Approval of Hospital/Medical/Infectious Waste Incinerator State Plan for Designated Facilities and Pollutants: Illinois

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.

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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

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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.

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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]

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