This quarterly newsletter provides updates on litigation, regulatory, legislative, and other notable developments involving chemicals of concern to business. Our present focus is on substances which are the subject of regulatory activity or scrutiny by various government agencies and potential litigants. This includes emerging contaminants, as well as substances identified by the Environmental Protection Agency (EPA or the Agency) under the 2016 amendments to the Toxic Substances Control Act (TSCA) for prioritization, risk evaluation, or regulation. We hope you find this publication informative, and we welcome your feedback on chemicals of interest to your organization. Read the entire newsletter online.
» Litigation
Case Challenging EPA Denial of Fluoridation Rulemaking Petition Held in Abeyance and Plaintiffs Directed to File New Petition
A federal district court in California issued an order holding in abeyance the lawsuit challenging EPA's denial of a TSCA Section 21 petition requesting that EPA regulate fluoridation of drinking water pursuant to Section 6(a) of TSCA. The court also directed the plaintiffs to submit a new petition to EPA. The court said plaintiffs needed to address "serious standing issues" and that recent scientific developments needed consideration.
Summary Judgment Motions Attack and Defend EPA Denial of Petition to Require Asbestos Reporting
Plaintiffs and EPA have filed summary judgment motions in two cases challenging EPA's denial of rulemaking petitions requesting that the Chemical Data Reporting Rule be amended to require reporting on asbestos. The plaintiffs argue the reporting is necessary to provide information for the ongoing risk evaluation of asbestos.
Second Circuit Vacated Reporting Exemption for Importers of Mercury-Containing Products but Upheld Two Other Mercury Reporting Exemptions
The Second Circuit Court of Appeals vacated an exemption for importers of assembled products containing mercury-added components in the 2018 Mercury Reporting Rule and upheld two other exemptions—one for manufacturers of products with mercury-added components and the other for manufacturers or importers of elemental mercury or mercury compounds in higher volumes.
» Federal Developments
Legislative Developments
Senators Identified Priority PFAS Provisions for Inclusion in Defense Bill
Senator Jeanne Shaheen and 20 other senators sent a letter to the committees negotiating the Fiscal Year 2021 National Defense Authorization Act, encouraging inclusion of five sections addressing per- and polyfluoroalkyl substances (PFAS) in the final bill (which is expected after the election), including increased funding for a health impacts study and requirements for PFAS blood testing for service members and their families and veterans.
House Appropriations Bill Would Bar EPA Withdrawal from Certain Regulation of PFOA and PFOS
An appropriations bill (H.R. 7608) passed by the House of Representatives would bar EPA from using funds to withdraw its preliminary regulatory determination to regulate perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) under the Safe Drinking Water Act or a yet-to-be-issued proposed rule designating PFOA and PFOS as "hazardous substances" under the Comprehensive Environmental Response, Compensation, and Liability Act.
Regulatory Developments
November 1 Deadline for CBI Substantiation for Active Substances on TSCA Inventory
By November 1, 2020, businesses that filed a Notice of Activity Form A to report a chemical substance as an "active" substance on the TSCA Inventory must substantiate any claim that the specific chemical identity of the substance constitutes confidential business information (CBI). Failure to submit by the deadline will result in EPA's denial of the claim.
November 30 Deadline for Chemical Data Reporting Submissions
The deadline for the current four-year cycle of reporting under the Chemical Data Reporting Rule is November 30, 2020. Manufacturers and importers must report if their production volume for a non-excluded chemical substance on the TSCA Inventory at a single site was at least 25,000 pounds for any reporting year between 2016 and 2019. A 2,500-pound threshold applies to substances that have been subject to certain regulatory or judicial actions under TSCA.
EPA Adopted Rule Intended to Improve Guidance Practices
Beginning on November 18, 2020, an EPA rule establishing procedures and requirements for issuance and maintenance of guidance will take effect. All effective, active guidance documents must be included on EPA's online portal, and guidance must meet certain minimum requirements. The rule provides that the public can petition EPA to modify or rescind active guidance or to reinstate rescinded guidance. EPA adopted the regulations to implement President Trump's 2019 executive order on "Promoting the Rule of Law Through Improved Agency Guidance Documents."
Environmental Groups Submitted TSCA Petition Asking EPA to Require PFAS Testing
The petition requests that the Agency require health and environmental effects testing of 54 PFAS the groups allege have been manufactured at a chemical production facility in Fayetteville, North Carolina. The petitioners sought issuance of a rule or order pursuant to TSCA Section 4 directing the manufacturer "to fund and carry out this testing under the direction of a panel of independent scientists."
EPA Released Final Scopes for Next 20 Risk Evaluations and Lists of Companies with Fee Obligations; Proposal for Fees Rule Amendments Goes to OMB
The final scope documents are for risk evaluations of the 20 substances that EPA designated as High-Priority Substances under TSCA Section 6 in December 2019. TSCA requires the risk evaluations to be completed by December 2022, with the possibility of a six-month extension. The companies subject to the fees obligations for a risk evaluation must contribute to a total fee of $1,350,000 for each evaluation, though EPA indicated it was considering "options for payment flexibilities" in light of the economic conditions caused by the COVID-19 pandemic. It is expected that EPA will propose certain exemptions to the fee obligations.
EPA in Process of Finalizing PBT Risk Management Rules
EPA has sent drafts of its final risk management rules for five persistent, bioaccumulative, and toxic (PBT) chemicals to the Office of Management and Budget for interagency review. The Agency has indicated that it plans to finalize these rules by the end of the year. TSCA Section 6(h) requires EPA to promulgate final risk management rules for the five chemicals by January 2021.
EPA Published Three Final Risk Evaluations; Two (So Far) Face Judicial Challenges
In June 2020, EPA issued its first final risk evaluation under the amended TSCA. The risk evaluation, for methylene chloride, found that the substance presents unreasonable risks to human health for 47 of the 53 conditions of use, including all consumer uses and most commercial uses. EPA faces two lawsuits challenging its findings of no unreasonable risk for other conditions of use. In August and September, EPA published two other final risk evaluations, for 1-bromopropane (1-BP) and for chemicals in the cyclic aliphatic bromide cluster (HBCD). The HBCD evaluation has been challenged in the Ninth Circuit.
Peer Review Reports Found Asbestos Risk Evaluation to Be Inadequate, Recommended Improvements to PCE and TCE Evaluations
Over the summer, the TSCA Science Advisory Committee on Chemicals (SACC) issued its peer review reports on the draft risk evaluations for asbestos, perchloroethylene (PCE), and trichloroethylene (TCE). The asbestos report stated that, overall, the draft evaluation "was not considered adequate and resulted in low confidence in the conclusions."
EPA Granted Manufacturer Request for Risk Evaluation of Siloxane
EPA granted a request submitted by the American Chemistry Council's Silicones Environmental, Health, and Safety Center on behalf of six manufacturers requesting that EPA conduct a risk evaluation of octamethylcyclotetrasiloxane (D4). EPA—which must now prepare a scope for its risk evaluation by April 6, 2021—posted a list of additional conditions of use that may warrant inclusion in the scope.
EPA Staffing News: Critical Report from Inspector General in August, Reorganization Plan in September
On August 17, 2020, EPA's Office of Inspector General issued an audit report that identified issues with EPA's resource planning. In September 2020, EPA officials advised staff of the Office of Chemical Safety and Pollution Prevention that the office was being reorganized with the intent of enabling the office to better handle the demands of the 2016 TSCA amendments and the pesticide office's functions addressing demands for new antimicrobial products in the face of the current health crisis.
Trade Groups Seeking Rule to Provide "Procedural Guardrails" for TSCA Risk Management Process
In June 2020, five trade associations submitted a petition to EPA requesting issuance of a risk management procedural rule under TSCA Section 6 to provide "procedural guardrails ... to guide EPA and affected stakeholders so that risk management is consistently applied and appropriately tailored." EPA determined that the Agency would consider the petition under the Administrative Procedure Act instead of under TSCA Section 21, which requires action by EPA within 90 days.
EPA Posted Plans to Issue Rules on Section 8(a) Reporting for Work Plan Chemicals and New Chemical Review Procedures
In the Spring 2020 unified regulatory agenda, EPA included items for a proposed rule under TSCA Section 8(a) that would require reporting on chemical substances included in the 2014 update of the TSCA Work Plan for Chemical Assessments and for amendments to the Agency's procedural regulations for new chemical review to reflect changes made in the 2016 amendments.
FDA and Manufacturers Announced Agreement to Phase Out Some Short-Chain PFAS from Food Packaging
The US Food and Drug Administration (FDA) announced that manufacturers of certain short-chain PFAS used for grease-proofing in food packaging materials had voluntarily agreed to phase out sales of the substances for use as food contact substances over three years, beginning in January 2021. The substances subject to the phase-out are a subset of short-chain PFAS that contain 6:2 fluorotelomer alcohol (6:2 FTOH).
EPA Finalized Significant New Use Rule for LCPFAC Substances that Encompasses Import of Certain Articles; Guidance Coming in December
An amended Significant New Use Rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) substances, as well as an amended SNUR for perfluoroalkyl sulfonate chemical substances, took effect on September 25. The final LCPFAC SNUR requires businesses to notify EPA at least 90 days before commencing manufacture, import, or processing of the specified chemical substances; it also requires notification prior to the import of articles containing certain LCPFAC substances as part of a surface coating. EPA has promised to issue long-awaited guidance clarifying the requirements in December of this year.
» State Regulatory & Legislative Action
California
California Laws Will Prohibit Certain Chemicals in Cosmetics, Require Disclosure of Ingredients in Cosmetic and Menstrual Products
Laws enacted in September 2020 will ban the sale and manufacture in California of cosmetic products containing certain intentionally added ingredients, including PFOA, PFOS, certain other PFAS, formaldehyde, and mercury and require disclosure of fragrance and flavor ingredients in cosmetics. A third law will require ingredient labels on menstrual product packaging.
Colorado
Colorado to Ban PFAS-Containing Firefighting Foams at Public-Use Airports in 2023 and Require Certificates of Registration for Facilities that Use and Store PFAS
A new law in Colorado amends 2019 restrictions on testing uses of PFAS-containing firefighting foams and establishes a ban on use of PFAS-containing firefighting foams at Federal Aviation Administration-designated public-use airports in Colorado beginning January 1, 2023. The 2020 law also requires establishment of a program for issuing certificates of registration to facilities and fire departments that use or store PFAS.
Maine
Maine Requires Reporting on PFOS-Containing Children's Products
PFOS and certain PFOS salts have been designated as "priority chemicals" under Maine's Safer Chemicals in Children's Products program, triggering reporting requirements for manufacturers and distributors of 10 categories of products.
Massachusetts
Massachusetts Set Single Drinking Water Standard for Sum of Six PFAS
The Massachusetts Department of Environmental Protection adopted a maximum contaminant level of 20 parts per trillion for the sum of six PFAS: PFOS; PFOA; perfluorohexane sulfonic acid (PFHxS); perfluorononanoic acid (PFNA); perfluoroheptanoic acid (PFHpA); and perfluorodecanoic acid (PFDA).
Michigan
Michigan Adopted Drinking Water Limits for Seven PFAS
On July 27, 2020, regulations setting maximum contaminant levels for seven PFAS were filed with the Michigan Secretary of State. The Department of Environment, Great Lakes, and Energy said the standards would apply to approximately 2,700 public water supplies and result in the addition of 42 sites to a portfolio of sites undergoing investigation by the Michigan PFAS Action Response Team.
New Michigan Laws Restrict and Impose Requirements on Use of PFAS-Containing Firefighting Foam
On July 8, 2020, Michigan enacted a law requiring reporting of any use of PFAS-containing firefighting foams immediately after the end of a fire or other incident. A second law prohibits use of PFAS-containing firefighting foam for training of firefighters and requires training on the proper use and handling of such firefighting foams.
New Hampshire
With Regulatory Standards Held Up in Court, New Hampshire Enacted PFAS Maximum Contaminant Levels
In July, New Hampshire Governor Chris Sununu signed legislation that established maximum contaminant levels and ambient groundwater quality standards for four PFAS. After this legislative enactment of standards, a state court vacated an injunction that had prevented enforcement of similar regulatory standards. The new law also creates low-interest loan programs for certain water systems and wastewater and/or wastewater residual treatment or storage facilities affected by PFAS.
New Jersey
New Jersey Adopted PFOA and PFOS Drinking Water Standards
Effective June 1, 2020, the New Jersey Department of Environmental Protection adopted maximum contaminant levels for PFOA and PFOS. The amendments to the New Jersey Safe Drinking Water Act regulations also include monitoring requirements for PFOA and PFOS. In addition, NJDEP amended regulations concerning discharges of hazardous substances, groundwater quality standards, and private well testing.
New York
Drinking Water Standards for PFOA, PFOS, and 1,4-Dioxane Took Effect in New York
Drinking water standards for 1,4-dioxane, PFOA, and PFOS took effect on August 26, 2020 in New York. Adoption of the standards triggers monitoring obligations for public water systems. Public water systems can request deferrals of violations if they have plans in place to achieve compliance.
Washington
Washington Identifies 11 Priority Consumer Products for Potential Regulation
The Washington Department of Ecology completed the second phase of its implementation of its Safer Products for Washington program by submitting a report to the legislature that identified 11 priority consumer products that are significant sources or uses of a priority chemical. Ecology is now investigating whether there are safer alternatives to the products.
Wisconsin
Emergency Rule Under Consideration to Implement New Restrictions on PFAS-Containing Firefighting Foam
On October 28, 2020, the Wisconsin Natural Resources Board considered a proposed emergency rule to implement requirements of a law enacted in February that bans the use and discharge, including for training purposes, of firefighting foam containing intentionally added PFAS. The proposed rule would establish requirements for uses exempted from the ban.
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