Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; Delaware; Control of Emissions From Existing Hospital/Medical/Infectious Waste Incinerators

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule.

SUMMARY:

EPA is approving the hospital/medical/infectious waste incinerator (HMIWI) 111(d)/129 plan (the “plan”) submitted by the Delaware Department of Natural Resources and Environmental Control (DNREC) on September 17, 1998. The plan was submitted to fulfill requirements of the Clean Air Act (CAA). The Delaware plan establishes emission limitations and other requirements for existing HMIWIs, and provides for the implementation and enforcement of those limitations and requirements.

DATES:

This final rule is effective June 13, 2000 unless by May 15, 2000 adverse or critical comments are received. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the Federal Register and inform the public that the rule will not take effect.

ADDRESSES:

Comments may be mailed to Makeba A. Morris, Chief, Technical Assessment Branch, Mailcode 3AP22, Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the documents relevant to this action are available for public inspection during normal business hours at the following locations: Air Protection Division, Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania; and the Department of Natural Resources and Environmental Control's offices at 715 Grantham Lane, New Castle; and 89 Kings Highway, Dover, Delaware.

FOR FURTHER INFORMATION CONTACT:

James B. Topsale at (215) 814-2190, or by e-mail at topsale.jim@epa.gov.

SUPPLEMENTARY INFORMATION:

This document is divided into Sections I through V and answers the questions posed below.

I. General Provisions

What is EPA approving?

What is a State 111(d)/129 plan?

What pollutant(s) will this action control?

What are the expected environmental and public health benefits from controlling HMIWI emissions?

II. Federal Requirements the Delaware 111(d)/129 Plan Must Meet for Approval

What general requirements must the DNREC meet to receive approval of the Delaware HMIWI 111(d)/129 plan?

What does the Delaware State plan contain?

Does the Delaware 11(d)/129 plan meet all EPA requirements for approval?

III. Requirements Affected HMIWI Owners/Operators Must Meet

How do I determine if my HMIWI is a designated facility subject to the Delaware 111(d)/129 plan?

What general requirements must I meet under the approved EPA 111(d)/129 plan?

What emissions limits must I meet, and in what time frame?

Are there any operational requirements for my HMIWI and emissions control system?

What are the testing, monitoring, recordkeeping, and reporting requirements for my HMIWI?

Is there a requirement for obtaining a Title V permit?

IV. Final EPA Action

V. Administrative Requirements

I. General Provisions

Q. What is EPA approving?

A. EPA is approving the Delaware 111(d)/129 plan for the control of air pollutant emissions from HMIWIs. On September 17, 1998, the Delaware Department of Natural Resources and Environmental Control (DNREC) submitted the plan to EPA for approval. EPA is publishing this action without prior proposal because we view this as a noncontroversial action and anticipate no adverse comments.

Q. What is a State 111(d)/129 plan?

A. Section 111(d) of the Clean Air Act (CAA) requires that “designated” pollutants, controlled under standards of performance for new stationary sources by section 111(b) of the CAA, must also be controlled at existing sources in the same source category to a level stipulated in an emission guidelines (EG) document. Section 129 of the CAA specifically addresses solid waste combustion and emissions controls based on what is commonly referred to as maximum achievable control technology (MACT). Section 129 requires EPA to promulgate a MACT based EG document and then requires states to develop 111(d)/129 plans that implement the EG requirements. The EG for HMIWI at 40 CFR part 60, subpart Ce, establish the MACT requirements under the authority of sections 111(d) and 129. These requirements must be incorporated into a state 111(d)/129 plan that is “at least as protective” as the EG, and that becomes Federally enforceable upon approval by EPA.

The procedures for adoption and submittal of State 111(d)/129 plans are codified in 40 CFR part 60, subpart B. Additional information on the submittal of State plans is provided in the EPA document, “Hospital/Medical/Infectious Waste Incinerator Emission Guidelines: Summary of the Requirements for section 111(d)/129 State Plans” (EPA-456/R-97-007, November, 1997).

Q. What pollutant(s) will this action control?

A. The promulgated September 15, 1997 EPA EG, subpart Ce, are applicable to existing HMIWIs (i.e., the designated facilities) that emit organics (dioxins/furans), carbon monoxide, metals (cadmium, lead, mercury, particulate matter), opacity, and acid gases (hydrogen chloride, sulphur dioxide, and nitrogen oxides). This action establishes emission limitations for each of these pollutants.

Q. What are the expected environmental and public health benefits from controlling HMIWI emissions?

A. HMIWI emissions can have adverse effects on both public health and the environment. Dioxin, lead, and mercury can bioaccumulate in the environment. Exposure to dioxins/furans has been linked to reproductive and developmental effects, changes in hormone level, and chloracne. Respiratory and other effects are associated with exposure to particulate matter, sulfur dioxide, cadmium, hydrogen chloride, and mercury. Health effects associated with exposure to cadmium, and lead included probable carcinogenic effects. Acid gases contribute to the acid rain that lowers the pH of surface waters and watersheds, harms forests, and damages buildings.

II. Federal Requirements the Delaware 111(d)/129 Plan Must Meet for Approval

Q. What general requirements must the DNREC meet to receive approval of the Delaware 111(d)/129 plan?

A. The plan must meet the requirements of both 40 CFR part 60, subparts B, and Ce. Subpart B specifies detailed procedures for the adoption and submittal of State plans for designated pollutants and facilities. The EG, subpart Ce, and the related new source performance (NSPS), subpart Ec, contain the requirements for the control of designated pollutants, as listed above, in accordance with sections 111(d) and 129 of the CAA. In general, the applicable provisions of Subpart Ec relate to compliance, emissions testing and monitoring; and recordkeeping and reporting. More specifically, the Delaware plan must meet the requirements of (1) 40 CFR part 60, subpart Ce, sections 60.30e through 60.39c, and the related subpart Ec provisions; and (2) 40 CFR part 60, subpart B, sections 60.23 through 26.

Q. What does the Delaware State plan contain?

A. Consistent with the requirements of subparts B, Ce and Ec, the Delaware Plan contains the following elements:

1. A demonstration of the State's legal authority to implement the section 111(d)/129 State HMIWI Plan;

2. Identification of the State's enforceable mechanism, Regulation No. 20, section 29;

3. Source and emission inventories, as required;

4. Emission limitation requirements that are at least as protective as those in subpart Ce;

5. A source compliance schedule;

6. Source testing, monitoring, recordkeeping, and reporting requirements;

7. HMIWI operator training and qualification requirements;

8. Requirements for development of a Waste Management Plan;

9. Records of the public hearing on the State plan;

10. Provision for State submittal to EPA of annual reports on progress in plan enforcement; and

11. A Title V permit application due date.

On August 15, 1998, the DNREC adopted an HMIWI regulation (Regulation 20, section 29) that became effective on September 11, 1998. The regulation applies to existing HMIWIs and incorporates by reference (IBR), with certain exceptions, the related and applicable subpart Ec, requirements.

Q. Does the Delaware 111(d)/129 plan meet all EPA requirements for approval?

A. Yes. The DNREC has submitted a 111(d)/129 plan that conforms to all EPA subpart B and Ce requirements cited above. Each of the above listed plan elements is approvable. Details regarding the approvability of the plan elements are included in the technical support document (TSD) associated with this action. A copy of the TSD is available, upon request, from the EPA Regional Office listed in the ADDRESSES section of this document.

III. Requirements Affected HMIWI Owners/Operators Must Meet

Q. How do I determine if my HMIWI is a designated facility subject to the Delaware 111(d)/129 plan?

A. If construction commenced on your HMIWI on or before June 20, 1996, and no modification commenced after March 16, 1998, your HMIWI may be the subject plan. The plan contains no lower applicability threshold based on incinerator capacity. However, there are designated facility exemptions. Those exemptions include incinerators that burn only pathological, low level radioactive, and/or chemotherapeutic waste; co-fired combustors; incinerators permitted under section 3005 of the Solid Waste Disposal Act; municipal waste combustors (MWC) subject to EPA's municipal waste combustor rule; pyrolysis units; and cement kilns. Details regarding applicability and exemptions provisions are stipulated in Regulation 20, section 29, and section 60.50c.

Q. What general requirements must I meet under the approved EPA 111(d)/129 plan?

A. In general, the Delaware HMIWI regulation establishes the following requirements:

1. Emission limitations for particulate matter (PM), opacity, carbon monoxide (CO), dioxins/furans (CDD/CDF), hydrogen chloride (HCl), sulfur dioxide (SO₂), nitrogen oxides (NO_X), lead (Pb), cadmium (Cd), and mercury (Hg).

2. Compliance and performance testing.

3. Operating parameter monitoring.

4. Operator training and qualification.

5. Development of a waste management plan.

6. Source testing, recordkeeping and reporting.

7. A Title V permit.

A full and comprehensive statement of the above requirements is in Delaware Regulation 20, section 29.

Q. What emissions limits must I meet, and in what time frame?

A. You must install an emissions controls system capable of meeting the maximum achievable control technology (MACT) emission limitations for the pollutants identified above. The pollutant emission limitations are stipulated in Regulation 20, section 29, and section 60.52c(a), Table 2. Also, the DNREC regulation at section 60.52c(b) establishes a 10 percent opacity limit. Compliance is required on or before September 11, 1999 for all designated facilities. With adequate justification, you may petition the DNREC for a compliance schedule extension. Petitions must include documentation of your analyses undertaken to support the need for an extension, and your evaluation of the option to transport the waste offsite to a commercial medical waste treatment and disposal facility on a temporary or permanent basis. Also, your extension request must include increments of progress that are no less stringent than those specified in the plan. In any case, your HMIWI must meet the emission limitation(s) as expeditiously as practicable, but no later than September 11, 2001.

Q. Are there any operational requirements for my HMIWI and emissions control system?

A. Yes, there are operational requirements. In summary, the operational requirements relate to: (1) The HMIWI and air pollution control devices (APCD) operating within certain established operating parameter limits, determined during the initial performance test; (2) the use of a trained and qualified HMIWI operator; and (3) the completion of an annual update of operation and maintenance information, and its review by the HMIWI operators.

Failure to operate the HMIWI or APCD within the established operating parameter limits constitutes an emissions violation for the controlled air pollutant. However, as an HMIWI owner/operator, you are provided an opportunity to establish revised operating limits, and demonstrate that your facility is meeting the required emission limitations, providing a repeat performance test is conducted in a timely manner. A fully trained and qualified operator must be available at your facility during the operation of the HMIWI, or the operator must be readily available to the facility within one hour. In order to be classified as a qualified operator, you must complete an appropriate HMIWI operator training course that meets the criteria stipulated in the plan's regulation. Also, as a HMIWI owner/operator, you are required to develop and update annually site-specific information regarding your facilities' operations. Each of your HMIWI operators is required on an annual basis to review the updated operational information. Details regarding operational requirements are stipulated in Regulation 20, section 29, and sections 60.56c(d)through (j) and 60.53c.

Q. What are the testing, monitoring, recordkeeping, and reporting requirements for my HMIWI?

A. Testing, monitoring, recordkeeping, and reporting requirements are summarized below:

You are required to conduct an initial performance test to determine compliance with the emission limitations for PM, opacity, CO, CDD/CDF, HCl, Pb, Cd, and Hg. As noted above, operating parameter limits are monitored and established during the initial performance test. Monitored HMIWI operating parameters include, for example, waste charge rate, secondary chamber and bypass stack temperatures. APCD operating parameters include, for example, CDD/CDF and Hg sorbent (e.g., carbon) flow rate, hydrogen chloride sorbent (e.g., lime) flow rate, PM control device inlet temperature, pressure drop across the control system, and liquid flow rate, including pH. After the initial performance test, compliance testing is then required annually to determine compliance with the emission limitations for PM, CO, and HCl. If all three performance tests over a 3-year period indicate compliance with the emission limit for a pollutant (PM, CO, or HCl), you may forgo a performance test for that pollutant for the subsequent 2 years.

Recordkeeping and reporting are required to document the results of the initial and annual performance tests, continuous monitoring of site-specific operating parameters, compliance with the operator training and qualification requirements, and development of the waste management plan. Records must be maintained for at least five years. Details regarding all testing, monitoring, recordkeeping, and reporting requirements are stipulated in Regulation 20, section 29, and sections 60.56c, 60.57c, and 60.58c.

Q. Is there a requirement for obtaining a Title V permit?

A. Yes, affected facilities are required to operate under a Title V permit no later than September 15, 2000. This is required under Regulation 20, section 29, and section 60.50c(l).

IV. Final EPA Action

EPA is approving Delaware's 111(d)/129 plan for controlling HMIWI emissions. This 111(d)129 plan approval does not include, those provisions, such as siting and fugitive emission requirements, that relate solely to facilities subject to the NSPS, subpart Ec. EPA action on the requested NSPS, subpart Ec, delegation to the DNREC will be taken under a separate action from this 111(d)/129 plan approval.

Based upon the rationale discussed above and in further detail in the TSD associated with this action, EPA is approving the Delaware 111(d)/129 plan for the control of HMIWI emissions from affected facilities. As provided by 40 CFR 60.28(c), any revisions to the Delaware section 111(d) plan or associated regulations will not be considered part of the applicable plan until submitted by the DNREC in accordance with 40 CFR 60.28 (a) or (b), as applicable, and until approved by EPA in accordance with 40 CFR part 60, subpart B. EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the 111(d)/129 plan should relevant adverse or critical comments be filed. This rule will be effective June 13, 2000 without further notice unless the Agency receives relevant adverse comments by May 15, 2000. If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this rule. Only parties interested in commenting on this rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on June 13, 2000 and no further action will be taken on the proposed rule.

V. Administrative Requirements

A. General Requirements

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing 111(d)/129 plan submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a 111(d)/129 plan submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a 111(d)/129 plan submission, to use VCS in place of a 111(d)/129 plan submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 13, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 62

• Environmental protection
• Administrative practice and procedure
• Air pollution control
• Intergovernmental relations
• Reporting and recordkeeping requirements

40 CFR Part 62, is amended as follows:

PART 62—[AMENDED]

1. The authority citation for part 62 continues to read as follows:

Authority: 42 U.S.C. 7401-7671q.

Subpart I—Delaware

2. A new center heading, and §§ 62.1975, 62.1976, and 62.1977 are added to subpart I to read as follows:

Emissions From Existing Hospital/Medical/Infectious Waste Incinerators (HMIWI)—Section 111(d)/129 Plan