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Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Proposed Rules and considered that information in the context of the applicable authorities and requirements of TSCA sections 4, 21, and 26. Notwithstanding that the burden is on the petitioners to present the facts which it is claimed establish that it is necessary for EPA to initiate the rule or issue the order sought, EPA
nonetheless also considered relevant information that was reasonably available to the Agency during the 90day petition review period. As detailed in Unit III.B.2 and III.B.3, EPA finds that the petitioners have not met their burden as defined in TSCA sections 4a1A and 21b1 because the petitioners have not provided the facts necessary for the Agency to determine for phosphogypsum and process wastewater that existing information and experience are insufficient and testing with respect to such effects is necessary to develop such information.
These deficiencies, among other findings, are detailed in this document.

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1. May Present Unreasonable Risk of Injury to Health or the Environment or Produced in Substantial Quantities EPA is not opining on the sufficiency of the information presented for purposes of determining whether phosphogypsum or process wastewater may present unreasonable risk because the Agency finds that petitioners have not provided the facts necessary for the Agency to determine that existing information and experience are insufficient and testing with respect to such effects is necessary to develop such information, as described in more detail below. However, EPA agrees that phosphogypsum and process wastewater are or will be produced in substantial quantities under TSCA
4a1AiiI.
2. Insufficient Information and Experience The petition does not set forth the facts necessary to demonstrate that there is insufficient information and experience on which the effects of phosphogypsum and process wastewater on health or the environment can reasonably be determined or predicted. The petitioners only claim that updated toxicity information using the TCLP
method is necessary and assert that information available is from an outdated Extraction Procedure.
However, EPA has found that there are TCLP data related to phosphogypsum and process wastewater available in the public domain Ref. 6. The petitioners failed to present facts indicating the nature and extent of existing TCLP data and articulate why this data is
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insufficient. The petitioners do not provide an assessment of existing data to support a finding of insufficient information and experience. The petitioners present no evidence that they undertook efforts such as a literature search of publicly available information, an analysis and characterization of the results of such a literature search, or an inventory of information they claim is missing from the public domain.
Extensive information on the heavy metal chemical substances contained in phosphogypsum and process wastewater is readily available. For example, EPA has published Integrated Risk Information System IRIS
assessments, which review existing information and characterize the hazards of chemicals, that are available for all of the heavy metals mentioned in the petition, as well as uranium Ref. 7.
Furthermore, the Agency for Toxic Substances and Disease Registry ATSDR has published Toxicological Profiles, which characterize the toxicologic and adverse health effects information for hazardous substances, for all of the metals, as well as for radon and the radionuclides referenced in the petition Ref. 8. The petitioners make no mention of the IRIS assessments, nor have they provided the facts necessary to show that this extensive body of existing information on toxicological effects, including the ATSDR
Toxicological Profiles cited in the petition, is insufficient. TSCA section 21 requires the petitioner, not EPA, to set forth the facts which it is claimed establish that it is necessary to issue, amend, or repeal a rule under TSCA
sections 4, 6, or 8, or an order under TSCA sections 4 or 5e. 15 U.S.C.
2620. Therefore, petitioners have failed to meet their burden.
3. Testing of Such Substance or Mixture With Respect to Such Effects Is Necessary To Develop Such Information The petition did not include any data, information, or analysis related to the need for testing of phosphogypsum and process wastewater or for the chemical substances, including the heavy metals and radionuclides contained in phosphogypsum and process wastewater. A petition without such information is facially incomplete because it fails to provide minimum factual information for EPA to make the threshold findings needed to respond to and act on the petition as contemplated by TSCA section 21. Even if the petitioners had successfully demonstrated the insufficiency of existing information, they still failed to demonstrate that testing of
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phosphogypsum and process wastewater is needed to develop the necessary information that they claim does not exist. Importantly, the petitioners provided no information regarding how testing by manufacturers of phosphogypsum and process wastewater would provide the sort of health and environmental effects data that petitioners believe is necessary. The petitioners could have presented information about the types of tests that could be conducted, including some analysis of the methods that could be used to identify the data or information submitted or used, hazard thresholds recommended, and exposure estimates.
Beyond an assertion that TCLP data is not available, the petitioners did not include any information on what type of testing they claim is needed.
4. Testing as a Mixture Petitioners do not indicate whether the requested testing would pertain to mixtures or to individual chemical substances within a mixture. With regard to testing phosphogypsum and process wastewater as a mixture, petitioners have not set forth facts sufficient to support the required finding for mixtures under TSCA
section 4a1: That the effects of phosphogypsum and process wastewater 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 has broad discretion to make this finding, and although petitioners did not specify whether their request was for testing of phosphogypsum and process wastewater as a mixture, EPA does not, at this time, believe this finding is warranted.
5. Environmental Justice Considerations Petitioners express environmental justice concerns and include examples of a phosphogypsum and process wastewater facility near a historic Black neighborhood, and another facility in a region of Louisiana which they state has environmental justice concerns related to impacts from a variety of industrial activities Ref. 1, pages 3638.
As a general matter, EPA shares the petitioners concerns regarding the potential for disproportionate impacts in communities with environmental justice concerns. However, petitioners must set forth the facts which it is claimed establish that it is necessary to issue a rule or order requiring testing under TSCA section 4a1A. As petitioners have not set forth facts sufficient for EPA to make these findings, EPA is not able to issue a test
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