[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:
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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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