By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on April 27, 2023, that it denied a January 26, 2023, petition from Blueland, Plastic Pollution Coalition, and partners, including Beyond Plastics, Plastic Oceans International, The Shaw Institute, Lonely Whale, 5 Gyres, Global Alliance for Incinerator Alternatives (GAIA), Oceanic Global Foundation, The Last Beach Cleanup, Rio Grande International Study Center, Inland Ocean Coalition, Occidental Arts and Ecology Center, Turtle Island Restoration Network, Friends of the Earth, Surfrider, and Made Safe. 88 Fed. Reg. 25590. The petition, filed under Section 21 of the Toxic Substances Control Act (TSCA), requested that EPA require manufacturers and processors of polyvinyl alcohol (PVA) affiliated with EPA’s Safer Choice certification program to fund and conduct health and environmental safety testing using independent, third-party scientists. The petition also requested, under the Administrative Procedure Act (APA), that EPA update the status of PVA on its Safer Chemical Ingredients List (SCIL) from “green circle” to “gray square” until testing is completed and reviewed by EPA. EPA states that “[a]fter careful consideration,” it has denied the TSCA petition and APA petition requests.
Disposition of Section 21 Response
EPA states that in considering the petition within the statutory 90-day petition review period, it evaluated the information presented or referenced in the petition and considered that information in the context of the applicable authorities and requirements contained in TSCA Sections 4, 21, and 26. EPA also evaluated relevant information that was “reasonably available” during the 90-day petition review period. According to EPA, it finds the petitioners have not provided the facts necessary to determine that existing information and experience are insufficient and that testing of such substance or mixture with respect to such effects is necessary to develop such information. These deficiencies include:
- May present unreasonable risk of injury to health or the environment or produced in substantial quantities: EPA finds that petitioners have not provided the facts necessary to determine that existing information and experience are insufficient and that testing with respect to such effects is necessary to develop such information. EPA states that it “agrees that PVA is or will be produced in substantial quantities and that there is or may be significant or substantial human exposure due to its common use in agriculture, foodstuffs, cleaning, and personal-care products,” however.
- Insufficiency of information in the petition: According to EPA, the petition does not set forth the facts necessary to demonstrate that there is “insufficient information and experience” on which the effects of PVA can reasonably be determined or predicted, as TSCA Section 4(a)(1) requires. EPA “finds the petitioners have not incorporated available existing information related to their request, or adequately indicated that gaps were located for data needed in order for EPA to make a decision using the best available science.” Such an evaluation is necessary for EPA to carry out TSCA Section 4, as provided under TSCA Section 26(h).
- Testing of such substance or mixture with respect to such effects is necessary to develop such information: EPA finds the petitioners have not explained why the testing requested, as compared to other testing or other data generation methods, would provide the quality of data being sought for EPA to make a decision using the best available science. EPA notes that such an evaluation is necessary for EPA to carry out TSCA Section 4, as provided under TSCA Section 26(h).
- Request for oversight by a third party: Regarding the petitioners’ request that testing be conducted only under the guidance and direction of independent third-party scientists, EPA finds that such an oversight arrangement is not in keeping with the authority provided under TSCA Section 21. Additionally, according to EPA, the petition has not demonstrated a need for additional measures ensuring the reliability of studies required under TSCA Section 4 beyond that already provided in the Good Laboratory Practice Standards in 40 C.F.R. Part 792, and the petitioners provide no legal, administrative, or organizational procedures for the implementation of such oversight. Therefore, EPA “has no obligation to grant or deny this request.”
EPA notes that additionally, because the authorities provided under TSCA Section 4 specifically relate to test rules, enforceable consent agreements, or orders issued directly to manufacturers and/or processors of a chemical substance, it cannot grant any requests made under Section 4 that extend beyond those statutory authorities. Therefore, according to EPA, the petitioners’ request for EPA to require third-party oversight of PVA testing, paid for by manufacturers and/or processors, is outside of the authorities provided in TSCA Section 4.
Disposition of the APA Portion of the Petition
EPA states that it has considered the evidence presented by petitioners and is denying the request to remove PVA from the SCIL for two reasons: the petition does not demonstrate that PVA fails to meet the Safer Choice criteria; and the data cited and explained in the notice indicate that the PVA structures allowed for use in Safer Choice-certified products under the EPA Safer Choice Standard meet the criteria of the program. EPA notes that the petition cites five blogs and eight peer-reviewed journal articles, mostly focused on the environmental impacts of microplastics rather than the soluble PVA used in Safer Choice-certified products. EPA identified additional peer-reviewed literature not discussed in the petition that is relevant to the PVA structures used in Safer Choice-certified products. According to EPA, the clear weight of the evidence presented in the notice demonstrates that the PVA structures allowed in Safer Choice-certified products meet the Safer Choice Criteria for Colorants, Polymers, Preservatives, and Related Chemicals. Specifically, “the PVA structures in Safer Choice-certified products that are the subject of this petition are not [persistent, bioaccumulative, and toxic (PBT)] substances, ‘very persistent and very bioaccumulative’ substances, or ‘very persistent and very toxic’ substances, and are expected to be of low concern for human health.” EPA therefore denies the request in the APA portion of the petition to change the status of PVA on the SCIL.
EPA states that it “does appreciate the petitioners’ concerns, especially related to plastic pollution and microplastics.” According to EPA, past efforts for transparency relevant to the petitioners’ concerns are reflected in the SCIL, and the SCIL includes a caveat for polymers: “Note for Polymers: The hazard profile of a polymer varies with its structure. Manufacturers using CAS numbers in this functional class may need to provide additional information for Safer Choice review,” available at https://www.epa.gov/saferchoice/safer-ingredients#searchList.