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.
By Lynn L. Bergeson and Margaret R. Graham
On September 20, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating that it is extending the compliance date by which submitters of Toxic Substances Control Act (TSCA) submissions containing information claimed as Confidential Business Information (CBI) and filed between June 22, 2016, and March 21, 2017, had to submit to EPA the substantiation required by TSCA Section 14(c)(3) for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA Section 14(c)(2). 82 Fed. Reg. 43964. The new deadline for substantiation of these claims is October 19, 2017. EPA states that this extension is in response to “concerns raised by industry stakeholders regarding the ability for companies to meet the previous September 19, 2017, deadline due to recent severe weather events,” and that it is “providing this additional flexibility for stakeholders because of the impacts of hurricanes Harvey and Irma.” Further, “because EPA published its interpretation that TSCA section 14(c)(3) requires up front substantiation after some companies had already asserted confidentiality claims subject to TSCA section 14(c)(3), the Agency set a future deadline for submission of substantiations pertaining to those submissions.”
More information on the CBI substantiation process is available in our memorandum The September 19th CBI Substantiation Deadline Fast Approaching.
Also on September 20, 2017, EPA announced it was scheduling three webinars to assist the regulated community with reporting under the TSCA Inventory Notification (Active-Inactive) rule. The webinars, scheduled for September 27, 2017, October 25, 2017, and November 29, 2017, from 1:00 p.m. - 3:00 p.m. (ET), will be identical and will include an overview of reporting requirements, a demo of the electronic reporting application (Central Data Exchange (CDX)), and will provide time for questions and answers. Registration for the webinars is not required. EPA’s TSCA Inventory webpage contains the information on how to access the webinar.
More information on the TSCA Inventory Notification (Active-Inactive) rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
By Lynn L. Bergeson and Carla N. Hutton
On September 6, 2017, at 10:00 a.m. (EDT), the House Science, Space, and Technology Subcommittees on Environment and on Oversight will hold a joint hearing on “Examining the Scientific and Operational Integrity of EPA’s IRIS Program.” The following witnesses are scheduled to testify:
- Dr. Kenneth Mundt, Principal, Ramboll Environ;
- Dr. James Bus, Senior Managing Scientist, Exponent; and
- Dr. Thomas Burke, former Deputy Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) and EPA’s Science Advisor under former President Obama; Johns Hopkins University.
President Trump’s proposed budget request for fiscal year 2018 would have eliminated EPA’s Integrated Risk Information System (IRIS) Program, although the IRIS Program is included in the final budget request. The EPA Science Advisory Board’s (SAB) August 29-30, 2017, meeting included an update from ORD’s National Center for Environmental Assessment on the IRIS Program. According to the presentation, IRIS is working to increase transparency and full implementation of systematic review; modernize the IRIS Program; modularize product lines; and enhance accessibility. Other IRIS improvements include implementing “next generation IRIS” and improved management practices. During the meeting, the SAB agreed to send a letter to EPA Administrator Scott Pruitt in support of the IRIS Program.
By Lynn L. Bergeson and Carla N. Hutton
As reported in our August 25, 2017, blog item, the U.S. Environmental Protection Agency (EPA) will hold a webinar on September 7, 2017, on its process for gathering use and exposure information on five persistent, bioaccumulative, and toxic (PBT) chemicals under the amended Toxic Substances Control Act (TSCA). EPA will provide background on new requirements for regulating certain PBT chemicals and explain how interested parties can provide use information to EPA on these five chemicals:
- 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.
- Your name;
- The organization you represent; and
- The PBT chemical on which you will speak.
EPA has established public dockets for each of the chemicals to facilitate receipt of information on exposure and use that may be useful to EPA’s rulemaking effort. EPA requests that any information be submitted to the dockets by December 9, 2017, so that the information can inform any regulatory action.