EPA Publishes A Working Approach for Identifying Potential Candidate Chemicals for Prioritization

On September 28, 2018 EPA released the approach it will use to identify chemicals that could be included in the next group of risk evaluations under the Toxic Substances Control Act (TSCA).  The approach is documented in the publication A Working Approach for Identifying Potential Candidate Chemicals for Prioritization (A Working Approach). EPA also announced that the Agency will be looking for input from the public on which chemicals should be prioritized for risk evaluation and which chemicals may be low priorities under TSCA.   By December 2019, EPA must designate at least 20 chemical substances as High-Priority for risk evaluation and 20 chemical substances as Low-Priority for which risk evaluation is not currently warranted.

A Working Approach lays out EPA’s near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA.  The Agency notes that it expects its approach for identifying candidates for prioritization to evolve over time as it develops expertise in identifying chemicals to enter prioritization, as well as in conducting prioritization and risk evaluations.

EPA’s working approach is to primarily look to the 2014 Work Plan for high-priority potential candidates.  The Agency explains that it generally intends to consider the three factors described below for selecting potential chemicals for prioritization.

  • In selecting chemicals as potential candidates for prioritization EPA expects to consider overarching Agency priorities. This may include, but is not limited to, a chemical or group of chemicals that are priorities for the Agency, including chemicals that other EPA program offices have deemed a priority for their program and suitable for current prioritization. In addition, EPA is committed to engaging and collaborating with partner federal agencies prior to and during the prioritization process.
  • Quantity and Quality of Information. EPA intends to consider the quantity and quality of information when identifying potential candidate chemicals for prioritization and risk evaluation.
  • Work Load. To address workload issues, EPA could use diverse approaches to consider current expertise or facilitate the analysis of candidate chemicals. For example, EPA could identify potential candidate chemicals that share certain characteristics with the first 10 chemical substances undergoing risk evaluation, 15 such as solvents, since focusing on the solvents remaining on the 2014 Work Plan would take advantage of the expertise developed on the six solvents currently undergoing risk evaluation (e.g., development of exposure scenarios).

In identifying potential candidates for low priority chemical designation, A Working Approach explains that EPA will use the best available science.  The document reports that EPA may identify substances from multiple sources, including one or more of the following chemical information resources:

  • EPA’s Safer Chemical Ingredients List;
  • EPA’s Chemical Assessment Management Program; and
  • Organization for Economic and Co-Operation Development Screening Information Data Sets assessment documents.

A Working Approach states that EPA intends to preferentially select CAS numbers that represent discretely defined structures, which can be more confidently associated with information on hazard, conditions of use, and exposure.

The document also includes a longer-term risk-based strategy for managing the larger TSCA chemical landscape which, according to the TSCA Inventory, is composed of more than 40,000 active chemicals. This longer-term approach proposes parsing chemicals into “bins” that can be used to inform multiple activities and priorities throughout EPA, including within the TSCA program.  In the near future, EPA will open a public docket to accept comments on this longer-term strategy.  In addition, the Agency plans to hold a public meeting on the strategy in early 2019.

EPA will also open 73 chemical-specific public dockets, one for each of the remaining chemicals on the 2014 TSCA Work Plan.  Additionally, there will be a general docket open for the public to suggest chemicals for risk evaluation that are not on the Work Plan.  Through these dockets, the public will have the opportunity to submit use, hazard, and exposure information on these chemicals.  The Agency will use this data to inform TSCA prioritization and risk evaluation for these chemicals.

EPA Publishes Direct Final Rules for 29 Significant New Use Rules

On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA). The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 43527. The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs. 83 Fed. Reg. 43538. All 29 chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The rules require persons who intend to manufacture (including import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that new use.

The covered chemicals vary, but include several substances intended for use as coatings additives. The requirements for each of the substances differ, but may include limitations on the uses of the substance, hazard communication, personal protective equipment use, and the submission of certain toxicity testing data. Both direct final rules will be effective on October 26, 2018.

EPA Issues Second Draft “Eco ISA” for NOx, SOx and PM

EPA recently released the second draft of an Integrated Science Assessment (ISA) for “ecological effects” from NOx, SOx and PM, which include effects on flora, fauna and water resources.  The ISA will be used to determine the need for revising the current secondary national ambient air quality standards (NAAQS) for these pollutants. Other welfare effects that could be caused by these substances, such as effects on visibility, climate or building materials, will be addressed in the ISAs for the primary (health-based) standards for the substances.

The NOx and SOx ecological effects previously were addressed in a 2008 ISA. The specific effects considered are too numerous to discuss here, but they are listed in a table in the new draft ISA that compares the 2008 conclusions with those presented in the new draft. All of the effects analyzed in the 2008 ISA were determined to be “causal” pursuant to EPA’s classification scheme (meaning that they are caused by the pollutants at issue). However, those determinations did not result in a change in the secondary standards, owing to the uncertainties involved in identifying ambient concentrations necessary to alleviate the effects. EPA took the position that the existing suite of primary and secondary standards also would provide adequate protection against these ecological effects.

In the new draft, all the effects determined to be causal in 2008 retain that classification. However, the new draft addresses the following five effects not classified in 2008:

  1. N deposition and the alteration of the physiology and growth of terrestrial organisms and the productivity of terrestrial ecosystems;
  2. Acidifying N and S deposition and the alteration of the physiology and growth of terrestrial organisms and the productivity of terrestrial ecosystems;
  3. N deposition and increased nutrient-enhanced coastal acidification;
  4. N deposition and changes in biota, including altered physiology, species richness, community composition, and biodiversity due to nutrient-enhanced coastal acidification;
  5. S deposition and changes in biota due to sulfide phytotoxicity, including alteration of growth and productivity, species physiology, species richness, community composition, and biodiversity in wetland and freshwater ecosystems.

All these effects, most of which were discussed in the 2008 ISA but not classified, would now be classified in the new ISA as causal on the basis of more recent information. The general conclusion is that new evidence supports the prior classifications and improves quantification of dose-response relationships. However, there is no clear statement that quantification has improved sufficiently to allow use of ecological effects as a basis for revising the standards, and in many cases the draft ISA finds that quantification remains subject to significant uncertainty.

Unlike the 2008 ISA, the new draft includes ecological effects from ambient PM. EPA’s last discussion of this issue, in the 2009 PM ISA, concluded that there is likely a causal relationship between PM deposition and various ecological effects, but that the specific relationships cannot be quantified as a result of a number of uncertainties. As a result, the PM secondary standards were not revised at the conclusion of the last review.  The new draft ISA draws the same conclusions on the basis of the more recent studies.

The Clean Air Scientific Advisory Committee (CASAC) will review this new draft of the Eco ISA, after which EPA is likely to finalize the ISA and prepare a draft Policy Assessment (PA) that makes recommendations for retaining or revising the current secondary standards based on the science presented in the ISA.

EPA Proposes Revision of AP42 Emission Factors for Liquid Storage Tanks

As a result of widespread interest EPA recently extended the comment deadline for proposed revisions to AP42 chapter 7, which specifies emission factors for organic liquid storage tanks. The AP42 emission factors are used to estimate emissions from specific industrial facilities and processes when no site-specific emissions data are available. They are used in a wide array of regulatory applications ranging from emissions inventories to permit applicability determinations to compliance and enforcement. The proposed changes for liquid storage tanks, which were prepared by the American Petroleum Institute, are extensive; in effect Chapter 7 is being rewritten. The results are unclear and may vary significantly among different types of tanks and facilities. Anyone who has relied on the AP42 factors for storage tanks, or may need to do so in the future, should evaluate the new emission factors and equations EPA is proposing. Comments are due by November 26.

EPA Proposed Regulations for Scientific Integrity in Contracting

On September 26, EPA published a proposal addressing scientific integrity in the context of agency contractors who perform scientific research or analyses. It would create a new standard contract clause designed to ensure that all scientific work performed for the Agency is done consistently with the agency’s scientific integrity policy, which dates from 2009. The proposal also includes regulations for addressing loss of scientific integrity, including steps for mitigation or termination in appropriate cases.

Contractors who become aware of “an actual or potential” loss of integrity would be required to report it to the contracting officer, who would ultimately decide on the remedy, if any. Contractors would bear the primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with its own institution. However, EPA would retain the ultimate oversight authority for EPA-supported research.

This could be a useful tool in addressing any noncompliance with EPA’s integrity policies that may come to light in research sponsored by EPA. However, there are a couple of apparent holes in the proposal. It does not clearly state that the contractor or contracting officer must investigate a loss (or potential loss) of integrity brought to their attention by a third party, such as a potentially regulated stakeholder. In addition, it focuses on EPA’s 2009 integrity policy but does not mention compliance with the regulations for strengthening integrity in regulatory science that EPA proposed earlier this year. Comments on this proposal are due by November 26.

EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory

On June 27, 2018, the Environmental Protection Agency (EPA) published the final “Reporting Requirements for the TSCA Mercury Inventory” Rule. As required under section 8(b)(10)(D) of the Toxic Substances Control Act (TSCA), EPA finalized reporting requirements for regulated entities to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States.”

The requirements apply to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process. The reporting requirements apply to “mercury” as both “elemental mercury” and “a mercury compound.” EPA provides a list of these compounds in the final rule. Reporting requirements vary based on whether the entity is manufacturing mercury, manufacturing a mercury added product, or intentionally using mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product. EPA will collect data through the Mercury Electronic Reporting (MER) application of its CDX system.

Based on the inventory of information collected, the Agency is directed to “identify any manufacturing processes or products that intentionally add mercury; and . . . recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.” EPA stated in the final rule that it is not making such identifications or recommendations at this time.

EPA will use data from the 2018 reporting year for the 2020 mercury inventory. The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019.

Sherwin-Williams to Remove Paint-Removal Products Containing Methylene Chloride

Sherwin-Williams is phasing out the use of paint-removal products containing methylene chloride by the end of this year. Both Lowe’s and Home Depot have also announced they will phase out paint removal products that contain methylene chloride. These actions are likely a response to EPA’s forthcoming rulemaking on the substance.

In January, 2017, EPA proposed prohibiting the consumer and commercial paint stripping used for methylene chloride. On May 10, 2018, EPA announced it was working on sending the finalized rulemaking to Office of Management and Budget “shortly.”

EPA Publishes NAAQS Proposals and Notices

EPA recently has published a plethora of proposed rules and notices governing or closely related to development of national ambient air quality standards (NAAQS). These include (in order by comment deadline):

Consideration of costs and benefits. On June 13 (83 FR 27524), EPA issued an advance notice of proposed rulemaking (ANPRM) soliciting comment on whether and how EPA should promulgate regulations that provide a consistent and transparent method for weighing costs and benefits in making regulatory decisions in a manner consistent with applicable authorizing statutes. With respect to NAAQS, a major issue will be whether and to what extent EPA can consider costs consistently with Supreme Court decisions holding that economic impacts generally may be considered in NAAQS implementation but not in NAAQS development. Comments are due by July 13.

Retention of SO2 NAAQS. On June 8 (83 FR 26752), EPA proposed to retain the existing standards for sulfur oxides. The proposal is based on findings that the existing standards provide adequate public health and welfare protection. A public hearing will be held July 10 and comments are due by August 9.

Scientific transparency. As we reported last month, EPA has proposed new rules for scientific transparency in rulemaking proceedings. The final rules are likely to be applied in EPA’s upcoming proceedings to review the NAAQS for ozone and particulate matter (PM). Comments on the transparency proposal are due by August 16.

Ozone information call. On June 26 (83 FR 29785), EPA published a notice announcing development of a new Integrated Science Assessment (ISA) for ozone and inviting interested parties to submit information on new ozone research or policy-relevant issues for consideration in the agency’s review of the current standards. When finalized, the ISA will contain the scientific information on which EPA will base its decision whether to revise the current standards. Responses to the information call are due by August 27.

Eco ISA for NOx, SOx and PM. On June 26 (83 FR 29786) EPA announced the availability of the Second External Review Draft Integrated Science Assessment for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter—Ecological Criteria. This is a ground-breaking ISA that reviews new evidence of ecological effects from emissions of these three pollutants. Such effects previously have been considered separately in the ISAs for each of the pollutants. This second draft builds on an initial draft that the agency released for public comment last year. This draft will be reviewed by EPA’s Clean Air Scientific Advisory Committee (CASAC) as well as the public. Public comments are due by September 4.

NAAQS implementation strategies. On June 26 (83 FR 29784), EPA published a notice soliciting information to facilitate CASAC consideration of any adverse public health, welfare, social, economic, or energy effects which may result from various strategies for NAAQS attainment and maintenance. Comments are due by October 24.

Two Seasoned Former EPA Enforcement Attorneys Join Verdant

Verdant is pleased to announce the addition of two seasoned former EPA enforcement attorneys — Jon Jacobs and Marie Quintin.  Both bring expertise in chemical products enforcement.

Jon Jacobs spent 27 years at EPA, first in the Office of Administrative Law Judges, then in the Office of Enforcement and Compliance Assurance.  During his tenure, Jon held many positions.  He was a senior attorney in EPA’s Office of Criminal Enforcement, Forensics, and Training where he specialized in environmental crimes involving EPA’s chemicals (TSCA) and pesticides (FIFRA) laws.  He also had national program management responsibilities such as drafting federal legislation, regulations, guidance, and policy.  Jon also served in OCEFT’s Washington Area Criminal Investigation Office as a regional criminal enforcement counsel where he advised EPA’s special agents in over 30 investigations of environmental crimes under all of EPA’s statutes.  Jon was a Special Assistant U.S. Attorney (SAUSA) assisting U.S. Attorney’s Offices in prosecuting cases in Maryland, Virginia, and the District of Columbia.    He has earned an international reputation for his expertise in pesticides, toxic substances, and emergency planning (EPCRA) issues.

Jon’s insider knowledge of EPA, DOJ, and other federal and state agencies offers a unique understanding of how EPA and the federal government operate.  He maintains well established relationships with many key players at EPA allowing him to develop innovative strategies, options, and solutions that many others are unable to accomplish.

Prior to entering private practice, Marie Quintin was a Regional Criminal Enforcement Counsel in the EPA’s regional office in New York City.  She served as legal advisor to the Criminal Investigation Division Special Agent in Charge and federal agents regarding legal issues related to criminal investigations, as well as advisor to the Regional Counsel and Regional program managers.  Marie developed and managed Clean Air Act (CAA) enforcement cases and represented the Agency in administrative and civil enforcement negotiations and litigation for cases in New York, New Jersey, Puerto Rico and the U.S. Virgin Islands.  She won a Gold Medal for her work as a member of the prosecutorial team in the Tonawanda Coke Corporation (TCC) Criminal case in 2014, in which TCC was convicted by a federal jury and ordered to pay a $12.5 million penalty and make $12.2 million in community service payments for criminal violations of the CAA and the Resource Conservation and Recovery Act (RCRA).

Over the course of Marie’s career, she has established strong relationships with influential decision makers at all levels of the EPA. She has served as an instructor for EPA Region 2’s Criminal Enforcement Division and taught courses in subjects such as environmental crimes, clean air act enforcement and policy.

“We welcome Jon and Marie to the firm – and we know our clients will too.  Marie and Jon enhance our pesticides and toxic substances practices, and they also bring substantial expertise with EPA enforcement of its air, water, and waste programs.  Both have robust civil and criminal enforcement experience, including litigation,” said Phil Moffat, the firm’s managing principal.

Jon Jacob said that “Verdant has an excellent reputation for helping clients navigate a complicated and quickly evolving landscape.  I look forward to deepening Verdant’s capabilities in these practice areas and enhancing its ability to serve our clients at the highest level across various industry sectors.”

California Proposal to List Nonylphenol Ethoxylates in Laundry Detergent as a Priority Product

The California Department of Toxic Substances Control has proposed listing nonylphenol ethoxylates (NPEs) in laundry detergent as a Priority Product. This would require manufacturers to use safer alternatives.  The detergents at issue are used by on-premises industrial laundries like hotels and hospitals.

DTSC is concerned about the hazard traits of NPEs and their degradation products.  NPEs are included on the European Union’s list of Substances of Very High Concern.  Laundry detergents with NPEs are sources of exposure to the environment and aquatic organisms.  In May, DTSC released a technical document Product-Chemical Profile for NPEs in Laundry Detergent, to explain the scientific, regulatory, and policy basis for the proposal.  The Department held a public workshop on June 11, 2018 to discuss its proposal.  DTSC is now preparing to undertake a rulemaking on these products.