Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
On September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance. EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document. EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents. The final rule will be effective 30 days after publication in the Federal Register. More information will be available in a forthcoming memorandum that will be posted on our website.
As reported in our March 23, 2020, memorandum, on March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA). Environmental Defense Fund v. Wheeler, No. 1:20-cv-762. On July 27, 2020, the parties submitted a joint case management statement. According to the statement, the parties agree that the case can be resolved by motions for summary judgment and that there is no need for a trial. The parties state that they disagree about whether administrative records exist and the availability and scope of discovery, however. Resolving these questions will implicate the timing for any discovery, the appropriate deadline for final amended pleadings, and the appropriate schedule for summary judgment briefing. The parties note that they are currently discussing options to resolve as many of these questions as possible and that they believe successfully resolving them could reduce the number and complexity of procedural issues before the court. In particular, according to the statement, the parties are discussing options to narrow the scope of factual and legal issues presented, which may minimize the potential for future disputes over the availability and scope of discovery. The parties propose to submit an updated case management statement no later than August 31, 2020.
This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.
This week I sat down with Congressman John M. Shimkus, a Member of the United States House of Representatives for the 15th District of Illinois. As listeners of the podcast know well, Congressman Shimkus is a senior Member of the House Energy and Commerce Committee. In this capacity, Congressman Shimkus has become a rock star in the industrial chemical community, given his tireless efforts to modernize the Toxic Substances Control Act (TSCA) , which of course resulted in passage four years ago of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).
Given Congressman Shimkus’s extensive involvement in and personal commitment to reforming TSCA, our conversation focused on the efforts that have been under way since June 2016 to implement the massive and complicated new law. We address many aspects of Lautenberg’s implementation, not just by the U.S. Environmental Protection Agency (EPA), but also efforts under way by other industrial chemical stakeholders, including industry, non-government organizations (NGOs), states, and the courts. We discuss the many, many rulemakings EPA has issued since 2016 and survey the next leg of EPA’s journey to implement the new law over the next 12 to 24 months, which will be extremely busy. Congressman Shimkus is as passionate today as he was four years ago about chemical safety, as you will hear in this recording.
ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.
On March 2, 2020, at ChemCon The Americas 2020 in Philadelphia, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention, sat down with Tjeerd Bokhout to discuss the implementation of Lautenberg and what can be expected through 2020. Ms. Dunn started off the discussion, noting that EPA is “getting our sea legs under us; we spent the first two or three years after enactment, really through 2019, setting up the bones of the program, the regulations, the structure, the fees rule, and now we’ve begun the deep process of looking at each chemical [for risk evaluation].” The conversation continued with discussion regarding how chemicals are selected for evaluation, surprises EPA encountered while making low-priority determinations, and what can be expected through the remainder of 2020. Ms. Dunn and Ms. Bergeson agreed that as more chemicals go through this review process, the quantity and type of information needed will standardize, leading to more predictability for all stakeholders. Now that a system is evolving, EPA plans to identify data gaps early to provide time to strategize how to acquire as much information as is required to evaluate properly a chemical on schedule and with minimal additional costs.
A full video of this informative interview, drawing back the curtain on both EPA and industry’s experience with the implementation of TSCA and details on what to prepare for in the near future, is available to stream now.
Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.
On June 20, 2019, Senators Tom Udall (D-NM), Cory Booker (D-NJ), Ed Markey (D-MA), Jeff Merkley (D-OR), and Sheldon Whitehouse (D-RI) sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler requesting information on EPA’s implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The letter notes that the Lautenberg Act was intended to enact reforms addressing “longstanding structural problems” with the Toxic Substances Control Act (TSCA). According to the letter, EPA’s implementation of the Lautenberg Act “has deviated dramatically from Congress’ intent and the new law’s requirements.” The Senators’ letter requests EPA’s responses to a number of questions regarding the following areas of concern:
Section 4: EPA’s failure to use its enhanced information authorities under TSCA. Under the Lautenberg Act, EPA can now acquire information where needed to review new chemicals or to prioritize or review the risks of a chemical already on the market. The law also makes clear that EPA can require the development of real-world exposure information. According to the Senators, in the nearly three years since enactment of the Lautenberg Act, “EPA has not once used these new authorities, and seems to be avoiding using them at all costs -- even where there are critical information gaps.”
Section 5, Part 1: EPA’s failure to protect workers when reviewing new chemicals under TSCA. The Lautenberg Act strengthened EPA’s authority to regulate chemicals that may present risks to workers “by explicitly naming workers as a ‘potentially exposed or susceptible subpopulation’ and requiring that EPA consider and address potential risks to workers when assessing new or existing chemicals.” According to the Senators, EPA is failing to use TSCA’s health standard, which is more stringent than the Occupational Safety and Health Administration’s (OSHA) workplace standards, to determine whether any of the new chemicals “may present an unreasonable risk” to workers. Where EPA finds a new chemical does or may present serious risks to workers, it is allowing that chemical onto the market without imposing any conditions to protect the workers. EPA’s “only justification for this is that it simply ‘expects’ that workers will protect themselves from harmful workplace exposures by wearing personal protective equipment (PPE) that the company is not required to provide or train workers to use properly.” This deference to OSHA regulations “allow[s] workers to be exposed to chemical risks that are a thousand or more times higher than are acceptable under TSCA.
Section 5, Part 2: EPA’s failure to adequately identify and review “reasonably foreseen” conditions of use when reviewing new chemicals under TSCA. When reviewing a new chemical, the Lautenberg Act directs EPA to examine the chemical under its “conditions of use” -- “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” According to the Senators, “EPA has attempted to skirt this requirement for an integrated assessment of both intended and reasonably foreseen conditions of use in several ways that are contrary” to TSCA’s requirements:
For most new chemicals that EPA has reviewed in recent months, it simply asserts there are no such reasonably foreseen uses;
For those new chemicals where EPA identifies a reasonably foreseen use, it merely states, without providing any analysis, that it expects that use to present no greater risk than the intended use. By doing this, EPA not only fails to demonstrate that the reasonably foreseen use is not likely to present an unreasonable risk, it also fails to consider that the combination of use could present such a risk; and
For the remaining new chemicals where EPA does identify a reasonably foreseen use and identifies some potential concern with that use, EPA has separately promulgated a significant new use rule (SNUR) that requires a company to notify EPA prior to engaging in that reasonably foreseen use. In these SNURs, EPA has not made clear that it would assess the potential exposure and risks from that use in combination with the already approved intended uses as part of its review of any such notice, however.
The Senators note that none of these recent policy changes to EPA’s examination of new chemicals’ conditions of use has been made public or subject to a public comment opportunity.
Section 6: EPA’s failure to assess even known conditions of use and pathways of exposure in conducting risk evaluations of existing chemicals under TSCA. The Lautenberg Act requires EPA to evaluate potential risks arising from activities across the entire lifecycle of a chemical, considering all “known” and “reasonably foreseen” circumstances, not just those “intended” by a company making or using a chemical. The letter states that EPA “has sought in numerous ways to limit the scope of its risk evaluations and risk determinations.” In its final Risk Evaluation Rule, EPA “asserted sweeping authority to pick and choose what activities and what exposures it includes in its risk evaluation of a chemical.” According to EPA, it can ignore any exposure to a chemical that also falls under the authority of another agency, such as OSHA, regardless of whether that agency has actually taken any action to mitigate the risks of the chemical. EPA also stated that it will exclude “legacy” activities associated with a chemical. EPA has begun to conduct risk evaluations that exclude most or all pathways of exposure to a chemical that falls under the jurisdiction of another statute administered by EPA.
Section 14: EPA’s failure to provide timely public access to non-confidential information and access by eligible parties to confidential business information under TSCA. The Lautenberg Act amended Section 14, enhancing requirements for companies’ assertion and substantiation, and EPA’s review of confidential business information (CBI) claims; for providing public access to chemical information; and for providing expanded access to CBI. Although these provisions were immediately effective, nearly three years after enactment, “there is little evidence that EPA is effectively implementing these provisions or requiring compliance with them.”
The letter is well written if not quite one-sided. Complicated issues require thoughtful analysis, and this letter demands a clear and compelling response from industry advocates that may well respectfully disagree with the Senators’ position on many of the points made in the letter. We suspect this letter may well be a point of discussion at Monday’s TSCA at Three conference.
On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments: Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act. The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA). GAO reviewed documents from the National Academy of Sciences (NAS) and EPA and interviewed EPA officials and representatives from two environmental and two industry stakeholder organizations. GAO found that while EPA made improvements in the IRIS Program, between June and December 2018, EPA leadership directed the Program to stop the assessment process during discussions about program priorities. GAO states that while EPA has responded to initial statutory deadlines in TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), challenges remain. Read the full memorandum for more information on the report including why GAO did the study, GAO’s findings, and an insightful commentary.
On July 24, 2018, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment periods for all ten problem formulation documents and the systematic review approach document in Toxic Substances Control Act (TSCA) risk evaluations that were published on June 11, 2018, by 21 days; comments on these documents are now due by August 16, 2018. EPA states that although the comment period will end in 21 days (August 16, 2018), “EPA will try to consider any additional comments received after this date. However, incorporation of late comments may not be included in the documents for peer review. There will be an additional comment period following the publication of each of the draft risk evaluations.”
On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended the Toxic Substances Control Act (TSCA). EPA lists the following milestones that it has completed at the two-year anniversary:
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:
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.
Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, product defense, and associated business issues.