Approval of Hospital/Medical/Infectious Waste Incinerator State Plan For Designated Facilities and Pollutants: Indiana

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[IN 109-1a; FRL-6507-5]

Approval of Hospital/Medical/Infectious Waste Incinerator State

Plan For Designated Facilities and Pollutants: Indiana

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is approving Indiana's State Plan for Hospital/Medical/

Infectious Waste Incinerators (HMIWI), submitted on September 30, 1999.

The State Plan adopts and implements the Emissions Guidelines (EG)

applicable to existing HMIWIs. This approval means that EPA finds the

State Plan meets Clean Air Act (Act) requirements. Once effective, this

approval makes the State Plan federally enforceable.

DATES: This rule is effective on February 15, 2000, unless EPA receives

adverse written comments by January 18, 2000. 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 Ryan Bahr, Environmental Engineer, at (312)

353-4366 before visiting the Region 5 Office).

FOR FURTHER INFORMATION CONTACT: Ryan Bahr, Environmental Engineer, at

(312) 353-4366.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we'',

``us'', or ``our'', are used we mean EPA. 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 Indiana 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 Indiana HMIWI State Plan.

Where are the Indiana HMIWI 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 if you plan to

continue operation of your HMIWI?

What must you do to obtain an extended compliance schedule if

you plan to install control equipment or make process changes and

continue operation?

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 Indiana HMIWI State Plan.

Why is the Indiana HMIWI State Plan approvable?

V. EPA Rulemaking Action.

VI. Administrative Requirements.

A. Executive Order 12866

B. Executive Orders 13132

C. Executive Order 13045

D. Executive Order 13084

E. Regulatory Flexibility Act

F. Unfunded Mandates

G. Submission to Congress and the Comptroller General

H. National Technology Transfer and Advancement Act

I. Petitions for Judicial Review

[[Page 70596]]

I. What is EPA approving in this action?

We are approving the September 30, 1999, Indiana State Plan

submission which implements the requirements of sections 111(d) and 129

of the Act for existing HMIWIs. This approval, once effective, will

make the Indiana 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 Indiana to Submit an HMIWI State Plan?

Sections 111(d) and 129 of the Act require States 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 at 40 CFR part 60, subpart Ce.

Section 129, we are requires us 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.

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 following Table summarizes the criteria for approving an HMIWI

State Plan:

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Requirement Elements

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Sections 111(d) and 129: State Plan must --Applicability.

be at least as protective as the EG. --Emission Limits.

--Compliance Schedules.

--Performance Testing.

--Monitoring/Inspection.

--Operator Training/

Certification.

--Waste Management Plan.

--Recordkeeping/Reporting.

40 CFR part 60, subpart B: Criteria for an --Demonstration of Legal

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 requirement State Plans must ensure that

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. Indiana used this document to develop its State Plan.

III. The Indiana HMIWI State Plan

Where Are the Indiana HMIWI Requirements Codified?

Indiana's State Plan requirements for HMIWIs are codified at 326

Indiana Administrative Code (IAC) 11-6. Indiana adopted the rule on

September 2, 1998. Indiana published the rule in the Indiana Register

on March 1, 1999, and it became effective on March 11, 1999.

Who Is Affected By the State Plan?

Consistent with the EG, Indiana's HMIWI rules cover existing

HMIWIs, with the exception of certain exempt HMIWIs, which only need to

meet certain recordkeeping and certification requirements. The table

below summarizes the Indiana HMIWI applicability criteria and

associated requirements:

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Category Requirements

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HMIWI for which construction commenced on Subject to control

or before June 20, 1996. requirements specified in

the EG.

Co-fired combustor........................ Not subject to control

requirements specified in

the EG but:

Must have an enforceable

requirement (e.g. a permit

condition) limiting

operation to co-fired

combustor status; and,

Must keep records on weight

of wastes and fuels burned

on a calendar quarter

basis.

HMIWIs which combust only these wastes: Not subject to control

requirements 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 an off-site Not subject to control

HMIWI. requirements specified in

the EG.

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For an HMIWI to be considered a ``co-fired combustor,'' it must be

subject to an enforceable 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

[[Page 70597]]

chemotherapeutic wastes part of the time can be exempt from control

requirements during those periods if they notify Indiana pursuant to

this operating scenario.

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:

You are exempt if:

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

Indiana HMIWI rule, you must comply with the requirements summarized

below:

-----------Summary of the Indiana HMIWI Control Requirements -----------

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Emission Limitations...................... --dioxins/furans.

Separate limits are established for three --hydrogen chloride.

categories of HMIWIs: --sulfur dioxide.

--small --oxides of nitrogen.

--medium --lead.

--large --cadmium.

--mercury.

--particulate matter.

--opacity.

--carbon monoxide.

Compliance provisions..................... --performance testing.

--operating parameter

monitoring.

--operating parameter

compliance.

--recordkeeping and

reporting.

Operator provisions....................... --Training.

--Certification.

--On-site Operator Manual.

Permit.................................... --Must apply for a Part 70

permit.

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Waste Management Plan Requirements

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Facilities Incinerating Hospital, Medical Prepare a plan that

or Infectious Waste. 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.

Submit annual waste

management progress

reports.

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If you would like to know the emission limit applicable to small,

medium and large HMIWIs, please reference 326 IAC 11-6-4.

The Indiana 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 if you plan to continue

operation of your HMIWI?

Under the Indiana HMIWI rule, a subject HMIWI must be in compliance

with the rule requirements by March 11, 2000, unless the source meets

the requirements for an extended compliance schedule. HMIWIs who plan

to install air pollution control equipment and who comply with the

requirements to obtain an extended schedule must comply by March 31,

2002.

However, even if a source has an extended schedule, the Indiana

rule requires compliance with the rule's operator training and

certification provisions by March 11, 2000.

What must you do to obtain an extended compliance schedule if you plan

to install control equipment or make process changes and continue

operation?

HMIWIs seeking an extended compliance schedule must have submitted

a control plan on or before June 30, 1999, which contained a plan for

the HMIWI to meet the rule's increments of progress. Indiana's rule

requires compliance with the following measurable and enforceable

increments of progress:

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Increments of progress Due date

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Submit a final control plan to the Indiana June 30, 1999.

Department of Environmental Management.

Award contracts for emission control March 31, 2000.

systems or for process modifications, or

issuance of orders for the purchase of

component parts to accomplish emission

control or process modifications.

Initiate on-site construction or March 31, 2001.

installation of emission control

equipment or process change.

Complete on-site construction or September 30, 2001.

installation of emission control

equipment or process change.

Be in final compliance.................... March 31, 2002.

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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 shut down by March 11, 2000, unless the source is installing

alternative control technology and the State approves its petition for

an extension. If a source petitions the State for an extension, the

source must submit its petition by November 11, 1999. The petition must

include an analysis that:

(1) Demonstrates that additional time is needed,

(2) considers the option of transporting the waste off-site, and

(3) includes a detailed compliance plan with measurable and

enforceable increments of progress that assure final compliance by

March 31, 2002.

What are the permit application deadlines?

The Indiana HMIWI rule requires all HMIWIs subject to the rule's

emission limits to submit a part 70 permit application by March 11,

2000. Each source's application needs to address the provisions of 326

IAC 11-6. This means that all HMIWI that have not previously applied

for a part 70 permit must submit their application by March 11, 2000.

For those HMIWI whose original application did not address the

provisions of 326 IAC 11-6, they must now update their application by

March 11, 2000, to include Indiana's rule 326 IAC 11-6.

What else does the State Plan include?

The State Plan includes: a demonstration of legal authority to

implement the EG, documentation of public hearing, comments and

responses, a source and emissions inventory, and a provision for State

progress reports to EPA. These materials were submitted to satisfy the

section

[[Page 70598]]

111(d) requirements under 40 CFR part 60, subpart B.

What public review opportunities were provided?

The Indiana Department of Environmental Management held public

hearings on the HMIWI rule on May 6, 1998, and September 2, 1998. IDEM

did not receive any comments on the rule. IDEM published public notices

on June 30, 1999, in newspapers throughout the state opening a comment

period on the State Plan and providing the opportunity for a public

hearing. IDEM did not receive a request for a hearing nor any comments

on the plan materials.

IV. Review and Approval of the Indiana HMIWI State Plan.

Why is the Indiana HMIWI State Plan approvable?

We compared the Indiana HMIWI rule 326 IAC 11-6 to our HMIWI EG. We

find the Indiana rule to be at least as stringent as the EG. Also, the

Indiana 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 Indiana HMIWI State Plan.

V. EPA Rulemaking Action.

We are approving, through direct final rulemaking action, Indiana's

sections 111(d) and 129 State Plan for HMIWIs. The EPA is publishing

this action without prior proposal because EPA views this as a

noncontroversial action and anticipates no adverse comments. However,

in a separate document in this Federal Register publication, the EPA is

proposing to approve the state plan revision should adverse written

comments be filed. This action will be effective February 15, 2000

without further notice unless EPA receives relevant adverse written

comment by January 18, 2000. Should the Agency receive such comments,

it will publish a final rule 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 February 15, 2000.

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 13132

Federalism (64 FR 43255, August 10, 1999) revokes and replaces E.O.

12612 (Federalism) and E.O. 12875 (Enhancing the Intergovernmental

Partnership). E.O. 13132 requires EPA to develop an accountable process

to ensure ``meaningful and timely input by State and local officials in

the development of regulatory policies that have federalism

implications.'' ``Policies that have federalism implications'' is

defined in the E.O. to include regulations that 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.'' Under E.O.

13132, EPA may not issue a regulation that has federalism implications,

that imposes substantial direct compliance costs, and that is not

required by statute, unless the Federal government provides the funds

necessary to pay the direct compliance costs incurred by State and

local governments, or EPA consults with State and local officials early

in the process of developing the proposed regulation. EPA also may not

issue a regulation that has federalism implications and that preempts

State law unless the Agency consults with State and local officials

early in the process of developing the proposed regulation.

This final 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 E.O. 13132. Thus, the

requirements of section 6 of the E.O. do not apply to this rule.

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 approvals under section 111(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 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

[[Page 70599]]

inquiry into the economic reasonableness of state action. The Clean Air

Act forbids EPA to base its actions concerning state plans on such

grounds. Union Electric Co. v. 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. 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.

I. 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 February 15, 2000. Filing a

petition for reconsideration by the Administrator of this final rule

does not affect the finality of this rule for the purposes of judicial

review nor does it extend the time within which a petition for judicial

review may be filed, and shall not postpone the effectiveness of such

rule or action. This action may not be challenged later in proceedings

to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 62

Environmental protection, Administrative practice and procedure,

Air pollution control, Intergovernmental relations, Hospital/medical/

infectious waste incinerators, Reporting and recordkeeping

requirements.

Dated: November 30, 1999.

Francis X. Lyons,

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 P--Indiana

2. A new center heading and sections 62.3640, 62.3641, and 62.3642

are added to subpart P to read as follows:

Metals, Acid Gases, Organic Compounds and Nitrogen Oxide Emissions

From Existing Hospital/Medical Infectious Waste Incinerators

Sec. 62.3640 Identification of plan.

Indiana submitted, September 30, 1999, a State Plan for

implementing the Emission Guidelines affecting Hospital/Medical

Infectious Waste Incinerators (HMIWI). The enforceable mechanism for

this plan is 326 Indiana Administrative Code 11-6. The rule was adopted

by the Indiana Pollution Control Board on September 2, 1998. The rule

was published in the Indiana Register on March 1, 1999, and became

effective on March 11, 1999.

Sec. 62.3641 Identification of sources.

The Indiana 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. 62.3642 Effective Date.

The Federal effective date of the Indiana State Plan for existing

Hospital/Medical/Infectious Waste Incinerators is February 15, 2000.

[FR Doc. 99-32176 Filed 12-16-99; 8:45 am]

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