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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.”

 

Newly proposed legislation in New York, announced by Gov. Andrew Cuomo during the release of his Executive Budget late last month, would look an awful lot like California’s “Proposition 65” program … but, presumably, with crucial differences.  As described by the Governor’s office, under the “Consumer Right to Know Act”:

[A]gencies will assess the feasibility of on-package labeling and develop regulations establishing a labeling requirement for designated products, developing a list of more than 1,000 carcinogens and other chemicals that will trigger labeling and identifying the types of consumer products that will be subject to the new regime.

Sound familiar?

The Governor’s press release, the full text of which is available here, also noted that the Department of Environmental Conservation would administer the law, in consultation with the Department of Health and the Department of State.

While few details have been released outside of this announcement, and no actual legislative text has been issued, the parallels to California’s consumer product warning requirements are obvious.  In fact, it would be surprising if New York, assuming the law is adopted, did not default to the California Office of Environmental Health Hazard Assessment’s existing Proposition 65 list of carcinogens and reproductive toxins as the basis for the program.  The same may be true for the text of any required warnings as well, if for no reason other than to ease compliance given that many products already bear the California-required warnings, as well as the potential for consumer confusion from potentially multiple warning statements.

The differences with Prop 65, however, are critical.  First and foremost, there has been no mention of any role for private plaintiff enforcement of the New York law.  Second, the determination of which products require a warning apparently will be accomplished through a state agency regulatory process, rather than left to individual companies.  These two factors — private plaintiff enforcement combined with placing the burden of proof on the business to justify not providing a warning — combined in California to spawn a host of questionable “bounty hunter” suits and an absurd proliferation of warnings that litter the Golden State and do little to advance public health.

It will be fascinating, if the proposal advances, to see what, if any, lessons New York has learned from the California Prop 65 experience and how the state handles a number of critical issues, such as:

• Which products will be subject to warning requirements … all consumer products?  or just certain ones?

• What level of exposure or risk will trigger the need for a warning?

• The list of “potentially hazardous chemicals” that the press release alludes to is practically infinitely long, as almost any substance is “potentially hazardous” at a sufficient dose.  Will New York address substances other than carcinogens and reproductive toxins?

• How will the law be enforced and by whom?  What will the penalties be for non-compliance?

 

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).

 

The California Office of Environmental Health Hazard Assessment (OEHHA), which oversees the state’s Proposition 65 program, is on the verge of finalizing an exemption from warning requirements for chemicals, such as acrylamide, “created by and inherent in the processes of roasting coffee beans or brewing coffee.”  The new regulation, which recently was sent to the state’s Office of Administrative Law (OAL) for a final review, would establish a new provision (Section 25704) entitled “Exposures to Listed Chemicals in Coffee Posing No Significant Risk.”

Proposed in June 2018, the exemption embodies OEHHA’s response to widespread backlash against a California court decision in favor of the plaintiff, the Council for Education and Research on Toxics (CERT), holding that dozens of coffee-serving defendants in the state violated Prop 65 by failing to provide warnings about exposure to acrylamide, despite the fact that the bulk of the science shows that drinking coffee does not increase cancer risk.  CERT is seeking millions of dollars in fines against the coffee roasting/retail defendants, though the penalty phase of the litigation has been put on hold pending resolution of the exemption rulemaking.  Finalizing the exemption, however, may not be the end of the case, as a CERT challenge to the legal sufficiency of the exemption also is pending in California court.

The OAL has until February 19 to review the regulation, and its accompanying “final statement of reasons,” including response to comments, and decide whether to accept, reject, or request further information from OEHHA.

For further information on the proposed exemption, please see my prior post from June 2018:  https://www.kelleygreenlawblog.com/2018/06/california-acts-decaffeinate-cancer-warnings-coffee/

 

 

Proposition 65 plaintiff groups are starting 2019 with a practically unprecedented bounty of enforcement actions underway.  According to information available from the California Attorney General’s Prop 65 website, almost 2,000 60-Day Notices of Violation have been filed since April 2018 with the vast majority remaining unresolved.  During the last quarter of 2018 alone, 607 new actions were initiated and 2,358 in total during the year.   An incredible 88% (2,083) of the actions filed in 2018 involved phthalates (especially DEHP and DINP), with lead, historically a Prop 65 favorite, a distant but still robust second with 570 actions during the year (note that some actions involve multiple chemicals).

This aggressive spate of activity continues a trend that has seen an almost 50% increase in Prop 65 plaintiff actions since the start of 2017 — following, coincidentally or not, the landmark Prop 65 reforms adopted in August 2016.  (A detailed overview of the 2016 amendments is available here.)  In 2017, there was a notable uptick in enforcement actions by Prop 65 plaintiff groups, with 2,711 actions filed (the 2017 totals are skewed somewhat by virtue of one plaintiff filing 675 notices in May 2017 regarding listed substances found in marijuana products; aside from those anomalies, 2,036 new actions were initiated that year).

A quick look at the number of 60-day notices (which are required to be filed with the state AG’s office) issued to businesses over the last decade shows just how popular (and increasingly so) Proposition 65 is with plaintiff “bounty hunters”:

YEAR # of 60-Day Notices of Violation
2018 2,358
2017 2,711   (2,036 per above)
2016 1,576
2015 1,336
2014 1,404
2013 1,097
2012 908
2011 1,079
2010 787
2009 604
2008 632

Why the increase in activity?  A number of factors clearly are involved, including the ever-increasing number of listed chemicals, as well as a larger number of active plaintiff groups that reflects a broader public consciousness regarding chemical issues.  Phthalates, lead, and, more recently, acrylamide are high profile attention-grabbing substances that are widely found in consumer goods and/or food products and are the focus of a large percentage of Prop 65 actions.  Of course, the increasing amount of money paid in settlements and fines (a substantial amount of which is paid to the plaintiff bounty hunter) no doubt is a lure as well.

Kelley Green Law will continue to follow Prop 65 developments closely and periodically examine enforcement trends as we move through the new year.

Happy 2019.

Environmental groups have filed a Notice of Intent to sue the U.S. Environmental Protection Agency (EPA) over its still draft decision not to establish a program to address potential spills of hazardous substances similar to the existing  “Spill Prevention, Countermeasure and Control” (SPCC) program for oil.  In June, EPA reversed course from an Obama-era agreement to initiate a rulemaking to impose SPCC requirements for hazardous substances, explaining in a proposal that the agency believes that existing regulations are adequate to meet its obligations under the Clean Water Act (CWA) and no new regulatory program is needed.  See my prior post for more details on EPA’s proposal.

Rather than wait for EPA to finalize the June proposal, the Natural Resources Defense Council (NRDC), Clean Water Action, Environmental Justice Health Alliance, and the Just Transition Alliance, filed on October 26 a recently posted Notice of Intent to sue the agency within 60 days for failure to move forward with what the groups consider long-overdue regulations:

Despite its duty to issue worst-case hazardous-substance spill regulations by August 1992, EPA missed its deadline. These regulations are now more than twenty-five years overdue. EPA’s decades-long failure to issue worst-case hazardous-substance spill regulations therefore violates the Agency’s nondiscretionary duty.

The groups cite for support CWA Section 311(j)(5)(A)(i), added as part of the Oil Pollution Act of 1990, which provides that “the President shall issue regulations which require an owner or operator [of a facility] … to prepare and submit to the President a plan for responding, to the maximum extent practicable, to a worst case discharge, and to a substantial threat of such a discharge, of oil or a hazardous substance.”

Based on the notice, it is apparent that the groups aim to assert both the non-discretionary nature of EPA’s duty to develop an “SPCC for hazardous substances” and,more than likely, the adequacy of EPA’s “non-regulation” proposal as failing to satisfy the statutory requirement to address “worst case discharges.”

By failing to act, the groups contend that EPA

… leaves the communities closest to the most dangerous chemical facilities in the country without any assurance that those facilities are – as Congress mandated – adequately planning to prevent and respond to catastrophic chemical spills, including those caused by floods, fires, and hurricanes. These communities, which are disproportionately low-income or communities of color, are entitled to all the protections for public health, drinking water supplies, and the environment Congress mandated in the Clean Water Act.

The 60-day notice period required by the CWA prior to filing a suit against the agency expires Christmas Day …meaning EPA could find a lump of coal in its stocking courtesy of NRDC et al. on December 25.

At the direction of the California Legislature, the Office of Environmental Health Hazard Assessment (OEHHA) is conducting a risk assessment of the potential adverse health impacts of synthetic food dyes on children, with a focus on neurobehavioral and other neurologic effects.  To support that investigation, OEHHA recently extended until February 19th a data call-in for information relating to possible exposures to and the toxicity of nine specific food dyes:

  • FD&C Blue No. 1 (CAS 3844-45-9)
  • FD&C Blue No. 2 (CAS 860-22-0)
  • FD&C Green No. 3 (CAS 2353-45-9)
  • Orange B (CAS 53060-70-1)
  • Citrus Red No. 2 (CAS 6358-53-8)*
  • Citrus Red No. 3 (CAS 16423-68-0)
  • FD&C Red No. 40 (CAS 25956-17-6)
  • FD&C Yellow #5 (CAS 1934-21-0)
  • FD&C Yellow #6 (CAS 2783-94-0)

(Citrus Red No. 2 currently is listed under Proposition 65 as a chemical known to the state to cause cancer.)

OEHHA is planning a symposium on the neurological and neurobehavioral impacts of synthetic food dyes in Summer/Fall 2019.  The risk assessment process will include a public review period and scientific peer review.

The 2018-2019 California state budget passed by the Legislature earlier this year included funding for OEHHA to review the scientific literature on the health effects of children’s exposure to synthetic food dyes and prepare a summary report by July 1, 2019.  The results will help inform potential legislation addressing food dyes, including possible reintroduction of an earlier bill (S.B. 504 introduced in 2017) that would have required (for the first time in the U.S. at the federal or state level) warning labels on all foods containing synthetic food dyes, including food served at restaurants.

The preamble to S.B. 504 included several notable (and alarming) declarations:

Synthetic food dyes trigger hyperactivity and other behavioral problems in some children with Attention Deficit/Hyperactivity Disorder (ADHD) or other behavioral disorders, and may also trigger these behaviors in other children without those disorders.

The removal of food dyes from the diet reduces symptoms in affected children.

Foods containing synthetic food dyes are heavily marketed to children.

Further information on the OEHHA data call-in can be found at this link.

 

Only a few months after new provisions went into effect (on August 30th), California’s Office of Environmental Health Hazard Assessment (OEHHA) is proposing to clarify the rules governing retailer and supply chain responsibility for providing warnings under Proposition 65.  These provisions (found in Section 25600.2 of Article 6 of the Prop 65 regs) are intended to provide greater certainty to retailers, distributors, and manufacturers on who is responsible for providing Prop 65 warnings and when, but have sparked a fair amount of confusion due to several ambiguous provisions.

The 2016 amendments to the warning provisions of Prop 65 aimed to limit potential retailer burdens by providing manufacturers (and distributors) with two basic compliance options: (1) affix an appropriate warning to the product; or (2) provide written notice to the retailer regarding the required warning for the product.  The manufacturer/distributor then must obtain confirmation of the retailer’s receipt electronically or in writing.  Retailers that receive such a notice are only liable if they fail to post, obscure, or alter a warning provided to it.  Retailers also may be liable for products sold under their own brand name or if they have “actual knowledge” that a warning is required for a product and there is no other potentially responsible party.

Most notably, OEHHA is proposing three main changes:

First, OEHHA proposes to allow distributors to satisfy their obligation by providing written notice and warning materials either to the retailer or to the business to which they directly sell or transfer the product (i.e., the next distributor in the supply chain).  The current rule only provides that such notice be sent to “the authorized agent for the retail seller.”  The proposal responds to business concerns that “the original manufacturer, distributor, importer, or others in the chain of commerce may not know where or by whom the product will ultimately be sold to a consumer.”

Second, OEHHA would clarify that where a business has not designated an authorized agent to receive Proposition 65 notices, the notice may be served on the business’s legal agent for service of process.

Third, OEHHA addresses the concept of “actual knowledge” that may trigger retailer responsibility for providing a warning.  Currently, the regulations state that retailers must provide a warning when they have “actual knowledge of a potential consumer product exposure and there is no manufacturer, producer, packager, importer, supplier, or distributor of the product who is subject to the act, and who has a designated agent for service of process or a place of business in California.”  The definition of “actual knowledge” would be expanded to clarify that “actual knowledge” must be of “sufficient specificity for the retail seller to readily identify the product that requires a warning.  Consistent with traditional agency/corporate law, OEHHA also would confine the scope of employees whose knowledge may be attributed to the business to either “an authorized agent for the organization, or an employee in a position of sufficient responsibility that his or her knowledge can be imputed or attributed to the retail seller.”

UPDATE:  OEHHA has extended the comment period through January 11, and scheduled a public meeting on January 3.

With the biggest sales day of the year shortly upon us, a new wave of on-line shopping Americans likely will see Proposition 65 warning notices for the first time.  Though California’s notorious program technically only applies within the state’s borders, Prop 65’s impact stretches well beyond.  Non-California businesses long have had to deal with Prop 65’s requirements since it was adopted by voter referendum in 1986.  Now, however, non-California consumers will be introduced to the ubiquitous warnings (that many Californians simply ignore) thanks to recent amendments emphasizing the need to provide warnings for internet purchases.  (For more details on the recent amendments, including the requirements for internet sales, please see my prior blog post.)

With an exponential increase in recent months of such internet warnings (and the fact that most businesses do not maintain “California-only” websites), consumers across the United States will be seeing many more of these warnings, perhaps for the first time, as they start their holiday shopping.  This article from Yahoo News (Article) — “‘This product contains chemicals known … to cause cancer’: How to navigate Prop 65’s scary warnings while toy shopping” — gives a sense of how consumers may respond … and, more importantly, hints at how such warnings should be understood.

In particular, consumers should keep in mind:

→ There are over 900 chemicals listed by the State of California as potentially causing cancer or reproductive/developmental harm.  Many of these substances are listed based on exposures (usually to laboratory animals) at levels hundreds or thousands of times higher than the level to which a person ever would be exposed.

→ Because of the punitive enforcement mechanisms of Prop 65 … and the proliferation of plaintiff “bounty hunters” that enforce the law … many businesses choose to provide a warning (even when one is not necessary) rather than defend a determination (based on sound science and common sense) not to provide a warning in a lawsuit at substantial cost.

→ Most importantly, remember that it is “the dose that makes the poison.”  The existence of a warning does not mean that the product actually poses any kind of meaningful risk.  In most cases, the presence of a warning only means that there may be some exposure to a listed substance, mainly due to the practicality of providing a warning even when one is not necessary.

Prop 65 is intended to force businesses to provide a warning if they choose not to reformulate listed chemicals out of their products.  For many products, reformulation is not an option.  Moreover, it may be impossible to avoid miniscule amounts of certain substances, such as lead, which are ubiquitous contaminants in many materials.  Hence, there is a proliferation of warnings on products that are provided simply out of an abundance of caution and serve no real risk-reduction purpose.  (Which is why they are routinely ignored by many Californians … unfortunately, the rest of the country is not nearly as familiar with them.)

Now these warnings are coming en masse to the Black Friday shopping website of your choice ….  something to consider while enjoying your turkey this Thanksgiving!

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.