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 Susan M. Kirsch
On May 22-23, 2018, the U.S. Environmental Protection Agency (EPA) hosted a Polyfluoroalkyl Substances (PFAS) National Leadership Summit (Summit) in Washington, D.C. The Summit convened federal and state regulators, including representatives from EPA’s Office of Water (OW), EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), the U.S. Food and Drug Administration (FDA), the U.S. Department of Defense (DOD), a small group of invited industry participants, and representative from the environmental non-governmental organization (NGO) community. The goals of the Summit were:
- To share information on efforts to characterize risks from PFAS and to develop monitoring and remediation technologies/techniques;
- To identify near-term actions to address current state and local challenges; and
- To develop risk communication strategies to address public concerns and questions surrounding PFAS.
EPA broadcast the opening remarks and perspectives delivered by EPA Administrator Pruitt; Peter Grevatt, Director of the Office of Ground Water and Drinking Water; Jeff Morris, Director of the Office of Pollution Prevention and Toxics (OPPT); Craig Butler, Direct of the Ohio Environmental Protection Agency and Chair of the Environmental Council of the States (ECOS) Water Committee; and Jessica Bowman, Senior Director of Global Fluoro-Chemistry, at the American Chemistry Council. During his remarks, Pruitt announced that EPA will soon classify two fluorochemicals, perfluorooctanoic acid (PFOA) and perfluoroctane sulfonate (PFOS), as hazardous substances, and that EPA will begin to development maximum contaminant levels (MCL) for PFOA and PFOS under the Safe Drinking Water Act. PFOA and PFOS are largely legacy chemicals that were the subject of voluntary phase out by chemical manufacturers. The presence of PFOA and PFOS at former manufacturing sites and detections in groundwater and drinking water have raised public health concerns and made headlines over the last several months, particularly in Northeast states.
Butler’s remarks highlighted the key questions that ECOS and state participants hoped to have addressed by EPA over the course of the Summit, including any plans for MCL development, guidance on contaminated site remediation and PFAS analytical methods, and EPA’s plan to address data and knowledge gaps about PFOA and PFOS, as well as the alternative short-chain PFAS chemistry that makes up the majority of current and new uses of PFAS. States are eager for direction and assistance from EPA on standard-setting and, in the absence of federal standards, some states have begun to set their own standards. A copy of the ECOS statement is available here.
Grevatt shared plans for further co-regulator discussions and community engagement as part of an EPA “roadshow” beginning in late June in Portsmouth, New Hampshire. Morris provided an overview of the rigors of the pre-market review process under the Toxic Substances Control Act (TSCA) and OPPT’s ongoing work to better understand the diverse range of PFAS in the marketplace.
EPA intended for the Summit to serve as a formal launch of an ongoing dialogue with states, the public, and industry on PFAS, and more details will likely be shared in the coming weeks and months. A recording of the May 22, 2018, broadcast is available on EPA’s YouTube channel. Copies of the slide presentations from the Summit are available on EPA’s PFAS Summit website.
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 Charles M. Auer and Richard E. Engler, Ph.D.
The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization. The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions. OPPT’s other functions are proposed to be distributed into a mission operations division and a division that sweeps together chemical right-to-know, economics, information reporting, and the Safer Choice/Design for the Environment (DfE) program. In an internal memo, OPPT Director Jeffery Morris, Ph.D., noting the thoughtful and insightful staff comments received on the earlier proposed reorganization, provides a two-week internal commenting period for the new proposal ending on May 9, 2018.
How to organize OPPT has been a perpetual conundrum with shifting “best approaches” over time. From our perspective, merging the existing chemicals function of the Chemical Control Division (CCD) with those of the National Program Chemicals Division (NPCD) into an Existing Chemicals Management Division makes sense. The existing NPCD branches that cover legacy chemical issues (e.g., lead, polychlorinated biphenyls (PCB), mercury, and asbestos) will presumably become risk management branches tasked with overseeing risk management activities for those chemicals under the amended Toxic Substances Control Act (TSCA or new TSCA). The other “first ten” risk evaluation chemicals that are currently being managed by the existing chemicals staff in CCD will become other risk management branches in the new structure. Creating a separate New Chemicals Management Division also makes sense in light of the challenges encountered by the office in its early implementation of Section 5 under new TSCA. Such a division will ensure a tight management focus on new chemicals issues without the need to also juggle complex existing chemicals issues. While this could present concerns regarding divergent decisions and policies between the two divisions, this seems to be less of an issue since the requirements in Sections 5 and 6 differ so much.
More information and commentary on this reorganization is available in our memorandum.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available. For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following:
- Reporting from the 2012 and 2016 Chemical Data Reporting cycles;
- Notices of Commencement received by EPA since June 21, 2006; and
- Notice of Activity Form A’s received by EPA through the February 7, 2018, deadline, per the TSCA Inventory Notification (Active-Inactive) Rule.
EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices received under the Active-Inactive Rule. EPA also posted a list of substances reported in a Notice of Activity Form A from February 8 through March 30, 2018. According to EPA, this list should assist processors in determining which of their substances on the Inventory have not yet been designated as “active” to date. Based on our review, the Inventory lists approximately 38,303 total active substances, or about 44.5 percent. The deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.
If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking. Our TSCA experts would be pleased to assist you with the reporting process!
More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under the key phrase TSCA Inventory and on our TSCA Reform News & Information web page. More information on EPA’s Final TSCA Inventory Notification (Active-Inactive) Rule is available in our memorandum, “EPA Issues Final TSCA Framework Rules.” Specific information on changes in the CDX system is available in our blog item, “EPA Updates eNOA Template in CDX System.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) have released an educational primer on U.S. and Canadian regulations regarding chemical substances. EPA states that the purpose of the primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations -- Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada. EPA, ECCC, and HC previously collaborated in the implementation of a Regulatory Cooperation Council (RCC) Work Plan on Chemicals Management that focused on SNURs and SNAcs. The primer states that an overarching issue identified during the roundtable discussions was the need for improved outreach and education, ranging from the basics of the SNUR/SNAc programs to specific requirements for various stakeholders, especially for potentially less-informed stakeholder groups, such as foreign suppliers, and small, niche companies in the U.S. and Canada. According to EPA, information in the primer will assist the regulated community to determine how to comply and engage their supply chains to help facilitate compliance for meeting SNUR and SNAc requirements. The primer notes that it does not substitute for any SNUR or SNAc provisions, nor is it a rule itself. The primer does not impose legally binding requirements on the regulated community or on EPA, ECCC, or HC.
By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham
On March 28, 2018, the Superior Court of California, Los Angeles County, issued its Statement of Decision (Phase II) (Defendants’ Alternative Significant Risk Level (ASRL) Affirmative Defense) that found that the defendants failed to meet their burden of proof on their ASRL affirmative defense. Council for Education and Research on Toxics (CERT) v. Starbucks Corporation (Starbucks), No. BC435759 (L.A. Super. Ct., filed April 13, 2010). CERT’s (plaintiff) complaint alleged that Starbucks, along with 18 other defendants (the total later reached 91 defendants when a second action was filed (now consolidated)), that sell ready-to-drink coffee failed to provide warnings to consumers that the coffee sold contained high levels of acrylamide, a carcinogenic chemical, in violation of Proposition 65 (Prop 65). The defendants denied the material allegations and asserted various affirmative defenses, violation of the First Amendment, and federal preemption. According to the order, the parties did not dispute that acrylamide, listed as a carcinogen by the International Agency for Research on Cancer (IARC), and under Prop 65 since 1990, is listed by the State of California as a chemical believed to cause cancer; or that they failed to provide warnings to consumers that the ready to drink coffee they sold contained high levels of acrylamide.
In Phase I of the trial, the court came to a similar conclusion, that defendants failed to meet their burden of proof by preponderance of evidence on their affirmative defenses of “no significant risk level,” First Amendment, and federal preemption to avoid the requirement of cancer warning labels as to the existence of acrylamide in brewed coffee. The trial on Phase II of the case ran from September 2017 to November 2017 and post-trial briefs were filed in December 2017 and January 2018. The order states that to have prevailed on their ASRL defense, defendants needed prove all of the below, which they failed to do:
- Establish that acrylamide is created by cooking or processing necessary to render the coffee safe or palatable (defendants only argued that acrylamide levels in coffee cannot be reduced at all without negatively affecting safety and palatability);
- Demonstrate that “sound considerations of public health” justify applying an alternative (less strict) risk level (defendants did not counter plaintiffs evidence that consumption of coffee increases harm to the fetus, infants, children, and adults; and the court found their proffered evidence that coffee itself confers some benefit to human health to be unpersuasive); and
- Present persuasive evidence of what would be an appropriate alternative risk level, taking into account the identified public health considerations (defendants did not conduct a quantitative risk assessment of the risk of cancer from exposure to acrylamide in coffee, necessary to prove an alternative risk level for acrylamide in coffee).
The ASRL affirmative defense is grounded on an exemption to the cancer hazard warning requirement under Prop 65, but as the defendants were not able to prevail on this defense, they will now be required to provide the Prop 65 warning language on their ready-to-drink coffee products, but the order does not specify any details regarding this. The decision also exposes the defendants to liability in terms of millions in fines. The defendants have until April 10, 2018, to file objections to the decision.
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 and Margaret R. Graham
On February 16, 2018, the U.S. District Court for the Northern District of California issued an order granting plaintiffs’, the Sierra Club and A Community Voice-Louisiana, motion for summary judgment. The court determined that the U.S. Environmental Protection Agency’s (EPA) final rule delaying the compliance date for the formaldehyde emission standards for composite wood products (Delay Rule) exceeded EPA’s authority under the Formaldehyde Standards in Composite Wood Products Act (Formaldehyde Act) codified as Title VI of the Toxic Substances Control Act (TSCA), vacated the Delay Rule, and set aside the year-long extension to December 12, 2018, of the compliance deadlines set out by EPA in the Delay Rule. Sierra Club v. Pruitt, Case No. 4:17-cv-06293. The Delay Rule, issued on September 25, 2017 (82 Fed. Reg. 44533), sought to extend further the compliance dates set out in its December 12, 2016, final rule that implemented the Formaldehyde Act (Formaldehyde Rule) (81 Fed. Reg. 89674), specifically: the December 12, 2017, manufactured-by date for emission standards, recordkeeping, and labeling provisions until December 12, 2018; the December 12, 2018, compliance date for import certification provisions until March 22, 2019; and the December 12, 2023, compliance date for provisions applicable to producers of laminated products until March 22, 2024.
As stated in the order, the Formaldehyde Act set out emission standards for domestically manufactured and imported composite wood products and directed EPA, by no later than July 1, 2013, to promulgate implementing regulations that would ensure compliance with the new emission standards; based on the Delay Rule’s further extension of deadlines, which sets both the manufacturing and emission standards compliance dates to December 12, 2018, EPA would have delayed the implementation for more than three years after the Formaldehyde Act had originally directed EPA to require compliance.
The order also denies defendant EPA’s cross-motion for summary judgment in which EPA states three arguments against plaintiffs’ motion: (1) plaintiffs’ challenge is waived, as plaintiffs did not comment on the proposed extension by raising the sole issue plaintiffs raise in their motion; (2) the statute upon which plaintiffs base their claim expressly provides for EPA to set the manufactured-by date more than 180 days from promulgation of the implementing regulations; and (3) EPA’s extension of the manufactured-by date was reasonable, supported by the record, and not arbitrary or capricious.
In its analysis, the court offered the following to support its holdings:
- The designation of a manufacturing date “no earlier than 180 days following promulgation of the regulations” found in the sell-through provision of the Formaldehyde Act must fall on the 180th day after the regulations take effect. EPA’s interpretation to set the manufacture date beyond 180 days from promulgation of the regulations effectively resets the compliance date in violation of the Formaldehyde Act’s mandatory expedient compliance deadline and the prohibition against stockpiling.
- EPA’s interpretation that it can designate the manufacture date beyond the 180 days limit for compliance with the emission standards is contrary to law and beyond the grant of authority bestowed upon it by Congress in the Formaldehyde Act.
- EPA’s interpretation creates inconsistency within the full text of the Formaldehyde Act, renders the 180-day compliance deadline superfluous, leads to the “absurd” result of permitting the perpetual delay of the effectiveness of the Formaldehyde Rule, and fails to satisfy the stated purpose of the Formaldehyde Act.
The court concluded that the issue of whether EPA should extend the deadline for compliance with the emission standards of the Formaldehyde Rule was adequately before it for consideration. The court stayed the order vacating the Delay Rule until the parties address the implementation of the compliance guidelines and the court directs them to provide, by March 9, 2018, a joint proposed submission or simultaneous briefing to address the timing for lifting the stay and expeditious implementation of the court’s order.
The ruling is one of several expected that will inform stakeholders on the scope of EPA’s authority under the Administrative Procedure Act (APA) and the underlying Act at issue, here the Formaldehyde Act, in undoing Obama-era regulations and the extent of Agency discretion in deciding whether and to what extent such rules can be unilaterally delayed or eliminated entirely. The Trump Administration has in unprecedented ways sought to roll back rules under a host of laws, environmental and otherwise, in ways that detractors claim are illegal and contrary to the APA and other laws. Here, the court emphasized the Formaldehyde Act’s “expeditious” emission compliance standards and reasoned that the repeated delays were simply inconsistent with Congress’ intent.
More information on the Formaldehyde Act under TSCA is available on our blog.
By Lynn L. Bergeson and Margaret R. Graham
On January 31, 2018, the U.S. Environmental Protection Agency (EPA) announced the release of its 2018 Annual Report on Risk Evaluations. Pursuant to Section 26(n)(2) of the amended Toxic Substances Control Act (TSCA), EPA is directed to publish an annual plan at the beginning of each calendar year identifying the chemical substances that will undergo risk evaluations during that year. The plan is to include both risk evaluations that will be initiated and that will be completed, the resources necessary for completion, and the status and schedule for ongoing evaluations. The 2018 annual plan identifies the next steps for the first ten chemical reviews currently underway and describes EPA’s work in 2018 to prepare for future risk evaluations.
EPA issued scoping documents on the first ten chemical reviews in June 2017. The plan states that in early calendar year 2018, EPA will be making refinements to these scope documents in the form of “problem formulation documents” that will include additional elements such as conceptual models. EPA will publish a notice in the Federal Register announcing the release of these problem formulation documents and will invite comments for 45 days.
The plan also states that EPA will initiate prioritization for 40 chemicals (at least 20 Low-Priority and 20 High-Priority candidates) by the end of calendar year 2018. By December 22, 2019, EPA plans to have designated 20 substances as Low-Priority and initiated risk evaluations on 20 High-Priority substances. Further, EPA will be proposing the much-anticipated TSCA Fees Rule in early-mid fiscal year (FY) 2018, and anticipates issuing a final rule in late FY2018.
Information on EPA’s 2017 Annual Report is available in our blog item EPA Publishes 2017 Annual Report on Chemical Risk Evaluations.