[Federal Register Volume 65, Number 172 (Tuesday, September 5, 2000)]
[Rules and Regulations]
[Pages 53605-53608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22516]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[MD-103-3055a; FRL-6862-4]


Approval and Promulgation of State Air Quality Plans for 
Designated Facilities and Pollutants; Maryland; 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 Maryland's 111(d)/129 plan (the ``plan'') for 
the control of air pollutant emissions from hospital/medical/infectious 
waste incinerators (HMIWIs). The plan was developed and submitted to 
EPA by the Maryland Department of the Environment, Air and Radiation 
Management Administration (MARMA), on April 14, 2000. EPA is publishing 
this approval action without prior proposal because we view this as a 
noncontroversial action and anticipate no adverse comments.

DATES: This final rule is effective October 20, 2000 unless by October 
5, 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 Denis M. Lohman, Acting 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 19103-2029; 
and the Maryland Air and Radiation Management Administration, 2500 
Broening Highway, Baltimore, Maryland 21224.

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/local 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 HMIWI 111(d)/129 Plan Must Meet for 
Approval

    What general EPA requirements must the MARMA meet in order to 
receive approval of its HMIWI 111(d)/129 plan?
    What does the Maryland plan contain?
    Does the Maryland plan meet all EPA requirements for approval?

III. Requirements for Affected HMIWI Owners/Operators

    How do I determine if my HMIWI is a designated facility subject 
to the MD 111(d)/129 plan?
    As an affected HMIWI owner/operator, 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?
    What must be included in my Waste Management Plan (WMP), and 
when must it be completed?
    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 Maryland 111(d)/129 plan (the ``plan'') for 
the control of air pollutant emissions from hospital/medical/infectious 
waste incinerators (HMIWIs). The plan was developed and submitted to 
EPA by the Maryland Department of the Environment, Air and Radiation 
Management Administration (MARMA), on April 14, 2000. EPA is publishing 
this approval action without prior proposal because we view this as a 
noncontroversial action and anticipate no adverse comments.
    Q. What is a State/local 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 and enforce the EG requirements. The HMIWI EG at 
40 CFR part 60, subpart Ce, establish the MACT requirements under the 
authority of both sections 111(d) and 129 of the CAA. These 
requirements must be incorporated into a State/local 111(d)/129 plan 
that is ``at least as protective'' as the EG, and is 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 September 15, 1997 promulgated EG, subpart Ce, are 
applicable to all existing HMIWIs (i.e., the designated facilities) 
that emit organics (dioxins/furans), carbon monoxide, metals (cadmium, 
lead, mercury), acid gases (hydrogen chloride, sulfur dioxide, and 
nitrogen oxides) and particulate matter. This action establishes 
emission limitations for each of these pollutants, including an opacity 
limitation.
    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 levels, 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 
include probable carcinogenic effects. Acid gases contribute to the 
acid rain that lowers the pH of surface waters and watersheds, harms 
crops and forests, and damages buildings. Implementation of the 
emissions control measures required under the Maryland plan will help 
mitigate most of the noted adverse environmental and public health 
impacts associated with the operation of HMIWI units.

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

    Q. What general requirements must the MARMA meet to receive 
approval of its 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 
standard (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 and performance testing, monitoring, 
reporting, and recordkeeping. More specifically, the Maryland 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 Maryland D plan contain?
    A. Consistent with the requirements of subparts B, Ce and Ec, the 
Maryland plan contains the following elements:
    1. A demonstration of Maryland's legal authority to implement the 
plan;
    2. Identification of the Maryland enforceable mechanism, Code of 
Maryland (COMAR) 26.11.08 Control of Incinerators, as amended.
    3. Source and emission inventories, as required;
    4. Emission limitation requirements that are no less stringent than 
those in subpart Ce;
    5. A source compliance schedule, including increments of progress, 
as required;
    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 Maryland plan;
    10. Provision for MARMA submittal to EPA of annual reports on 
progress in plan enforcement; and
    11. A Title V permit application due date.
    On October 22, 1999, the Secretary of the Department of the 
Environment proposed in the Maryland Register to amend COMAR 26.11.08 
Control of Incinerators, at .01, .02, .04, .05, and .09 and to add .08-
1, specifically relating to HMIWIs. These regulatory amendments were 
adopted on March 7, 2000, and became effective on April 17, 2000.
    Q. Does the Maryland 111(d)/129 plan meet all EPA requirements for 
approval?
    A. Yes. The MARMA has submitted a plan that conforms to all EPA 
subparts B and Ce requirements. 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 MD 111(d)/129 plan?
    A. If construction commenced on your HMIWI on or before June 20, 
1996, it is subject to the plan. The plan contains no lower 
applicability threshold based on incinerator capacity. However, there 
are designated facility exemptions, as referenced in COMAR 
26.11.08.02H. 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 a 
Clean Air Act combustor rule; pyrolysis units; and cement kilns.
    Q. As an affected HMIWI owner/operator, what general requirements 
must I meet under the approved EPA 111(d)/129 plan?
    A. In general, the COMAR for HMIWI establish the following 
requirements:

 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)
 Compliance and performance testing
 Inspection of small rural HMIWI units
 Operating parameter monitoring
 Operator training and qualification
 Development of a waste management plan
 Recordkeeping and reporting
 Title V permit

    A full and comprehensive statement of the above requirements is 
incorporated in COMAR 26.11.08.08-1, and in related COMAR for 
incinerators.
    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 available control technology (MACT) emission limitations 
for the pollutants identified above. The pollutant emission limitations 
are stipulated in COMAR 26.11.08.08-1A and .08-1B.
    The 111(d)/129 plan requires you to achieve compliance with all 
COMAR requirements for HMIWI on or before March 15, 2001. However, you 
may petition the MARMA for an extension of the compliance date. The 
petition request must be submitted on or before September 15, 2000, and 
must include the following:
    (a) Documentation of the analyses undertaken to support the need 
for an extension, including an explanation of why March 15, 2001 is not 
sufficient time to comply;
    (b) A demonstration of the feasibility to transport the waste 
offsite to a commercial medical waste treatment and disposal facility 
on either a temporary or permanent basis; and
    (c) A compliance plan and schedule that includes specific 
increments of progress dates, as required under COMAR 26.11.08.08-
1C(1)(b), and a final compliance date that is no later than March 15, 
2002.
    Under COMAR 26.11.08.08-1.C(1)(b), proposed compliance date 
extensions beyond March 15, 2001 must be submitted to both MARMA and 
EPA for approval. EPA will consider approving a proposal for a 
compliance date extension if the proposed compliance plan and schedule 
is (1) expeditious, (2) approved by MARMA, and (3) consistent with the 
provisions of 40 CFR 60.24(f), and 60.28, subpart B, relating to EPA 
requirements for the adoption and submittal of state 111(d)/129 plans.
    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 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 your HMIWI operators.
    Failure to operate the HMIWI and/or air pollution control device 
(APCD) within certain established operating parameter limits 
constitutes an emissions violation for the controlled air pollutant. 
However, as a HMIWI owner/operator, you are provided an opportunity to 
establish revised operating limits, and demonstrate that

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your facility is meeting the required emission limitation, providing a 
repeat performance test is conducted in a timely manner, as specified 
in the regulation.
    Under the Maryland 111(d)/129 plan, effective April 17, 2000, a 
fully trained and qualified operator is required on site whenever your 
HMIWI unit is in operation. In order to be classified as a qualified 
operator, you must complete an appropriate HMIWI operator training 
course that meets the criteria referenced in COMAR 26.11.08.09B and C. 
In addition, effective March 1, 2001, you must maintain documentation 
of training (operator training manual) on site. The COMAR at 
26.11.08.09C(5) requires that the cited documentation be updated 
annually at the time of the required annual review course, and meet the 
requirements of 40 CFR 60.53c(h) that define the scope of the required 
documentation.
    The COMAR incorporates by reference (IBR) all applicable 
operational requirements of the EG and the related NSPS.
    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 source (stack) test to 
determine compliance with the emission limitations for PM, opacity, CO, 
CDD/CDF, HCl, Pb, Cd, and Hg. The initial source test must be completed 
no later than 180 days after your final compliance date. Consistent 
with the EG, no initial compliance test is required for the oxides of 
sulfur and nitrogen. Nevertheless, both the MARMA and the EPA have 
discretionary authorities under existing state and federal regulations 
to require, if deemed necessary, source tests for these pollutants. 
After the initial source test, compliance testing is then required 
annually (no more than 12 months following the previous test) to 
determine compliance with the emission limitations for PM, CO, and HCl.
    As noted above, operating parameter limits are monitored and 
established during the initial performance test. Monitored HMIWI 
operating parameters include, for example, charge rate, secondary 
chamber and bypass stack temperatures. APCD operating parameters 
include, for example, CDD/CDF and Hg sorbent (e.g., carbon) flow rate, 
HCl sorbent (e.g., lime) flow rate, PM control device inlet 
temperature, pressure drop across the control system, and liquid flow 
rate, including pH.
    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 a waste 
management plan (WMP). Records must be maintained for at least five 
years.
    The COMAR also IBR all the applicable testing, monitoring, 
recordkeeping, and reporting requirements of the EG and the related 
NSPS.
    Q. What must be included in my Waste Management Plan (WMP), and 
when must it be completed?
    A. In summary, your WMP must identify both the feasibility of, and 
the approach for, separating certain components of solid waste from the 
health care waste stream in order to reduce the amount of toxic 
emissions from the incinerated waste. Also, in developing your WMP, you 
must consider the American Hospital Association publication entitled 
``An Ounce of Prevention: Waste Reduction Strategies for Health Care 
Facilities.'' This publication (AHA Catalog No. 057007) is available 
for purchase from the American Hospital Association (AHA) Service, 
Inc., Post Office Box 92683, Chicago, Illinois 60675-2683. For more 
details regarding these requirements see 40 CFR part 60, subpart Ec, 
section 60.55c.
    Submittal of the WMP to the MARMA is required no later than 60 days 
following the initial performance tests required under COMAR 
26.11.08.08-1A(4) and B(5).
    Q. Is there a requirement for obtaining a Title V permit?
    A. Yes, if your HMIWI is an affected facility, you must have 
submitted a complete Title V application to the MARMA no later than 
July 15, 2000.

IV. Final EPA Action

    The Maryland 111(d)/129 plan for controlling HMIWI emissions is 
approvable. Based upon the rationale discussed above and in further 
detail in the TSD associated with this action, EPA is approving 
Maryland's 111(d)/129 plan for the control of HMIWI emissions from 
designated facilities. As provided by 40 CFR 60.28(c), any revisions to 
the Maryland plan or associated regulations will not be considered part 
of the applicable plan until submitted by the MARMA 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) plan should 
relevant adverse or critical comments be filed. This rule will be 
effective October 20, 2000 without further notice unless the Agency 
receives relevant adverse comments by October 5, 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 October 20, 
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

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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 November 6, 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 approving the Maryland 111(d)/129 plan for 
HMIWI 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: August 21, 2000.
Bradley M. Campbell,
Regional Administrator, Region III.

    40 CFR Part 62, Subpart V, 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 V--[Amended]

    2. A new center heading and Secs. 62.5160, 62.5161, and 62.5162 is 
added to Subpart V to read as follows:

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


Sec. 62.5160  Identification of plan.

    Section 111(d)/129 plan for HMIWIs and the associated Code of 
Maryland (COMAR) 26.11.08 regulations, as submitted on April 14, 2000.


Sec. 62.5161  Identification of sources.

    The plan applies to all existing HMIWIs located in Maryland for 
which construction was commenced on or before June 20, 1996.


Sec. 62.5162  Effective date.

    The effective date of the plan is October 20, 2000.

[FR Doc. 00-22516 Filed 9-1-00; 8:45 am]
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