Consumer Product Safety Commission to Regulate Non-Polymeric Organohalogen Flame Retardants

On September 20, 2017, the Consumer Product Safety Commission (CPSC or Commission) voted to regulate non-polymeric organohalogen flame retardants (OFRs).  With this vote, CPSC granted a petition from a group of NGOs to initiate rulemaking under the Federal Hazardous Substances Act (FHSA) to address hazards posed by the substances.  In addition, the Commission requested that manufacturers of children’s products, furniture, mattresses, and electronics casings immediately eliminate the use of OFRs.  The Commission also urged distributors and retailers to inquire about the existence of OFRs in their products.

The Commission noted that it has the authority to address products containing OFRs on a class-wide basis.  The Commission further noted that in order to determine that OFRs as a class constitute a “hazardous substance” under FHSA, CPSC need only determine that OFRs are toxic.  Under FHSA, a substance is toxic if it has the capacity to produce injury or illness through ingestion, inhalation, or absorption through any bodily surface, and may cause substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use of those products.

To address OFRs, CPSC will convene a Chronic Hazard Advisory Panel (CHAP) to assess and issue a report on the risks to consumers’ health and safety from the use of non-polymeric OFRs in the following products:

  • Durable infant and toddler products, children’s toys, child care articles and other children’s products;
  • Upholstered furniture sold for use in residences;
  • Mattresses and mattress pads; and
  • Plastic casings surrounding electronics.

The Commission also directed that a Guidance Document on Hazardous Additive, Non-Polymeric Organohalogen Flame Retardants be published in the Federal Register.  A prepublication draft of the Guidance has been released.

These actions by the CPSC come more than two years after Earthjustice and the Consumer Federation of America petitioned CPSC to adopt rules to protect consumers and children from the health hazards caused OFRs.  Groups joining the petition include the American Academy of Pediatrics, Consumers Union, and the International Association of Fire Fighters.

Clorox Sued for Deceptive Marketing Practices

A group of consumers recently sued Clorox for unjust, unfair, and deceptive practices in misrepresenting the environmental and other benefits of “Green Works” products in violation of California and New York law.  The complaint was filed in the U.S. District Court for the Northern District of California.  Plaintiff’s seek class action status.

The complaint alleges that Clorox has made false representations that Green Works products are naturally derived, environmentally sound, and safer alternatives to other cleaning products.  For example, the complaint asserts that the products contain unnatural and harmful chemical ingredients which are associated with skin irritation, allergic reactions, immune system toxicity, and aquatic toxicity.

The complaint includes a number of charges that Clorox has violated California and New York law.  The complaint alleges that Clorox has violated California’s Consumers Legal Remedies Act with unfair methods of competition and unfair and deceptive acts and practices by falsely representing that the Green Works products are naturally derived, green, environmentally sound, and relatively safe products compared to other cleaning products.  It alleges that Clorox has violated California’s Unfair Competition Law by engaging in unlawful, fraudulent, and unfair conduct; that “misleading marketing, advertising, packaging, and labeling of Products is likely to deceive reasonable consumers.”  In addition, the complaint alleges that Clorox has violated New York General Business Law through false advertising concerning the Green Works products.

Remedies sought by the plaintiffs include relabeling to remove representations that the products provide “natural” benefits and are environmentally sound and naturally derived.  In addition, the plaintiffs seek restitution and that Clorox disgorge all revenues obtained as a result of its unlawful, fraudulent, and unfair conduct.

CDR Reporting Violations to Cost Ricoh Electronics $245,990

EPA recently settled its case against Ricoh Electronics, Inc., for inaccurate reporting and recordkeeping of chemical substances imported by its facilities located in Tustin and Santa Ana, CA, and Lawrenceville, GA.  Under the settlement, Ricoh Electronics will pay a fine of $245,990.

These violations were found when the Agency inspected the company’s Chemical Data Reporting (CDR) submissions.  EPA reports that in 2012, Ricoh filed a timely, but inaccurate, CDR report of the total annual volumes of three chemical substances imported in 2011 at its Tustin facility, and one chemical substance imported at its Santa Ana facility.  In addition, the Agency found that the company did not have records documenting the quantity of 10 chemical substances imported to its Lawrenceville, Ga., facility in 2015.

CDR reporting under TSCA requires the companies submit information to EPA regarding the chemical substances that they manufactured of imported at volumes of 25,000 pounds or more.  Reporting is only required for substances listed on the TSCA Inventory.  The submission period for the most recent CDR data collection ended in October 2016.  Reporting will not be required again until 2020.

EPA-Small Business Administration Meeting on Methylene Chloride in Furniture Refinishing

On August 18, 2017 EPA announced a Public Meeting on Methylene Chloride in Furniture Refinishing in collaboration with the Small Business Administration (SBA) Office of Advocacy.

On September 12, 2017, EPA, in collaboration with the SBA Office of Advocacy, is holding a public workshop on the use of the paint remover, methylene chloride, in furniture refinishing. This workshop will inform EPA’s understanding of the use of methylene chloride in furniture refinishing. Federal and state governments, industry professionals, furniture refinishing experts, non-government organizations, and academic experts, among others, will discuss the role of methylene chloride in furniture refinishing, potential alternatives, economic impacts, and other issues identified in EPA’s proposed rule [insert hyperlink] regulating certain uses of methylene chloride.

The proposed rule deferred action on the use of methylene chloride in commercial furniture refinishing.  It proposed a prohibition on the manufacture (including import), processing, and distribution in commerce of methylene chloride for most other types of paint and coating removal.

Information from the September 12, 2017 meeting will allow EPA to better understand current work practices and obtain additional information on the economic considerations involved in selecting chemical products for paint and coating removal in the furniture refinishing sector.

The meeting will be held at EPA Region 1 Headquarters in Boston, Massachusetts from 9:00am to 4:00pm.  EPA is also providing remote access for people who are unable to attend in person.

EPA has established an online registration system.

National Academy of Sciences Releases Strategy on Evaluating Low-Dose Effects of Endocrine Disruptors

On July 18, 2017, the National Academies of Sciences released a report detailing a strategy for evaluating the evidence of low-dose effects of endocrine disruptors (called endocrine active chemicals (EACs) in the report).  The Academies emphasized the importance of the strategy, noting that even small alterations in hormone concentrations, particularly during embryonic development, can have lasting and significant effects.

EPA asked the Academies to develop the strategy in response to evidence suggesting that some chemicals have effects at doses lower than those studied in traditional toxicity testing.  By commissioning the strategy, the Agency is working to address concerns that its current toxicity-testing protocols might be inadequate to identify all potential hazards to human health.

The strategy presents a three phase approach:

  • Surveillance for evidence that a chemical may cause a health effect or that a health effect may be missed by traditional toxicity-testing methods,
  • Investigation and analysis of the evidence, and
  • Acting on the evidence.

The Academies noted that EPA is already conducting many activities consistent with the proposed strategy.  However, the report notes that the Agency’s current approach does not necessarily use these activities to assess low-dose exposure to EACs.

The Academies made recommendations for EPA’s decision-making about its regulatory toxicity-testing practices to facilitate a greater emphasis on regular consideration of the adequacy of toxicity testing for assessing low-dose exposure to EACs.  Recommendations include:

  • Develop an active surveillance program focused specifically on low-dose exposures to EACs that includes regularly monitoring published research, gathering input from stakeholders, and considering human exposure information. The Academies recommend that the surveillance program periodically identify, scope, and prioritize potential areas of focus related to low-dose effects, such as particular chemicals and end points.
  • Use human environmental exposure or biomonitoring data to define the subset of data that should be considered as reflective of low-dose exposure.

Two examples of the application of this strategy are provided in the report.  These examples demonstrate how the strategy can be applied, and how results from its application can be integrated and considered with other relevant data to draw conclusions about causal associations.  To develop these examples, the Academies reviewed the effects of phthalates, specifically diethylhexyl phthalate (DEHP), on male reproductive-tract development and the effects of  polybrominated diphenyl ethers (PBDEs) in relation to developmental neurotoxicity.

The Academies assessment of DEHP concluded that the available data support the hazard conclusion that in utero exposure is presumed to be associated with decreased androgen production.  However, the Academies found challenges drawing conclusions about dose response.  The report explains that it is difficult to directly compare the effects of different levels of DEHP exposure in animals and humans because animal studies typically report administered doses whereas studies in humans rely on the measurement of DEHP metabolites in body fluids.  The Academies flag this as a situation where current toxicity-testing methods can identify a hazard that is presumed to be of concern to humans, but current methods might not be able to accurately predict exposures at which humans are affected.

The Academies review also identified associations between perinatal PBDE exposure and neurobehavioral outcomes.  Again the Academies found difficulties directly comparing PBDE exposure in animal studies to that occurring in humans.  In addition, the Academies report that estimates of human daily intake suggest that human exposure is several orders of magnitude lower than that used for benchmark doses in animal studies.  The Academies concluded that this is another situation where current toxicity-testing methods can identify a hazard that is presumed to be of concern to humans, but current methods might not be able to accurately predict exposures at which humans are affected.

EPA has not yet announced how it will implement the strategy.  The Agency’s efforts to research EACs are detailed on it’s website.

The full report is available here.

Ninth Circuit Vacates EPA Conditional Approval of Nanoscale Silver Antimicrobial

On May 30, 2017, the Ninth Circuit Court of Appeals vacated EPA’s conditional approval of Nanosilva NSPW-L30SWS, a type of antimicrobial silver registered as a materials preservative for textiles and plastics.  NRDC v. United States EPA, 2017 U.S. App. LEXIS 9360  (9th Cir. 2017).  The active ingredient in the product is nanoscale silver.  The National Resources Defense Council (NRDC), Center for Food Safety (CFS), and the International Center for Technology Assessment (ICTA), appealed the conditional approval. The Ninth Circuit found that EPA had not sufficiently supported its finding that early approval was in the public interest – a requirement for conditional approval under the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA).  EPA granted conditional approval of the product in May 2015.

Under FIFRA, EPA is permitted to issue conditional registration for a pesticide containing an active ingredient not contained in any currently registered pesticide, only where: 1) use of that pesticide will not cause any unreasonable adverse effect on the environment, and 2) use of the pesticide is in the public interest.  7 U.S.C. § 136a(c)(7)(C).  The Ninth Circuit explained that the Agency considers this type of conditional registration when it has not received sufficient data to determine that long-term use of a pesticide is reasonable.  Id.  In its decision to grant conditional approval of NSPW, EPA found that use of the pesticide is in the public interest because it has the “potential” to reduce the amount of silver released into the environment.

NRDC, CFS, and ICTA disputed the factual premises underlying the EPA’s public-interest finding.  Petitioners challenged the Agency’s findings that:

  • NSPW has a lower application rate (e., it uses less silver) than conventional-silver pesticides;
  • NSPW has a lower mobility rate (e., it is less likely to release silver into the environment in detectable quantities); and
  • Current users of conventional-silver pesticides will switch to NSPW and/or that NSPW will not be incorporated into new products (i.e., registration of NSPW will reduce the amount of silver pesticides used).

While the Ninth Circuit found that EPA’s analysis supported finding both lower application rate and lower mobility rate, it also found that the Agency “impermissibly relie[d] on unsubstantiated assumptions” to support the finding that the conditional registration of NSPW will reduce the amount of silver pesticides used.  EPA had concluded that use of NSPW is in the public interest because it has the “potential” to reduce the amount of silver released into the environment. The Ninth Circuit held that EPA’s conclusion requires two interrelated and unstated assumptions.  The Ninth Circuit found that

  • EPA assumed that current users of conventional-silver pesticides will replace those pesticides with NSPW (“the substitution assumption”); and
  • EPA assumed that NSPW will not be incorporated into new products to the extent that such incorporation would actually increase the amount of silver released into the environment (“the no-new-products assumption”).

The Ninth Circuit held that neither assumptions are supported by substantial evidence.[1]  In fact, the Ninth Circuit found that if the EPA’s substitution and no-new-products assumptions are incorrect, NSPW may actually increase the amount of silver released into the environment, which would contravene the identified public interest.  The Ninth Circuit explained that

EPA may not satisfy the [substantial evidence] requirement by simply finding that a pesticide has the “potential” to be in the public interest—especially where the pesticide also has the “potential” to contravene the public interest. Accordingly, where an essential premise of a public-interest finding is only supported by bare assumptions, as in the present case, we will find substantial evidence lacking.

NRDC v. United States EPA, 2017 U.S. App. LEXIS 9360  (9th Cir. 2017).

[1] The Ninth Circuit held EPA to the substantial evidence standard as dictated by FIFRA.  7 U.S.C. § 136n(b).  The Court explained that “[s]ubstantial evidence means more than a mere scintilla but less than a preponderance; it is such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” Nat. Res. Def. Council v. EPA (NRDC), 735 F.3d 873, 877 (9th Cir. 2013).