[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Rules and Regulations]
[Pages 43091-43094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20305]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[Region 2 Docket No. NY 32-194a, FRL-6414-1]


Approval and Promulgation of State Plans for Designated 
Facilities; New York

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the 
State Plan submitted by New York to implement and enforce the Emission 
Guidelines (EG) for existing Hospital/Medical/Infectious Waste 
Incinerators (HMIWI). The EG require states to develop plans to reduce 
toxic air emissions from all HMIWIs.

DATES: This direct final rule is effective on October 8, 1999 without 
further notice, unless EPA receives adverse comment by September 8, 
1999. 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: All comments should be addressed to: Raymond Werner, Acting 
Chief, Air Programs Branch, Environmental Protection Agency, Region 2 
Office, 290 Broadway, 25th Floor, New York, New York 10007-1866.
    Copies of the state submittal are available at the following 
addresses for inspection during normal business hours:

Environmental Protection Agency, Region 2 Office, Air Programs Branch, 
290 Broadway, 25th Floor, New York, New York 10007-1866.
New York State Department of Environmental Conservation, Division of 
Air Resources, 50 Wolf Road, Albany, New York 12233.

FOR FURTHER INFORMATION CONTACT: Ted Gardella or Craig Flamm, Air 
Programs Branch, Environmental Protection Agency, Region 2 Office, 290 
Broadway, 25th Floor, New York, New York 10007-1866, (212) 637-3892 or 
(212) 637-4021, respectively.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What action is EPA taking today?
II. Why is EPA approving New York's State Plan?
III. Why does EPA want to regulate air emissions from HMIWIs?
IV. What are EPA's requirements for HMIWIs?
V. Are any sources exempt from the federal requirements?
VI. What is a State Plan?
VII. What does New York's State Plan contain?
VIII. What sources are affected by New York's State Plan?
IX. What steps do affected sources need to take?
X. What are EPA's conclusions?
XI. Administrative Requirements

I. What Action Is EPA Taking Today?

    EPA is approving New York's State Plan submitted on September 9, 
1998, and supplemented on March 11, May 12, and May 15, 1999, for the 
control of air emissions from HMIWIs throughout the State, except for 
those HMIWIs located on Indian Nation land. When EPA developed the New 
Source Performance Standards (NSPS) for HMIWIs, we simultaneously 
developed the Emission Guidelines (EG) to control air emissions from 
older HMIWIs (see 62 FR 48348-48391, September 15, 1997). New York 
State developed a State Plan, as required by section 111(d) of the 
Clean Air Act (the Act), to adopt the EG into their body of 
regulations, and we are acting today to approve New York's State Plan.
    Under section 129 of the Act, the EG are not federally enforceable. 
Section 129(b)(2) of the Act requires states to submit to EPA for 
approval State Plans that implement and enforce the EG. State Plans 
must be at least as protective as the EG, and they become federally 
enforceable upon approval by EPA. The procedures for adopting and 
submitting State Plans are located in 40 CFR part 60, subpart B.
    EPA originally issued the subpart B provisions on November 17, 
1975. EPA amended subpart B on December 19, 1995, to allow the subparts 
developed under section 129 to include specifications that supersede 
the general provisions in subpart B regarding the schedule for 
submittal of State Plans, the stringency of the emission limitations, 
and the compliance schedules, see 60 FR 65414 (December 19, 1995). This 
action approves the State Plan submitted by New York to implement and 
enforce the EG, as it applies to older HMIWI units.

II. Why Is EPA Approving New York's State Plan?

    EPA has evaluated the HMIWI State Plan submitted by New York for 
consistency with the Act, EPA guidelines and policy. EPA has determined 
that New York's State Plan meets all requirements and, therefore, EPA 
is approving New York's Plan to implement and enforce the EG, as it 
applies to older HMIWIs.

III. Why Does EPA Want To Regulate Air Emissions From HMIWIs?

    When burned, hospital waste and medical/infectious waste emit 
various air pollutants, including hydrochloric acid, dioxin/furan, 
toxic metals (lead, cadmium, and mercury) and particulate matter. 
Mercury is highly hazardous and is of particular concern because it 
persists in the environment and bioaccumulates through the food web. 
Serious developmental and adult effects in humans, primarily damage to 
the nervous system, have been associated with exposures to mercury. 
Harmful effects in wildlife have also been reported; these include 
nervous system damage and behavioral and reproductive deficits. Human 
and wildlife exposure to mercury occur mainly through eating of fish. 
When inhaled, mercury vapor attacks also the lung tissue and is a 
cumulative poison. Short-term exposure to mercury in certain forms can 
cause hallucinations and impair consciousness. Long-term exposure to 
mercury in certain forms can affect the central nervous system and 
cause kidney damage.
    Exposure to particulate matter can aggravate existing respiratory 
and cardiovascular disease and increase risk of premature death. 
Hydrochloric acid is a clear colorless gas. Chronic exposure to 
hydrochloric acid has been reported to cause gastritis, chronic 
bronchitis, dermatitis, and photosensitization. Acute exposure to high 
levels of chlorine in humans may result in chest pain, vomiting, toxic 
pneumonitis, pulmonary edema, and death. At lower levels, chlorine is a 
potent irritant to the eyes, the upper respiratory tract, and lungs.
    Exposure to dioxin and furan can cause skin disorders, cancer, and 
reproductive effects such as endometriosis. These pollutants can also 
affect the immune system.

IV. What Are EPA's Requirements for HMIWIs?

    On September 15, 1997, under sections 111 and 129 of the Act, EPA 
issued the NSPS applicable to new HMIWIs and the EG applicable to older 
HMIWIs. The NSPS and EG are codified at 40 CFR part 60, subparts Ec and 
Ce, respectively, see 62 FR 48348 (September 15, 1997).
    Under the EG, EPA requires that affected older HMIWIs do the 
following:
    (1) Control emissions for the following designated pollutants:

[[Page 43092]]

particulate matter, sulfur dioxide, hydrogen chloride, oxides of 
nitrogen, carbon monoxide, lead, cadmium, mercury, and dioxins and 
dibenzofurans.
    (2) Control stack opacity.
    (3) Include operator training/qualification, waste management 
plans, and testing/monitoring of pollutants and operating parameters.
    (4) Inspect small incinerator equipment located in rural areas.
    The Federal NSPS and EG define an HMIWI as any device that combusts 
any amount of medical/infectious waste or hospital waste. The terms 
medical infectious waste or hospital waste are defined in 40 CFR 
60.51c.
    The HMIWI source category is divided into three subcategories based 
on waste burning capacity: small (less than or equal to 200 pounds per 
hour (lb/hr)), medium (more than 200 lb/hr up to 500 lb/hr), and large 
(more than 500 lb/hr).

V. Are Any Sources Exempt From the Federal Requirements?

    The following incinerator source categories are exempt from the 
federal requirements for HMIWIs:
    (1) Incinerators that burn only pathological, low-level radiation, 
and/or chemotherapeutic waste (all defined in section 60.51c). However, 
the owner or operator must notify the EPA Administrator of an exemption 
claim and the owner or operator must keep records of the periods of 
time when only pathological, low-level radioactive, and/or 
chemotherapeutic waste is burned.
    (2) Any unit required to have a permit under section 3005 of the 
Solid Waste Disposal Act.
    (3) Incinerators that are subject to the NSPS and EG for Municipal 
Waste Combustors.
    (4) Existing incinerators, processing operations, or boilers that 
co-fire medical/infectious waste or hospital waste with other fuels or 
wastes and that combust less than ten percent or less medical/
infectious waste and hospital waste by weight (on a calendar quarter 
basis). However, the owner or operator must notify the EPA 
Administrator of an exemption claim and the owner or operator must keep 
records of the amount of each fuel and waste fired.

VI. What Is a State Plan?

    Section 111(d) of the Act requires that pollutants controlled under 
NSPS must also be controlled at older sources in the same source 
category. Once an NSPS is issued, EPA then publishes an EG applicable 
to the control of the same pollutant from existing (designated) 
facilities. States with designated facilities must then develop a State 
Plan to adopt the EG into their body of regulations. States must also 
include in their State Plan other elements, such as inventories, legal 
authority, and public participation documentation, to demonstrate their 
ability to enforce the State Plans.

VII. What Does New York's State Plan Contain?

    On September 9, 1998, the New York State Department of 
Environmental Conservation (NYSDEC) submitted its section 111(d) State 
Plan for implementing EPA's EG for older HMIWI units located in New 
York State. This submittal was supplemented by the NYSDEC on March 11, 
May 12, and May 15, 1999.
    New York has adopted by reference the requirements of the EG in 
Part 200 of title 6 of the New York Code of Rules and Regulations 
(6NYCRR) of the State of New York, entitled, ``General Provisions'' and 
in Subpart 219-1 of 6NYCRR entitled ``Incineration-General 
Provisions.'' These adoptions were effective on October 1, 1998. New 
York will enforce the requirements under Part 201, entitled, ``Permits 
and Registration'' which was also effective on October 1, 1998. By 
incorporating the EG by reference into Part 200, NYSDEC has the 
authority to include them as applicable requirements in the permits for 
the designated facilities and to enforce such requirements. For 
consistency, Subpart 219-1, which addresses the applicability of the 
various Part 219 Subpart requirements (New York's incineration rules) 
now includes the new requirements and necessary definition changes.
    New York's State Plan contains the following:
    (1) A demonstration of the State's legal authority to implement the 
section 111(d) State Plan;
    (2) State rules adopted into 6NYCRR as the mechanism for 
implementing and enforcing the State Plan;
    (3) An inventory of fifteen known HMIWI facilities, including 
eighteen incinerator units, along with measurements of their toxic air 
emissions;
    (4) Emission limits that are as protective as the EG;
    (5) Enforceable compliance schedules incorporated into each 
facility's existing State operating permit. Compliance dates vary from 
one year from the effective date of EPA approval of New York's State 
Plan to not later than September 15, 2002;
    (6) Testing, monitoring, reporting and recordkeeping requirements 
for the designated facilities;
    (7) Records for the public hearing; and
    (8) Provisions for progress reports to EPA.
    New York's State Plan was reviewed for approval with respect to the 
following criteria: 40 CFR 60.23 through 60.26, ``Subpart B--Adoption 
and Submittal of State Plans for Designated Facilities''; and, 40 CFR 
60.30e through 60.39e, ``Subpart Ce--Emission Guidelines and Compliance 
Times for Hospital/Medical/Infectious Waste Incinerators.''

VIII. What Sources Are Affected by New York's State Plan?

    New York's State Plan regulates all the sources covered by EPA's EG 
for older HMIWIs for which construction commenced on or before June 20, 
1996. If your facility meets this criterion, you are subject to these 
regulations.

IX. What Steps Do Affected Sources Need To Take?

    Affected sources must meet the requirements listed in the EG, 
summarized as follows:
    (1) Determine the size of your incinerator by establishing its 
maximum design capacity.
    (2) Determine the specific emission limits that apply to you. Each 
size category of HMIWI has certain emission limits established that 
your incinerator must meet (see Table 1 of 40 CFR part 60, subpart Ce). 
The emission limits apply at all times, except during startup, 
shutdown, or malfunctions, provided that no waste has been charged 
during these events. (40 CFR 60.33e, as listed at 62 FR 48382, 
September 15, 1997).
    (3) Meet the provisions required of small rural incinerators, if 
applicable. (See 40 CFR 60.33e(b), 60.36e, 60.37e(c)(d), and 60.38e(b), 
as listed at 62 FR 48380, September 15, 1997).
    (4) Meet a 10% opacity limit on your discharge, averaged over a 
six-minute block (see 40 CFR 60.33e(c), as listed at 62 FR 48380, 
September 15, 1997).
    (5) Provide for a qualified HMIWI operator available to supervise 
the operation of your incinerator. This operator must be trained and 
qualified through a State-approved program, or a training program that 
meets the requirements listed under 40 CFR part 60.53c(c) (see 40 CFR 
60.34e, as listed at 62 FR 48380).
    (6) Provide for operator certification, as discussed in (5) above, 
no later than one year after we approve New York's State Plan (see 40 
CFR 60.39e(e), as listed at 62 FR 48382).

[[Page 43093]]

    (7) Develop and submit to NYSDEC a waste management plan. This plan 
must be developed under guidance provided by the American Hospital 
Association publication, An Ounce of Prevention: Waste Reduction 
Strategies for Health Care Facilities, 1993, and must be submitted to 
NYSDEC no later than sixty days following the initial performance test 
(see 40 CFR 60.35e, as listed at 62 FR 48380; and 40 CFR 60.38e, as 
listed at 62 FR 48381).
    (8) Conduct an initial performance test to determine your 
incinerator's compliance with these emission limits. This performance 
test must be completed by the date specified at 40 CFR 60.37e and 60.8, 
as listed at 62 FR 48380.
    (9) Install and maintain devices to monitor the parameters listed 
under Table 3 to Subpart Ec (see 40 CFR 60.37e(c), as listed at 62 FR 
48381).
    (10) Document and maintain information concerning pollutant 
concentrations, opacity measurements, charge rates, and other 
operational data. This information must be maintained for a period of 
five years (see 40 CFR 60.38e, as listed at 62 FR 48381).
    (11) Report to NYSDEC the results of your initial performance test, 
the values for your site-specific operating parameters, and your waste 
management plan. This information must be reported within 60 days 
following your initial performance test, and must be signed by the 
facilities manager (see 40 CFR 60.38e, as listed at 62 FR 48381).
    (12) Comply with all the requirements of this State Plan within one 
year after we approve it; however, there are provisions to extend your 
compliance date (see 40 CFR 60.39e, as listed at 62 FR 48381). Those 
sources who have modified their state operating permits to include a 
compliance schedule to come into compliance with the State Plan within 
a year or more of our approval, must do so by the dates specified in 
their individual compliance schedules.

X. What Are EPA's Conclusions?

    EPA has determined that New York's State Plan meets all 
requirements and, therefore, EPA is approving New York's Plan to 
implement and enforce the EG, as it applies to older HMIWIs.
    EPA is publishing this rule without prior proposal because the 
Agency views this as a noncontroversial submittal and anticipates no 
relevant 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 State Plan 
should relevant adverse comments be filed. This rule will be effective 
October 8, 1999 without further notice unless the Agency receives 
relevant adverse comments by September 8, 1999.
    If the EPA receives such comments, then EPA will publish a timely 
withdrawal in the Federal Register 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. Any 
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 8, 1999 and no further action will be 
taken on the proposed rule.

XI. Administrative Requirements

Executive Order 12866

    The Office of Management and Budget has exempted this regulatory 
action from review under Executive Order (E.O.) 12866 entitled 
``Regulatory Planning and Review.''

Executive Order 12875

    Under Executive Order 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 any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 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 implements requirements specifically set forth by the 
Congress in sections 111 and 129 of the Clean Air Act, as amended in 
1990, without the exercise of any discretion by EPA. Accordingly, the 
requirements of section 1(a) of Executive Order 12875 do not apply to 
this rule.

Executive Order 13045

    E.O. 13045, entitled ``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 is not an 
economically significant action under Executive Order 12866 and does 
not involve decisions intended to mitigate environmental health or 
safety risks.

Executive Order 13084

    Under Executive Order 13084, EPA may not issue a regulation that is 
not required by statute, that significantly 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, Executive Order 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 implements requirements specifically set forth by the 
Congress in sections 111 and 129 of the Clean Air Act, as amended in 
1990, without the exercise of any discretion by EPA. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

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

[[Page 43094]]

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 State Plan approvals under section 111 
of the Act do not create any new requirements but simply approve 
requirements that the State is already imposing. Therefore, because the 
Federal State Plan approval does not create any new requirements, EPA 
certifies 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 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).

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.

Submission to Congress and the General Accounting Office

    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. Sec. 804(2).

Petitions for Judicial Review

    Under section 307(b)(1) of the Act, petitions for judicial review 
of this action must be filed in the United States Court of Appeals for 
the appropriate circuit by October 8, 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, Air pollution control, Intergovernmental 
relations, Hospital/Medical/Infectious Waste Incinerators, Reporting 
and recordkeeping requirements.

    Dated: July 23, 1999.
William J. Muszynski,
Acting Regional Administrator, Region 2.

    Part 62, chapter I, title 40 of the Code of Federal Regulations 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 et seq.

Subpart HH--New York

    2. Part 62 is amended by adding Sec. 62.8105 and an undesignated 
heading to subpart HH to read as follows:

Metals, Acid Gases, Organic Compounds, Particulates and Nitrogen 
Oxide Emissions From Existing Hospital/Medical/Infectious Waste 
Incinerators


Sec. 62.8105  Identification of plan.

    (a) The New York State Department of Environmental Conservation 
submitted to the Environmental Protection Agency a ``State Plan for 
implementation and enforcement of 40 CFR part 60, subpart CE, Emissions 
Guidelines for Hospitals/Medical/Infectious Waste Incinerators'' on 
September 9, 1998 and supplemented on March 11, May 12, and May 15, 
1999.
    (b) Identification of sources: The plan applies to all existing 
HMIWI facilities for which construction was commenced on or before June 
20, 1996, as described in 40 CFR Part 60, Subpart Ce.
    (c) The effective date for the portion of the plan applicable to 
existing Hospital/Medical/Infectious Waste Incinerators is October 8, 
1999.

[FR Doc. 99-20305 Filed 8-6-99; 8:45 am]
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