By Lynn L. Bergeson and Carla N. Hutton
On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA). EPA states that some of the key revisions include:
- Simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD);
- Updating requirements for making confidentiality claims to align with the requirements in amended TSCA; and
- Adding reporting exemptions for specific types of byproducts manufactured in certain equipment.
Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool. The reporting period will still begin on June 1, 2020. EPA will host a webinar on Tuesday, March 31, 2020, to discuss the revised reporting requirements, provide an overview of the 2020 CDR submission period, and to give an introduction to the updated e-CDRweb reporting tool. EPA has posted pre-publication versions of the final rules amending the CDR rule and extending the reporting period. More information will be available in a forthcoming memorandum that will be posted on our website.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a company’s site and customized live webinar training, so companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.
Toxic Substances Control Act (TSCA) awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how the U.S. Environmental Protection Agency’s (EPA) ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.
TSCA Tutor™ online training courses include:
- Video lessons.
- Detailed hand-out materials, including copies of all presentations and relevant course materials from EPA and other sources.
- Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.
The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes five former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.
Online courses are offered at $100 for one-hour modules and $200 for 2-hour modules, or $1,400 for the full 12-module training. Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.TSCAtutor.com
, or read our full course descriptions here
TSCA Tutor -- Curriculum
- An Overview of TSCA (Course number T101)
- New TSCA at a Glance (Course number T102)
- Import Requirements, TSCA Section 13 (Course number T103)
- Export Requirements, TSCA Section 12 (Course number T104)
- Confidential Business Information (CBI) (Course number T105)
- Reporting and Retention of Information, TSCA Section 8 (Course number T106)
- Inspections and Audits (Course number T201)
- Preparing for a TSCA Audit
- TSCA Penalties/Overview of Self-Confession Policy
- TSCA Section 5, Part 1: TSCA Chemical Inventory, Exemptions (Course number T202)
- TSCA Inventory
- TSCA Section 5, Part 2: New Chemicals/New Use (Course number T203)
- New Chemicals/New Use
- Chemical Data Reporting (CDR) (Course number T204)
- CDR Overview
- Byproduct Reporting under CDR
- Chemical Testing (Regulatory)/Animal Welfare, TSCA Section 4 (Course number T205):
- Chemical Testing
- How to Prepare/Engage If a Chemical of Interest Is Listed under TSCA Section 4
- Prioritization and Risk Evaluation, TSCA Section 6 (Course number T206)
- Overview of Section 6 Risk Framework -- Prioritization, Evaluation, and Management
- How to Prepare/Engage If a Chemical of Interest Is Listed under Section 6
Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. Visit www.lawbc.com for more information.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) issued a press release on September 10, 2019, announcing that EPA Administrator Andrew Wheeler signed a directive to prioritize efforts to reduce animal testing. Administrator Wheeler also announced $4.25 million in funding to five universities to research the development and use of alternative test methods and strategies that reduce, refine, and/or replace vertebrate animal testing. Administrative Wheeler directs the Office of Chemical Safety and Pollution Prevention (OCSPP) and the Office of Research and Development (ORD) “to prioritize ongoing efforts and to direct existing resources toward additional activities that will demonstrate measurable impacts in the reduction of animal testing while ensuring protection of human health and the environment.” The directive states that EPA “will reduce its requests for, and [its] funding of, mammal studies by 30 percent by 2025 and eliminate all mammal study requests and funding by 2035. Any mammal studies requested or funded by the EPA after 2035 will require Administrator approval on a case-by-case basis.” Administrative Wheeler requests that OCSPP and ORD hold a joint animal conference on new approach methods (NAM), with the first conference to be held in 2019.
Five universities were awarded grants through EPA’s Science to Achieve Results Program. According to EPA, the research focuses on advancing the development and use of alternative test methods and strategies to reduce, refine, and/or replace vertebrate animal testing. The grantees are advancing the science of non-vertebrate alternative test methods and strategies in chemical hazard assessment. The grantees include:
- Johns Hopkins University to develop a human-derived brain model to assess the mechanism by which environmental chemicals might cause developmental neurotoxicity;
- Vanderbilt University to test their organ-on-a-chip to study the blood brain barrier and potential brain injury after organophosphate exposure;
- Vanderbilt University Medical Center to use their Endo Chip technology to research how preexisting diseases affect cellular responses to environmental toxicants with a focus on reproductive disorders in women;
- Oregon State University to develop in vitro test methods for fish species to screen chemicals in complex environmental mixtures; and
- University of California Riverside to use human cells to develop a cost-effective end point to characterize potential skeletal embryotoxicants.
By Lynn L. Bergeson and Carla N. Hutton
On July 29, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT). 84 Fed. Reg. 36728. EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA): decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP). The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action. For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1). Comments are due September 27, 2019. Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.
By Lynn L. Bergeson and Kathleen M. Roberts
In the March 27, 2019, Federal Register, the U.S. Environmental Protection Agency (EPA) issued its final regulatory rulemaking that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. 84 Fed. Reg. 11420. See Bergeson & Campbell, P.C.’s memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses.”
Starting on August 26, 2019, which is 90 days after the effective date of the final rule, a company that manufactures, processes, or distributes in commerce methylene chloride is required to provide notification to downstream users of the consumer use paint remover restrictions via Safety Data Sheets (SDS). We write to emphasize that this notification requirement applies to all manufacturers, processors, or distributors of methylene chloride and is not limited only to those companies engaged with paint remover products. The EPA rulemaking provides the following specific text that must be included in the SDS:
- SDS Section 1.(c): “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”
- SDS Section 15: “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”
More information is available in our July 22, 2019, memorandum, “Communication and Recordkeeping Requirements Related to EPA Ban on Consumer Use Paint Removers Containing Methylene Chloride Go in Effect on August 26, 2019.”
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.
By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton
On April 5, 2019, the U.S. Environmental Protection Agency (EPA) issued a final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN). 84 Fed. Reg. 13531. The final rule is significant because the 13 chemical substances are not also subject to consent orders. During the review, EPA identified certain reasonably foreseen conditions of use that it designated as significant new uses in the final SNURs. The final SNURs effectively prohibit the designated new use unless a person submits a notice to EPA, EPA makes a determination, and it takes any necessary action to mitigate any identified potential risk. The final rule will become effective on June 4, 2019. Please see our full memorandum for more information on this final rule.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On March 15, 2019, U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler signed a final rule prohibiting the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer paint and coating removal, including distribution to and by retailers; requiring manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these prohibitions; and requiring recordkeeping. The rule states that EPA has determined that “the use of methylene chloride in consumer paint and coating removal presents an unreasonable risk of injury to health due to acute human lethality.” This final rule does not prohibit the use of methylene chloride in commercial paint and coating removal, however. EPA is instead soliciting comment, through an advance notice of proposed rulemaking (ANPRM) also signed by Administrator Wheeler on March 15, 2019, on questions related to a potential training, certification, and limited access program as an option for risk management for all of the commercial uses of methylene chloride in paint and coating removal. More information will be available on these issuances in a forthcoming memorandum to be available on our Regulatory Developments webpage.
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 and Margaret R. Graham
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:
- 1-Bromopropane (1-BP);
- Carbon Tetrachloride;
- Cyclic Aliphatic Bromide Cluster (HBCD Cluster);
- Methylene Chloride;
- N-Methylpyrrolidone (NMP);
- Pigment Violet 29; and
- Trichloroethylene (TCE).
EPA states the systematic review approach document will guide its selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information. Comments will be due 45 days after publication in the Federal Register. Also included on the systematic review web page is EPA’s Response to Public Comments Related to the Supplemental Files Supporting the TSCA Scope Documents for the First Ten Risk Evaluations.
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.
More information on the first ten chemical evaluations is available on our blog. A more detailed analysis will be available next week on our regulatory developments webpage.