[Federal Register Volume 65, Number 158 (Tuesday, August 15, 2000)]
[Rules and Regulations]
[Pages 49868-49894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20341]
[[Page 49867]]
-----------------------------------------------------------------------
Part II
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 62
Federal Plan Requirements for Hospital/Medical/Infectious Waste
Incinerators Constructed On or Before June 20, 1996; Final Rule
Federal Register / Vol. 65, No. 158 / Tuesday, August 15, 2000 /
Rules and Regulations
[[Page 49868]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 62
[AD-FRL-6848-9]
RIN 2060-AI25
Federal Plan Requirements for Hospital/Medical/Infectious Waste
Incinerators Constructed On or Before June 20, 1996
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On September 15, 1997, EPA adopted emission guidelines for
existing hospital/medical/infectious waste incinerators (HMIWI).
Sections 111 and 129 of the Clean Air Act (CAA) require States with
existing HMIWI subject to the emission guidelines to submit plans to
EPA that implement and enforce the emission guidelines. Indian Tribes
may submit, but are not required to submit, Tribal plans to implement
and enforce the emission guidelines in Indian country. State plans were
due from States with HMIWI subject to the emission guidelines on
September 15, 1998. If a State or Tribe with existing HMIWI does not
submit an approvable plan within 2 years after promulgation of the
emission guidelines (September 15, 1999), sections 111(d) and 129 of
the CAA require EPA to develop, implement, and enforce a Federal plan
for HMIWI in that State/Tribal jurisdiction. The EPA proposed a Federal
plan for HMIWI in the Federal Register on July 6, 1999. This action
promulgates the Federal plan to implement emission guidelines for HMIWI
located in States and Indian country without effective State or Tribal
plans. This Federal plan is an interim action because on the effective
date of an approved State/Tribal plan, the Federal plan will no longer
apply to HMIWI covered by the State/Tribal plan.
EFFECTIVE DATE: The effective date of this final rule is September 14,
2000.
ADDRESSES: Docket. Dockets A-98-24 and A-91-61 contain the supporting
information for this promulgated rule and the supporting information
for EPA's promulgation of emission guidelines for existing HMIWI,
respectively. Public comments on the proposed rule for this action were
received in Docket A-98-24. The dockets are available for public
inspection and copying between 8 a.m. and 5:30 p.m., Monday through
Friday, at EPA's Air and Radiation Docket and Information Center (Mail
Code 6102), 401 M Street, SW., Washington, D.C. 20460, or by calling
(202) 260-7548. The docket is located in Room M-1500, Waterside Mall
(ground floor, central mall). The fax number for the Center is (202)
260-4000 and the E-mail address is [email protected]. A reasonable
fee may be charged for copying. In addition to the docket, an
electronic copy of this document can be found at the EPA Unified Air
Toxics Website (http://www.epa.gov/ttn/uatw/129/hmiwi/rihmiwi.html).
FOR FURTHER INFORMATION CONTACT: For procedural and implementation
information regarding this Federal plan, contact Ms. Valerie Broadwell
at (919) 541-3310, Program Implementation and Review Group, Information
Transfer and Program Integration Division (MD-12), U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina 27711
([email protected]). For technical information regarding State
plans, contact Mr. Rick Copland at (919) 541-5265, Combustion Group,
Emission Standards Division (MD-13), U.S. Environmental Protection
Agency, Research Triangle Park, North Carolina 27711
([email protected]). If you have State-specific questions regarding
the implementation of this Federal plan, contact your EPA Regional
Office. Regional Office contacts are provided in SUPPLEMENTARY
INFORMATION.
SUPPLEMENTARY INFORMATION: Regulated Entities. If you own or operate an
existing HMIWI and are not already subject to an EPA-approved and
effective State or Tribal plan, then you are regulated by this action.
Existing HMIWI are those that commenced construction on or before June
20, 1996. Regulated categories and entities include those listed in
Table 1.
Table 1.--Regulated Entities a
------------------------------------------------------------------------
Category Examples of regulated entities
------------------------------------------------------------------------
Industry......................... Hospitals, nursing homes, research
laboratories, other health care
facilities, commercial waste
disposal companies.
Federal Government............... Armed services, public health
service, Federal hospitals, other
Federal health care facilities.
State/local/Tribal Government.... State/county/city hospitals and other
health care facilities.
------------------------------------------------------------------------
\a\ This table is not intended to be exhaustive, but rather, provides a
guide for the public regarding entities likely to be regulated by this
Federal plan. This table lists the types of entities that EPA is aware
of that could potentially be regulated. Other types of entities not
listed in the table could also be affected. To determine whether your
facility is regulated by the standards or emission guidelines for
HMIWI, you should carefully examine the applicability criteria in
subpart HHH.
Judicial Review. This section 111(d)/129 rule for HMIWI was
proposed on July 6, 1999 (64 FR 36425). This notice promulgating a rule
for HMIWI constitutes final administrative action concerning that
proposal. Under section 307(b)(1) of the CAA, judicial review of this
final rule is available only by filing a petition for review in the
U.S. Court of Appeals for the District of Columbia Circuit by October
16, 2000. Under section 307(d)(7)(B) of the CAA, only an objection to
this rule that was raised with reasonable specificity during the period
for public comment can be raised during judicial review. Moreover,
under section 307(b)(2) of the CAA, the requirements established by
today's final action may not be challenged separately in any civil or
criminal proceeding brought by the EPA to enforce these requirements.
EPA Regional Office Contacts. Table 2 is a listing of EPA Regional
Office contacts who can answer questions regarding implementation of
this Federal plan.
Table 2.--EPA Regional Contacts for HMIWI
----------------------------------------------------------------------------------------------------------------
Region Regional contact Phone/Fax States and protectorates
----------------------------------------------------------------------------------------------------------------
I................... John Courcier................ 617-918-1659................. CT, ME, MA, NH, RI, VT.
[email protected]........ 617-918-1505 (fax) ............................
II.................. Christine DeRosa............. 212-637-4022................. NJ, NY, Puerto Rico, Virgin
Islands.
[email protected]..... 212-637-3901 (fax) ............................
Ted Gardella................. 212-637-3892 ............................
[email protected]..... 212-637-3901 (fax) ............................
III................. James B. Topsale............. 215-814-2190................. DE, DC, MD, PA, VA, WV.
[[Page 49869]]
[email protected].......... 215-814-2114 (fax) ............................
IV.................. Scott Davis.................. 404-562-9127................. AL, FL, GA, KY, MS, NC, SC,
TN.
[email protected]......... 404-562-9095 (fax) ............................
V................... Ryan Bahr.................... 312-353-4366................. IN.
[email protected]............ 312-886-5824 (fax) ............................
Charles Hatten............... 312-886-6031................. WI.
[email protected]....... 312-886-5824 (fax) ............................
Mark Palermo................. 312-886-6082................. IL, OH.
[email protected]......... 312-886-5824 (fax) ............................
Victoria Hayden.............. 312-886-4023................. WI.
[email protected]...... 312-886-5824 (fax) ............................
Doug Aburano................. 312-353-6960................. MN.
[email protected]...... 312-886-5824 (fax) ............................
VI.................. Mick Cote.................... 214-665-7219................. AR, LA, NM, OK, TX.
[email protected]............ 214-665-7263 (fax) ............................
VII................. Wayne Kaiser................. 913-551-7603................. IA, KS, MO, NE.
[email protected]......... 913-551-7844 (fax) ............................
Ward Burns................... 913-551-7960................. ............................
[email protected]........... 913-551-7844 (fax) ............................
VIII................ Meredith Bond................ 303-312-6438................. CO, MT, ND, SD, UT, WY.
[email protected]........ 303-312-6064 (fax) ............................
IX.................. Patricia Bowlin.............. 415-744-1188................. AZ, CA, HI, NV, American
Samoa, Guam.
[email protected]...... 415-744-1076 (fax) ............................
X................... Catherine Woo................ 206-553-1814................. AK, ID, OR, WA.
[email protected]........ 206-553-0110 (fax) ............................
----------------------------------------------------------------------------------------------------------------
Preamble Outline.
I. Background
A. HMIWI Regulations
B. Who This HMIWI Federal Plan Affects
C. Implementing Authority
D. HMIWI Federal Plan and Indian Country
E. Status of State Plan Submittals
II. Required Elements of the HMIWI Federal Plan
III. Considerations in Developing the Final Federal Plan
A. Compliance Schedule
B. Title V Permitting Requirements
C. Transfer of Authority
IV. Summary of Federal Plan Requirements
A. Applicability
B. Emission Limits
C. Additional Requirements
D. Compliance Dates
1. HMIWI That Continue Operation
2. HMIWI That Have or Will Shut Down
3. Summary of Compliance Dates
V. Implementation of the Federal Plan and Delegation
A. Background of Authority
B. Delegation of the Federal Plan and Retained Authorities
C. Mechanisms for Transferring Authority
1. State or Tribe Submits a Plan After HMIWI Located in the Area
Are Subject to the Federal Plan
2. State Takes Delegation of the Federal Plan
VI. Title V Operating Permits
VII. Administrative Requirements
A. Docket
B. Paperwork Reduction Act
C. Executive Order 12866
D. Executive Order 13132
E. Executive Order 13045
F. Executive Order 13084
G. Unfunded Mandates Act
H. Regulatory Flexibility Act and Small Business Regulatory
Enforcement Fairness Act
I. National Technology Transfer and Advancement Act
J. Submission to Congress and the General Accounting Office
I. Background
A. HMIWI Regulations
On September 15, 1997, EPA promulgated emission guidelines for
existing HMIWI under authority of sections 111 and 129 of the CAA. See
62 FR 48348 (to be codified at 40 CFR part 60, subpart Ce, Secs. 60.30e
through 60.39e). To make these emission guidelines enforceable, States
with existing HMIWI were required to submit to EPA, within 1 year
following promulgation of the emission guidelines, a State plan that
implements and enforces the emission guidelines. States without any
existing HMIWI were required to submit to the Administrator a letter of
negative declaration certifying that there are no HMIWI in the State.
No plan is required for States that do not have any HMIWI.
As discussed in section I.D of this preamble, Indian Tribes may,
but are not required to, submit Tribal plans to cover HMIWI in Indian
country. A Tribe may submit to the Administrator a letter of negative
declaration certifying that no HMIWI are located in the Tribal area. No
plan is required for Tribes that do not have any HMIWI.
Sections 111 and 129 of the CAA and 40 CFR 60.27(c) and (d) require
EPA to develop, implement, and enforce a Federal plan to cover existing
HMIWI located in States that do not have an approved plan. Hospital/
medical/infectious waste incinerators located in States or Tribal areas
that mistakenly submit a letter of negative declaration would be
subject to the Federal plan until a State or Tribal plan that includes
these HMIWI is approved and effective.
Today's action adopts a Federal plan for HMIWI that are not yet
covered by an approved State or Tribal plan. The elements of the
Federal plan are summarized in section II of this preamble. This HMIWI
Federal plan was proposed in the Federal Register on July 6, 1999 (64
FR 36425). Comment letters on the proposed Federal plan were received
through September 8, 1999. An opportunity for a public hearing was
offered, but no requests were received and a public hearing was not
held. Public comments and EPA responses are documented in ``Hospital/
medical/Infectious Waste Incinerators: Background Information for
Federal Plan--Summary of Public Comments and Responses,'' (EPA-456/R-
00-003), Docket A-98-24, Item III-B-1. The EPA's responses to the
public comments and changes to the regulation are also summarized in
section III of this preamble.
B. Who This HMIWI Federal Plan Affects
This HMIWI Federal plan will affect existing HMIWI for which
construction commenced on or before June 20, 1996.
[[Page 49870]]
The HMIWI will be subject to this Federal plan if any of the following
is true on the effective date of the Federal plan:
(1) The State or Tribal plan has not become effective; \1\
---------------------------------------------------------------------------
\1\ The effective date of a State or Tribal plan from EPA's
perspective (a State and Tribe may have an earlier effective date)
is 30 days after the State or Tribal plan approval is published in
the Federal Register if the approval is via the regular regulatory
procedure of proposal with opportunity for comment followed by
promulgation. If the approval is by direct final rule making, the
effective date of the State/Tribal plan is 60 days after the
approval is published in the Federal Register if no adverse comments
are received.
---------------------------------------------------------------------------
(2) The State or Tribal plan was in effect but was subsequently
vacated in whole or in part; or
(3) The State or Tribal plan was in effect but was subsequently
revised such that it is no longer as protective as the emission
guidelines.
The specific applicability of this plan is described in
Secs. 62.14400 through 62.14403 of subpart HHH.
Once an approved State or Tribal plan is in effect, the Federal
plan will no longer apply to HMIWI covered by such plan. An approved
State or Tribal plan is a plan that EPA has reviewed and approved based
on the requirements in 40 CFR part 60, subpart B to implement and
enforce 40 CFR part 60, subpart Ce. The State plan is effective on the
date specified in the notice published in the Federal Register
announcing EPA's approval.
Today's adoption of this HMIWI Federal plan does not preclude a
State or Tribe from submitting a plan later. If a State or Tribe
submits a plan after today's publication of the HMIWI Federal plan, EPA
will review and approve or disapprove the State/Tribal plan. If EPA
approves the plan, then the Federal plan no longer applies as of the
effective date of the State/Tribal plan. (See the discussion in ``State
or Tribe Submits A Plan After HMIWI Located in the Area Are Subject to
the Federal Plan'' in section V.C.1 of this preamble.) If an HMIWI was
overlooked by a State or Tribe and the State/Tribe submitted a negative
declaration letter, the HMIWI would be subject to this Federal plan.
C. Implementing Authority
The EPA Regional Administrators have been delegated the authority
for implementing the HMIWI Federal plan. All reports required by this
Federal plan should be submitted to the appropriate Regional Office
Administrator. Table 2 under SUPPLEMENTARY INFORMATION lists the names
and addresses of the EPA Regional Office contacts and the States that
they cover.
D. HMIWI Federal Plan and Indian Country
The term ``Indian country,'' as used in this preamble, means (1)
all land within the limits of any Indian reservation under the
jurisdiction of the United States government, notwithstanding the
issuance of any patent, and including rights-of-way running through the
reservation; (2) all dependent Indian communities within the borders of
the United States whether within the original or subsequently acquired
territory thereof, and whether within or without the limits of a State;
and (3) all Indian allotments, the Indian titles to which have not been
extinguished, including rights-of-way running through the same.
The Tribal Authority Rule authorizes eligible Tribal governments to
submit to EPA a Tribal plan for HMIWI (64 FR 7254, February 12, 1998).
The Tribal Authority Rule also contains a discussion on the EPA's
authority to implement Clean Air Act programs in Indian country. The
Federal plan will apply throughout Indian country except where a Tribal
plan has been explicitly approved by EPA to cover an area of Indian
country. This approach is consistent with that in the proposed Federal
Operating Permits Rule (62 FR 13747, March 21, 1997). The preamble to
the proposed HMIWI Federal plan discussed and requested comments on
application of the HMIWI Federal plan in Indian country. The EPA
received no comments on this issue.
E. Status of State Plan Submittals
Sections 111(d) and 129(b)(2) of the CAA, as amended, 42 U.S.C.
7411(d) and 7429(b)(2), authorize EPA to develop and implement a
Federal plan for HMIWI located in States with no approved and effective
State plan. Table 3 summarizes the current status of State plans. The
HMIWI covered in EPA-approved State plans are not subject to the HMIWI
Federal plan, as of the effective date specified in the Federal
Register notice announcing EPA's approval of the State plan. The EPA is
not expecting State plans to be submitted by the States that submitted
negative declarations. However, in the unlikely event that there are
HMIWI located in these States, this Federal plan would automatically
apply to them.
Table 3.--Status of State Plans
------------------------------------------------------------------------
------------------------------------------------------------------------
I. States with EPA-Approved State Plans... Alabama, Alleghany County in
Pennsylvania, Arizona,
Colorado, Delaware,
Georgia, Idaho, Illinois,
Indiana, Iowa, Kansas,
Louisiana, Mississippi,
Missouri, Montana,
Nebraska, New Hampshire,
New York, North Dakota,
South Dakota, Utah, West
Virginia, and Wyoming.
II. Negative Declaration Submitted to EPA. District of Columbia,
Forsyth County in North
Carolina, Huntsville in
Alabama, Jefferson County
in Kentucky, Nashville/
Davidson County in
Tennessee, Nevada, New
Mexico, Oregon, and
Vermont.
III. Final State Plan Submitted to EPA.... Florida, Maryland, and
Pennsylvania.
IV. Draft State Plan Submitted to EPA..... Chattanooga/Hamilton County
Tennessee, Knox County in
Tennessee, Memphis/Shelby
County in Tennessee,
Michigan, Minnesota, New
Jersey, Ohio, Oklahoma,
Puerto Rico, Rhode Island,
South Carolina, Texas, and
Virginia.
------------------------------------------------------------------------
The EPA is currently reviewing final and draft State plans
submitted by the States listed in parts III and IV of Table 3. The
Federal plan covers HMIWI in these States until these State plans are
approved by EPA and become effective. Other States are making
significant progress on their State plans and EPA expects many State
plans to be approved in the next several months. As Regional Offices
approve State plans, they will also, in the same action, amend the
appropriate subpart of 40 CFR part 62 to codify their approvals. The
EPA is not aware of any Indian Tribes that are developing Tribal plans.
The EPA will maintain a list of State plan submittals and approvals
on the Unified Air Toxics Website at http://www.epa.gov/ttn/uatw/129/hmiwi/rihmiwi.html. The list will help HMIWI owners or operators
determine whether their HMIWI is affected by a State plan, a Tribal
plan, or the Federal plan. Hospital/medical/infectious waste
incinerator owners and operators can also contact the EPA Regional
Office for the State in which their HMIWI is located to determine
whether there is an approved and effective State plan in place.
II. Required Elements of the HMIWI Federal Plan
Sections 111(d) and 129 of the CAA, as amended, 42 U.S.C. 7411(d)
and
[[Page 49871]]
7429(b)(2), require States to develop and implement State plans for
HMIWI to implement and enforce the promulgated emission guidelines.
Subparts B and Ce of 40 CFR part 60 require States to submit State
plans that include specified elements. Because this Federal plan is
being adopted in lieu of State plans, it includes the same essential
elements: (1) Identification of legal authority and mechanisms for
implementation, (2) inventory of HMIWI, (3) emissions inventory, (4)
emission limits, (5) compliance schedules, (6) public hearing
requirements, (7) testing, monitoring, inspection, reporting, and
recordkeeping requirements, (8) waste management plan requirements, (9)
operator training and qualification requirements, and (10) progress
reporting. Each State plan element was discussed in detail as it
relates to the Federal plan in the preamble to the proposed rule (64 FR
36425). Table 4 lists each element and identifies where it is located
or codified. The EPA received public comments on the mechanisms for
implementation, inspection requirements, compliance schedules, and
title V permitting requirements. A summary of these comments and EPA's
responses is presented in section III of this preamble.
Table 4.--Required Elements and Location
------------------------------------------------------------------------
Required element of the HMIWI Federal plan Where located
------------------------------------------------------------------------
Identification of legal authority and Section 129(b)(3) of the
mechanisms for implementation. CAA.
Identification of mechanisms for Section V of this preamble.
implementation.
Inventory of HMIWI........................ Docket A-98-24, Item II-B-1.
Emissions inventory....................... Docket A-98-24, Item II-B-1.
Emission limits........................... 40 CFR 62.14410 to 62.14413
of subpart HHH.
Compliance schedules...................... 40 CFR 62.14470 to 62.14472
of subpart HHH.
Public hearing requirements............... Section II.I of 64 FR 36431,
July 6, 1999.
Testing and monitoring requirements....... 40 CFR 62.14450 to 62.14455
of subpart HHH.
Inspection requirements................... 40 CFR 62.14440 to 62.14443
of subpart HHH.
Reporting and recordkeeping requirements.. 40 CFR 62.14460 to 62.14465
of subpart HHH.
Waste management plan requirements........ 40 CFR 62.14430 to 62.14432
of subpart HHH.
Operator training and qualification 40 CFR 62.14420 to 62.14425
requirements. of subpart HHH.
Progress reports.......................... Section II.J of 64 FR 36431,
July 6, 1999.
------------------------------------------------------------------------
III. Considerations in Developing the Final Federal Plan
This section of the preamble summarizes the changes to the HMIWI
Federal plan considered as a result of the public comments received on
the proposed plan. There were six comments received on the proposed
Federal plan. The majority of the comments addressed minor
inconsistencies between the emission guidelines promulgated on
September 15, 1997 and the proposed Federal plan. Three areas (the
compliance schedule; title V operating permit requirements for
incinerators burning only pathological waste, low-level radioactive
waste, and/or chemotherapeutic waste, and co-fired combustors; and
delegation of authority) are addressed in detail in the following
discussion. The public comments in their entirety are summarized and
addressed in the promulgation background information document (EPA-456/
R-00-003, Docket A-98-24, Item III-B-1).
A. Compliance Schedule
During the public comment period one commenter expressed concern
over the uncertainties associated with the March 2, 1999 U.S. Court of
Appeals decision concerning the emission limits for existing HMIWI. The
commenter stated that the court decision has created enough uncertainty
with respect to the final emission limits and that compliance with the
emission limits in the Federal plan should not be required until the
Federal court is satisfied. The Sierra Club and Natural Resources
Defense Council (NRDC) challenged EPA's rule establishing HMIWI
standards, complaining principally that EPA failed to comply with the
specifications of the maximum achievable control technology (MACT)
floors for new and existing HMIWI. Although the court rejected the
petitioners' statutory construction challenge, the court did conclude
that there are serious doubts about the reasonableness of EPA's
treatment of the floor requirements, and remanded the rule for further
explanation. The court decided not to vacate the standard. Rather, the
current regulation remains in place as requested by Sierra Club and
NRDC. In light of the court decision, EPA is obligated to adhere to the
compliance schedule set forth in the Emission Guidelines. Therefore,
the EPA must promulgate the final Federal plan as scheduled.
B. Title V Permitting Requirements
One commenter objected to EPA's proposal to exempt both co-fired
combustors and HMIWI that combust only pathological, low-level
radioactive, and/or chemotherapeutic waste from title V permitting
requirements. The commenter indicated that EPA's interpretation of
title V applicability conflicts with the requirements of both section
502(a) and section 129(e) of the CAA. The commenter noted that section
502(a) requires sources subject to standards under section 111 to
obtain title V permits. In addition, section 129(e) requires that
``Beginning (1) 36 months after the promulgation of a performance
standard * * * each unit in the category shall operate pursuant to a
permit issued under this subsection and title V.'' The commenter
interpreted EPA's position as follows: If co-fired combustors (as
defined in section 62.14490 of subpart HHH) and HMIWI combusting only
pathological waste, low-level radioactive waste, and/or
chemotherapeutic waste (also defined in section 62.14490 of subpart
HHH) comply with their recordkeeping obligations, they need not obtain
a title V permit. However, if they fail to keep the required records,
they must obtain a title V permit. The commenter mentioned that general
title V permits could be crafted to reduce the burden of title V
permitting for these exempt sources.
The commenter pointed out that under EPA's proposal not to require
title V permits for these sources, control agencies and the public will
not be able to determine whether the sources are keeping the proper
records; records which are the basis for creating and continuing the
exemption from title V permitting. The commenter stated that nothing in
the proposed rule requires sources to submit summaries of the required
records or to certify that they are keeping the records. The commenter
noted that if a title V permit were required, sources would be required
to certify that they are conducting the required recordkeeping. The
commenter requested that EPA either require sources to obtain title V
permits or
[[Page 49872]]
adopt an equally enforceable and transparent mechanism to require
sources to certify that they are conducting the required recordkeeping
and to ensure that citizens can access information relevant to the
obligation to keep such records. The commenter noted that if these
records are maintained onsite at a source, then the relevant agency may
take the position that the records are not subject to disclosure under
``freedom of information'' laws. Therefore, the commenter requested
that this rule: (1) Require these sources to submit these records to
the appropriate public authority on request; and (2) require that EPA,
State and local agencies adopt rules providing that the relevant agency
will request these records from sources if they are requested by the
public.
A second commenter disagreed with EPA's assessment that reporting
and recordkeeping requirements are not substantive elements of the
HMIWI rule for purposes of title V even though pathological, low-level
radioactive, and chemotherapeutic wastes are being considered under the
Industrial Combustion Coordinated Rulemaking (ICCR). The commenter
noted that recordkeeping and reporting supplies the agency with vital
information to ensure that rules are functioning as intended and helps
to supply data needed to develop new rules such as the ICCR. In
addition, recordkeeping and reporting require a significant amount of
employee time and facility dollars.
The second commenter stated that the CAA requires specific reasons
for a decision by EPA that a source should not be required to file a
title V permit. The commenter noted that section 502(a) of the CAA
states that EPA may exempt a source in one or more source categories if
EPA finds that ``compliance with such requirements is impracticable,
infeasible, or unnecessarily burdensome on such categories. * * *''
However, the law does not state that EPA may exempt a source category
when only recordkeeping and reporting are required. The commenter noted
that requiring co-fired combustors and HMIWI combusting only
pathological waste, low-level radioactive waste, and/or
chemotherapeutic waste to file a title V permit application may not be
practicable at this time because EPA may develop a rule with specific
emission limits for these sources in the near future. However, the
commenter stated that offering these types of sources several years of
additional time to come into compliance without requiring that they
take some action towards understanding their obligations under the CAA
is inappropriate.
The EPA disagrees with both commenters' views concerning this
Federal plan. The Federal plan requires owners or operators of HMIWI
combusting only pathological waste, low-level radioactive waste, and/or
chemotherapeutic waste and co-fired combustors to fulfill certain
recordkeeping and reporting requirements to demonstrate that they are
exempt from the emission control-related requirements of the Federal
plan. These emission control-related requirements include emission
limits; waste management plan requirements; operator training and
qualification requirements; inspection requirements; compliance and
performance testing requirements; monitoring requirements; and the
emission control-related reporting and recordkeeping requirements, but
not the reporting and recordkeeping requirements related to the
applicability of the Federal plan and necessary for these sources to
demonstrate exemption.
The reporting and recordkeeping requirements that these sources
must fulfill (in section 62.14400 [Applicability] of subpart HHH)
differ from the emission control-related reporting and recordkeeping
requirements (in sections 62.14460 through 62.14465 [Reporting and
Recordkeeping] of subpart HHH) of the Federal plan. Section 62.14400
requires owners or operators of HMIWI that combust only pathological
waste, low-level radioactive waste, and/or chemotherapeutic waste and
owners or operators of co-fired combustors to submit a one-time
notification of an exemption claim. In addition to this exemption
claim, owners or operators of HMIWI that combust only pathological
waste, low-level radioactive waste, and/or chemotherapeutic waste must
keep records on a calendar quarter basis of the periods of time when
these types of waste are the only types of waste combusted. Owners or
operators of co-fired combustors must keep records on a calendar
quarter basis of the weight of hospital waste and medical/infectious
waste combusted and the weight of all other fuels and wastes combusted.
The emission control-related reporting and recordkeeping requirements
for HMIWI include notifications, records, and reports pertaining to
waste management, parameter monitoring, operator training, inspections,
and performance testing.
The EPA interprets CAA section 502(a) and 40 CFR 70.3(a)(2) and
71.3(a)(2) to mean that sources subject to this exemption (HMIWI
combusting only pathological waste, low-level radioactive waste, and/or
chemotherapeutic waste, and co-fired combustors) are not subject to
standards or regulations under section 111 for purposes of title V
permitting. The Agency believes that the recordkeeping and reporting
requirements with which these facilities must comply if they are to
attain and maintain their exemptions are not the type of requirements
that make them ``subject to'' a standard or regulation under section
111 within the meaning of the first sentence of section 502(a). In
EPA's view, facilities in this unique position do not even meet the
threshold criteria for sources required to obtain title V permits under
section 502(a) of the CAA. Therefore, these sources are not required to
apply for title V permits on the basis of the applicability of
recordkeeping and reporting requirements necessary to qualify for
exemption from the emission control-related requirements of the Federal
plan. (Although these recordkeeping and reporting requirements do not
trigger the requirement to apply for a title V permit, they must be
incorporated into any title V permit these sources may be required to
obtain for reasons other than subpart HHH.) However, owners and
operators of these sources that do not comply with the recordkeeping
and reporting requirements necessary to attain and maintain exemption
from the Federal plan will become subject to the emission control-
related requirements and will have to obtain title V permits. While
HMIWI combusting pathological, low-level radioactive, and/or
chemotherapeutic waste and co-fired combustors subject to this
exemption need not obtain title V permits now as a matter of Federal
law, they are not prohibited from applying for title V permits.
As the second commenter stated, section 502(a) of the CAA also
provides a mechanism for the Administrator to ``promulgate regulations
to exempt'' one or more source categories from title V permitting
requirements, if EPA finds that compliance with such requirements is
``impracticable, infeasible, or unnecessarily burdensome on such
categories, except that the Administrator may not exempt any major
source from such requirements.'' The EPA is not invoking this mechanism
to justify its conclusion that facilities subject to exemptions from
emissions-control related requirements are not required to obtain title
V permits. These facilities have not been ``exempted'' from title V
within the meaning of the last sentence of section 502(a), and the
Agency has not made or does not purport to have
[[Page 49873]]
made the statutory showing of impracticability, infeasibility or
unnecessary burden for these sources. Rather, as stated earlier, the
Agency believes that the recordkeeping and reporting requirements with
which these facilities must comply are not the type that would make
them ``subject to'' a standard under section 111 or 502(a) of the CAA.
These reporting and recordkeeping requirements are simply conditions
for exemption from the emission control-related requirements of the
Federal plan.
Under the Federal plan sources are not required to routinely submit
to EPA the records they are required to maintain onsite to support
their exemption from the section 129 standard. However, we are adding
two provisions to the regulation to facilitate public access to those
records. First, the regulation requires in Secs. 62.14400(b)(1) and
(b)(2) that these sources must submit these records to EPA upon
request. Second, the regulation requires in Sec. 62.14400(c) that EPA
request these records from these sources if requested by a citizen
under the Freedom of Information Act, consistent with EPA regulations
set forth at 40 CFR part 2. Should a State take delegation of the
Federal plan rather than submitting an approvable State plan, the State
would have the obligation to obtain these records from sources
following receipt of a citizen request under applicable freedom of
information laws (comparable to the Freedom of Information Act) and
make such information available to the requestor.
Additionally, to clarify what the records maintained by co-fired
combustors must contain in order for an exemption from the emission
control-related requirements of subpart HHH and title V permitting to
be allowed, we have added language to Sec. 62.14400(b)(2). Language in
this section states that the records maintained by the owner or
operator of a co-fired combustor must reflect that the source continues
to meet the definition of co-fired combustor in Sec. 62.14490. Language
has been added to Sec. 62.14400(c) stating that the records required by
paragraphs (b)(1) and (b)(2) of Sec. 62.14400 must be maintained by the
relevant sources for a period of at least 5 years. Language has also
been added to Sec. 62.14400(c) stating that the notifications of
exemption claims also required by paragraphs (b)(1) and (b)(2) of
Sec. 62.14400 must be maintained by the EPA or delegated enforcement
authority for a period of at least 5 years. Such notifications are to
be made available upon request.
C. Transfer of Authority
One commenter raised the question of whether the authority to
implement the Federal plan could be transferred to States and local
agencies through the title V operating permits program. The commenter
noted that part IV of the preamble to the proposed Federal plan (in
section C on page 36432) describes two mechanisms for transferring
authority to State and local agencies and that part V of the preamble
discusses title V operating permits programs. These two mechanisms as
described on page 36432 of the proposed Federal plan are (1) the
approval of a State plan after the Federal plan is in effect; and (2)
if a State does not submit or obtain approval of its own plan, EPA
delegation to a State of the authority to implement certain portions of
the HMIWI Federal plan. The commenter recommended that the preamble to
the final Federal plan recognize the title V operating permits program
as a third mechanism for transferring authority to State and local
agencies. The commenter noted that many State and local agencies
implement title V programs and that title V permits must include the
requirements of the Federal plan. Thus, title V permitting authorities
already have implementation responsibility for the Federal plan through
the title V permits program, regardless of whether the authority to
implement the Federal plan is delegated to the State or local agency.
The commenter stated that the authority to implement the Federal plan
would be most useful before a title V permit is issued. The commenter
stated that the time required for a State to request and obtain
authority to implement the Federal plan through delegation is similar
to the lead time required in the Federal plan for submitting title V
permit applications. The commenter requested an explanation of why
delegation of the Federal plan is necessary if a title V program is in
place.
There are legal and practical reasons why incorporating a standard
into a permit without formal delegation is not equivalent to taking
formal delegation and then issuing a part 70 permit containing the
standard. The Act and part 70 require States, local agencies, or Tribes
wishing to adopt a part 70 permitting program to have the legal
authority to place all applicable requirements (including HMIWI
standards) in permits and to implement and enforce them in that
context. However, this requirement is not legally equivalent to formal
delegation, nor does it take the place of formal delegation. When a
State takes formal delegation, EPA allows the State to implement and
enforce a standard independent of a title V permit. This is significant
because a title V source may be allowed to operate without a title V
permit for a number of years in some cases between the time it first
triggers the requirement to apply for a permit and the issuance of the
permit. Prior to the issuance of a part 70 permit and absent formal
delegation, the State may not implement and enforce the requirements of
a standard. Moreover, a source with a title V permit with a permit term
less than 3 years is not required by part 70 to reopen the permit to
include new applicable requirements, such as the HMIWI standard. See 40
CFR Sec. 70.7(f)(1)(i). However, the source must still comply with that
standard. Delegation enables a State to implement and enforce the
standard outside of the permit until permit renewal.
The commenter also mentioned that the last statement in part IV of
the preamble to the proposed Federal plan, which indicates that EPA
would retain responsibility for enforcement after delegation, should be
qualified to reflect State and local enforcement responsibility after a
title V permit is issued. The commenter questioned whether EPA or the
State and local title V permitting authorities would have enforcement
responsibilities for the Federal plan after a title V permit is issued
to a source.
The EPA first notes that the language in the proposal preamble to
which the commenter refers was errant and has been deleted from the
preamble to the final rule. Rather, EPA's position on this issue is
accurately reflected in the same part of the proposal preamble (part
IV) that the commenter references under the section titled ``Delegation
of the Federal Plan and Retained Authorities'': ``The EPA will continue
to hold enforcement authority along with the State or Tribe even when a
State or Tribe has received delegation of the Federal plan.'' Moreover,
the retained authorities discussion immediately following this sentence
in the proposal preamble does not address enforcement of the Federal
plan, and Sec. 62.14495 of the proposed and final rules does not
include enforcement of the Federal plan as an authority retained by the
EPA Administrator. In fact, both State and Tribal permitting
authorities that have taken delegation, as well as the EPA, will have
responsibility for bringing enforcement actions against sources
violating Federal plan requirements. Prior to delegation, only the EPA
will have enforcement authority. In neither instance does the title V
permit status of a source affect the enforcement
[[Page 49874]]
responsibility of EPA and the State or Tribal permitting authorities.
IV. Summary of Federal Plan Requirements
The HMIWI Federal rule (40 CFR part 62, subpart HHH) which
implements this Federal plan includes emission limits, monitoring and
performance testing requirements, inspection requirements (for small
rural HMIWI only), waste management plan requirements, operator
training and qualification requirements, and recordkeeping and
reporting requirements. The requirements are summarized in this
section.
A. Applicability
The HMIWI Federal plan applies to existing HMIWI that either are
not covered by an approved and effective State or Tribal plan or are
located in a State or Tribal area that has incorrectly submitted a
negative declaration. An existing HMIWI is an HMIWI for which
construction commenced on or before June 20, 1996. Hospital/medical/
infectious waste incinerators for which construction commenced after
June 20, 1996 or modification commenced after March 16, 1998 are not
subject to the Federal plan; they are new sources and are subject to 40
CFR part 60 subpart Ec New Source Performance Standards (NSPS). An
HMIWI is defined as any device that combusts any amount of medical/
infectious waste or hospital waste. The terms ``medical/infectious
waste'' and ``hospital waste'' are defined in Sec. 62.14490 of subpart
HHH.
Incinerators that burn only pathological, low-level radioactive, or
chemotherapeutic waste (all defined in Sec. 62.14490 of subpart HHH)
are not subject to the emission control-related requirements of the
Federal plan during periods when they burn such wastes provided that
they notify EPA of an exemption claim and keep records of the periods
of time when only pathological, low-level radioactive, or
chemotherapeutic waste is burned. Existing incinerators, processing
operations, or boilers that cofire hospital waste and/or medical/
infectious waste with other fuels or wastes and combust 10 percent or
less combined medical/infectious and hospital waste by weight (on a
calendar quarter basis) are also not subject to the emission control-
related requirements of the Federal plan provided they file an
exemption claim and keep records of the amounts of each fuel and waste
burned. Any unit required to have a permit under section 3005 of the
Solid Waste Disposal Act is exempt from the Federal plan, as are
municipal waste combustors subject to 40 CFR 60 subparts Cb, Ea, or Eb.
Finally, pyrolysis units (as defined in Sec. 62.14490 of subpart HHH)
and cement kilns firing hospital waste and/or medical/infectious waste
are also not subject to this Federal plan.
The HMIWI source category is divided into small (200 lb/
hr), medium (>200 to 500 lb/hr), and large (>500 lb/hr) subcategories
based on waste burning capacity. Waste burning capacity is determined
either by the maximum design capacity or by the ``maximum charge rate''
established during the most recent performance test. In other words, a
source may change its size designation by establishing an enforceable
``maximum charge rate'' lower than its design capacity. For example, a
``medium'' unit with a design capacity of 250 lb/hr may establish a
maximum charge rate of 200 lb/hr and be considered a ``small'' unit for
purposes of the Federal plan. Separate requirements apply to each
subcategory of existing HMIWI.
B. Emission Limits
Table 5 provides the emission limits for existing HMIWI covered by
the Federal plan. In addition to the emission limits presented in Table
5, all HMIWI are subject to a 10 percent stack opacity limitation.
Stack opacity will be determined using EPA Reference Method 9.
The Federal plan contains alternative emission limits for small
HMIWI that meet the following ``rural criteria': (1) The small HMIWI is
located at least 50 miles from the nearest Standard Metropolitan
Statistical Area (SMSA) boundary; and (2) the small HMIWI burns no more
than 2,000 pounds of hospital waste and medical/infectious waste per
week. For this Federal plan, the list of areas comprising each SMSA as
of June 30, 1993 (defined by the Office of Management and Budget [OMB])
will be used to determine whether a small HMIWI meets the ``rural
criteria.'' The list of areas comprising each SMSA is presented in OMB
Bulletin No. 93-17 entitled ``Revised Statistical Definitions for
Metropolitan Areas.'' This document is available for public inspection
and copying at EPA's Air and Radiation Docket and Information Center
(Docket A-91-61, Item IV-J-125). See the ADDRESSES section at the
beginning of this preamble for the telephone number and location of the
docket. In addition, OMB Bulletin No. 93-17 is available at: http://www.census.gov/population/estimates/ metro-city/93mfips.txt, or from
National Technical Information Services, 5285 Port Royal Road,
Springfield, Virginia 22161, (703) 487-4650 (document number PB 93-192-
664). The emission limits for small HMIWI that meet the rural criteria
are provided in Table 6.
Table 5.--Summary of Federal Plan Emission Limits for HMIWI
----------------------------------------------------------------------------------------------------------------
Emission limits
Pollutant ------------------------------------------------------------------------------
Small HMIWI Medium HMIWI Large HMIWI
----------------------------------------------------------------------------------------------------------------
Particulate matter............... 115 mg/dscm (0.05 gr/ 69 mg/dscm (0.03 gr/ 34 mg/dscm (0.015 gr/
dscf). dscf). dscf).
Carbon monoxide.................. 40 ppmv.................. 40 ppmv................. 40 ppmv.
Dioxins/furans................... 125 ng/dscm total CDD/CDF 125 ng/dscm total CDD/ 125 ng/dscm total CDD/
(55 gr/10\9\ dscf) or CDF (55 gr/10\9\ dscf) CDF (55 gr/10\9\ dscf)
2.3 ng/dscm TEQ (1.0 gr/ or 2.3 ng/dscm TEQ (1.0 or 2.3 ng/dscm TEQ (1.0
10\9\ dscf). gr/10\9\ dscf). gr/10\9\ dscf).
Hydrogen chloride................ 100 ppmv or 93% reduction 100 ppmv or 93% 100 ppmv or 93%
reduction. reduction.
Sulfur dioxide................... 55 ppmv.................. 55 ppmv................. 55 ppmv.
Nitrogen oxides.................. 250 ppmv................. 250 ppmv................ 250 ppmv.
Lead............................. 1.2 mg/dscm (0.52 gr/ 1.2 mg/dscm (0.52 gr/ 1.2 mg/dscm (0.52 gr/
10\3\ dscf) or 70% 10\3\ dscf) or 70% 10\3\ dscf) or 70%
reduction. reduction. reduction.
Cadmium.......................... 0.16 mg/dscm (0.07 gr/ 0.16 mg/dscm (0.07 gr/ 0.16 mg/dscm (0.07 gr/
10\3\ dscf) or 65% 10\3\ dscf) or 65% 10\3\ dscf) or 65%
reduction. reduction. reduction.
Mercury.......................... 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/
10\3\ dscf) or 85% 10\3\ dscf) or 85% 10\3\ dscf) or 85%
reduction. reduction. reduction.
----------------------------------------------------------------------------------------------------------------
[[Page 49875]]
Table 6.--Summary of Emission Limits for Small HMIWI That Meet the Rural
Criteria
------------------------------------------------------------------------
Pollutant Emission limits
------------------------------------------------------------------------
Particulate matter.................. 197 mg/dscm (0.086 gr/dscf).
Carbon monoxide..................... 40 ppmv.
Dioxins/furans...................... 800 ng/dscm total CDD/CDF (350 gr/
10\9\ dscf) or 15 ng/dscm TEQ
(6.6 gr/10\9\ dscf).
Hydrogen chloride................... 3,100 ppmv.
Sulfur dioxide...................... 55 ppmv.
Nitrogen oxides..................... 250 ppmv.
Lead................................ 10 mg/dscm (4.4 gr/10\3\ dscf).
Cadmium............................. 4 mg/dscm (1.7 gr/10\3\ dscf).
Mercury............................. 7.5 mg/dscm (3.3 gr/10\3\ dscf).
------------------------------------------------------------------------
C. Additional Requirements
This section presents the other major provisions of the Federal
plan for HMIWI. With the exception of the emission limits referenced
above and the compliance and performance testing requirements and the
inspection requirements described in this section, HMIWI that meet the
small rural criteria are to comply with the same additional
requirements as all other existing HMIWI. This section does not attempt
to show all requirements of the Federal plan. The regulatory text of
subpart HHH contains a full and comprehensive statement of the
requirements of the Federal plan.
The Federal plan contains operator training and qualification
requirements for all HMIWI. Each facility is required to have at least
one trained and qualified operator on duty or on-call. The trained and
qualified operator must pass an HMIWI operator training course and meet
qualification requirements. Also, each facility is required to develop
site-specific HMIWI operating procedures. Employees involved with HMIWI
operation must review the site-specific operating information annually.
The Federal plan requires all facilities to develop a waste
management plan that identifies the feasibility and approach of
separating certain components of the healthcare waste stream in order
to reduce the amount of toxic emissions from incinerated waste.
The compliance and performance testing requirements in the Federal
plan differ for small rural HMIWI and for all other HMIWI. Small rural
HMIWI are required to conduct an initial performance test to determine
compliance with the PM, CO, CDD/CDF, and Hg emission limits and opacity
limit, and to establish operating parameters. In addition, small rural
HMIWI are required to conduct annual tests to determine compliance with
the opacity limit.
The compliance and performance testing requirements in the Federal
plan require facilities with small non-rural, medium, and large HMIWI
to conduct an initial performance test to determine compliance with the
PM, CO, CDD/CDF, HCl, Pb, Cd, and Hg emission limits and the opacity
limit, and to establish operating parameters. These HMIWI are also
required to conduct annual performance tests to determine compliance
with the PM, CO, and HCl emission limits and opacity limit. The Federal
plan allows facilities to conduct performance tests for PM, CO, and HCl
every third year if the previous three performance tests demonstrate
that the facility is in compliance with the emission limits for PM, CO,
and HCl.
The Federal plan contains monitoring requirements for all HMIWI.
Each facility is required to install and maintain equipment to
continuously monitor operating parameters including secondary chamber
temperature, waste feed rate, use of the bypass stack, and Air
Pollution Control Device (APCD) operating parameters as appropriate.
The Federal plan requires facilities to obtain monitoring data at all
times during HMIWI operation.
In addition, the Federal plan contains reporting and recordkeeping
requirements for all HMIWI. Facilities are required to maintain records
for 5 years of results from the initial performance test and all
subsequent performance tests, monitored operating parameters,
inspections (small rural HMIWI only), and operator training and
qualification. Facilities are required to submit the results of the
initial performance test and all subsequent performance tests, and to
submit reports on emission rates or operating parameters that have not
been recorded or which exceeded applicable limits.
D. Compliance Dates
1. HMIWI That Continue Operation
The Federal plan requires owners or operators of HMIWI to either:
(1) Come into compliance with the plan within 1 year after the plan is
promulgated (by August 15, 2001); or (2) meet increments of progress
and come into compliance by September 15, 2002. Increments of progress
are necessary in order to ensure that HMIWI needing more time to comply
are making progress toward meeting the emission limits. This HMIWI
Federal plan includes as its compliance schedule the same five
increments of progress from 40 CFR 60.21(h), as required by 40 CFR
60.24(e)(1), along with defined and enforceable dates for completion of
each increment.
The HMIWI owner or operator is responsible for meeting each of the
five increments of progress for each HMIWI no later than the applicable
compliance date. The owner or operator must notify EPA as each
increment of progress is achieved, as well as when any is missed. The
notification must identify the increment and the date the increment is
achieved (or missed). If an owner or operator misses an increment
deadline, the owner or operator must also notify EPA when the increment
is finally achieved. The owner or operator must mail the notification
to the applicable EPA Regional Office within 10 business days after the
increment date defined in the Federal plan. (See Table 1 under the FOR
FURTHER INFORMATION CONTACT section of this document for a list of
Regional Offices.)
The definition of each increment of progress, along with its
required completion date, follows.
Submit Final Control Plan. To meet this increment, the owner or
operator of each HMIWI must submit a plan that describes, at a minimum,
the APCD and/or process changes that will be employed so that each
HMIWI complies with the emission limits and other requirements. A final
control plan is not required for units that will be shut down.
Completion date: September 15, 2000.
Award Contract. To award a contract means the HMIWI owner or
operator enters into legally binding agreements or contractual
obligations that cannot be canceled or modified without substantial
financial loss to the owner or operator. The EPA anticipates that the
owner or operator may award a number of contracts to complete the
retrofit. To meet this increment of progress, the HMIWI owner or
operator must award a contract or contracts to initiate onsite
construction, to initiate onsite installation of air pollution control
devices, and/or to incorporate process changes. The owner or operator
must mail a copy of the signed contract(s) to EPA within 10 business
days of entering the contract(s). Completion date: April 15, 2001.
Begin Onsite Construction. To begin onsite construction,
installation of air pollution control devices, or process change means
to begin any of the following:
(1) Installation of an air pollution control device in order to
comply with the final emission limits as outlined in the final control
plan;
[[Page 49876]]
(2) Physical preparation necessary for the installation of an air
pollution control device in order to comply with the final emission
limits as outlined in the final control plan;
(3) Alteration of an existing air pollution control device in order
to comply with the final emission limits as outlined in the final
control plan;
(4) Alteration of the waste combustion process to accommodate
installation of an air pollution control device in order to comply with
the final emission limits as outlined in the final control plan; or
(5) Process changes identified in the final control plan in order
to meet the emission standards. Completion date: December 15, 2001.
Complete Onsite Construction. To complete onsite construction means
that all necessary air pollution control devices or process changes
identified in the final control plan are in place, onsite, and ready
for operation on the HMIWI. Completion date: July 15, 2002.
Final Compliance. To be in final compliance means to incorporate
all process changes or complete retrofit construction in accordance
with the final control plan and to connect the air pollution control
equipment or process changes such that, if the HMIWI is brought on
line, all necessary process changes or air pollution control equipment
will operate as designed. Completion date: September 15, 2002.
If an HMIWI does not achieve final compliance by September 15,
2002, the Federal plan requires the HMIWI to shut down by September 15,
2002, complete the retrofit while not operating, and be in compliance
upon restarting. Shut down is necessary in order to avoid being out of
compliance and subject to possible enforcement action.
2. HMIWI That Have or Will Shut Down
a. Inoperable HMIWI and HMIWI That Shut Down. In cases where an
HMIWI has been shut down and there are no plans to restart, the HMIWI
may be left off the source inventory for this Federal plan if it is
rendered inoperable. The HMIWI owner/operator may do one or more of the
following to render an HMIWI inoperable: (1) Weld the waste charge door
shut, (2) remove stack (and by-pass stack, if applicable), (3) remove
combustion air blowers, and/or (4) remove burners or fuel supply.
Any owner or operator that plans to shut down their HMIWI rather
than comply with the Federal plan requirements must do so by August 15,
2001, the date 1 year after the Federal plan is promulgated. The
Federal plan contains provisions allowing HMIWI owners or operators
that are planning to shut down the opportunity to petition EPA for an
extension beyond the 1-year compliance date (but no later than
September 15, 2002). An example of a facility that might petition EPA
for such an extension is a facility installing an onsite alternative
waste treatment technology. It is possible that installation cannot be
completed within 1 year, and the facility has no feasible waste
disposal options other than onsite incineration while the alternative
technology is being installed. The requirements for a petition for an
extension to shut down under the Federal plan are set forth at section
62.14471 of subpart HHH.
All HMIWI that continue to operate 1 year after the Federal plan
promulgation date must comply with the operator training and
qualification requirements and the inspection requirements of the plan
within 1 year after the plan is promulgated. This requirement includes
HMIWI that comply within 1 year, as well as those that have been
granted an extension beyond the 1-year compliance date (i.e., HMIWI
with extended retrofit schedules and HMIWI granted an extension to shut
down after the 1-year compliance date).
b. HMIWI That Have Shut Down and Will Restart.
Hospital/medical/infectious waste incinerators that are known to
have already shut down (but are not known to be inoperable) are
included in the source inventory for this Federal plan.
Restarting Before September 15, 2002. If the owner or operator of
an inactive HMIWI plans to restart before September 15, 2002, the
Federal plan requires the owner or operator to submit a control plan
for the HMIWI and bring the HMIWI into compliance with the applicable
compliance schedule. Final compliance is required for all pollutants
and all HMIWI no later than September 15, 2002.
Restarting After September 15, 2002. Under this Federal plan, a
control plan is not needed for inactive HMIWI that restart after
September 15, 2002. However, before restarting, such HMIWI must
complete the operator training and qualification requirements and
inspection requirements (if applicable) and complete retrofit or
process modifications upon restarting. Performance testing to
demonstrate compliance would be required within 180 days after
restarting. There is no need to show that the increments of progress
have been met since these steps will have occurred before restart while
the HMIWI was shut down and not generating emissions. An HMIWI that
operates out of compliance after September 15, 2002 will be in
violation of the Federal plan and subject to enforcement action.
3. Summary of Compliance Dates
A summary of dates for compliance with the Federal plan for HMIWI
is presented in Table 7.
Table 7.--Compliance Times Under the Federal Plan for All HMIWI
------------------------------------------------------------------------
Requirement Compliance time
------------------------------------------------------------------------
Operator training and qualification....... Within 1 year after
promulgation of the Federal
plan (for HMIWI that
continue to operate beyond
1 year after promulgation).
Waste management plan..................... Within 60 days after initial
performance test.
Final compliance with emission limits..... Within 1 year after
promulgation of the Federal
plan or by September 15,
2002 if the source is
granted an extension.
Initial performance test.................. Within 180 days after
achieving final compliance.
Repeat performance test................... Within 12 months following
initial performance test
and annually thereafter
\a\.
Parameter monitoring...................... Continuously, upon
completion of initial
performance test.
Inspection (small rural HMIWI only)....... Within 1 year after
promulgation of the Federal
plan (for HMIWI that
continue to operate beyond
1 year after promulgation).
Recordkeeping............................. Continuously, upon
completion of initial
performance test.
Reporting................................. Within 60 days after initial
performance test; annually
for subsequent reporting
requirements; semiannually,
if noncompliance.
------------------------------------------------------------------------
\a\ Facilities may conduct performance tests for PM, CO, and HCl every
third year if the previous three performance tests demonstrate that
the facility is in compliance with the emission limits for PM, CO, and
HCl.
V. Implementation of the Federal Plan and Delegation
A. Background of Authority
Under sections 111(d) and 129(b) of the CAA, EPA is required to
adopt emission guidelines that are applicable to existing solid waste
incineration sources. These emission guidelines are not enforceable
until EPA approves a
[[Page 49877]]
State or Tribal plan or adopts a Federal plan that implements and
enforces them, and the State, Tribal, or Federal plan has become
effective. As discussed above, the Federal plan regulates HMIWI in
States or Tribal areas that do not have approved plans in effect.
Congress has determined that the primary responsibility for air
pollution prevention and control rests with State and local agencies.
See section 101(a)(3) of the CAA. Consistent with that overall
determination, Congress established sections 111 and 129 of the CAA
with the intent that the States and local agencies take the primary
responsibility for ensuring that the emission limitations and other
requirements in the emission guidelines are achieved. Also, in section
111(d) of the CAA, Congress explicitly required that EPA establish
procedures that are similar to those under section 110(c) for State
Implementation Plans. Although Congress required EPA to propose and
promulgate a Federal plan for States that fail to submit approvable
State plans on time, EPA strongly encourages States to submit
approvable plans. The EPA strongly encourages States that are unable to
submit approvable plans to request delegation of the Federal plan so
that they can have primary responsibility for implementing the emission
guidelines, consistent with Congress' intent.
Approved and effective State plans or delegation of the Federal
plan is EPA's preferred outcome since EPA believes that State and local
agencies not only have the responsibility to carry out the emission
guidelines, but also have the ``insider'' knowledge and enforcement
resources critical to achieving the highest rate of compliance. For
these reasons, EPA will do all that it can to expedite delegation of
the Federal plan to State and local agencies, whenever possible.
The EPA also believes that Indian Tribes are the primary parties
responsible for regulating air quality within Indian country. See EPA's
Indian Policy (``Policy for Administration of Environmental Programs on
Indian Reservations,'' signed by William D. Ruckelshaus, Administrator
of EPA, dated November 4, 1984), reaffirmed in a 1994 memorandum (``EPA
Indian Policy,'' signed by Carol M. Browner, Administrator of EPA,
dated March 14, 1994).
B. Delegation of the Federal Plan and Retained Authorities
If a State or Indian Tribe intends to take delegation of the
Federal plan, the State or Indian Tribe must submit to the appropriate
EPA Regional Office a written request for delegation of authority. The
State or Indian Tribe must explain how it meets the criteria for
delegation. See generally ``Good Practices Manual for Delegation of
NSPS and NESHAP'' (EPA, February 1983). In order to obtain delegation,
an Indian Tribe must also establish its eligibility to be treated in
the same manner as a State (see section I.D of the preamble). The
letter requesting delegation of authority to implement the Federal plan
must demonstrate that the State or Tribe has adequate resources, as
well as the legal and enforcement authority to administer and enforce
the program. As mentioned in section III.C, an MOA between the State or
Tribe and the EPA would set forth the terms and conditions of the
delegation, the effective date of the agreement, and would also serve
as the mechanism to transfer authority. Upon signature of the
agreement, the appropriate EPA Regional Office would publish an
approval notice in the Federal Register, thereby incorporating the
delegation authority into the appropriate subpart of 40 CFR part 62.
If authority is not delegated to a State or Indian Tribe, EPA will
implement the Federal plan. Also, if a State or Tribe fails to properly
implement a delegated portion of the Federal plan, EPA will assume
direct implementation and enforcement of that portion. The EPA will
continue to hold enforcement authority along with the State or Tribe
even when a State or Tribe has received delegation of the Federal plan.
In all cases where the Federal plan is delegated, the EPA will retain
and will not transfer authority to a State or Tribe to approve the
following items:
(1) Alternative site-specific operating parameters established
by facilities using HMIWI controls other than a wet scrubber or dry
scrubber followed by a fabric filter; and
(2) Alternative methods of demonstrating compliance.
Hospital/medical/infectious waste incinerator owners or
operators who wish to establish alternative operating parameters or
alternative methods of demonstrating compliance should submit a
request to the Regional Office Administrator with a copy to the
appropriate State or Tribe.
C. Mechanisms for Transferring Authority
There are two mechanisms for transferring implementation authority
to State or Tribal agencies: (1) EPA approval of a State or Tribal plan
after the Federal plan is in effect; and (2) if a State or Tribe does
not submit or obtain approval of its own plan, EPA delegation to a
State or Tribe of the authority to implement certain portions of this
Federal plan to the extent appropriate and if allowed by State or
Tribal law. Both of these options are described in more detail below.
1. State or Tribe Submits a Plan After HMIWI Located in the Area Are
Subject to the Federal Plan
After HMIWI in a State or Tribal area become subject to the Federal
plan, the State or Tribal agency may still adopt and submit a plan to
EPA. If EPA determines that the State or Tribal plan is as protective
as the emission guidelines, EPA will approve the State or Tribal plan.
If EPA determines that the plan is not as protective as the emission
guidelines, EPA will disapprove the plan and the HMIWI covered in the
State or Tribal plan would remain subject to the Federal plan until a
State or Tribal plan covering those HMIWI is approved and effective.
Upon the effective date of a State or Tribal plan, the Federal plan
would no longer apply to HMIWI covered by such a plan and the State or
Tribal agency would implement and enforce the State or Tribal plan in
lieu of the Federal plan. When an EPA Regional Office approves a State
or Tribal plan, it will amend the appropriate subpart of 40 CFR part 62
to indicate such approval.
2. State Takes Delegation of the Federal Plan
State or Tribal agencies may assume implementation of this Federal
plan. As discussed above, EPA believes that it is advantageous and the
best use of resources for State or Tribal agencies to agree to
undertake, on EPA's behalf, administrative and substantive roles in
implementing the Federal plan to the extent appropriate and where
authorized by State or Tribal law. These functions could include
administration and oversight of compliance reporting and recordkeeping
requirements, HMIWI inspections, and preparation of notices of
violation. Both States, or Tribal agencies, that have taken delegation,
as well as EPA, will have responsibility for bringing enforcement
actions against sources violating Federal plan provisions.
VI. Title V Operating Permits
Sources subject to this HMIWI Federal plan must obtain title V
operating permits. Those title V operating permits must assure
compliance with all applicable requirements for the source, including
all applicable requirements of this Federal plan. See 40 CFR
70.6(a)(1), 70.2, 71.6(a)(1) and 71.2.
Under section 129(e) of the CAA, owners or operators of HMIWI
subject to
[[Page 49878]]
this Federal plan must operate pursuant to a title V permit no later
than 36 months after promulgation of the HMIWI emission guidelines
(i.e., by September 15, 2000), or by the effective date of the State,
Tribal, or Federal title V permits program that covers the area in
which the unit is located, whichever is later.\2\ If an owner or
operator is required to obtain a title V permit for the first time by
virtue of being subject to the Federal plan, the owner or operator must
submit a complete title V permit application by the applicable permit
deadline (i.e., by September 15, 2000) or the effective date of the
State, Tribal, or Federal operating permits program, whichever is
later.\3\
---------------------------------------------------------------------------
\2\ One area covered by title V permitting programs is the Outer
Continental Shelf. See 40 CFR 55.6.
\3\ Section 503(d) of the CAA and 40 CFR 70.7(b) and 71.7(b)
allow a source to operate without being in violation of title V once
the source has submitted a timely and complete permit application,
even if the source has not yet received a final title V operating
permit from the permitting authority. To this end, the application
should be submitted early enough for the permitting authority to
find the application either complete or incomplete before the
application deadline. In the event the application is found
incomplete by the permitting authority, the source must submit the
information needed to make the application complete by the
application deadline in order to obtain the application shield. See
40 CFR 62.14481 and 40 CFR 70.5(a)(2) and 71.5(a)(2).
---------------------------------------------------------------------------
An earlier permit deadline may apply if an HMIWI is subject to
title V for another reason. If an owner or operator is already subject
to title V by virtue of some other requirement and has submitted a
timely and complete permit application but the title V permit has not
yet been released by the permitting authority, then the owner or
operator should supplement its title V application by including the
applicable requirements of the Federal plan in accordance with 40 CFR
70.5(b) or 71.5(b).
If an owner or operator of an HMIWI is already subject to title V
by virtue of some other requirement on the effective date of this
Federal plan and already possesses a title V permit with a remaining
term of 3 or more years, then the owner or operator will receive from
its permitting authority a notice of intent to reopen the title V
permit to include the requirements of the Federal plan in accordance
with the procedures established in 40 CFR 70.7(f) or 71.7(f). An owner
or operator of an HMIWI with a title V permit having a remaining term
of less than 3 years on the effective date of this Federal plan need
not modify its title V permit, as a matter of Federal law, to include
the Federal plan requirements until that permit is renewed.\4\ However,
the owner or operator remains subject to, and must act in compliance
with, the Federal plan requirements.
---------------------------------------------------------------------------
\4\ See CAA section 502(b)(6); 40 CFR 70.7(f)(1)(I) and
71.7(f)(1)(I). The CAA authorizes State, Tribal and Federal
operating permits programs to require permits to be reopened and
modified to incorporate the requirements of the Federal plan when
fewer than 3 years remaining on a source's permit, however, so
permitting authorities could reopen permits sooner than required by
Federal law. Such reopenings should be completed no later than 18
months after promulgation of the applicable requirement. Any sources
in this situation may wish to consult their operating permits
program regulations or permitting authorities to determine whether
revisions to their permits are necessary to incorporate the Federal
plan requirements.
---------------------------------------------------------------------------
Owners or operators of HMIWI that burn only pathological waste,
low-level radioactive waste, and/or chemotherapeutic waste and co-fired
combustors, as defined in Sec. 62.14490 of subpart HHH, must comply
only with certain recordkeeping and reporting requirements set forth in
the Federal plan. See Sec. 62.14400. These HMIWI and co-fired
combustors are not subject to the emission control-related requirements
of the Federal plan as long as they comply with the recordkeeping and
reporting requirements set forth as conditions for their exemption.
Therefore, as discussed in section III.B of this preamble and in the
preamble to the proposed Federal plan (64 FR 36425, July 6, 1999),
owners and operators of these sources are not required to obtain title
V operating permits as a matter of Federal law if the only reason they
would potentially be subject to title V is these non-emission control-
related recordkeeping and reporting requirements. See Sec. 62.14480.
However, owners and operators of HMIWI that burn only pathological
waste, low-level radioactive waste, and/or chemotherapeutic waste and
co-fired combustors that do not comply with the recordkeeping and
reporting requirements necessary to qualify for exemption from the
other requirements of the Federal plan will become subject to those
other requirements and will have to obtain title V permits. Moreover,
if, in the future, EPA promulgates regulations subjecting any of these
sources to requirements other than these recordkeeping and reporting
requirements, these sources could become subject to title V at that
time.
VII. Administrative Requirements
This section addresses the following administrative requirements:
Docket, Paperwork Reduction Act, Executive Orders 12866, 13132, 13045,
and 13084, Unfunded Mandates Reform Act, Regulatory Flexibility Act,
Small Business Regulatory Enforcement Fairness Act, and the National
Technology Transfer and Advancement Act. Since today's promulgated rule
merely implements the emission guidelines promulgated on September 15,
1997 (codified at 40 part 60, subpart Ce) as they apply to HMIWI and
does not impose any new requirements, much of the following discussion
of administrative requirements refers to the documentation of
applicable administrative requirements in the preamble to the 1997 rule
promulgating the emission guidelines (62 FR 48347-48379, September 15,
1997).
A. Docket
The docket is intended to be an organized and complete file of the
administrative records compiled by EPA. The docket is a dynamic file
because material is added throughout the rulemaking process. The
docketing system is intended to allow members of the public and
industries involved to readily identify and locate documents so they
can effectively participate in the rulemaking process. Along with
proposed and promulgated standards and their preambles, the contents of
the docket (with limited exceptions) will serve as the record in the
case of judicial review. See section 307(d)(7)(A) of the CAA.
As discussed above, a docket has been prepared for this action
pursuant to the procedural requirements of section 307(d) of the CAA,
42 U.S.C. 7607(d). Docket number A-91-61 contains the technical support
for the September 15, 1997 emission guidelines. Public comments
received on the proposal for this rulemaking and additional supporting
information are included in Docket A-98-24.
B. Paperwork Reduction Act
The information collection requirements in this rule have been
submitted for approval to the OMB under the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. An information collection request (ICR) document
has been prepared by EPA (ICR No. 1899.01) and a copy may be obtained
from Ms. Sandy Farmer by mail at OP Regulatory Information Division, U.
S. Environmental Protection Agency, Office of Environmental Information
Collection Strategies Division (2822), 1200 Pennsylvania Avenue, NW,
Washington, D.C. 20460; by E-mail at [email protected]; or by
calling (202) 260-2740. A copy may also be downloaded off the Internet
at http://www.epa.gov/icr.
This ICR reflects the burden estimate for the emission guidelines
which were promulgated in the Federal Register on
[[Page 49879]]
September 15, 1997. The burden estimate includes the burden associated
with State/Tribal plans as well as the burden associated with the
Federal plan. Consequently, the burden estimates described below
overstate the information collection burden associated with the Federal
plan. However, upon approval by EPA, a State/Tribal plan becomes
Federally enforceable. Therefore, it is important to estimate the full
burden associated with the State/Tribal plans and the Federal plan. As
State/Tribal plans are approved, the Federal plan burden will decrease,
but the overall burden of the State/Tribal plans and the Federal plan
will remain the same.
The information collected will be used by EPA to ensure that the
HMIWI regulatory requirements are implemented and are complied with on
a continuous basis. Records and reports are necessary to enable EPA to
identify existing HMIWI that may not be in compliance with the HMIWI
regulatory requirements. Based on reported information, EPA will decide
which units should be inspected and what records or processes should be
inspected. The records that owners and operators of existing HMIWI
maintain will indicate to EPA whether personnel are operating and
maintaining control equipment properly.
Based on the inventory of HMIWI used to develop the emission
guidelines, the HMIWI regulatory requirements (i.e., the State/Tribal
plans and Federal plan) are projected to affect approximately 2,373
existing HMIWI in the United States or protectorates. A number of State
plans are expected to be approved within the next year. When a State
plan is approved, the Federal plan will no longer apply to HMIWI
covered in that State plan.
The estimated average annual burden for industry for the first 3
years after the promulgation of the emission guidelines is 133,404
hours annually at a cost of $5,858,292 per year to meet the monitoring,
recordkeeping, and reporting requirements. The estimated average annual
burden, over the first 3 years, for the regulatory agencies (State and
Federal) is 10,984 hours at a cost of $438,736 (including travel
expenses) per year.
Burden means total time, effort, or financial resources expended by
persons to generate, maintain, retain, disclose, or provide information
to or for a regulatory agency. This includes the time needed to do the
following: Review instructions; develop, acquire, install, and use
technology and systems for the purposes of collecting and validating
information; process, maintain, and disclose information; amend
previously applicable instructions and requirements to reflect new
HMIWI State or Federal plan requirements; train personnel to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR part 15.
Send comments on the Agency's need for this information, the
accuracy of the burden estimates provided, and any suggested methods
for minimizing respondent burden, including the use of automated
collection techniques to the Director, OP Regulatory Information
Division, U. S. Environmental Protection Agency (2137), 1200
Pennsylvania Ave., NW, Washington, D.C. 20460; and to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street, N.W., Washington, D.C. 20503, marked ``Attention: Desk
Officer for EPA.'' Include the ICR number in any correspondence.
Because OMB is required to make a decision on the ICR between 30 and 60
days after today's request for comment, a comment to OMB is best
assured of having its full effect if OMB receives it by September 14,
2000.
C. Executive Order 12866
Under Executive Order 12866, 58 FR 51735 (October 4, 1993), EPA
must determine whether the regulatory action is ``significant'' and,
therefore, subject to OMB review and the requirements of the Executive
Order. The EPA considered the 1997 emission guidelines to be
significant and the rules were reviewed by OMB in 1997. See 62 FR
48374. The Federal plan promulgated today would simply implement the
1997 emission guidelines and does not result in any additional control
requirements or impose any additional costs above those previously
considered during promulgation of the 1997 emission guidelines.
Therefore, this regulatory action is considered ``not significant''
under Executive Order 12866.
D. Executive Order 13132, Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), 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 section 6 of 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. The 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 proposed rule does not have federalism implications. It 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. Thus, the requirements of
section 6 of the Executive Order do not apply to this proposed rule.
Although section 6 of Executive Order 13132 does not apply to this
final rule, EPA did consult with State and local officials to enable
them to provide timely input in the development of this final rule.
E. Executive Order 13045
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 affect 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
feasible alternatives considered by the Agency.
The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the
[[Page 49880]]
analysis required under section 5-501 of the Order has the potential to
influence the regulation. This rule is not subject to Executive Order
13045 because (1) it is not an economically significant regulatory
action as defined by Executive Order 12866, and (2) it is based on
technology performance and not on health or safety risks.
F. Executive Order 13084
Under Executive Order 13084, 63 FR 27655 (May 19, 1998), EPA may
not issue a regulation that is not required by statute, that
significantly or uniquely affects the communities of Indian Tribal
governments, and that imposes substantial direct compliance costs on
those communities, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by the Tribal
governments, or EPA consults with those governments. If EPA complies by
consulting, Executive Order 13084 requires EPA to provide to the OMB,
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.''
The Federal plan promulgated today does not significantly or
uniquely affect communities of Indian Tribal governments. The Federal
plan does not impose any enforceable duties on those governments.
Moreover, this Federal plan simply implements the 1997 emission
guidelines and does not result in any additional control requirements
or impose any additional costs above those previously considered during
promulgation of the 1997 emission guidelines. Thus, the requirements of
section 3(b) of Executive Order 13084 do not apply to this rule.
G. Unfunded Mandates Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures by State, local, and Tribal governments, in
the aggregate, or by the private sector, of $100 million or more in any
1 year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.
Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including Tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
An unfunded mandates statement was prepared and published in the
preamble to the September 15, 1997 NSPS and emission guidelines. See 62
FR at 48374-48378. The EPA has determined that the HMIWI Federal plan
does not include any new Federal mandates or additional requirements
above those previously considered during promulgation of the 1997
emission guidelines. Therefore, the requirements of the UMRA do not
apply to this rule.
H. Regulatory Flexibility Act and Small Business Regulatory Enforcement
Fairness Act
The Regulatory Flexibility Act (RFA) of 1980, as amended by the
Small Business Regulatory Enforcement Fairness Act (SBREFA), 5 U.S.C.
601 et seq., requires Federal agencies to give special consideration to
the impacts of regulations on small entities, which are defined as
small businesses, small organizations, and small governments. During
the 1997 HMIWI emission guidelines rulemaking, EPA estimated that small
entities would not be affected by the promulgated emission guidelines
and standards, and therefore, a regulatory flexibility analysis was not
required. See 62 FR at 48378-48379. This Federal plan would not
establish any new requirements. Therefore, pursuant to the provisions
of 5 U.S.C. 605 (b), EPA has determined that this Federal plan will not
have a significant impact on a substantial number of small entities,
and thus a regulatory flexibility analysis is not required.
I. 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 standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
The NTTAA does not apply because the Federal plan promulgated today
implements an existing rule to which NTTAA did not apply. In addition,
the emission guidelines, which the Federal plan is based on, does not
require new technology or impose new technical standards.
J. Submission to Congress and the General Accounting Office
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
SBREFA of 1996, generally provides that before a rule may take effect,
the agency promulgating the rule must submit a rule report, which
includes a copy of the rule, to each House of the Congress and to the
Comptroller General of the United States. The 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
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).
List of Subjects in 40 CFR Part 62.
Environmental protection, Air pollution control, Intergovernmental
relations, Reporting and recordkeeping requirements.
[[Page 49881]]
Dated: August 4, 2000.
Carol M. Browner,
Administrator.
1. The authority citation for part 62 continues to read as follows:
Authority: 42 U.S.A. 7401-7642.
2. Amend Sec. 62.13 by adding paragraph (c) to read as follows:
Sec. 62.13 Federal Plans
* * * * *
(c) The substantive requirements of the hospital/ medical/
infectious waste incinerator Federal plan are contained in subpart HHH
of this part. These requirements include emission limits, compliance
schedules, testing, monitoring and reporting and recordkeeping
requirements.
* * * * *
3. Add subpart HHH consisting of Secs. 62.14400 through 62.14495 as
follows:
Subpart HHH--Federal Plan Requirements for Hospital/ Medical/Infectious
Waste Incinerators Constructed on or before June 20, 1996.
Applicability
Sec.
62.14400 Am I subject to this subpart?
62.14401 How do I determine if my HMIWI is covered by an approved
and effective State or Tribal plan?
62.14402 If my HMIWI is not listed on the Federal plan inventory,
am I exempt from this subpart?
62.14403 What happens if I modify an existing HMIWI?
Emission Limits
62.14410 Are there different emission limits for different
locations and sizes of HMIWI?
62.14411 What emission limits apply to my HMIWI?
62.14412 What stack opacity requirements apply?
62.14413 When do the emission limits and stack opacity
requirements apply?
Operator Training and Qualification
62.14420 Am I required to have a trained and qualified operator?
62.14421 How does an operator become trained and qualified?
62.14422 What are the requirements for a training course that is
not part of a State-approved program?
62.14423 What are the qualification requirements for operators who
do not participate in a State-approved program?
62.14424 What documentation must I maintain onsite?
62.14425 When must I review the documentation?
Waste Management Plan
62.14430 Must I prepare a waste management plan?
62.14431 What must my waste management plan include?
62.14432 When must my waste management plan be completed?
Inspection Requirements
62.14440 Which HMIWI are subject to inspection requirements?
62.14441 When must I inspect my small rural HMIWI?
62.14442 What must my inspection include?
62.14443 When must I do repairs?
Performance Testing, and Monitoring Requirements
62.14450 What are the testing requirements for small rural HMIWI?
62.14451 What are the testing requirements for HMIWI that are not
small rural?
62.14452 What test methods and procedures must I use?
62.14453 What must I monitor?
62.14454 How must I monitor the required parameters?
62.14455 What if my HMIWI goes outside of a parameter limit?
Reporting and Recordkeeping Requirements
62.14460 What records must I maintain?
62.14461 For how long must I maintain records?
62.14462 Where must I keep the records?
62.14463 What reporting requirements must I satisfy?
62.14464 When must I submit reports?
62.14465 Who must sign all submitted reports?
Compliance Schedule
62.14470 When must I comply with this subpart if I plan to
continue operation of my HMIWI?
62.14471 When must I comply with this subpart if I plan to shut
down?
62.14472 When must I comply with this subpart if I plan to shut
down and later restart?
Permitting Obligation
62.14480 Does this subpart require me to obtain an operating
permit under title V of the Clean Air Act and implementing
regulations?
62.14481 When must I submit a title V permit application for my
HMIWI?
Definitions
62.14490 Definitions.
Delegation of Authority
62.14495 What authorities will be retained by the EPA
Administrator?
Tables
Table 1 of Subpart HHH of Part 62--Emission Limits for Small Rural,
Small, Medium, and Large Hmiwi
Table 2 of Subpart HHH of Part 62--Toxic Equivalency Factors
Table 3 of Subpart HHH of Part 62--Operating Parameters to Be
Monitored and Minimum Measurement and Recording Frequencies
Subpart HHH--Federal Plan Requirements for Hospital/Medical/
Infectious Waste Incinerators Constructed on or Before June 20,
1996
Applicability
Sec. 62.14400 Am I subject to this subpart?
(a) You are subject to this subpart if paragraphs (a)(1), (2), and
(3) of this section are all true:
(1) You own or operate an HMIWI that is not covered by an EPA
approved and effective State or Tribal plan;
(2) Construction of the HMIWI commenced on or before June 20, 1996;
and
(3) You do not meet any of the exemptions in paragraph (b) of this
section.
(b) The following exemptions apply:
----------------------------------------------------------------------------------------------------------------
If you . . . And you . . . And you . . . Then you . . .
----------------------------------------------------------------------------------------------------------------
(1) Own or operate an HMIWI that Notify the EPA Keep records on a Are not subject to the
combusts only pathological Administrator (or calendar quarter basis other sections of this
waste, low-level radioactive delegated enforcement of the periods of time subpart during periods
waste, and/or chemothera-peutic authority) of an when only pathological when only pathological,
waste (all defined in 40 CFR exemption claim. waste, low-level radio low-level radioactive,
62.14490). active waste, and/or and/or chemotherapeutic
chemo therapeutic waste wastes are combusted.
is combusted, and you
submit such records to
the EPA Administrator
(or delegated
enforcement authority)
upon request,.
[[Page 49882]]
(2) Own or operate a co-fired Notify the EPA Keep records on a Are not subject to the
combustor (defined in 40 CFR Administrator (or calendar quarter basis other sections of this
62.14490). delegated enforcement of the weight of subpart.
authority) of an hospital waste and
exemption claim and you medical/infectious
provide an estimate of waste combusted as well
the relative weight of as the weight of all
hospital waste, medical/ other fuels and wastes
infectious waste, and combusted at the co-
other fuels and/or fired combustor, and
wastes to be combusted. these records reflect
that the source
continues to meet the
definition of co-fired
combustor in 40 CFR
62.14490, and you
submit such records to
the EPA Administrator
(or delegated
enforcement authority)
upon request.
(3) Own or operate a combustor ......................... ........................ Are not subject to this
that must have a permit under subpart.
Section 3005 of the Solid Waste
Disposal Act.
(4) Own or operate a combustor ......................... ........................ Are not subject to this
which meets the applicability subpart.
requirements of 40 CFR part 60
subpart Cb, Ea, or Eb (standards
or guidelines for certain
municipal waste combustors).
(5) Own or operate a pyrolysis ......................... ........................ Are not subject to this
unit (defined in 40 CFR subpart.
62.14490) processing hospital
waste and/or medical/infectious
waste.
(6) Own or operate a cement kiln ......................... ........................ Are not subject to this
firing hospital waste and/or subpart.
medical/infectious waste.
----------------------------------------------------------------------------------------------------------------
(c) Owners or operators of sources that qualify for the exemptions
in paragraphs (b)(1) or (b)(2) of this section must submit records
required to support their claims of exemption to the EPA Administrator
(or delegated enforcement authority) upon request. Upon request by any
person under the regulation at part 2 of this chapter (or a comparable
law or regulation governing a delegated enforcement authority), the EPA
Administrator (or delegated enforcement authority) must request the
records in (b)(1) or (b)(2) from an owner or operator and make such
records available to the requestor to the extent required by part 2 of
this chapter (or a comparable law governing a delegated enforcement
authority). Records required under paragraphs (b)(1) and (b)(2) of this
section must be maintained by the source for a period of at least 5
years. Notifications of exemption claims required under paragraphs
(b)(1) and (b)(2) of this section must be maintained by the EPA or
delegated enforcement authority for a period of at least 5 years. Any
information obtained from an owner or operator of a source accompanied
by a claim of confidentiality will be treated in accordance with the
regulations in part 2 of this chapter (or a comparable law governing a
delegated enforcement authority).
Sec. 62.14401 How do I determine if my HMIWI is covered by an approved
and effective State or Tribal plan?
This part (40 CFR part 62) contains a list of all States and Tribal
areas with approved Clean Air Act section 111(d)/129 plans in effect.
However, this part is only updated once a year. Thus, if this part does
not indicate that your State or Tribal area has an approved and
effective plan, you should contact your State environmental agency's
air director or your EPA Regional Office to determine if approval
occurred since publication of the most recent version of this part.
Sec. 62.14402 If my HMIWI is not listed on the Federal plan inventory,
am I exempt from this subpart?
Not necessarily. Sources subject to this subpart include, but are
not limited to, the inventory of sources listed in Docket A-98-24 for
the Federal plan.
Sec. 62.14403 What happens if I modify an existing HMIWI?
(a) If you commenced modification (defined in 40 CFR 62.14490) of
an existing HMIWI after March 16, 1998, you are subject to 40 CFR part
60, subpart Ec (40 CFR 60.50c through 60.58c) and you are not subject
to this subpart, except as provided in paragraph (b) of this section.
(b) If you made physical or operational changes to your existing
HMIWI solely for the purpose of complying with this subpart, these
changes are not considered a modification, and you are not subject to
40 CFR part 60, subpart Ec (40 CFR 60.50c through 60.58c). You remain
subject to this subpart.
Emission Limits
Sec. 62.14410 Are there different emission limits for different
locations and sizes of HMIWI?
Yes, there are different emission limits for small rural, small,
medium, and large HMIWI. To determine the size category of your HMIWI,
consult the definitions in 40 CFR 62.14490.
Sec. 62.14411 What emission limits apply to my HMIWI?
You must operate your HMIWI in compliance with the emission limit
requirements for your HMIWI size category listed in Table 1 of this
subpart.
Sec. 62.14412 What stack opacity requirements apply?
Your HMIWI (regardless of size category) must not discharge into
the atmosphere from the stack any gases that exhibit greater than 10
percent opacity (6-minute block average).
[[Page 49883]]
Sec. 62.14413 When do the emission limits and stack opacity
requirements apply?
The emission limits and stack opacity requirements of this subpart
apply at all times except during periods of startup, shutdown, or
malfunction, provided that no hospital waste or medical/infectious
waste is charged to your HMIWI during periods of startup, shutdown, or
malfunction.
Operator Training and Qualification
Sec. 62.14420 Am I required to have a trained and qualified operator?
You must have a fully trained and qualified HMIWI operator, either
at your facility or able to be at your facility within 1 hour. The
trained and qualified HMIWI operator may operate the HMIWI directly or
be the direct supervisor of one or more HMIWI operators.
Sec. 62.14421 How does an operator become trained and qualified?
(a) The HMIWI operator can obtain training and qualification
through a State-approved program or as provided in paragraph (b) of
this section.
(b) If there are no State-approved training and qualification
programs available or if your operator does not want to participate in
a State-approved program, then your operator must complete a training
course that includes the requirements in Sec. 62.14422 and satisfy the
qualification requirements in Sec. 62.14423.
Sec. 62.14422 What are the requirements for a training course that is
not part of a State-approved program?
A training course must include:
(a) Twenty-four hours of training that includes all of the
following subjects:
(1) Environmental concerns, including pathogen destruction and
types of emissions;
(2) Basic combustion principles, including products of combustion;
(3) Operation of the type of incinerator to be used by the
operator, including proper startup, waste charging, and shutdown
procedures;
(4) Combustion controls and monitoring;
(5) Operation of air pollution control equipment and factors
affecting performance (if applicable);
(6) Methods to monitor pollutants (continuous emission monitoring
systems and monitoring of HMIWI and air pollution control device
operating parameters) and equipment calibration procedures (where
applicable);
(7) Inspection and maintenance of the HMIWI, air pollution control
devices, and continuous emission monitoring systems;
(8) Actions to correct malfunctions and conditions that may lead to
malfunction;
(9) Bottom and fly ash characteristics and handling procedures;
(10) Applicable Federal, State, and local regulations;
(11) Work safety procedures;
(12) Prestartup inspections; and
(13) Recordkeeping requirements.
(b) An examination designed and administered by the instructor; and
(c) Reference material distributed to the attendees covering the
course topics.
Sec. 62.14423 What are the qualification requirements for operators
who do not participate in a State-approved program?
(a) Operators who do not participate in a State-approved program
must satisfy paragraphs (a)(1) and (2) of this section:
(1) The operator must complete a training course that satisfies the
requirements in Sec. 62.14422; and
(2) The operator must have either 6 months experience as an HMIWI
operator, 6 months experience as a direct supervisor of an HMIWI
operator, or completion of at least two burn cycles under the
observation and supervision of two qualified HMIWI operators.
(b) The operator's qualification is valid after paragraphs (a)(1)
and (2) of this section are completed.
(c) To remain qualified, the operator must complete and pass an
annual review or refresher course of at least 4 hours covering, at a
minimum, the following:
(1) Update of regulations;
(2) Incinerator operation, including startup and shutdown
procedures;
(3) Inspection and maintenance;
(4) Responses to malfunctions or conditions that may lead to
malfunction; and
(5) Discussion of operating problems encountered by attendees.
(d) If the operator's qualification lapses, he or she must renew it
by one of the following methods:
(1) For a lapse of less than 3 years, complete and pass a standard
annual refresher course described in paragraph (c) of this section;
(2) For a lapse of 3 years or more, complete and pass a training
course with the minimum criteria described in Sec. 62.14422.
Sec. 62.14424 What documentation must I maintain onsite?
(a) You must maintain the following at the facility:
(1) Summary of the applicable standards under this subpart;
(2) Description of basic combustion theory applicable to an HMIWI;
(3) Procedures for receiving, handling, and charging waste;
(4) Procedures for startup, shutdown, and malfunction;
(5) Procedures for maintaining proper combustion air supply levels;
(6) Procedures for operating the HMIWI and associated air pollution
control systems within the standards established under this subpart;
(7) Procedures for responding to malfunction or conditions that may
lead to malfunction;
(8) Procedures for monitoring HMIWI emissions;
(9) Reporting and recordkeeping procedures; and
(10) Procedures for handling ash.
(b) You must keep the information listed in paragraph (a) of this
section in a readily accessible location for all HMIWI operators. This
information, along with records of training, must be available for
inspection by the EPA or its delegated enforcement agent upon request.
Sec. 62.14425 When must I review the documentation?
(a) You must establish a program for reviewing the information
listed in Sec. 62.14424 annually with each HMIWI operator (defined in
Sec. 62.14490).
(b) You must conduct your initial review of the information listed
in Sec. 62.14424 by February 15, 2001, or prior to assumption of
responsibilities affecting HMIWI operation, whichever is later.
(c) You must conduct subsequent reviews of the information listed
in Sec. 62.14424 annually.
Waste Management Plan
Sec. 62.14430 Must I prepare a waste management plan?
Yes. All HMIWI owners or operators must have a waste management
plan.
Sec. 62.14431 What must my waste management plan include?
Your waste management plan must identify both the feasibility of,
and the approach for, separating certain components of solid waste from
the health care waste stream in order to reduce the amount of toxic
emissions from incinerated waste. The waste management plan you develop
may address, but is not limited to, paper, cardboard, plastics, glass,
battery, or metal recycling, or purchasing recycled or recyclable
products. Your waste management plan may include different goals or
approaches for different areas or departments of the facility and need
not include new waste management goals for every waste stream. When you
develop your waste management plan it
[[Page 49884]]
should identify, where possible, reasonably available additional waste
management measures, taking into account the effectiveness of waste
management measures already in place, the costs of additional measures,
the emission reductions expected to be achieved, and any other
potential environmental or energy impacts they might have. In
developing your waste management plan, you must consider the American
Hospital Association publication entitled ``Ounce of Prevention: Waste
Reduction Strategies for Health Care Facilities.'' This publication
(AHA Catalog No. 057007) is available for purchase from the American
Hospital Association (AHA) Service, Inc., Post Office Box 92683,
Chicago, Illinois 60675-2683.
Sec. 62.14432 When must my waste management plan be completed?
As specified in Secs. 62.14463 and 62.14464, you must submit your
waste management plan with your initial report, which is due 60 days
after your initial performance test.
Inspection Requirements
Sec. 62.14440 Which HMIWI are subject to inspection requirements?
Only small rural HMIWI (defined in Sec. 62.14490) are subject to
inspection requirements.
Sec. 62.14441 When must I inspect my small rural HMIWI?
(a) You must inspect your small rural HMIWI by August 15, 2001.
(b) You must conduct inspections as outlined in Sec. 62.14442
annually (no more than 12 months following the previous annual
equipment inspection).
Sec. 62.14442 What must my inspection include?
At a minimum, you must do the following during your inspection:
(a) Inspect all burners, pilot assemblies, and pilot sensing
devices for proper operation, and clean pilot flame sensor as
necessary;
(b) Check for proper adjustment of primary and secondary chamber
combustion air, and adjust as necessary;
(c) Inspect hinges and door latches, and lubricate as necessary;
(d) Inspect dampers, fans, and blowers for proper operation;
(e) Inspect HMIWI door and door gaskets for proper sealing;
(f) Inspect motors for proper operation;
(g) Inspect primary chamber refractory lining, and clean and
repair/replace lining as necessary;
(h) Inspect incinerator shell for corrosion and/or hot spots;
(i) Inspect secondary/tertiary chamber and stack, and clean as
necessary;
(j) Inspect mechanical loader, including limit switches, for proper
operation, if applicable;
(k) Visually inspect waste bed (grates), and repair/ seal, as
necessary;
(l) For the burn cycle that follows the inspection, document that
the incinerator is operating properly and make any necessary
adjustments;
(m) Inspect air pollution control device(s) for proper operation,
if applicable;
(n) Inspect waste heat boiler systems to ensure proper operation,
if applicable;
(o) Inspect bypass stack components;
(p) Ensure proper calibration of thermocouples, sorbent feed
systems and any other monitoring equipment; and
(q) Generally observe that the equipment is maintained in good
operating condition.
Sec. 62.14443 When must I do repairs?
You must complete any necessary repairs within 10 operating days of
the inspection unless you obtain written approval from the EPA
Administrator (or delegated enforcement authority) establishing a
different date when all necessary repairs of your HMIWI must be
completed.
Performance Testing and Monitoring Requirements
Sec. 62.14450 What are the testing requirements for small rural HMIWI?
(a) If you operate a small rural HMIWI (defined in Sec. 62.14490),
you must conduct an initial performance test for PM, opacity, CO,
dioxin/furan, and Hg using the test methods and procedures outlined in
Sec. 62.14452.
(b) After the initial performance test is completed or is required
to be completed under Sec. 62.14470, whichever date comes first, if you
operate a small rural HMIWI you must determine compliance with the
opacity limit by conducting an annual performance test (no more than 12
months following the previous performance test) using the applicable
procedures and test methods listed in Sec. 62.14452.
(c) The 2,000 lb/wk limitation for small rural HMIWI does not apply
during performance tests.
(d) The EPA Administrator may request a repeat performance test at
any time.
Sec. 62.14451 What are the testing requirements for HMIWI that are not
small rural?
(a) If you operate an HMIWI that is not a small rural HMIWI, you
must conduct an initial performance test for PM, opacity, CO, dioxin/
furan, HCl, Pb, Cd, and Hg using the test methods and procedures
outlined in Sec. 62.14452.
(b) After the initial performance test is completed or is required
to be completed under Sec. 62.14470, whichever date comes first, you
must:
(1) Determine compliance with the opacity limit by conducting an
annual performance test (no more than 12 months following the previous
performance test) using the applicable procedures and test methods
listed in Sec. 62.14452.
(2) Determine compliance with the PM, CO, and HCl emission limits
by conducting an annual performance test (no more than 12 months
following the previous performance test) using the applicable
procedures and test methods listed in Sec. 62.14452. If all three
performance tests over a 3-year period indicate compliance with the
emission limit for a pollutant (PM, CO, or HCl), you may forego a
performance test for that pollutant for the next 2 years. At a minimum,
you must conduct a performance test for PM, CO, and HCl every third
year (no more than 36 months following the previous performance test).
If a performance test conducted every third year indicates compliance
with the emission limit for a pollutant (PM, CO, or HCl), you may
forego a performance test for that pollutant for an additional 2 years.
If any performance test indicates noncompliance with the respective
emission limit, you must conduct a performance test for that pollutant
annually until all annual performance tests over a 3-year period
indicate compliance with the emission limit.
(c) The EPA Administrator may request a repeat performance test at
any time.
Sec. 62.14452 What test methods and procedures must I use?
You must use the following test methods and procedures to conduct
performance tests to determine compliance with the emission limits:
(a) All performance tests must consist of a minimum of three test
runs conducted under representative operating conditions;
(b) The minimum sample time must be 1 hour per test run unless
otherwise indicated in this section;
(c) You must use EPA Reference Method 1 of 40 CFR part 60, appendix
A to select the sampling location and number of traverse points;
(d) You must use EPA Reference Method 3, 3A, or 3B of 40 CFR part
60, appendix A for gas composition analysis, including measurement of
[[Page 49885]]
oxygen concentration. You must use EPA Reference Method 3, 3A, or 3B of
40 CFR part 60, appendix A simultaneously with each reference method;
(e) You must adjust pollutant concentrations to 7 percent oxygen
using the following equation:
[GRAPHIC] [TIFF OMITTED] TR15AU00.000
Where:
Cadj = pollutant concentration adjusted to 7 percent oxygen;
Cmeas = pollutant concentration measured on a dry basis at
standard conditions
(20.9-7) = 20.9 percent oxygen--7 percent oxygen (defined oxygen
correction basis);
20.9 = oxygen concentration in air, percent; and
%O2 = oxygen concentration measured on a dry basis at
standard conditions, percent.
(f) Except as provided in paragraph (l) of this section, you must
use EPA Reference Method 5 or 29 of 40 CFR part 60, appendix A to
measure particulate matter emissions;
(g) Except as provided in paragraph (l) of this section, you must
use EPA Reference Method 9 of 40 CFR part 60, appendix A to measure
stack opacity;
(h) Except as provided in paragraph (l) of this section, you must
use EPA Reference Method 10 or 10B of 40 CFR part 60, appendix A to
measure the CO emissions;
(i) Except as provided in paragraph (l) of this section, you must
use EPA Reference Method 23 of 40 CFR part 60, appendix A to measure
total dioxin/furan emissions. The minimum sample time must be 4 hours
per test run. If you have selected the toxic equivalency standards for
dioxin/furans under Sec. 62.14411, you must use the following
procedures to determine compliance:
(1) Measure the concentration of each dioxin/furan tetra-through
octa-congener emitted using EPA Reference Method 23;
(2) For each dioxin/furan congener measured in accordance with
paragraph (i)(1) of this section, multiply the congener concentration
by its corresponding toxic equivalency factor specified in Table 2 of
this subpart;
(3) Sum the products calculated in accordance with paragraph (i)(2)
of this section to obtain the total concentration of dioxins/furans
emitted in terms of toxic equivalency.
(j) Except as provided in paragraph (l) of this section, you must
use EPA Reference Method 26 of 40 CFR part 60, appendix A to measure
HCl emissions. If you have selected the percentage reduction standards
for HCl under Sec. 62.14411, compute the percentage reduction in HCl
emissions (%RHCl) using the following formula:
[GRAPHIC] [TIFF OMITTED] TR15AU00.001
Where:
%RHCl = percentage reduction of HCl emissions achieved;
Ei = HCl emission concentration measured at the control
device inlet, corrected to 7 percent oxygen (dry basis at standard
conditions); and
Eo = HCl emission concentration measured at the control
device outlet, corrected to 7 percent oxygen (dry basis at standard
conditions).
(k) Except as provided in paragraph (l) of this section, you must
use EPA Reference Method 29 of 40 CFR part 60, appendix A to measure
Pb, Cd, and Hg emissions. If you have selected the percentage reduction
standards for metals under Sec. 62.14411, compute the percentage
reduction in emissions (%Rmetal) using the following
formula:
[GRAPHIC] [TIFF OMITTED] TR15AU00.002
Where:
%Rmetal = percentage reduction of metal emission (Pb, Cd, or
Hg) achieved;
Ei = metal emission concentration (Pb, Cd, or Hg) measured
at the control device inlet, corrected to 7 percent oxygen (dry basis
at standard conditions); and
Eo = metal emission concentration (Pb, Cd, or Hg) measured
at the control device outlet, corrected to 7 percent oxygen (dry basis
at standard conditions).
(l) If you are using a continuous emission monitoring system (CEMS)
to demonstrate compliance with any of the emission limits under
Secs. 62.14411 or 62.14412, you must:
(1) Determine compliance with the appropriate emission limit(s)
using a 12-hour rolling average, calculated each hour as the average of
the previous 12 operating hours (not including startup, shutdown, or
malfunction). Performance tests using EPA Reference Methods are not
required for pollutants monitored with CEMS.
(2) Operate a CEMS to measure oxygen concentration, adjusting
pollutant concentrations to 7 percent oxygen as specified in paragraph
(e) of this section.
(3) Operate all CEMS in accordance with the applicable procedures
under appendices B and F of 40 CFR part 60.
(m) Use of the bypass stack during a performance test will
invalidate the performance test.
Sec. 62.14453 What must I monitor?
(a) If your HMIWI is a small rural HMIWI, or your HMIWI is equipped
with a dry scrubber followed by a fabric filter, a wet scrubber, or a
dry scrubber followed by a fabric filter and wet scrubber:
(1) You must establish the appropriate maximum and minimum
operating parameters, indicated in Table 3, as site-specific operating
parameters during the initial performance test to determine compliance
with the emission limits; and
[[Page 49886]]
(2) After the date on which the initial performance test is
completed or is required to be completed under Sec. 62.14470, whichever
comes first, your HMIWI must not operate above any of the applicable
maximum operating parameters or below any of the applicable minimum
operating parameters listed in Table 3 and measured as 3-hour rolling
averages (calculated each hour as the average of the previous 3
operating hours), at all times except during startup, shutdown,
malfunction, and performance tests.
(b) If your HMIWI is not a small rural HMIWI, and you are using an
air pollution control device other than a dry scrubber followed by a
fabric filter, a wet scrubber, or a dry scrubber followed by a fabric
filter and a wet scrubber to comply with the emission limits under
Sec. 62.14411, you must petition the EPA Administrator for site-
specific operating parameters to be established during the initial
performance test and you must continuously monitor those parameters
thereafter. You may not conduct the initial performance test until the
EPA Administrator has approved the petition.
Sec. 62.14454 How must I monitor the required parameters?
(a) You must install, calibrate (to manufacturers' specifications),
maintain, and operate devices (or establish methods) for monitoring the
applicable maximum and minimum operating parameters listed in Table 3
of this subpart such that these devices (or methods) measure and record
values for the operating parameters at the frequencies indicated in
Table 3 of this subpart at all times except during periods of startup
and shutdown. For charge rate, the device must measure and record the
date, time, and weight of each charge fed to the HMIWI. This must be
done automatically, meaning that the only intervention from an operator
during the process would be to load the charge onto the weighing
device. For batch HMIWI, the maximum charge rate is measured on a daily
basis (the amount of waste charged to the unit each day).
(b) For all HMIWI except small rural HMIWI, you must install,
calibrate (to manufacturers' specifications), maintain, and operate a
device or method for measuring the use of the bypass stack, including
the date, time, and duration of such use.
(c) For all HMIWI except small rural HMIWI, if you are using
controls other than a dry scrubber followed by a fabric filter, a wet
scrubber, or a dry scrubber followed by a fabric filter and a wet
scrubber to comply with the emission limits under Sec. 62.14411, you
must install, calibrate (to manufacturers' specifications), maintain,
and operate the equipment necessary to monitor the site-specific
operating parameters developed pursuant to Sec. 62.14453(b).
(d) You must obtain monitoring data at all times during HMIWI
operation except during periods of monitoring equipment malfunction,
calibration, or repair. At a minimum, valid monitoring data must be
obtained for 75 percent of the operating hours per day for 90 percent
of the operating days per calendar quarter that your HMIWI is
combusting hospital waste and/or medical/infectious waste.
Sec. 62.14455 What if my HMIWI goes outside of a parameter limit?
(a) Operation above the established maximum or below the
established minimum operating parameter(s) constitutes a violation of
established operating parameter(s). Operating parameter limits do not
apply during startup, shutdown, malfunction, and performance tests.
(b) Except as provided in paragraph (f) or (g) of this section, if
your HMIWI is a small rural HMIWI,
------------------------------------------------------------------------
Then you are in
And your HMIWI . . . violation of . . .
------------------------------------------------------------------------
Operates above the maximum charge rate (3-hour The PM, CO, and
rolling average for continuous and intermittent dioxin/furan
HMIWI, daily average for batch HMIWI) and below emission limits.
the minimum secondary chamber temperature (3-hour
rolling average) simultaneously.
------------------------------------------------------------------------
(c) Except as provided in paragraph (f) or (g) of this section, if
your HMIWI is equipped with a dry scrubber followed by a fabric filter:
------------------------------------------------------------------------
Then you are in
And your HMIWI . . . violation of . . .
------------------------------------------------------------------------
(1) Operates above the maximum charge rate (3-hour The CO emission
rolling average for continuous and intermittent limit.
HMIWI, daily average for batch HMIWI) and below
the minimum secondary chamber temperature (3-hour
rolling average) simultaneously.
(2) Operates above the maximum fabric filter inlet The dioxin/furan
temperature (3-hour rolling average), above the emission limit.
maximum charge rate (3-hour rolling average for
continuous and intermittent HMIWI, daily average
for batch HMIWI), and below the minimum dioxin/
furan sorbent flow rate (3-hour rolling average)
simultaneously.
(3) Operates above the maximum charge rate (3-hour The HCl emission
rolling average for continuous and intermittent limit.
HMIWI, daily average for batch HMIWI) and below
the minimum HCl sorbent flow rate (3-hour rolling
average) simultaneously.
(4) Operates above the maximum charge rate (3-hour The Hg emission
rolling average for continuous and intermittent limit.
HMIWI, daily average for batch HMIWI) and below
the minimum Hg sorbent flow rate (3-hour rolling
average) simultaneously.
(5) Uses the bypass stack (except during startup, The PM, dioxin/
shutdown, or malfunction). furan, HCl, Pb, Cd,
and Hg emission
limits.
------------------------------------------------------------------------
(d) Except as provided in paragraph (f) or (g) of this section, if
your HMIWI is equipped with a wet scrubber:
------------------------------------------------------------------------
Then you are in
And your HMIWI . . . violation of . . .
------------------------------------------------------------------------
(1) Operates above the maximum charge rate (3-hour The CO emission
rolling average for continuous and intermittent limit.
HMIWI, daily average for batch HMIWI) and below
the minimum secondary chamber temperature (3-hour
rolling average) simultaneously.
[[Page 49887]]
(2) Operates above the maximum charge rate (3-hour The PM emission
rolling average for continuous and intermittent limit.
HMIWI, daily average for batch HMIWI) and below
the minimum pressure drop across the wet scrubber
(3-hour rolling average) or below the minimum
horsepower or amperage to the system (3-hour
rolling average) simultaneously.
(3) Operates above the maximum charge rate (3-hour The dioxin/furan
rolling average for continuous and intermittent emission limit.
HMIWI, daily average for batch HMIWI), below the
minimum secondary chamber temperature (3-hour
rolling average), and below the minimum scrubber
liquor flow rate (3-hour rolling average)
simultaneously.
(4) Operates above the maximum charge rate (3-hour The HCl emission
rolling average for continuous and intermittent limit.
HMIWI, daily average for batch HMIWI) and below
the minimum scrubber liquor pH (3-hour rolling
average) simultaneously.
(5) Operates above the maximum flue gas The Hg emission
temperature (3-hour rolling average) and above limit.
the maximum charge rate (3-hour rolling average
for continuous and intermittent HMIWI, daily
average for batch HMIWI) simultaneously.
(6) Uses the bypass stack (except during startup, The PM, dioxin/
shutdown, or malfunction). furan, HCl, Pb, Cd,
and Hg emission
limits.
------------------------------------------------------------------------
(e) Except as provided in paragraph (f) or (g) of this section, if
your HMIWI is equipped with a dry scrubber followed by a fabric filter
and a wet scrubber:
------------------------------------------------------------------------
Then you are in
And your HMIWI . . . violation of . . .
------------------------------------------------------------------------
(1) Operates above the maximum charge rate (3-hour The CO emission
rolling average for continuous and intermittent limit.
HMIWI, daily average for batch HMIWI) and below
the minimum secondary chamber temperature (3-hour
rolling average) simultaneously.
(2) Operates above the maximum fabric filter inlet The dioxin/furan
temperature (3-hour rolling average), above the emission limit.
maximum charge rate (3-hour rolling average for
continuous and intermittent HMIWI, daily average
for batch HMIWI), and below the minimum dioxin/
furan sorbent flow rate (3-hour rolling average)
simultaneously.
(3) Operates above the maximum charge rate (3-hour The HCl emission
rolling average for continuous and intermittent limit.
HMIWI, daily average for batch HMIWI) and below
the minimum scrubber liquor pH (3-hour rolling
average) simultaneously.
(4) Operates above the maximum charge rate (3-hour The Hg emission
rolling average for continuous and intermittent limit.
HMIWI, daily average for batch HMIWI) and below
the minimum Hg sorbent flow rate (3-hour rolling
average) simultaneously.
(5) Uses the bypass stack (except during startup, The PM, dioxin/
shutdown, or malfunction). furan, HCl, Pb, Cd,
and Hg emission
limits.
------------------------------------------------------------------------
(f) You may conduct a repeat performance test within 30 days of
violation of applicable operating parameter(s) to demonstrate that your
HMIWI is not in violation of the applicable emission limit(s). You must
conduct repeat performance tests pursuant to this paragraph using the
identical operating parameters that indicated a violation under
paragraph (b), (c), (d) or (e) of this section.
(g) If you are using a CEMS to demonstrate compliance with any of
the emission limits in Table 1 of this subpart or Sec. 62.14412, and
your CEMS indicates compliance with an emission limit during periods
when operating parameters indicate a violation of an emission limit
under paragraphs (b), (c), (d), or (e) of this section, then you are
considered to be in compliance with the emission limit. You need not
conduct a repeat performance test to demonstrate compliance.
(h) You may conduct a repeat performance test in accordance with
Sec. 62.14452 at any time to establish new values for the operating
parameters.
Reporting and Recordkeeping Requirements
Sec. 62.14460 What records must I maintain?
You must maintain the following:
(a) Calendar date of each record;
(b) Records of the following data:
(1) Concentrations of any pollutant listed in Table 1 and/or
measurements of opacity;
(2) The HMIWI charge dates, times, and weights and hourly charge
rates;
(3) Fabric filter inlet temperatures during each minute of
operation, as applicable;
(4) Amount and type of dioxin/furan sorbent used during each hour
of operation, as applicable;
(5) Amount and type of Hg sorbent used during each hour of
operation, as applicable;
(6) Amount and type of HCl sorbent used during each hour of
operation, as applicable;
(7) Secondary chamber temperatures recorded during each minute of
operation;
(8) Liquor flow rate to the wet scrubber inlet during each minute
of operation, as applicable,
(9) Horsepower or amperage to the wet scrubber during each minute
of operation, as applicable;
(10) Pressure drop across the wet scrubber system during each
minute of operation, as applicable;
(11) Temperature at the outlet from the wet scrubber during each
minute of operation, as applicable;
(12) The pH at the inlet to the wet scrubber during each minute of
operation, as applicable;
(13) Records of the annual equipment inspections, any required
maintenance, and any repairs not completed within 10 operating days of
an inspection or the time frame established by the EPA Administrator or
delegated enforcement authority, as applicable;
(14) Records indicating use of the bypass stack, including dates,
times, and durations; and
(15) If you are complying by monitoring site-specific operating
parameters under Sec. 62.14453(b), you must monitor all operating data
collected.
(c) Identification of calendar days for which data on emission
rates or operating parameters specified under paragraph (b)(1) through
(15) of this
[[Page 49888]]
section were not obtained, with an identification of the emission rates
or operating parameters not measured, reasons for not obtaining the
data, and a description of corrective actions taken;
(d) Identification of calendar days, times and durations of
malfunctions, and a description of the malfunction and the corrective
action taken.
(e) Identification of calendar days for which data on emission
rates or operating parameters specified under paragraphs (b)(1) through
(15) of this section exceeded the applicable limits, with a description
of the exceedances, reasons for such exceedances, and a description of
corrective actions taken.
(f) The results of the initial, annual, and any subsequent
performance tests conducted to determine compliance with the emission
limits and/or to establish operating parameters, as applicable.
(g) Records showing the names of HMIWI operators who have completed
review of the documentation in Sec. 62.14424 as required by
Sec. 62.14425, including the date of the initial review and all
subsequent annual reviews;
(h) Records showing the names of the HMIWI operators who have
completed the operator training requirements, including documentation
of training and the dates of the training;
(i) Records showing the names of the HMIWI operators who have met
the criteria for qualification under Sec. 62.14423 and the dates of
their qualification; and
(j) Records of calibration of any monitoring devices as required
under Sec. 62.14454.
Sec. 62.14461 For how long must I maintain records?
You must maintain the records specified under Sec. 62.14460 for a
period of at least 5 years.
Sec. 62.14462 Where must I keep the records?
You must maintain all records specified under Sec. 62.14460 onsite
in either paper copy or computer-readable format, unless an alternative
format is approved by the EPA Administrator.
Sec. 62.14463 What reporting requirements must I satisfy?
You must report the following to the EPA Administrator (or
delegated enforcement authority):
(a) The initial performance test data as recorded under
Sec. 62.14450(a) or Sec. 62.14451(a) (whichever applies);
(b) The values for the site-specific operating parameters
established pursuant to Sec. 62.14453, as applicable;
(c) The waste management plan as specified in Sec. 62.14431;
(d) The highest maximum operating parameter and the lowest minimum
operating parameter for each operating parameter recorded for the
calendar year being reported, pursuant to Sec. 62.14453, as applicable;
(e) The highest maximum operating parameter and the lowest minimum
operating parameter, as applicable, for each operating parameter
recorded pursuant to Sec. 62.14453 for the calendar year preceding the
year being reported, in order to provide a summary of the performance
of the HMIWI over a 2-year period;
(f) Any information recorded under Sec. 62.14460(c) through (e) for
the calendar year being reported;
(g) Any information recorded under Sec. 62.14460(c) through (e) for
the calendar year preceding the year being reported, in order to
provide a summary of the performance of the HMIWI over a 2-year period;
(h) The results of any performance test conducted during the
reporting period;
(i) If no exceedances or malfunctions occurred during the calendar
year being reported, a statement that no exceedances occurred during
the reporting period;
(j) Any use of the bypass stack, duration of such use, reason for
malfunction, and corrective action taken; and
(k) Records of the annual equipment inspections, any required
maintenance, and any repairs not completed within 10 days of an
inspection or the time frame established by the EPA Administrator (or
delegated enforcement authority).
Sec. 62.14464 When must I submit reports?
(a) You must submit the information specified in Sec. 62.14463(a)
through (c) no later than 60 days following the initial performance
test.
(b) You must submit an annual report to the EPA Administrator (or
delegated enforcement authority) no more than 1 year following the
submission of the information in paragraph (a) of this section and you
must submit subsequent reports no more than 1 year following the
previous report (once the unit is subject to permitting requirements
under title V of the Clean Air Act, you must submit these reports
semiannually). The annual report must include the information specified
in Sec. 62.14463(d) through (k), as applicable.
(c) You must submit semiannual reports containing any information
recorded under Sec. 62.14460(c) through (e) no later than 60 days
following the end of the semiannual reporting period. The first
semiannual reporting period ends 6 months following the submission of
information in paragraph (a) of this section. Subsequent reports must
be submitted no later than 6 calendar months following the previous
report.
Sec. 62.14465 Who must sign all submitted reports?
All reports must be signed by the facilities manager (defined in
Sec. 62.14490).
Compliance Schedule
Sec. 62.14470 When must I comply with this subpart if I plan to
continue operation of my HMIWI?
If you plan to continue operation of your HMIWI, then you must
follow the requirements in paragraph (a) or (b) of this section
depending on when you plan to come into compliance with the
requirements of this subpart.
(a) If you plan to continue operation and come into compliance with
the requirements of this subpart by August 15, 2001, then you must
complete the requirements of paragraphs (a)(1) through (a)(4) of this
section.
(1) You must comply with the operator training and qualification
requirements and inspection requirements (if applicable) of this
subpart by August 15, 2001.
(2) You must achieve final compliance by August 15, 2001. This
includes incorporating all process changes and/or completing retrofit
construction, connecting the air pollution control equipment or process
changes such that the HMIWI is brought on line, and ensuring that all
necessary process changes and air pollution control equipment are
operating properly.
(3) You must conduct the initial performance test required by
Sec. 62.14450(a) (for small rural HMIWI) or Sec. 62.14451(a) (for HMIWI
that are not small rural HMIWI) within 180 days after the date when you
are required to achieve final compliance under paragraph (a)(2) of this
section.
(4) You must submit an initial report including the results of the
initial performance test and the waste management plan no later than 60
days following the initial performance test (see Secs. 62.14463 and
62.14464 for complete reporting and recordkeeping requirements).
(b) If you plan to continue operation and come into compliance with
the requirements of this subpart after August 15, 2001, but before
September 15, 2002, then you must complete the requirements of
paragraphs (b)(1) through (b)(4) of this section.
(1) You must comply with the operator training and qualification
[[Page 49889]]
requirements and inspection requirements (if applicable) of this
subpart by August 15, 2001.
(2) You must demonstrate that you are taking steps towards
compliance with the emission limits in the subpart by completing the
increments of progress in paragraphs (b)(2)(i) through (b)(2)(v) of
this section. You must submit notification to the EPA Administrator (or
delegated enforcement authority) within 10 business days of completing
(or failing to complete by the applicable date) each of the increments
of progress listed in paragraphs (b)(2)(i) through (b)(2)(v) of this
section. Your notification must be signed by your facilities manager
(defined in Sec. 62.14490).
(i) You must submit a final control plan by September 15, 2000.
Your final control plan must, at a minimum, include a description of
the air pollution control device(s) or process changes that will be
employed for each unit to comply with the emission limits and other
requirements of this subpart.
(ii) You must award contract(s) for onsite construction, onsite
installation of emission control equipment, or incorporation of process
changes by April 15, 2001. You must submit a signed copy of the
contract(s) awarded.
(iii) You must begin onsite construction, begin onsite installation
of emission control equipment, or begin process changes needed to meet
the emission limits as outlined in the final control plan by December
15, 2001.
(iv) You must complete onsite construction, installation of
emission control equipment, or process changes by July 15, 2002.
(v) You must achieve final compliance by September 15, 2002. This
includes incorporating all process changes and/or completing retrofit
construction as described in the final control plan, connecting the air
pollution control equipment or process changes such that the HMIWI is
brought on line, and ensuring that all necessary process changes and
air pollution control equipment are operating properly.
(3) You must conduct the initial performance test required by
Sec. 62.14450(a) (for small rural HMIWI) or Sec. 62.14451(a) (for HMIWI
that are not small rural HMIWI) within 180 days after the date when you
are required to achieve final compliance under paragraph (b)(2)(v) of
this section.
(4) You must submit an initial report including the result of the
initial performance test and the waste management plan no later than 60
days following the initial performance test (see Secs. 62.14463 and
62.14464 for complete reporting and recordkeeping requirements).
Sec. 62.14471 When must I comply with this subpart if I plan to shut
down?
If you plan to shut down, then you must follow the requirements in
either paragraph (a) or (b) of this section depending on when you plan
to shut down.
(a) If you plan to shut down by August 15, 2001, rather that come
into compliance with the requirements of this subpart, then you must
shut down by August 15, 2001, to avoid coverage under any of the
requirements of this subpart.
(b) If you plan to shut down rather than come into compliance with
the requirements of this subpart, but are unable to shut down by August
15, 2001, then you may petition EPA for an extension by following the
procedures outlined in paragraphs (b)(1) through (b)(3) of this
section.
(1) You must submit your request for an extension to the EPA
Administrator (or delegated enforcement authority) by November 13,
2000. Your request must include:
(i) Documentation of the analyses undertaken to support your need
for an extension, including an explanation of why your requested
extension date is sufficient time for you to shut down while August 15,
2001, does not provide sufficient time for shut down. Your
documentation must include an evaluation of the option to transport
your waste offsite to a commercial medical waste treatment and disposal
facility on a temporary or permanent basis; and
(ii) Documentation of incremental steps of progress, including
dates for completing the increments of progress, that you will take
towards shutting down. Some suggested incremental steps of progress
towards shut down are provided as follows:
------------------------------------------------------------------------
Then your increments of
If you . . . progress could be . . .
------------------------------------------------------------------------
Need an extension so you can install an Date when you will enter
onsite alternative waste treatment into a contract with an
technology before you shut down your alternative treatment
HMIWI,. technology vendor,
Date for initiating onsite
construction or
installation of the
alternative technology, and
Date for completing onsite
construction or
installation of the
alternative technology, and
Date for shutting down the
HMIWI.
Need an extension so you can acquire the
services of a commercial medical/
infectious waste disposal company before
you shut down your HMIWI,.
Date when price quotes will
be obtained from commercial
disposal companies,
Date when you will enter
into a contract with a
commercial disposal
company, and
Date for shutting down the
HMIWI.
------------------------------------------------------------------------
(2) You must shut down no later than September 15, 2002.
(3) You must comply with the operator training and qualification
requirements and inspection requirements (if applicable) of this
subpart by August 15, 2001.
Sec. 62.14472 When must I comply with this subpart if I plan to shut
down and later restart?
If you wish to shut down and later restart, then you must follow
the compliance times in paragraph (a), (b), or (c) of this section
depending on when you shut down and restart.
(a) If you plan to shut down and restart prior to September 15,
2002, then you must:
(1) Meet the compliance schedule outlined in Sec. 63.14470(a) if
you restart prior to August 15, 2001; or
(2) Meet the compliance schedule outlined in Sec. 62.14470(b) if
you restart after August 15, 2001. Any missed increments of progress
need to be completed prior to or upon the date of restart.
(b) If you plan to shut down by August 15, 2001, and restart after
September 15, 2002, then you must complete the requirements of
paragraphs (b)(1) through (b)(5) of this section.
(1) You must shut down by August 15, 2001.
(2) You must comply with the operator training and qualification
requirements and inspection
[[Page 49890]]
requirements (if applicable) of this subpart before restarting your
HMIWI.
(3) You must achieve final compliance upon restarting your HMIWI.
This includes incorporating all process changes and/or completing
retrofit construction, connecting the air pollution control equipment
or process changes such that the HMIWI is brought on line, and ensuring
that all necessary process changes and air pollution control equipment
are operating properly.
(4) You must conduct the initial performance test required by
Sec. 62.14450(a) (for small rural HMIWI) or Sec. 62.14451(a) (for HMIWI
that are not small rural HMIWI) within 180 days after the date when you
restart.
(5) You must submit an initial report including the results of the
initial performance test and the waste management plan no later than 60
days following the initial performance test (see Secs. 62.14463 and
62.14464 for complete reporting and recordkeeping requirements).
(c) If you plan to shut down after August 15, 2001, and restart
after September 15, 2002, then you must complete the requirements of
paragraphs (c)(1) and (c)(2) of this section.
(1) You must petition EPA for an extension by following the
procedures outlined in Sec. 63.14471 paragraphs (b)(1) through (b)(3).
(2) You must comply with the requirements of paragraphs (b)(2)
through (b)(5) of this section.
Permitting Obligation
Sec. 62.14480 Does this subpart require me to obtain an operating
permit under title V of the Clean Air Act and implementing regulations?
This subpart requires you to obtain an operating permit under title
V of the Clean Air Act and implementing regulations (``title V
permit'') unless you are only subject to the recordkeeping and
reporting requirements listed at Sec. 62.14400(b)(1) or (b)(2), and
Sec. 62.14400(c), of this subpart. Also, if you own or operate a unit
described in Sec. 62.14400(b)(3), (b)(4), (b)(5) or (b)(6), you are not
subject to any requirements of this subpart; therefore, this subpart
does not require you to obtain a title V permit.
Sec. 62.14481 When must I submit a title V permit application for my
HMIWI?
You must submit a title V permit application in time for it to be
determined or deemed complete by no later than September 15, 2000 or by
the effective date of a title V permits program in the jurisdiction in
which the unit is located, whichever is later. (An earlier deadline may
apply if your HMIWI is also subject to title V permitting requirements
because of some other triggering requirement.) A ``complete'' title V
permit application is one that has been approved by the appropriate
permitting authority as complete under Section 503 of the Clean Air Act
and 40 CFR parts 70 and 71. It is not enough to have submitted a title
V permit application by September 15, 2000 because the application must
be determined or deemed complete by the permitting authority by that
date for your HMIWI to operate after that date in compliance with
Federal law.
Definitions
Sec. 62.14490 Definitions.
Batch HMIWI means an HMIWI that is designed such that neither waste
charging nor ash removal can occur during combustion.
Biologicals means preparations made from living organisms and their
products, including vaccines, cultures, etc., intended for use in
diagnosing, immunizing, or treating humans or animals or in research
pertaining thereto.
Blood products means any product derived from human blood,
including but not limited to blood plasma, platelets, red or white
blood corpuscles, and other derived licensed products, such as
interferon, etc.
Body fluids means liquid emanating or derived from humans and
limited to blood; dialysate; amniotic, cerebrospinal, synovial,
pleural, peritoneal and pericardial fluids; and semen and vaginal
secretions.
Bypass stack means a device used for discharging combustion gases
to avoid severe damage to the air pollution control device or other
equipment.
Chemotherapeutic waste means waste material resulting from the
production or use of antineoplastic agents used for the purpose of
stopping or reversing the growth of malignant cells.
Co-fired combustor means a unit combusting hospital waste and/or
medical/infectious waste with other fuels or wastes (e.g., coal,
municipal solid waste) and subject to an enforceable requirement
limiting the unit to combusting a fuel feed stream, 10 percent or less
of the weight of which is comprised, in aggregate, of hospital waste
and medical/infectious waste as measured on a calendar quarter basis.
For purposes of this definition, pathological waste, chemotherapeutic
waste, and low-level radioactive waste are considered ``other'' wastes
when calculating the percentage of hospital waste and medical/
infectious waste combusted.
Continuous emission monitoring system or CEMS means a monitoring
system for continuously measuring and recording the emissions of a
pollutant.
Continuous HMIWI means an HMIWI that is designed to allow waste
charging and ash removal during combustion.
Dioxins/furans means the combined emissions of tetra-through octa-
chlorinated dibenzo-para-dioxins and dibenzofurans, as measured by EPA
Reference Method 23.
Dry scrubber means an add-on air pollution control system that
injects dry alkaline sorbent (dry injection) or sprays an alkaline
sorbent (spray dryer) to react with and neutralize acid gases in the
HMIWI exhaust stream forming a dry powder material.
Fabric filter or baghouse means an add-on air pollution control
system that removes particulate matter (PM) and nonvaporous metals
emissions by passing flue gas through filter bags.
Facilities manager means the individual in charge of purchasing,
maintaining, and operating the HMIWI or the owner's or operator's
representative responsible for the management of the HMIWI. Alternative
titles may include director of facilities or vice president of support
services.
High-air phase means the stage of the batch operating cycle when
the primary chamber reaches and maintains maximum operating
temperatures.
Hospital means any facility which has an organized medical staff,
maintains at least six inpatient beds, and where the primary function
of the institution is to provide diagnostic and therapeutic patient
services and continuous nursing care primarily to human inpatients who
are not related and who stay on average in excess of 24 hours per
admission. This definition does not include facilities maintained for
the sole purpose of providing nursing or convalescent care to human
patients who generally are not acutely ill but who require continuing
medical supervision.
Hospital/medical/infectious waste incinerator or HMIWI or HMIWI
unit means any device that combusts any amount of hospital waste and/or
medical/infectious waste.
Hospital/medical/infectious waste incinerator operator or HMIWI
operator means any person who operates, controls or supervises the day-
to-day operation of an HMIWI.
Hospital waste means discards generated at a hospital, except
unused items returned to the manufacturer. The definition of hospital
waste does not include human corpses, remains, and
[[Page 49891]]
anatomical parts that are intended for interment or cremation.
Infectious agent means any organism (such as a virus or bacteria)
that is capable of being communicated by invasion and multiplication in
body tissues and capable of causing disease or adverse health impacts
in humans.
Intermittent HMIWI means an HMIWI that is designed to allow waste
charging, but not ash removal, during combustion.
Large HMIWI means:
(1) Except as provided in paragraph (2) of this definition;
(i) An HMIWI whose maximum design waste burning capacity is more
than 500 pounds per hour; or
(ii) A continuous or intermittent HMIWI whose maximum charge rate
is more than 500 pounds per hour; or
(iii) A batch HMIWI whose maximum charge rate is more than 4,000
pounds per day.
(2) The following are not large HMIWI:
(i) A continuous or intermittent HMIWI whose maximum charge rate is
less than or equal to 500 pounds per hour; or
(ii) A batch HMIWI whose maximum charge rate is less than or equal
to 4,000 pounds per day.
Low-level radioactive waste means waste material which contains
radioactive nuclides emitting primarily beta or gamma radiation, or
both, in concentrations or quantities that exceed applicable federal or
State standards for unrestricted release. Low-level radioactive waste
is not high-level radioactive waste, spent nuclear fuel, or by-product
material as defined by the Atomic Energy Act of 1954 (42 U.S.C.
2014(e)(2)).
Malfunction means any sudden, infrequent, and not reasonably
preventable failure of air pollution control equipment, process
equipment, or a process to operate in a normal or usual manner.
Failures that are caused, in part, by poor maintenance or careless
operation are not malfunctions. During periods of malfunction the
operator must operate within established parameters as much as
possible, and monitoring of all applicable operating parameters must
continue until all waste has been combusted or until the malfunction
ceases, whichever comes first.
Maximum charge rate means:
(1) For continuous and intermittent HMIWI, 110 percent of the
lowest 3-hour average charge rate measured during the most recent
performance test demonstrating compliance with all applicable emission
limits.
(2) For batch HMIWI, 110 percent of the lowest daily charge rate
measured during the most recent performance test demonstrating
compliance with all applicable emission limits.
Maximum design waste burning capacity means:
(1) For intermittent and continuous HMIWI,
[GRAPHIC] [TIFF OMITTED] TR15AU00.003
Where:
C = HMIWI capacity, lb/hr
PV = primary chamber volume, ft\3\
15,000 = primary chamber heat release rate factor, Btu/ft\3\/hr
8,500 = standard waste heating value, Btu/lb;
(2) For batch HMIWI,
[GRAPHIC] [TIFF OMITTED] TR15AU00.004
Where:
C = HMIWI capacity, lb/hr
PV = primary chamber volume, ft\3\
4.5 = waste density, lb/ft\3\
8 = typical hours of operation of a batch HMIWI, hours.
Maximum fabric filter inlet temperature means 110 percent of the
lowest 3-hour average temperature at the inlet to the fabric filter
(taken, at a minimum, once every minute) measured during the most
recent performance test demonstrating compliance with the dioxin/furan
emission limit.
Maximum flue gas temperature means 110 percent of the lowest 3-hour
average temperature at the outlet from the wet scrubber (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with the mercury (Hg) emission limit.
Medical/infectious waste means any waste generated in the
diagnosis, treatment, or immunization of human beings or animals, in
research pertaining thereto, or in the production or testing of
biologicals that is listed in paragraphs (1) through (7) of this
definition. The definition of medical/infectious waste does not include
hazardous waste identified or listed under the regulations in part 261
of this chapter; household waste, as defined in Sec. 261.4(b)(1) of
this chapter; ash from incineration of medical/infectious waste, once
the incineration process has been completed; human corpses, remains,
and anatomical parts that are intended for interment or cremation; and
domestic sewage materials identified in Sec. 261.4(a)(1) of this
chapter.
(1) Cultures and stocks of infectious agents and associated
biologicals, including: Cultures from medical and pathological
laboratories; cultures and stocks of infectious agents from research
and industrial laboratories; wastes from the production of biologicals;
discarded live and attenuated vaccines; and culture dishes and devices
used to transfer, inoculate, and mix cultures.
(2) Human pathological waste, including tissues, organs, and body
parts and body fluids that are removed during surgery or autopsy, or
other medical procedures, and specimens of body fluids and their
containers.
(3) Human blood and blood products including:
(i) Liquid waste human blood;
(ii) Products of blood;
(iii) Items saturated and/or dripping with human blood; or
(iv) Items that were saturated and/or dripping with human blood
that are now caked with dried human blood; including serum, plasma, and
other blood components, and their containers, which were used or
intended for use in either patient care, testing and laboratory
analysis or the development of pharmaceuticals. Intravenous bags are
also include in this category.
(4) Sharps that have been used in animal or human patient care or
treatment or in medical, research, or industrial laboratories,
including hypodermic needles, syringes (with or without the attached
needle), Pasteur pipettes, scalpel blades, blood vials, needles with
attached tubing, and culture dishes (regardless of presence of
infectious agents). Also included are other types of broken or unbroken
glassware that were in contact with infectious agents, such as used
slides and cover slips.
[[Page 49892]]
(5) Animal waste including contaminated animal carcasses, body
parts, and bedding of animals that were known to have been exposed to
infectious agents during research (including research in veterinary
hospitals), production of biologicals or testing of pharmaceuticals.
(6) Isolation wastes including biological waste and discarded
materials contaminated with blood, excretions, exudates, or secretions
from humans who are isolated to protect others from certain highly
communicable diseases, or isolated animals known to be infected with
highly communicable diseases.
(7) Unused sharps including the following unused, discarded sharps:
hypodermic needles, suture needles, syringes, and scalpel blades.
Medium HMIWI means:
(1) Except as provided in paragraph (2) of this definition;
(i) An HMIWI whose maximum design waste burning capacity is more
than 200 pounds per hour but less than or equal to 500 pounds per hour;
or
(ii) A continuous or intermittent HMIWI whose maximum charge rate
is more than 200 pounds per hour but less than or equal to 500 pounds
per hour; or
(iii) A batch HMIWI whose maximum charge rate is more than 1,600
pounds per day but less than or equal to 4,000 pounds per day.
(2) The following are not medium HMIWI:
(i) A continuous or intermittent HMIWI whose maximum charge rate is
less than or equal to 200 pounds per hour or more than 500 pounds per
hour; or
(ii) A batch HMIWI whose maximum charge rate is more than 4,000
pounds per day or less than or equal to 1,600 pounds per day.
Minimum dioxin/furan sorbent flow rate means 90 percent of the
highest 3-hour average dioxin/furan sorbent flow rate (taken, at a
minimum, once every hour) measured during the most recent performance
test demonstrating compliance with the dioxin/furan emission limit.
Minimum Hg sorbent flow rate means 90 percent of the highest 3-hour
average Hg sorbent flow rate (taken, at a minimum, once every hour)
measured during the most recent performance test demonstrating
compliance with the Hg emission limit.
Minimum horsepower or amperage means 90 percent of the highest 3-
hour average horsepower or amperage to the wet scrubber (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with the applicable emission limits.
Minimum hydrogen chloride (HCl) sorbent flow rate means 90 percent
of the highest 3-hour average HCl sorbent flow rate (taken, at a
minimum, once every hour) measured during the most recent performance
test demonstrating compliance with the HCl emission limit.
Minimum pressure drop across the wet scrubber means 90 percent of
the highest 3-hour average pressure drop across the wet scrubber PM
control device (taken, at a minimum, once every minute) measured during
the most recent performance test demonstrating compliance with the PM
emission limit.
Minimum scrubber liquor flow rate means 90 percent of the highest
3-hour average liquor flow rate at the inlet to the wet scrubber
(taken, at a minimum, once every minute) measured during the most
recent performance test demonstrating compliance with all applicable
emission limits.
Minimum scrubber liquor pH means 90 percent of the highest 3-hour
average liquor pH at the inlet to the wet scrubber (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with the HCl emission limit.
Minimum secondary chamber temperature means 90 percent of the
highest 3-hour average secondary chamber temperature (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with the PM, CO, or dioxin/furan emission
limits.
Modification or Modified HMIWI means any change to an HMIWI unit
after March 16, 1998, such that:
(1) The cumulative costs of the modifications, over the life of the
unit, exceed 50 per centum of the original cost of the construction and
installation of the unit (not including the cost of any land purchased
in connection with such construction or installation) updated to
current costs, or
(2) The change involves a physical change in or change in the
method of operation of the unit which increases the amount of any air
pollutant emitted by the unit for which standards have been established
under section 129 or section 111.
Operating day means a 24-hour period between 12:00 midnight and the
following midnight during which any amount of hospital waste or
medical/infectious waste is combusted at any time in the HMIWI.
Operation means the period during which waste is combusted in the
incinerator excluding periods of startup or shutdown.
Particulate matter or PM means the total particulate matter emitted
from an HMIWI as measured by EPA Reference Method 5 or EPA Reference
Method 29.
Pathological waste means waste material consisting of only human or
animal remains, anatomical parts, and/or tissue, the bags/containers
used to collect and transport the waste material, and animal bedding
(if applicable).
Primary chamber means the chamber in an HMIWI that receives waste
material, in which the waste is ignited, and from which ash is removed.
Pyrolysis means the endothermic gasification of hospital waste and/
or medical/infectious waste using external energy.
Secondary chamber means a component of the HMIWI that receives
combustion gases from the primary chamber and in which the combustion
process is completed.
Shutdown means the period of time after all waste has been
combusted in the primary chamber. For continuous HMIWI, shutdown must
commence no less than 2 hours after the last charge to the incinerator.
For intermittent HMIWI, shutdown must commence no less than 4 hours
after the last charge to the incinerator. For batch HMIWI, shutdown
must commence no less than 5 hours after the high-air phase of
combustion has been completed.
Small HMIWI means:
(1) Except as provided in paragraph (2) of this definition;
(i) An HMIWI whose maximum design waste burning capacity is less
than or equal to 200 pounds per hour; or
(ii) A continuous or intermittent HMIWI whose maximum charge rate
is less than or equal to 200 pounds per hour; or
(iii) A batch HMIWI whose maximum charge rate is less than or equal
to 1,600 pounds per day.
(2) The following are not small HMIWI:
(i) A continuous or intermittent HMIWI whose maximum charge rate is
more than 200 pounds per hour;
(ii) A batch HMIWI whose maximum charge rate is more than 1,600
pounds per day.
Small rural HMIWI means a small HMIWI which is located more than 50
miles from the boundary of the nearest Standard Metropolitan
Statistical Area and which burns less than 2,000 pounds per week of
hospital waste and medical/ infectious waste.
Standard conditions means a temperature of 20 deg.C and a pressure
of 101.3 kilopascals.
Standard Metropolitan Statistical Area or SMSA means any areas
listed in
[[Page 49893]]
OMB Bulletin No. 93-17 entitled ``Revised Statistical Definitions for
Metropolitan Areas'' dated June 30, 1993. This information can also be
obtained from the nearest Metropolitan Planning Organization.
Startup means the period of time between the activation of the
system and the first charge to the unit. For batch HMIWI, startup means
the period of time between activation of the system and ignition of the
waste.
Wet scrubber means an add-on air pollution control device that
utilizes an alkaline scrubbing liquor to collect particulate matter
(including nonvaporous metals and condensed organics) and/or to absorb
and neutralize acid gases.
Delegation of Authority
Sec. 62.14495 What authorities will be retained by the EPA
Administrator?
The following authorities will be retained by the EPA Administrator
and not transferred to the State or Tribe:
(a) The requirements of Sec. 62.14453(b) establishing operating
parameters when using controls other than a dry scrubber followed by a
fabric filter, a wet scrubber, or a dry scrubber followed by a fabric
filter and a wet scrubber.
(b) Alternative methods of demonstrating compliance under 40 CFR
60.8.
Table 1 of Subpart HHH of Part 62.--Emission Limits for Small Rural, Small, Medium, and Large HMIWI
--------------------------------------------------------------------------------------------------------------------------------------------------------
Emission limits
Units (7 percent oxygen, ------------------------------------------------------------------------------------------
Pollutant dry basis at standard HMIWI size
conditions) ------------------------------------------------------------------------------------------
Small rural Small Medium Large
-------------------------------------------------------------------------------------------------------------------------------------------------------
Particulate matter............... Milligrams per dry 197 (0.086) 115 (0.05) 69 (0.03) 34 (0.015)
standard cubic meter
(grains per dry standard
cubic foot).
Carbon monoxide.................. Parts per million by 40 40 40 40
volume.
Dioxins/furans................... Nanograms per dry 800 (350) or 125 (55) or 125 (55) or 125 (55) or
standard cubic meter 15 (6.6) 2.3 (1.0) 2.3 (1.0) 2.3 (1.0)
total dioxins/furans
(grains per billion dry
standard cubic feet) or
nanograms per dry
standard cubic meter TEQ
(grains per billion dry
standard cubic feet).
Hydrogen chloride................ Parts per million by 3,100 100 or 93% 100 or 93% 100 or 93%
volume or percent
reduction.
Sulfur dioxide................... Parts per million by 55 55 55 55
volume.
Nitrogen oxides.................. Parts per million by 250 250 250 250
volume.
Lead............................. Milligrams per dry 10 (4.4) 1.2 (0.52) or 70% 1.2 (0.52) or 70% 1.2 (0.52) or 70%
standard cubic meter
(grains per thousand dry
standard cubic feet) or
percent reduction.
Cadmium.......................... Milligrams per dry 4 (1.7) 0.16 (0.07) or 65% 0.16 (0.07) or 65% 0.16 (0.07) or 65%
standard cubic meter
(grains per thousand dry
standard cubic feet) or
percent reduction.
Mercury.......................... Milligrams per dry 7.5 (3.3) 0.55 (0.24) or 85% 0.55 (0.24) or 85% 0.55 (0.24) or 85%
standard cubic meter
(grains per thousand dry
standard cubic feet) or
percent reduction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2 of Subpart HHH of Part 62.--Tonic Equivalency Factors
------------------------------------------------------------------------
Toxic
Dioxin/furan congener equivalency
factor
------------------------------------------------------------------------
2,3,7,8-tetrachlorinated dibenzo-p-dioxin.................. 1
1,2,3,7,8-pentachlorinated dibenzo-p-dioxin................ 0.5
1,2,3,4,7,8-hexachlorinated dibenzo-p-dioxin............... 0.1
1,2,3,7,8,9-hexachlorinated dibenzo-p-dioxin............... 0.1
1,2,3,6,7,8-hexachlorinated dibenzo-p-dioxin............... 0.1
1,2,3,4,6,7,8-heptachlorinated dibenzo-p-dioxin............ 0.01
Octachlorinated dibenzo-p-dioxin........................... 0.001
2,3,7,8-tetrachlorinated dibenzofuran...................... 0.1
2,3,4,7,8-pentachlorinated dibenzofuran.................... 0.5
1,2,3,7,8-pentachlorinated dibenzofuran.................... 0.05
1,2,3,4,7,8-hexachlorinated dibenzofuran................... 0.1
1,2,3,6,7,8-hexachlorinated dibenzofuran................... 0.1
1,2,3,7,8,9-hexachlorinated dibenzofuran................... 0.1
2,3,4,6,7,8-hexachlorinated dibenzofuran................... 0.1
1,2,3,4,6,7,8-heptachlorinated dibenzofuran................ 0.01
1,2,3,4,7,8,9-heptachlorinated dibenzofuran................ 0.01
Octachlorinated dibenzofuran............................... 0.001
------------------------------------------------------------------------
[[Page 49894]]
Table 3 of Subpart HHH of Part 62.--Operating Parameters To Be Monitored and Minimum Measurement and Recording
Frequencies
----------------------------------------------------------------------------------------------------------------
Minimum frequency HMIWI
-------------------------------------------------------------------------------
HMIWI
HMIWI \a\ with
\a\ with dry
Operating parameters to be Small dry HMIWI scrubber
monitored Data measurement Data recording rural scrubber \a\ with followed
HMIWI followed wet by
by scrubber fabric
fabric filter
filter and wet
--------------------------------------------------------------------------------------------------------scrubber
Maximum operating parameters:
Maximum charge rate......... Once per charge... Once per charge...
Maximum fabric filter inlet Continuous........ Once per minute...
temperature.
Maximum flue gas temperature Continuous........ Once per minute...
Minimum operating parameters:
Minimum secondary chamber Continuous........ Once per minute...
temperature.
Minimum dioxin/furan sorbent Hourly............ Once per hour.....
flow rate.
Minimum HCl sorbent flow Hourly............ Once per hour.....
rate.
Minimum mercury (Hg) sorbent Hourly............ Once per hour.....
flow rate.
Minimum pressure drop across Continuous........ Once per minute...
the wet scrubber or minimum
horsepower or amperage to
wet scrubber.
Minimum scrubber liquor flow Continuous........ Once per minute...
rate.
Minimum scrubber liquor pH.. Continuous........ Once per minute...
----------------------------------------------------------------------------------------------------------------
\a\ Does not include small rural HMIWI.
[FR Doc. 00-20341 Filed 8-14-00; 8:45 am]
BILLING CODE 6560-50-U