Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule.  As noted in our June 29, 2016, memorandum, “TSCA Reform:  EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended the Toxic Substances Control Act (TSCA).  EPA lists the following milestones that it has completed at the two-year anniversary:

In addition, registration is still available for Bergeson & Campbell, P.C.‘s (B&C®) June 25, 2018, complimentary webinar, “TSCA at 2: An Update on Implementation and Hot Topics.”  Speakers will include:

  • Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
  • Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
  • Michael Gould, EH&S Committee Chairman, RadTech North America; and
  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.

More information on these developments will be available in our forthcoming memorandum and posted to our Recent Regulatory Developments web page, as well as in our subsequent TSCA blog items.


 

By Lynn L. Bergeson and Margaret R. Graham

On June 1, 2018, the U.S. Environmental Protection Agency (EPA) released the much anticipated first ten problem formulation documents; its systematic review approach document; and a significant new use rule (SNUR) proposal enabling it to prevent new uses of asbestos for public comment.  Links and short summaries are provided below.

EPA states that the problem formulation documents refine the conditions of use, exposures, and hazards presented in the scope of the risk evaluations for the first ten chemicals to be evaluated under the Toxic Substances Control Act (TSCA) and present refined conceptual models and analysis plans that describe how EPA expects to evaluate the risks and that they are an important interim step prior to completing and publishing the final risk evaluations by December 2019.  Comments on the problem formulation documents will be due 45 days after these documents are published in the Federal Register.  The problem formulation documents are:

  1. Asbestos
  2. 1-Bromopropane (1-BP);
  3. Carbon Tetrachloride;
  4. 1,4-Dioxane;
  5. Cyclic Aliphatic Bromide Cluster (HBCD Cluster);
  6. Methylene Chloride;
  7. N-Methylpyrrolidone (NMP);
  8. Perchloroethylene;
  9. Pigment Violet 29; and
  10. Trichloroethylene (TCE).

EPA states the systematic review approach document will guide its selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information.  Comments will be due 45 days after publication in the Federal Register.  Also included on the systematic review web page is EPA’s Response to Public Comments Related to the Supplemental Files Supporting the TSCA Scope Documents for the First Ten Risk Evaluations.  

For asbestos, EPA is proposing an asbestos SNUR for certain uses of asbestos (including asbestos-containing goods) that would require manufacturers and importers to receive EPA approval before starting or resuming manufacturing, and importing or processing of asbestos.  EPA states that this review process, the first such action on asbestos ever proposed, would provide EPA with the opportunity to evaluate the intended use of asbestos and, when necessary, take action to prohibit or limit the use.  Comments will be due 60 days after publication in the Federal Register.

More information on the first ten chemical evaluations is available on our blog.  A more detailed analysis will be available next week on our regulatory developments webpage.


 

By Lynn L. Bergeson and Margaret R. Graham

On March 9, 2018, as a first step in developing a proposed rule regulating certain persistent, bioaccumulative, and toxic (PBT) chemicals, the U.S. Environmental Protection Agency (EPA) announced that it is seeking nominations for individuals who represent small businesses, small governments, and small non-for-profit organizations to serve as Small Entity Representatives (SER) to provide input on potential impacts of PBT regulation.  EPA states the role of a SER is “to provide advice and recommendations to ensure that the Panel carefully considers small entity concerns regarding the impact of the potential rule on their organizations and to communicate with other small entities within their sector who do not serve as SERs,” and will ask the SERs to provide comments on behalf of their company, community, or organization and advise a soon to be created Small Business Advocacy Review (SBAR) panel regarding potential impacts to small businesses that could result from the regulation of certain identified PBTs.  The SBAR panel will include federal representatives from EPA, the Small Business Administration, and the Office of Management and Budget (OMB).  After collecting input from the small entities, the panel will make recommendations to the Agency on the development of a proposed rule to regulate these PBT chemicals.

Under Section 6(h) of the Toxic Substances Control Act (TSCA), EPA is required, not later than three years after the date of enactment (June 22, 2019), to propose rules regarding the regulation of certain PBTs selected from the 2014 update of the TSCA Work Plan for Chemical Assessments that:  (1) EPA has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other have been identified; and (2) exposure to which under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator, or the environment, on the basis of an exposure and use assessment conducted by the Administrator.  The PBT chemicals that EPA has selected are:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics, wiring insulation, and building and construction materials;
  • Hexachlorobutadiene (HCBD), used as a solvent in the manufacture of rubber compounds and as hydraulic, heat transfer or transformer fluid;
  • Pentachlorothiophenol (PCTP), used as a mercaptan (sulfur) cross-linking agent to make rubber more pliable in industrial uses;
  • Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer products and as lubricant, hydraulic fluid, and other industrial uses; and
  •  2,4,6-Tris(tert-butyl) phenol, an antioxidant that can be used as a fuel, oil, gasoline or lubricant additive. 

The Regulatory Flexibility Act requires agencies to establish a SBAR panel for rules that may have a significant economic impact on a substantial number of small entities.  EPA states that the panel process will offer “an opportunity for small businesses, small governments and small not-for-profit organizations … to provide advice and recommendations to ensure that the EPA carefully considers small entity concerns regarding the impact of the potential rule on their organizations.” 

EPA states eligible SERs are small entities that manufacture, process, distribute in commerce, use, or dispose any of the five selected PBT chemicals.  EPA is seeking self-nominations directly from entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted through the instructions outlined on EPA’s Potential SBAR Panel website and must be received by March 22, 2018.  More information about the SBAR process is available online. 


 

By Kathleen M. Roberts, Richard E. Engler, Ph.D., and Lynn L. Bergeson

On December 11, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened its public meeting on possible approaches for identifying potential candidates for prioritization under the amended Toxic Substances Control Act (TSCA).  Key presenters were Jeffery Morris, Ph.D., Directory of OPPT, as well as several other OPPT staff, Health Canada (HC) and Environmental and Climate Change Canada (ECCC), and Russell S. Thomas with EPA’s Office of Research and Development (ORD).

The presentations from the meeting are listed below and available on EPA's website:

Nancy Beck, Ph.D. opened the workshop by welcoming attendees and provided some overview remarks.  Dr. Beck noted that the workshop could result in more than one approach being considered, or could result in no process being adopted.  Dr. Beck explained why EPA does not wish to prioritize chemicals with poor datasets.  Unless EPA has sufficient information to conclude there is no unreasonable risk, EPA must proceed with risk evaluations within the specified timelines with increased uncertainties.  This will result in a risk management process that has numerous default assumptions and uncertainty that will be difficult to defend.  Such risk management results will likely be subject to litigation, which will be costly in terms of time and resources to both EPA and the stakeholders. 

Dr. Morris stated that EPA hopes to implement a pre-prioritization approach by June 2018 to help ensure prioritization can begin in December 2018.

In its review of potential adjustments to the TSCA Work Plan for Chemical Assessments (TSCA Work Plan) approach, EPA staff clarified that there would be no changes to the current TSCA Work Plan chemical list last updated in 2014.  It was suggested that EPA could rely on the current TSCA Work Plan approach as an interim method for pre-prioritization as EPA works to refine other approaches.  EPA acknowledged that neither the current TSCA Work Plan approach nor the SCIL process included screens for certain criteria articulated in the amended TSCA legislation, including storage near significant sources of drinking water. 

Based on comments by presenters at the workshop and references in EPA documentation, it appears that chemical substances of unknown or variable composition, complex reaction products and biological materials (UVCB) will be difficult to screen in the pre-prioritization approaches reviewed.

In response to EPA’s comment that active substances will be the starting point for pre-prioritization screening, one non-governmental organization (NGO) group raised concerns with legacy issues that might be associated with inactive substances (e.g., substances contained in products or materials that have been in use for years).  NGO groups also commented that the hurdle for identifying a high priority chemical should be relatively low; whereas the hurdle for identifying a low priority chemical should be very high and could potentially include a required minimum data set.

All stakeholders expressed appreciation to EPA for the presentations and the various approaches reviewed.  During the public comments, there did not appear to be specific support for any one approach. 

We note that none of the approaches included specifics as to how EPA would assess whether the chemical being reviewed had sufficient data available to initiate prioritization and potential risk evaluation.  Given EPA’s clear objective to avoid having data-poor chemicals being prioritized, this issue needs to be clearly and definitively addressed in EPA’s practices.  Nor was there consideration as to how other governmental regulatory assessments could be incorporated into a pre-prioritization approach.

EPA will be accepting comments on the approach to prioritizing chemicals until January 25, 2018, in Docket ID EPA-HQ-OPPT-2017-0586.  More information on the December 6, 2017, public meeting on EPA’s new chemicals review program is available in our blog under key phrase public meeting.  


 

By Lynn L. Bergeson and Margaret R. Graham

On November 14, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 11, 2017, Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations under the Toxic Substances Control Act (TSCA) meeting.  EPA states that during this meeting, it will describe goals, guiding principles, and possible approaches for identifying potential candidate chemicals for prioritization; and take comment on possible approaches.  Under amended TSCA, EPA is required to establish processes for prioritizing and evaluating risks from existing chemicals.  The meeting materials include:

  • Agenda for Public Meeting.  The Agenda includes the following topics:  identifying potential candidates for prioritization:  background, goal, guiding principles, and milestones; overview of TSCA Work Plan methodology; TSCA Work Plan as a tool for identifying potential candidates; Canada’s Chemicals Management Plan; EPA’s Safer Chemicals Ingredients List; Functional Category Approach, based on use and exposure potential; Functional Category Approach, based on chemical structure and function; and systematic integration of traditional and new approaches.  Featured speakers are Nancy Beck, Ph.D., Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OSCPP) and Jeff Morris, Ph.D., Director of the Office of Pollution Prevention and Toxics (OPPT). 
  • Discussion Document -- Possible Approaches and Tools for Identifying Potential Candidate Chemicals for Prioritization.  EPA states that the discussion document introduces a set of approaches that it is considering to help guide the identification of potential candidates for prioritization, and is intended to be a starting point for a dialogue with stakeholders on best practices for EPA’s activities during this phase.  EPA is asking for input on the approaches presented here, as well as any additional recommendations.

The December 11, 2017, meeting will take place from 9:00 a.m. to 5:00 p.m. (EST) at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants.  Online requests to participate must be received on or before December 5, 2017.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0586 on www.regulations.gov with a copy to .(JavaScript must be enabled to view this email address)Registration for this meeting is available online.  In addition to hearing oral comments at the meeting, EPA is also accepting written comments and materials submitted to the docket for this meeting until January 25, 2018.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 9, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 6, 2017, New Chemicals Review Program Implementation meeting.  NOTE WELL: This is a critically important meeting for companies that innovate in the chemical space and are now preparing Toxic Substance Control Act (TSCA) Premanufacture Notifications (PMN) or will in the future.  EPA states that this meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework.  The meeting materials include:

  • Agenda for Public Meeting.  The Agenda includes the following topics: the decision-making framework; TSCA orders and Significant New Use Rules (SNUR) in the context of new chemicals review; the Points to Consider document as well as the pilot results and other questions; the decision guidelines manual; chemical categories; sustainable futures; a discussion of questions submitted in advance; and two public comment periods.  Featured speakers are Nancy Beck, Ph.D., Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OSCPP) and Jeff Morris, Ph.D., Director of the Office of Pollution Prevention and Toxics (OPPT).
  • New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.  EPA states that this document includes EPA’s general decision framework for new chemicals and a breakdown of how EPA intends to approach each of the five types of new-chemical determinations required.
  • Points to Consider When Preparing TSCA New Chemical Notifications (Draft).  This draft document, dated November 6, 2017, provides concise information to assist submitters in preparing a PMN, Significant New Use Notice (SNUN), or exemption notice (e.g., Low Volume Exemption or LVE) that (1) meets the requirements of TSCA Section 5 and applicable regulations; and (2) facilitates EPA’s review of Section 5 notices by ensuring that the information received accurately and completely reflects the intended manufacture, processing, distribution in commerce, use, and disposal of the new chemical substances subject to the Section 5 notice.  EPA states this is a draft published for comment, but does not specify a deadline for submitting comments.
  • Overview of Comments Received on the Draft "Points to Consider" Document.  This document summarizes 151 comments received on the draft Points to Consider document.  It organizes them by topic.  The topics addressed are aquatic haz/tox; chemistry; data; engineering; environmental release and disposal information; fate; a general category; human health haz/tox; regulatory; release to water; standard review; uses; risk; exposure; and prenotice meetings.  These comments have not been posted in the docket for this meeting.
  • New Chemicals Decision Guidelines Manual – Detailed Outline.  EPA states that this manual will summarize how EPA reviews new chemical submissions and the policies and decision guidelines used in making decisions under TSCA Section 5.  It will provide an overview of both risk assessment and risk management approaches. Further, it is intended to help stakeholders determine what forms of regulation and restrictions on the manufacture, distribution, use, and/or disposal of a new chemical substance may arise from an EPA determination.

The December 6, 2017, meeting will take place from 9:00 a.m. to 5:00 p.m. (EST) at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants.  Online requests to participate must be received on or before December 5, 2017.  EPA states it plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0585 on www.regulations.gov with a copy to .(JavaScript must be enabled to view this email address)Registration for this meeting is available online.  In addition to hearing oral comments at the meeting, EPA is also accepting written comments and materials submitted to the docket for this meeting until January 20, 2018.

More information on the subsequent Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations meeting on December 11, 2017, is available in our blog item EPA Schedules Two Meetings to Discuss TSCA Implementation Activities, Requests Comments.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register in which it will announce two meetings to discuss implementation activities under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, as well as request public comments.  The meetings are:

  • New Chemicals Review Program Implementation Meeting:  December 6, 2017, from 9:00 a.m. to 5:00 p.m. (EST).  EPA’s first meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework.  EPA will describe its review process for new chemical substances under the amended statute and interested parties will have the opportunity to provide input and to ask questions.  EPA states it plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0585 on www.regulations.govRegistration for this meeting is available online.
  • Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations Meeting:  December 11, 2017, from 9:00 a.m. to 5:00 p.m. (EST).  EPA’s second meeting will focus on possible approaches for identifying potential candidate chemical substances for EPA’s prioritization process under TSCA.  As amended, TSCA required that EPA establish processes for prioritizing and evaluating risks from existing chemical substances.  EPA will describe and take comment on a number of possible approaches that could guide it in the identification of potential candidate chemical substances.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0586 on www.regulations.govRegistration for this meeting is available online.

Online requests to participate in either meeting must be received on or before December 5, 2017.  Both meetings will be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants. EPA states that more information on the specifics of the meetings will be made available in the dockets and on EPA’s website prior to the meeting.


 

By Lynn L. Bergeson and Margaret R. Graham

On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval.  Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator.”  While the “framework rules” have been the subject of considerable focus since last June, this guidance is as important, subject to the one year deadline, and likely to provide significant insights into EPA’s thinking on risk evaluations.  EPA must publish the final rule in the Federal Register by June 22, 2017.

More information on the final rule on Procedures for Evaluating Existing Chemical Risks under TSCA is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On June 1, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Evaluating Existing Chemical Risks under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.  

EPA’s proposed rule describes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use; and identifies the steps of a risk evaluation process including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination.  This process would be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. Comments were due March 20, 2017; 87 comments were filed.  Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017

More information on the rule as proposed is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

In January, the U.S. Environmental Protection Agency (EPA) issued its initial report to Congress on its capacity to implement certain provisions of the amended Toxic Substances Control Act (TSCA).  The report, prepared by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for the Committees on Energy and Commerce, and appropriations of the U.S. House of Representatives, and the Committees on Environment and Public Works, and Appropriations of the U.S. Senate, was directed to be provided within six months of enactment under Section 26(m)(1) of amended TSCA.  In the report, EPA states that it anticipates “ramping up from 10 risk evaluations in FY2017 to 15 in FY2018, reaching 20 by the end of FY2019,” which is necessary “to accomplish an ongoing pace of at least 20 EPA-initiated risk evaluations underway” by the end of calendar year (CY) 2019.  EPA also provides a table on page five, Table 1: TSCA Risk Evaluations, Numbers Underway and Resources Estimates, which presents estimates for its annual costs, calculated by dividing the average lifecycle costs of the actions by the number of years the statute provides for the agency to complete those actions, and then multiplying the result by the numbers of actions required/anticipated to be underway each year.  The total annual costs range from $12.3 million for FY2017 to $35.8 million for FY2021.  The report refers to the rule to implement the fee collection provisions, stating it is “currently under development,” but does not provide any more details on when it will be issued.

On January 30, 2017, President Trump issued a Memorandum for the Heads of Executive Departments and Agencies in the Federal Register which directs federal agencies to “support the expansion of manufacturing in the United States through expedited reviews of and approvals for proposals to construct or expand manufacturing facilities and through reductions in regulatory burdens affecting domestic manufacturing.”  82 Fed. Reg. 8667.  The memo will require the Secretary of the Department of Commerce (DOC) to conduct outreach to stakeholders concerning the impact of federal regulations on domestic manufacturing and to solicit comments for 60 days concerning “Federal actions to streamline permitting and reduce regulatory burdens for domestic manufacturers.”  DOC is also instructed to coordinate this process with the Secretaries of EPA, the U.S. Department of Agriculture (USDA), the U.S. Department of Energy (DOE), and the Administrator of the Small Business Administration (SBA), among others, and within 60 days after the process is completed, to submit a report setting forth a plan to streamline federal permitting processes for domestic manufacturing and “to reduce regulatory burdens affecting domestic manufacturers,” identifying “priority actions as well as recommended deadlines for completing actions.”

Also on January 30, 2017, President Trump issued an Executive Order on reducing regulation and controlling regulatory costs casually referred to as the “one in, two out” order which states that when executive departments and agencies “publicly propos[e] for notice and comment or otherwise promulgat[e] a new regulation, [they] shall identify at least two existing regulations to be repealed.”  The order also states that no incremental costs can be accrued for any new regulations unless required by law or advised in writing by the Director of the Office of Management and Budget (OMB).  For any costs that are accrued, it is directed for them to be “offset by the elimination of existing costs associated with at least two prior regulations.”  In the order, the OMB Director is tasked with providing guidance on implementation, as well as identifying the total amount of costs allowed for each agency “in issuing new regulations and repealing regulations for the next fiscal year.”  The regulations exempt from this order are: regulations issued with respect to a military, national security, or foreign affairs function; regulations related to agency organization, management, or personnel; and other categories exempted by the OMB Director. 


 
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