[Federal Register Volume 64, Number 129 (Wednesday, July 7, 1999)]
[Rules and Regulations]
[Pages 36600-36605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17028]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 62
[IL188-1a; FRL-6371-5]
Approval of Hospital/Medical/Infectious Waste Incinerator State
Plan for Designated Facilities and Pollutants: Illinois
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: We are approving Illinois' State Plan for Hospital/Medical/
Infectious Waste Incinerators (HMIWI), submitted on May 28, 1999. The
State Plan adopts and implements our Emissions Guidelines (EG)
applicable to existing HMIWIs. Our approval means that we find the
State Plan meets Clean Air Act (Act) requirements. Once effective, our
approval makes the State Plan federally enforceable.
DATES: This rule is effective on September 7, 1999, unless EPA receives
adverse written comments by August 6, 1999. If adverse written comment
is received, EPA will publish a timely withdrawal of the rule in the
Federal Register and inform the public that the rule will not take
effect.
ADDRESSES: Written comments should be sent to: J. Elmer Bortzer, Chief,
Regulation Development Section, Air Programs Branch (AR-18J), U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois 60604. You can inspect copies of the State Plan submittal at
the following address: U.S. Environmental Protection Agency, Region 5,
Air and Radiation Division, 77 West Jackson Boulevard, Chicago,
Illinois 60604. (We recommend you contact Mark J. Palermo,
Environmental Protection Specialist at (312) 886-6082 before visiting
the Region 5 Office).
FOR FURTHER INFORMATION CONTACT: Mark J. Palermo, Environmental
Protection Specialist, at (312) 886-6082.
SUPPLEMENTARY INFORMATION: The supplemental information is organized in
the following order:
I. What is EPA approving in this action?
II. The HMIWI State Plan Requirement.
What is an HMIWI State Plan?
Why are we requiring Illinois to submit an HMIWI State Plan?
Why do we need to regulate HMIWI emissions?
What criteria must an HMIWI State Plan meet to be approved?
III. The Illinois HMIWI State Plan.
Where are the Illinois HMIWI State Plan requirements codified?
Who is affected by the State Plan?
Who is exempt from the State Plan?
What does the State Plan require?
When must the State Plan requirements be met?
What must you do to obtain an extended compliance schedule?
What must you do if you intend to permanently shut down?
What are the permit application deadlines?
What else does the State Plan include?
What public review opportunities were provided?
IV. Review and Approval of the Illinois HMIWI State Plan.
Why is the Illinois HMIWI State Plan approvable?
V. EPA Rulemaking Action.
VI. Administrative Requirements.
A. Executive Order 12866
B. Executive Order 12875
C. Executive Order 13045
D. Executive Order 13084
E. Regulatory Flexibility Act
F. Unfunded Mandates
G. Submission to Congress and the Comptroller General
H. Paperwork Reduction Act
I. National Technology Transfer and Advancement Act
J. Petitions for Judicial Review
I. What Is EPA Approving in This Action?
We are approving the May 28, 1999, Illinois State Plan which
implements the requirements of sections 111(d) and 129 of the Act for
existing HMIWIs. This approval, once effective, will make the Illinois
HMIWI rules included in the plan federally enforceable.
II. The HMIWI State Plan Requirement.
What is an HMIWI State Plan?
An HMIWI State Plan is a plan to control air pollutant emissions
from existing incinerators which burn hospital waste or medical/
infectious waste. The plan also includes source and emission
inventories of these incinerators in the State.
Why Are We Requiring Illinois To Submit an HMIWI State Plan?
States are required under sections 111(d) and 129 of the Act to
submit State Plans to control emissions from existing HMIWIs in the
State. The State Plan requirement was triggered when we published the
Emissions Guidelines (EG) for HMIWIs on September 15, 1997 (see 62 FR
48348). The EG is codified under 40 CFR part 60, subpart Ce.
Under section 129, we are required to promulgate EGs for several
types of existing solid waste incinerators. These EGs establish the
Maximum Achievable Control Technology (MACT) standards that States must
adopt to comply with the Act. The HMIWI EG also establishes
requirements for monitoring, operator training, permits, and a waste
management plan that must be included in State Plans.
The intent of the State Plan requirement is to reduce several types
of air pollutants associated with waste incineration.
Why do we need to regulate HMIWI emissions?
The State Plan establishes control requirements which reduce the
following emissions from HMIWIs: particulate matter, sulfur dioxide,
hydrogen chloride, nitrogen oxides, carbon monoxide, lead, cadmium,
mercury, dioxin, and dibenzofurans.
[[Page 36601]]
These pollutants can cause adverse effects to the public health and
the environment. Dioxin, lead, and mercury bioaccumulate through the
food web. Serious developmental and adult effects in humans, primarily
damage to the nervous system, have been associated with exposures to
mercury. Exposure to dioxin and furans can cause skin disorders,
cancer, and reproductive effects such as endometriosis. Dioxin and
furans can also affect the immune system. Acid gases affect the
respiratory tract, as well as contribute to the acid rain that damages
lakes and harms forests and buildings. Exposure to particulate matter
has been linked with adverse health effects, including aggravation of
existing respiratory and cardiovascular disease and increased risk of
premature death. Nitrogen oxide emissions contribute to the formation
of ground level ozone, which is associated with a number of adverse
health and environmental effects.
What criteria must an HMIWI State Plan meet to be approved?
The criteria for approving an HMIWI State Plan is summarized in the
following table:
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Requirement Elements
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Sections 111(d) and 129: State Plan --Applicability
must be at least as protective as the --Emission Limits
EG. --Compliance Schedules
--Performance Testing
--Monitoring/Inspection
--Operator Training/
Certification
--Waste Management Plan
--Recordkeeping/Reporting
40 CFR part 60, subpart B: Criteria for --Demonstration of Legal
an approvable section 111(d) plan. Authority
--Enforceable Mechanism
--Evidence of public hearing
--Source and Emission
Inventories
--State Progress Report
Commitment
Section 129(e): Title V permit State Plans must ensure that
requirement. affected HMIWI facilities
submit Title V permit
applications to the State by
September 15, 2000.
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We issued a guidance document describing in more detail the
requirements for an approvable HMIWI State Plan, entitled ``Hospital/
Medical/Infectious Waste Incinerator Emission Guidelines: Summary of
the Requirements for Section 111(d)/129 State Plans,'' published
November 1997. Illinois used this document to develop its State Plan.
III. The Illinois HMIWI State Plan
Where are the Illinois HMIWI requirements codified?
Illinois' State Plan requirements for HMIWIs are codified at 35
Ill. Adm. Code 229. The rule was adopted on May 6, 1999, and became
effective on May 15, 1999. The rule was published in the Illinois
Register, volume 23, issue 22, p. 6477, on May 28, 1999.
Who is affected by the State Plan?
Consistent with the EG, Illinois' HMIWI rules cover existing
HMIWIs, with the exception of certain exempt HMIWIs, which only need to
meet certain recordkeeping and certification requirements. Also,
hospitals which send HMIWI waste to an off-site HMIWI are covered by
waste management plan requirements. The Illinois HMIWI applicability
criteria and associated requirements are summarized in the table below.
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Category Requirements
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HMIWI for which construction Subject to control requirements specified
commenced on or before June in the EG.
20, 1996.
Co-fired combustor........... Not subject to control requirements
specified in the EG but:
Must have permit condition limiting
operation to co-fired combustor status;
and,
Must keep records on weight of wastes or
fuels burned on a calendar quarter
basis.
HMIWIs which combust only Not subject to control requirements
these wastes: specified in the EG but:
--pathological Must keep records on a calendar quarter
basis demonstrating that only exempt
wastes are burned; and,
--low-level radioactive
--chemotherapeutic Must provide State and EPA certification
that the HMIWI burns only these wastes.
Hospitals that send waste to Not subject to control requirements
an off-site HMIWI. specified in the EG but:
Must meet certain waste management plan
requirements.
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For an HMIWI to be considered a ``co-fired combustor,'' it must be
subject to an enforceable permit condition limiting combustion of
hospital or medical infectious waste to 10% or less of total waste
burned, by weight, on a calendar quarter basis. For purposes of the co-
fired combustor exemption, pathological waste, chemotherapeutic waste,
and low-level radioactive wastes are considered ``other'' wastes when
calculating the percentage of hospital waste and medical/infectious
waste combusted.
HMIWIs which combust pathological wastes, low-level radioactive
waste, or chemotherapeutic wastes part of the time can be exempt from
control requirements during those periods if it notifies the IEPA
pursuant to this operating scenario in its CAAPP application.
[[Page 36602]]
Who is exempt from the State Plan?
Incinerators that would otherwise meet the HMIWI definition are
completely exempt from the rule if they meet any of the following
criteria:
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You are exempt if:
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You are a combustor required to have a permit under section 3005 of the
Solid Waste Disposal Act, 42 U.S.C. 6925;
You are a municipal waste combustor subject to 40 CFR part 60, subparts
Cb, Ea or Eb;
You are a pyrolysis unit (i.e., a unit that uses endothermic
gasification to treat hospital waste or medical/infectious waste in
order to render such waste harmless);
You are a cement kiln firing hospital waste or medical/infectious waste;
or, You are an HMIWI subject to the New Source Performance Standards
(NSPS) for HMIWIs, 40 CFR part 60, subpart Ec.
------------------------------------------------------------------------
What does the State Plan require?
If you are an HMIWI subject to control requirements under the
Illinois HMIWI rule, you must comply with the requirements summarized
below:
Summary of the Illinois HMIWI Control Requirements
------------------------------------------------------------------------
------------------------------------------------------------------------
Emission Limitations
Separate limits are --Dioxins/furans.
established for four --Hydrogen chloride
categories of HMIWIs: --Sulfur dioxide.
--small --Oxides of nitrogen.
--medium --Lead.
--large --Cadmium.
--rural --Mercury.
--Particulate matter.
--Opacity.
--Carbon monoxide.
Compliance provisions........ --Performance testing.
--Operating parameter monitoring.
--Operating parameter compliance.
--Inspection requirements (rural HMIWIs).
--Recordkeeping and reporting.
Operator provisions.......... --Training.
--Certification.
--On-site Operator Manual.
Permit...................... --Must apply for a CAAPP permit.
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Waste Management Plan Requirements
(Requirements vary depending upon the type of facility)
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Hospitals Using On-Site Submit a plan that identifies ways to
Incinerators. reduce the amount and toxicity of
incinerated waste, and provides an
implementation schedule where feasible.
Submit the plan at the same time the
initial performance test results are
reported.
Submit annual waste management progress
reports.
Update the plan every five years
coinciding with issuance or renewal of a
CAAPP permit.
Hospitals Transporting Waste By September 15, 2000, conduct an
Off-Site to an HMIWI. assessment of current waste management
program and identify ways to reduce
volume and toxicity of incinerated
waste.
Submit annual waste management progress
reports.
HMIWIs Accepting Waste Provide information to customers annually
Generated Off-Site. on available ways to reduce the amount
and toxicity of incinerated waste.
Submit a plan on how and what information
will be distributed.
Submit plan at the same time the initial
performance test results are reported.
Other HMIWIs................. Submit a plan that identifies ways to
reduce the amount and toxicity of
incinerated waste, and provides an
implementation schedule where feasible.
Submit the plan at the same time the
initial performance test results are
reported.
Update the plan every 5 years to coincide
with the issuance or renewal of a CAAPP
permit.
------------------------------------------------------------------------
The Illinois rule also prescribes various criteria and
considerations in developing the plan, and specifies the components
which the plan must include.
When must the State Plan requirements be met?
Under the Illinois HMIWI rule, a subject HMIWI must be in
compliance with the rule requirements by September 15, 2000, and must
conduct an initial performance test by that date, unless the source
requests an extended compliance schedule. Any HMIWI requesting an
extended schedule must demonstrate compliance by September 15, 2002, or
must cease operation of the
[[Page 36603]]
HMIWI until compliance with the rule is achieved.
Notwithstanding an extended schedule, however, the Illinois rule
requires, consistent with the EG, compliance with the rule's operator
training and certification provisions by September 15, 2000.
What must you do to obtain an extended compliance schedule?
HMIWIs seeking an extended compliance schedule must submit a CAAPP
application, on or before November 15, 1999, which requests an extended
compliance schedule. In accordance with EG requirements, this
compliance schedule must include documentation supporting the need for
an extension, a final control plan for the HMIWI, and incremental steps
to be taken toward compliance, which, at a minimum, include the
increments of progress listed below.
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Increments of progress Due date
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Finalize all contracts for the February 29, 2000
purchase of either pollution
control equipment, process
modification or control system.
Begin process modifications or November 30, 2000
construction/installation of air
pollution control devices for the
HMIWI.
Complete either the process August 31, 2001
modifications or the installation/
construction of the new air
pollution control equipment.
Initial start-up of the retrofitted January 15, 2002
HMIWI.
Complete the initial performance Within 180 days of initial start-
test in accordance with rule up
requirements.
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What must you do if you intend to permanently shut down?
For all HMIWIs that intend to permanently shut down, the source
must notify IEPA of that intent by November 15, 1999, and take certain
affirmative steps, described in the rule, to demonstrate that the HMIWI
has been rendered permanently inoperable by September 15, 2000.
What are the permit application deadlines?
The Illinois HMIWI rule requires all HMIWIs subject to the rule's
emission limits to operate pursuant to CAAPP permit by September 15,
2000. All HMIWIs which are currently not required to obtain CAAPP
permits must apply for an CAAPP permit by September 15, 2000, unless
the source is seeking an extended compliance schedule. To avail
themselves of the extended compliance schedule described above, sources
must submit their CAAPP application requesting the extension by
November 15, 1999.
HMIWIs that currently have CAAPP permits have special deadlines to
make revisions incorporating the HMIWI rule requirements, depending
upon how much time is remaining in the CAAPP permit term.
What else does the State Plan include?
The State Plan includes a demonstration of legal authority to
implement the EG, documentation of public hearing, comment, and
response, a source and emissions inventory, and provision for State
progress reports to EPA. These materials were submitted to satisfy the
section 111(d) requirements under 40 CFR part 60, subpart B.
What public review opportunities were provided?
The Illinois Pollution Control Board held public hearings on the
HMIWI State Plan on January 21, 1999, in Chicago, Illinois, and
February 3, 1999, in Springfield, Illinois. Illinois also accepted and
formally responded to written public comments on its rule.
IV. Review and Approval of the Illinois HMIWI State Plan.
Why is the Illinois HMIWI State Plan approvable?
We compared the Illinois HMIWI rule 35 Ill.Adm.Code 229 against our
HMIWI EG. We find the Illinois rule to be at least as protective as the
EG. Also, the Illinois State Plan satisfies the requirements for an
approvable section 111(d) plan under subparts B and Ce of 40 CFR part
60. For these reasons, we are approving the Illinois HMIWI State Plan.
V. EPA Rulemaking Action.
We are approving, through direct final rulemaking action, Illinois'
section 111(d)/129 State Plan for HMIWIs. The EPA is publishing this
action without prior proposal because EPA views this as a
noncontroversial revision and anticipates no adverse comments. However,
in a separate document in this Federal Register publication, the EPA is
proposing to approve the SIP revision should adverse written comments
be filed. This action will be effective September 7, 1999 without
further notice unless EPA receives relevant adverse written comment by
August 6, 1999. Should the Agency receive such comments, it will
publish a timely withdrawal informing the public that this action will
not take effect. Any parties interested in commenting on this action
should do so at this time. If no such comments are received, the public
is advised that this action will be effective on September 7, 1999.
VI. Administrative Requirements.
A. Executive Order 12866
The Office of Management and Budget (OMB) has exempted this
regulatory action from Executive Order (E.O.) 12866, entitled
``Regulatory Planning and Review.''
B. Executive Order 12875
Under E.O. 12875, EPA may not issue a regulation that is not
required by statute and that creates a mandate upon a state, local, or
tribal government, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by those
governments. If the mandate is unfunded, EPA must provide to the Office
of Management and Budget a description of the extent of EPA's prior
consultation with representatives of affected state, local, and tribal
governments, the nature of their concerns, copies of written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, E.O. 12875 requires EPA to
develop an effective process permitting elected officials and other
representatives of state, local, and tribal governments ``to provide
meaningful and timely input in the development of regulatory proposals
containing significant unfunded mandates.'' Today's rule does not
create a mandate on state, local or tribal governments. The rule does
not impose any enforceable duties on these entities. Accordingly, the
requirements of section 1(a) of E.O. 12875 do not apply to this rule.
[[Page 36604]]
C. Executive Order 13045
Protection of Children from Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is
determined to be ``economically significant'' as defined under E.O.
12866, and (2) concerns an environmental health or safety risk that EPA
has reason to believe may have a disproportionate effect on children.
If the regulatory action meets both criteria, the Agency must evaluate
the environmental health or safety effects of the planned rule on
children, and explain why the planned regulation is preferable to other
potentially effective and reasonably feasible alternatives considered
by the Agency.
This rule is not subject to E.O. 13045 because it does not involve
decisions intended to mitigate environmental health or safety risks.
D. Executive Order 13084
Under E.O. 13084, EPA may not issue a regulation that is not
required by statute, that significantly affects or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments. If the mandate is unfunded,
EPA must provide to the Office of Management and Budget, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, E.O. 13084 requires EPA to develop an
effective process permitting elected and other representatives of
Indian tribal governments ``to provide meaningful and timely input in
the development of regulatory policies on matters that significantly or
uniquely affect their communities.'' Today's rule does not
significantly or uniquely affect the communities of Indian tribal
governments. Accordingly, the requirements of section 3(b) of E.O.
13084 do not apply to this rule.
E. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions. This final rule will not have a significant impact on a
substantial number of small entities because SIP approvals under
section 110 and subchapter I, part D of the Clean Air Act do not create
any new requirements but simply approve requirements that the State is
already imposing. Therefore, because the Federal SIP approval does not
create any new requirements, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
Moreover, due to the nature of the Federal-State relationship under the
Clean Air Act, preparation of flexibility analysis would constitute
Federal inquiry into the economic reasonableness of state action. The
Clean Air Act forbids EPA to base its actions concerning SIPs on such
grounds. Union Electric Co., versus U.S. EPA, 427 U.S. 246, 255-66
(1976); 42 U.S.C. 7410(a)(2).
F. Unfunded Mandates
Under section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
annual costs to State, local, or tribal governments in the aggregate;
or to private sector, of $100 million or more. Under section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
EPA has determined that the approval action promulgated does not
include a Federal mandate that may result in estimated annual costs of
$100 million or more to either State, local, or tribal governments in
the aggregate, or to the private sector. This Federal action approves
pre-existing requirements under State or local law, and imposes no new
requirements. Accordingly, no additional costs to State, local, or
tribal governments, or to the private sector, result from this action.
G. 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This rule is not a ``major'' rule as defined by 5 U.S.C.
804(2).
H. Paperwork Reduction Act
This action does not contain any information collection
requirements which requires OMB approval under the Paperwork Reduction
Act (44 U.S.C. 3501 et seq.).
I. National Technology Transfer and Advancement Act
Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 requires Federal agencies to evaluate existing
technical standards when developing a new regulation. To comply with
NTTAA, EPA must consider and use ``voluntary consensus standards''
(VCS) if available and applicable when developing programs and policies
unless doing so would be inconsistent with applicable law or otherwise
impractical.
The EPA believes that VCS are inapplicable to this action. Today's
action does not require the public to perform activities conducive to
the use of VCS.
J. 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 September 7, 1999. 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, Hospital/medical/
infectious
[[Page 36605]]
waste incinerators, Reporting and recordkeeping requirements.
Dated: June 23, 1999.
Jerri-Anne Garl,
Acting Regional Administrator, Region 5.
40 CFR part 62 of the Code of Federal Regulations is amended as
follows:
1. The authority citation for part 62 continues to read as follows:
Authority: 42 U.S.C. 7401-7642.
Subpart O--Illinois
2. A new center heading and sections 62.3340, 62.3341, and 62.3342
are added to read as follows:
* * * * *
Metals, Acid Gases, Organic Compounds and Nitrogen Oxide Emissions
From Existing Hospital / Medical Infectious Waste Incinerators
Sec. 62.3340 Identification of plan.
Illinois submitted, on May 28, 1999, a State Plan for implementing
the Emission Guidelines affecting Hospital/Medical Infectious Waste
Incinerators (HMIWI). The enforceable mechanism for this plan is 35
Ill. Adm. Code 229. The rule was adopted by the Illinois Pollution
Control Board on May 6, 1999. The rule became effective on May 15,
1999, and was published in the Illinois Register on May 28, 1999 at 23
Ill. Reg. 6477
Sec. 62.3341 Identification of sources.
The Illinois State Plan for existing Hospital/Medical/Infectious
Waste Incinerators (HMIWI) applies to all HMIWIs for which construction
commenced either on or before June 20, 1996.
Sec. 62.3342 Effective Date.
The effective date of the Illinois State Plan for existing
Hospital/Medical/Infectious Waste Incinerators is September 7, 1999.
[FR Doc. 99-17028 Filed 7-6-99; 8:45 am]
BILLING CODE 6560-50-P
