Federal Plan Requirements for Hospital/Medical/Infectious Waste Incinerators Constructed On or Before June 20, 1996
Federal RegisterJul 6, 1999
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SUMMARY: On September 15, 1997, EPA adopted emission guidelines for
existing hospital/medical/infectious waste incinerator(s) (HMIWI).
Sections 111 and 129 of the Clean Air Act (Act or 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 Act require EPA to develop, implement, and
enforce a Federal plan for HMIWI in that State/Tribal area. In this
action the EPA proposes a Federal plan to implement emission guidelines
for HMIWI located in States and Indian country without effective State
or Tribal plans. This Federal plan will most likely be an interim
action for many of these areas because when a State/Tribal plan becomes
effective, the Federal plan will no longer apply to HMIWI covered by
such plan.
DATES: Comments. You must submit comments on this proposal on or before
September 7, 1999.
Public Hearings. The EPA will hold public hearings, if requested.
Requests must be received by August 5, 1999. See the ADDRESSES section
of this preamble for information on requesting a public hearing. You
can obtain the date and location of the public hearing(s) by calling
(919) 541-5420 or by E-mailing to [email protected] after August 5,
1999.
ADDRESSES: Comments. Send your comments on this proposal (in duplicate,
if possible) to: Air and Radiation Docket and Information Center (MC-
6102), Attention docket number A-98-24, U. S. Environmental Protection
Agency, 401 M Street, SW., Washington, DC 20460. You may also submit
your comments electronically by following the instructions in the
SUPPLEMENTARY INFORMATION section of this preamble.
Docket. Docket numbers A-98-24 and A-91-61 contain the supporting
information for this proposed rule and the supporting information for
EPA's promulgation of emission guidelines for existing HMIWI,
respectively. These dockets are available for public inspection and
copying between 8:00 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 A-and-R-D[email protected]. A reasonable fee may
be charged for copying. In addition to the docket, you can find an
electronic copy of this document at the EPA/STAPPA/ALAPCO Unified Air
Toxics Website (http://www.epa.gov/ttn/uatw/129/hmiwi/rihmiwi.html).
Public Hearings. The public hearing(s) will be held in the
respective EPA Regional Office covering the State from which a request
was received. If you wish to speak at a public hearing you should
notify Mr. Lalit Banker, Program Implementation and Review Group,
Information Transfer and Program Integration Division (MD-12), U. S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711, telephone (919) 541-5420.
FOR FURTHER INFORMATION CONTACT: If you have questions on this
proposal, contact Mr. Lalit Banker at (919) 541-5420, 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]). If
you have technical questions, 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 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, you may be covered by this proposed
action. Existing HMIWI are those that commenced construction,
modification, or reconstruction on or before June 20, 1996. Regulated
categories and entities include those listed in Table 1.
Table 1.--Regulated Entities a
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Category Examples of regulated entities
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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
proposed 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. 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.
Electronic submittal of comments. You may submit comments and data
on this proposed rule via E-mail. Send E-mail submittals to A-and-R-
D[email protected]. You may file E-mail comments at most Federal Depository
Libraries. Do not submit confidential business information through E-
mail. You may also submit comments and data on diskettes in WordPerfect
5.1 or 6.1 file format or ASCII file format. Electronic comments must
avoid the use of special characters or any form of encryption. Identify
all comments and data for this proposal, whether in paper form or
electronic form, by docket number A-98-24.
[[Page 36427]]
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
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Region Regional contact Phone/Fax States and protectorates
----------------------------------------------------------------------------------------------------------------
I............ John Courcier, 617-918-1659; 617- CT, ME, MA, NH, RI, VT.
[email protected] 918-1505 (fax).
epa.gov.
II........... Christine DeRosa, de 212-637-4022; 212- NJ, NY, Puerto Rico, Virgin Islands.
[email protected] 637-3901 (fax).
epa.gov.
Ted Gardella, 212-637-3892; 212-
[email protected] 637-3901 (fax).
a.gov.
III.......... James B. Topsale, 215-814-2190; 215- DE, DC, MD, PA, VA, WV.
[email protected]. 814-2114 (fax).
IV........... Scott Davis, 404-562-9127; 404- AL, FL, GA, KY, MS, NC, SC, TN.
[email protected] 562-9095 (fax).
v.
V............ Ryan Bahr, 312-353-4366; 312- IN.
[email protected]. 886-5824 (fax).
Charles Hatten, 312-886-6031; 312- WI.
[email protected] 886-5824 (fax).
gov.
Mark Palermo, 312-886-6082; 312- IL, OH.
[email protected] 886-5824 (fax).
epa.gov.
Victoria Hayden, hay 312-886-4023; 312- WI.
[email protected] 886-5824 (fax).
epa.gov.
Doug Aburano, aburan 312-353-6960; 312- MN.
[email protected]. 886-5824 (fax).
VI........... Mick Cote, 214-665-7219; 214- AR, LA, NM, OK, TX.
[email protected]. 665-7263 (fax).
VII.......... Wayne Kaiser, 913-551-7603; 913- IA, KS, MO, NE.
[email protected] 551-7844 (fax).
v.
Ward Burns, 913-551-7960; 913- .....................................................
[email protected]. 551-7844 (fax).
VIII......... Meredith Bond, 303-312-6438; 303- CO, MT, ND, SD, UT, WY.
[email protected] 312-6064 (fax).
ov.
IX........... Patricia Bowlin, 415-744-1188; 415- AZ, CA, HI, NV, American Samoa, Guam.
[email protected] 744-1076 (fax).
.gov.
X............ Catherine Woo, 206-553-1814; 206- AK, ID, OR, WA.
[email protected] 553-0110 (fax).
ov.
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Preamble Outline
I. Background
A. HMIWI Regulations
B. Who This HMIWI Federal Plan Affects
C. Implementing Authority
D. HMIWI Federal Plan and Indian Country
1. Tribal Implementation
2. EPA Implementation
3. Applicability in Indian Country
E. HMIWI Federal Plan and Compliance Schedules
1. Due Within 1 Year of Promulgation
2. Special Provisions of Sec. 60.39e(d)
F. Status of State Plan Submittals
II. Required Elements of the HMIWI Federal Plan
A. Legal Authority and Enforcement Mechanism
1. EPA's Legal Authority in States
2. EPA's Legal Authority in Indian Country
B. Inventory of Affected HMIWI
C. Inventory of Emissions
D. Emission Limits
E. Increments of Progress
1. How EPA Determined the Compliance Schedule
2. Owner/Operator Responsibilities
3. Failure to Comply
F. Waste Management Plan Requirements
G. Testing, Monitoring, Inspection, Recordkeeping, and Reporting
Requirements
H. Operator Training and Qualification Requirements
I. Record of Public Hearings
J. Progress Reports
III. HMIWI That Have or Will Shut Down
A. Inoperable Units
B. HMIWI That Have Shut Down
1. Restarting Before September 15, 2002
2. Restarting After September 15, 2002
IV. 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
V. Title V Operating Permits
VI. Owner/Operator Responsibilities
A. Applicability
B. Emission Limits
C. Additional Requirements
VII. Administrative Requirements
A. Docket
B. Paperwork Reduction Act
C. Executive Order 12866
D. Executive Order 12875
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
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 Act. 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 Act 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. Furthermore,
EPA plans to develop, implement, and enforce a Federal plan for Indian
country until Tribes receive approval to administer their own programs.
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 proposes
the HMIWI Federal plan.
B. Who This HMIWI Federal Plan Affects
This proposed HMIWI Federal plan would affect existing HMIWI for
which construction commenced on or before June 20, 1996. HMIWIs would
be subject to this Federal plan if any of the following is true on the
effective date of the Federal plan:
[[Page 36428]]
(1) The State or Tribal plan has not become effective;a
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\a\ 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 proposed
Secs. 62.14400 through 62.14403 of subpart HHH.
The Federal plan would become effective 30 days after final
promulgation. Once an approved State or Tribal plan is in effect, the
Federal plan would no longer apply to HMIWI covered by such plan.
C. Implementing Authority
The EPA Regional Administrators will be the delegated 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 HMIWI Federal plan would apply throughout Indian country to
ensure that there is not a regulatory gap for existing HMIWI in Indian
country. However, Indian tribes now have the authority under the Act to
develop Tribal plans in the same manner that States develop State
plans. On February 12, 1998, EPA promulgated regulations that outline
provisions of the Act for which EPA is authorized to treat Tribes in
the same manner as States. See 63 FR 7254 (Final Rule for Indian
Tribes: Air Quality Planning and Management, (Tribal Authority Rule))
(codified at 40 CFR part 49). As of March 16, 1998, the effective date
of the Tribal Authority Rule, EPA has had authority under the Act to
approve Tribal programs such as Tribal plans to implement and enforce
HMIWI emission guidelines.
1. Tribal Implementation
Section 301(d) of the Act authorizes the Administrator to treat an
Indian tribe as a State under certain circumstances. The Tribal
Authority Rule, which implements section 301(d) of the Act, identifies
provisions of the Act for which a Tribe should be treated as a State.
See 40 CFR 49.3 and 49.4. Under the Tribal Authority Rule, a Tribe is
treated as a State for purposes of this Federal plan. If a Tribe meets
the criteria below, EPA can delegate to an Indian tribe authority to
implement the Federal plan in the same way it can delegate authority to
a State:
(1) The applicant is an Indian tribe recognized by the Secretary of
the Interior;
(2) The Indian tribe has a governing body carrying out substantial
governmental duties and functions;
(3) The functions to be exercised by the Indian tribe pertain to
the management and protection of air resources within the exterior
boundaries of the reservation or other areas within the tribe's
jurisdiction; and
(4) The Indian tribe is reasonably expected to be capable, in the
EPA Regional Administrator's judgement, of carrying out the functions
to be exercised in a manner consistent with the terms and purposes of
the Act and all applicable regulations. See 40 CFR 49.6.
2. EPA Implementation
The Act also provides EPA with the authority to administer Federal
programs in Indian country. This authority is based in part on the
general purpose of the Act, which is national in scope. Section 301(a)
of the Act provides EPA broad authority to issue regulations that are
necessary to carry out the functions of the Act. The EPA believes that
Congress intended for EPA to have the authority to operate a Federal
program when Tribes choose not to develop a program, do not adopt an
approvable program, or fail to adequately implement an air program
authorized under section 301(d) of the Act.
Section 301(d)(4) of the Act authorizes the Administrator to
directly administer provisions of the Act to achieve the appropriate
purpose where Tribal implementation is not appropriate or
administratively not feasible. The Agency's interpretation of its
authority to directly implement Clean Air Act programs in Indian
country is discussed in more detail in the proposed Federal Operating
Permits Rule, see 62 FR 13747 (March 21, 1997), and in the Tribal
Authority Rule. See 63 FR at 7262-7263.
Many Tribes may have delayed development of air quality regulations
and programs pending promulgation of the Tribal Authority Rule. As
mentioned previously, Tribes may, but are not required to, submit an
HMIWI plan under section 111(d) of the Act.
3. Applicability in Indian Country
The Federal plan would apply throughout Indian country except where
a State or 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 cited above where the rationale
is discussed in detail. The EPA requests comments on applying the HMIWI
Federal plan in Indian country as described here.
E. HMIWI Federal Plan and Compliance Schedules
The emission guidelines require the HMIWI owner or operator to come
into compliance with the State or Tribal plan within 1 year after
approval of such plan, or within 1 year after promulgation of the
Federal plan (whichever applies). See 40 CFR 60.39e(b). However, if the
State or Tribal plan contains measurable and enforceable increments of
progress, the HMIWI may be allowed up to 3 years after approval of the
plan (but in no case later than September 15, 2002) to come into
compliance. See 40 CFR 60.39e(c).
This proposed Federal plan contains measurable and enforceable
increments of progress that allow sources up to 3 years after
promulgation of the Federal plan to comply (but in no case later than
September 15, 2002.) The increments of progress are discussed in
section II.E of this preamble.
1. Due Within 1 Year of Promulgation
Except under the special circumstances that are discussed below,
HMIWI that are planning to shut down rather than comply with the
requirements of the Federal plan must do so by the date 1 year after
the Federal plan is promulgated. In addition, according to
Sec. 60.39e(e) of subpart Ce, all HMIWI that continue to operate 1 year
after the Federal plan promulgation date must comply with the operator
[[Page 36429]]
training and qualification requirements and the inspection requirements
of the plan within 1 year. This 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 pursuant to Sec. 60.39e(d) of subpart Ce).
2. Special Provisions of Sec. 60.39e(d)
The Federal plan may contain provisions allowing HMIWI that are
planning to shut down the opportunity to petition the State, Tribe, or
EPA for an extension beyond the 1-year compliance date. See 40 CFR
60.39e(d). This proposed Federal plan contains provisions for granting
and denying petitions for an extension beyond the 1-year compliance
deadline (but no later than September 15, 2002). An example of a
facility that might petition the enforcement authority 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 under the Federal plan, which are
set forth at proposed Sec. 62.14471 of subpart HHH, are the same as the
requirements listed at Sec. 60.39e(d) of subpart Ce, except that EPA
proposes a specific date of 90 days following promulgation of the
Federal plan by which petitions must be submitted to EPA under the
Federal plan. This time frame, which is more than 2 years after
promulgation of the emission guidelines and more than 9 months from
today's proposal, should give sources sufficient time to examine their
waste disposal options and to prepare the necessary documentation to
justify their need for an extension. This time frame also gives EPA
sufficient time to grant or deny the petition before the 1-year
compliance deadline arrives.
F. Status of State Plan Submittals
Sections 111(d) and 129(b)(2) of the Act, 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. The EPA has received final State plans from New York,
Delaware, Louisiana, Georgia, Alabama, North Dakota, Montana, and
Colorado. The EPA has received draft State plans from Puerto Rico,
Maryland, West Virginia, Pennsylvania, Iowa, Ohio, Indiana, Minnesota,
Illinois, Michigan, South Dakota, Utah, Washington, and Wyoming. Other
States are making significant progress on their State plans and EPA
expects many State plans to be approved before this Federal plan is
final.
The EPA anticipates letters of negative declaration from New Mexico
and Oregon. The EPA is not aware of any Indian tribes that are
developing Tribal plans.
The preamble of the final Federal plan will list States and Tribes
that have an EPA-approved plan in effect on the date the final Federal
plan is signed by the EPA Administrator. 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 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
Because the EPA is proposing a Federal plan to cover HMIWI located
in States or Tribes where plans are not in effect, this proposal
includes the same elements as are required for State plans: (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; (7) testing, monitoring,
inspection, reporting, and recordkeeping; (8) waste management plan;
(9) operator training and qualification; and (10) progress reporting.
See 40 CFR part 60 subparts B and C and sections 111 and 129 of the
Act. Docket item II-B-3 in docket A-98-24 identifies each element and
indicates where it is addressed. Each element is described below as it
relates to the proposed HMIWI Federal plan.
A. Legal Authority and Enforcement Mechanism
A State or Tribal plan must demonstrate that the State or Tribe has
the legal authority to adopt and implement the emission guidelines. 40
CFR 60.26. In its plan, the State or Tribe must identify the
enforcement mechanism for implementing the emission guidelines, such as
a State or Tribal rule.
1. EPA's Legal Authority in States
Section 301(a) of the Act provides the EPA with broad authority to
write regulations that carry out the functions of the Act. Sections
111(d) and 129(b)(3) of the Act authorize the EPA to develop a Federal
plan for States that do not submit approvable State plans.
2. EPA's Legal Authority in Indian Country
Section 301(a) provides EPA with the authority to administer
Federal programs in Indian country. Section 301(d)(4) of the Act
authorizes the Administrator to directly administer provisions of the
Act where Tribal implementation of those provisions is not appropriate
or administratively not feasible. See section I.D. of this preamble for
a more detailed discussion of EPA's authority to administer the HMIWI
Federal plan in Indian country.
The EPA is proposing this Federal regulation under the legal
authority of the Act to implement the emission guidelines in those
States and areas of Indian country not covered by an approved plan. As
discussed in section IV of this document, implementation and
enforcement of the Federal plan may be delegated to Tribal, State, or
local agencies when requested by a State, Tribal, or local agency, and
when EPA determines that such delegation is appropriate.
B. Inventory of Affected HMIWI
A State or Tribal plan must include an inventory of HMIWI affected
by the emission guidelines. 40 CFR 60.25(a). Consistent with this
requirement, docket number A-98-24, item II-B-1 contains an inventory
of all the HMIWI EPA is aware of that will be covered by this proposed
Federal plan.
This inventory was initially created in 1995 in connection with
development of the HMIWI emission guidelines. In late 1998, EPA gave
States an opportunity to submit updates to the 1995 list. Many States
responded and in most cases, EPA was able to incorporate these updates.
However, EPA recognizes that this list may not be complete. Therefore,
sources subject to this Federal plan would include, but would not be
limited to, the HMIWI listed in docket A-98-24, item II-B-1. States,
Tribes, or individuals with corrections to the Federal plan inventory
are invited to submit their corrections during the comment period for
this proposal.
Hospital/medical/infectious waste incinerators that are located in
a State
[[Page 36430]]
or Tribal area with an approved and effective plan, but that are not
covered by such plan (for example, because they were inadvertently
omitted from the coverage of the plan and the plan fails to contain
language that would include inadvertently omitted HMIWI), would
automatically be covered by the Federal plan. There will be no need to
reopen the Federal plan to add such HMIWI.
C. Inventory of Emissions
A State plan must include an emissions estimate for HMIWI subject
to the emission guidelines. 40 CFR 60.25(a). The pollutants to be
inventoried are dioxins/furans, cadmium (Cd), lead (Pb), mercury (Hg),
particulate matter (PM), hydrogen chloride (HCl), nitrogen oxides
(NOX), carbon monoxide (CO), and sulfur dioxide
(SO2). For this proposal, EPA has estimated the emissions
from each HMIWI that would be covered by the Federal plan for the nine
pollutants regulated by the Federal plan. This emissions inventory is
included in item II-B-1 in docket A-98-24.
Pollutant emissions are expressed in kilograms per year (kg/yr) for
most pollutants and grams per year (g/yr) for dioxins/furans. The
emissions inventory is based on available information about the HMIWI
and emission factors developed for purposes of calculating nationwide
air impacts of the emission guidelines. Refer to the emissions
estimates memorandum in docket A-98-24 (item II-B-1) for the complete
emissions inventory and details on the calculations.
D. Emission Limits
A State plan must include emission limits. 40 CFR 60.24(a). Section
129(b)(2) of the Act requires these emission limits to be ``at least as
protective as'' those in the emission guidelines. The emission limits
in this proposed HMIWI Federal plan are the same as those contained in
the emission guidelines.
The HMIWI source category is divided into three subcategories based
on waste burning capacity: Small (200 pounds per hour [1b/
hr]), medium (>200 to 500 lb/hr), and large (>500 lb/hr). Separate
emission limits apply to each subcategory of existing HMIWI. Small
HMIWI that meet certain ``rural criteria'' are allowed to meet less
stringent emission limits. The numerical emission limits and additional
requirements are summarized in section VI of this preamble.
E. Increments of Progress
Increments of progress are required for HMIWI that need more than 1
year from State plan approval to comply, or in the case of the Federal
plan, more than 1 year after promulgation of the final Federal plan. 40
CFR 60.24(e)(1). 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 proposed 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.
1. How EPA Determined the Compliance Schedule
The increments of progress and the time proposed for their
completion are based on case studies conducted by EPA of eight HMIWI
that completed retrofits of the types of controls needed to meet the
subpart Ce emission limits. These case studies are documented in docket
A-98-24, item II-A-1. Based on these case studies, it appears that some
HMIWI may need more than 1 year to retrofit with controls. Using the
schedules from the case studies as a basis, the EPA determined the
proper intervals for each of the subpart B increments.
To ensure compliance, the five increments of progress proposed for
the Federal plan are the minimum increments of progress allowed by
subpart B, see 40 CFR 60.21(h), and are found at proposed
Sec. 62.14470(b) of subpart HHH. The following increments would apply
to all HMIWI, regardless of category or size, that require longer than
1 year after the promulgation date of this Federal plan to comply:
(1) Submit final control plan;
(2) Award contracts for control systems or process modifications or
orders for purchase of components;
(3) Begin onsite construction or installation of the air pollution
control device(s) or process changes;
(4) Complete onsite construction or installation of the air
pollution control device(s) or process changes; and
(5) Final compliance.
Subpart Ce suggests additional increments of progress, however, the
EPA is proposing not to include additional increments of progress. By
not imposing additional increments of progress, EPA hopes to minimize
burden on the industry that could result with more increments. EPA,
however, solicits comment on whether additional increments are
warranted.
2. Owner/Operator Responsibilities
The HMIWI owner or operator is responsible for meeting each of the
five increments of progress for each HMIWI unit 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
proposed 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 air pollution control devices 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;
(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;
[[Page 36431]]
(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.
The EPA believes this compliance schedule is achievable and
necessary based on the following:
(1) When determining completion dates for the increments of
progress, EPA applied the maximum amount of time that most HMIWI in
the case study needed in order to comply;
(2) Since September 15, 1997 when the emission guidelines were
promulgated, HMIWI owners and operators have known that they would
need to make process changes or install controls by September 15,
2002; and
(3) The EPA believes that a compliance schedule with enforceable
increments of progress is necessary to ensure final compliance by
September 15, 2002.
3. Failure to Comply
If an HMIWI does not achieve final compliance by September 15,
2002, this proposed Federal plan would require 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.
F. Waste Management Plan Requirements
Under the emission guidelines, State plans must require owners and
operators of HMIWI to develop waste management plans in compliance with
40 CFR 60.55c. See 40 CFR 60.35e. The proposed HMIWI Federal plan
includes the same requirement (see proposed 40 CFR 62.14430 and
62.14431 of subpart HHH).
G. Testing, Monitoring, Inspection, Recordkeeping, and Reporting
Requirements
Under the emission guidelines, State plans must include the
testing, monitoring, recordkeeping, and reporting requirements set
forth at 40 CFR 60.37e and 60.38e of subpart Ce. The proposed HMIWI
Federal plan includes virtually the same requirements (see proposed 40
CFR 62.14450 through 62.14455 and Secs. 62.14460 through 62.14465 of
subpart HHH).
Minor changes are proposed to the testing and monitoring
requirements to clarify the meaning of those requirements and to insert
some text that was inadvertently omitted from the emission guidelines.
Subpart Ce specifies a 3-hour rolling average when monitoring maximum
charge rate. While this is correct for continuous and intermittent
HMIWI, it is not correct for batch HMIWI. For batch HMIWI, the
requirement is proposed to be a daily average, consistent with the
definition of maximum charge rate for batch units.
H. Operator Training and Qualification Requirements
Under the emission guidelines, State plans must include the
operator training and qualification requirements set forth at 40 CFR
60.53c. See 40 CFR 60.34e. The proposed HMIWI Federal plan includes
these requirements as well (see proposed 40 CFR 62.14420 through
62.14425 of subpart HHH).
I. Record of Public Hearings
A State must provide opportunity for public participation in
adopting the State plan. See 40 CFR 60.23(c). In adopting any HMIWI
Federal plan, the EPA will hold public hearing(s) at appropriate
Regional Offices, if requested. A record of the public hearing(s), if
any, will appear in the docket.
J. Progress Reports
Under the emission guidelines, States or Tribes with approved and
effective plans must send annual progress reports to the appropriate
Regional Office to show their progress toward implementation of the
emission guidelines. 40 CFR 60.25(e). Under the Federal plan, the EPA
Regional Offices will prepare these progress reports. States or Tribes
that have been delegated the authority to implement and enforce this
Federal plan would also be required to submit annual progress reports
to the appropriate EPA Regional Office.
Appendix D of 40 CFR part 60 requires reporting of emissions data
to the Aerometric Emissions Information Retrieval System Facility
Subsystem (AIRS). These reports can be combined with the State
implementation plan report required by 40 CFR 51.321 in order to avoid
double reporting. Under the proposed Federal plan, EPA Regional Offices
would report AIRS emissions data. If a State or Tribe has been
delegated the authority to implement and enforce the Federal plan, the
State or Tribe would report emissions data to AIRS.
Each progress report must include the following items: (1) Status
of enforcement actions; (2) status of increments of progress; (3)
identification of sources that have shut down or started operation; (4)
emission inventory data for sources that were not in operation at the
time of plan development, but that began operation during the reporting
period; (5) additional data as necessary to update previously submitted
source and emission information; and (6) copies of technical reports on
any performance testing and monitoring.
III. HMIWI That Have or Will Shut Down
A. Inoperable Units
In cases where an HMIWI has shut down and does not intend to
restart, the HMIWI may be left off the source inventory in a State,
Tribal, or this Federal plan if it is rendered inoperable. The HMIWI
owner/operator may do 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.
B. HMIWI That Have Shut Down
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 of this proposed Federal plan. Such
units must also be identified in any State or Tribal plan submitted to
EPA.
1. Restarting Before September 15, 2002
If the owner or operator of an inactive HMIWI plans to restart
before September 15, 2002, the owner or operator would be required 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. (See
section II.E for the discussion on compliance schedules and increments
of progress.)
[[Page 36432]]
2. Restarting After September 15, 2002
Under this proposed Federal plan, a control plan would not be
needed for inactive HMIWI that restart after September 15, 2002.
However, before restarting, such HMIWI would have to 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
would be no need to show that the increments of progress have been met
since these steps would 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 would be in violation of the
Federal plan and subject to enforcement action.
IV. Implementation of the Federal Plan and Delegation
A. Background of Authority
Under sections 111(d) and 129(b) of the Act, 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 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 Act. Consistent with that overall
determination, Congress established sections 111 and 129 of the Act
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 Act, 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 1994 in a memorandum
entitled ``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 (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. A Memorandum of Agreement (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 States, Tribes, and local 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, Tribal, or local 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 plan and the State,
Tribal, or local 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.
[[Page 36433]]
2. State Takes Delegation of the Federal Plan
State, Tribal, or local 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, Tribal, or local 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 draft notices of
violation. The EPA would retain responsibility for bringing enforcement
actions against sources violating Federal plan provisions.
V. Title V Operating Permits
Section 502(a) of the Act requires sources ``subject to standards
or regulations under section 111'' to obtain title V operating permits.
See also 40 CFR 70.3(a)(2) and 71.3(a)(2). Because EPA is proposing
this Federal plan under sections 111 and 129 of the Act, sources
subject to this Federal plan must obtain title V permits. Those title V
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 Act, owners or operators of HMIWI
subject to 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 permit program that covers the
area in which the unit is located, whichever is later. 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.b
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\b\ Section 503(d) of the Act 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
proposed 40 CFR 62.14481 and 40 CFR 70.5(a)(2) and 71.5(a)(2).
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An earlier permit deadline may apply if an HMIWI is subject to
title V for another reason. For example, an HMIWI might already be
subject to title V as a result of being a major source under one or
more of three major source definitions in title V--section 112, section
302, or part D of title I of the Act. See 40 CFR 70.3(a)(1) and
71.3(a)(1) (subjecting major sources to title V permitting) and
Secs. 70.2 and 71.2 (defining major source for purposes of title V). An
HMIWI might also already be subject to title V if it is subject to some
other earlier promulgated standard under section 111 or 112 of the Act.
See 40 CFR 70.3(a)(2) and (3), 71.3(a)(2) and (3). 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.c
However, the owner or operator remains subject to, and must act in
compliance with, the Federal plan requirements.
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\c\ 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 permit 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 permit program
regulations or permitting authorities to determine whether revisions
to their permits are necessary to incorporate the Federal plan
requirements.
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Owners or operators of combustors that burn only pathological
waste, low-level radioactive waste, and/or chemotherapeutic waste and
co-fired combustors, as defined in this proposed Federal plan, must
comply only with certain recordkeeping and reporting requirements set
forth in the proposed Federal plan. See proposed Sec. 62.14400. They
are not subject to the other substantive emissions 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. 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
nonemissions control-related recordkeeping and reporting requirements.
See proposed Sec. 62.14480. The EPA interprets the CAA and the
regulations at parts 70 and 71 to mean that these sources are ``not
subject to standards or regulations under section 111'' for purposes of
title V permitting. See CAA section 502(a) and 40 CFR 70.3(a)(2) and
71.3(a)(2). Therefore, these sources would not be 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
substantive emissions control-related requirements of this proposed
Federal plan. However, owners and operators of sources 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 would
become subject to those other requirements and would have to obtain
title V permits. Moreover, if, in the future, EPA promulgates
regulations subjecting any of these sources to substantive requirements
other than these recordkeeping and reporting requirements, these
sources could become subject to title V at that time.
Section 502(a) of the Act requires title V permits of listed
sources, including any source ``subject to standards or regulations
under section 111 * * *.'' See also 40 CFR 70.3(a)(2) and 71.3(a)(2).
The EPA reads the recordkeeping and reporting requirements of this
proposed Federal plan, which are simply conditions for exemption from
the other substantive emissions control-related requirements of the
Federal plan, not to be requirements that would make a source ``subject
to'' a section 111 standard (here the HMIWI Federal plan) within the
[[Page 36434]]
meaning of these statutory and regulatory provisions. Accordingly,
HMIWI that comply with the recordkeeping and reporting requirements
necessary for their exemption from the other substantive emissions
control-related requirements of the Federal plan are not ``subject to''
the Federal plan solely for purposes of being required to obtain a
title V permit. Hospital/medical/ infectious waste incinerators that
are subject to Federal plan requirements other than these recordkeeping
or reporting conditions as well as HMIWI that fail to comply with any
of the conditions for exemption from these other substantive emissions
control-related Federal plan requirements are subject to title V
permitting under section 502(a).
It is worth noting that section 502(a) of the Act 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
regulations.'' The EPA is not invoking this mechanism to justify its
conclusion that the HMIWI discussed above are not required to obtain
title V permits. These HMIWI have not been ``exempted'' from title V
within the meaning of the last sentence of section 502(a), and the
Agency does not purport to have made the statutory showing of
impracticability, infeasibility or unnecessary burden for these
sources. Rather, the Agency believes that the recordkeeping and
reporting requirements with which these HMIWI must comply 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, HMIWI 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 Act.
In addition to being consistent with the governing statutory
provisions, EPA believes this approach is sound and environmentally
protective. Where HMIWI have only recordkeeping and/or reporting
obligations designed to show they are not subject to the other
requirements of the Federal plan, EPA does not believe that it makes
sense to compel them to obtain title V permits based upon a possible
technical argument that in that minimal sense they are subject to the
subpart for purposes of section 502(a) of the Act. Moreover, because
these HMIWI may well not currently be covered by applicable Federal
requirements other than this Federal plan's recordkeeping and reporting
requirements, a contrary approach would lead to the paradoxical and
unreasonable result that these HMIWI would be obtaining title V permits
whose sole requirements were conditions demonstrating their exemption
from the other substantive requirements of the Federal standard that
triggered the need to obtain a permit.
In addition to the likely bareness of these HMIWI title V permits,
the applicability and compliance provisions these HMIWI must meet are
simpler than the usual applicable requirements in a title V permit.
Therefore, the multiple, sometimes complex applicability determinations
so integral to the title V permit issuance process are accomplished
here through simple notifications to EPA (or delegated EPA Regional
Office, State, or Tribe). While title V permits are important in
helping States and Tribes, EPA, sources, and the public assure
compliance with a source's Clean Air Act obligations, the Agency does
not believe this objective would be significantly advanced by these
sources obtaining title V permits, particularly not to a degree that
would outweigh the time, resources, expense and permit fees associated
with the permit process in this instance. The EPA believes the approach
described herein comports with the Act and Federal regulations,
represents a sensible solution to these uniquely situated sources, and
affords the environmental protection demanded by the law.
VI. Owner/Operator Responsibilities
The proposed HMIWI Federal rule (40 CFR part 62, subpart HHH) which
will implement 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. These emission standards and requirements are
the same as those in the emission guidelines (40 CFR part 60, subpart
Ce). The requirements are summarized in this section.
A. Applicability
The HMIWI Federal plan would apply to existing HMIWI that 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
the 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 proposed Sec. 62.14490 of
subpart HHH.
Incinerators that burn only pathological, low-level radioactive, or
chemotherapeutic waste (all defined in proposed Sec. 62.14490 of
subpart HHH) are required to 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. However, these HMIWI
are not subject to the other substantive requirements of the Federal
plan during periods when they burn such wastes provided that they
comply with the applicable notification and recordkeeping requirements.
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 other substantive 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 part 60
subparts Cb, Ea, or Eb. Finally, pyrolysis units (as defined at 40 CFR
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
[[Page 36435]]
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 1 of subpart HHH provides the emission limits for existing
HMIWI covered by the proposed Federal plan. In addition to the emission
limits presented in Table 1, 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 alternative emission limits for small HMIWI that meet the
rural criteria are provided in Table 1 of subpart HHH.
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 proposed Federal plan.
The proposed Federal plan contains operator training and
qualification requirements for all HMIWI. Each facility would be
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 would be required to develop site-specific HMIWI operating
procedures. Employees involved with HMIWI operation must review the
site-specific operating information annually.
The proposed Federal plan would require 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 proposed
Federal plan differ for small rural HMIWI and for all other HMIWI.
Small rural HMIWI would be required to conduct an initial performance
test to determine compliance with the PM, CO, CDD/CDF, and Hg emission
limits and opacity limit, and establish operating parameters. In
addition, small rural HMIWI would be required to conduct annual tests
to determine compliance with the opacity limit.
The compliance and performance testing requirements in the proposed
Federal plan would 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 opacity limit, and establish operating parameters. These
HMIWI would also be required to conduct annual performance tests to
determine compliance with the PM, CO, and HCl emission limits and
opacity limit. The proposed Federal plan would allow 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 proposed Federal plan contains monitoring requirements for all
HMIWI. Each facility would be required to install and maintain
equipment to continuously monitor operating parameters including
secondary chamber temperature, waste feed rate, bypass stack, and air
pollution control device (APCD) operating parameters as appropriate.
The proposed Federal plan would require facilities to obtain monitoring
data at all times during HMIWI operation.
In addition, the proposed Federal plan contains reporting and
recordkeeping requirements for all HMIWI. Facilities would be required
to maintain records for 5 years of results from the initial performance
test and all subsequent performance tests, operating parameters,
inspections (small rural HMIWI only), and operator training and
qualification. Facilities would be 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.
A summary of dates for compliance with the Federal plan for HMIWI
is presented in Table 3.
Table 3.--Compliance Times Under the Federal Plan for All HMIWI
------------------------------------------------------------------------
Requirement Compliance time
------------------------------------------------------------------------
Operator training and Within 1 year after promulgation of the
qualification. 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 Within 1 year after promulgation of the
emission limits. 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 Within 1 year after promulgation of the
only). Federal plan (for HMIWI that continue to
operate beyond 1 year after
promulgation.
Recordkeeping................ Continuously, upon completion of initial
performance test.
[[Page 36436]]
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 HC1 every
third year if the previous three performance tests demonstrate that
the facility is in compliance with the emission limits for PM, CO, and
HC1.
VII. Administrative Requirements
This section addresses the following administrative requirements:
Docket, Paperwork Reduction Act, Executive Orders 12866, 12875, 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 proposed rule
merely implements the emission guidelines promulgated on September 15,
1997 (codified at 40 CFR 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 Act.
As discussed above, a docket has been prepared for this action
pursuant to the procedural requirements of section 307(d) of the Act,
42 U.S.C. 7607(d). Docket number A-91-61 contains the technical support
for the September 15, 1997 emission guidelines. Docket number A-98-24
contains additional supporting information for this proposed rule.
B. Paperwork Reduction Act
The information collection requirements in this proposed 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 (2137), 401 M Street,
SW., Washington, DC 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 September 15,
1997.d The burden estimate includes the burden associated
with State/Tribal plans as well as the burden associated with today's
proposed 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.
---------------------------------------------------------------------------
\d\ In promulgating the September 15, 1997 rule setting the NSPS
and emission guidelines, EPA assessed only the ICR requirements
associated with the NSPS. See 62 FR at 48373-74.
---------------------------------------------------------------------------
The information collected would be used by EPA to ensure that the
HMIWI regulatory requirements are implemented and are complied with on
a continuous basis. Records and reports would be necessary to enable
EPA to identify existing HMIWI that may not be in compliance with the
HMIWI regulatory requirements. Based on reported information, EPA would
decide which units should be inspected and what records or processes
should be inspected. The records that owners and operators of existing
HMIWI maintain would 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 year following Federal
plan promulgation. 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 would be
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) would be 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), 401 M Street,
SW., Washington, DC 20460; and to the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725 17th Street,
NW.,
[[Page 36437]]
Washington, DC 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 August 5, 1999. The final rule will
respond to any OMB or public comments on the information collection
requirements contained in this proposal.
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 proposed 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 12875
Under Executive Order 12875, 58 FR 58093 (October 26, 1993), EPA
may not issue a regulation that is not required by statute and that
creates a mandate upon a State, local, or Tribal government, unless the
Federal government provides the funds necessary to pay the direct
compliance costs incurred by those governments or EPA consults with
those governments. If EPA complies by consulting, Executive Order 12875
requires EPA to provide to OMB a description of the extent of EPA's
prior consultation with representatives of affected State, local, and
Tribal governments, the nature of their concerns, any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and Tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create a mandate on State, local, or Tribal
governments. The rule does not impose any enforceable duties on these
entities. 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.
Accordingly, the requirements of section 1(a) of Executive Order 12875
do not apply to this 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 analysis required under section 5-501 of the Order has the
potential to influence the regulation. This proposed 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 proposed today does not significantly or uniquely
affect communities of Indian Tribal governments. The proposed Federal
plan would 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), Pub.
L. 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
[[Page 36438]]
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 48374-78. The EPA has determined that the proposed 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 proposed 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 48378-79. This proposed Federal plan would not
establish any new requirements. Therefore, pursuant to the provisions
of 5 U.S.C. 605(b), EPA certifies 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''), Pub L. 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 proposed Federal plan would
implement 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.
List of Subjects in 40 CFR Part 62
Environmental protection, Air pollution control, Intergovernmental
relations, Reporting and recordkeeping requirements.
Dated: June 17, 1999.
Carol M. Browner,
Administrator.
40 CFR part 62 is proposed to be amended as follows:
PART 62--[AMENDED]
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. Amend part 62 by adding subpart HHH consisting of Secs. 62.14400
through Sec. 62.14499 as follows:
Subpart HHH--Federal Plan Requirements for Hospital/Medical/Infectious
Waste Incinerators Constructed on or before June 20, 1996
Sec.
Applicability
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?
Compliance, 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?
[[Page 36439]]
Definitions
62.14490 Definitions.
Delegation of Authority
62.14495 What authorities will be retained by the EPA Administrator?
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 requirements of
waste, low-level radioactive delegated enforcement of the periods of time this subpart during
waste, and/or chemothera-peutic authority) of an when only pathological periods when only
waste (all defined in 40 CFR exemption claim. waste, low-level pathological, low-level
62.14490). radioactive waste, and/ radioactive, and/or
or chemotherapeutic chemotherapeutic wastes
waste is combusted. are combusted.
(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 requirements of
62.14490). delegated enforcement of the weight of this subpart.
authority) of an hospital waste and
exemption claim and you medical/infectious
provide an estimate of waste combusted, and
the relative weight of the weight of all other
hospital waste, medical/ fuels and wastes
infectious waste, and combusted at the co-
other fuels and/or fired combustor.
wastes to be combusted.
(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.
----------------------------------------------------------------------------------------------------------------
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 Sec. 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 Sec. 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.
[[Page 36440]]
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).
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 within [date 6 months after publication of the final
rule] or prior to assumption of responsibilities affecting HMIWI
operation, whichever date 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,
[[Page 36441]]
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 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 ``An 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 Sec. 62.14463 and Sec. 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 [date 1 year after
publication of final rule].
(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.
Compliance, 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;
[[Page 36442]]
(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
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:
Cadj = Cmeas (20.9-7)/(20.9-%O2)
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] TP06JY99.000
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] TP06JY99.001
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
Sec. 62.14411 or Sec. 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
(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
[[Page 36443]]
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 violation
And your HMIWI of
------------------------------------------------------------------------
Operates above the maximum charge rate (3- The PM, CO, and dioxin/
hour rolling average for continuous and furan emission limits.
intermittent HMIWI, daily average for batch
HMIWI) and below 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 violation
And your HMIWI of
------------------------------------------------------------------------
(1) Operates above the maximum charge rate (3- The CO emission limit.
hour rolling average for continuous and
intermittent 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 The dioxin/furan emission
inlet temperature (3-hour rolling average), limit.
above the 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- The HCl emission limit.
hour rolling average for continuous and
intermittent 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- The Hg emission limit.
hour rolling average for continuous and
intermittent 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 The PM, dioxin/furan,
startup, shutdown, or malfunction). 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 violation
And your HMIWI of
------------------------------------------------------------------------
(1) Operates above the maximum charge rate (3- The CO emission limit.
hour rolling average for continuous and
intermittent HMIWI, daily average for batch
HMIWI) and below the minimum secondary
chamber temperature (3-hour rolling average)
simultaneously.
(2) Operates above the maximum charge rate (3- The PM emission limit.
hour rolling average for continuous and
intermittent 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- The dioxin/furan emission
hour rolling average for continuous and limit.
intermittent 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- The HCl emission limit.
hour rolling average for continuous and
intermittent 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 limit.
temperature (3-hour rolling average) and
above 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 The PM, dioxin/furan,
startup, shutdown, or malfunction). HCl, Pb, Cd, and Hg
emission limits.
------------------------------------------------------------------------
[[Page 36444]]
(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 violation
And your HMIWI of
------------------------------------------------------------------------
(1) Operates above the maximum charge rate (3- The CO emission limit.
hour rolling average for continuous and
intermittent 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 The dioxin/furan emission
inlet temperature (3-hour rolling average), limit.
above the 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- The HCl emission limit.
hour rolling average for continuous and
intermittent 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- The Hg emission limit.
hour rolling average for continuous and
intermittent 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 The PM, dioxin/furan,
startup, shutdown, or malfunction). 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 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 paragraphs (b)(1) through
(15) of this 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
[[Page 36445]]
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 [date 1 year after publication of
final rule], 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 [date 1 year after publication of final rule].
(2) You must achieve final compliance by [date 1 year after
publication of final rule]. 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 Sec. 62.14463 and
Sec. 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 [date 1 year after publication
of final rule], 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
requirements and inspection requirements (if applicable) of this
subpart by [date 1 year after publication of final rule].
(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
[[Page 36446]]
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 Sec. 62.14463 and
Sec. 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 [date 1 year after publication of
final rule] rather that come into compliance with the requirements of
this subpart, then you must shut down by [date 1 year after publication
of final rule] 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 [date
1 year after publication of final rule], 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 [date 90 days
after publication of final rule]. 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 [date 1
year after publication of final rule] 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:
----------------------------------------------------------------------------------------------------------------
If you. . . Then your increments of progress could be. . .
----------------------------------------------------------------------------------------------------------------
Need an extension so you can install an onsite --Date when you will enter into a contract with an
alternative waste treatment technology before you shut alternative treatment technology vendor,
down your HMIWI. --Date for initiating onsite construction or
installation of the alternative technology,
--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 --Date when price quotes will be obtained from
commercial medical/infectious waste disposal company commercial disposal companies,
before you shut down your HMIWI. --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 [date 1 year after publication of the final rule].
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) or (b) of this section depending
on when you 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 [date 1 year after publication of the final rule];
or
(2) Meet the compliance schedule outlined in Sec. 62.14470(b) if
you restart after [date 1 year after publication of the final rule].
Any missed increments of progress need to be completed prior to or upon
the date of restart.
(b) If you plan to shut down and restart after 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
requirements and inspection requirements (if applicable) of this
subpart before restarting your HMIWI.
(2) 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.
(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
restart.
(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 Sec. 62.14463 and
Sec. 62.14464 for complete reporting and recordkeeping requirements).
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 Secs. 62.14400(b)(1) or (b)(2). Also,
if you own or operate a unit described in Secs. 62.14400(b)(3), (b)(4),
(b)(5) or (b)(6), you are not subject to any requirements
[[Page 36447]]
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 permit program in the State or Tribal
area in which the unit is located, whichever is later. (An earlier
deadline may apply if your HMIWI is also subject to title V's
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 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
[[Page 36448]]
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;
C = PV x 15,000/8,500
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;
C = PV x 4.5/8
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 included 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.
(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 inclu
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