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.
The U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) on June 6, 2018, announced two public meetings related to the harmonization of transportation and hazard communication standards with international standards. 83 Fed. Reg. 26338. The first meeting -- led by PHMSA -- will solicit public input on current proposals and items for inclusion in the agenda of the 53rd session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG). The second meeting will be spearheaded by the U.S. Occupational Safety and Health Administration (OSHA) and will focus on preparation for the 35th session of the United Nations (UN) Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS). Both meetings will take place on Tuesday, June 12, 2018, at DOT Headquarters, West Building, Oklahoma City Conference Room, 1200 New Jersey Avenue, SE, Washington, D.C. 20590-0001. The PHMSA meeting is scheduled for 9:00 a.m. to 12:00 p.m. (EDT) and the OSHA meeting is scheduled for 1:00 p.m. to 4:00 p.m. (EDT). Registration for the meetings is available online. DOT and OSHA will also provide conference call-in and Skype meeting capabilities.
The primary purpose of PHMSA’s meeting is to prepare for the 53rd session of the UNSCOE TDG. UNSCOE will consider proposals for the 21st Revised Edition of the United Nations Recommendations on the Transport of Dangerous Goods (Model Regulations), which may be implemented into relevant domestic, regional, and international regulations from January 1, 2021. Topics on the agenda for the UNSCOE TDG meeting include:
OSHA’s meeting will focus on preparation for the 35th session of the UNSCEGHS. It will provide interested groups and individuals with an update on GHS-related issues, as well as solicit input on the development of U.S. positions on proposals submitted to the UNSCEGHS.
EPA Releases Problem Formulations Documents on First Ten Chemicals; Systematic Review Approach Document; and Asbestos SNUR
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:
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.
EPA Schedules Public Meeting on Formaldehyde Emission Standards for Composite Wood Products Final Rule Technical Issues
On May 24, 2018, the U.S. Environmental Protection Agency (EPA) announced it would be hosting a public meeting on June 28, 2018, from 1:00 p.m. to 4:00 p.m. (EDT) in Washington, D.C. regarding technical issues in the Formaldehyde Emission Standards for Composite Wood Products Final Rule published on December 12, 2016. 83 Fed. Reg. 24104. The Federal Register notice states that the meeting will “inform EPA's potential development of a proposed rule to address … technical issues and to further align the rule requirements with the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II program.” EPA states that this meeting is open to the public but that the primary audience for this public meeting is Third Party Certifiers (TPC) and panel producers who contract with TPCs to certify composite wood products under the December 12, 2016, final rule.
The notices states that EPA is most interested in receiving comments or questions on the specific technical issues that will be outlined on the meeting agenda including timing and ways to implement any changes should the agency decide to propose additional technical amendments; and other technical rule provisions that can help improve consistency with CARB's regulation, improve clarity in the rule, and help improve overall implementation of the rule. The meeting agenda will be available in the docket in advance of the meeting. Registration is requested by June 22, 2018, and is available online.
More information on composite wood products under the Toxic Substances Control Act (TSCA) is available on our blog.
On May 25, 2018, the U.S. Environmental Protection Agency (EPA) extended until August 16, 2018, the comment period on its proposed rule titled “Strengthening Transparency in Regulatory Science.” 83 Fed. Reg. 24255. EPA also announced that it will hold a public hearing on the controversial proposed rule on July 17, 2018. The April 30, 2018, proposal (83 Fed. Reg. 18768) is intended to strengthen the transparency of EPA regulatory science. The proposed regulation provides that for the science pivotal to EPA’s significant regulatory actions, EPA will ensure that the data and models underlying the science is publicly available in a manner sufficient for validation and analysis. The rule has sparked controversy, as many stakeholders view it as an attempt by EPA to dilute science-based regulatory decisions. Among other reasons for the extension is the request made of 20 Senators on May 15 seeking an extension of the comment period on the controversial proposal. They joined various state Attorneys General, among others, in claiming the proposal had far-reaching implications and required far more than 30 days for comment.
More information about the proposed science rule is available in our memorandum EPA Releases Strengthening Transparency in Regulatory Science Proposed Rule.
On May 22-23, 2018, the U.S. Environmental Protection Agency (EPA) hosted a Polyfluoroalkyl Substances (PFAS) National Leadership Summit (Summit) in Washington, D.C. The Summit convened federal and state regulators, including representatives from EPA’s Office of Water (OW), EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), the U.S. Food and Drug Administration (FDA), the U.S. Department of Defense (DOD), a small group of invited industry participants, and representative from the environmental non-governmental organization (NGO) community. The goals of the Summit were:
EPA broadcast the opening remarks and perspectives delivered by EPA Administrator Pruitt; Peter Grevatt, Director of the Office of Ground Water and Drinking Water; Jeff Morris, Director of the Office of Pollution Prevention and Toxics (OPPT); Craig Butler, Direct of the Ohio Environmental Protection Agency and Chair of the Environmental Council of the States (ECOS) Water Committee; and Jessica Bowman, Senior Director of Global Fluoro-Chemistry, at the American Chemistry Council. During his remarks, Pruitt announced that EPA will soon classify two fluorochemicals, perfluorooctanoic acid (PFOA) and perfluoroctane sulfonate (PFOS), as hazardous substances, and that EPA will begin to development maximum contaminant levels (MCL) for PFOA and PFOS under the Safe Drinking Water Act. PFOA and PFOS are largely legacy chemicals that were the subject of voluntary phase out by chemical manufacturers. The presence of PFOA and PFOS at former manufacturing sites and detections in groundwater and drinking water have raised public health concerns and made headlines over the last several months, particularly in Northeast states.
Butler’s remarks highlighted the key questions that ECOS and state participants hoped to have addressed by EPA over the course of the Summit, including any plans for MCL development, guidance on contaminated site remediation and PFAS analytical methods, and EPA’s plan to address data and knowledge gaps about PFOA and PFOS, as well as the alternative short-chain PFAS chemistry that makes up the majority of current and new uses of PFAS. States are eager for direction and assistance from EPA on standard-setting and, in the absence of federal standards, some states have begun to set their own standards. A copy of the ECOS statement is available here.
Grevatt shared plans for further co-regulator discussions and community engagement as part of an EPA “roadshow” beginning in late June in Portsmouth, New Hampshire. Morris provided an overview of the rigors of the pre-market review process under the Toxic Substances Control Act (TSCA) and OPPT’s ongoing work to better understand the diverse range of PFAS in the marketplace.
EPA intended for the Summit to serve as a formal launch of an ongoing dialogue with states, the public, and industry on PFAS, and more details will likely be shared in the coming weeks and months. A recording of the May 22, 2018, broadcast is available on EPA’s YouTube channel. Copies of the slide presentations from the Summit are available on EPA’s PFAS Summit website.
EPA Issues Statements of Findings: Five New Chemical Substances Not Likely to Present an Unreasonable Risk
On May 17, 2018, the U.S. Environmental Protection Agency (EPA) issued a notice releasing statements of findings on new chemical substances made on Toxic Substances Control Act (TSCA) Section 5(a) notices during the period from February 1, 2018, to March 31, 2018. 83 Fed. Reg. 22978. EPA is required to do so per TSCA Section 5(g) after its review of TSCA Section 5(a) notices when it makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. EPA posted these determinations on its website when they were made. The statements of findings, all related to premanufacture notices (PMN), and their website links are:
P-18-0044, P-18-0045, and P-18-0083 are notable in that EPA identified a hazard other than “low hazard” for health or the environment and nevertheless concluded that exposures were low enough that the substances are not likely to present an unreasonable risk under the reasonably foreseeable conditions of use. In the cases of P-18-0044 and P-18-0045, EPA identified health hazards, but EPA expects that exposures to the general population will be low and that there will not be consumer uses. Furthermore, EPA expects that workers will “use adequate personal protective equipment.” In the case of P-18-0083, EPA identified acute and chronic aquatic toxicity concentrations of concern of >20,000 and >1,000 parts per billion, respectively. Even though these do not meet EPA’s thresholds for “low hazard,” EPA does not expect releases to exceed those thresholds.
More information on TSCA’s implementation is available on our TSCA Reform News & Information web page.
On May 7, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) final rule entitled Mercury; Reporting Requirements for the TSCA Mercury Inventory.
The OIRA 2018 Spring Regulatory Agenda for this rulemaking, item RIN 2070-AK22, states that EPA’s rulemaking to implement new Toxic Substances Control Act (TSCA) Section 8(b)(10)(D) will promulgate 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.’ The requirements would be applicable to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process.”
More information on the proposed rule issued in October 2017 is available in our blog item “EPA Issues Proposed Rule on Reporting Requirements for Mercury Inventory Under New TSCA.”
On May 1, 2018, the Hawaii Senate and House of Representatives passed a bill that will ban the sale, offer of sale, or distribution in Hawaii of any sunscreen that contains oxybenzone or octinoxate, or both, without a prescription issued by a licensed healthcare provider to preserve marine ecosystems, beginning January 1, 2021: S.B. No. 2571, Environment; Water Pollution; Sunscreen; Oxybenzone; Octinoxate; Sale; Distribution; Prohibition. The bill received unanimous approval in the Senate and only four of 51 House members voted against it, but Governor David Y. Ige (D) has not signed the bill as yet. The bill states that scientific studies have shown that both chemicals can induce “feminization in adult male fish and increase reproductive diseases in marine invertebrate species (e.g., sea urchins), vertebrate species (e.g., fish such as wrasses, eels, and parrotfish), and mammals (in species similar to the Hawaiian monk seal)” and induce “deformities in the embryonic development of fish, sea urchins, coral, and shrimp and induce neurological behavioral changes in fish that threaten the continuity of fish populations.”
Oxybenzone and octinoxate are among a group of chemical filters of ultraviolet (UV) light used in sunscreens. According to an Environmental Working Group 2017 survey, oxybenzone is found in 65 percent of commercially available chemically based sunscreens. There is disagreement among the scientific community about the role that oxybenzone and other chemical sunscreens play in the degradation of coral reefs. This February 2017 article in Nature discusses available science on reefs and sunscreens, including research findings that legislative champions of the Hawaii bill used as support for proposing its ban. As a possible alternative, mineral-based sunscreens, such as those with titanium dioxide and zinc oxide, have not been shown to cause harm to corals, according to the National Oceanic and Atmospheric Administration (NOAA).
Hawaii’s Department of Land and Natural Resources (DLNR) has been requesting that people who enter the ocean and use beach showers avoid using sunscreens containing oxybenzone since September 2016, stating that “studies have shown that oxybenzone causes deformities in coral larvae (planulae), making them unable to swim, settle out, and form new coral colonies. It also increases the rate at which coral bleaching occurs.”
Several sunscreen manufacturers and trade associations opposed the bill, citing the U.S. Food and Drug Association’s (FDA) approval of oxybenzone and octinoxate (a/k/a octyl methoxycinnamate) as active ingredients in sunscreen. FDA’s website lists oxybenzone and octyl methoxycinnamate as “acceptable active ingredients in products that are labeled as sunscreen” that protect “skin from the sun’s harmful UV rays.”
If enacted, Hawaii’s ban will be the first of its kind in the U.S. and in the world. Among U.S. states and territories, coral reefs can also be found off the coasts of Florida, Texas, Puerto Rico, and the Virgin Islands. These states and territories, and other countries with direct interests in preserving reef ecosystems, may begin to explore similar bans.
The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization. The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions. OPPT’s other functions are proposed to be distributed into a mission operations division and a division that sweeps together chemical right-to-know, economics, information reporting, and the Safer Choice/Design for the Environment (DfE) program. In an internal memo, OPPT Director Jeffery Morris, Ph.D., noting the thoughtful and insightful staff comments received on the earlier proposed reorganization, provides a two-week internal commenting period for the new proposal ending on May 9, 2018.
How to organize OPPT has been a perpetual conundrum with shifting “best approaches” over time. From our perspective, merging the existing chemicals function of the Chemical Control Division (CCD) with those of the National Program Chemicals Division (NPCD) into an Existing Chemicals Management Division makes sense. The existing NPCD branches that cover legacy chemical issues (e.g., lead, polychlorinated biphenyls (PCB), mercury, and asbestos) will presumably become risk management branches tasked with overseeing risk management activities for those chemicals under the amended Toxic Substances Control Act (TSCA or new TSCA). The other “first ten” risk evaluation chemicals that are currently being managed by the existing chemicals staff in CCD will become other risk management branches in the new structure. Creating a separate New Chemicals Management Division also makes sense in light of the challenges encountered by the office in its early implementation of Section 5 under new TSCA. Such a division will ensure a tight management focus on new chemicals issues without the need to also juggle complex existing chemicals issues. While this could present concerns regarding divergent decisions and policies between the two divisions, this seems to be less of an issue since the requirements in Sections 5 and 6 differ so much.
More information and commentary on this reorganization is available in our memorandum.
On April 26, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt was grilled by Members of the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Environment at a hearing titled The Fiscal Year 2019 U.S. Environmental Protection Agency Budget. The budget was plainly not the primary topic as the House Committee Members covered a lot of ground. Pruitt fielded many questions and comments from House Democrats on his alleged ethical lapses regarding spending, security details, retaliation towards EPA employees who reportedly questioned his practices, and concerns about a hostile work environment. Lawmakers from both sides of the aisle expressed concern over the installation of a secure phone booth in his office. His opening statement addressed these criticisms only vaguely, stating that they are merely a distraction and an attempt to “attack and derail the President’s agenda and these administration’s priorities.” There were also questions concerning the delay of the proposed rule banning the use of methylene chloride, and criticism regarding EPA’s recent proposed rule to strengthen transparency in regulatory science (the “secret” Science Rule).
No attempt is made here to summarize the lengthy hearing.
Pruitt’s testimony statement is available here. It does not contain information on the Science Rule, but it briefly references the implementation of the Toxic Substances Control Act (TSCA) in a section entitled “Ensuring the Safety of Chemicals in Commerce.”
More information on the many TSCA implementation initiatives is available on our TSCA Reform News & Information webpage, as well as the TSCAblogTM. A summary of Pruitt’s testimony before the Senate Committee on Environment and Public Works is available in our blog item “Pruitt Addresses Legacy Issues, TSCA Implementation in Oversight Hearing.”
On April 24, 2018, the U.S. Environmental Protection Agency (EPA) announced that it would be presenting a webinar to assist processors with reporting under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule, published in the Federal Register on August 11, 2017. This webinar, scheduled for May 23, 2018, from 1:00 p.m. to 4:00 p.m. (EDT) will “include an overview of reporting requirements for processors, a demonstration of the electronic reporting application (Central Data Exchange, or CDX), and will provide time for questions and answers.” Registration for the webinar is not required. The webinar will be available through the following link on May 23: http://epawebconferencing.acms.com/tsca_inventory/. A link to access the TSCA Inventory is available here. The upcoming deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.
EPA to Provide Supplemental Analysis of Alternative Small Business Size Standard Definitions in User Fees Rulemaking Docket and Extend User Fees Rulemaking Comment Period
On April 24, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register that it will be adding a supplemental analysis, “Supplemental Analysis of Alternative Small Business Size Standard Definitions and their Effect on TSCA User Fee Collection,” to the rulemaking docket for the User Fees for the Administration of the Toxic Substances Control Act (TSCA) proposed rule published on February 26, 2018. EPA will also be extending the comment period for the proposed rule for an additional 30 days “to give interested parties the opportunity to consider this additional analysis and prepare meaningful comments.” Comments will be due within 30 days of publication (by May 24, 2018). The original comment deadline was April 27, 2018.
Regarding the supplemental analysis, EPA states that it “provides additional estimates for the impact of setting the small business definition based on an employee-based threshold.” More information on the proposed rule is available in our February 9, 2018, memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”
On April 19, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) proposed rule entitled “Strengthening Transparency and Validity in Regulatory Science.” This new proposed rule, item 2080-AA14, has not been published in the regulatory agenda; the only information available concerning the content of this rule is its title.
On April 11, 2018, OIRA received an advanced notice of proposed rulemaking from EPA entitled “Increasing Consistency and Transparency in Considering Costs and Benefits in the Rulemaking Process.” The OIRA 2017 Fall Regulatory Agenda for this rulemaking, item RIN 2010-AA12, states that EPA is considering “developing implementing regulations that would increase consistency across EPA divisions and offices, increase reliability to affected stakeholders, and increase transparency during the development of regulatory actions,” and that by developing implementing regulations through a notice-and-comment rulemaking process “it will provide the public with a better understanding on how EPA is evaluating costs when developing a regulatory action and allow the public to provide better feedback to EPA on potential future proposed rules.”
More information on regulatory agenda items is available on our blog under key phrase regulatory agenda.
The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available. For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following:
EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices received under the Active-Inactive Rule. EPA also posted a list of substances reported in a Notice of Activity Form A from February 8 through March 30, 2018. According to EPA, this list should assist processors in determining which of their substances on the Inventory have not yet been designated as “active” to date. Based on our review, the Inventory lists approximately 38,303 total active substances, or about 44.5 percent. The deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.
If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking. Our TSCA experts would be pleased to assist you with the reporting process!
More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under the key phrase TSCA Inventory and on our TSCA Reform News & Information web page. More information on EPA’s Final TSCA Inventory Notification (Active-Inactive) Rule is available in our memorandum, “EPA Issues Final TSCA Framework Rules.” Specific information on changes in the CDX system is available in our blog item, “EPA Updates eNOA Template in CDX System.”