Seventh Circuit Adopts Carcinogen Exposure Test

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The Federal Court of Appeals for the Seventh Circuit recently joined the 6th and 9th Circuits in holding that a plaintiff seeking recovery for harm from carcinogen exposure must demonstrate that the exposure was a “substantial contributing factor” to the injury. The opinion notes that cancer causation “is dosage dependent—that is, the risk of contracting lung cancer from asbestos depends on the length of time of exposure and the amount of exposure. To determine whether any exposure constitutes a substantial contributing factor, therefore, one would have to understand the timing and amount of exposure.” The court rejected arguments that de minimis exposures are compensable, holding that the “any exposure” theory “ignored fundamental principles of toxicology that illnesses like cancer are dose dependent.” The court also rejected a cumulative exposure theory, under which “every minute of exposure adds to the cumulative exposure and thus becomes a substantial contributing factor,” finding that such an approach is “merely more of the same.”

While these are toxic tort cases, the opinions may be relevant to regulatory consideration of similar issues. For example, EPA must consider exposure in regulating new and existing products under the 2016 TSCA Amendments. Exposure also must be considered in making the “substantial risk” determination under TSCA Section 8(e). These opinions suggest that the courts will take a hard look at exposure data in these and other similar regulatory contexts. The case is Krik v. Exxon Mobile Corp., 7th Cir. No. 15-3112 (decided August 31, 2017).

EPA Defends “Exceptional Events” Rule

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In pleadings recently filed with the Federal Court of Appeals for the D.C. Circuit, EPA has defended the “Exceptional Events” rule issued by the Obama Administration last October. The rule is designed to excuse exceedances of national ambient air quality standards (NAAQS) where they are caused by natural events such as wildfires or dust storms. It is particularly important in western states where such events occur frequently.

EPA revised the rule in response to state and industry complaints that the prior rule was overly cumbersome and unevenly applied. Various environmental groups challenged the new rule in the D.C. Circuit, arguing that it excuses some events that are caused at least in part by human activity, such as windblown dust from construction or mining activities. EPA counters that Congress did not define “natural event” in the relevant statute, and that the agency opted for a middle ground that covers events in which human activity plays little or no direct causal role. The agency also notes that the rule only allows the exclusion where” reasonable emission controls” have been adopted.

The exceptional events rule is likely to play a critical role in evaluating NAAQS exceedances caused by the recent hurricanes and western wildfires. Under EPA’s current interpretation, it cannot excuse violations of permit or SIP provisions, but it can be used to ensure that future SIP or permit provisions are not based on extreme conditions. Historically, the primary tool for excusing SIP or permit violations caused by natural disasters has been provisions that excuse violations caused by startup, shutdown or malfunction (SSM) conditions. But those protections have been eroded as a result of recent court decisions and related Obama Administration policies that the Trump Administration is now trying to revise. Much of the regulatory response to the recent disasters in the air quality arena will be shaped by the fate of the exceptional events and SSM rules, which will in turn be shaped by the occurrence of the disasters and the likelihood that we will continue to experience them.

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

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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

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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.

New Prop 65 Regulations Become Operative on August 30, 2018

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New consumer warnings will be required under California’s Prop 65 on August 30, 2018.  On September 2, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a final rule amending Article 6 of the regulations implementing Proposition 65 (Prop 65) that requires enhanced warning messages. Prop 65 requires a “clear and reasonable” warning on products that expose California consumers to chemicals of concern (“Prop 65-listed chemicals”).  The new regulation has changed what constitutes a “clear and reasonable” warning.  As the final rule becomes effective on August 30, 2018, businesses should begin to assess their products, consider the clear and reasonable warning requirements, and prepare for the deadline to minimize the risk of enforcement litigation.

The final rule imposes requirements on content and methods of transmission, which includes disclosure of one or more Prop 65-listed chemicals that resulted in the warning and an accompanying symbol.  An abbreviated warning, however, will be permitted when a company provides an “on-product” warning.  If an “on-product” warning is used, the business need not disclose the specific Prop 65 chemical(s).

Until the August 30, 2018 effective date, companies selling into California can use either the old or the new regulatory warnings. Indeed, businesses are not required to re-label products that are already in the stream of commerce.  OEHHA has ensured that “the regulations allow the old safe harbor warnings to remain and be considered compliant if the product was manufactured prior to the effective date of the new regulations.”  As such, if a business is selling into California, compliance with the new regulatory warnings must be in effect on all manufactured products on August 30, 2018.

It is prudent for businesses to begin the compliance process shortly because it will take time to assess which products are sold into California, to design new product labels and/or compliant materials, to approve such materials, and to implement the necessary changes.

EPA Announces Changes to the New Chemical Review Program

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In the wake of the 2016 amendment to the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) has been focusing on streamlining new chemical review. On August 7, 2017, the Agency announced several related changes to the new chemical review process. Major reforms include:

  • Where a Premanufacture Notice (PMN) raises risk concerns, EPA will allow manufacturers to submit an amended PMN to address those concerns, and will base its judgment on the amended PMN.
  • Where EPA has concerns with product uses that can reasonably be foreseen but are not the intended uses described in the PMN, EPA’s concerns can be addressed through significant new use rules (SNURs).
  • Identification of reasonably foreseen conditions of use that are not addressed in a PMN will be fact-specific. EPA will find that a use is reasonably foreseeable where facts suggest that the use is not only possible but probable.
  • Section 5 testing orders will be confined to cases where they are necessary to reduce uncertainty in “unreasonable risk” findings, and will be structured to reduce or replace animal testing where appropriate.

EPA also announced that it will increase the full-time staff for new chemical review and will streamline related work processes. In addition, to help companies prepare PMNs, EPA will institute a voluntary pre-submission consultation process to provide submitters with a clear understanding of what information will be most useful for EPA’s review of their new chemical submission, and of what they can expect from EPA during the review process. Further support for submitters will be available this fall. EPA announced that it will publish for public comment draft guidance to provide more certainty and clarity regarding how EPA makes new chemical determinations and what external information will help facilitate these determinations.

Overview of TSCA Inventory Reset

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The Environmental Protection Agency (EPA) published the final rule establishing the process for TSCA “Inventory Reset” under the Toxic Substances Control Act (TSCA) on August 11, 2017. The final rule was effective as of the same day. The TSCA Inventory Reset process concerns chemical substances that are listed on the TSCA Inventory; it does not apply to every chemical substance in commerce, as many such substances are exempt from Inventory listing requirements. The Reset process is designed to identify which of the listed chemical substances are and are not actively in commerce. Inventory Reset is required by the Lautenberg amendments to TSCA.

Substances identified as “in commerce” will be placed on the “Active Inventory.” Substances not currently in commerce will be placed on the “Inactive Inventory.” Companies will not be able to lawfully manufacture, import, or process any chemical substance on the “Inactive Inventory” without first notifying the substance to EPA. The Active and Inactive Inventories will be created through “retrospective” reporting. Retrospective reporting requires companies to notify EPA regarding the non-exempt chemicals they manufactured or imported during the ten years prior to Lautenberg’s enactment (June 21, 2006 and June 21, 2016). Manufacturer/importer reporting began the day the final rule was published. Companies have 180 days to submit notifications. In addition, a subsequent 180-day reporting period, beginning April 9, 2018, is designated for reporting by processors. Companies may report substances that they processed during the ten-year look back period.

After retrospective reporting closes, EPA will formally establish the Active and Inactive Inventories. Once these Inventories are published, forward-looking reporting will be required before a company can lawfully manufacture, import, or process any chemical substance on the “Inactive Inventory.” In addition, EPA has designated the period between retrospective and forward-looking reporting as the “Transition Period.” The forward-looking reporting requirements are optional, but recommended, during this period.

Considerable effort to coordinate with the companies that manufacture and supply one’s raw materials will be required to ensure that these products remain available for use in the company’s commercial activities.

CDR Reporting Violations to Cost Ricoh Electronics $245,990

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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 Announces Superfund Task Force Recommendations

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Environmental Protection Agency (EPA) Administrator Scott Pruitt assembled a task force to provide recommendations on how to restructure and improve the Superfund cleanup process. On July 25, 2017, the Task Force announced its recommendations. The Task Force Report to Administrator Pruitt identified 14 strategies and 42 specific recommendations to achieve the following five goals:

  1. Expediting cleanup and remediation;
  2. Reinvigorating responsible party cleanup and reuse;
  3. Encouraging private investment;
  4. Promoting redevelopment and community revitalization; and
  5. Engaging partners and stakeholders.

The Superfund Program governs the investigation and cleanup of the nation’s most complex hazardous waste sites. The National Priorities List (NPL) includes those sites that are of national priority among these sites because of known or threatened releases of hazardous substances. Currently, there are 1,336 sites on the NPL, of which 1,179 are privately owned sites and 157 are federal facilities. Sites on the NPL are in various stages of remediation.

The recommendations of the Superfund Task Force are meant to improve and expedite the process of site remediation and promote reuse of the remediated sites.

Administrator Pruitt also issued a memo outlining 11 specific actions that should be implemented expeditiously to improve the Superfund program. These include maximizing deletions and partial deletions of sites off the NPL.

The Task Force will be implementing the strategies and recommendations throughout the next year.

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

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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.