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 Margaret R. Graham
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.”
Links to the problem formulation dockets are available in our blog item “EPA Releases Problem Formulations Documents on First Ten Chemicals; Systematic Review Approach Document; and Asbestos SNUR” and a more detailed analysis is available in our memorandum “EPA Takes ‘Three Important Steps’ Intended to Ensure Chemical Safety.”
By Charles M. Auer, Oscar Hernandez, Ph.D., and Lynn L. Bergeson
On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment. Release of the final Strategic Plan occurred on the second anniversary of enactment of amendments to the Toxic Substances Control Act (TSCA).
The goal of the strategy is to reduce the level of testing in vertebrates for chemicals regulated under TSCA. EPA describes alternative test methods and strategies as different descriptors that have a common goal. The former is based on reduction, refinement, and replacement of animal test methods (the 3Rs), while strategies incorporate more than just toxicity test methods to characterize hazard. The strategy as proposed relies on a range of applications and testing approaches to characterize human health and environmental endpoints.
Collectively, alternative test methods and strategies combine to define a new term: new approach methodologies (NAM). The NAM designation is used as a broadly descriptive reference to any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of vertebrates. For the purposes of TSCA, EPA recognizes this new term (i.e., NAM) as encompassing any “alternative test methods and strategies to reduce, refine or replace vertebrate animals.”
A much more detailed summary and analysis of this important issue is available in our memorandum.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Molly R. Blessing
Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018. Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online. This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next.
On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended to “assist companies in creating structurally descriptive chemical names for chemical substances whose specific chemical identities are claimed confidential, for purposes of protecting the specific chemical identities from disclosure while describing the chemical substances as specifically as practicable, and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory.” EPA states that the guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act, was developed in response to the requirement under new TSCA Section 14(c)(4) that EPA “develop guidance regarding – (A) the determination of structurally descriptive generic names, in the case of claims for protection from disclosure of specific chemical identity…” and the requirement under new TSCA Section 14(c)(1)(C) that submitters who assert a confidentiality claim for a specific chemical identity must include a structurally descriptive generic name developed consistent with EPA guidance. The guidance updates and replaces the 1985 guidance published in the TSCA Inventory, 1985 Edition (Appendix B: “Generic names for Confidential Chemical Substance Identities”). EPA states that, also consistent with Sections 14(c)(4) and 14(c)(1)(C), EPA will be reviewing generic names upon receipt in TSCA filings where chemical identity is claimed as confidential for consistency with the guidance. EPA encourages companies to consult the Agency’s Office of Pollution, Prevention, and Toxics (OPPT) if they feel that it will be necessary to mask more than one structural element of a specific chemical name to mask a confidential chemical identity. More information on this guidance is available in our full memorandum.
By Kathleen M. Roberts, Jason E. Johnston, M.S., Sheryl Lindros Dolan, and Margaret R. Graham
On June 25, 2018, the U.S. Environmental Protection Agency (EPA) held a preparatory meeting for experts selected to serve as letter peer reviewers for EPA's Exposure and Use Assessment and Human Health and Environmental Hazard Summary for five persistent, bioaccumulative, and toxic (PBT) chemicals. A list of those chemicals is available here. Although the meeting was scheduled for four hours, it adjourned after only two hours, as there were only a few questions from peer reviewers and only two outside stakeholders providing oral comments. Below are some highlights/takeaways from the meeting:
- All five PBT chemicals being reviewed scored high for hazard;
- Two PBT chemicals were pulled from EPA action under the Toxic Substances Control Act (TSCA) Section 6 because manufacturers requested risk evaluations for them prior to the September 19, 2016, deadline;
- Four of the PBT chemicals scored high or moderate for exposure; one scored low (pentachlorothiophenol (PCTP));
- For exposure assessment, EPA split up information as “core exposure data” or “supplemental exposure data”: core exposure data would be environmental data, monitoring, biomonitoring, modeled concentrations, or modeled dose; and supplemental exposure data would be environmental fate, engineering data, or other information related to exposure information or pathways;
- EPA identified exposure scenarios -- looking at source/use, environmental pathways, and receptors;
- EPA did not conduct any new modeling on the chemicals but did use modeled data from published literature;
- EPA did not conduct an exhaustive literature search, review, or assessment of hazard data, it used data readily available, as described in the Human Health and Environmental Hazard Summary; the EPA document “Supplemental Information for the Exposure and Use Assessment of Five Persistent, Bioaccumulative and Toxic Chemicals” outlines the literature search process used for exposure data; and
- Exposure scenarios include both quantitative and qualitative information.
No written comments were submitted prior to the peer review webinar. Only three people signed up for oral comments, and one was not present online. The two public commenters noted concerns regarding the likelihood of exposure, including the potential for accidental exposures; the lack of EPA focus on susceptible subpopulations; EPA’s intent not to address exposures that are already regulated under other EPA programs; and the need to assess the risk of bias.
Per the language in amended TSCA, EPA must issue risk management proposals to reduce exposures to the extent practicable by June 19, 2019.
Any public comments submitted by July 23, 2018, will be shared with peer reviewers. Comments submitted between July 23, 2018, and August 17, 2018, will be available to EPA for consideration. All comments are due by August 17, 2018. A recording of the webinar, slides, and other materials from the meeting will be posted in Docket EPA-HQ-OPPT-2018-0314. There are currently six supporting documents posted:
Stay up-to-date on TSCA implementation issues via our Recent Regulatory Developments web page and our TSCAblog.
By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
On June 22, 2018, the U.S. Environmental Protection Agency published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury). The final rule applies to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to the Toxic Substances Control Act (TSCA), such as for the manufacture of pharmaceuticals and pesticides). EPA will use data from the 2018 reporting year for the 2020 mercury inventory. The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019. The final rule will be effective 60 days after publication in the Federal Register, which is scheduled for June 27, 2018.
The reporting requirements include activities that are established TSCA terms, including manufacture, import, distribution in commerce, storage, and export. EPA notes that the reporting requirements also apply to the otherwise intentional use of mercury in a manufacturing process. Persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, are required to report amounts of mercury in pounds (lbs.) used in such activities during a designated reporting year. Reporters must also identify specific mercury compounds, mercury-added products, manufacturing processes, and how mercury is used in manufacturing processes, as applicable, from preselected lists. For certain activities, reporters must provide additional, contextual data.
The final reporting requirements do not apply to: (1) persons who do not first manufacture, import, or otherwise intentionally use mercury; (2) persons who only generate, handle, or manage mercury-containing waste; (3) persons who only manufacture mercury as an impurity; and (4) persons engaged in activities involving mercury not with the purpose of obtaining an immediate or eventual commercial advantage. Within the category of persons who must report, there are certain persons who are not required to provide specific data elements. To avoid reporting that is unnecessary or duplicative, the final rule includes certain exemptions for persons who already report for mercury and mercury-added products to the TSCA Section 8(a) Chemical Data Reporting (CDR) rule and the Interstate Mercury Education and Reduction Clearinghouse (IMERC) Mercury-Added Products Database, respectively.
More detail is provided in our June 25, 2018, memorandum regarding the provisions of the final rule, including EPA’s rationale for fulfilling specific statutory provisions and terms. While the final rule includes summaries of public comments received and EPA’s responses and determinations, EPA notes that some of these issues are discussed in greater detail in its Response to Comments. EPA states that its Response to Comments will be available in Docket EPA-HQ-OPPT-2017-0421, although it is not there at this time.
By Lynn L. Bergeson and Carla N. Hutton
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:
In addition, registration is still available for Bergeson & Campbell, P.C.‘s (B&C®) June 25, 2018, complimentary webinar, “TSCA at 2: An Update on Implementation and Hot Topics.” Speakers will include:
- Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
- Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
- Michael Gould, EH&S Committee Chairman, RadTech North America; and
- Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
More information on these developments will be available in our forthcoming memorandum and posted to our Recent Regulatory Developments web page, as well as in our subsequent TSCA blog items.
By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
On June 20, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).” EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications, “promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to better move chemicals through the evaluation process.” EPA incorporated comments from a December 2017 public meeting and feedback received on a November 2017 draft of the document into its guidance. EPA also issued a “Response to Comments Received on Points to Consider Posted for Comment November 2017.” EPA states that it expects that use of the guidance will result in “more robust submissions.” EPA encourages companies to contact its new chemicals program to set up a pre-submission (or “pre-notice”) meeting before submitting their premanufacture notices (PMN). According to EPA, the pre-submission meeting is an opportunity to discuss the planned new chemical submission and to understand EPA’s approach to reviewing new chemicals for potential risks early in the process.
More information will be available in our detailed analysis to be issued in a memorandum later today and posted to our Recent Regulatory Developments web page.
By Lynn L. Bergeson and Margaret R. Graham
On May 25, 2018, the U.S. Environmental Protection Agency (EPA) announced it would host a half-day preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five Persistent, Bioaccumulative, and Toxic (PBT) chemicals. Section 6(h) of the Toxic Substances Control Act (TSCA) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances that were identified in EPA’s TSCA Work Plan for Chemical Assessments: 2014 update. The selected chemicals are:
- Decabromodiphenyl ethers (DECA);
- Hexachlorobutadiene (HCBD);
- Pentachlorothiophenol (PCTP);
- Phenol, isopropylated, phosphate (3:1) (PIP3/ITPP); and
- 2,4,6-Tris(tert-butyl) phenol (2, 4, 6 TRIS).
EPA prepared an Exposure and Use Assessment and a Human Health and Environmental Hazard Summary in response to the requirements under TSCA Section 6(h) to summarize conclusions of toxicity and whether there is likely exposure to these PBT chemicals and EPA organized letter peer reviews for the Exposure and Use Assessment and the Human Health and Environmental Hazard Summary. The Federal Register notice announcing the meeting states that during the preparatory meeting, “the individual letter peer reviewers will have the opportunity to comment on and ask questions regarding the scope and clarity of the draft charge questions.” EPA’s background papers, related supporting materials, and charge/questions for these letter peer reviews are now available in Docket No. EPA-HQ-OPPT-2018-0314 on www.regulations.gov.
The meeting is scheduled for June 25, 2018, from 1:00 p.m. to 5:00 p.m. (EDT) and will be held via teleconference and webcast only. Registration is available online. Those requesting to provide oral comments (approximately five minutes) are asked to register by June 21, 2018. Though the peer reviewers may not be able to consider fully written comments submitted after July 23, 2018, EPA will consider all comments submitted on or before August 17, 2018.
More information, including the list of experts, is available on EPA’s TSCA Peer Review website.