FDA BPA Study Released

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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

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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.

2008 Ozone Plan Rebuffed by DC Circuit

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In a wide-ranging opinion issued February 16, the D.C. Circuit invalidated major aspects of EPA’s Implementation Rule for the 2008 national ambient air quality standard (NAAQS) for ozone. (South Coast Air Quality Management District v. EPA, No. 15-1115). Primary holdings are as follows:

  • States cannot take credit for NOx or VOC emission reductions outside of a nonattainment area for purposes of meeting the 15% reduction “rate of progress” requirement or the 3% “reasonable further progress” requirement.
  • In nonattainment areas, EPA cannot revoke a prior NAAQS without putting in place the “anti-backsliding” rules required by Section 172 (e) of the Act, which requires maintenance of controls “not less stringent than” the pre-existing nonattainment plan requirements. This applies to all measures in the plan that are “designed to constrain” ozone pollution.
  • The anti-backsliding requirements apply fully to so-called “orphan” nonattainment areas, which are meeting the 2008 NAAQS but were never reclassified to attainment under the 1997 standard, unless the area has been redesignated as attainment for the 2008 standard.
  • The anti-backsliding requirements also apply to so-called “orphan maintenance areas” – areas that had been nonattainment for the prior standard but were redesignated to maintenance areas.
  • EPA’s selection of 2011 as the baseline year for tracking reasonable further progress in attaining the 2008 ozone standard was reasonable, given EPA’s rationale that 2011 was the first year in which three years of monitoring data would be available.
  • Nonattainment areas that had achieved the 15% rate of progress reduction under the 1997 standard need not do so again under the current standard.
  • Compliance with the “reasonably available control technology” (RACT) requirement may be demonstrated on an area-wide basis, without requiring each individual source to employ RACT.

In 2017, the Obama Administration issued a proposed Implementation Rule for the ozone standards adopted in 2013, but the proposal has not been finalized. EPA reportedly had been planning to issue a new proposal, but recently announced that a final rule would be issued based on the Obama proposal. The agency now will need to take this opinion in account in crafting its final rule for the 2013 standard.

TSCA Inventory Reset Deadline Is Approaching

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The TSCA Inventory Reset process is designed to identify which listed chemical substances are and which are not actively used in commerce. 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 rule establishes “retrospective” (as well as “forward-looking”) reporting requirements. During the initial retrospective reporting period, companies must report on each Inventory-listed substance that they manufactured or imported for a non-exempt purpose during the ten-year look back period (June 21, 2006 and June 21, 2016). The deadline for this reporting period is February 7, 2018.

A subsequent 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 if the substances are not already on EPA’s Active Inventory or Interim Active Inventory.

EPA Releases the 2018 Plan for Chemical Risk Evaluations under TSCA

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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.

EPA Rescinds MACT “Once In Always In” Policy

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In late January, EPA issued a guidance memorandum rescinding the agency’s prior policy that once a source becomes a major source subject to a maximum achievable control technology (MACT) standard under section 112 of the Clean Air Act (CAA), it cannot be reclassified later as an area source not subject to MACT. The prior policy, known as the “once in always in” policy, dates from guidance issued in 1995. Under the new policy, a major source can become an area source if it takes an enforceable limit on its potential to emit (PTE) hazardous air pollutants (HAP) below the major source thresholds (i.e., 10 tons per year (tpy) of any single HAP or 25 tpy of any combination of HAP). A source that was previously classified as major, but which so limits its PTE, will no longer be subject either to the major source MACT or other major source requirements that were applicable to it as a major source under CAA section 112.

The legal basis for this action is that the “once in always in” policy contradicts the plain language of the definitions of “major source” in CAA section 112(a)(l) and “area source” in CAA section 112(a)(2). EPA has twice proposed to rescind the policy since it was adopted in 1995, but neither proposal was finalized. The new guidance rescinding the prior policy is effective immediately. EPA also will take comment on a rulemaking proposal to codify the new policy, to be published at a later date. Several opposition groups have announced their intention to file lawsuits seeking to overturn the new policy.

UK to Publish a new Chemicals Strategy

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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

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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

Safer Consumer Products Schedules Public Hearing on its Proposal to List Paint or Varnish Strippers Containing Methylene Chloride as a Priority Product

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A public hearing on California’s Safer Consumer Product’s third proposed Priority Product regulation will be held on January 8, 2018. The hearing will begin at 1:00 PM in the Sierra Hearing Room at the CalEPA Building, located at 1001 “I” Street, Sacramento, California, and remain open until 5:00 PM or until no attendees present testimony, whichever occurs first. Prior to attending the meeting, all visitors are required to sign in at the Visitor and Environmental Services Center, located inside the main entrance of the building.

The comment period for the proposed regulation closes on January 18, 2018. Any interested person(s) may submit written comments relevant to the proposed regulatory action to DTSC in either electronic or hard-copy formats. Written comments may be submitted electronically through CalSAFER, the Safer Consumer Products information management system.

Hard-copy written comments may be delivered to:

Proposed Regulations
Office of Legal Affairs
Department of Toxic Substances Control
1001 “I” Street
Sacramento, California 95812-0806

EPA Offers Free Training On the Hazardous Waste Generator Improvements Rule

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EPA’s Office of Resource Conservation and Recovery (ORCR) will hold a free full-day workshop on the 2016 Hazardous Waste Generator Improvements Final Rule. The workshop will be held on Wednesday, February 7, 2018, in Arlington, VA, from 8:30 to 3:00 PM. The workshop will cover all the major provisions of the rule, looking at regulatory text and common implementation questions that have come up since the rule was issued in final. During the workshop EPA will answer following questions:

  • Which components of the hazardous waste generator regulatory program were revised?
  • Which gaps in the regulations were addressed in this rule?
  • What flexible options are provided by this rule for hazardous waste generators to manage their hazardous waste in a cost-effective and protective manner?
  • How were the hazardous waste generator regulations reorganized to make them more user-friendly and thus improve their usability by the regulated community?

The workshop will be held at EPA’s Conference Center in the Potomac Yard building in Arlington, VA. Click here to register online.