[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 6560-50-P