[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]
[[Page 53605]]
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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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