By Lynn L. Bergeson and Margaret R. Graham
On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was releasing the approach it will use to identify chemicals that could be included in the next group of risk evaluations under the Toxic Substances Control Act (TSCA) titled “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization” (Working Approach). EPA states that the information set forth in this document is “intended to describe the general approaches EPA may consider to identify existing chemicals as potential candidates for prioritization,” and the ultimate goal of these approaches “is to identify potential candidates from which EPA will select candidates for prioritization, consistent with its regulations at 40 C.F.R. § 702.5.”
EPA also released the pre-publication version of the Federal Register notice of availability of the Working Approach and “A Summary of Public Comments By Topic” (Summary). The pre-publication notice states that EPA will be opening a public docket to accept comments on the Working Approach until November 15, 2018. These comments will inform a public meeting to be held in early 2019. Upon publication of the Federal Register notice, EPA will open 74 chemical-specific public dockets, one for each of the 73 remaining chemicals on the 2014 Update to the TSCA Work Plan for Chemical Assessments that have not received manufacturer requests for EPA evaluation and an additional general docket for chemicals not on the Work Plan. These dockets will be open until December 1, 2019. A link to the list of these dockets is available here.
More information on TSCA implementation is available on our website under key phrase Lautenberg Implementation.
By Lynn L. Bergeson and Margaret R. Graham
On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued the user fees final rule for the administration of the Toxic Substances Control Act (TSCA), the fourth and remaining framework rule to be issued in final under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).
This final rule, that amends 40 C.F.R. Parts 700, 720, 723, 725, 790, and 791, “describes the final TSCA fees and fee categories for fiscal years 2019, 2020, and 2021”; “explains the methodology by which the final TSCA fees were determined”; “identifies some factors and considerations for determining fees for subsequent fiscal years”; and “includes amendments to existing fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.” The final rule has not been published yet in the Federal Register so an effective date is not yet available; a pre-publication version is available here.
Specifically, EPA is establishing fees applicable to any person required to submit information to EPA under TSCA Section 4; or a notice, including an exemption or other information, to be reviewed by EPA under TSCA Section 5; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b). EPA is also establishing standards for determining which persons qualify as "small business concerns" and thus would be subject to lower fee payments.
In the press release announcing the rule, EPA Acting Administrator Andrew Wheeler states that this rule will “provide resources needed to support the valuable work EPA does to review chemicals for safety, manage risk as required, and make chemical information available as appropriate.” During fiscal years 2019-2021, EPA states it will “work to track costs and will use that information to adjust future fees, if appropriate.”
EPA also announced that it will be hosting a series of webinars focusing on making TSCA submissions and paying fees under the final rule. The webinars are scheduled for October 10, 2018, from 1:00 p.m. - 2:30 p.m. (EST); October 24, 2018, from 1:00 p.m. - 2:30 p.m. (EST); and November 7, 2018, from 1:00 p.m. - 2:30 p.m. (EST).
More information on TSCA implementation is available on our website under key phrase Lautenberg Implementation. A detailed Bergeson & Campbell, P.C. (B&C®) memorandum on the TSCA user fees final rule is forthcoming.
By Lynn L. Bergeson and Margaret R. Graham
On September 13, 2018, EPA announced it was requesting public nominations of scientific experts to be considered for ad hoc participation and possible membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). 83 Fed. Reg. 46487. The notice states that all nominees will be considered for ad hoc participation in the TSCA SACC’s peer reviews of the EPA’s risk evaluations for the first ten chemical substances addressed under TSCA. Further, all nominees may be considered for TSCA SACC membership to fulfill short term needs when a vacancy occurs on the chartered Committee. As part of a broader process for developing a pool of candidates, EPA staff solicits from the public and stakeholder communities nominations of prospective candidates for service as ad hoc reviewers and possibly members of TSCA SACC.
EPA states in the notice that any interested person or organization may nominate qualified individuals to be considered as prospective candidates, including themselves. It is requested for individuals nominated to have expertise in one or more of the following areas: women's health; children’s health; genetic variability; disproportionately exposed populations; aging; other susceptible populations; biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic (PBPK) modeling; pharmacology; ecological risk assessment; environmental fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; biostatistics; computational toxicology; fiber science; inhalation toxicology; volatile organics; and systematic review. Nominations are due by October 29, 2018.
By Lynn L. Bergeson and Carla N. Hutton
On August 31, 2018, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) for review a final rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). As reported in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal,” as amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” Under the amendments to TSCA, EPA has authority to require payment from manufacturers and processors who:
- Are required to submit information by test rule, test order, or enforceable consent agreement (ECA) (TSCA Section 4);
- Submit notification of or information related to intent to manufacture a new chemical or significant new use of a chemical (TSCA Section 5); or
- Manufacture or process a chemical substance that is subject to a risk evaluation, including a risk evaluation conducted at the request of a manufacturer (TSCA Section 6(b)).
EPA’s February 26, 2018, proposed rule described the proposed TSCA fees and fee categories for fiscal years (FY) 2019, 2020, and 2021, and explained the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent FYs. In proposing the new TSCA user fees, EPA also proposed amending long-standing user fee regulations governing the review of Section 5 premanufacture notices (PMN), exemption applications and notices, and significant new use notices (SNUN). Under the proposed rule, after implementation of final TSCA user fees regulations, certain manufacturers and processors would be required to pay a prescribed fee for each Section 5 notice or exemption application, Section 4 testing action, or Section 6 risk evaluation for EPA to recover certain costs associated with carrying out certain work under TSCA. EPA did not propose specific fees for submission of confidential business information (CBI).
By Lynn L. Bergeson and Carla N. Hutton
On August 29, 2018, the Democrats on the House Committee on Energy and Commerce issued a press release announcing that they have renewed their request for a hearing on the U.S. Environmental Protection Agency’s (EPA) implementation of the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act to the Toxic Substances Control Act (TSCA). The Democrats note this is the fourth request they have made for hearings to be held on EPA’s management of toxic chemicals. According to the press release, the Democrats “remain concerned that EPA’s implementation of the reformed TSCA program contradicts the new law’s language and intent and undermines public confidence in the program.” The press release states that the Democrats “are concerned that EPA is ignoring its own scientific evidence and the recommendations of its experienced career staff regarding TSCA implementation at the expense of public health. They point to a recent report from the New York Times that found EPA officials proposed a rulemaking to review applications for use of asbestos in consumer products over the objections of EPA attorneys and scientists.” The Democrats “also charge that EPA has abandoned its statutory mandate to review all new and existing chemicals known or foreseeable uses and exposure putting human health and the environment at risk,” possibly resulting in an incomplete evaluation of the health and environmental risk of a number of “extremely toxic chemicals, including asbestos, perchloroethylene (PERC), methylene chloride, and trichloroethylene (TCE).” The letter was signed by Ranking Member Frank Pallone, Jr. (D-NJ), Environment Subcommittee Ranking Member Paul Tonko (D-NY), Raul Ruiz (D-CA), Scott Peters (D-CA), Gene Green (D-TX), Diana DeGette (D-CO), Jerry McNerney (D-CA), Tony Cardenas (D-CA), Debbie Dingell (D-MI), and Doris Matsui (D-CA).
By Lynn L. Bergeson and Carla N. Hutton
On August 27, 2018, the Natural Resources Defense Council (NRDC) filed a motion in the U.S. Court of Appeals for the Second Circuit asking to dismiss voluntarily its petition for review of the U.S. Environmental Protection Agency’s (EPA) “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” NRDC v. EPA, No. 18-25. NRDC petitioned the court on January 5, 2018, for review of EPA’s November 2017 Framework Document. In its petition for review, NRDC described the Framework Document as a final rule, and argued in its May 1, 2018, opening brief that, based on the Framework Document, EPA “limits its review of a new chemical substance to the manufacturer’s intended conditions of use and disregards Congress’s instruction to address risk concerns through enforceable orders and regulations.” On July 31, 2018, EPA filed its opening brief, which included a declaration from Dr. Jeffery Morris, Director of EPA’s Office of Pollution Prevention and Toxics (OPPT). According to Morris, EPA considers the “conditions of use” of the premanufacture notice (PMN) when making determinations under TSCA Section 5(a)(3). Morris notes that under TSCA Section 3(4), the term “conditions of use” means “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.” Since EPA issued the Framework Document for comment, it has made 150 determinations on PMNs under TSCA Section 5(a)(3), but “has not yet followed the SNUR approach described in the Framework.” For 19 PMNs, EPA determined that the new chemical substance was not likely to present an unreasonable risk. According to EPA, “[f]or none of these determinations did EPA consider whether a significant new use rule had been issued in concluding that unreasonable risk was unlikely.” Additionally, for 131 determinations, EPA made a determination under TSCA Section 5(a)(3)(B) related to the sufficiency of information regarding the substance, and then issued orders under TSCA Section 5(e). The basis for a significant number of these determinations was related to the reasonably foreseen conditions of use of the new chemical substance at issue. Notwithstanding EPA’s pronouncement in the Framework Document that it anticipated using significant new use rules in similar cases, “none of these determinations followed that approach.” NRDC states that, in light of these representations, it “has elected to move for voluntary dismissal of this petition for review.”
By Lynn L. Bergeson and Carla N. Hutton
On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA). The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 43527. The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs. 83 Fed. Reg. 43538. In each rule, EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The direct final rules require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification will initiate EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. Both direct final rules will be effective on October 26, 2018. Written adverse comments on one or more of the SNURs must be received by September 26, 2018. If EPA receives written adverse comments, on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of the direct final rules before their effective date. In addition to the direct final rules, EPA published proposed rules for both the direct final rules. 83 Fed. Reg. 43606, 83 Fed. Reg. 43607. Comments on the proposed rules are due September 26, 2018.
By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Oscar Hernandez, Ph.D.
The U.S. Environmental Protection Agency’s (EPA) release of its Toxic Substances Control Act (TSCA) Section 5(a)(3)(C) determination for P-16-0510 represents a significant step in EPA’s implementation of the New Chemicals Program under new TSCA. The substance is a polymer (a copolymer of ethylene glycol and propylene glycol end-capped with acrylamide groups). It is intended to be used as a deodorizer in a variety of products, including floor cleaners, cat litter, fabric freshener sprays, and other consumer products.
Notably, EPA’s determination document specifies the conditions of use that are intended, known, and reasonably foreseen. EPA states that there are no known or reasonably foreseen conditions of use other than those intended by the submitter. This may appear to be a controversial statement. Based on EPA’s interpretation of “conditions of use,” it would not pass legal muster to speculate that “anybody could manufacture or use it for anything” and, hence, impose use restrictions to prevent purely speculative applications with no basis in fact or reality. EPA has repeatedly stated that it would base what is reasonably foreseen on information, knowledge, or experience, not on any conceivable condition of use.
EPA identifies the new chemical’s potential health hazard endpoints based on the acrylate/acrylamide category. The concerns are based on acrylamide itself and some low molecular acrylamide analogs and include mutagenicity, developmental toxicity, reproductive effects, neurotoxicity, and a “marginal potential” for oncogenicity. This too may sound alarming. The real question, however, is how toxic is the new chemical and are exposures expected to exceed a “safe” level.
In this case, EPA specifically considers the low-molecular weight (LMW) components of the polymer (i.e., the “worst case”) in its assessment and identifies two analogs of the LMW components. Both analogs have similar structural features (they are end-capped with acrylates), so both are expected to share the same mode of action, and have similar molecular weights as the LMW components of the premanufacture notification (PMN) substance. EPA states that it also considered the toxicity of acrylamide in its assessment. We note, however, that acrylamide is not a good analog because it is substantially lower molecular weight than the LMW components of the PMN substance. Based on the identified analogs, EPA set a no observable adverse effect level (NOAEL) of 250 mg/kg/day for systemic toxicity based on a combined repeat dose/reproductive/developmental toxicity screening test (OECD 422). This study tests for a chemical’s potential to cause toxicity and the primary endpoints of concern relevant to the category (developmental, reproductive, and neurotoxicity). This NOAEL would put the substance in the low-to-moderate toxicity category. Note that despite the nominally alarming set of health endpoints identified in EPA’s category assessment, the 422 study shows the analog is not especially toxic to mammals. By way of contrast, EPA’s most recent Integrated Risk Information System (IRIS) assessment of acrylamide identified a NOAEL of 0.5 mg/kg-day.
EPA also identifies ecotoxicity concerns. Using its predictive models, EPA predicts toxicity levels for both acute and chronic effects to aquatic species and sets concentrations of concern (CoC) at 425 ppb for acute exposures and 43 ppb for chronic exposures. These levels put the substance in the “moderate” category for environmental hazard.
EPA then applies exposure modeling to predict exposures to workers, the general population, and consumers. EPA found that predicted exposures are sufficiently below EPA’s concern level to not present an unreasonable risk to workers, the general population, or consumers. EPA even found that at the “worst case” of 100 percent PMN substance, exposures would still be sufficiently below EPA’s concern level. EPA also evaluated surface water concentrations and found that the estimated maximum acute and chronic concentrations did not exceed the CoCs.
EPA reviewed the PMN, reviewed likely and potential exposures to workers, the general population, consumers, and aquatic species, and did not identify any foreseeable conditions of use that would lead EPA to predict that unreasonable risk was likely.
This is a marked and welcomed departure from previous TSCA Section 5(a)(3)(C) decisions. In nearly all cases in the past, EPA only made a not likely determination if it identified a low hazard for both health and ecological effects (“low/low” cases). Absent a low/low finding, EPA seemingly believed that there could be some conditions of use that could contribute exposures that could exceed EPA’s concern levels. Based on our review, EPA did not explain how it differentiated between “any possible/foreseeable” and “reasonably foreseeable” conditions of use. Instead, if EPA could imagine a set of circumstances that could elicit an exceedance, EPA was of the view that new TSCA precluded it from making a Section 5(a)(3)(C) finding. (While some stakeholders might applaud an approach based on concepts such as the European Union’s Precautionary Principle, this is not how new TSCA, or U.S. environmental legislation more generally, is structured.)
In the case of P-16-0510, EPA more carefully applied new TSCA as written when it identified a low/moderate health concern and a moderate eco concern, and nevertheless took a reasonable approach grounded on the law to go beyond mere consideration of potential hazard and to interpret the “reasonably foreseen” conditions of use and assess unreasonable risk as new TSCA requires. We support this more measured approach and believe it better meets the statutory intent and requirements. As we have written previously, in our view, a “not likely” finding is not limited to cases in which toxicity is so low that exceedances are unimaginable. Rather, EPA must limit its consideration to those conditions of use that are reasonably likely to occur and must evaluate unreasonable risks, not merely hazard, and regulate to protect to the “extent necessary” to protect against such unreasonable risks.
We applaud EPA’s more measured approach that likely indicates a maturation of its understanding of what is needed to meet a not likely determination. We urge EPA to articulate its thinking on what is and is not “reasonably foreseeable” and what PMN submitters can do to help EPA understand not only what is intended, but what might be reasonably foreseen to occur.
By Lynn L. Bergeson
On August 7, 2018, EPA is expected to announce the extension of the comment period on the problem formulations for the risk evaluations for the first 10 chemicals under Toxic Substances Control Act (TSCA) Section 6. The notice extends the comment period on the problem formulations and the document titled Application of Systematic Review of TSCA Risk Evaluations, an additional 21 days, until August 16, 2018. Reportedly EPA received several requests to extend the deadline.
By Jessie Nguyen and Lynn L. Bergeson
On August 1, 2018, the U.S. Senate Committee on Environment and Public Works (EPW Committee) held a hearing entitled “Examining EPA’s Agenda: Protecting the Environment and Allowing America’s Economy to Grow.” Testifying at the hearing was Andrew Wheeler, the U.S. Environmental Protection Agency’s (EPA) Acting Administrator. Witness testimony and an archive of the hearing are available online. The hearing was intended to provide Wheeler with the opportunity to present himself for the first time in front of the EPW Committee as the Acting Administrator, and to update the EPW Committee on EPA’s agenda since the resignation of Scott Pruitt, EPA’s former Administrator. Wheeler’s testimony highlighted three main priorities for EPA moving forward: (1) regulatory certainty between EPA and state/local governments; (2) improvement of programs within EPA; and (3) increased transparency in risk communication.
During the questioning, Wheeler informed the EPW Committee that the clean-up of the Chesapeake Bay and the prevention of future lead contamination are high priorities for the Agency. When questioned by Senator John Boozman (R-AR) about EPA’s relationship with stakeholders, Wheeler stated that clear communication between EPA and its stakeholders is essential before implementing any regulatory action. EPA is also committed to working with other government agencies to enhance their regulatory process.
Next, the Trump Administration’s decision to roll back auto fuel efficiency and emissions standards, as well as the partial revocation of California’s ability to set its own emissions standards, was met with strong objection from Democratic Senators. Senator Edward Markey (D-MA) stated that the oil industry is “scared to death that $1 trillion will stay stranded in the pockets of consumers. That’s why the Trump Administration is moving to roll back these standards.” Wheeler stated his belief that the roll back in emissions standards has saved American consumers $500 billion dollars and 12,000 lives. Moving forward, Wheeler wants to come up with a “50-states solution” for emissions standards to address the issue of air pollutants and reduce cross-state pollution.
The topic of chemicals was brought up by Senator Cory Booker (D-NJ) as he is concerned that EPA’s failure to consider all sources of exposure for risk assessment will pose an unreasonable risk to human health -- especially to vulnerable populations such as children, pregnant women, and the elderly. Senator Booker urged EPA to ban trichloroethylene (TCE) on the applications for which proposed rules were issued and ban methylene chloride since they are known carcinogens with recognized health hazards. Wheeler said EPA is moving forward with the assessment of these chemicals, but he declined to promise on a definitive timeframe. Similarly, Senator Shelley Moore Capito (R-WV) urged EPA to release the toxicological report on perfluorooctane sulfonate (PFOS) and set a safety level for PFOS in soil and water.
In response to a question on clean energy by Senator Sheldon Whitehouse (D-RI), Wheeler stated he will not give preferential treatment for one source of energy over another; EPA’s role is to regulate pollutants, not to identify a preferential fuel source. Other miscellaneous topics included Wheeler’s commitment to not abuse his hiring authority. He expressed a willingness to notify the EPW Committee on EPA’s hiring process. In response to Senator Tammy Duckworth’s (D-IL) request, EPA will also make a commitment to reduce lead exposure.