Kelley Green Law Chemical law, emerging contaminants, and regulatory news and insights Tue, 02 Jul 2024 23:47:06 -0400 60 hourly 1 EPA Requires TRI Reporting of Small Concentrations of PFAS; Expands Supplier Notification for Lead and Other Chemicals of Concern Mon, 23 Oct 2023 00:00:00 -0400 Earlier today, the U.S. Environmental Protection Agency (“EPA”) finalized elimination of the de minimis exemption for reporting of per- and polyfluoroalkyl substances (“PFAS”) under the Toxic Release Inventory (“TRI”). EPA is officially designating PFAS as Chemicals of Special Concern, for which the de minimis exemption is not applicable and, therefore, tracking and reporting of small concentrations in mixtures and products used at facilities is required.

The de minimis exemption allows facilities to ignore negligible amounts of substances in chemical mixtures when present at concentrations below 1% (or 0.1% for carcinogens) in the materials they process or otherwise use in their manufacturing process. While PFAS are widely present in numerous products and chemical mixtures due to their heat-, water- and stain-resistant qualities, typically they are present at very low concentrations. As a result, as we have discussed previously, only a relatively small number of TRI reports for PFAS have been filed with the agency in recent years. Indeed, out of the 75,890 total entries reported to TRI for all chemicals in 2021 (from approximately 21,000 facilities), EPA received a mere 92 PFAS reporting forms on 46 different PFAS from 45 facilities. In contrast, there are approximately 650 PFAS are currently in commerce from about 120,000 facilities that involve merely the handling and/or potential release of PFAS.

The final rule also makes the de minimis exemption unavailable for purposes of supplier notification requirements to downstream facilities for all Chemicals of Special Concern, which in addition to PFAS includes a number of persistent, bioaccumulative and toxic (“PBT”) chemicals such as lead, mercury, and dioxins. EPA contends that the change will help “ensure that purchasers of mixtures and trade name products containing these chemicals are informed of their presence in mixtures and products they purchase.” Critics contend however, that this change – particularly for lead, which is naturally occurring and widely present in the environment and raw materials – will dramatically expand the universe of materials for which downstream facilities must track the usage, disposal, and lead content, adding millions of hours to the already labor-intensive reporting burden.

When EPA proposed to eliminate the de minimis exemption, the Agency received mixed feedback. EPA and several environmental organizations argue that the exemption is a “reporting loophole” allowing facilities to avoid reporting listed chemicals, thereby diminishing public trust, reducing transparency, and keeping community members in the dark about chemicals they believe to be hazardous to human health. Industry stakeholders, on the other hand, contend that the de minimis exemption makes the TRI program dramatically more workable by limiting the scope of substances for which reporting is required. Moreover, the exemption is pragmatic and tries to avoid forcing companies to hunt for information on miniscule amounts of substances present in trace quantities that ultimately pose little to no risk.

Interestingly, EPA’s decision to scale back the exemption to the TRI reporting requirement, and thus open the PFAS reporting floodgates, coincides with the Agency’s issuance of a final Toxic Substances Control Act (“TSCA”) rule that similarly requires companies to electronically disclose to EPA information on PFAS uses, production volumes, disposal, exposures, and hazards, dating all the way back to 2011. Together, these two rules will dramatically expand the amount of regulatory reporting industry will conduct related to PFAS.

The new TRI requirements apply starting with the 2024 reporting year (reports due July 1, 2025). A copy of the final rule is available here: Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting.”

Washington State Adopts Restrictions and Reporting Requirements for PFAS, Flame Retardants, Phthalates and Bisphenols in Wide Range of Consumer Products Thu, 29 Jun 2023 07:05:00 -0400 Joining the ranks of California, Minnesota, Maine, and New York, Washington state has officially finalized a ban on the manufacture, sale, and distribution of a variety of products containing per- and polyfluoroalkyl substances (“PFAS”), as well as several other “high profile” chemicals of concern, including flame retardants, phthalates, and bisphenols.

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.

EU Proposes Ban on PFAS in Most Products Fri, 10 Feb 2023 17:45:45 -0500 The European Union (“EU”) is preparing to adopt the world’s most sweeping ban on per- and poly-fluoroalkyl substances (“PFAS”), including with respect to the presence of the so-called “forever substances” in practically all consumer and commercial products.

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.

Maine Makes a Bold Move in Banning Most PFAS-Containing Products Mon, 29 Aug 2022 16:12:08 -0400 Last month, the Maine legislature introduced broad and sweeping restrictions on a range of products containing per- and polyfluoroalkyl substances (“PFAS”). These restrictions are some of the most comprehensive in the country, and, in effect, would ban PFAS in almost all products in the state by 2030. Specifically, the law mandates that on January 1, 2030, “a person may not sell, offer for sale or distribute for sale” products where PFAS have been “intentionally added,” except in cases of “unavoidable use.” Though PFAS have faced heightened public and regulatory scrutiny in the last few years, an outright ban like this is the first of its kind. Unsurprisingly, environmentalists and industry-members are clashing on the merits of the restrictions, with the former heralding it as a guiding light for other states to follow, and the latter fearful that it is the latest contribution to a balkanized regulatory system that will paralyze industry and deprive consumers of essential goods.

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.

EPA Expands List of PFAS Subject to Toxic Release Inventory Reporting Fri, 22 Jul 2022 15:25:42 -0400 Earlier this week, on July 18, 2022, U.S. EPA issued a final rule that subjects five new per- and polyfluoroalkyl substances (“PFAS”) to the Toxics Release Inventory (“TRI”) reporting requirements under Section 313 of the Emergency Planning and Community Right-to-Know Act (“EPCRA”). The listings are automatic and not subject to notice-and-comment rulemaking under the authority of the 2020 National Defense Authorization Act (“NDAA”), which directed EPA to add PFAS to the TRI reporting program.

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)
A fourth PFAS -- which we will refer to by its CAS number (CASRN 203743-03-7) due to its absurdly long chemical name -- was added based on its inclusion on the "active" TSCA Inventory last year after its chemical identity was no longer claimed as confidential by at least one manufacturer.

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.

EPA “Fenceline Communities Screening Strategy” Aims to Advance Environmental Justice Agenda Wed, 26 Jan 2022 12:01:49 -0500 EPA released this past Friday the agency’s draft strategy for examining health and environmental risks in communities that reside near facilities that emit chemicals undergoing TSCA review. The "fenceline communities screening strategy” is an initial and explicit injection of “environmental justice” principles into the realm of chemical risk evaluation and management. The Biden Administration has identified and regularly invokes EJ as a core focus and priority of EPA.
“ 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

Specifically, the draft “TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities" is a screening level methodology to evaluate potential exposures and risks to human health in proximity to (1) facilities with air emissions of chemicals undergoing risk evaluation under TSCA section 6, and (2) waterbodies receiving direct or indirect releases of chemicals undergoing risk evaluation under TSCA section 6. EPA defines "fenceline communities" as:

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.

Notably, EPA intends to apply the methodology to reassess risks from seven of the ten chemicals for which the agency relatively recently published risk evaluations under TSCA: 1-bromopropane (1-BP), methylene chloride (MC), n-methylpyrrolidone (NMP), carbon tetrachloride, trichloroethylene, and perchloroethylene, and 1,4-dioxane. The draft strategy includes initial "case studies" applying the strategy to 1-BP, MC and NMP as examples of how the strategy is intended to work.

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.

EPA Proposes Extension Until 2024 for Compliance with Problematic PBT Rule Tue, 26 Oct 2021 17:50:04 -0400 As the U.S. EPA embarks on a full review of regulations addressing the sale, distribution and use of five "persistent, bioaccumulative and toxic" (PBT) substances, the agency already is proposing to extend until 2024 the compliance date with the existing rule for one of the five PBTs - phenol, isopropylated phosphate (3:1) (known as "PIP (3:1)").

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 current proposed extension follows the agency's September announcement that it plans to propose by the Spring of 2023 new rulemakings for all five PBT chemicals addressed in the January 2021 final rule: in addition to PIP (3:1), Decabromodiphenyl ether (DecaBDE), 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP), Hexachlorobutadiene (HCBD), and Pentachlorothiophenol (PCTP).

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.

The Prop 65 Annual Conference: Notes from the Front 2021 Mon, 27 Sep 2021 19:31:38 -0400 (Virtually - once again) Live from San Francisco, Kelley Green Law Blog is reporting today from the Prop 65 Clearinghouse 2021 Conference ... the largest annual gathering of stakeholders from the full spectrum of actors involved with California’s “Proposition 65," including state regulators and legislators, plaintiff enforcers, defense and corporate counsel, tox and risk assessment consultants, product manufacturers, trade associations, and environmental and public health NGOs. The popularity of the conference, with over 250 participants, continues to demonstrate the extensive reach of Prop 65, touching businesses well-beyond the borders of California, particularly with the exponential growth over the last several years in product sales over the internet. As I have remarked in prior commentaries (2018 and 2020), the conference is valuable not only to gain insights into the latest trends, current developments, and future direction of the program, but also as a helpful reminder, for this defense counsel, of the role and motivations of the other stakeholders in the Prop 65 universe.

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.
Thanks for joining us at the conference and we hope to be broadcasting live and in person next year from the City by the Bay! As always, for the latest on Prop 65 stay tuned to Kelley Green Law Blog.

EPA Expands List of PFAS Subject to TRI Reporting Thu, 03 Jun 2021 16:55:05 -0400 The U.S. Environmental Protection Agency (EPA) is adding three per-/poly-fluoroalkyl substances (PFAS) to the list of substances reportable under the agency's Toxic Release Inventory (TRI) reporting program. Consistent with a recently leaked document highlighting priorities of the Office of Pollution Prevention and Toxics (OPPT), the agency announced earlier today (June 3) the addition of perfluorooctyl iodide (CAS No. 507-63-1), potassium perfluorooctanoate (2395-00-8), and silver(I) perfluorooctanoate (335-93-3) for the 2021 reporting year, meaning that the three PFAS are subject to reporting by July 1, 2022.

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.

EPA Considering Expanded TSCA CDR and TRI Reporting Requirements, Environmental Justice Analyses Tue, 25 May 2021 12:21:00 -0400 The new 2021-2023 strategic plan of the U.S. EPA's Office of Pollution Prevention and Toxics (OPPT) floats a series of potential expanded reporting requirements under the agency's Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) and Environmental Protection and Community Right-to-Know Act (EPCRA) Toxic Release Inventory (TRI) programs. The TRI and CDR programs are the most significant and wide-reaching chemical reporting programs administered by the agency and the source of much of the data EPA relies on to guide regulatory actions involving all of the agency's programmatic offices, including air, water, waste, pesticides and chemicals.

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.
For OPPT, the CDR and TRI databases are critical sources of information for chemical risk evaluations, the pace of which is increasing substantially as EPA implements the aggressive chemical assessment mandates from the 2016 TSCA amendments. While annual reporting may make sense for certain chemicals/activities -- such as TRI, where environmental releases may vary on a year-to-year basis (e.g., due to one-time release events), the utility of annual CDR reporting is questionable, as production volumes and the downstream exposure patterns for most chemicals typically do not vary substantially for the large majority of reporting facilities. Balancing these factors will be critical in ensuring that any revised CDR rule does not simply result in repetitive "busy work" for most companies.

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.

EPA Grants Temporary Reprieve to TSCA PBT Chemical Prohibition, Re-Opens Comment Period Tue, 09 Mar 2021 18:09:02 -0500 Facing a massive uproar from industry groups and companies, late yesterday EPA put a hold on enforcement of a newly effective prohibition on one "PBT" chemical and announced a new comment period to re-examine the rules issued on January 6, 2021, for five PBTs under section 6(h) of the Toxic Substances Control Act (TSCA).

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)
Despite a multi-year rulemaking process, it appears that a large majority of effected industries were unaware of how widespread at least one of the regulated PBT substances is in the products or components that they manufacture or import. 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, semi-conductor manufacturing equipment, wiring harnesses, and even, as EPA noted, "equipment used to move COVID-19 vaccines and keep them at appropriate temperature." However, PIP(3:1) has not been prominent on the regulatory radar screen until now, in part because it is not regulated as yet in the European Union.

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

To avoid imminent supply chain disruptions to large sectors of the economy, EPA agreed to the last minute reprieve and instituted a 180-day pause in enforcement of the PIP (3:1) prohibitions, exercising its enforcement discretion in the form of a "no action assurance" letter.

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.

TSCA section 6(h) requires EPA to take expedited action on specific PBT chemicals to address risk and reduce exposures to the extent practicable. Based on the statutory criteria, EPA identified five PBT chemicals for expedited action in 2016 and issued a proposed rule in 2019, with the rule made final two months ago. Under TSCA section 6(h), no additional risk evaluation is required for PBT chemicals. Accordingly, unlike most chemical reviews arising under TSCA, the PBT rulemaking jumps right to the "risk management" phase.

This whole episode is a high profile reminder of the need for companies to have a system in place to track all chemicals that are present in their products, or that are vital to their manufacturing activities, and to monitor regulatory actions that will impact those substances.

EPA Extends TSCA Chemical Data Reporting Deadline to January 29 Mon, 23 Nov 2020 16:27:17 -0500 Citing difficulties experienced by numerous submitters using EPA's online reporting portal, the agency has extended the TSCA Chemical Data Reporting (CDR) deadline for two months.

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.

EPA Announces Remedy to Overly Broad TSCA Fee Requirements, Including Relief for Natural Gas Combustion Operations Wed, 25 Mar 2020 18:20:52 -0400 The many U.S. companies that combust natural gas as part of their operations received good news today, as EPA announced that it will amend the Toxic Substances Control Act (TSCA) "Fees Rule" to exclude from coverage manufacturers that only produce a chemical as a byproduct or impurity, as well as companies that import articles containing the chemical. The agency move comes in response to an uproar from the manufacturing community, which came to realize that the Fees Rule, as it stands now, imposes financial responsibility on "manufacturers" for funding EPA's evaluation of a substance even if they only produce the substance as an incidental or trace byproduct, or if it happens to be contained at low levels in a product they import. At least one of the first 20 "high priority" substances undergoing risk evaluation -- formaldehyde -- is generated in trace levels through combustion of natural gas, meaning that hundreds of companies would be on the hook for contributing to the $1.35 million evaluation fee.

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.

Many companies only recently became aware of the breadth of the Fees Rule, particularly with respect to formaldehyde formed in trace amounts during natural gas combustion. For those companies, and the many also who import articles containing formaldehyde (e.g., treated wood products among others), today's EPA announcement comes as welcome relief.

EPA Punts on Meaningful Revisions to TSCA Reporting of Recycled Byproducts Wed, 01 May 2019 15:45:41 -0400 In 2017, at the direction of a provision in the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act, which fundamentally reformed the Toxic Substances Control Act (TSCA), EPA convened a group of stakeholders representing environmental groups, states, tribes, industry, and agency officials to negotiate a rulemaking to limit the burden of reporting requirements under the Chemical Data Reporting (CDR) rule for manufacturers of inorganic byproducts that are sent for recycling. The effort was doomed from the start when the agency decided that it would only pursue rulemaking if all stakeholders reached consensus on a recommendation (thereby giving environmental groups an effective veto over even modest reductions in reporting, which they had no interest in or compelling reason to support). At least, however, EPA recognized eventually that the amended Act required the agency to propose something to address the byproduct reporting situation.

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.

EPA also proposes a petition process to expand the list of CDR-exempted byproducts, similar to an existing petition process for chemicals of “low current interest.” While the petition option is nice, it simply puts the ball back in the court of the individual company or industry to seek and justify their own exemption.

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:


(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.

Comments are due June 24th.

EPA Proposes Changes to Key Chemical Data Reporting Rule Fri, 12 Apr 2019 16:55:34 -0400 The U.S. EPA announced today proposed amendments to the Chemical Data Reporting (CDR) rule with an aim "to better support Agency data collection efforts, align reporting with the Frank R. Lautenberg Chemical Safety for the 21st Century Act by requiring that confidentiality claims be substantiated, and make chemical reporting easier by streamlining complex submissions."

“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 The proposed amendments can be found here.

EPA Issues First Set of Priority Chemicals for TSCA Risk Assessment Wed, 20 Mar 2019 17:01:15 -0400 Earlier today, US EPA released the inaugural draft list of 20 "high priority" and 20 "low priority" chemicals for risk evaluation purposes as required by the 2016 amendments to the Toxic Substances Control Act (TSCA). EPA must finalize the listings by December 2019, at which point "high priority" chemicals will be required to go through the new TSCA risk evaluation process (the "low priority" designation indicates that risk evaluation is not warranted at this time).

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.
The EPA action is unlikely to quell calls for prompt release of the IRIS risk assessment for formaldehyde, which has been near-completion for almost two years (after an initial draft assessment in 2010 was the subject of intense opposition based on the agency's preliminary finding that exposure to the substance was associated with increased risk for leukemia). Significantly, the TSCA review process is likely to be narrower and focused on a limited set of uses of the chemical, whereas an IRIS risk assessment would have broader applicability for regulators and toxicologists seeking to assess a wide range of uses.

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.

Updated TSCA Inventory Identifies "Active" Chemicals in Commerce Wed, 20 Feb 2019 17:58:03 -0500 EPA has released the updated TSCA Chemical Substance Inventory, with, for the first time, "active" and "inactive" designations as required by the 2016 Amendments to the Toxic Substances Control Act (TSCA). Of the 86,228 chemicals on the Inventory, less than half (40,655 or 47%) are designated as "active." The updated Inventory can be accessed here.

The designations are based on reporting by chemical manufacturers, importers, and processors, which concluded on October 5, 2018, under the agency's TSCA Inventory Notification (Active-Inactive) Rule. "Active" substances also include those that were reported during the 2012 and 2016 Chemical Data Reporting cycles. All substances not reported as “active” are identified as “inactive.”

While seemingly mundane, this is important stuff: chemicals that are classified as “inactive” will not be able to be manufactured or imported into the U.S. without going through EPA’s pre-manufacture notice (PMN) and review process. PMN is something to avoid, particularly after the 2016 amendments shifted the burden of proof to require that EPA now make an affirmative finding that the substance does not pose an unreasonable risk to health or the environment before allowing it on the market.

For processors (i.e., companies that use chemicals), it is imperative to confirm with suppliers that the chemicals they receive from them are designated as "active." Manufacture, import or use of (or placement on the market of a product containing) an "inactive" substance can incur serious penalties. Companies that wish to start using an "inactive" substance must submit to EPA, within 90 days prior to the anticipated start of such use, a Notice of Activity (Form B) to EPA to change the Inventory designation from "inactive" to "active."

EPA Rule Addressing Methylene Chloride Risks Stalled by "Shutdown" ... While Activists File First "New TSCA" Court Challenge for EPA Failure to Act Fri, 25 Jan 2019 08:00:51 -0500 During confirmation hearings before Congress last week, Acting EPA Administrator Andrew Wheeler indicated that a long-awaited EPA rule to restrict consumer and commercial uses of methylene chloride as a paint and coating remover has been delayed by the government shutdown, after being submitted to the Office of Management and Budget on December 21st. Meanwhile, on January 14th, environmental groups and the parents of two men killed after exposure to the solvent, filed suit in the U.S. District Court for the District of Vermont seeking to compel EPA to finalize a January 2017 proposal to ban methylene chloride in most consumer and commercial paint and coating removal products.

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).

Midterm Elections Signal Increase in TSCA Oversight Thu, 15 Nov 2018 13:12:48 -0500 With Democrats now in control of the House, Congressional oversight of EPA's implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA) is set to ramp up. The expected incoming chair of the House Energy & Commerce Committee, Rep. Frank Pallone (D-NJ), announced yesterday his intentions to hold a hearing early next year to address what he calls the agency’s "broad efforts to undermine" the revised TSCA. Pallone was an early House sponsor of the bipartisan 2016 legislation that fundamentally revised TSCA and triggered a series of regulatory requirements that EPA must fulfill within a relatively aggressive timeframe.

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.”

The remaining draft assessments for the first wave of chemicals to be evaluated under the revised TSCA are scheduled to be issued by or soon after the new year. Given the precedent that these initial risk assessments will establish for future chemical reviews, they are expected to be a key focus of oversight by House majority Democrats.

TSCA Chemical Inventory “Reset” Reporting Deadline: October 5 Wed, 03 Oct 2018 17:22:31 -0400 Reminder that Friday is the deadline for chemical “processors” to file notifications with EPA to ensure that the chemicals they use are designated as “active” substances on the TSCA Inventory. “Active” designation is important as chemicals that are “inactive” will be treated as new chemicals for which pre-manufacture (or pre-import) notification and safety determination requirements will apply. Many, if not most, chemicals in use in the U.S. likely already have been reported, but if you have not checked the EPA database of chemicals for which notifications already have been received, you should consider doing so now to avoid unanticipated supply disruptions.

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.