U.S. EPA Releases its PFAS Strategic Roadmap
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
On Monday, October 18, 2021, U.S. EPA released its PFAS Strategic Roadmap (Roadmap) outlining the agency’s three-year strategy for addressing per- and polyfluoroalkyl substances (PFAS). The Roadmap acknowledges that U.S. EPA cannot solve the problem of “forever chemicals” by tackling only one route of exposure or one use at a time. Instead, the Roadmap outlines a multi-pronged approach with specific emphasis on the following:
- Accounting for the full lifecycle of PFAS, their unique properties, the ubiquity of their uses, and the multiple pathways for exposure;
- Focusing on preventing PFAS from entering the environment in the first instance which is a foundational step in reducing the exposure and risks of PFAS contamination;
- Holding polluters accountable for releases of PFAS into the environment;
- Investing in scientific research to fill gaps in understanding PFAS to drive science-based decision making; and
- Ensuring that disadvantaged communities have equitable access to solutions.
In order to achieve these objections, U.S. EPA’s Roadmap identifies the following specific agency actions:
- U.S. EPA’s Office of Chemical Safety and Pollution Prevention commits to:
- Publish a national PFAS testing strategy to generate toxicity data on PFAS compounds (Fall 2021);
- Ensure robust TSCA review for new PFAS chemical submissions (ongoing);
- Review previous TSCA regulatory decisions to ensure that the those decisions were sufficient protective of human health and the environment (ongoing);
- Enhance PFAS reporting under the Toxics Release Inventory (Spring 2022); and
- Finalize new PFAS reporting under TSCA Section 8 (Winter 2022).
- U.S. EPA’s Office of Water commits to:
- Finalize the Fifth Unregulated Contaminants Monitoring Rule to require testing for 29 PFAS substances (Fall 2021);
- Establish an MCL for PFOA and PFOS (Fall 2023);
- Finalize the toxicity assessments for GenX and five additional addition PFAS compounds (Fall 2021);
- Publish health advisories for GenX and PFBS (Spring 2022);
- Set Effluent Limitations Guidelines to restrict PFAS discharges nine different industrial categories (2022); and
- Leverage the National Pollutant Discharge Elimination System (NPDES) program to reduce the discharges of PFAS and obtain more comprehensive information on PFAS discharges (Winter 2022).
- S. EPA’s Office of Land and Emergency Management commits to:
- Designate PFOA and PFOS as CERCLA hazardous substances (Summer 2023);
- Evaluate designation of other PFAS compounds as CERCLA hazardous substances (Spring 2022); and
- Issue updated guidance on the destruction of PFAS and PFAS-containing materials (Fall 2023).
In addition to U.S. EPA’s Roadmap, the White House announced ongoing efforts by the following seven agencies to address PFAS pollution: the White House Council on Environmental Quality (CEQ), the Departments of Defense, Agriculture, Homeland Security, and Health and Human Services, Food and Drug Administration, and the Federal Aviation Administration. We will continue to track these ongoing efforts to regulate PFAS at the Corporate Environmental Lawyer blog.
California Law Adds New Restrictions on Recyclability Claims
By Allison A. Torrence
On October 5, 2021, California Governor Newsom signed SB 343, addressing recyclability claims on products and in advertising. The Act amends existing sections of California’s Business and Professions Code as well as the Public Resource Code relating to environmental advertising. These laws collectively provide California’s version of recyclability consumer protection laws, similar to but going beyond the Federal Trade Commission Guides for the Use of Environmental Marketing Claims (“Green Guides”).
Prior to SB 343, existing California law made it unlawful for any person to make any untruthful, deceptive, or misleading environmental marketing claim, and required that environmental marketing claims be substantiated by competent and reliable evidence. Additionally, a person making any recyclability claims was required to maintain written records supporting the validity of those representations, including whether, the claims conform with the Green Guides.
Those requirements are generally left intact, with additional obligations added by SB 343. The first big change made by SB 343 is to specifically add the use of the chasing arrow symbol as a way that a person might make a misleading environmental marketing claim in marketing or on a product label. (Business and Professions Code § 17580(a).) Next, SB 343 requires the Department of Resources Recycling and Recovery, by January 1, 2024, to update regulations requiring disposal facilities to provide information on recycling data. Based on the information published by the department, a product or packaging is considered recyclable only if the product or packaging is collected for recycling by recycling programs for jurisdictions that collectively encompass at least 60% of the population of the state. (Public Resources Code § 42355.51(d)(2).) The new law also provides additional criteria related to curb-side recycling, that grow more stringent over time, and PFAS content of plastic material, among other provisions. (Public Resources Code § 42355.51(d)(3).) A person making recyclability claims must keep written records of whether the consumer good meets all of the criteria for statewide recyclability pursuant to these new provisions. (Business and Professions Code § 17580(a)(6).)
Finally, while existing California law governed what resin identification code could be placed on plastic containers (i.e., #1 PETE, #2 HDPE), SB 343 states that resin identification code numbers cannot be placed inside a chasing arrows symbol unless the rigid plastic bottle or rigid plastic container meets the new statewide recyclability criteria discussed above. (Public Resources Code § 18015(d).)
This new law is another hurdle facing companies making environmental marketing claims. For companies selling products in California, it is not sufficient to simply follow the FTC Green Guides. Instead, companies must be aware of the specific nuances and requirements in California and developments in other states.
Analysis of Recent and Forthcoming State Legislation on Toxic Chemicals in Cosmetics and Personal Care Products and Preemptive Effects of Existing Federal Legislation
By Matthew G. Lawson
According to a report released in February 2021 by the organization Safer States, at least 27 US states will consider proposed legislation to regulate toxic chemicals in 2021. While a large driver of the proposed state laws is growing public concern over drinking water contamination from “emerging contaminants,” including PFAS (per- and polyfluorinated alkyl substances) and 1,4-dioxane, a secondary focus has been to minimize the risk of adverse human health effects from exposure to these toxic chemicals in cosmetics and personal care products. Two states—New York and California—are spearheading these efforts through recently enacted laws to limit or prohibit certain toxic chemicals in cosmetics and personal care products that are set to take effect in 2022 and 2025, respectively. As other states consider their own bills to enact similar regulation of chemicals in cosmetics and personal care products, heightened attention will likely be paid to what extent the existing federal regulation of these products may preempt this new wave of state legislation.
- Federal Regulation of Chemicals in Cosmetics and Personal Care Products
At the federal level, chemicals used in cosmetics and other personal care products are primarily regulated by either the Toxic Substrates Control Act (TSCA) or the Federal Food, Drug, and Cosmetic Act (FD&C Act). While TSCA broadly applies to any “chemical substance,” certain chemicals or uses of chemicals are exempt from TSCA if they are regulated by other federal statutes. Such products include “cosmetics” regulated by the FD&C Act, which are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.” While the distinction between a cosmetic and personal care product may not always be apparent to the consumer, the difference is crucial with respect to federal oversight of the chemicals contained in the product.
Non-cosmetic, personal care products are regulated under TSCA, as amended by the Frank R. Lautenberg Chemical Safety Act of the 21st Century, which requires the Environmental Protection Agency (EPA) to identify “high-priority chemicals” used in existing commerce and determine whether any current uses of the chemicals “present an unreasonable risk of injury to health or the environment.” Where an unreasonable risk is identified, the EPA has discretion to impose conditions on or outright ban the chemical use. Prior to introducing a new chemical or new use of an existing chemical into commerce, manufacturers are required to provide notice to the EPA so that the agency may assess whether the proposed chemical or use will pose an unreasonable risk. In contrast, chemicals used in cosmetic products are regulated by the Food and Drug Administration (FDA) pursuant to the FD&C Act and generally do not require registration or preapproval by the agency before being introduced into commerce. Moreover, the FDA does not have authority to require a recall where it identifies a potential health hazard in a cosmetic product. However, the FDA does have authority to regulate the labeling of cosmetic products and to outright ban specific ingredients from being used in cosmetics generally.
- State Regulation of Chemicals in Cosmetics and Other Personal Care Products—Newly Enacted Laws and Anticipated Future Legislation
While the regulation of chemicals in cosmetic and personal care products has historically been left to the purview of the EPA and the FDA, in recent years a growing number of states have expressed interest in directly regulating chemicals in cosmetic and personal care products sold within their jurisdictions. In 2019 and 2020, state regulation of these chemicals took a significant step forward as New York and California signed into law two bills regulating chemicals used in cosmetic and/or personal care products. A brief description of both state laws is provided below.
- New York: On December 9, 2019, Governor Cuomo signed into law New York Senate Bill 4389-B/A.6295-A, making New York the first and only state to set a maximum contaminant limit of 1,4-dioxane in consumer products. While there are no direct consumer uses of 1,4-dioxane, the compound may be present in cosmetics and personal care products as a byproduct of the manufacturing process (according to one 2007 Study, approximately 22% of cosmetic and other personal care products may contain 1,4-dioxane). New York’s legislation, which takes effect on December 31, 2022, prohibits the sale of personal care products containing more than 2 ppm of 1,4-dioxane and the sale of cosmetic products containing more than 10 ppm of 1,4-dioxane.
- California: On September 30, 2020, Governor Newsom signed into law the Toxic-Free Cosmetics Act, California Assembly Bill 2762, banning 24 chemicals, including mercury, formaldehyde, and certain types of PFAS, from being used in cosmetic, beauty, and personal care products sold in California. California’s legislation is set to take effect in 2025 and will mark the first state-level prohibition on the various chemicals in cosmetic products.
In addition to New York and California’s recently enacted legislation, there are at least five bills currently being considered by various states that would further regulate chemicals in cosmetic and/or personal care products sold within the respective jurisdictions. A brief summary of these state bills is provided below:
- Connecticut: SB 404—Prohibiting the sale or distribution of consumer products that contain PFAS (currently before the Joint Committee on Public Health).
- Maryland: HB 0643—Prohibiting the sale or distribution of cosmetic products that contain PFAS, mercury, and other chemicals in certain instances (currently passed in both chambers and before the Governor).
- New Jersey: A 189 / S 1843—Prohibiting the sale and distribution of nail salon products that contain dibutyl phthalates, toluene, or formaldehyde (currently before the Assembly Consumer Affairs Committee); A 1720—Prohibiting the sale of hand sanitizers and body cleaning products containing triclosan (currently before the Assembly Consumer Affairs Committee).
- New York: A 143 / S 3331—Creating a list of “chemicals of concerns” known to exist in personal care products, requiring manufacturers of such products to disclose any chemicals of concerns contained in their products and prohibiting the sale of personal care products containing chemicals of concerns after three years (currently referred to Environmental Conservation Committee).
- Federal Preemption of State Laws
As more states continue to adopt new legislation to regulate chemicals in cosmetic and personal care products, manufacturers and/or trade organizations will likely bring preemption challenges to these state regulations. In the context of cosmetic products, the FD&C Act prohibits state or local governments from enacting “any requirement for labeling or packaging of cosmetics that is different from or in addition to, or that is otherwise not identical with” the federal rules. Thus, state laws that do not directly regulate the labeling or packing of cosmetics products but instead regulate the contents of these products will likely not run afoul of the FD&C Act’s preemption clause.
In contrast, state legislation governing chemicals in personal care products may be at a higher risk of being preempted by TSCA. TSCA broadly prohibits the enforcement of any state chemical regulation of a particular substance once the EPA completes a risk evaluation for the substance and either: (1) determines that the chemical will not present an unreasonable risk; or (2) concludes that the chemical presents an unreasonable risk under the circumstances of use, and promulgates a rule that restricts manufacturing or use of the chemical to mitigate the identified risks. Notably, the scope of TSCA’s preemption extends only to chemical uses examined in the EPA’s risk evaluation—meaning that the EPA’s failure to examine the use of a chemical in personal care products would make state regulation fair game. In addition, even where a risk evaluation of a particular chemical has been completed, TSCA will not preempt state laws that (1) only impose reporting, monitoring, or information obligations; or (2) environmental laws that regulate air quality, water quality, or hazardous waste treatment or disposal.
Early insight into the full scope of TSCA’s preemption provisions will likely be provided by anticipated challenges to individual state’s regulation of 1,4-dioxane. As explained above, New York has already taken steps to regulate 1,4-dioxane in personal care products and other states may soon look to follow suit. However, on January 8, 2021, the EPA released its final risk evaluation for 1,4-dioxane under TSCA. See 86 Fed. Reg. 1495. The EPA’s initial risk evaluation identified a number of “use conditions” in which 1,4-dioxane posed an unreasonable risk to occupational workers, but did not consider “use conditions” involving 1,4-dioxane’s presence in consumer products. In response to protests from industry, EPA’s final risk evaluation included a supplemental analysis of eight use conditions for 1,4-dioxane as a byproduct in consumer goods, including use in hobby materials; automotive care products; cleaning and furniture care products; laundry and dishwashing products; paints and coatings; and spray polyurethane foam. No unreasonable risks for these consumer uses were identified. Because the EPA’s supplemental risk evaluation examined but did not find any unreasonable risks from 1,4-dioxane in consumer products, an argument could be made that states are preempted from enacting their own 1,4-dioxane limits in consumer products. However, because the EPA’s risk evaluation did not specifically exclude cosmetic or personal care products, individual states may be able to argue that the preemption scope is limited only to the specific uses of 1,4-dioxane that were specifically examined during EPA’s risk evaluation. The resolution of any challenges to New York and other states’ regulation of 1,4-dioxane in consumer products will likely provide key insights into the scope of TSCA’s preemption powers.
Earth Day 2021: CERCLA and RCRA in The Biden Administration: Elevating Climate Change and Environmental Justice in Addressing Hazardous Wastes
By Andi S. Kenney
We close out the Corporate Environmental Lawyer Blog's weeklong celebration of Earth Day with the two federal programs aimed at cleaning up existing toxic waste sites and preventing the creation of new ones: the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (“CERCLA”) and the Resource Conservation and Recovery Act (“RCRA”). The Trump Administration considered the remedial and regulatory roles of the CERCLA and RCRA programs as core EPA functions, so it did not target them for regulatory rollbacks like it did for many federal clean air (including climate change), clean water, and environmental review requirements. Nonetheless, the new occupant of the White House will change the focus of both these programs—in large part by elevating climate change and environmental justice considerations in decision-making.
Early in the Trump Administration, Scott Pruitt, then the EPA Administrator convened a Superfund Task Force that identified five priorities: (1) expediting cleanup and remediation, (2) invigorating responsible party cleanup and reuse, (3) encouraging private party investment, (4) promoting redevelopment and community revitalization, and (5) engaging partners and stakeholders. The Task Force set forth 42 recommendations to achieve those goals.
Following the Task Force recommendations, the Trump Administration prioritized 54 sites and completed remediation and delisted over 50 sites from the National Priorities List. The focus was often sites with redevelopment potential. At many of those sites, surprisingly aggressive settlements with potentially responsible parties funded the work. At the same time, however, the number of unfunded orphan sites (those with remediation plans but no funding source) grew as federal appropriations were limited. By January 2021, there were at least 34 unfunded orphan sites, many in at-risk areas.
The Biden Administration is expected to retain the goals and many of the recommendations from the Task Force, but it will redeploy resources to meet its priorities. Climate change (a phrase that literally had been removed from the Superfund Strategic Plan), and environmental justice (which seeks to address the disproportionately high health and environmental risks found among low-income and minority communities) will reemerge as key considerations in CERCLA decision-making, especially in site prioritization and remediation plans. A 2019 GAO report indicated that these issues are often linked. It identified roughly 2/3 (975/1570) of the NPL listed Superfund sites as vulnerable to climate-related risks—hurricanes, flooding, wildfires and/or rising sea levels. Many of these sites were also located near low-income and minority communities. Biden will seek to pair his climate change and environmental justice goals with his redevelopment and infrastructure plans through Brownfield grants and other incentives.
The Biden Administration has also signaled it will address emerging contaminants. As noted by Steve Siros in Wednesday's Corporate Environmental Lawyer Blog, EPA is likely to designate per- and polyfluoroalkyl substances (“PFAS”) as “hazardous substances” under CERCLA and may set a maximum contaminant level (“MCL”) for these compounds under the Safe Drinking Water Act (“SDWA”). These actions could have a significant impact on new and existing cleanups. First, designating PFAS a “hazardous substance” would require facilities to report PFAS releases, which could trigger more investigations and cleanups. Second, any PFAS limits under the SDWA or state regulations would become Applicable or Relevant and Appropriate Requirements (“ARARs”) that would have to be considered in CERCLA listing and remedy decisions. Finally, these changes would require PFAS contamination to be evaluated in EPA’s five year review at each site and potentially trigger reopeners in prior settlements. Tighter standards for other chemicals, such as 1,4-dioxane, could have similar results.
Resources are already being deployed to support these efforts and additional funding for Brownfield and Superfund projects is in the works. The American Rescue Plan Act of 2021 provides $100 million for EPA grants to address disproportionate environmental harms to at-risk populations and air quality monitoring. According to the American Jobs Plan Fact Sheet dated March 31, 2021, the Administration is proposing an additional $5 billion for Brownfield and Superfund sites and an additional $10 billion to monitor and remediate PFAS. The Administration is also proposing to restore the Superfund tax, which expired in 1995, to ensure that resources are available in the Superfund Trust to address unfunded site cleanups. Similarly, the Administration is considering reversing the financial responsibility exemption for chemical manufacturers, petroleum and coal products manufacturers and electric power generation, transmission and distribution facilities that was issued in the waning days of the previous Administration.
Like CERCLA, RCRA was not a focus of the Trump Administration’s regulatory rollbacks—though funding cutbacks affected rule development and enforcement. The Biden Administration has already signaled that it intends to reenergize enforcement, including criminal prosecutions, which may lead to an increase in federal overfiling in RCRA enforcement actions, especially in states with lax enforcement histories.
Trump’s most significant RCRA actions addressed coal ash, referred to as Coal Combustion Residuals (“CCR”). The Trump CCR rules, which were promulgated after the Obama-era CCR rule was vacated, are being reviewed for consistency with Biden’s Executive Order Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis. Likewise, the CCR Permit Program and the Beneficial Use Rules or Electric Utilities, which were pending on Inauguration Day, are subject to the Presidential memorandum freezing regulations pending review.
Biden’s focus on environmental justice and climate change will impact RCRA permit evaluations and enforcement, both in process and in substance. Procedurally, those seeking RCRA permits, and even RCRA permitted facilities, may be subject to additional notification requirements, more community involvement, and greater scrutiny. Substantively, the social cost of carbon and chemical exposure risks will become part of the evaluation.
Biden’s other climate change initiatives may have more significant RCRA impacts down the road. For example, the push toward electric vehicles will reduce the demand for gas stations at current levels. That change, combined with the fact that underground storage tanks installed or upgraded to comply with the 1988 underground storage tank standards are nearing the end of their useful lives, will trigger tank closures throughout the country. More broadly, the transition from a fossil fuel economy to a clean fuel economy will reveal many other environmental issues that will require substantial efforts and resources to address.
The Biden Administration is already changing the course of environmental law. With CERCLA and RCRA, the shifts will be more subtle than in other areas, but the focus on climate change and environmental justice will have profound impacts on whose voices are heard and where, and how, resources are deployed. The Corporate Environmental Lawyer Blog will continue to monitor and report on developments in these areas and others. In the meantime, thank you for sharing Earth Day (and Earth Week) with us!
Earth Day 2021: Heightened Chemical Regulation under the Biden Administration
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
A key platform of President Biden’s environmental agenda is increased regulatory scrutiny with respect to chemical substances under the Toxic Substances Control Act (TSCA). Regulating chemicals in order to minimize the threat to human health and the environment is clearly also critical to achieving the aims and goals of Earth Day, especially considering that the publication of Rachel Carson’s Silent Spring helped spark the global environmental movement that eventually culminated in the first Earth Day in 1970.
Turning now to the present, in the waning months of the Trump administration, there was a flurry of U.S. EPA activity under TSCA, including the issuance of risk evaluations for a number of high-priority chemical substances, including asbestos, 1,4-dioxane, and trichloroethylene. Notwithstanding that these risk evaluations concluded that at least some uses of each of the ten high priority chemicals posed an unreasonable risk, these risk evaluations were widely criticized for failing to take into consideration reasonably foreseeable uses or failing to adequately consider various scientific studies. There had been much speculation that President Biden would reject all of the Trump-era TSCA risk evaluations and in fact, one of President Biden’s first actions in the White House was to direct U.S. EPA to review the TSCA risk evaluation process as well as the methylene chloride risk evaluation specifically.
Rather than throwing the baby out with the bathwater, however, U.S. EPA is moving forward to develop risk mitigation plans for each of these high priority chemicals. At the same time, Michal Freedhoff, the acting assistant administrator for U.S. EPA’s Office of Chemical Safety and Pollution, noted that U.S. EPA would be taking a hard look at these risk evaluations. In a prepared statement, Ms. Freedhoff stated:
Our goal is to allow risk management actions on these first ten chemicals to move forward as much as possible, while looking back surgically at specific areas in some of the risk evaluations to supplement them as appropriate in order to ensure we are meeting our statutory obligations and using the best available science to truly protect human health and the environment.
As to the next 20 chemicals in the risk assessment pipeline, U.S. EPA has already announced that it will reassess its TSCA risk evaluation process, including refining its approach for selecting and reviewing scientific studies. U.S. EPA noted that it would not rely on U.S. EPA’s Application of Systematic Review in TSCA Risk Evaluations, a guidance document issued by U.S. EPA in 2018 that was much maligned by the National Academy of Scientists.
One can also expect an increased focus on environmental justice issues by U.S. EPA in connection with evaluating the risks posed by chemical substances. This will most likely play out in connection with an increased focus on chemical substance exposure for fence-line and front-line communities during the risk evaluation process.
Finally, there will also be increasing pressure on the Biden Administration to regulate new emerging contaminants such as per- and polyfluoroalkyl substances (PFAS) under both TSCA and the Safe Drinking Water Act. PFAS compounds have not yet been considered for prioritization under TSCA but are likely to be on a list of high priority chemicals in the future. In the meantime, U.S. EPA is likely to move forward with designating at least PFAS compounds as hazardous substances under CERCLA as well as evaluating whether to set an MCL for these compounds under the Safe Drinking Water Act.
Please check back on Jenner & Block’s Corporate Environmental Lawyer for more Earth Day content throughout the week.
U.S. EPA Embraces Prior Administration’s PFAS Drinking Water Proposals
By Steven M. Siros, Co-Chair, Environmental and Workplace Health & Safety Law Practice
On February 22, 2021, U.S. EPA announced that it was moving forward with implementation of several regulatory proposals issued in the waning days of the Trump Administration. First, U.S. EPA announced that it was finalizing its regulatory determination under the Safe Drinking Water Act (SDWA) for perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA). A regulatory determination is the first regulatory step in setting a maximum contaminant level (MCL) for these contaminants. The final regulatory determination, signed by Acting EPA Administrator Jane Nishida, reached the same conclusions as had been reached by former EPA Administrator Andrew Wheeler—(1) that these contaminants may have an adverse effect on the human health; (2) that the contaminants are known to be present in public water systems at a sufficient frequency and at levels that pose public health concerns; and (3) that regulation of these contaminants presents a meaningful opportunity to reduce health risks. Interestingly, U.S. EPA’s regulatory determination specifically acknowledges that its 2016 Lifetime Health Advisory Levels of 70 parts per trillion for both PFOA and PFOS continue to represent the best available peer reviewed scientific assessment for these chemicals, notwithstanding that many comments were submitted encouraging U.S. EPA to update and revise its 2016 Lifetime Health Advisory Levels. It is likely to take about four years to promulgate a final MCL for PFOS and PFOA.
U.S. EPA also reissued its proposed Fifth Unregulated Contaminant Monitoring Rule (UCMR5). The reissued USMR5 is identical to the draft that was issued on January 14, 2021 at the tail end of the Trump Administration but was temporarily put on hold when the Biden Administration took office. The proposed UCMR5 would require community water systems serving 3,300 people or more to monitor for a group of 30 chemicals (29 of which are PFAS substances) between 2023 and 2025. The monitoring is intended to provide U.S. EPA with data on the national occurrence of these chemicals in drinking water that at least in part will guide U.S. EPA in promulgating regulatory determinations for other PFAS substances. U. S. EPA will accept public comment on the draft UCMR5 for a period of 60 days following publication in the Federal Register.
We will continue to provide updates on U.S. EPA’s efforts to regulate PFAS substances in the Corporate Environmental Lawyer.
OSHA Issues Proposed Update to Hazard Communication Standard
By Matthew G. Lawson
On February 5, 2021, the U.S. Occupational Safety and Health Administration (OSHA) issued a proposed rule updating its Hazard Communication (“Haz Com”) Standard to align its rules with those in the seventh version of the United Nation’s Globally Harmonized System of Classification and Labeling of Chemicals (GHS), published in 2017. OSHA’s proposed regulatory update is being issued as the United States’ major international trading partners, including Canada, Australia, New Zealand, and those in Europe, similarly prepare to align their own hazard communications rules with the seventh version of the GHS.
Originally established in 1983, OSHA’s Haz Com Standard provides a systematized approach to communicating workplace hazards associated with exposure to hazardous chemicals. Under the Haz Com Standard, chemical manufacturers and/or importers are required to classify the hazards of chemicals which they produce or import into the United States, and all employers are required to provide information to their employees about the hazardous chemicals to which they are exposed, by means of a hazard communication program, labels and other forms of warning, safety data sheets, and information and training. At an international level, the GHS provides a universally harmonized approach to classifying chemicals and communicating hazard information. Core tenants of the GHS include universal standards for hazard testing criteria, warning pictograms, and safety data sheets for hazardous chemicals.
In a pre-published version of the proposed rule, OSHA’s proposed modifications to the Haz Com Standard include codifying enforcement policies currently in OSHA’s compliance directive, clarifying requirements related to the transport of hazardous chemicals, adding alternative labeling provisions for small containers and adopting new requirements related to preparation of Safety Data Sheets. Key modifications included in the proposed rule, include:
- New flexibility for labeling bulk shipments of hazardous chemicals, including allowing labels to be placed on the immediate container or transmitted with shipping papers, bills of lading, or by other technological or electronic means that are immediately available to workers in printed form on the receiving end of the shipment;
- New alternative labeling options where a manufacturer or importer can demonstrate that it is not feasible to use traditional pull-out labels, fold-back labels, or tags containing the full label information normally required under the Haz Com Standard, including specific alternative requirements for containers less than or equal to 100ml capacity and for containers less than or equal to 3ml capacity; and
- New requirements to update the labels on individual containers that have been released for shipment but are awaiting future distribution where the manufacturer, importer or distributer becomes aware of new significant information regarding the hazards of the chemical.
OSHA last updated its Haz Com Standard in 2012, to align the standard with the then recently published third version of GHS. In its newly proposed rule, OSHA clarifies that it is “not proposing to change the fundamental structure” of its Haz Com Standard, but instead seeking to “address specific issues that have arisen since the 2012 rulemaking” and to provide better alignment with international trading partners. According to OSHA, its proposed modifications to the Haz Com Standard “will increase worker protections, and reduce the incidence of chemical-related occupational illnesses and injuries by further improving the information on the labels and Safety Data Sheets for hazardous chemicals.”
OSHA is currently accepting comments on its proposed rule until April 19, 2021. Comments may be submitted electronically to Docket No. OSHA-2019-0001at http://www.regulations.gov, which is the Federal e-Rulemaking Portal.
U.S. EPA Issues Final Guidance on PFAS SNUR
By Steven M. Siros, Co-Chair, Environmental and Workplace Health and Safety Law Practice
On January 19, 2021, four days after the close of the comment period, U.S. EPA issued its final guidance document to aid in implementation of its Significant New Use Rule (SNUR) for long-chain perfluoroalkyl carboxylate and perfluoroalkyl sulfonate chemical substances (PFAS). Not surprisingly, in light of the short time between the close of comments and issuance of the guidance, the final guidance remained largely unchanged from the draft version.
In July 2020, U.S. EPA finalized its PFAS SNUR that requires notice and U.S. EPA review before manufacturing and processing for use certain long-chain PFAS that have been phased out in the United States. In addition, articles containing these long-chain PFAS as part of a surface coating cannot be imported into the United States without submission of a Significant New Use Notice (SNUN).
The guidance provides examples of what would and would not be articles subject to the SNUR as well as clarification on what is meant as a “surface coatings.” Although U.S. EPA declined to provide a regulatory definition of “surface coating” in the PFAS SNUR, the guidance indicates that any long-chain PFAS meeting one of the following two criteria would be a surface coating covered by the SNUR:
- Coating on any surface of an article that is in direct contact with humans or the environment during the article’s normal use or reuse, whether the coating is oriented towards the interior or exterior of the article; or
- Coating on any internal component, even if facing the interior of the article, if that component is in contact with humans or the environment during the article’s normal use or reuse.
Many environmental groups noted that the “direct contact” standard and the refusal to consider potential exposures associated with the disposal and/or misuse of these articles was contrary to the provisions of the PFAS SNUR and these groups are urging the Biden Administration to revisit the guidance. Because the new guidance is not labeled as “significant”, it did not need to follow the formal notice-and-comment process but this would also arguably allow the incoming Biden administration to quickly rework and issue its own guidance for implementing the PFAS SNUR.
We will continue to provide updates on efforts by the Biden Administration to implement the PFAS SNUR on the Corporate Environmental Lawyer blog.
EPA Extends CDR Reporting Deadline
By Steven M. Siros
The chemical industry has received some relief from a November 30th deadline to submit information to U.S. EPA pursuant to the Chemical Data Reporting Rule (“CDR”). Section 8(a) of the Toxic Substances Control Act (“TSCA”) authorizes U.S. EPA to promulgate rules pursuant to which manufacturers and processors of chemical substances must maintain records and submit information to U.S. EPA. To that end, U.S. EPA promulgated the CDR that requires entities that manufacture certain chemicals listed on the TSCA inventory in excess of 25,000 pounds annually (lower thresholds apply for certain listed chemicals) to report basic production information to U.S. EPA every four years. The 2020 reporting deadline had been November 30, 2020.
U.S. EPA recently revised the CDR to comply with the 2016 TSCA amendments. These revisions were intended to improve the reliability and usefulness of the data collected and reduce the overall reporting burden on regulated entities. For example, the revised rule allows for the use of data and processing codes based on those already in use by the Organization for Economic Cooperation and Development. The rule also incorporates exemptions for certain byproducts and amends the requirements to claim that the submitted data constitutes confidential business information (“CBI”) (requiring the upfront substantiation of all CBI claims).
On October 26th, the American Chemical Council requested a 60-day extension from the November 30th deadline, noting significant technical issues with the electronic CDR submission platform. Notwithstanding objections from a variety of environmental groups, U.S. EPA has extended the CDR reporting deadline to January 29, 2021. The extension is good news for the regulated community as it works to compile the substantial information necessary to comply with the CDR requirements.
We will continue to track and provide updates on the CDR and other reporting obligations for chemical manufacturer on Jenner & Block’s Corporate Environmental Lawyer blog.
California Becomes First State to Ban PFAS in Cosmetics
By Steven M. Siros
On August 30, 2020, the California legislature passed the Toxic Free Cosmetics Act making California the first state to ban certain chemicals from cosmetics. Governor Newson signed the bill into law on October 1, 2020. The new law amends existing regulatory programs in California and provides that cosmetics containing any of a specific list of 24 chemicals will be considered “adulterated” and therefore unable to be sold in California. The specific list of chemicals includes certain phthalates and formaldehyde. However, the chemicals that have received the most attention are various per- and polyfluoroalkyl (PFAS) substances. Although some states have previously implemented legislation banning certain chemicals in cosmetic products (Minnesota banned formaldehyde in certain children’s personal care products; Washington requires that certain chemicals in children’s products be reported), California has become the first state to implement such a broad ban on these listed chemicals in cosmetics generally.
The ban will take effect on January 1, 2025 providing companies with time to take the necessary steps to eliminate any of the 24 listed chemicals from their cosmetic products. Of course, many companies have already taken steps to eliminate these chemicals from their products especially since many of these chemicals are already on California’s Proposition 65 list. However, unlike with Proposition 65 where compliance can be demonstrated by the provision of the requisite warnings, the Toxic Free Cosmetics Act will require elimination of these chemicals (with the exception of unavoidable trace quantities).
We will continue to provide regulatory updates as more states are likely to follow California’s lead in regulating these chemicals in various personal care products.