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###### Environmental Protection Agency

          - 40 CFR Part 62 
          - [Docket # RI040-7167a; FRL-6971-1] 

# 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,                               ( print 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                           ( print 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                           ( print 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                           ( print 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 § 62.9825 to read as follows: 

§ 62.9825 

                        (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 § 62.9990 and a new undesignated center heading to read as follows: 

## Air Emissions From Existing Hospital/Medical/Infectious Waste Incinerators

§ 62.9990 

(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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