By Lynn L. Bergeson, Carla N. Hutton, and Jessie Nguyen
On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan. OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.” Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) that are related to the Toxic Substances Control Act (TSCA):
- Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions (RIN 2070-AJ65): EPA promulgated a final rule under TSCA Section 5 to establish notification procedures for review of certain new microorganisms before they are introduced into commerce. EPA received petitions to add Trichoderma reesei and Bacillus amyloliquefaciens to the list of microorganisms that may be used as recipient microorganisms to qualify for the exemption from full notification and reporting. Based on EPA’s evaluation of these petitions, EPA states that it made a preliminary determination that certain strains of both microorganisms will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism, provided that certain criteria for the introduced genetic material and the physical containment conditions are met, and issued a proposed rule. EPA is developing a revised proposal that will address concerns raised by commenters, and is considering expanding the earlier proposal to prohibit the inclusion of antibiotic resistance genes in the introduced genetic material in microorganisms qualifying for the TSCA Section 5(h)(4) exemption. EPA intended to issue a notice of proposed rulemaking (NPRM) in May 2018;
- Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate (PFAS) Chemical Substances; Significant New Use Rule (SNUR) (RIN 2070-AJ99): EPA is developing a SNUR under TSCA Section 5(a)(2) for LCPFAC chemical substances, and for perfluorooctanoic acid (PFOA) or its salts. On January 21, 2015, EPA proposed to amend a SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses. EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles. In addition, EPA proposed to amend a SNUR for PFAS chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets. EPA intended to issue a supplemental NPRM in May 2018 following changes to TSCA brought about by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. EPA plans to issue a final rule in July 2019;
- Procedural Rule: Review of Confidential Business Information (CBI) Claims for the Identity of Chemicals on the TSCA Inventory -- Amended TSCA Section 8(b)(4)(C) (RIN 2070-AK21): EPA is developing a proposed rule to implement TSCA Section 8(b)(4)(C), which requires EPA to establish a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the active TSCA Inventory. EPA intends to publish an NPRM in January 2019 and a final rule in December 2019;
- TSCA Chemical Data Reporting (CDR) Revisions (RIN 2070-AK33): EPA will revise the reporting requirements to align better with new TSCA requirements. EPA intends to issue an NPRM in September 2018 and a final rule in September 2019;
- Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (RIN 2070-AJ94): On July 28, 2016, EPA issued a rule proposing changes to the applicable Significant New Uses of Chemical Substances regulations to align EPA’s regulations, where possible, with the final revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standards. EPA intends to issue a final rule in September 2018;
- Certain Nonylphenols (NP) and Nonylphenol Ethoxylates (NPE); SNUR (RIN 2070-AJ96): On October 1, 2014, EPA issued a proposed SNUR under TSCA Section 5(a)(2) for certain NPs and NPEs. EPA intends to issue a final SNUR in December 2018;
- Mercury; Reporting Requirements for the TSCA Mercury Inventory (RIN 2070-AK22): On October 26, 2017, EPA issued a rule proposing reporting requirements under TSCA Section 8(b)(10)(D) 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.” EPA intends to issue a final rule in June 2018; and
- Service Fees for the Administration of TSCA (RIN 2070-AK27): On February 26, 2018, EPA issued a rule proposing to implement TSCA Section 26(b)(1), which authorizes EPA to issue a rule to establish fees to defray the cost of administering Sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under Section 14 information on chemical substances. EPA intends to issue a final rule in August 2018.
By Lynn L. Bergeson and Carla N. Hutton
On June 6, 2018, the New York State Department of Environmental Conservation (NYSDEC) released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program. The Disclosure Program is similar to the recently enacted California Cleaning Product Right to Know Act of 2017 which requires the disclosure of cleaning product ingredients by way of website or product label. The Household Cleansing Product Information Disclosure Program requires manufacturers of cleaning products sold in New York to disclose chemical ingredients and identify any ingredients that appear on authoritative lists of chemicals of concern on their websites. New York states that it “will be the first state in the nation to require such disclosure and the State’s program goes beyond initiatives in other states by requiring the robust disclosure of byproducts and contaminants, as well as chemicals with the potential to trigger asthma in adults and children.” NYSDEC has posted the Household Cleansing Product Information Disclosure Program Certification Form and Program Policy and a response to comments.
Our recent memorandum provides an in-depth review of important information from the Disclosure Program Certification Form and Program Policy, including covered products and definitions, information to be disclosed, the lists of chemicals of concern covered by the Program, and the effective dates. With the first disclosures due July 1, 2019, manufacturers need to review the Program Policy and begin compiling information concerning the ingredients of their products.
By Christopher R. Bryant
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:
- Explosives and related matters;
- Listing, classification, and packing;
- Electric storage systems;
- Transport of gases;
- Global harmonization of regulations on the Transport of Dangerous Goods with the Model Regulations;
- Guiding principles for the Model Regulations;
- Cooperation with the International Atomic Energy Agency;
- New proposals for amendments to the Model Regulations;
- Issues relating to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS); and
- Miscellaneous issues.
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.
By Lynn L. Bergeson and Margaret R. Graham
On June 1, 2018, the U.S. Environmental Protection Agency (EPA) released the much anticipated first ten problem formulation documents; its systematic review approach document; and a significant new use rule (SNUR) proposal enabling it to prevent new uses of asbestos for public comment. Links and short summaries are provided below.
EPA states that the problem formulation documents refine the conditions of use, exposures, and hazards presented in the scope of the risk evaluations for the first ten chemicals to be evaluated under the Toxic Substances Control Act (TSCA) and present refined conceptual models and analysis plans that describe how EPA expects to evaluate the risks and that they are an important interim step prior to completing and publishing the final risk evaluations by December 2019. Comments on the problem formulation documents will be due 45 days after these documents are published in the Federal Register. The problem formulation documents are:
- 1-Bromopropane (1-BP);
- Carbon Tetrachloride;
- Cyclic Aliphatic Bromide Cluster (HBCD Cluster);
- Methylene Chloride;
- N-Methylpyrrolidone (NMP);
- Pigment Violet 29; and
- Trichloroethylene (TCE).
EPA states the systematic review approach document will guide its selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information. Comments will be due 45 days after publication in the Federal Register. Also included on the systematic review web page is EPA’s Response to Public Comments Related to the Supplemental Files Supporting the TSCA Scope Documents for the First Ten Risk Evaluations.
For asbestos, EPA is proposing an asbestos SNUR for certain uses of asbestos (including asbestos-containing goods) that would require manufacturers and importers to receive EPA approval before starting or resuming manufacturing, and importing or processing of asbestos. EPA states that this review process, the first such action on asbestos ever proposed, would provide EPA with the opportunity to evaluate the intended use of asbestos and, when necessary, take action to prohibit or limit the use. Comments will be due 60 days after publication in the Federal Register.
More information on the first ten chemical evaluations is available on our blog. A more detailed analysis will be available next week on our regulatory developments webpage.
By Lynn L. Bergeson and Margaret R. Graham
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.
By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham
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.
By Susan M. Kirsch
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:
- To share information on efforts to characterize risks from PFAS and to develop monitoring and remediation technologies/techniques;
- To identify near-term actions to address current state and local challenges; and
- To develop risk communication strategies to address public concerns and questions surrounding PFAS.
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.
By Richard E. Engler, Ph.D. and Margaret R. Graham
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:
- EPA Case Number: P-16-0415; chemical name: generic: polyurethane; polymer exemption flag (generic name); intended uses: coating for oil and gas industry; known and reasonably foreseen use(s): paint additive and coating additive.
- EPA Case Number: P-18-0002; chemical name: generic: phosphinic acid, P,P-alkyl-, salt (generic name); intended use(s) (specific): chemical intermediate for a non-halogenated flame retardant; known and reasonably foreseen use(s): chemical intermediate; flame retardant.
- EPA Case Number: P-18-0021; chemical name: generic: dicarboxylic acids, polymers with substituted poly (substituted alkendiyl), 3-hydroxy-2-(hydroxyalkyl)-2-alkylalkenoic acid, 5-substituted-1-(substituted alkyl)-1,3,3-trialkyl carbomonocyle, alkanediol, alkane-triol, alcohol blocked compounds with aminoalcohol; polymer exemption flag (generic name); intended use(s) (generic): paint; known and reasonably foreseen use(s): adhesive and sealant chemical.
- EPA Case Numbers: P-18-0044 - 0045:
- P-18-0044: chemical name: generic: fatty acids (generic name); intended use(s) (generic): intermediate species known and reasonably foreseen use(s): chemical intermediate; lubricant and lubricant additive; viscosity adjustor; coating.
- P-18-0045: chemical name: generic: fatty acids, alkyl esters; intended use(s) (generic): application coating; known and reasonably foreseen use(s): lubricant intermediate; mold release agent; plasticizer; processing aid.
- EPA Case Number: P-18-0083; chemical name: specific: 2-propenoic acid, telomers with bualc.-2-[(2-propen-1-yloxy)methyl]oxirane reaction products, sodium bisulfite and sodium 2-hydroxy-3-(2-propen-1-yloxy)-1-propanesulfonate(1:1), sodium salts, peroxydisulfuric acid([(HO)S(O)2]2O2) sodium salt (1:2)-initiated. (CASRN: 2118944-42-4); intended use(s) (generic): dispersant additive; known and reasonably foreseen use(s): chelating agent.
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.
By Lynn L. Bergeson and Margaret R. Graham
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.”
By Susan M. Kirsch and Margaret R. Graham
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.