[Federal Register Volume 65, Number 73 (Friday, April 14, 2000)]
[Rules and Regulations]
[Pages 20086-20090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9233]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[DE040-1023a; FRL-6577-7]


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.

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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.

[[Page 20087]]


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 [email protected].

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;

[[Page 20088]]

    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 
(NOX), 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

[[Page 20089]]

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.

    Dated: April 3, 2000.
Bradley M. Campbell,
Regional Administrator, Region III.

    40 CFR Part 62, is amended as follows:

[[Page 20090]]

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 Secs. 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


Sec. 62.1975  Identification of plan.

    Section 111(d)/129 plan for HMIWI and the associated Delaware 
Department of Natural Resources, Division of Air and Waste Management, 
Regulation No. 20, section 29, as submitted on September 17, 1998.


Sec. 62.1976  Identification of sources.

    The plan applies to all Delaware existing HMIWI for which 
construction was commenced on or before June 20, 1996.


Sec. 62.1977  Effective date.

    The effective date of the plan for hospital/medical/infectious 
waste incinerators is June 13, 2000.

[FR Doc. 00-9233 Filed 4-13-00; 8:45 am]
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