EPA Announces Cross-Agency Effort to Address PFAS

On December 4, 2017, the EPA announced a “a cross-agency effort to address per and polyfluoroalkyl substances (PFAS).”  The press release notes that the PFAS effort will include perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), as well as GenX, a substance developed as a replacement for the older chemicals.

The Agency pledged to:

  • Identify a set of near-term actions to help support local communities;
  • Enhance coordination with states, tribes and federal partners to provide communities with critical information and tools to address PFAS;
  • Increase ongoing research efforts to identify new methods for measuring PFAS and filling data gaps; and
  • Expand proactive communications efforts regarding PFAS and their health effects.

However, the Agency did not promise to take regulatory action.

The EPA issued Significant New Use Rules (SNURs) for PFOS-related substances in 2002.   It also issued a SNUR for the use of perfluorinated chemicals in carpets and carpet aftercare products in 2013.  In addition, the Agency partnered with manufacturers in the US and globally to reduce or eliminate use of PFASs.  U.S. companies voluntarily phased out producing the chemicals between 2000 and 2002.  Foreign companies achieved a 95 percent reduction in PFOA and PFOA-related chemicals in the emissions from their facilities and in their products.

The EPA has also published drinking water health advisories for PFOA and PFOS.

More information about the Agency’s efforts regarding these substances can be found here.

Irene Hantman and Kurt Blase to Present on New Requirements for Chemicals in Commerce

Tuesday, December 12, 2017 at 2PM ET, Irene Hantman and Kurt Blase will conduct a webinar for the American Chemical Society on New Requirements for Chemicals in Commerce – Chemical Regulation under TSCA Reform.  Register for the webinar here.

The Lautenberg amendments to TSCA impose new reporting requirements on chemicals in commerce through Inventory Reset Reporting.  Inventory Reporting is necessary to keep chemicals in commerce lawfully.  These requirements also have implications for raw materials.  The presentation will address these issues.  It will also address how the amendments require EPA to ensure that new chemicals do not present an unreasonable risk to human health and the environment.  This has significant implications for new chemicals notification – the Premanufacture Notification requirement.  In addition, the webinar will discuss the reporting requirements of the Nanoscale Materials Reporting Rule.  (This rule was not required by the Lautenberg amendments.)


“Back to Basics”: NAAQS Attainment Plans and Designations

(This post is an adaptation of an article published in the November 2017 newsletter of the Air Quality Committee, a committee of the American Bar Association’s Section of Environment, Energy, and Resources. A PDF of the article is available here.)

By Kurt Blase

EPA Administrator Pruitt has announced a new “Back-to-Basics Agenda” to “refocus” EPA on its mission and return power to the states. This is likely to affect EPA’s review of state plans for attainment of the ozone standard and other national ambient air quality standards (NAAQS).

 Background Concentrations

Many states, particularly in the West, have predicted nonattainment of the 2015 ozone standard as a result of ozone background concentrations not susceptible to localized controls. They argue that in such cases, employment of additional local control measures would provide negligible public health benefits, but would impose substantial costs. They also point to evidence that the resulting economic dislocation causes significant public health problems.

This is one area where EPA arguably has broad discretion to defer to the states.  Clean Air Act (CAA) Section 107 provides that “Each state shall have the primary responsibility for ensuring air quality within the entire geographic area comprising such State . . .”  EPA may construe Section 107 to give states wide latitude to address background issues. And the federal courts may defer.  For example, the Supreme Court has noted that “the most important forum for consideration of claims of economic and technological infeasibility is before the state agency formulating the implementation plan.” Whitman v. American Trucking Ass’ns, Inc., 531 U.S. 457, 470 (2001)(quoting Union Electric Co. v. EPA, 427 U.S. at 266).

Foreign Emissions

CAA Section 179B allows EPA to approve state plans that do not require actual attainment in areas that would be in attainment “but for” emissions emanating from outside the US.  In the ozone implementation rule proposed by the Obama Administration, EPA requested comment on whether this relief is limited to emissions from Canada and Mexico.  However, the statute imposes no such requirement and, as EPA noted, contributions to U.S. ozone concentrations can be made by international sources not located in bordering countries.

EPA’s proposal also sought comment on a requirement that all “reasonably available control measures” (RACM) must be employed to qualify for relief from foreign emissions. Again, however, the statute does not require that, and it provides EPA with flexibility to approve state plans that do not require actual attainment or impose ineffective controls in cases involving international emissions.

Intrastate Controls

The ozone implementation proposal would require intrastate sources outside of a nonattainment area to employ RACM. Once again, however, nothing in the nonattainment provisions of the Act requires that. If a state determines that a source outside the recommended boundary may contribute, it can require any necessary controls pursuant to other provisions of the Act.

While these issues are a focus of the current ozone debate, they are not limited to the ozone NAAQS and apply to the other standards as well. With respect to NAAQS attainment plans and designations, “back to basics” is real: the statute gives EPA ample flexibility to defer to state choices provided a rational basis consistent with statutory requirements is employed.

California Proposes Restrictions on the Use of Paint and Varnish Strippers Containing Methylene Chloride

The California Department of Toxic Substances Control (DTSC) is seeking public comment on its proposal to list Paint and Varnish Strippers Containing Methylene Chloride as a Priority Product.  The comment period opened on November 17, 2017.  It will close January 18, 2018.   The proposed regulation is available on the agency’s website.  If the regulation is adopted, manufacturers will be required to conduct an Alternatives Analysis to identify and evaluate safer options.

DTSC proposes to list Paint or Varnish Strippers Containing Methylene Chloride as a Priority Product in regulation because workers and consumers could be exposed to methylene chloride during normal use of paint or varnish strippers.  Inhalation and dermal exposure to methylene chloride is associated with adverse health effects, including cancer of the brain, liver, and biliary tract, and central nervous system depression, intoxication and unconsciousness. Numerous deaths have been reported in workers and consumers who were exposed to methylene chloride during use of paint or varnish strippers.

Once a Priority Product has been adopted in regulation, responsible entities who manufacture the product must notify DTSC. Following the initial notification, a responsible entity may choose to remove the chemical of concern (COC) from the Priority Product; stop selling or distributing the Priority Product in California; or perform an Alternatives Analysis (AA) to determine how best to limit adverse public health and environmental impacts posed by the COC in the product. The Preliminary Alternatives Analysis Report for this Priority Product shall be submitted within 180 days after the effective date of this regulation.

If a responsible entity chooses to follow the AA process (rather than removing the COC from the product or the product from commerce in California), then DTSC may impose regulatory responses, based on alternative selected by that responsible entity, which are designed to prevent or significantly reduce the potential for adverse impacts to public health and the environment.  DTSC reports that it intends to maximize the use of alternatives of least concern and give preference to those that provide the greatest level of inherent protection.  Information about the requirements for AAs can be found on DTSC’s website.

EPA Releases Policy Regarding Independence of its Scientific Advisory Committees

On October 31, EPA released a one-page directive and a more detailed memorandum governing the independence of its various scientific advisory committees. The basic principles announced by the agency are as follows:

  1. Strengthen Member Independence: No member of an EPA advisory committee can be a current recipient of an EPA grant or otherwise in a position that would reap direct benefit from such a grant. This does not apply to state, tribal or local government agencies that receive EPA grants.
  2. Increase State, Tribal and Local Government Participation: Committee balance should include participation from state, tribal and local governments, consistent with the committee’s purpose and function.
  3. Enhance Geographic Diversity: Committees should be balanced with members from different states and EPA regions, with an emphasis on members from historically underrepresented areas.
  4. Promote Fresh Perspectives: Committee membership should be rotated regularly.

As discussed in the EPA memorandum, much of this is driven by the longstanding requirement in the Federal Advisory Committee Act that advisory committees must be “fairly balanced” as to scientific points of view. Enforcement of this requirement has often been difficult in the past, as judicial remedies have largely been ineffective.

As also discussed in the memorandum, the composition of some advisory committees, such as the Clean Air Scientific Advisory Committee (CASAC), is dictated by statute. In most cases, however, the statutory requirements (for CASAC, a state regulator, a public health expert, an industry scientist, etc.) leave ample room for application of these principles within the statutory confines.

The EPA materials do not address whether members of current committees can be replaced before their terms expire. Another question is whether the principles apply only to committee members or also to “consultants” who are not official committee members. For example, the current CASAC PM review panel has 27 members, only six of whom are official CASAC members.

With respect to most current committees, it seems unlikely that these principles will be used to displace current members. However, to the extent that a current member advances a position believed to be scientifically unsound, opponents will be free to argue that the advice should be discounted if inconsistent with these principles. Further, the membership of many key committees will be up for renewal prior to the 2020 election. For example, EPA is currently seeking members for the new TSCA scientific review committee, and the current CASAC PM panel expires in 2018, well before EPA is expected to complete the current PM standard review.

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.