By Lynn L. Bergeson and Carla N. Hutton
On August 31, 2018, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) for review a final rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). As reported in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal,” as amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” Under the amendments to TSCA, EPA has authority to require payment from manufacturers and processors who:
- Are required to submit information by test rule, test order, or enforceable consent agreement (ECA) (TSCA Section 4);
- Submit notification of or information related to intent to manufacture a new chemical or significant new use of a chemical (TSCA Section 5); or
- Manufacture or process a chemical substance that is subject to a risk evaluation, including a risk evaluation conducted at the request of a manufacturer (TSCA Section 6(b)).
EPA’s February 26, 2018, proposed rule described the proposed TSCA fees and fee categories for fiscal years (FY) 2019, 2020, and 2021, and explained the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent FYs. In proposing the new TSCA user fees, EPA also proposed amending long-standing user fee regulations governing the review of Section 5 premanufacture notices (PMN), exemption applications and notices, and significant new use notices (SNUN). Under the proposed rule, after implementation of final TSCA user fees regulations, certain manufacturers and processors would be required to pay a prescribed fee for each Section 5 notice or exemption application, Section 4 testing action, or Section 6 risk evaluation for EPA to recover certain costs associated with carrying out certain work under TSCA. EPA did not propose specific fees for submission of confidential business information (CBI).
By Lynn L. Bergeson
On August 7, 2018, EPA is expected to announce the extension of the comment period on the problem formulations for the risk evaluations for the first 10 chemicals under Toxic Substances Control Act (TSCA) Section 6. The notice extends the comment period on the problem formulations and the document titled Application of Systematic Review of TSCA Risk Evaluations, an additional 21 days, until August 16, 2018. Reportedly EPA received several requests to extend the deadline.
By Lynn L. Bergeson and Margaret R. Graham
On May 25, 2018, the U.S. Environmental Protection Agency (EPA) announced it would host a half-day preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five Persistent, Bioaccumulative, and Toxic (PBT) chemicals. Section 6(h) of the Toxic Substances Control Act (TSCA) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances that were identified in EPA’s TSCA Work Plan for Chemical Assessments: 2014 update. The selected chemicals are:
- Decabromodiphenyl ethers (DECA);
- Hexachlorobutadiene (HCBD);
- Pentachlorothiophenol (PCTP);
- Phenol, isopropylated, phosphate (3:1) (PIP3/ITPP); and
- 2,4,6-Tris(tert-butyl) phenol (2, 4, 6 TRIS).
EPA prepared an Exposure and Use Assessment and a Human Health and Environmental Hazard Summary in response to the requirements under TSCA Section 6(h) to summarize conclusions of toxicity and whether there is likely exposure to these PBT chemicals and EPA organized letter peer reviews for the Exposure and Use Assessment and the Human Health and Environmental Hazard Summary. The Federal Register notice announcing the meeting states that during the preparatory meeting, “the individual letter peer reviewers will have the opportunity to comment on and ask questions regarding the scope and clarity of the draft charge questions.” EPA’s background papers, related supporting materials, and charge/questions for these letter peer reviews are now available in Docket No. EPA-HQ-OPPT-2018-0314 on www.regulations.gov.
The meeting is scheduled for June 25, 2018, from 1:00 p.m. to 5:00 p.m. (EDT) and will be held via teleconference and webcast only. Registration is available online. Those requesting to provide oral comments (approximately five minutes) are asked to register by June 21, 2018. Though the peer reviewers may not be able to consider fully written comments submitted after July 23, 2018, EPA will consider all comments submitted on or before August 17, 2018.
More information, including the list of experts, is available on EPA’s TSCA Peer Review website.
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-Bromopropane (1-BP);
- Carbon Tetrachloride;
- Cyclic Aliphatic Bromide Cluster (HBCD Cluster);
- Methylene Chloride;
- N-Methylpyrrolidone (NMP);
- Pigment Violet 29; and
- 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 May 7, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) final rule entitled Mercury; Reporting Requirements for the TSCA Mercury Inventory.
The OIRA 2018 Spring Regulatory Agenda for this rulemaking, item RIN 2070-AK22, states that EPA’s rulemaking to implement new Toxic Substances Control Act (TSCA) Section 8(b)(10)(D) will promulgate reporting requirements “for applicable persons to provide information to assist in the preparation of an ‘inventory of mercury supply, use, and trade in the United States,’ where ‘mercury’ is defined as ‘elemental mercury’ and ‘a mercury compound.’ The requirements would be applicable to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process.”
More information on the proposed rule issued in October 2017 is available in our blog item “EPA Issues Proposed Rule on Reporting Requirements for Mercury Inventory Under New TSCA.”
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 Lynn L. Bergeson, Susan M. Kirsch, and Margaret R. Graham
On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt. In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” Toxic Substances Control Act (TSCA), as being of “significant importance” and a “top priority for ensuring the safety of chemicals in the marketplace.” In opening remarks, Senator Tom Carper (Ranking Member of the EPW Committee) (D-DE)) challenged Pruitt’s record on implementing TSCA reform, stating that EPA has not truly used the authority bestowed on it through TSCA to declare that products being sold on the market are safe, therefore, consumers do not have the confidence that they deserve and that Congress intended in passing TSCA. Pruitt did not respond to this comment, and did not go on to address TSCA implementation in his brief opening remarks. Instead, Pruitt devoted the bulk of his opening statement to highlighting specific areas where EPA’s environmental protection goals dovetail well with opportunities for economic growth. These issues/economic opportunities included: investment in infrastructure to eradicate lead from drinking water within a decade; advancing initiatives that incentivize private companies to take on clean-up projects at abandoned mines; and remediation activities at “Superfund” sites -- hazardous waste sites regulated under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).
Senator Jeff Merkley (D-OR) expressed concern that EPA’s chemical reviews under TSCA were only focusing on new “items” (chemicals) being made, but overlooking “legacy” chemicals already in the environment (e.g., asbestos). Merkley cited a report that claimed that review of the ten chemicals on the priority list were being “slow-walked.” In response, Pruitt stated “it is an absolute priority during [EPA’s] first year,” the three TSCA final rules were issued consistent with the implementation schedule in the first year, and the backlog of chemical reviews has been addressed through the addition of resources.
Senator Kirsten Gillibrand (D-NY) expressed her concerns regarding the toxic levels of perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) that have been found throughout New York State, stating that EPA was not using its TSCA authority to regulate these chemicals, as the implementation final rules “ignored the public’s exposure to the past uses of chemicals called legacy uses” that could still have the potential to contaminate groundwater. She also stated her concern that due to this oversight, EPA will not likely study the health risks of widespread exposure to chemicals such as PFOS/PFOS. She requested of Pruitt to revise the TSCA implementation rules to address legacy issues, so that “all uses of a chemical, including legacy uses, are studied.” Pruitt stated that as PFOA and PFOS have not been manufactured since early 2000, they are in fact legacy uses, and that EPA was “very much going to focus” on this issue. Gillibrand appeared to be content with his answer, as she did not demand a further commitment from him. In regards to the Hudson River, Gillibrand requested that data from the sediment sampling be integrated into EPA’s five year review plan regarding the effectiveness of dredging for removing polychlorinated biphenyl (PCB) from the Hudson River. Pruitt stated that EPA was reviewing the samples currently and that there is more work to be done to get clarity on this issue. Gillibrand requested Pruitt to personally review the final report to ensure that all issues have been addressed and Pruitt confirmed that he would.
Near the close of the hearing, Senator Carper further stated that EPA has failed to follow through on its proposed ban of three highly toxic chemicals that Congress gave it the authority to ban when it enacted TSCA reform: specifically methylene chloride, tricholoroethylene (TCE), and methylpyrrolidone (NMP), and asked Pruitt to commit to using EPA’s authority to ban them within the next 30 days. Pruitt responded that they are on the priority list and that he will confirm this with the agency (that they are priorities, not that they will be banned in 30 days). EPA’s delay in finalizing the bans was among the failures cited in the Senate EPW Minority Staff report, released January 29, 2018, “Basically Backward: How the Trump Administration is Erasing Decades of Air, Water and Land Protections and Jeopardizing Public Health.”
Several Senators indicated their intention to submit additional questions for the record. Pruitt has until February 13, 2018, to submit written responses, which will be made available on the EPW Committee website. The full hearing is available on the EPW Committee’s website.
By Lynn L. Bergeson and Margaret R. Graham
On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a Petition for Review in the U.S. Court of Appeals for the Second Circuit (Second Circuit) of what is characterized as a U.S. Environmental Protection Agency (EPA) “final rule” issued November 7, 2017, entitled “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” The Framework Document, as it has come to be called, is the “final rule” at issue and was posted in EPA’s docket opened for comments related to its two Toxic Substances Control Act (TSCA) public meetings that took place in December. It is reasonable to assume that the Framework Document is not referred to by EPA as a final rule and was not published in the Federal Register as a final rule because EPA believes it is a document that outlines a conceptual approach to how EPA may go about making decisions on new chemicals. EPA specifically states the document, referred to as a “draft” in the Federal Register notice that announced the two public meetings, “outlines EPA’s approach to making decisions on new chemical notices submitted to EPA under TSCA section 5, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act,” and 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 under the statute.”
The citizen action petition raises novel and interesting legal questions, and is quite different from the other petitions for review, one for each framework final rule, that are pending. Whether the newest legal challenge will survive procedural motions that EPA can be expected to file to dismiss the action remains to be seen. More information on the framework rule petitions for review is available on our blog under key phrases framework rules and petition for review.
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:
- Identifying Potential Candidates for Prioritization: Background, Goal, Guiding Principles, and Milestones -- Dr. Morris, Director, OPPT
- Overview of TSCA Work Plan Methodology -- Maria Doa, Director, Chemical Control Division, OPPT
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: The TSCA Work Plan as a Tool for Identifying Potential Candidates -- Dan Chang, OPPT
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: Approaches to Prioritization and to Streamlined Assessments -- Canada’s Chemical Management Plan – HC and ECCC
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: EPA’s Safer Chemical Ingredients List (SCIL) -- Clive Davies and Lauren Sweet, OPPT
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: Functional Category Approach Based on Use and Exposure Potential -- Joel Wolf and Ana Corado, OPPT
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: Integration of Traditional and New Approach Methods -- Russell S. Thomas, ORD
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 December 6, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the public comment period to receive information on the five persistent, bioaccumulative, and toxic (PBT) chemicals that are subject to Section 6(h) of the Toxic Substances Control Act (TSCA) which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals. Comments were initially due on December 9, 2017; they are now due on January 12, 2018. EPA states it is interested in information from the public about these chemicals, including uses, products containing these chemicals, exposed populations, and alternatives to these chemicals. Very few comments have been filed regarding these chemicals thus far. The chemicals and corresponding docket numbers are:
- Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics and polyurethane foam -- Docket ID Number EPA-HQ-OPPT-2016-0724;
- Hexachlorobutadiene (HCBD), used in the manufacture of rubber compounds and lubricants and as a solvent -- Docket ID Number EPA-HQ-OPPT-2016-0738;
- Pentachlorothiophenol (PCTP), used as an agent to make rubber more pliable in industrial uses -- Docket ID Number EPA-HQ-OPPT-2016-0739;
- Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer products and other industrial uses, Docket ID Number EPA-HQ-OPPT-2016-0730; and
- 2,4,6-Tris(tert-butyl) phenol, used as a fuel, oil, gasoline or lubricant additive -- Docket ID number EPA-HQ-OPPT-2016-0734.
More information on the PBTs is available on our blog under keyword PBTs.