EPA Science Advisors Support Current SO2 NAAQS

EPA’s Clean Air Scientific Advisory Committee (CASAC) has now completed its review of the agency’s draft Policy Assessment (PA) for the SO2 NAAQS, and supports the EPA staff recommendation that the current scientific literature does not support revision of the current primary (health based) SO2 NAAQS.

In a draft letter recently released, CASAC notes that “key uncertainties” have emerged since the prior SO2 review, particularly with regard to “at-risk” subgroups such as children who are: obese; of African-American ethnicity; severely asthmatic; and/or live in high density areas near sources of exposure. The Committee believes that while many uncertainties remain in quantifying the sizes of the risks for these groups, they should nonetheless be considered in ensuring that the standard provides an adequate margin of safety. CASAC also recommends that efforts should be made to gather the data necessary to ensure that protection of these groups can be considered with less uncertainty in future reviews of the standard.

According to the draft letter, the Committee believes it possible that the current 75 ppb level may not provide an adequate margin of safety in these groups. However, because there is considerable uncertainty in quantifying the sizes of these higher risk subpopulations and the effect of SO2 on them, the Committee did not recommend reconsideration of the level at this time. CASAC strongly recommends that future assessments better quantify the numbers of individuals expected to be affected at the current (or proposed alternative) standard in these groups so that a more informed judgment about the margin of safety in high risk subgroups can be made. In particular, the Committee suggests that EPA express the size of the at-risk population both in percentage form (which is currently done) and also with numerical estimates, providing the number of people expected to be at risk, given the margin of safety.

The Committee recommended a few changes in the draft PA and stated that with those changes it need not review another draft. We expect that CASAC will finalize its draft letter soon and that EPA will then move to finalize the PA and propose to retain the current standard. We doubt that the current Administration will seize on the “margin of safety” points in the CASAC letter to propose a revised standard (as some prior administrations might have done). However, those issues are likely to be a primary focus of the next review of the SO2 standard.

Apart from SO2, this letter is significant because it is the first official CASAC action under the newly appointed Chair, Anthony Cox, and the other new members appointed by this Administration. It therefore appears that the reported “backlog” of NAAQS reviews caused by CASAC appointment delays will now begin to break.

EPA Releases Draft Guidance on TSCA CBI Disclosures and Requests Comments

On March 13, 2018, EPA released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose TSCA confidential business information (CBI) with an expanded set of people. Comments will be accepted until April 16, 2018.

Amendments to the Toxic Substances Control Act (TSCA) expanded the categories of people who may now access information claimed as CBI under TSCA. Information that a business claims as CBI under TSCA is protected from disclosure until the business withdraws the CBI claim, until the CBI claim expires, until EPA determines that the claim is not entitled to confidential treatment, or as authorized under TSCA and EPA regulations.

The draft guidance documents are:

D.C. Circuit Revises Its Decision on the Definition of Solid Waste

On March 6, 2018, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit or Court) issued an unsigned per curiam opinion revising its July 2017 decision, which struck down portions of the U.S. Environmental Protection Agency’s (EPA) 2015 Definition of Solid Waste (DSW) Rule. American Petroleum Institute v. EPA, D.C. Cir. App., No. 09-1038. This revision followed the Court’s invitation in its July 2017 decision to have parties provide additional briefing. Both industry and EPA took advantage of the invitation and filed petitions for rehearing.

The Court modified its July 2017 opinion in three ways: (1) severing and affirming EPA’s removal of the spent petroleum catalyst bar from the vacated portions of the Verified Recycler Exclusion; (2) vacating the 2015 Rule’s mandatory Factor 4 of the legitimate recycling determination in its entirety; and (3) reinstating the 2008 Rule version of Factor 4 of the legitimate recycling determination. This blog post focuses on the legitimate recycling determination.

EPA has established a legitimate recycling determination for what constitutes legitimate recycling of hazardous materials and described activities it considers to be illegitimate or sham recycling. 40 C.F.R. §260.43. The legitimate recycling determination consists of four factors:

  1. Legitimate recycling must involve a hazardous secondary material that provides a useful contribution to the recycling process or to a product or intermediate of the recycling process.
  2. The recycling process must produce a valuable product or intermediate.
  3. The generator and the recycler must manage the hazardous secondary material as a valuable commodity when it is under their control.
  4. The product of the recycling process must be comparable to a legitimate product or intermediate.

Based on the Court’s 2017 decision, Factors 1, 2, and 3 were upheld as mandatory factors that must be met by a recycler in order for the recycling process to be considered legitimate recycling. However, the Court vacated Factor 4 only as it applied to sham recycling as defined in 40 C.F.R. § 261.2(g). Thus, after its 2017 decision, Factor 4 still applied to those specific exclusions in which Factor 4 was specifically included, for example, the generator-controlled exclusion.

In its amended 2018 opinion, the Court vacated Factor 4 under all circumstances, even those written into specific exclusions. Now, the 2008 version of Factor 4 is reinstated, which requires only that the factor be “considered” and is not mandatory. Therefore, recyclers of hazardous materials must now meet Factors 1, 2, and 3 of the legitimate recycling determination, and must only consider Factor 4.

EPA Proposes to Add Aerosols to the Universal Waste Regulations

On March 16, 2018, the Environmental Protection Agency (EPA or the Agency) proposed adding hazardous waste aerosol cans to the universal waste program under the federal Resource Conservation and Recovery Act (RCRA) regulations. Comments are due by April 16, 2018. Aerosol cans are widely used for dispensing a broad range of products including paints, solvents, pesticides, food and personal care products, and many others.

Any person who generates a solid waste must determine whether the solid waste qualifies as hazardous waste. The waste may be hazardous either because it is listed as a hazardous waste or because it exhibits one or more of the characteristics of hazardous waste. Aerosol cans are frequently hazardous due to the ignitability characteristic, and in some cases may also contain listed or exhibit other hazardous waste characteristics.

The universal waste rules establish a streamlined hazardous waste management system for widely generated hazardous wastes as a way to encourage environmentally sound collection and proper management of the wastes within the system. Hazardous waste batteries, certain hazardous waste pesticides, mercury-containing equipment, and hazardous waste lamps are already included on the federal list of universal wastes. The universal waste regulations are a set of alternative hazardous waste management standards that operate in lieu of regulation under RCRA Subtitle C.

The streamlined universal waste regulations are expected to ease regulatory burdens on retail stores and others that discard hazardous waste aerosol cans, promote the collection and recycling of these cans, and encourage the development of municipal and commercial programs to reduce the quantity of these wastes going to municipal solid waste landfills or combustors.

A copy of the proposed rule can be found here.

New NSR Guidance Considers Emissions Decreases

EPA recently issued new Guidance for determining whether a proposed new or modified source of air pollutants would cause a significant increase in emissions, requiring a major source permit. See Memorandum from Administrator Pruitt to Regional Administrators re: Project Emissions Accounting Under the New Source Review Preconstruction Permitting Program (March 13,2018).

To date, EPA has employed a two-step process for evaluating projected emissions for major source status. Under step 1, the agency determines whether the project by itself – including emission controls – would cause a significant increase in emissions. Under step 2, the agency then looks at other “contemporaneous” projects at the facility – defined as those constructed within the past two years – to determine whether all of the projects combined would result in a “significant net increase” in emissions from the entire facility. If so the facility will require a major source permit.

With a few brief exceptions, the agency throughout its history has not allowed consideration of emissions decreases in step 1. The emissions baseline for the new project is set at zero, and offsets for emissions decreases are not considered until step 2. The practical effect has been to require all major sources to model both steps, even though the modeling in step 1 might show a decrease at that point, precluding the need to move to step 2 (e.g., the project includes new emission controls and also involves shutting down other emissions sources within the plant to produce an emissions decrease).

The new Guidance, effective immediately, revises EPA’s approach to allow consideration of net emissions decreases in step 1. The agency now believes that the prior approach had the practical effect of preventing some projects from proceeding and significantly delaying others, even though those projects would not have resulted in a significant emissions increase. The agency also recognizes that the increased efficiency of new production technologies can result in emission reductions even while expanding production. In such situations, the complexities associated with modeling multi-year contemporaneous netting under Step 2 at a large facility have dissuaded some meritorious projects. The new interpretation is designed to correct this, and the agency believes it is consistent with the relevant language of the Clean Air Act and current NSR regulations.

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.