[Federal Register Volume 64, Number 92 (Thursday, May 13, 1999)]
[Rules and Regulations]
[Pages 25831-25834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12001]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[FRL-6340-6]


Approval and Promulgation of State Plans for Designated 
Facilities and Pollutants; North Dakota; Control of Emissions From 
Existing Hazardous/Medical/Infectious Waste Incinerators

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: We are approving the section 111(d) Plan submitted by the 
North Dakota Department of Health on October 6, 1998, to implement and 
enforce the Emissions Guidelines (EG) for existing Hazardous/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 July 12, 1999, without 
further notice, unless we receive adverse comments by June 14, 1999. If 
we receive adverse comments, we 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: You should address comments on this action to Richard R. 
Long, EPA Region 8, Office of Air and Radiation (8P-AR), 999 18th 
Street, Suite 500, Denver, Colorado 80202. Copies of all materials 
considered in this rulemaking may be examined during normal business 
hours at the following locations: EPA Region 8 offices, 999 18th 
Street, Suite 500, Denver, Colorado 80202, and at the North Dakota 
Department of Health offices, 1200 Missouri Avenue, Bismarck, North 
Dakota 58504-5264.

FOR FURTHER INFORMATION CONTACT: Kathleen Paser at 303-312-6526.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What action is being taken by EPA today?
II. Why do we need to regulate HMIWI emissions?
III. What is a State Plan?
IV. What does the North Dakota State Plan contain?
V. Is my HMIWI subject to these regulations?
VI. What steps do I need to take?
VII. Administrative Requirements

I. What Action Is Being Taken by EPA Today?

    We are approving North Dakota's State Plan, as submitted on October 
6, 1998 for the control of air emissions from HMIWIs, except for those 
HMIWIs located in Indian Country. When we developed our New Source 
Performance Standard (NSPS) for HMIWIs, we also developed Emissions 
Guidelines (EG) to control air emissions from older HMIWIs. (See 62 FR 
48348-48391, September 15, 1997). North Dakota 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 it.
    We are publishing this action without prior proposal because we 
view this as a noncontroversial amendment and anticipate no adverse 
comments. However, in a separate document in this Federal Register 
publication, we are proposing to approve the revision should 
significant, material, and adverse comments be filed. This action is 
effective July 12, 1999, unless by June 14, 1999, adverse or critical 
comments are received. If we receive such comments, this action will be 
withdrawn before the effective date by publishing a subsequent document 
that will withdraw the final action. All public comments received will 
be addressed in a subsequent final rule based on this action serving as 
a proposed rule. We will not institute a second comment period on this 
action. Any parties interested in commenting on this action should do 
so at this time. If no such comments are received, this action is 
effective July 12, 1999.

II. Why Do We Need To Regulate HMIWI Emissions?

    When burned, hospital waste and medical/infectious waste emit 
various air pollutants, including hydrochloric acid, dioxin/furan, and 
toxic metals (lead, cadmium, and mercury). 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 the ingestion 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 has been linked with adverse health 
effects, including aggravation of existing respiratory and 
cardiovascular disease and increased 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.

[[Page 25832]]

    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. What Is a State Plan?

    Section 111(d) of the Act requires that pollutants, controlled 
under the NSPS must also be controlled at older sources in the same 
source category. Once an NSPS is promulgated, we then publish 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 this State Plan other elements, such as 
inventories, legal authority, and public participation documentation, 
to demonstrate the ability to and enforce.

IV. What Does the North Dakota State Plan Contain?

    North Dakota adopted the Federal NSPS and EG by reference into its 
State regulations at NDAC 33-15-12-02. The North Dakota State Plan 
contains:
    1. A demonstration of the State's legal authority to implement the 
section 111(d) State Plan;
    2. State rules adopted into NDAC 33-15-12 as the mechanism for 
implementing the emission guidelines. The North Dakota 23-25-10 gives 
the North Dakota Department of Health the authority to enforce any 
properly adopted rule.
    3. An inventory of approximately 76 known designated facilities, 
along with estimates of their toxic air emissions;
    4. Emission limits that are as protective as the EG;
    5. A compliance date of 3 years after environmental protection 
agency approval of the state plan but not later than September 16, 
2002.
    6. Testing, monitoring, reporting and recordkeeping requirements 
for the designated facilities;
    7. Records from the public hearing; and,
    8. Provisions for progress reports to EPA.
    The North Dakota 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. A 
detailed discussion of our evaluation of the North Dakota State Plan is 
included in our technical support document, located in the official 
file for this action.

V. Is My HMIWI Subject to These Regulations?

    The EG for existing HMIWIs affect any HMIWI built on or before June 
20, 1996. If your facility meets this criterion, you are subject to 
these regulations.

VI. What Steps Do I Need To Take?

    You must meet the requirements listed in NDAC 33-15-12-02 Subpart 
Ce, summarized as follows:
    1. Determine the size of your incinerator by establishing its 
maximum design capacity.
    2. Each size category of HMIWI has certain emission limits 
established which your incinerator must meet. See Table 1 of 40 CFR 
part 60, subpart Ce to determine the specific emission limits which 
apply to you. 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. There are provisions to address small rural incincerators 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. You must meet a 10% opacity limit on your discharge, averaged 
over a six-minute block (40 CFR 60.33e(c), as listed at 62 FR 48380, 
September 15, 1997).
    5. You must have 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) (40 CFR 
60.34e, as listed at 62 FR 48380).
    6. Your operator must be certified, as discussed in paragraph 5 
above, no later than one year after we approve this North Dakota State 
Plan (40 CFR 60.39e(e), as listed at 62 FR 48382).
    7. You must develop and submit to the North Dakota Department of 
Health 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 the Department of Health no 
later than one year after we approve this State Plan (40 CFR 60.35e, as 
listed at 62 FR 48380).
    8. You must conduct an initial performance test to determine your 
incinerator's compliance with these emission limits. This performance 
test must be completed within 36 months of North Dakota's State Plan 
approval (40 CFR 60.37e and 60.8, as listed at 62 FR 48380).
    9. You must install and maintain devices to monitor the parameters 
listed under Table 3 to Subpart Ec (40 CFR 60.37e(c), as listed at 62 
FR 48381).
    10. You must 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 (40 CFR 60.38e, as listed at 62 FR 48381).
    11. You must report to the North Dakota Health Department 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 (40 CFR 
60.38e, as listed at 62 FR 48381).
    12. In general, you must 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 (40 CFR 60.39e, as listed at 
62 FR 48381).

VII. Administrative Requirements

A. Executive Order 12866

    The Office of Management and Budget has exempted this regulatory 
action from review under Executive Order 12866, entitled Regulatory 
Planning and Review.

B. Executive Order 12875

Executive Order 12875: Enhancing the Intergovernmental Partnership
    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, or EPA consults with those governments. If EPA complies by 
consulting, Executive Order 12875 requires EPA to 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

[[Page 25833]]

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.

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 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.

D. Executive Order 13084

Executive Order 13084: Consultation and Coordination With Indian Tribal 
Governments
    Under E.O. 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, or EPA consults with those 
governments. If EPA complies by consulting, Executive Order 13084 
requires EPA to 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 officials 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.

E. 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 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. Pursuant to section 605(b) of the RFA, I certify that 
this rule will not have a significant economic impact on a substantial 
number of small entities. This Federal action approves pre-existing 
requirements under, State, law and imposes no new requirements on any 
entity affected by this rule, including small entities. Therefore, 
these amendments 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 
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 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.

G. Submission to Congress and the Comptroller General

    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 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. 804(2).

H. 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 July 12, 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, Administrative practice and procedure, 
Air pollution control, Intergovernmental relations, Reporting and 
recordkeeping requirements.

    Dated: April 30, 1999.
Patricia D. Hull,
Acting Administrator, Region VIII.
    40 CFR part 62 is amended as follows:

PART 62--[AMENDED]

    1. The authority citation for part 62 continues to read as follows:

    Authority: 42 U.S.C. 7401-7642.

Subpart JJ--North Dakota

    2. Add a new undesignated center heading and Secs. 62.8610, 
62.8611, and 62.8612 to subpart JJ to read as follows:

[[Page 25834]]

AIR EMISSIONS FROM HAZARDOUS/MEDICAL/INFECTIOUS WASTE INCINERATORS


Sec. 62.8610  Identification of Plan.

    Section 111(d) Plan for Hazardous/Medical/Infectious Waste 
Incinerators and the associated State regulation in section 33-15-12-02 
of the North Dakota Administrative Code submitted by the State on 
October 6, 1998.


Sec. 62.8611  Identification of Sources.

    The plan applies to all existing hazardous/medical/infectious waste 
incinerators for which construction was commenced on or before June 20, 
1996, as described in 40 CFR Part 60, Subpart Ce.


Sec. 62.8612  Effective Date.

    The effective date for the portion of the plan applicable to 
existing hazardous/medical/infectious waste incinerators is July 12, 
1999.
[FR Doc. 99-12001 Filed 5-12-99; 8:45 am]
BILLING CODE 6560-50-U