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Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Proposed Rules
under which they are seeking a test rule.
On pages 13 and 14 of the petition, for example, petitioners list the criteria to evaluate the request for testing under TSCA section 4a1Ai. However, in addition, the petition also includes reference to TSCA section 4a1Aii.
Because the petitioners were not clear whether they were seeking testing under TSCA section 4a1Ai or 4a1Aii, EPA considered the criteria in both sections in evaluating the petition. Additionally, because petitioners did not indicate whether the requested testing would pertain to mixtures or to individual chemical substances within a mixture, EPA
considered both in evaluating the petition.

quantities under TSCA section 4a1AiiI, petitioners provide information about the size of phosphogypsum stacks, the amount of phosphogypsum produced annually, and the volume of process wastewater that can be stored in stacks Ref. 1.
Regarding production in substantial quantities, petitioners point to an EPA
web page indicating that phosphogypsum is produced in quantities of 5.2 tons for every ton of phosphoric acid produced Ref. 4. In addition, petitioners cite to information indicating that approximately 46
million tons of phosphogypsum are created in the United States annually Ref. 5.

1. May Present an Unreasonable Risk of Injury to Health or the Environment or Produced in Substantial Quantities The petitioners claim that phosphogypsum and process wastewater located across the United States may present an unreasonable risk of injury to human health and the environment under TSCA section 4a1AiI. The petitioners claim that in EPAs 1991 regulatory determination under the Bevill Amendment to RCRA section 3001b3A of RCRA, regarding the exemption of processing ores and minerals, including phosphate rock, EPA indicated that phosphogypsum and process wastewater were more appropriate to address under a TSCA
regulatory program. The petitioners make a general assertion that EPAs investigation of a TSCA regulatory program to manage phosphogypsum and process wastewater means these substances not only may, but do, pose an unreasonable risk of injury to human health and the environment Ref. 1, page 40. The petitioners point to the following studies and contend that worker exposure at phosphate fertilizer plants is associated with adverse health effects, however, an exposure-response relationship could not be established in these studies:
Yiin, JH et al., 2016 Ref. 2; and Kim, Kwang Po et al., 2006 Ref. 3.
In addition, petitioners include information regarding the toxicity of several chemical substances they indicate are phosphogypsum constituents arsenic, lead, nickel, cadmium, chromium, silver, antimony, copper, mercury, and thallium, as well as information on radionuclides uranium, thorium, and radium Ref. 1, pages 1923.
As support for the claim that phosphogypsum and process wastewater are produced in substantial
2. Insufficient Information and Experience
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Without providing supporting rationale, the petitioners assert that updated information is needed, including:
Information on population-level exposure risks for radionuclides and radon emissions for phosphogypsum stacks; and Information on the number and size of the phosphogypsum stacks.
The petitioners also state that the majority of the available phosphogypsum and process wastewater research is focused on potential commercial uses, rather than toxicity and other health and environmental effects relevant to an unreasonable risk finding Ref. 1, page 40.
3. Testing of Such Substance or Mixture With Respect to Such Effects Is Necessary To Develop Such Information The petitioners claim that a TSCA
section 4 testing rule is necessary to fill gaps in current science and to better inform a future risk evaluation, citing the need for updated information on population-level exposure risks for radionuclide and radon emissions for phosphogypsum stack systems since the population around each phosphogypsum stack has likely increased Ref. 1, page 40. The petitioners also claim it is necessary to update toxicity information using the Toxicity Characteristic Leaching Procedure TCLP method Ref. 1, page 40. The petitioners provide no further information identifying specific gaps in the TCLP information already available, or why additional testing is necessary under TSCA section 4a1A.

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III. Disposition of TSCA Section 21
Portion of the Petition A. What is EPAs response?
After careful consideration, EPA has denied the TSCA section 21 portion of the petition. A copy of the Agencys response, which consists of the letter to the petitioners and this document, is posted on the EPA petition website at https www.epa.gov/assessing-andmanaging-chemicals-under-tsca/
tscasection-21reporting. The response, the petition Ref. 1, and other information is available in the docket for this TSCA section 21 petition see ADDRESSES.
B. What was EPAs reason for this response to the request for testing under TSCA section 4?
TSCA section 21 does provide for the submission of a petition seeking the initiation of a proceeding for the issuance of a rule under TSCA section 4. The petition must set forth the facts which it is claimed establish that it is necessary to issue the requested rule.
15 U.S.C. 2620b1. When determining whether the petition meets that burden, EPA will consider whether the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or any combination of such activities, may present an unreasonable risk of injury to health or the environment under TSCA
section 4a1AiI, or whether the chemical substance or mixture is or will be produced in substantial quantities, and it enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to such substance or mixture under TSCA section 4a1AiiI. In addition, EPA will consider whether information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance or mixture. 15 U.S.C.
2620b4BiI see also 15 U.S.C.
2603a1. Furthermore, EPAs decision to grant a petition for the promulgation of a TSCA section 4 rule requires a finding that testing of such substance or mixture with respect to such effects is necessary to develop such information. 15 U.S.C. 2603a1.
In the case of a mixture, the petitioners must set forth facts to establish that the effects of the mixture would not be reasonably and more efficiently determined or predicted by testing the chemical substances which comprise the mixture. 15 U.S.C. 2603a1.
EPA evaluated the information presented or referenced in the petition
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