Small Business Definitions

Description: EPA must review the adequacy of standards for identifying small manufacturers and processors, and revise as warranted.
 
Deadline: Determine whether revision is warranted within 180 days of enactment.
 
Goal: Plan and schedule for revisions published with the determination.

Report to Congress

Description: EPA must report to Congress on its capacity, and the resources needed, to conduct risk evaluations and to issue rules to address unreasonable risks. EPA must also report on capacity to conduct industry-requested risk evaluations, the likely demand for such requests, and the anticipated schedule for accommodating the demand.
 
Deadline: First report must be submitted 180 days after enactment -- mid-December 2016 -- and every five years thereafter.

 

Later Mandatory Actions (To Be Completed Within the First Few Years of Implementation)

 

Mercury Use/Product Reporting Rule

Deadline: Final rule two years after enactment -- mid-June 2018.

CBI Review/Substantiation Rule

Deadline: Final rule one year after publication of TSCA Inventory reset of active chemicals (not later than 1.5 years after enactment).

Generic Names for CBI Chemicals

Deadline: Guidance two years after enactment -- mid-June 2018.

Negotiated Rulemaking on Byproducts Reporting for Chemical Data Reporting (CDR)

Deadline: Proposed rule (if produced by negotiating process) three years from enactment -- mid-June 2019.

Alternative Testing Methods Strategy

Deadline: Publish strategy two years after enactment -- mid-June 2018.

COMMENTARY

We are pleased that EPA is making strong early efforts to communicate and engage with stakeholders about its early implementation of the new TSCA and its thinking regarding specific provisions. Completing the items listed in the Implementation Plan represents a prodigious amount of work for EPA over the coming months and years. Stakeholders will need to be prepared to respond thoughtfully to rules, lists, and process descriptions as they appear in the Federal Register, or as they are posted.

We do have comments on a few of the items noted by EPA in its plan. One concerns the EPA statement regarding new chemicals which claims, "as a legal matter, [that] the new law effectively resets the 90-day review period." We presume this EPA statement applies only to new chemical cases which have not reached day 90 (this includes notices still within the initial period or those that that have been voluntarily suspended). While we do not have the benefit of seeing EPA's legal analysis, we disagree with EPA's legal view that, based on the text of the act, the review clock resets (effectively or otherwise) for such cases, presumably with day one being the date of enactment of the law. Companies whose notifications are caught up in this EPA decision need to think carefully about their options, and take any needed steps to protect their legal rights. If we can be of assistance, please contact Lynn L. Bergeson directly at (202) 557-3801 or lbergeson@lawbc.com.

We welcome the fact that EPA will work to get the SACC up and running within six months, especially when the statutory deadline is one year. We believe there will be numerous topics on which EPA will want to consult with the SACC. We agree that having this Committee available in December 2016, rather than June 2017, will help all stakeholders while ensuring that EPA has more timely access to the sound scientific thinking that the SACC should provide.

Our last comment is to note a disagreement with the way that EPA has characterized an item near the end of the list. This concerns the Negotiated Rulemaking on Byproducts Reporting for Chemical Data Reporting (CDR; emphasis added). While we agree that this rulemaking will affect CDR reporting, by our reading, the provision at play is broader than CDR. Section 8(a)(6)(A), the relevant subsection, states that the rule to be developed limits "the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts" (emphasis added). Thus, it needs to be understood as affecting all rules under Section 8(a).

ADDITIONAL RESOURCES

EPA will hold a webinar on Thursday, June 30, 2016, from 2:00 p.m. to 3:00 p.m. (EDT) to provide an overview of the Act. EPA states that this initial webinar will be informational only to help inform those unfamiliar with the new law. The login for the webinar will be available online; participants must sign in as guests. Audio will be available by calling 1-866-299-3188 and entering code 2025648098#.

As a service to those in the regulated community, Bergeson & Campbell, P.C. (B&C®) has collaborated with Chemical Watch in assembling an impressive faculty of TSCA experts to present a series of complimentary webinars titled "'The New TSCA' -- What You Need to Know." Webinar 1, "Overview and Summary of Major Changes: What to Expect and When to Expect It," was presented June 13, 2016. For a copy of the webinar recording, please contact hlewis@lawbc.com.

Webinar 2, "Impacts on New and Existing Chemicals Programs," will be held July 14, 2016. All chemical stakeholders doing business in the U.S., as well as foreign entities with business interests in the U.S. will need to understand the fundamental shifts in requirements, and the new concepts and approaches that are introduced by the law. Questions such as: "How is the new requirement that EPA must make affirmative determinations on all Section 5 new chemicals likely to play out and to what effect?"; "What are the potential impacts of the new Section 4 testing authority on EPA and industry?"; "How significant are the changes to Section 6 and the regulation of existing chemicals, and what can be expected over the coming years?"; and more will be discussed.

Speakers:

  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell P.C. (B&C®.)
     
  • Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund
     
  • Charles M. Auer, Charles Auer & Associates, LLC, former Director of the Office of Pollution Prevention and Toxics (OPPT), EPA
     
  • Oscar Hernandez, Ph.D., Senior Regulatory Chemist, B&C, former Director of the Risk Management Division in OPPT, EPA
     
  • Richard E. Engler, Senior Chemist, B&C, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program

Topics Covered:

  • Section 4 Chemical Testing
    • EPA's more flexible and strengthened legal authority for testing, and how it might be used to support:
      • Section 5 needs and purposes
      • Section 6 prioritization and Risk Evaluation (RE) processes
    • Effect of the animal welfare provision
  • Section 5 New Chemicals and Significant New Uses (NC/SNU)
    • Effect of changes to Section 5, including the requirements that EPA make an affirmative determination on all Section 5 notices
    • Explanation of the new Section 5 process to regulate NC/SNUs and associated legal/policy implications
  • Section 6 Prioritization, Risk Evaluation (RE), and Risk Management (RM) of Existing Chemicals
    • Details of the process, approaches, and legal requirements that must be met for each of:
      • Prioritization
      • RE
      • RM

Register Online

Future Webinars in "The New TSCA" Series:

Dates and registration links for these future webinars will be circulated in the coming weeks:

Webinar 3: Information and Reporting (Sections 8 and 14)
Webinar 4: Other Provisions -- PBTs, Preemption, Green/Sustainable Chemistry

TSCAblog™, launched on June 23, 2016, provides a convenient platform for our professionals to offer timely updates, expert insight, and clear analysis on TSCA implementation matters.


 
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