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.