The rule was published by Washington’s Department of Ecology (“WDE”) on May 31, pursuant to the state’s Safer Products for Washington (“SPW”) chemical safety law that passed in 2019. The SPW charged WDE with identifying priority chemicals and making regulatory determinations to limit their uses in various categories of consumer products. Priority chemicals WDE determined to lack alternatives for their respective consumer products are instead subject to reporting requirements. The draft rule was originally promulgated in December of last year.

Specifically, the rule prohibits manufacture, sale, and distribution of the following products with intentionally added PFAS:

• Aftermarket stain- and water-resistance treatments
  • Effective January 1, 2025
• Carpets and rugs
  • Effective January 1, 2025
• Leather and textile furniture and furnishings intended for indoor use
  • Effective January 1, 2026
• Leather and textile furniture and furnishings intended for outdoor use
  • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
  • Notification will be due to WDE by January 31, 2025

Interestingly, the regulation includes a novel provision that “presumes the detection of total fluorine indicates the intentional addition of PFAS.” This presumption is rebuttable upon a showing that PFAS were not intentionally added to the product. Notably, fluorine may be detected in some products due to residual or trace contaminant levels of PFAS that are thought to be widespread in the water supply, soil, and in recycled plastics and other materials.

Outside of PFAS, the regulation similarly prohibits the manufacture, sale and distribution of other specified consumer products with non-PFAS priority chemicals. Those priority chemicals and specified products are:

• Ortho-phthalates
  • Fragrances in beauty products and personal care products
    • Effective January 1, 2025
  • Vinyl flooring
    • Effective January 1, 2025
• Organohalogen flame retardants
  • Electric and electronic products with plastic external enclosures, intended for indoor use
    • Effective January 1, 2027 or 2028, depending on the product.
  • Electric and electronic products with plastic external enclosures, intended for outdoor use
    • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
    • Notification will be due to WDE by January 31, 2025
• Flame retardants
  • Covered wall padding made from polyurethane foam
    • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
    • Notification will be due to WDE by January 31, 2025
  • Other recreational products made from polyurethane foam
    • Effective January 1, 2025
• Alkylphenol ethoxylates
  • Laundry detergent
    • Effective January 1, 2025
• Bisphenols
  • Drink cans
    • Effective January 1, 2025
  • Food cans
    • Because WDE determined that there are no chemical alternatives for these consumer goods, they shall instead be subject only to the reporting requirement.
    • Notification will be due to WDE by January 31, 2025
  • Thermal paper
    • Effective January 1, 2026

Where prohibitions are not feasible because of a lack of alternatives, reporting is required. The reporting notification for each priority consumer product is due one year from the effective date. They must include the CAS RN of the priority chemical that is intentionally added, the product category or categories that contain the priority chemical, the product component within the product category that contains the priority chemical, a description of the function of the priority chemical, and the concentration range of each intentionally added priority chemical in each product component in each product category.

The new regulations allow manufacturers, sellers and distributors to apply for exemptions to all of the abovementioned prohibitions, and WDE will evaluate exemptions on a case-by-case basis. In considering exemptions, WDE considers the priority chemical’s functional necessity, feasibility of legal compliance, potential alternatives (or the lack thereof), and unforeseen events and circumstances limiting the availability of alternatives.

First-time violators could be subject to civil penalties upwards of $5,000 per violation. Repeat violators are subject to penalties up to $10,000 per violation.

Interestingly, the rule includes language that seeks to avoid future federal preemption of Washington’s new ban and reporting requirements. In particular, the legislation anticipates possible regulation both by the U.S. Environmental Protection Agency (“EPA”) under the Toxic Substances Control Act (“TSCA”) and the Consumer Product Safety Commission (“CPSC”) under the Consumer Product Safety Act (“CPSA”) and/or the Federal Hazardous Substances Act (“FHSA”). TSCA authorizes the EPA to block state-level chemical rules by either issuing federal regulations for the same uses or through a finding establishing the relevant uses of the chemical present no “unreasonable risk” and thus do not require restriction.

It appears WDE sought to sidestep preemption by including provisions in the final rule that transition the program’s outright bans into preemption-immunized reporting requirements should the federal government regulate under TSCA. The final rule extends this language to specified CPSC and FHSA authorities as well.

Though WDE is certainly innovative in their preemption theory, their prohibition and reporting language mirrors the regulatory language employed by other states, including California, New York and Colorado. This language, combined with recent draft legislative language from the Northeast Waste Management Officials’ Association, seem to demonstrate that states are increasingly interested in collaborating with their neighbors to create a consistent, unified regulatory landscape that broadly governs PFAS and other chemicals.

On February 7, the EU Chemical Agency (“ECHA”) issued the plan – known as the “Universal Restriction Proposal” – that would ban the use of PFAS in many of the most common applications (such as clothing, food packaging, cookware, and cosmetics) within 18 months of enactment. For products where PFAS-free alternatives are known but not widely available (e.g., technical textiles for medical applications, industrial food and feed production, hard chrome plating), a five-year phase-in ban would apply. For products where alternatives are currently unknown (e.g., professional protective apparel, certain specialty textiles, laboratory refrigerants), the ban would be phased-in over 12 years. The ban would apply to imports as well as domestically-produced goods.

The proposed ban would apply to nearly 10,000 different PFAS chemical formulations, with few exceptions, and is intended to cover the vast majority of PFAS uses. The chemical scope of the restriction proposal is broadly defined as: “Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it).”

The proposal – which was crafted by Germany and the Netherlands with support from Norway, Sweden and Denmark, after the countries compiled a “dossier” reflecting several years of research – recommends that the chemicals be restricted under the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”) regulation.

“This proposal is actually the broadest restriction proposal that has ever been prepared and submitted.”

- Frauke Averbeck, German Federal Institute of Occupational Safety and Health, February 7

Following release of the proposal, ECHA’s two scientific subdivisions, the Risk Assessment Committee (“RAC”) and the Socio-Economic Analysis Committee (“SEAC”), will now conduct their own scientific evaluation. This process usually takes about a year, but, given the complexity of the matter, some experts anticipate an even longer review period.

A six month public comment process (“open consultation” period in EU parlance) is scheduled to start on March 22. During this process, interested parties can submit comment on the proposed restrictions to ECHA, as well as provide information on the availability of PFAS-free alternatives or lack thereof. An online information session will be held April 5.

Once ECHA reviews the committees’ scientific evaluations and stakeholder comments, the agency will finalize recommendations to submit to the European Commission, which, together with the EU Member States, will then vote on the potential restriction. The proposal is expected to be issued as a final rule sometime in 2025, potentially going into effect in 2026 or 2027.

The proposed restrictions will have global ramifications. In addition to EU-based product manufacturers and end-users, imported products also are covered by the ban. Such a broad ban will necessitate careful supply chain communication and oversight to ensure that product components and raw materials do not contain banned PFAS. Such supply chain management can be particularly challenging given the widespread historical use of PFAS and their presence as impurities or residuals in a wide variety of recycled materials and other raw materials. Further, demand for PFAS-free alternatives is likely to become intense and lead to potential shortages of needed production inputs.

While the ban is not likely to come into force for several years, companies are advised to start planning now to evaluate the presence of PFAS in their products and throughout their supply chain, as well as to develop and secure PFAS-free alternatives.

The “unavoidable use” exception to the pending ban is the subject of a rulemaking process by the Maine Department of Environmental Protection (“DEP”) and awaits further detail. Depending on the nuances of this exception, the law could very well ban a vast range of products. Compliance for many companies is expected to be difficult, and given already strained supply chains, could result in certain products not being sold in the state altogether. Moreover, the law imposes a heavy administrative burden on the DEP, which will now be tasked with verifying compliance for a massive swath of products, ranging across fabrics, cleaning products, paints, fire-fighting foams, cookware, food packaging, food processing equipment, and cosmetics, among others.

A particularly notable criticism is that all PFAS are not the same. Indeed, there are over 9,000 types of PFAS (identified so far), each with their own unique chemical makeup and profiles. Maine’s bold stroke is therefore scientifically overbroad and will impose unnecessary burdens on many of the product manufacturers and retailers doing business in the state. Moreover, in a state that has ambitions of transitioning to more renewable energy sources, PFAS provide crucial insulation and physical, thermal, and chemical resistance to technologies vital to solar and wind energy.

Science driven and industry sensitive alternatives are certainly prevalent in sister states. In fact, states like California, Colorado, Connecticut, Hawaii, Maryland, Minnesota, New York, Oregon, Rhode Island, Vermont and Washington, have enacted less restrictive PFAS statutes than the total ban Maine proposes. Many of those states too, along with Georgia, Iowa, Massachusetts, Michigan, New Hampshire, New Jersey, North Carolina, Pennsylvania and Wisconsin all have proposed legislation regulating PFAS in some capacity.

That said, current scientific research suggests that exposure to high levels of certain PFAS may lead to adverse health outcomes. This, combined with their presence in various environmental media, consumer goods, and food product packaging, could make them a broad and slow-building threat to human health.

Given the sophistication and complexity behind PFAS regulation, painting with broad prohibitions like Maine’s is certainly bold. No other state in the union, even those with notoriously more rigid regulatory structures for environmental issues, have an outright and total ban on PFAS. A one-size-fits-all solution is simply impractical and overbroad, disrupting economies and industry while reducing consumer’s access to essential goods and services. Of course, when health is at stake, further investigation is warranted. This analysis can and should be conducted in a way that is congruous with the nation’s recovering supply chain and economic apparatus.

The NDAA set forth several mechanisms by which additional PFAS were to be added to the TRI list of reportable chemicals, including issuance of a final toxicity value or significant new use rule ("SNUR") for a substance, or addition of a PFAS substance to the "active" TSCA Inventory. Pursuant to that authority, EPA added the following three chemicals to TRI based on adoption of a final toxicity value in April 2021:

• Perfluorobutane sulfonic acid (“PFBS”) CASRN 375-73-5)
• Perfluorobutanesulfonate (CASRN 45187-15-3)
• Potassium perfluorobutane sulfonate (CASRN 29420-49-3)

For these four PFAS, first TRI reports will be due to EPA by July 1, 2023, for calendar year 2022 data.

A fifth PFAS -- another with an extra-long chemical name (CASRN 65104-45-2) -- was added to the TRI list as it was determined to be covered by a SNUR issued in July 2020 for long-chain PFAS. Oddly, because the chemical met the terms of a 2020 SNUR, this PFAS was deemed to be "officially" added to the TRI list as of January 1, 2021, meaning that it was subject to reporting for the 2021 calendar year (reports that were due July 1, 2022). EPA does not address if it actually expected a facility to report by this past July 1 for a chemical not added publicly to the TRI list until issuance of a rule that becomes effective August 17, 2022.

The TRI listings are the latest in an ever-growing range of Agency actions to address PFAS. It is clear that the list of TRI-reportable PFAS will steadily expand as EPA continues to issue SNURS and finalize more and more toxicity values. The Agency has recently issued updated Health Advisories for four PFAS chemicals commonly found in drinking water, cosmetics and food packaging, and is also making $1 billion available in grant funding to help communities dealing with PFAS contamination. The grant money is allocated through the Infrastructure Investments and Jobs Act, which in total, authorizes $5 billion for the Agency to reduce PFAS in drinking water in communities facing disproportionate impacts of water contamination. This, combined with increased Congressional support and heightened public attention to PFAS and environmental issues in general, positions EPA deftly for more opportunities to address PFAS.

“ To protect human health and the environment, we must evaluate and understand all chemical exposures to communities, particularly historically underserved communities who have been disproportionately exposed to pollution for generations,”

-Michal Freedhoff, assistant EPA administrator for chemical safety and pollution prevention

Members of the general population that are in proximity to air emitting facilities or a receiving waterbody, and who therefore may be disproportionately exposed to a chemical undergoing risk evaluation under TSCA section 6. For the air pathway, proximity goes out to 10,000 meters from an air emitting source. For the water pathway, proximity does not refer to a specific distance measured form a receiving waterbody, but rather to those members of the general population that may interact with the receiving waterbody and thus may be exposed.

For future TSCA risk evaluations, including the 20 chemicals currently undergoing risk evaluation, EPA plans to "expand this first version of the framework to include a method to address broader potential environmental justice concerns and cumulative or aggregate exposures to chemicals."

Comments on the draft strategy are due February 22nd and the agency's Science Advisory Committee on Chemicals (SACC) will hold a public meeting, virtually March 15-17, to peer review the methodology. A copy of the strategy and further information is available at EPA's website.

Originally finalized this past January, the PBT rules immediately drew widespread criticism, particularly with regard to PIP (3:1) and the broad prohibition on the processing, import, and other distribution in commerce of components and products containing the substance, initially scheduled to come into effect on March 8, 2021. PIP (3:1) is a widely used plasticizer and flame retardant that is present in a wide range of components, particularly electronics including cell phones, laptop computers, wiring harnesses, and other equipment used across a broad spectrum of industries. With only limited exemptions in the current PBT rule, many companies were faced with a major compliance dilemma that could prevent access to and import of critical parts or materials. In response, EPA adopted a "no action assurance" policy that paused enforcement of certain provisions of the PIP (3:1) rule for six months. In September, EPA further extended the enforcement pause until March 8, 2022.

Now, EPA is proposing a further extension until October 31, 2024 of the compliance deadline for the provisions related to PIP (3:1) in articles.

EPA is proposing to further extend the compliance dates related to articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) to ensure supply chains for key consumer and commercial goods are not disrupted.

- EPA Press Release, October 21, 2021

The latest proposed rule seeks to further extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, along with associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles.

In the proposal, EPA describes specific kinds of information the agency is seeking to support finalizing the proposed compliance date extension, including:

• Specific uses of PIP (3:1) in articles throughout their supply chains;
• "Concrete steps taken" to identify, test, and qualify substitutes for those uses;
• Specific product certifications that would require updating (such as flammability standards);
• An estimate of the time that would be required to remove the substance; and
• Documentation of specific needs for replacement parts, including the service life of the equipment and the identification of any applicable regulatory requirements for the assurance of replacement parts.

The provisions of the January 2021 rules remain in effect while EPA works on the new rulemaking effort, with the exception of PIP (3:1) as noted above.

Further information on the proposed PIP (3:1) rulemaking is available at EPA's website.

Following are some of those “insights," observations and other musings from the front lines of Prop 65:

I started my career as a pre-school teacher - which proved to be good preparation for dealing with [Prop 65] stakeholders!

- Carol Monahan Cummings, Chief Counsel of OEHHA and Conference Chair

• Conference Chair, Carol Monahan Cummings, Chief Counsel of the Office of Environmental Health Hazard Assessment (OEHHA) for the past 18 years, provided the "view from the lead agency" and highlighted OEHHA's work over the last two decades to make warnings more meaningful to consumers and less vague, as well as OEHHA's attempts to reduce the "over-warning" phenomenon. I would argue that the effort on the first issue has proven relatively successful (e.g., adding chemical names to the warnings and establishing webpages to provide more detail on potential exposures), but that OEHHA has been spectacularly unsuccessful in addressing "over-warning."
• Over-warning was a common theme running through many of the panel discussions. For years, OEHHA and private plaintiff enforcers have bemoaned the proliferation of Prop 65 warnings on products for which a warning technically may not be required (due to no or minimal exposure, for instance) but is provided "prophylactically" to avoid the risk of a lawsuit. As summarized by Eric Somers with Lexington Law Group, which represents the Center for Environmental Health, a prominent Prop 65 enforcement organization: "Over-warning diminishes the impact of warnings over time ... consumers become less risk averse about those warnings and less inclined to take steps to avoid the exposure ... and companies will be less inclined to [do something to] reduce exposures to the chemical."
• However, "prophylactic" warnings are entirely reasonable from a business perspective. As one defense counsel panelist summed it up: "it is simple cost-benefit analysis ... if the chemical is there, unless your science [showing no exposure] is undisputed" -- something that is very rare -- "then the business is looking to mitigate risks."

If the chemical is there, then I'd be hard-pressed to say that there is not a risk [of being sued].

• In discussing the future of the current "short-form warning," panelists were in agreement that OEHHA's contention that proposed amendments are needed in part because the short-form warning contributes to over-warning was a "red herring." The over-warning phenomenon long-preceded adoption of the short-form option in 2016. Eric Somers, with the plaintiff-side Lexington Law Group, summarized: "Over-warning is caused by aggressive enforcement and the business desire to mitigate risk."
• Over-warning is not the result of specific regulatory safe-harbor warning text or mechanisms of delivery; rather, it is directly related to the practical reality that to avoid being forced into a settlement the only other option for a business is to go to trial, with all its related uncertainties and costs. As I wrote at the time the 2016 amendments were adopted: "By focusing exclusively on the question of how to provide 'clear and reasonable' warnings, ... the amendments fail to address perhaps the most important question facing businesses confronted with Proposition 65 compliance: the issue of when warnings are required is not addressed at all. Hence, businesses will remain challenged by the paramount issue of whether a warning is required, particularly for a product that may contain a listed chemical but for which the company believes, based on its own due diligence and proper science, that exposure is below a safety threshold.... While a business rightfully should develop data on potential exposures to a listed chemical in a product, and assess the safety of that exposure, plaintiffs remain free to challenge such exposure/safety assessments and drag businesses into the expensive and time-consuming Proposition 65 enforcement process."
• OEHHA earlier this year proposed to limit the use of "short-form" warnings to situations where space is constrained (products with 5 square inches of label space or less); to eliminate their use for internet and catalog warnings; and to require identification of a chemical for which the warning is being provided.
• Objections from the business community are focused more on the process than the content/details of the short-form warning: after going through a multi-year regulatory process that resulted in the current "short form" option in 2016, and having now implemented those label changes, it is frustrating to have to "go through this again" only a few years later. "Changing a label on a product is expensive."
• Factors that plaintiffs consider in assessing whether to bring a case:
  • The potential for harm if nothing is done, particularly with respect to chemicals with adverse impacts at low exposure levels (such as lead)
  • Opportunities for reformulation to reduce or eliminate exposures to a listed chemical in a product
  • The potential for a broad industry-wide impact by provoking change in a manufacturing process or inputs
  • Whether a warning would be effective if reformulation is not viable
  • Environmental justice (EJ) impacts - seek to address marketing of certain products to EJ communities (based on input from those living in and actively working with EJ communities)
• Great discussion of the pending First Amendment case involving warnings related to acrylamide in foods (CalChamber vs Bonda, 9th Circuit): does compelling a "safe harbor" warning violate the First Amendment rights of a business? By way of legal background, such "compelled speech must be purely factual and non-controversial." How does this standard apply for a chemical, such as acrylamide (or, in a prior case, glyphosate) where there remains robust scientific debate about the risk of cancer or reproductive harm from exposure to a given chemical?
• Ideas for addressing the explosion of food cases that do not address realistic risks: reform the certificate of merit process to make the plaintiff's initial showing more robust for chemicals in food; adopt more "safe harbor" levels for acrylamide and other chemicals that form in specific foods to provide more certainty for industry; require a "meet and confer" process prior to litigation for the parties to determine what the appropriate level of the substance should be in food.
• As a lawyer that has represented many new and often smaller companies in navigating the waters of Prop 65, it was great to see a panel session dedicated to the challenges "small businesses" face in complying with Prop 65. Small companies typically lack the resources that larger businesses have to assess compliance with Prop 65 (testing, risk assessment), implement appropriate warning and labeling, or to defend a case when a plaintiff comes calling (or even to "call their bluff"). While there is a "small business" exemption (for companies with less than 10 employees), in practice, the exemption often is of little utility due to indemnity provisions commonly found in contracts between small business producers and downstream distributors and retailers. Panelists cited strong arm tactics by some plaintiffs to "buffalo" small businesses into a settlement. Others cited the impact of broader industry-wide settlements (put together by larger players in an industry or trade associations) that are onerous for small businesses to comply with.
• The good news is that (once again) reform legislation is being developed in the California Assembly ... however, amendments to a voter-adopted initiative require a two-thirds super-majority of both houses of the state legislature. Historically, Prop 65 reform legislation has struggled to pass due to the multiple stakeholders involved with diverging interests -- and, if passed, been too watered-down to provide meaningful relief to businesses.
• The proposed cannabis "safe harbor" warnings will provide new and unique warnings for cannabis smoke and THC products (and different modes of consumption; ingestion, inhalation, topical). Question whether these products are truly sufficiently unique to warrant distinct warning language from other consumer products. The more specified warnings are consistent with OEHHA's goal of making warnings increasingly tailored to provide more detailed information to consumers.
• The conference concluded with a spirited discussion on the topic of the "Divide Between Businesses and Environmentalists Over What Prop. 65 Has Accomplished." From my own perspective, every day I see Prop 65 cases that are charitably described as frivolous, and the vast majority of cases seem to target chemicals that are present at trivial levels and simply do not pose any sort of meaningful risk. Hence, the "over-warning" phenomenon. But it is undeniably true that Prop 65 has been highly successful in focusing the attention of companies and the public on the chemicals that are in products manufactured, used, consumed and purchased every day. In this respect, Prop 65 remains perhaps the single most consequential state-level environmental/public health regulatory program in the US, with global reach.

The biggest accomplishment of Prop 65 is the extent of the law's general deterrence function ... reformulation that occurs behind the scenes, using the Prop 65 list as a check, outside of enforcement, and is completely invisible to the public."

- Claudia Polsky, Clinical Professor of Law and Director, Environmental Law Clinic, UC Berkeley

• Panel debate centered on the role of the private enforcement mechanism. Supporters cite the actions of private plaintiffs as the engine that drives companies to pay attention to Prop 65 and the list of chemicals. Without this mechanism, it would be similar to TSCA at the federal level, dealing only with a small subset of listed chemicals and providing minimal incentive to companies outside of that small group of chemicals. Critics maintain that the private enforcement mechanism is an incredibly inefficient means of achieving the same regulatory results, with little relationship between the penalty paid and the extent of the public benefit achieved. The system has resulted in widespread over-warning, due to the threat of relatively unrestrained private enforcement, and misallocation of public health resources towards minimal or non-existent risks.
• Would a program like "Safer Products" (under the California Department of Toxic Substances Control) be more appropriate? On one hand, government regulatory programs "move like molasses" and are not cost-effective ... though private enforcement focuses costs on one segment of society, businesses that may or may not be primarily responsible for an exposure risk. A government-directed regulatory program, however, would target meaningful risks and weed out the large majority of current cases that are trivial and not truly in the public interest.
• More active public enforcement, with the attorney general and/or district attorneys taking more Prop 65 cases, would be one possible solution ... though resources may not be available to do so.
• Ultimately, the future of Prop 65 relies on the ability to impose proper limits on private enforcement while preserving the core function of plaintiffs as putting teeth into Prop 65.

Last June, EPA issued an initial list of 160 PFAS for inclusion in the TRI program pursuant to a mandate in the National Defense Authorization Act for Fiscal Year 2020 ("NDAA"). The NDAA also requires addition to the TRI list of PFAS that subsequently are the subject of other agency actions, such as a Toxic Substances Control Act (TSCA) significant new use rule (SNUR), designation as an active TSCA substance, or agency adoption of a final toxicity value. The three new PFAS each were included within the scope of a June 2020 SNUR.

Based on the NDAA criteria, it is expected that EPA soon will add perfluorobutane sulfonic acid (PFBS) to the TRI list, after the agency released an updated toxicity assessment for the substance in April. EPA's regulatory agenda anticipates further expansion of the TRI PFAS list in the future.

The internal EPA planning document (recently obtained and released by Inside EPA) includes a number of noteworthy changes under consideration, though lacks additional explanation or detail, including:

• "Develop option for annual CDR reporting for priority chemicals": CDR currently requires manufacturers and importers of chemicals to report on-site production and downstream use and exposure information to EPA every four years. It is unclear whether the plan refers to (as some accounts have suggested) "optional" facility reporting on an annual basis or -- more likely in this author's view -- development of a rulemaking "option" for OPPT to establish mandatory annual CDR reporting for certain chemicals of high interest;
• Expansion of TRI reporting to additional industry sectors, including, specifically, Natural Gas Processing;
• Expanding the list of PFAS chemicals subject to TRI reporting; and
• Enhanced CDR and TRI data analysis to support environmental justice (EJ) and TSCA chemical prioritization initiatives.

In keeping with the Biden Administration's focus on environmental justice, the plan alludes to a greater emphasis on utilizing the CDR/TRI data to identify underprivileged communities (e.g., "conduct TRI/EJ mapping projects") and the chemicals that pose heightened risks to those communities.

A copy of the OPPT strategic plan is available here.

The five chemicals subject to the PBT rules include:

• Phenol, isopropylated phosphate (3:1) (PIP (3:1))
• Decabromodiphenyl ether (DecaBDE)
• 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)
• Hexachlorobutadiene (HCBD)
• Pentachlorothiophenol (PCTP)

With the prohibition entering into effect on March 8, and only limited exemptions in the current rule, many companies were faced with a major dilemma in that compliance could prevent access to and import of critical parts or materials.

Stakeholders note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging. They assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles. It was not EPA’s intent during the development of the rule to have such a broad disruptive impact.

- U.S. EPA Press Release, March 8, 2021

In addition, EPA is initiating a 60-day comment period seeking input on both the PIP (3:1) compliance issues and whether the PBT rules sufficiently reduce exposure to the five chemicals, with a particular re-examination of exposures to potentially exposed or susceptible subpopulations, and the environment, and whether additional or alternative measures should be considered.

The EPA press release, with links to additional information, is available here.

The CDR rule requires manufacturers (including importers) of chemical substances listed on the TSCA Chemical Substance Inventory to report data on chemical manufacturing, processing, and use every four years. The information collected through the CDR program, according to the agency, "helps EPA understand exposure to these chemicals and screen and prioritize chemicals to identify and evaluate potential human health and environmental effects."

The report requires submission of detailed on-site production and downstream industrial and consumer use information for substances manufactured or imported in quantities of 25,000 pounds or more. The current reporting cycle began June 1 and was scheduled to close on November 30. The new reporting deadline is January 29.

Additional information on CDR reporting is available at EPA's website.

In addition, because the Fees Rule will not formally be amended until 2021, EPA issued a No Action Assurance on enforcement for the same classes of "manufacturers."

More information on EPA's planned amendment of the Fees Rule and the No Action Assurance is available at the agency's website.

Before today's action, a wide range of companies were scrambling to determine if they must "self-identify" to EPA as a "manufacturer" of one of the 20 chemicals in advance of a March 27th deadline (later extended to May 27th). Critically, for Fees Rule purposes, the term “manufacture” does not include the usual TSCA exemptions for coincidentally manufactured byproducts or impurities, or for trace/de minimis levels, as EPA made clear when it adopted the Fees Rule in 2018 . More recently, in a February 27th webinar, EPA reiterated that unintentionally produced trace level combustion byproducts were considered "manufactured" and subject to fee payment:

QUESTION: I'd like to know if manufacturing is going to be inclusive of what I'm going to kind of characterize as secondary atmospheric chemistry where a substance is produced in minute quantities as exhaust from combustion sources like combustion turbines and heaters and boilers, and not through what would typically be considered a manufacturing line, where there’s a specific product being produced.

EPA RESPONSE: ... So, manufacture is defined in TSCA - the law itself - to include import as well as manufacture and production of the chemical, and there are no exclusions for manufacture of chemicals that occur as you described in a secondary way, as a byproduct, or unintentionally or coincidentally in association with another process. If the chemical is produced, it's considered manufactured under TSCA and such an activity would be subject to the TSCA fees rule requirements.

For background, the CDR rule requires manufacturers (including importers) of chemical substances listed on the TSCA Chemical Substance Inventory to report data on chemical manufacturing, processing, and use every four years. EPA uses the data to help assess the potential human health and environmental effects of these chemicals. The next reporting cycle begins June 1, 2020, and requires submission of detailed information for 2019, as well as production related information for 2016-2018.

Numerous byproduct materials -- things like furnace pollution control dust, slags, drosses, skimmings, mill scale, etc. -- are listed on the TSCA Inventory and reportable under the program. There are some existing exemptions, but for the most part, if these materials are sent for recycling then they are subject to reporting, but if disposed they are not (which is something of a disincentive to recycle!). The vast majority of such materials (or the chemical substances contained in them) are reported under other EPA programs, such as the Toxic Release Inventory or RCRA Biennial Waste reports, or available from other sources.

The negotiating committee came up with numerous practical recommendations to eliminate some of the duplicative or relatively useless information requirements for recycled byproducts. For example, furnace dust typically is sent off-site to a processor that recycles the metals in the dust (and subsequently reports the extracted metals under the CDR program). Requiring the facility that generates the furnace dust also to report on the dust under the CDR program is of no utility. Nevertheless, practical suggestions to remedy this were unable to reach consensus with all stakeholders, largely out of fear, as best I could tell, that somehow theoretically vital information would be lost or that the exemption would set a precedent that could be extended to other materials in the future.

Well, on April 25th, EPA published proposed revisions intended to streamline reporting for 2020 under the TSCA CDR program. Unfortunately, the provisions related to recycled byproducts fail to provide any meaningful relief to companies subject to reporting and do nothing to address the unnecessary reporting of information for these materials. EPA proposes limited new provisions related to byproducts:

(1) Allowing the option to report using metal categories for the constituents of inorganic byproducts -- i.e., instead of reporting for "furnace dust" a facility could instead file reports for the individual metals (e.g., zinc, nickel, etc.) in the byproduct. The utility of this option is questionable and it seems unlikely that a mill would choose to report for a specific metal (or, in most cases, numerous metals), rather than file a single report using the byproduct name listed on the Inventory which would cover all possible reportable metals in that byproduct (a point I and others made during the committee negotiations); and

(2) Adding two exemptions for specifically identified byproducts that are recycled in a site limited, enclosed system and for byproducts that are manufactured as part of non-integral pollution control and boiler equipment.

In short, EPA's proposal does practically nothing to limit byproduct reporting requirements or reduce burdens, as directed by the Lautenberg Act.

TSCA section 8(a)(6)s:

NEGOTIATED RULEMAKING.—

(A) The Administrator shall enter into a negotiated rulemaking pursuant to subchapter III of chapter 5 of title 5, United States Code, to develop and publish, not later than 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, a proposed rule providing for limiting the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.

(B) Not later than 3 and one-half years after such date of enactment, the Administrator shall publish a final rule resulting from such negotiated rulemaking.

“This is a continuing effort in every aspect of our program to ensure that the public has information on chemicals in commerce, that EPA has the information necessary to conduct our chemical reviews, and that reporting burden is minimized and simplified,” Alexandra Dapolito Dunn, the recently confirmed Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, stated in support of the proposal.

The CDR rule requires manufacturers (including importers) of chemical substances listed on the TSCA Chemical Substance Inventory to report data on chemical manufacturing, processing, and use every four years. EPA uses the data to help assess the potential human health and environmental effects of these chemicals. The next reporting cycle begins June 1, 2020, and requires submission of detailed information for 2019, as well as production related information for 2016-2018.

In addition to new provisions governing claims of "confidential business information" (CBI), the proposed CDR amendments would: • Update the definition of small entities (small manufacturers) that are exempt from reporting. • Add exemptions for specific types of byproducts. • Simplify reporting, including allowing manufacturers to use certain processing and use data codes already in use as part of international codes developed through the Organization for Economic Co-operation and Development. • Remove outdated rule text and consolidate exemptions.

The byproduct reporting exemption provisions are based in large part on input received during the work of a 2017 negotiated rulemaking committee that, while ultimately unable to reach consensus with all environmental stakeholders, developed a number of practical recommendations for reducing the burden of reporting for byproducts sent for recycling. Information on these types of materials are largely available from other EPA and public sources.

There will be a 60 day comment period upon official publication of the proposal in the Federal Register (docket EPA-HQ-OPPT-2018-0321 on www.regulations.gov). The proposed amendments can be found here.

There will be a 90-day comment period, upon publication of the draft list notification in the Federal Register (scheduled for March 21), with the aim of collecting additional information from the public regarding "uses, hazards, and exposure for these chemicals."

When prioritization is completed later this year, a 3-year risk evaluation process will be initiated to determine if the "high priority" chemicals, under their conditions of use, present an unreasonable risk to human health and the environment. In announcing the list, EPA made clear that the "high or low" designation does not mean that the agency "has determined the chemical poses unreasonable risk or no risk to human health or the environment; it means we are beginning the prioritization process."

Most notably, the draft "high priority" chemical list includes formaldehyde, which the agency recently dropped (to much criticism from environmental groups and Democratic Members of Congress) as a priority chemical under the Integrated Risk Information System (IRIS), despite years of work under that program. By shifting the formaldehyde assessment to the TSCA program, EPA emphasized that the agency will build off the existing IRIS work but also be able to streamline potential regulatory action to address any identified risks from the use of formaldehyde.

“Moving forward evaluating formaldehyde under the TSCA program does not mean that the formaldehyde work done under IRIS will be lost. In fact, the work done for IRIS will inform the TSCA process. By using our TSCA authority EPA will be able to take regulatory steps; IRIS does not have this authority.” - Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention.

In addition to formaldehyde, the 20 high priority candidate chemicals include seven chlorinated solvents, six phthalates, four flame retardants, a fragrance additive, and a polymer precursor. The 20 low priority candidate chemicals were selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's "safer choice" criteria.

The EPA home page for prioritization, including the draft list of "high" and "low" priority chemicals, can be found here.

The lawsuit is notable as the first challenge involving EPA's new authority under 2016 amendments to the Toxic Substances Control Act (TSCA) that directs EPA to ban or restrict chemicals that present an unreasonable risk to human health or the environment. A 2014 EPA risk assessment found that short-term exposures to high concentrations of methylene chloride-based paint and coating strippers can be fatal. On January 19, 2017, during the last days of the Obama Administration, EPA issued a preliminary determination that the use of methylene chloride in paint and coating removal poses an unreasonable risk of injury to health. EPA also proposed prohibitions and restrictions on the manufacture, processing, and distribution in commerce of methylene chloride for all consumer and most types of commercial paint and coating removal and on the use of methylene chloride in commercial paint and coating removal in specified sectors.

While EPA consistently has signaled its intent to finalize the rule, on the same day that the draft final rule was sent to OMB for review, the agency also sent for OMB review a preliminary draft rule entitled “Commercial Paint and Coating Removal Training, Certification and Limited Access Program.” While no details are available, issuance of the draft "training" rule signals that at least some of the more stringent provisions applicable to commercial uses of the solvent from the January 2017 proposal may have be relaxed in the pending final rule.

In particular, the lawsuit seeks a court order directing EPA to “perform their mandatory duty under sections 6(a) and 7 of [TSCA] to address the serious and imminent threat to human health presented by paint removal products containing methylene chloride." Under TSCA section 6(a), EPA is directed to ban or restrict chemicals that it determines present an unreasonable risk to human health or the environment. The plaintiffs contend that EPA has “violated the explicit command in TSCA section 6(a) that it 'shall' by rule restrict a chemical determined to present an unreasonable risk of injury, applying such requirements that are 'necessary so that the chemical substance no longer presents such risk.'” The plaintiffs also have alleged EPA failure to abide by TSCA section 7 requirements “to protect the public against 'imminently hazardous' chemical substances.”

The case is Vermont Public Interest Research Group et al v. Wheeler et al. (D. Vt., No. 19-00009, 1/14/19).

While signed into law by President Obama, the major framework rules that govern how the agency moves forward with prioritizing, evaluating, and regulating existing and new chemicals has fallen primarily to the Trump Administration. Like any major legislation, the "new TSCA" embodies a multitude of compromises, with differing interpretations competing to be codified in regulations. Over the last several months, numerous controversies have arisen over how the Trump EPA is implementing the law's new requirements, most notably with respect to how EPA defines the scope of uses (intended and reasonably foreseen) that must be evaluated in assessing the risks of a given chemical.

Rep. Pallone's most recent statement, in fact, was issued in conjunction with the release by EPA of the first of ten draft risk assessments for existing chemicals.

“The new draft risk evaluation of [Pigment Violet 29] raises serious red flags about the Trump EPA’s commitments to scientific integrity and protecting the public health. EPA appears to have purposely discounted known environmental hazards, numerous foreseeable uses, and all manufacturing below reporting thresholds for the Chemical Data Reporting Rule. This is disturbing but falls in line with the Trump Administration’s ongoing attempts to weaken the updated TSCA law. We look forward to holding hearings on this draft and EPA’s broad efforts to undermine the Lautenberg Act early next year.”

EPA intends to issue the first TSCA Inventory with all substances designated as “active” or “inactive” within a few months after the October 5 reporting deadline.

For further information on the TSCA Inventory “reset” effort, please see my prior post below.

https://www.kelleygreenlawblog.com/2018/06/chemical-reset-make-sure-substances-manufacture-import-use-epa-active/