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.
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.”
The U.S. Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) have released an educational primer on U.S. and Canadian regulations regarding chemical substances. EPA states that the purpose of the primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations -- Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada. EPA, ECCC, and HC previously collaborated in the implementation of a Regulatory Cooperation Council (RCC) Work Plan on Chemicals Management that focused on SNURs and SNAcs. The primer states that an overarching issue identified during the roundtable discussions was the need for improved outreach and education, ranging from the basics of the SNUR/SNAc programs to specific requirements for various stakeholders, especially for potentially less-informed stakeholder groups, such as foreign suppliers, and small, niche companies in the U.S. and Canada. According to EPA, information in the primer will assist the regulated community to determine how to comply and engage their supply chains to help facilitate compliance for meeting SNUR and SNAc requirements. The primer notes that it does not substitute for any SNUR or SNAc provisions, nor is it a rule itself. The primer does not impose legally binding requirements on the regulated community or on EPA, ECCC, or HC.
The National Academies of Sciences, Engineering, and Medicine released a new report on April 11, 2018, that finds that the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has made “substantial progress” in implementing recommendations outlined by the National Academies in previous reports. According to the April 11, 2018, press release, the transformation of IRIS began several years ago, after the release of a 2011 National Academies report that provided suggestions for creating a more systematic and transparent IRIS process. In a 2014 report, the National Academies reviewed the changes implemented by EPA since 2011 and concluded that the improvements were considerable. Under the Program’s new leadership, EPA asked the National Academies to review again its progress toward addressing past recommendations. The press release states that the National Academies’ latest review, Progress Toward Transforming the Integrated Risk Information System (IRIS) Program, finds that the IRIS Program has made substantial progress in incorporating systematic-review methods into its process and assessments. The IRIS Program has also established a systematic-review working group and engaged subject-matter experts. According to the report, these groups should increase efficiency and consistency among assessments and improve the scientific rigor of the assessments. Although the National Academies Committee to Review Advances Made to the IRIS Process “offers some refinements and identifies a few possibilities for further development,” the report states that “its overall conclusion is that EPA has been responsive and has made substantial progress in implementing National Academies[’] recommendations.”
EPA Appoints Additional Members to Science Advisory Committee on Chemicals; NGO Scientists Decline Appointment
On March 22, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt appointed 11 additional members to the Science Advisory Committee on Chemicals. Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the purpose of the Committee is to provide independent advice and expert consultation, at the request of the EPA Administrator, with respect to the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures or approaches supporting implementation of the Act. According to EPA, these additional members “will increase the balance of scientific perspectives and add experts with experience in labor, public interest, animal protection and chemical manufacturing and processing to the committee.” The additional 11 members -- three from non-governmental organizations (NGO), four from industry, and four from academia or governmental organizations -- will supplement the 18 expert members that were appointed on January 19, 2017. The Committee will meet three to four times a year for two years, and its charter can be extended. EPA has not yet scheduled the Committee’s first meeting.
Two of the members have reportedly declined the appointment. Dr. Michael Wilson, National Director for Occupational and Environmental Health at the BlueGreen Alliance, “notified EPA that he was unable to accept the appointment,” according to a spokesperson for the BlueGreen Alliance. Dr. Jennifer McPartland, Senior Scientist at the Environmental Defense Fund, has also declined the appointment. Ruthann Rudel, Director of Research at the Silent Spring Institute, stated that she is “collecting some advice and information” and has not decided whether to accept the appointment.
On April 4, 2018, the U.S. Environmental Protection Agency (EPA) announced the following management changes in its Office of Pollution Prevention and Toxics (OPPT):
These are significant leadership changes and are likely intended to maximize OPPT efficiency. We applaud OPPT’s continuing efforts to implement TSCA and the changes occasioned by the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act almost two years ago.
On March 28, 2018, the Superior Court of California, Los Angeles County, issued its Statement of Decision (Phase II) (Defendants’ Alternative Significant Risk Level (ASRL) Affirmative Defense) that found that the defendants failed to meet their burden of proof on their ASRL affirmative defense. Council for Education and Research on Toxics (CERT) v. Starbucks Corporation (Starbucks), No. BC435759 (L.A. Super. Ct., filed April 13, 2010). CERT’s (plaintiff) complaint alleged that Starbucks, along with 18 other defendants (the total later reached 91 defendants when a second action was filed (now consolidated)), that sell ready-to-drink coffee failed to provide warnings to consumers that the coffee sold contained high levels of acrylamide, a carcinogenic chemical, in violation of Proposition 65 (Prop 65). The defendants denied the material allegations and asserted various affirmative defenses, violation of the First Amendment, and federal preemption. According to the order, the parties did not dispute that acrylamide, listed as a carcinogen by the International Agency for Research on Cancer (IARC), and under Prop 65 since 1990, is listed by the State of California as a chemical believed to cause cancer; or that they failed to provide warnings to consumers that the ready to drink coffee they sold contained high levels of acrylamide.
In Phase I of the trial, the court came to a similar conclusion, that defendants failed to meet their burden of proof by preponderance of evidence on their affirmative defenses of “no significant risk level,” First Amendment, and federal preemption to avoid the requirement of cancer warning labels as to the existence of acrylamide in brewed coffee. The trial on Phase II of the case ran from September 2017 to November 2017 and post-trial briefs were filed in December 2017 and January 2018. The order states that to have prevailed on their ASRL defense, defendants needed prove all of the below, which they failed to do:
The ASRL affirmative defense is grounded on an exemption to the cancer hazard warning requirement under Prop 65, but as the defendants were not able to prevail on this defense, they will now be required to provide the Prop 65 warning language on their ready-to-drink coffee products, but the order does not specify any details regarding this. The decision also exposes the defendants to liability in terms of millions in fines. The defendants have until April 10, 2018, to file objections to the decision.