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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).

 

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.

 

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.

 

 

 

 

By November 2021, the European Union (EU) is requiring that clothing, accessories, footwear and other textiles (such as furniture upholstery and bed linens) be essentially free of 33 “CMR” substances, including lead, cadmium, arsenic, hexavalent chromium, formaldehyde, several phthalates, and certain azodyes, aromatic amines, and hydrocarbons, among other substances often found in a variety of dyes, flame retardants, and stain- and water-proofing agents.  The restrictions, adopted on October 10 under Annex XVII of the EU’s REACH legislation, apply to textile products sold in the EU that may come into contact with human skin (or be inhaled or ingested) and aim to reduce exposures to substances identified as carcinogens, mutagens, or reproductive toxins (so-called “CMR” substances).

The regulation specifies acceptable de minimis levels for the 33 substances, ranging from as low as 1 mg/kg to 3,000 mg/kg.  Amounts above these levels, whether present intentionally or as an impurity, would be prohibited.

The restrictions do not apply to (a) products made exclusively of natural leather, fur or hide; (b) non-textile fasteners and non-textile decorative attachments; (c) second-hand clothing or other products; (d) carpets, rugs, and other textile floor coverings; or (e) medical devices or personal protective equipment, as well as disposable (i.e., single or limited use) textiles.

While a two year phase-in is provided to allow for manufacturers to conform to the new restrictions, a number of companies reportedly already have reformulated away from the listed substances and adopted (supposedly) less hazardous alternatives or are on track to do so.

The full text of the new EU regulation can be found here:  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2018.256.01.0001.01.ENG&toc=OJ:L:2018:256:TOC.

 

 

 

A new framework of fees to cover the costs of implementing the provisions of the 2016 amendments to the Toxic Substances Control Act (TSCA) will go into effect October 1st, under a final rule issued yesterday by EPA.  The fees are designed to collect $20 million annually from chemical manufacturers, importers, and processors, or about 25% of the expected agency costs of implementing the new mandates of TSCA, including chemical prioritization and risk evaluation tasks, as well as review of toxicity and exposure data submitted under an EPA test order.

These fees are intended to achieve the goals articulated by Congress by providing a sustainable source of funds for EPA to fulfill its legal obligations to conduct activities such as designating applicable substances as High- and Low-Priority, conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, requiring testing of chemical substances and mixtures, and evaluating and reviewing new chemical submissions, as required under TSCA sections 4, 5 and 6, as well as and collecting, processing, reviewing, and providing access to and protecting information about chemical substances from
disclosure as appropriate under TSCA section 14.

Examples of some of the fees manufacturers (and sometimes processors) would pay include:

• $1.3 million for agency-initiated chemical risk evaluations;

• $2.5 million for manufacturer-requested risk evaluations for chemicals not on EPA’s 2014 TSCA Work Plan list, and $1.25 million for chemicals on the list;

• Between $9,800 and $22,800 for EPA review of toxicity, exposure, and other information companies submit in response to an EPA order, regulation, or negotiated agreement;

• $16,000 for EPA review of new chemicals (or certain new uses).

The final rule largely adopts the user fee program as proposed in February, with certain modifications to the procedures for identifying manufacturers subject to the fees, the fee calculation for chemical reviews requested by manufacturers (which are substantially higher than the fees for agency-initiated reviews), and the standard for identifying “small businesses” subject to fee reductions of approximately 80%.

The fee rule is the fourth and final of EPA’s “framework rules” for implementing the 2016 TSCA amendments.  The first three rules addressed chemical prioritization for risk assessment; the process for conducting risk evaluation; and update of the TSCA existing chemical inventory.

Further details and background information on the fee rule is available from EPA’s website:  www.epa.gov/tsca-fees.

** UPDATE 8/29/2018 ** NTP just released a draft report recommending that “frequent and long term night shift work … that causes circadian disruption is known to be a human carcinogen” based on human studies.  Continue Reading This is Not a Dream … Agencies Actually are Reviewing the Cancer Risks of Night Shift Work (UPDATED)