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.
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 Charles M. Auer and Richard E. Engler, Ph.D.
The U.S. Environmental Protection Agency (EPA) has updated its eNOA upload template that was initially released in 2017 to assist filers with the Central Data Exchange (CDX) system. The eNOA, or electronic Notice of Activity (NOA) Form, is used for retrospective reporting under the amended Toxic Substances Control Act’s (TSCA) Inventory notification requirements. The eNOA template, available for download from within the eNOA system on CDX, assists users to upload many substance identities in a batch. The template file is a comma separated value (CSV) file, CSV-NAA.csv, that is readable by most spreadsheet and database programs. The change means that if submitters attempt to use the old template, the CSV file will not upload properly and will generate errors in CDX.
The template was updated by adding a new field name. The new field name that will be added to the CSV file is “Isjoint,” and the field explanation is “NOA is joint with another submitter;” which permits filers to upload and start multiple joint submissions in a batch. The field names required, along with their field explanations, are:
- Isjoint: NOA is joint with another submitter.
- CASRN: CASRN with our without dashes; after upload, dashes will be present. Must be “TRUE” or “FALSE”;
- Accession Number: Accession number for substances listed on the confidential portion of the Inventory;
- Chemical Cbi: Submitter seeking to maintain CBI claim for substance identity. Must be “TRUE” or “FALSE”;
- Submitter Cbi: Submitter claiming CBI for submitter identity. Must be “TRUE” or “FALSE”;
- Company Details Cbi: Submitter claiming CBI for submitting company details. Must be “TRUE” or “FALSE”;
- Technical [Contact] Cbi: Submitter claiming CBI for technical contact identity. NB: “Contanct” is misspelled in the template. Must be “TRUE” or “FALSE”;
- Substantiation CBI: Submitter claiming CBI for substantiation statement(s). Must be “TRUE” or “FALSE”; and
- ShowCbiQuestions: Set to TRUE to substantiate CBI claims. This is required for submitter, company, and technical contact claims. Must be “TRUE” or “FALSE.”
By Lynn L. Bergeson
Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, "Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018," is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018. This 38-page document is chock-full of insights, predictions, and useful information.
Happy New Year and enjoy reading our predictions!
By Lynn L. Bergeson and Margaret R. Graham
On December 19, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice extending the comment period for the proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory for 16 days, from December 26, 2017, to January 11, 2018. The notice states that “EPA received requests to extend the comment period and believes it is appropriate to do so … to give stakeholders additional time to assess the impacts of the proposal, review technical documents in the docket, and prepare comments. The 2016 amendments TSCA require EPA to establish periodic mercury reporting requirements for any person that manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process to assist in the development of an inventory of mercury and other recommended actions. EPA’s proposed rule, issued on October 26, 2017 (82 Fed. Reg. 49564), specifically requires reporting on the manufacture, import, distribution in commerce, storage, and export of mercury.
More information on this proposed rule is available in our memorandum December 26, 2017, Deadline Approaching for Comments on EPA’s Proposed Reporting Requirements for TSCA Mercury Inventory.
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 November 27, 2017, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation (Safer Chemicals, Healthy Families v. EPA, Case Nos. 17-72260, 17-72501, and 17-72968 (consolidated)), the Ninth Circuit issued an order on several pending motions. It granted the American Chemistry Council’s (ACC) (and other industry groups) motion to intervene on behalf of respondent U.S. Environmental Protection Agency (EPA); denied the respondents’ motions to transfer Case Nos. 17-72260 and 17-72501 to the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit); denied respondents’ requests to hold Case Nos. 17-72260 and 17-72501 in abeyance; granted the motions to consolidate Case Nos. 17-72260, 17-72501, and 17-72968; and set an amended briefing schedule. The consolidated opening brief is now due January 23, 2018; the consolidated answering brief and the intervenors’ brief are due February 22, 2018; and the optional reply brief is due within 21 days after service of the answering and intervenors’ briefs.
In the Fourth Circuit case on the petition for review of the TSCA framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the petitioners’ motions to transfer to the Ninth Circuit are still pending; on November 21, 2017, the Fourth Circuit deferred the ruling until the Ninth Circuit ruled on its own pending motions to transfer. As the Ninth Circuit has now denied the motions to transfer (per above), the Fourth Circuit will soon make a decision about whether this case should also be heard by the Ninth Circuit. A new briefing schedule has not been set.
In the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) case on the petition for review of the TSCA framework rule TSCA Inventory Notification (Active-Inactive) Requirements (EDF v. EPA, Case No. 17-1201), there are no current delays due to transfers or consolidations. Respondent EPA filed a motion to extend time to file its brief on November 7, 2017; petitioner Environmental Defense Fund (EDF) filed its statement of intent regarding appendix deferral on November 8, 2017, and filed its initial submissions including the statement of issues on November 8-9, 2017; and respondent EPA filed the certified index to the record on November 27, 2017. ACC and other industry groups were granted leave to intervene on behalf of respondent EPA on November 13, 2017. The briefing schedule has not been set.
More information on these petitions for review is available on our blog under key phrases framework rules and petition for review.
By Lynn L. Bergeson and Margaret R. Graham
On December 9, 2016, the U.S. Environmental Protection Agency (EPA) opened five dockets to collect information on five persistent, bioaccumulative, and toxic (PBT) chemicals. EPA requested information on uses, products containing these chemicals, exposed populations, and alternatives to these chemicals. These five chemicals were selected on October 11, 2016, to receive expedited action under Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals. The deadline to submit comments is fast approaching: December 9, 2017. The five chemicals and their corresponding dockets are:
- Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics and polyurethane foam -- Docket ID No. EPA-HQ-OPPT-2016-0724;
- Hexachlorobutadiene (HCBD), used in the manufacture of rubber compounds and lubricants and as a solvent -- Docket ID No. EPA-HQ-OPPT-2016-0738;
- Pentachlorothio-phenol (PCTP), used as an agent to make rubber more pliable in industrial uses -- Docket ID No. EPA-HQ-OPPT-2016-0739;
- Tris (4-isopropylphenyl) phosphate, used as a flame retardant in consumer products and other industrial uses -- Docket ID No. EPA-HQ-OPPT-2016-0730; and
- 2,4,6-Tris(tert-butyl)phenol, used as a fuel, oil, gasoline or lubricant additive -- Docket ID No. EPA-HQ-OPPT-2016-0734.
In August 2017, EPA provided background information for each of the five PBT chemicals in the form of use documents which provide a preliminary summary of available information collected by EPA on the manufacturing (including importing), processing, distribution in commerce, use, and disposal of each chemical. Amended TSCA gives EPA three years to propose rules to reduce risks and exposures from these PBT chemicals to the extent practicable (until June 22, 2019), and EPA must issue the rules in final within 18 months of when they are proposed.
More information on the PBTs is available on our blog under keyword PBTs.
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.