By Lynn L. Bergeson and Margaret R. Graham
On January 18, 2018, the U.S. Environmental Protection Agency (EPA) posted additional documents on its website, specifically materials from two webinars, designed to assist manufacturers reporting for the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule that became effective on August 11, 2017. The rule, which established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, requires manufacturers to report to EPA by February 7, 2018, for the retrospective reporting period that began on August 11, 2017 (180 days after the final rule was published in the Federal Register). The webinar slides and transcripts posted have three general sections: (1) an overview of the new reporting requirements; (2) a demonstration of the electronic reporting application in CDX; and (3) a question and answer session, where technical questions related to the reporting requirements and the electronic reporting application were addressed. These materials are:
An additional helpful development for manufacturers is the recent launch of the American Chemistry Council’s (ACC) TSCA Inventory Reset CDX Receipt Database. The database allows manufacturers, importers, and processers under TSCA to upload and share Central Data Exchange (CDX) receipts. Further, it is being reported that EPA will also be providing and updating a list of frequently asked questions prior to the February 7 deadline.
Following this retrospective reporting for manufacturers, EPA will include the active designations, determined by the notices received, on a draft of the Inventory. EPA will publish the draft Inventory with the active designations “as soon as is practicable” following the close of the 180-day submission period. The draft Inventory will not have the legal effect of actually designating any chemical substance as inactive, however, and EPA does not construe it as the list with “designations of active substances and inactive substances” from which forward-looking reporting commences. EPA states that it concludes that new TSCA is referring to the completed product of the initial cycle of sorting between active and inactive substances, not the preliminary product of the initial cycle of such sorting.
More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and on our TSCA Reform News & Information webpage.
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 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 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 January 3, 2018, the U.S. Environmental Protection Agency announced it would be hosting two webinars to support Third-Party Certifiers (TPC) in generating and entering annual report information into the Central Data Exchange (CDX). Registration is available online through the following links: the webinars will be held on January 9, 2018, from 1:00 p.m. to 3:00 p.m. (EST); and on February 1, 2018, from 9:00 a.m. to 11:00 a.m. (EST). Both webinar presentations will provide an overview of the TPC annual report requirements and a live demonstration of the reporting process through CDX.
As required under the Toxic Substances Control Act (TSCA) Title VI final rule that implemented the Formaldehyde Standards for Composite Wood Products Act, EPA-recognized TPCs must submit an annual report to EPA through CDX on or before March 1, 2018. The required information includes the name and location of the mill(s), the types of products certified for them, and quarterly test data on each product. Providing certification services for multiple mills and submitting that information to the CDX database may take a considerable amount of time, therefore, EPA strongly suggests for TPCs to start entering the required information and existing testing data for each panel producer as soon as possible to ensure that they meet the deadline. Basic information on each panel producer, such as name(s), product type(s), and testing information that is available now can be entered into CDX immediately.
EPA also stated the importance of retaining the password; the password created for the annual report will be required later to amend, finalize, and submit the report to the EPA. If this password is lost, it cannot be recovered, and a new annual report submission would need to be created.
More information is available on EPA’s website.
By Christopher R. Bryant and Lynn L. Bergeson
On December 27, 2017, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) ordered the U.S. Environmental Protection Agency (EPA) to revise its nearly 17-year-old standard for levels of lead in paint and dust within one year. A Cmty. Voice v. EPA, No. 16-72816. The Ninth Circuit held that “EPA was under a duty stemming from the Toxic Substances Control Act and the Residential Lead-Based Paint Hazard Reduction Act of 1992 to update lead-based paint and dust-lead hazard standards in light of the obvious need, and a duty under the Administrative Procedure Act to fully respond to petitioners’ rulemaking petition.” The decision stems from a petition filed in June 2016 by environmental and health groups seeking this action. The order came in the form of a writ of mandamus, an unusual court order and extraordinary judicial remedy that requires an official or agency to perform a certain duty, in this case for EPA to issue a proposed rule within 90 days of this decision and to promulgate the final rule within a year of when the proposed rule is issued. The court stated that in doing so, it was mindful of the Agency’s arguments that officials needed more time to deliberate a complex new standard.
While not entirely surprising given the Circuit, the decision relies on a seldom used remedy that rarely succeeds in judicial settings. It reflects the court’s sharp rebuff of the Administration’s apparent decision to delay action on the lead standard. Given the many challenges EPA’s Office of Pollution Prevention and Toxics will face in the New Year, complying with the court’s order will not be easy.
By Lynn L. Bergeson and Margaret R. Graham
On December 22, 2017, the U.S. Environmental Protection Agency (EPA) sent to the Office of Management and Budget (OMB) a proposed rule establishing fees on certain submissions under amended Toxic Substances Control Act (TSCA) Sections 4, 5, and 6. EPA has indicated that it expects to propose the rule in the early part of the New Year: EPA’s regulatory agenda lists February 2018 for the proposed rule and September 2018 for the final rule.
More information on the TSCA fees rulemaking and requirements is available in our blog item “EPA Hosts August 11, 2016, Public Meeting on Proposed Rule for Revised TSCA Fees,” in our memorandum “TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA,” and in our September 20, 2016, webinar “‘The New TSCA’ Webinar 4: Administration of the Act, Preemption, Fees, and Green Chemistry.”
By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham
On December 21, 2017, the U.S. District Court for the Northern District of California ruled that the U.S. Environmental Protection Agency (EPA) had wrongly dismissed a Toxic Substances Control Act (TSCA) Section 21 petition submitted by Food & Water Watch, Inc. and other citizens seeking the regulation of fluoridation of drinking water supplies under TSCA Section 6(a) on grounds that the ingestion of fluoride poses an unreasonable risk to humans. Food & Water Watch, Inc. v. EPA, Case No. 17-cy-02162-EMC (N.D. Cal.) (Food & Water Watch). In 2017, EPA denied the Section 21 petition on the grounds that it failed to address conditions of use other than the fluoridation of drinking water. 82 Fed. Reg. 11878 (Feb. 27, 2017).
In a fairly scathing rebuke of EPA’s legal positions, the court denied EPA’s motion to dismiss the petitioner’s judicial challenge of EPA’s administrative denial of the Section 21 petition and, in so doing, essentially rejected EPA’s interpretation that a citizen petition must evaluate all conditions of use of a chemical substance in a TSCA Section 6(b) risk evaluation. While we are hesitant to note that “we told you so” in our March 7, 2017, blog item, the analysis noted there was spot on.
At issue in Food & Water Watch is EPA’s legal position that TSCA Section 6 requires that EPA consider all conditions of use in proceedings under that provision. The court rejected this view noting that the “argument has no basis in the statutory text,” and there “is no good reason to believe that the term’s [conditions of use] appearance … [in Section 21] … obligates all citizen petitioners to address all conditions of use.” The court also noted that EPA’s interpretation creates “a disparity between citizen petitions and manufacturer requests” for a Section 6(b) risk evaluation. Under the rules, a manufacturer’s request may be limited only to those particular conditions of use of interest to the manufacturer, citing 40 C.F.R. Section 702.37(b)(4). The court also noted EPA’s change of view on this issue between the proposed and final risk evaluation rule. EPA initially proposed that risk evaluations must consider all conditions of use, but concluded in the final rule that EPA may focus its review on fewer than all conditions of use.
The court’s analysis is clear and well written, and goes into some detail on EPA’s legal reasoning and the problems it identified with it.
This ruling raises interesting issues when viewed in the broader context of pending judicial challenges to EPA’s TSCA framework rules. In those challenges, citizen advocates challenge EPA’s view, as articulated in the final framework rules, that the Agency retains discretion to assess those conditions of use it believes are most relevant for a particular chemical evaluation. In other words, they challenge EPA’s view that fewer than all conditions of use must be considered in a risk evaluation, the very position the court in Food & Water Watch rejected for purposes of Section 21 petitions challenging EPA’s interpretation of a citizen’s legal burden under TSCA Section 6(a). Given that the judicial challenge to the risk evaluation final rule is being heard in the U.S. Court of Appeals for the Ninth Circuit, this district court decision is particularly relevant.
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.