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Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Rules and Regulations
II. Have the requirements for approval of the SIP revision been met?
The States submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR
51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice of the revisions from August 1, 2018, to October 4, 2018, and held a public hearing on September 27, 2018. The State received and addressed four comments from three sources, including the EPA. In addition, as explained in the proposal 85 FR 3304, January 21, 2020 and in more detail in the EPAs technical support document TSD, which is part of this docket, the revision meets the substantive SIP
requirements of the CAA, including section 110 and the implementing regulations.

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III. The EPAs Responses to Comments The public comment period on the EPAs proposed rule opened January 21, 2020, the date of its publication in the Federal Register, and closed on February 20, 2020. During this period, the EPA received comments from two commenters, which are addressed below.
Comment 1: One commenter submitted several comments regarding revisions in 10 CSR 106.062 paragraph 3B2. and subparagraph 3B2.A. that would expand the materials which crematories and animal incinerators are allowed to burn from 100% human and animal remains to 90% human and animal remains with up to 10% illegal and waste pharmaceutical drugs. The comments raise multiple approvability issues. First, the commenter states the EPA failed to provide any analysis or basis for its assertion that allowing crematories and animal incinerators to burn up to 10% pharmaceuticals would not impact the stringency of the SIP or air quality. Second, the commenter states the EPA applied faulty logic in relying on the Commercial and Industrial Solid Waste Incinerator CISWI rules exemption for pathological waste incinerators that burn 90% pathological waste. The commenter contends that the 90%
cutoff in the CISWI rule is not a 10%
catch-all burn-what-you-will provision, rather it is intended to distinguish those units designed and used primarily for pathological material destruction from other units. There is no CISWI rule provision that allows for the other 10%
of the material to be illegal and waste pharmaceutical drugs. Third, the commenter said the EPAs analysis fails to recognize that incineration of
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pharmaceutical drugs may be subject to other federal regulations under sections 112 or 129 of the Clean Air Act or the Resource Conservation and Recovery Act RCRA depending on their contents. Finally, the commenter states the EPA failed to analyze whether allowing crematories and animal incinerators to burn pharmaceuticals would increase hazardous air pollutant emissions to such an extent that the source would exceed the major source threshold and therefore not be eligible for the construction permit-by-rule per 10 CSR 106.0621A.
Response to Comment 1: Because of the issues raised in these comments, the EPA is not acting on the revised language that would allow crematories and animal incinerators to burn up to 10% by weight of illegal and waste pharmaceuticals. Missouri added these provisions as a means of disposing materials collected from drug take-back events and programs. However, the revisions in the States rule conflict with requirements related to drug take-back programs established by the EPAs final regulation, Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine 84 FR 5816, February 22, 2019. Specifically, the requirements for drug take-back programs codified at 40
CFR 266.506, list five types of permitted combustors that must be used to destroy waste pharmaceuticals, and crematoriums and animal incinerators are not included on the list for this purpose. The EPA explains in the preamble of the final hazardous waste pharmaceuticals rule that crematories and animal incinerators are not allowed to be used for disposal of materials collected from drug take-back programs because these units typically do not use air pollution control devices to limit toxic air pollutants such as mercury and dioxins and furans. In addition to the hazardous waste pharmaceuticals rule, there may be other state and federal regulations applicable to crematories and animal incinerators. Missouri has represented to the EPA that it is in the process of revising 10 CSR 106.062 to remove the problematic language allowing crematories and animal incinerators to burn illegal and waste pharmaceutical drugs. As evidence of Missouris rulemaking to revise 10 CSR
106.062, the rulemaking report summarizing the changes Missouri plans to make is included in this docket.
Comment 2: The commenter states that Missouris rule lacks necessary enforceability provisions. For instance, the commenter states that the rule is not clear whether the demonstration of 99.9% combustion efficiency applies to
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sources that rely on manufacturers specifications, and it is incomplete because it does not specify what pollutants must be demonstrated to meet the 99.9% combustion efficiency.
In addition, the commenter states that the compliance provisions for stack tests and opacity limit requirements fail to identify the appropriate test methods.
The commenter says the rule also lacks provisions that apply to owners that follow manufacturers specifications.
Finally, the commenter states that the recordkeeping and reporting provisions are inadequate.
Response to Comment 2: To apply for a Missouri permit-by-rule, an applicant completes an application. The application form contains the conditions of operation, including methods of compliance. The applicant signs the form to accept the conditions.
This becomes the final permit issued by the Missouri Department of Natural Resources.1 It is EPAs understanding that Missouri is in the process of updating the application form to reflect the changes made in this revision to the State rule.
The revised rule language clearly specifies the following two compliance demonstration options for crematories and animal incinerators: 1 Operate in accordance with manufacturers specifications or 2 demonstrate a 99.9% combustion efficiency. Higher combustion efficiencies minimize the products of incomplete combustion and associated air pollutants.
The EPA reviewed a number of Missouri construction permits for crematories and animal incinerators that have been issued through the States formal construction permitting process in accordance with the SIP-approved rule, 10 CSR 106.060 Construction Permits Required. The revised compliance options and enforceability provisions in 10 CSR 106.062 for crematories and animal incinerators are consistent with the language in the permits for these units that have been issued under 10 CSR 106.060.
The rule language regarding opacity and reporting and recordkeeping requirements was not materially revised from the provisions in the previously approved SIP. The EPA did not intend to solicit comments on the rule requirements that the state did not materially change in this rulemaking.
The agency initially approved 10 CSR
106.062 in 2006 71 FR 38997, July 11, 2006, and the opacity and reporting and recordkeeping provisions have not 1 Missouris permit-by-rule application forms may be found here https dnr.mo.gov/forms/
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