EPA Publishes TSCA User Fee Proposed Rule

Under the proposed TSCA User Fee Rule, submitters would pay $16,000 for each PMN. This was announced on February 8, 2018, when the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Scott Pruitt signed a proposed rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). The current fee for a PMN submission is $2,500. EPA estimates the average cost of a PMN for processing, reviewing, making determinations, and taking any regulatory action such as with a SNUR or an order is approximately $55,000. Fees would also apply to submissions related to risk evaluation and EPA mandated testing of chemical substances and mixtures.

The proposed rule was published on February 27, 2018. Comments on the rule must be received on or before April 27, 2018 (Docket Number EPA-HQ-OPPT-2016-0401).

Amended TSCA provides EPA the authority to charge fees to chemical manufacturers, including importers, and processors to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” These fees are to be used for “developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and other information; reviewing Confidential Business Information (CBI); and, making determinations in a timely and transparent manner with respect to the safety of new chemicals before they enter the marketplace.” However, EPA is not proposing to assess greater fees for submissions containing CBI claims.

Under the amendments to TSCA, EPA has authority to require payment from manufacturers and processors who:

  • Are required to submit information by test rule, test order, or enforceable consent agreement (ECA) under section 4;
  • Submit a PMN, SNUR, LVE or other notification under section 5); or
  • Manufacture or process a chemical substance that is subject to a risk evaluation under section 6, including a risk evaluation conducted at the request of a manufacturer.

Beginning in fiscal year (FY) 2019 , EPA will be required to adjust fees every three years to reflect inflation and ensure that fees are sufficient to collect 25 percent of the costs to EPA in administering TSCA sections 4, 5, 6, and 14, up to $25 million. The proposed rule provides a description of proposed TSCA fees and fee categories for FYs 2019, 2020, and 2021, and explains the basis for its proposal.

California Issues Expanded Draft Priority Product Workplan

The California Department of Toxic Substances Control (DTSC) recently issued a Draft Three-Year Priority Product Work Plan (2018-2020) under the state Safer Consumer Products program (also known as the “green chemistry” program). The draft Work Plan would supersede the current plan adopted in 2015, and lists the categories of products that DTSC intends to investigate under the program for the next three years. Public comments on the draft Work Plan will be accepted until March 9.

The new draft Work Plan includes seven product categories. Five were carried over from the prior Work Plan: (1) beauty, personal care and hygiene products; (2) cleaning products; (3) household, school and workplace furnishings; (4) building products and materials used in construction and renovation; (5) consumable office, school, and business supplies. The two new categories proposed are food packaging and lead acid batteries.

The Work Plan does not specifically identify any product as a regulatory priority, but identifies categories from which DTSC will propose future priority products. DTSC is limited to regulation of products within these categories, except for other products identified by legislation, Executive Order or a petition to DTSC that has been granted.

In investigating potential priority products, DTSC intends to solicit information from manufacturers and their supply chain partners as well as trade associations and others with relevant expertise. They also may make targeted information requests to specific industry sectors; gather information through public workshops and comment periods; and issue “information call ins” as described in the state regulations. This information would be available to the public except for trade secrets protected by the regulations. DTSC expects to engage in discussion with industry experts about product formulations, supply chain considerations, and industrial toxicology studies among other topics that can expand and refine their knowledge for the purposes of selecting priority products.

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.

2008 Ozone Plan Rebuffed by DC Circuit

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

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

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.