[Federal Register Volume 66, Number 82 (Friday, April 27, 2001)]
[Rules and Regulations]
[Pages 21092-21096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10425]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 62
[Docket # RI040-7167a; FRL-6971-1]
Approval and Promulgation of State Plans for Designated
Facilities and Pollutants: Rhode Island; Plan for Controlling Emissions
From Existing Hospital/Medical/Infectious Waste Incinerators
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: The Environmental Protection Agency (EPA) approves the
Sections 111(d)/129 State Plan submitted by the Rhode Island Department
of Environmental Management (RIDEM) on August 23, 2000. This State Plan
is for implementing and enforcing provisions at least as protective as
the Emissions Guidelines (EGs) applicable to existing Hospital/Medical/
Infectious Waste Incinerators (HMIWIs) for which construction commenced
on or before June 20, 1996.
DATES: This direct final rule is effective on June 26, 2001 without
further notice unless EPA receives significant adverse comment by May
29, 2001. If adverse comment is received EPA will publish a timely
withdrawal in the Federal Register informing the public that this rule
will not take effect.
ADDRESSES: You should address your written comments to: Mr. Steven
Rapp, Manager, Air Permits Unit, Office of Ecosystem Protection, U.S.
EPA-New England, Region 1, One Congress Street,
[[Page 21093]]
Suite 1100 (CAP), Boston, Massachusetts 02114-2023.
Documents which EPA has incorporated by reference for previous
rulemaking are available for public inspection at the Air and Radiation
Docket and Information Center, Environmental Protection Agency, 401 M
Street, SW., Washington, DC 20460. You may examine copies of materials
the RIDEM submitted to EPA relative to this action during normal
business hours at the following locations: Environmental Protection
Agency-New England, Region 1, Air Permits Unit, Office of Ecosystem
Protection, Suite 1100, One Congress Street, Boston, Massachusetts
02114-2023, and Rhode Island Department of Environmental Management,
Office of Air Resources, 235 Promenade Street, Providence, Rhode Island
02908-5767, (401) 222-2808.
The interested persons wanting to examine these documents should
make an appointment with the appropriate office at least 24 hours
before the day of the visit.
FOR FURTHER INFORMATION CONTACT: John Courcier at (617) 918-1659.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. What action is EPA taking today?
II. Why Does EPA Want To Regulate Air Emissions From HMIWIs?
III. When did EPA first publish these requirements?
IV. Who must comply with the requirements?
V. Are any sources exempt from the requirements?
VI. By what date must HMIWIs in Rhode Island achieve compliance?
VII. What happens if an HMIWI does not/cannot meet the requirements
by the final compliance date?
VIII. What options are available to operators if they cannot achieve
compliance within one year of the effective date of the State Plan?
IX. What Is a State Plan?
X. What did the state submit as part of its State Plan?
XI. Why Is EPA Approving Rhode Island's State Plan?
XII. Why does EPA need to approve State Plans?
XIII. Administrative Requirements
I. What Action Is EPA Taking Today?
EPA is approving Rhode Island's State Plan submitted on September
20, 2000 for the control of air emissions from HMIWIs throughout the
State. When EPA developed the New Source Performance Standards (NSPS)
for HMIWIs, the Agency simultaneously developed the Emission Guidelines
(EGs) to control air emissions from existing HMIWIs (see 62 FR 48348-
48391, September 15, 1997). Rhode Island developed a State Plan, as
required by sections 111(d) and 129 of the Clean Air Act (the Act), to
adopt the EGs into its body of regulations, and EPA is acting today to
approve Rhode Island's State Plan for regulating existing HMIWI units.
EPA is publishing this approval action without prior proposal
because the Agency views this as a noncontroversial action and
anticipates no 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. If EPA receives no
significant, material, and adverse comments by May 29, 2001, this
action will be effective June 26, 2001.
If EPA receives significant, material, and adverse comments by the
above date, the Agency will withdraw this action before the effective
date by publishing a subsequent document in the Federal Register that
will withdraw this final action. EPA will address all public comments
received in a subsequent final rule based on the parallel proposed rule
published in today's Federal Register. EPA will not institute a second
comment period on this action. Any parties interested in commenting on
this action should do so at this time.
II. 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.
III. When Did EPA First Publish These Requirements?
The EPA proposed the EGs in the Federal Register on June 20, 1996.
On September 15, 1997, according to sections 111 and 129 of the Clean
Air Act (Act), the EPA published the final form of the EGs applicable
to existing HMIWIs. The EGs are at 40 CFR part 60, subpart Ce. See 62
FR 48348.
IV. Who Must Comply With the Requirements?
All HMIWIs that commenced construction on or before June 20, 1996
(``existing HMIWIs'') must comply with these requirements.
V. Are Any Sources Exempt From the Requirements?
The following incinerator source categories are exempt from the
federal requirements for existing 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/or EGs 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
[[Page 21094]]
records of the amount of each fuel and waste fired.
VI. By What Date Must HMIWIs in Rhode Island Achieve Compliance?
All existing HMIWIs in the state of Rhode Island must comply with
these requirements by October 20, 2000, unless RIDEM grants an
extension. However, final compliance must be achieved no later than
September 16, 2002.
VII. What Happens if an HMIWI Does Not/Cannot Meet the Requirements
by the Final Compliance Date?
Any existing HMIWI that fails to meet the requirements by September
16, 2002 must shut down. The unit will not be allowed to start up until
the owner/operator installs the controls necessary to meet the
requirements.
VIII. What Options Are Available to Operators if They Cannot
Achieve Compliance by October 20, 2000?
If an existing HMIWI cannot achieve compliance by October 20, 2000,
the operator must agree to meet certain increments of progress until
they achieve compliance. The State Plan details the increments of
progress for the affected HMIWIs.
IX. What Is a State Plan?
Section 111(d) of the Act requires that pollutants controlled under
NSPS must also be controlled at existing 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 State
Plans to adopt the EGs into their body of regulations. States must also
include in their State Plans other elements, such as inventories, legal
authority, and public participation documentation, to demonstrate their
ability to enforce the State Plans.
X. What Did the State Submit as Part of Its State Plan?
The State of Rhode Island submitted its Sections 111(d)/129 State
Plan to EPA for approval on August 23, 2000 and supplemented it on
September 28, 2000. The State adopted the EG requirements into the
Rhode Island Air Pollution Control Regulation No. 39, ``Hospital/
Medical/Infectious Waste Incinerators'' on August 1, 2000. The State
Plan contains:
(1) A demonstration of the State's legal authority to implement the
State Plan.
(2) Rhode Island Air Pollution Control Regulation No. 39 as the
enforceable mechanism.
(3) An inventory of the sources on page 7 of the State Plan.
(4) An emissions inventory on pages 7 through 9 of the State Plan.
(5) Emission limits, at least as protective as the EGs, that are
contained in APC Reg No. 39.5.
(6) Provisions for compliance schedules that are contained in APC
Reg. No. 39.3.
(7) Testing, monitoring, and inspection requirements that are
contained in APC Reg. Nos. 39.6, 39.7, 39.8 and 39.11.
(8) Reporting and Recordkeeping requirements that are contained in
APC Reg. No. 39.9.
(9) Operator training and qualification requirements that are
contained in APC Reg. No. 39.10.
(10) Requirements for the development of a Waste Management Plan
that are contained in APC Reg. No. 39.3.2.
(11) A record of the public notice and hearing requirements.
(12) Provisions for state progress reports to EPA that are
contained on page 2 of the State Plan.
(13) Title V permit application due date requirements that are
contained in APC Reg. No. 39.3.1.
(14) A final compliance date of September 15, 2002.
XI. Why Is EPA Approving Rhode Island's State Plan?
EPA has evaluated the HMIWI State Plan submitted by Rhode Island
for consistency with the Act, EPA guidelines and policy. EPA has
determined that Rhode Island's State Plan meets all requirements and,
therefore, EPA is approving Rhode Island's Plan to implement and
enforce the EGs, as it applies to existing HMIWIs. EPA is not approving
those portions of Air Pollution Control Regulation No. 39 that apply to
HMIWIs constructed after June 20, 1996.
EPA's approval of Rhode Island's State Plan is based on our
findings that:
(1) RIDEM provided adequate public notice of public hearings for
the proposed rule-making that allows Rhode Island to carry out and
enforce provisions that are at least as protective as the EGs for
HMIWIs, and
(2) RIDEM demonstrated legal authority to adopt emission standards
and compliance schedules applicable to the designated facilities;
enforce applicable laws, regulations, standards and compliance
schedules; seek injunctive relief; obtain information necessary to
determine compliance; require record keeping; conduct inspections and
tests; require the use of monitors; require emission reports of owners
and operators; and make emission data publicly available.
A detailed discussion of EPA's evaluation of the State Plan is
included in the technical support document (TSD) located in the
official file for this action and available from the EPA contact listed
above. The State Plan meets all of the applicable approval criteria.
XII. Why Does EPA Need To Approve State Plans?
Under section 129 of the Act, EGs are not federally enforceable.
Section 129(b)(2) of the Act requires states to submit State Plans to
EPA for approval. Each state must show that its State Plan will carry
out and enforce the EGs. State Plans must be at least as protective as
the EGs, and they become federally enforceable upon EPA's approval. The
procedures for adopting and submitting State Plans are 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.
XIII. Administrative Requirements
A. Executive Order 12866
The Office of Management and Budget (OMB) has exempted this
regulatory action from Executive Order 12866, entitled ``Regulatory
Planning and Review.''
B. Executive Order 13132
Federalism (64 FR 43255, August 10, 1999) revokes and replaces
Executive Orders 12612 (Federalism) and 12875 (Enhancing the
Intergovernmental Partnership). Executive Order 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 Executive Order 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
[[Page 21095]]
Executive Order 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 Executive Order 13132,
because it merely approves an existing state rule implementing a
federal standard, and does not alter the relationship or the
distribution of power and responsibilities established in the Clean Air
Act. Thus, the requirements of section 6 of the Executive Order 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
Executive Order 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 Executive Order 13045 because it does
not involve decisions intended to mitigate environmental health or
safety risks that EPA has reason to believe may have a disproportionate
effect on children.
D. Executive Order 13084
Under Executive Order 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, 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 action does not create any new requirements on any entity
affected by this State Plan. Thus, the action will not significantly or
uniquely affect the communities of Indian tribal governments.
Accordingly, the requirements of section 3(b) of Executive Order 13084
do not apply to this rule.
E. Regulatory Flexibility Act
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000.
State Plan approvals under section 111(d) and section 129(b)(2) of
the Clean Air Act do not create any new requirements on any entity
affected by this rule, including small entities. They simply approve
requirements that the state is already imposing. Furthermore, in
developing the HMIWI emission guidelines and standards, EPA prepared a
written statement pursuant to the Regulatory Flexibility Act which it
published in the 1997 promulgation notice (see 62 FR 48348). In
accordance with EPA's determination in issuing the 1997 HMIWI emission
guidelines, this State Plan does not include any new requirements that
will have a significant economic impact on a substantial number of
small entities. Therefore, because the Federal 111(d) Plan approval
does not impose any new requirements and pursuant to section 605(b) of
the Regulatory Flexibility Act, the Regional Administrator certifies
that this rule will not have a significant impact on a substantial
number of small entities.
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
costs to State, local, or tribal governments in the aggregate, or to
the 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 on by the rule.
In developing the HMIWI emission guidelines and standards, EPA
prepared a written statement pursuant to section 202 of the Unfunded
Mandates Act which it published in the 1997 promulgation notice (see 60
FR 48374 to 48378). The EPA has determined that this State Plan does
not include any new Federal mandates above those previously considered
during promulgation of the 1997 HMIWI guidelines. The State Plan does
include an emission limitation for mercury that will be more stringent
than the limit required by the EGs. However, that limit is not the
result of a Federal mandate. In approving the State Plan, EPA is
approving pre-existing requirements under State law and imposing no new
requirements. Accordingly, no additional costs to State, local, or
tribal governments, or to the private sector, result from EPA's
approval of State Plan provisions that may be more stringent than the
EG requirements, nor will EPA's approval of the State Plan
significantly or uniquely affect small governments. Thus, this action
is not subject to the requirements of sections 202, 203, 204, and 205
of the Unfunded Mandates Act.
G. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996, EPA submitted 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
General Accounting
[[Page 21096]]
Office prior to publication of the rule in today's 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(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
In approving or disapproving State Plans under section 129 of the
Clean Air Act, EPA does not have the authority to revise or rewrite the
State's rule, so the Agency does not have authority to require the use
of particular voluntary consensus standards. Accordingly, EPA has not
sought to identify or require the State to use voluntary consensus
standards. Furthermore, Rhode Island's Plan incorporates by reference
test methods and sampling procedures for existing HMIWI units already
established by the emissions guidelines for HMIWIs at 40 CFR Part 60,
Subpart Ce, and does not establish new technical standards for HMIWIs.
Therefore, the requirements of the NTTAA are not applicable to this
final rule.
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 June 26, 2001. 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), 42
U.S.C. 7607(b)(2). EPA encourages interested parties to comment in
response to the proposed rule rather than petition for judicial review,
unless the objection arises after the comment period allowed for in the
proposal.
List of Subjects in 40 CFR Part 62
Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.
Dated: April 12, 2001.
Ira W. Leighton,
Acting Regional Administrator, EPA New England.
40 CFR Part 62 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. 7401-7671q.
Subpart OO--Rhode Island
2. Subpart OO is amended by adding a new Sec. 62.9825 to read as
follows:
Sec. 62.9825 Identification of Plan.
(a) Identification of Plan. Rhode Island Plan for the Control of
Designated Pollutants from Existing Plants (Section 111(d) Plan).
(b) The plan was officially submitted as follows:
(1) Control of air emissions from existing hospital/medical/
infectious waste incinerators, submitted on August 2, 2000.
(2) [Reserved]
(c) Designated facilities. The plan applies to existing facilities
in the following categories of sources:
(1) Hospital/medical/infectious waste incinerators.
(2) [Reserved]
3. Subpart OO is amended by adding a new Sec. 62.9990 and a new
undesignated center heading to read as follows:
Air Emissions From Existing Hospital/Medical/Infectious Waste
Incinerators
Sec. 62.9990 Identification of sources.
(a) The plan applies to the following existing hospital/medical/
infectious waste incinerators that were still operating as of the date
of publication, and to any other unit for which construction commenced
on or before June 20, 1996:
(1) Eleanor Slater Hospital/Zambarano Unit, Pascoag.
(2) Our Lady of Fatima Hospital, North Providence.
(3) Rhode Island Hospital, Providence.
(4) Roger Williams Hospital, Providence.
(b) [Reserved].
[FR Doc. 01-10425 Filed 4-26-01; 8:45 am]
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