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 November 29, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has scheduled the first public meetings of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). The first meeting, a preparatory virtual meeting, and will be held on January 8, 2019, from 2:00 p.m. to 4:00 p.m. (EST). The second meeting, a four-day in-person meeting, will be held on January 29, 2019, from 1:00 p.m. (EST) to 5:30 p.m. and on January 30, 31, and February 1, 2019, from 9 a.m. to 5:30 p.m. (EST). The official announcement is scheduled to be published in the Federal Register on November 30, 2018. Further information, including the location of the in-person meeting and how to register, will be posted on EPA’s TSCA Scientific Peer Review Committees website.
The topic for this first series of meetings is the peer review of the draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 and associated documents developed under EPA’s existing chemical substance process under TSCA. EPA states that the two-hour preparatory virtual meeting on January 8, 2019, will consider the scope and clarity of the draft charge questions for this peer review -- included with EPA’s Transmission of Background Materials and Charge to the Panel for the TSCA SACC Reviewing the Draft Risk Evaluation for C.I. Pigment Violet 29 (Attachment 23). The 4-day, in-person, public meeting will be comprised of the peer review panel deliberations and a general TSCA orientation for the TSCA SACC. A portion of the in-person meeting will be closed to the public, however, for the discussion of information claimed as confidential business information (CBI).
During these upcoming meetings, EPA states that the public is invited to provide oral comments for the peer review on the draft risk evaluation for C.I. Pigment Violet 29 and related documents; comments submitted by January 14, 2019, on the draft risk evaluation will be provided to the peer review panel members before the in-person meeting. Comments on the draft charge questions will be accepted prior to and during the 2-hour preparatory virtual meeting (but preferably by January 7, 2019); the TSCA SACC peer review panel will consider these comments during their discussions.
More information on the draft risk evaluation for C.I. Pigment Violet 29 is available in our memorandum EPA Publishes First Draft TSCA Chemical Risk Evaluation.
On November 26, 2018, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that Lek Kadeli joined OCSPP’s Immediate Office as Acting Deputy Assistant Administrator (AA) (Management). EPA states that Lek has extensive experience managing and supporting a wide range of environmental and human health related programs. Lek has worked at EPA previously; for eight years he was the Principal Deputy AA in EPA’s Office of Research of Development (ORD), serving several periods during that time as ORD’s Acting AA. Lek has also served as Director for ORD’s Office of Resource Management and Administration; Chief of ORD’s Resources Planning and Execution Staff; Office of International Activities Senior Budget Officer; and, as a budget analyst in the Office of Administration and Resource Management’s Office of Comptroller.
Most recently, Lek worked at the World Bank Group in Washington, D.C. as the co-program manager of the Pollution Management and Environmental Health Program, Environment and National Resources Global Practice. Lek holds a B.A. in Political Science from George Mason University, and a M.A. in National Security Studies from Georgetown University.
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29 presents an unreasonable risk to health or the environment under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. According to the notice, EPA is also submitting these same documents to the TSCA Science Advisory Committee on Chemicals (SACC) to peer review the draft risk evaluation. EPA intends to publish a separate Federal Register notice containing the peer review meeting details. Comments on the draft risk evaluation are due January 14, 2019. EPA will provide all comments submitted on the draft risk evaluation to the TSCA SACC peer review panel, which will have the opportunity to consider the comments during its discussions. More information is available in the full memorandum.
The U.S. Senate Committee on Environment and Public Works (EPW) will hold a hearing on the nomination of Alexandra Dapolito Dunn to be the U.S. Environmental Protection Agency (EPA) Assistant Administrator (AA) for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) on Thursday, November 29, 2018, at 10:30 a.m. (EST) in room 406 of the Dirksen Senate Office Building. The hearing will be webcast and will be available on the EPW Committee website.
Ms. Dunn has been serving as the Regional Administrator for EPA’s New England Region (Region 1) since January of this year. Prior to joining EPA, Ms. Dunn served as Executive Director and General Counsel for the Environmental Council of the States (ECOS), a national nonprofit, nonpartisan organization committed to helping state agencies improve environment outcomes for Americans. While at ECOS, Ms. Dunn helped state governments improve water infrastructure, reduce air pollution, clean up contaminated sites, manage chemical safety, and enhance economic development. Before joining ECOS, Ms. Dunn was Executive Director and General Counsel for the Association of Clean Water Administrators. Ms. Dunn was also a former chair of the American Bar Association’s (ABA) Section of Environment, Energy, and Resources (SEER). More information on Ms. Dunn’s experience and accolades is available in EPA’s press release announcing her nomination.
In September 2018, the U.S. Environmental Protection Agency (EPA) issued a consent agreement with Chevron USA, Inc. (Chevron) related to an alleged violation of the Toxic Substances Control Act (TSCA).
EPA’s issuance of a consent agreement for the alleged TSCA violation is not especially newsworthy. Neither is the agreed upon penalty for the violation, which could be considered minor based on the penalty provisions allowed under TSCA. What is newsworthy here is that the alleged violation, technically three as the violation occurred on three separate days, was related to the research and development (R&D) exemption. Specifically, EPA alleged that Chevron did not appropriately label chemicals that it had distributed to other companies for R&D purposes. In our experience, the R&D exemption under TSCA is seldom the subject of enforcement scrutiny. This may be changing.
The R&D exemption is a critical aspect of TSCA and it offers many companies significant flexibility to research new chemical innovations. The exemption is self-implementing and thus does not require pre-approval by or submissions to EPA. Nonetheless, there are specific restrictions and recordkeeping requirements associated with reliance on that exemption. The consent agreement at issue here confirms that EPA will hold companies accountable to these requirements. The enforcement action is an important reminder to all entities relying upon the R&D exemption to ensure that they comply strictly with each element of the exemption requirements as identified under TSCA Section 5(h)(3).
Companies relying on the R&D exemption for new chemical development may wish to review internal files and processes to ensure compliance, as EPA has shown its intent to pursue violations and associated penalties for non-compliance instances.
On October 17, 2018, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda). There are many interesting entries, some of which are flagged here.
Not surprisingly, the U.S. Environmental Protection Agency (EPA) listed implementing Toxic Substances Control Act (TSCA) amendments to enhance public health and chemical safety as one of its top priorities. According to EPA, the amendments to TSCA that were enacted in June 2016 require EPA “to evaluate existing chemicals on the basis of the health risks they pose -- including risks to vulnerable groups and to workers who may use chemicals daily as part of their jobs.” If unreasonable risks are found, EPA must then take steps to eliminate these risks but, “during the risk management phase, EPA must balance the risk management decision with potential disruption based on compliance to the national economy, national security, or critical infrastructure.” The following TSCA items were included.
The rules in the proposed rule stage are:
The rules in the final rule stage are:
The following Long-Term Action was also listed:
For information on the TSCA items included in the Spring 2018 Regulatory Agenda, please see our blog item “EPA’s Spring 2018 Unified Agenda and Regulatory Plan Includes TSCA Rulemakings.”
B&C is launching a podcast November 1, 2018. It’s called All Things Chemical™ and it will engage listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space.
A teaser introduction to the podcast is available now. Full episodes will be available November 1, 2018, on iTunes, Spotify, and Stitcher.
On October 17, 2018, the U.S. Environmental Protection Agency (EPA) issued its final fees rule under the Toxic Substances Control Act (TSCA) in the Federal Register. 83 Fed. Reg. 52694. The final rule largely tracks the proposed rule. EPA is establishing fees applicable to any person required to submit information to EPA; or a notice, including an exemption or other information, to be reviewed by EPA; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation. This final rulemaking describes the final TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the final TSCA fees were determined. It 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. As required in TSCA, EPA is also establishing standards for determining which persons qualify as “small business concerns” and thus would be subject to lower fee payments. Small businesses will be eligible to receive a substantial discount of approximately 80 percent on their fees. EPA will host a series of webinars focusing on making TSCA submissions and paying fees under the final rule. The first webinar was held on October 10, 2018. The other two webinars will be held on October 24, 2018, from 1:00 p.m. to 2:30 p.m. (EDT) and on November 7, 2018, from 1:00 p.m. to 2:30 p.m. (EDT). Our memorandum provides an overview of the final rule with specific information about final fee amounts and timing and a commentary. The final rule is effective on October 18, 2018.
The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN). 83 Fed. Reg. 52179. The proposed rule is significant. Unlike other recent SNURs (i.e., those enacted since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent orders. For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule. The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 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 the 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. Comments on the proposed SNURs are due November 15, 2018.
Please see the full memorandum for more information on the proposed rule and an illuminating commentary.
As part of Amazon’s commitment to responsible sourcing, Amazon has posted its chemicals policy, which includes its first Restricted Substance List (RSL). Amazon states that it defines chemicals of concern as those chemicals that: (1) meet the criteria for classification as a carcinogen, mutagen, reproductive, or other systemic toxicant; or (2) are persistent, bioaccumulative, and toxic. Amazon “strategically prioritize[s] which chemicals of concern to focus on based on product type, customer concerns, and the availability of safer alternatives.” The baseline list of chemicals of concern included on the RSL are those chemicals that Amazon seeks to avoid in Amazon-owned Private Brand Baby, Household Cleaning, Personal Care, and Beauty products in the U.S. According to Amazon, it will expand the policy to additional brands, product categories, and geographies over time.
Read the full memorandum for more information and an insightful commentary.
EPA Issues Working Approach For Identifying Potential Candidate Chemicals For Prioritization under TSCA
On October 5, 2018, the U.S. Environmental Protection Agency (EPA) issued the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under TSCA. 83 Fed. Reg. 50366. EPA notes that it will seek public comment on the approach document and on which chemicals should be identified as potential candidates for the initial 20 high-priority and 20 low-priority chemicals that must be identified pursuant to TSCA Section 6(b)(2)(B). Comments are due by November 15, 2018.
The document, A Working Approach for Identifying Potential Candidate Chemicals for Prioritization, lays out EPA’s thinking regarding a near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA. The approach document also includes a longer-term risk-based strategy for managing the larger TSCA chemical landscape that, according to the portion of the TSCA Chemical Substance Inventory (Inventory) that includes the substances designated as active (TSCA Active Inventory), is expected to include over 38,000 chemicals reported as “active” under the TSCA Inventory Notification (Active-Inactive) Requirements final rule. More information is available in our memorandum “EPA Releases Working Approach for Identifying Potential Candidate Chemicals for Prioritization under TSCA.”
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.
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.
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.
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:
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).