Regulatory Developments

EPA Proposes to Add PFAS Subject to TRI Reporting to List of Chemicals of Special Concern

December 7, 2022 PRINT

The U.S. Environmental Protection Agency (EPA) proposed on December 5, 2022, to add per- and polyfluoroalkyl substances (PFAS) subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) to the list of Lower Thresholds for Chemicals of Special Concern (chemicals of special concern). 87 Fed. Reg. 74379. EPA notes that these PFAS already have a lower reporting threshold of 100 pounds. Adding these PFAS to the list of chemicals of special concern will cause such PFAS to be subject to the same reporting requirements as other chemicals of special concern (i.e., it would eliminate the use of the de minimis exemption and the option to use Form A and would limit the use of range reporting for PFAS). EPA states that "[r]emoving the availability of these burden-reduction reporting options will result in a more complete picture of the releases and waste management quantities for these PFAS." In addition, EPA proposes to remove the availability of the de minimis exemption for purposes of the Supplier Notification Requirements for all chemicals on the list of chemicals of special concern. According to EPA, this change will help ensure that purchasers of mixtures and trade name products containing such chemicals are informed of their presence in mixtures and products they purchase. Comments are due February 3, 2023.

Designating PFAS Automatically Added to the TRI List by the NDAA as Chemicals of Special Concern

EPA proposes to add all PFAS included on the Toxics Release Inventory (TRI) list pursuant to NDAA Section 7321(b) and 7321(c) (see 40 C.F.R. Section 372.65(d) and (e)) to the list of chemicals of special concern at 40 C.F.R. Section 372.28. EPA first created the list of chemicals of special concern to increase the utility of TRI data by ensuring that the data collected and shared through TRI are "relevant and topical." EPA states that it lowered the reporting thresholds for chemicals of special concern "because even small quantities of releases of these chemicals can be of concern." Chemicals of special concern are also excluded from the de minimis exemption, may not be reported on Form A (Alternate Threshold Certification Statement), and have limits on the use of range reporting.

The de minimis exemption allows facilities to disregard small concentrations of TRI chemicals not classified as chemicals of special concern in mixtures or other trade name products when making threshold determinations and release and other waste management calculations. EPA notes that the de minimis exemption does not apply to the manufacture of a TRI chemical except if that chemical is manufactured as an impurity and remains in the product distributed in commerce, or if the chemical is imported below the appropriate de minimis level. EPA states that the de minimis exemption does not apply to a byproduct manufactured coincidentally because of manufacturing, processing, otherwise use, or any waste management activities.

Form A provides facilities that "otherwise meet TRI-reporting thresholds the option of certifying on a simplified reporting form provided that they do not exceed 500 pounds for the total annual reportable amount (subsequently in this document) for that chemical, and that their amounts manufactured, processed, or otherwise used do not exceed 1 million pounds." All chemicals of special concern (except certain instances of reporting lead in stainless steel, brass, or bronze alloys) are excluded from Form A eligibility. EPA states that Form A does not include any information on releases or other waste management, nor does it include source reduction information or any other chemical-specific information other than the identity of the chemical.

According to EPA, for certain data elements (Part II, Sections 5, 6.1, and 6.2 of Form R), for chemicals not classified as chemicals of special concern, the reportable quantity may be reported either as an estimate or by using the range codes that have been developed. Currently, TRI reporting provides three reporting ranges: 1-10 pounds, 11-499 pounds, and 500-999 pounds.

EPA states that it "anticipates that the elimination of these burden reduction tools will increase the amount and quality of data collected for PFAS and is consistent with the concern for small quantities of PFAS."

Elimination of the Supplier Notification Requirement De Minimis Exemption for Chemicals of Special Concern

EPA also proposes to eliminate the use of the de minimis exemption under the Supplier Notification Requirements at 40 C.F.R. Section 372.45(d)(1) for all substances on the list of chemicals of special concern. The revised text would read as follows:

If a mixture or trade name product contains no toxic chemical in excess of the applicable de minimis concentration as specified in 40 CFR 372.38(a) except for chemicals listed under 40 CFR 372.28 which are excluded from the de minimis exemption.

The de minimis exemption allows suppliers not to provide notifications for mixtures or trade name products containing the listed toxic chemicals if the chemicals are present at concentrations below one percent of the mixture (0.1 percent for carcinogens). EPA notes that the de minimis exemption is not a small quantity exemption, it is a small concentration exemption. Therefore, EPA states, "it is possible that significant quantities of chemicals of special concern can be overlooked by reporting facilities if suppliers can use the de minimis exemption." For example, according to EPA, if a mixture or trade name product contains 0.9 percent of a listed PFAS and 100,000 pounds of the product is purchased, the supplier need not provide notification and the purchaser could be unaware of and not account for 900 pounds of PFAS. EPA states that the impact of this exemption for persistent, bioaccumulative, and toxic (PBT) chemicals with ten-pound reporting thresholds is even greater. Using the same 100,000-pound example, if mercury were present at 0.9 percent, then that same 900 pounds would be 90 times the mercury reporting threshold.

According to EPA, it is also possible that quantities of chemicals of special concern would be included in supplier notifications by reporting facilities if suppliers cannot use the de minimis exemption. For example, if a mixture or trade name product contains 0.9 percent of a listed PFAS and 1,000 pounds of the product is purchased, the supplier would need to provide notification for nine pounds of PFAS. This would also impact PBT chemicals with ten-pound reporting thresholds. Using the same 1,000-pound example, if mercury was present at 0.9 percent, then that same nine pounds would be below the mercury reporting threshold. Such quantities may become reportable in aggregate, however, if a reporting entity receives multiple shipments (including from multiple suppliers) of a given product in a year and performs a threshold activity in excess of the TRI reporting threshold. Further, TRI supplier notification regulations do not require a person to consider the total quantity of the chemical being supplied but rather require the person to consider the concentration of the chemical in the product or mixture. Including a consideration of quantity rather than concentration shipped would complicate as well as reduce the ability of supplier notifications to inform downstream recipients of products and mixtures containing a TRI-listed chemical.

The PBT chemicals and chemical categories that are classified as chemicals of special concern, and thus would also be impacted by this change, are as follows:

  • Aldrin;
     
  • Benzo[g,h,i]perylene;
     
  • Chlordane;
     
  • Dioxin and dioxin-like compounds category (manufacturing; and the processing or otherwise use of dioxin and dioxin-like compounds category if the dioxin and dioxin-like compounds are present as contaminants in a chemical and if they were created during the manufacturing of that chemical);
     
  • Heptachlor;
     
  • Hexabromocyclododecane category;
     
  • Hexachlorobenzene;
     
  • Isodrin;
     
  • Lead (this lower threshold does not apply to lead when it is contained in stainless steel, brass or bronze alloy);
     
  • Lead compounds category;
     
  • Mercury;
     
  • Mercury compounds category;
     
  • Methoxychlor;
     
  • Octachlorostyrene;
     
  • Pendimethalin;
     
  • Pentachlorobenzene;
     
  • Polychlorinated biphenyls (PCB);
     
  • Polycyclic aromatic compounds category (PAC);
     
  • Tetrabromobisphenol A;
     
  • Toxaphene; and
     
  • Trifluralin.
     

Commentary

Bergeson & Campbell, P.C. (B&C®) commends EPA for the pragmatic approaches it included in the proposed rule. The two greatest areas of uncertainty for assessing the potential risks of PFAS are hazard and exposure. EPA's "National PFAS Testing Strategy" will aid EPA with obtaining the necessary information on hazards for various types of PFAS, whereas the proposed rule will aid EPA with obtaining relevant information on environmental releases, waste management, and pollution prevention/recycling information. TRI data, along with other relevant information, can aid EPA with making preliminary determinations on potential risks to human health and the environment. Therefore, EPA's proposal to include PFAS on the list of chemicals of special concern and to remove the de minimis exemption, the option to use Form A, and range reporting will significantly improve the types of data EPA receives on PFAS, which in turn, will aid EPA with prioritizing chemical substances under the Toxic Substances Control Act (TSCA).

B&C recognizes that EPA's proposal to remove the availability of the above-mentioned burden-reduction reporting options may not be well received by interested stakeholders, particularly small businesses. Collecting this information will, however, aid interested stakeholders with evaluating whether they may be subject to potential liabilities stemming from the presence of PFAS in their products, given the extremely low toxicity values that EPA has recently issued on these substances (e.g., chronic oral reference dose for "GenX" equals 3 ng/kg-bw/day). This knowledge would inform interested parties on the potential need to replace PFAS-containing components in their portfolios and to transition to other non-PFAS chemistries.

The proposed rule will have comparably positive informational benefits for EPA on PBT chemicals/chemical categories in that it will provide EPA with greater knowledge on potential exposures to these substances. It will also ensure that interested parties have greater knowledge of the potential presence of PBT substances in their products, specifically since the de minimis level is based on relative concentration (e.g., <1 percent in a trade name product) and not a specific quantity. We recognize that this will cause a reporting burden on interested stakeholders. We believe, however, that this burden will be outweighed by the information obtained, since it will aid interested stakeholders with making informed decisions on potential liabilities from the presence of PBT substances in their products and the potential need to explore replacement chemistries.

B&C is encouraged by EPA's decision making in the proposed rule. We have routinely commented on EPA's proposed and final decisions on various topics, where we believe the Agency has not made decisions that were supported by science and the law. See, e.g., our memorandum on EPA's final revised risk determination on methylene chloride. In this instance, however, we believe that EPA has taken a pragmatic approach that will aid EPA with obtaining the information it needs, and aid interested stakeholders with obtaining relevant information for determining the need to find replacement chemistries because of potential risk concerns identified from more complete exposure and release information.


 
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