FDA BPA Study Released

On February 23, 2018, the FDA National Center for Toxicological Research (NCTR) released a draft report on the chronic toxicity of BPA in rats.  NCTR found few significant effects of BPA.  In the press release reporting these findings, FDA announced that “initial review [of the study findings] supports our determination that currently authorized uses of BPA continue to be safe for consumers.” The NCTR study will undergo external peer review April 26, 2018 during a meeting at National Toxicology Program (NTP) offices in Research Triangle Park, North Carolina.

The study evaluated chronic and early life exposure to BPA in rats. Endpoints evaluated include growth; weight; hematology; and tumor development in the liver, kidney, thyroid, parathyroid, uterine, ovary, prostate, and mammary gland. Overall, the study found “minimal effects” in the BPA-dosed rats.  NCTR did report that the study found an increase in mammary gland tumors at 2.5 µg BPA/kg/bw/day dose group.  The findings note that the incidence rate in this group was only marginally higher than historical rates for the strain of rats used for the study.

The study is part of a collaborative effort called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA), which was established by the FDA and the National Institute of Environmental Health Sciences of the National Institutes of Health after a 2008 NTP report raised concerns about developmental effects in rodents exposed to relatively low doses of BPA.  In addition to the NCTR study, the effort involves studies of various health endpoints, conducted at academic institutions, using offspring of rodents derived from the core study.

More information on the NTP meeting is available here.  The NTP website also provides information on submitting public comments on the draft report.

New Methylisothiazolinone Labeling Requirement in the European Union

Consumer products containing methylisothiazolinone (MIT) will need to be labeled to indicate that the product contains an allergen  when the substance is present at greater than 0.0015%. This is based on a classification approved by the European Commission’s REACH committee on February 20, 2018.  Product labeling will be required to state, “Contains methylisothiazolinone.  May cause an allergic skin reaction.” These requirements are expected to become binding at the end of 2019.  The proposal must first be reviewed by the European Parliament.

Under existing classification, labeling, and packaging regulations, products containing MIT must be labeled as skin sensitizers when the substance is present at 1.0% or more.  The EU currently bans MIT in “leave on” cosmetic products, limits MIT in “rinse-off” products, and restricts the presence of the substance in toys.

EPA Releases the 2018 Plan for Chemical Risk Evaluations under TSCA

As required under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has released its annual plan for chemical risk evaluations. The annual plan identifies the next steps for the first 10 chemical reviews currently underway, and describes EPA’s work in 2018 to prepare for future risk evaluations.

EPA was required to initiate ten risk evaluations in 2016, and is required to initiate at least 20 more within 3 years after enactment of the Lautenberg Act, or by December 2019. EPA designated the first ten chemical substances on December 19, 2016. By the end of 2018, the EPA will initiate prioritization for 40 chemicals – at least 20 Low-Priority and 20 High-Priority candidates. By December 22, 2019, EPA will designate 20 substances as Low-Priority and initiated risk evaluations on 20 High-Priority substances.

In order to support these risk evaluations and other key aspects of TSCA implementation, EPA stated that it will be proposing a draft TSCA Fees Rule in early 2018, which will provide estimates of the resources required to undertake risk evaluations.

UK to Publish a new Chemicals Strategy

The UK recently issued A Green Future: Our 25 Year Plan to Improve the Environment.  The document sets out a UK plan “to help the natural world regain and retain good health.”  The plan states that the government will publish a new Chemicals Strategy to tackle chemicals of national concern that will build on existing approaches. This new strategy will set priorities for action and detail how goals will be achieved.  According to A Green Future, the plan will also support collaborative work on human biomonitoring, address combination effects of different chemicals and improve the way the government tracks chemicals across supply chains.

 

A Green Future commits the UK to the following actions:

  • Publish an overarching Chemicals Strategy to set out its approach as the UK leaves the EU.
  • Explore options to consolidate monitoring and horizon-scanning work to develop an early warning system for identifying emerging chemical issues.
  • Consider how to address tracking chemicals in products to reduce barriers to recycling and reuse whilst preventing a risk from harmful chemicals.
  • Work internationally to strengthen the standardization of methods that assess chemical safety to identify and share information on emerging concerns and new approaches to risk assessments.

NRDC Petitions 2nd Circuit to Review EPA’s New Chemicals Decision-Making Framework

On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a petition for review with the United States Court of Appeals for the Second Circuit, asking that the court review “a final rule of the U.S. Environmental Protection Agency (EPA) entitled New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  A stay was not filed with the petition.

On its website, NRDC asserts that it filed the petition to overturn the Agency’s “Framework” “because it is both unlawful under TSCA and was adopted without the minimum legal requirements for ‘rules.’”

The case is Natural Resources Defense Council v. U.S. Environmental Protection Agency, 2d Cir., No. 18-25

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.