United States
Environmental Protection
Agency
Office of Air Quality
Planning and Standards
Research Triangle Park, NC 27711
EPA-456/R-00-003
June 2000
Air
HOSPITAL/MEDICAL/INFECTIOUS WASTE
EPA INCINERATORS: BACKGROUND
INFORMATION FOR FEDERAL PLAN
SUMMARY OF PUBLIC COMMENTS AND
RESPONSES
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Hospital/Medical/Infectious Waste Incinerators:
Background Information for Federal Plan
Summary of Public Comments and Responses
For U. S. Environmental Protection Agency
Office of Air and Radiation
Office of Air Quality Planning and Standards
EPA-456/R-00-003
June 2000
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TABLE OF CONTENTS
Page
1.0 OVERVIEW , , 1-1
2.0 LIST OF COMMENTERS 2-1
3.0 COMMENTS AND RESPONSES 3-1
3.1 APPLICABILITY OF THE FEDERAL PLAN 3-1
3.2 STATE PLAN INFORMATION 3-2
3.3 COMPLIANCE SCHEDULES 3-2
3.3.1 Suspension of Compliance Schedule 3-2
3,3.2 Definition of Final Compliance 3-3
3.3.3 Increments of Progress 3-4
3.4 INSPECTIONS AND REPAIRS 3-6
3.5 TITLE V PERMITTING REQUIREMENTS ............' 3-6
3.6 TRANSFERRING OF AUTHORITY 3-11
LIST OF TABLES
Table Page
2-1. LIST OF COMMENTERS ON THE PROPOSED FEDERAL PLAN 2-1
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1.0 OVERVIEW
Under the authority of sections 111 and 129 of the Clean Air Act (CAA), the U.S.
Environmental Protection Agency (EPA) promulgated Emission Guidelines for existing
hospital/medical/infectious waste incinerators (HMIWI) on September 15, 1997. States with
existing HMIWI subject to the Emission Guidelines were required by the CAA to submit, within
one year following promulgation of the Emission Guidelines, a State plan that implements and
enforces the Emission Guidelines. Indian tribes could also submit Tribal plans to implement and
enforce the Emission Guidelines in Indian country. If a State or Tribe with existing HMIWI does
not submit an approvable plan within two years after promulgation of the Emission Guidelines,
EPA is required to develop, implement, and enforce a Federal plan for HMIWI in that State or
Tribal area.
The EPA proposed Federal plan for HMIWI was published in the Federal Register on
July 6, 1999. In the proposal notice, EPA requested comments from all interested parties on the
Federal plan. The purpose of this document is to summarize and respond to the comments EPA
received. The summary of comments and responses presented in this document serves as the
basis for any revisions made to the HMIWI Federal plan between proposal and promulgation of
the Federal plan.
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2.0 LIST OF COMMENTERS
The public comment period on the proposed Federal plan lasted from July 6, 1999 to
September 7, 1999, A total of six letters commenting on the proposed Federal plan were
received. These comments have been placed in the docket for the Federal plan (Docket A-98-24)
under categories TV-D and IV-G. Table 2-1 lists all persons who submitted written comments,
their affiliations, and the recorded docket item number assigned to their correspondence.
TABLE 2-1. LIST OF COMMENTERS ON THE PROPOSED FEDERAL PLAN
Docket Item No. Commenter and Affiliation
IV-D-Ql D. K. Chamberlain
Pennsylvania Department of Environmental Protection
IV-D-02 K, Michaels
Arkansas Department of Environmental Quality
IV-D-03 R. Fritz
Wisconsin Department of Natural Resources
IV-D-04 A. P. Jacobsohn
Environmental Industry Associations
IV-G-01 D. G. Hawkins
Natural Resources Defense Council
IV-G-02 B. Mathur
Illinois Environmental Protection Agency
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3.0 COMMENTS AND RESPONSES
3.1 APPLICABILITY OF THE FEDERAL PLAN
Comment: Commenter IV-G-02 believes there is an unnecessary overlap between the
applicability of the Federal plan and State plans. The Federal plan applies to any existing
HMIWI that is not covered by a State or Tribal plan; in addition, the Federal plan also applies to
any existing HMIWI that is located in a State or Tribal area with an approved and effective plan,
if the HMIWI is not covered by such plan. The commenter believes that all HMIWI within a
State with an approved and effective plan should be subject to the State plan rather than some
facilities being subject to the Federal plan. The commenter requested that the overlap in the
Federal plan be eliminated.
Response: The EPA acknowledges that States, such as the Illinois, have gone to great
lengths to identify operating HMIWI in their respective States and include them in their State
plans or have drafted sufficiently broad language to include all facilities in their respective State.
However, EPA recognizes that not all plans may be as thorough as the Illinois plan and there may
be circumstances where States have inadvertently excluded facilities in their plans or not written
their plan sufficiently broad enough to include all facilities operating in their State. In these
circumstances, EPA believes that it is necessary for those facilities to be covered by the Federal
plan. Therefore, EPA included language in the proposal to ensure that all facilities are either
covered by a State plan or the Federal plan. The Agency has retained the applicability language
of the proposal in the final Federal plan.
Comment: Commenter IV-D-01 stated that the discussion in Section DI(A) of the
preamble pertaining to "Inoperable Units" should be revised to be consistent with EPA's
"Hospital/Medical/Infectious Waste Incinerator Emission Guidelines: Summary of the
Requirements for Section 11 l(d)/129 State Plans." To ensure consistency with the Emission
Guidelines, the commenter believes that the following criteria should be included with the
discussion of rendering an incinerator inoperable: (1) waste charge door welded shut;
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(2) stack/by-pass stack removed; and (3) combustion air blowers removed.
Response: The Agency has revised the preamble to clarify the criteria for rendering an
incinerator inoperable.
3.2 STATE PLAN INFORMATION
Comment: Commenter IV-G-02 requested that EPA include Illinois in its list of States
with an approved State plan in the final Federal plan.
Response: The EPA has revised the list of States with approved plans and has included
Illinois in the list of States with approved plans.
Comment: Commenter IV-D-01 believes that the Agency incorrectly stated that it has
received a "draft plan" from Pennsylvania. The EPA Region IH has stated that the Pennsylvania
State plan is not approvable until Pennsylvania submits federally enforceable State operating
permits containing enforceable increments of progress and compliance schedules as a plan
revision. The commenter stated that Pennsylvania has completed public participation for their
permit program and will submit a revised program no later than September 10, 1999.
Response: As discussed above, EPA has revised the list of States with approved plans and
has revised that list to include the appropriate status of Pennsylvania.
3.3 COMPLIANCE SCHEDULE
• 3.3,1 Suspension of Compliance Schedule.
Comment: Commenter IV-D-02 stated that the compliance schedule contained in the
proposed Federal plan should be suspended. The commenter believes that the March 2, 1999
U. S. Court of Appeals decision has resulted in uncertainties for the final emission limits for
existing HMIWI. The resulting uncertainties make compliance with the emission limits in the
Federal plan difficult because the commenter believes the final standards will be lower than those
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presented in the proposed Federal plan. Therefore, the commenter requested that facilities not be
required to comply with the standards until such time as the Federal court is satisfied with the
emission limits for existing HMIWI.
Response: On March 2, 1999, the United States Court of Appeals for the District of
Columbia Circuit ruled on the case of Sierra Club and Natural Resources Defense Council
(NRDC) versus the United States Environmental Protection Agency. The petitioners, the Sierra
Club and NRDC, challenged EPA's rule establishing HMIWI standards, complaining principally
that EPA failed to comply with the specifications of the maximum achievable control technology
(MACT) floors for new and existing HMIWI. Although the court rejected the petitioners'
statutory construction challenge, the court did conclude that there are serious doubts about the
reasonableness of EPA's treatment of the floor requirements, and remanded the rule for further
explanation. The court decided not to vacate the standard. Rather, the current regulation remains
in place as requested by Sierra Club and NRDC. In light of the court decision, EPA is obligated
to adhere to the compliance schedule set out in the Emission Guidelines. Therefore, the EPA
will promulgate the final Federal plan as scheduled.
3.3.2 Definition of Final Compliance
Comment: Commenter IV-G-02 believes that the definition of "final compliance" in the
Federal plan should be revised to match the definition of "final compliance" in the Emission
Guidelines. The commenter stated that EPA's definition of "final compliance" in the proposed
Federal plan does not contain provisions for an initial compliance test. The commenter believes
that the Federal plan allows facilities, that have obtained an extension beyond the September 15,
2000 deadline, to conduct an initial performance test 180 days after the final compliance date of
September 15, 2002. In addition, the commenter stated that sources that do not obtain an
extension from the September 15, 2000 compliance deadline should be required to conduct an
initial performance test by September 15, 2000, as required by the Emission Guidelines, rather
than be in "final compliance" as the Federal plan requires. The commenter requested that the
final compliance dates in the Federal plan be revised to match those in the Emission Guidelines.
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Response: The Agency disagrees that there is a discrepancy between the definition of
final compliance in the Emission Guidelines and the Federal plan. The EPA asserts that if a
facility has retrofitted all air pollution control equipment and the equipment is operating as
designed, then the facility has reached compliance and should meet all emission limits. As
defined in section 62.14470 of subpart HHH, by the final compliance date, a facility must have
incorporated all process changes or completed retrofit construction as designed in the final
control plan. The EPA maintains that facilities meeting this definition will produce emissions
below the emission limits in the Federal plan. Consistent with section 129(b)(2) of the Clean Air
Act, the HMIWI Federal plan requires final compliance by September 15,2002, which is five
years after promulgation of the Emission Guidelines.
The final Federal plan allows a facility up to 180 days after installation of equipment to
complete performance testing. The EPA contends that it is appropriate to allow a facility up to
180 days to conduct performance testing after installation of equipment. This is consistent with
New Source Performance Standards and the National Emission Standards for Hazardous Air
Pollutants, The 180 days allows a facility to make final adjustments and tune the newly installed
control equipment, reach stable operation, and perform a stack test. If the initial compliance test
submitted to EPA shows the facility failed to attain the emission limits or if an initial compliance
test is not submitted within the required 180 days, then EPA can take appropriate enforcement
action. A State may require the performance test earlier in their State plan.
3.3.3 Increments of Progress
Comment: Commenter IV-D-04 stated that the agency's attention to reasonable dates for
completion of requirements in the Federal plan will ensure that all affected entities are able to
comply. However, the commenter stated that the Federal plan is missing one element in the
increments of progress that was included in the Emission Guidelines. The commenter stated that
under section 60.39e(d)(l)(i) of the Emission Guidelines, State plans that allow a facility to
petition for an extension of time beyond one year after plan approval must "include an evaluation
of the option to transport the waste off-site to a commercial medical waste treatment and disposal
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facility on a temporary or permanent basis." The commenter stated that under section
62,14470(b) of the proposed Federal plan for facilities that plan to comply later than one year
after Federal plan promulgation, there is no requirement to provide an evaluation of the off-site
option. The commenter also stated that the same element is missing under section 62.14472 in
the proposed Federal plan for facilities that plan to shut down and then restart their incinerators.
The commenter indicated that the evaluation of the off-site disposal option is significant
because it forces facilities to perform a more thorough evaluation of their waste disposal options
when developing their waste management plans, hi addition, it forces facilities to avoid waiting
until the last minute to take action in response to the HMIWI rule. The commenter noted that
many facilities are unaware of the time necessary to develop an effective waste management plan
that considers the many factors that go into a decision about waste disposal methods (e.g., cost of
waste disposal options, facility image, etc.). The commenter asserted that facilities should only
be allotted extra time to comply when they have a legitimate reason for needing the time, and not
because they waited too long to take action.
Response: Sections 60.39e(c) and (d) of the Emission Guidelines allow State plans.to
provide facilities with additional time beyond the 1-year compliance date. Section 60.39e(c)
allows facilities installing the appropriate pollution control beyond 1 year to comply with the
Emission Guidelines provided they meet certain measurable and enforceable activities. Section
60.39e(d) allows facilities beyond 1 year to close down their HMIWI provided they meet certain
criteria, including an evaluation of the option to transport waste offsite to a commercial medical
waste treatment and disposal facility on a temporary or permanent basis. The Agency disagrees
with the commenter that 40 CFR 62.14470(b) of the proposed Federal plan should include an
evaluation of the option to transport waste off-site to a commercial medical waste treatment
facility. 40 CFR 62.14470(b) parallels section 60.39e(c) of the Emission Guidelines which does
not require facilities to perform an analysis of the option to transport waste off-site to a
commercial medical waste treatment facility. The Agency does agree with the commenter that a
requirement for facilities who are planning to shut down beyond the 1-year compliance date and
re-start operations after September 15, 2002 will need to perform an evaluation of the option to
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transport waste off-site to a commercial medial waste treatment facility. Section 62.14472 of the
final regulation has been modified to accommodate this change.
3.4 INSPECTIONS AND REPAIRS
Comment: Commenter IV-G-02 stated that section 62.14443 of the proposed Federal plan
is inconsistent with the requirements for inspections in the Emission Guidelines. The commenter
stated that section 62.14443 of the Federal plan provides that any necessary repairs must be
completed within 10 operating days of the inspection while the Emission Guidelines require that
any repairs must be made within 10 days. The commenter recommended deletion of the term
"operating" in the Federal plan.
Response: Under section 60.36e(a)(2) of the Emission Guidelines, the owner or operator
is required to complete repairs within 10 operating days following an equipment inspection. The
word "operating" was inadvertently omitted from section 60.38e(b)(l) of the Emission
Guidelines. Therefore, section 62,14460(b)(13) of the Federal Plan has been revised to
accurately capture the intent of the Emission Guidelines, requiring repairs to be completed within
10 operating days,
3.5 TITLE V PERMITTING REQUIREMENTS
Comment: Commenter FV-G-01 objected to EPA's proposal to exempt both co-fired
combustors and HMIWI that combust only pathological, low-level radioactive, and/or
chernotherapeutic waste from title V permitting requirements. The commenter indicated that
EPA's interpretation of title V applicability conflicts with the requirements of both section
502(a) and section 129(e) of the CAA. The commenter noted that section 502(a) requires
sources subject to standards under section 111 to obtain title V permits. In addition, section
129(e) requires that "Beginning (I) 36 months after the promulgation of a performance standard
...each unit in the category shall operate pursuant to a permit issued under this subsection and
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Title V." The commenter interpreted EPA's position as follows: If co-fired combustors (as
defined in 40 CFR 62.14490) and HMIWI combusting only pathological waste, low-level
radioactive waste, and/or chemotherapeutic waste (also defined in 40 CFR 62.14490) comply
with their recordkeeping obligations, they need not obtain a Title V permit. However, if they fail
to keep the required records, they must obtain a Title V permit. The commenter mentioned that
general title V permits could be crafted to reduce the burden of title V permitting for these
exempt sources.
Commenter IV-G-01 pointed out that under EPA's proposal not to require title V permits
for these sources, control agencies and the public will not be able to determine whether the
sources are keeping the proper records; records which are the basis for creating and continuing
the exemption from title V permitting. The commenter stated that nothing in the proposed rule
requires sources to submit summaries of the required records or to certify that they are keeping
the records. The commenter noted that if a title V permit were required, sources would be
required to certify that they are conducting the required recordkeeping. The commenter
requested that EPA either require sources to obtain title V permits or adopt an equally
enforceable and transparent mechanism to require sources to certify that they are conducting the
required recordkeeping and to ensure that citizens can access information relevant to the
obligation to keep such records. The commenter noted that if these records are maintained onsite
at a source, then the relevant agency may take the position that the records are not subject to
disclosure under "freedom of information" laws. Therefore, the commenter requested that this
rule: (1) require these sources to submit these records to the appropriate public authority on
request; and (2) require that EPA, State and local agencies adopt rales providing that the relevant
agency will request these records from sources if they are requested by the public.
Another commenter, IV-D-04, disagreed with EPA's assessment that reporting and
recordkeeping requirements are not substantive elements of the HMIWI rule for purposes of
Title V even though pathological, low-level radioactive, and chemotherapeutic wastes are being
considered under the Industrial Combustion Coordinated Rulemaking (ICCR). The commenter
noted that recordkeeping and reporting supplies the agency with vital information to ensure that
rules are functioning as intended and helps to supply data needed to develop new rales such as
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the ICCR. In addition,.recordkeeping and reporting require a significant amount of employee
time and facility dollars.
Commenter IV-D-04 stated that the CAA requires specific reasons for a decision by EPA
that a source should not be required to file a title V permit. The commenter noted that section
502(a) of the CAA states that EPA may exempt a source in one or more source categories if EPA
finds that "compliance with such requirements is impracticable, infeasible, or unnecessarily
burdensome on such categories..." However, the law does not state that EPA may exempt a
source category when only recordkeeping and reporting are required. The commenter noted that
requiring co-fired combustors and HMIWI combusting only pathological waste, low-level
radioactive waste, and/or chemotherapeutic waste to file a title V permit application may not be
practicable at this time because EPA may develop a rule with specific emission limits for these
sources in the near future. However, the commenter stated that offering these types of sources
several years of additional time to come into compliance without requiring that they take some
action towards understanding their obligations under the .CAA is inappropriate.
Response: The EPA disagrees with both eommenters' views concerning this Federal plan.
The Federal plan requires owners or operators of HMIWI combusting only pathological waste,
low-level radioactive waste, and/or chemotherapeutic waste and co-fired combustors to fulfill
certain recordkeeping and reporting requirements to demonstrate that they are exempt from the
emission control-related requirements of the Federal plan. These emission control-related
requirements include emission limits; waste management plan requirements; operator training
and qualification requirements; inspection requirements; compliance and performance testing
requirements; monitoring requirements; and the emission control-related reporting and
recordkeeping requirements, but not the reporting and recordkeeping requirements related to the
applicability of the Federal plan and necessary for these sources to demonstrate exemption.
The reporting and recordkeeping requirements that these sources must fulfill (in
section 62.14400 [Applicability] of subpart HHH) differ from the emission control-related
reporting and recordkeeping requirements (in sections 62.14460 through 62.14465 [Reporting
and Recordkeeping] of subpart HHH) of the Federal plan. Section 62.14400 requires owners or
operators of HMIWI that combust only pathological waste, low-level radioactive waste, and/or
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chemotherapeutic waste and owners or operators of co-fired combustors to submit a one-time
notification of an exemption claim. In addition to this exemption claim, owners or operators of
HMIWI that combust only pathological waste, low-level radioactive waste, and/or
chemotherapeutic waste must keep records on a calendar quarter basis of the periods of time
when these types of waste are the only types of waste combusted. Owners or operators of co-
fired combustors must keep records on a calendar quarter basis of the weight of hospital waste
and medical/infectious waste combusted and the weight of all other fuels and wastes combusted.
The emission control-related reporting and recordkeeping requirements for HMIWI include
notifications, records, and reports pertaining to waste management, parameter monitoring,
operator training, inspections, and performance testing.
The EPA interprets CAA section 502(a) and 40 CFR 70.3(a)(2) and 71.3(a)(2) to mean
that sources subject to this exemption (combusting only pathological waste, low-level radioactive
waste, and/or chemotherapeutic waste, and co-fired combustors) are "not subject to standards or
regulations under section 111" for purposes of title V permitting. The Agency believes that the
recordkeeping and reporting requirements with which these facilities must comply if they are to
attain and maintain their exemptions are not the type of requirements that make them "subject to"
a standard or regulation under section 111 within the meaning of the first sentence of section
502(a). In EPA's view, facilities in this unique position do not even meet the threshold criteria
for sources required to obtain title V permits under section 502(a) of the Act. Therefore, these
sources are not required to apply for title V permits on the basis of the applicability of
recordkeeping and reporting requirements necessary to qualify for exemption from the emission
control-related requirements of the Federal plan. However, owners and operators of these
sources that do not comply with the recordkeeping and reporting requirements necessary to attain
and maintain exemption from the Federal plan will become subject to the emission control-
related requirements and will have to obtain title V permits. While HMIWI combusting
pathological, low-level radioactive, and/or chemotherapeutic waste and co-fired combustors
subject to this exemption need not obtain title V permits now, they are not prohibited from
applying for title V permits.
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As Commenter IV-D-04 stated, 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 facilities subject to exemptions from
emissions-control related requirements are not required to obtain title V permits. These facilities
have not been "exempted" from title V within the meaning of the last sentence of section 502(a),
and the Agency has not made or does not purport to have made the statutory showing of
impracticability, infeasibility or unnecessary burden for these sources. Rather, as stated earlier,
the Agency believes that the recordkeeping and reporting requirements with which these facilities
must comply are not the type that would make them "subject to" a standard under section 111 or
502(a) of the Act. These reporting and recordkeeping requirements are simply conditions for
exemption from the emission control-related requirements of the Federal plan.
Under the Federal plan sources are not required to routinely submit to EPA the records
they are required to maintain onsite to support their exemption from the section 129 standard.
However, we are adding two provisions to the regulation to facilitate public access to those
records. First, the regulation requires in sections 62.14400(b)(l) and (b)(2) that these sources
must submit these records to EPA upon request. Second, the regulation requires in section
62.14400(c) that EPA request these records from these sources if requested by a citizen under the
Freedom of Information Act, consistent with EPA regulations set forth at 40 CFR part 2. Should
a State take delegation of the Federal Plan rather than submitting an approvable State Plan, the
State would have the obligation to obtain these records from sources following receipt of a
citizen request under applicable freedom of information laws (comparable to the Freedom of
Information Act) and make such information available to the requestor.
Additionally, to clarify what the records maintained by co-fired combustors must contain
in order for an exemption from subpart HHH and title V permitting to be allowed, we have added
language to section 62.1440Q(b)(2). Language in this section states that the records maintained
by the owner or operator of a co-fired combustor must reflect that the source continues to meet
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the definition of co-fired cornbustor in section 62.14490. Language has been added to section
62.14400(c) stating that the records required by paragraphs (b)(l) and (b)(2) of section 62.14400
must be maintained by the relevant sources for a period of at least 5 years. Language has also
been added to section 62.1440G(c) stating that the notifications of exemption claims also required
by paragraphs (b)(l) and (b)(2) of section 62.14400 must be maintained by the EPA or delegated
enforcement authority for a period of at least 5 years. Such notifications are to be made available
upon request,
3.6 TRANSFERRING OF AUTHORITY
Comment: Commenter IV-D-03 raised the question of whether the authority to
implement the Federal Plan could be transferred to States and local agencies through the title V
operating permits program. The commenter noted that part IV of the preamble to the proposed
Federal plan {in section C on page 36432) describes two mechanisms for transferring authority to
State and local agencies and that part V of the preamble discusses title V operating permits
programs. These two mechanisms as described on page 36432 of the proposed Federal plan are
(1) the approval of a State plan after the Federal plan is in effect; and (2) if a State does not
submit or obtain approval of its own plan, EPA delegation to a State of the authority to
implement certain portions of the HMIWI Federal plan. The commenter recommended that the
preamble to the final Federal plan recognize the title V operating permits program as a third
mechanism for transferring authority to State and local agencies. The commenter noted that
many State and local agencies implement title V programs and that title V permits must include
the requirements of the Federal plan. Thus, title V permitting authorities already have
implementation responsibility for the Federal plan through the title V permits program,
regardless of whether the authority to implement the Federal plan is delegated to the State or
local agency. The commenter stated that the authority to implement the Federal plan would be
most useful before a title V permit is issued. The commenter stated that the time required for a
State to request and obtain authority to implement the Federal plan through delegation is similar
to the lead time required in the Federal plan for submitting title V permit applications. The
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commenter requested an explanation of why delegation of the Federal plan is necessary if a
title V program is in place.
Response: There are legal and practical reasons why incorporating a standard into a
permit without formal delegation is not equivalent to taking formal delegation and then issuing a
part 70 permit containing the standard. The Act and part 70 require States, local agencies or
Tribes, wishing to adopt a part 70 permitting program to have the legal authority to place all
applicable requirements (including HMIWI standards) in permits and to implement and enforce
them in that context. However, this requirement is not legally equivalent to formal delegation,
nor does it take the place of formal delegation. When a State takes formal delegation, EPA
allows the State to implement and enforce a standard independent of a title V permit. This is
significant because a title V source may be allowed to operate without a title V permit for a
number of years in some cases between the time it first triggers the requirement to apply for a
permit and the issuance of the permit. Prior to the issuance of a part 70 permit and absent formal
delegation, the State may not implement and enforce the requirements of a standard. Moreover, a
source with a title V permit with a permit term less than 3 years is not required by part 70 to
reopen the permit to include new applicable requirements, such as the HMIWI standard. See 40
CFR section 70.7(f)(l)(i). However, the source must still comply with that standard. Delegation
enables a State to implement and enforce the standard outside of the permit until permit renewal.
Comment: Commenter FV-D-03 also mentioned that the last statement in part IV of the
preamble to the proposed Federal plan, which indicates that EPA would retain responsibility for
enforcement after delegation, should be qualified to reflect State and local enforcement
responsibility after a title V permit is issued. The commenter questioned whether EPA or the
State and local title V permitting authorities would have enforcement responsibilities for the
Federal plan after a title V permit is issued to a source,
Response: The EPA first notes that the language in the proposal preamble to which the
commenter refers was errant and has been deleted from the preamble to the final rule. Rather,
EPA's position on this issue is accurately reflected in the same part of the proposal preamble
(part TV) that the commenter references under the section titled "Delegation of the Federal Plan
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and Retained Authorities": "The EPA will continue to hold enforcement authority along with the
State or Tribe even when a State or Tribe has received delegation of the Federal plan."
Moreover, the retained authorities discussion immediately following this sentence in the proposal
preamble does not address enforcement cf the Federal plan, and section 62,14495 of the
proposed and final rules does not include enforcement of the Federal plan as an authority retained
by the EPA Administrator. In fact, both State and local permitting authorities that have taken
delegation, as well as the EPA, will have responsibility for bringing enforcement actions against
sources violating Federal plan requirements. Prior to delegation, only the EPA will have
enforcement authority. In neither instance does the title V permit status of a source affect the
enforcement responsibility of EPA or the State and local permitting authorities.
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TECHNICAL REPORT DATA
(Please read Instructions on reverse before completing)
1. REPORT NO. 2.
EPA-456/R-00-003
4. TITLE AND SUBTITLE
Hospital/Medical/Infectious Waste Incinerators
Background
Information for Federal Plan, Summary of Public Comments and
Responses
7. AUTHOR®
9. PERFORMING ORGANIZATION NAME AND ADDRESS
Midwest Research Institute
5520 Dillard Road, Suite 100
Gary, NC 275 11
12. SPONSORING AGENCY NAME AND ADDRESS
U.S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Office of Air and Radiation
Research Triangle Park, NC 2771 1
3, RECIPIENTS ACCESSION NO,
5. REPORT DATE
June 2000
6, PERFORMING ORGANIZATION CODE
S. PERFORMING ORGANIZATION REPORT NO.
10. PROGRAM ELEMENT NO.
1 1 . CONTRACT/GRANT NO.
68-D6-0012
13. TYPE OF REPORT AND PERIOD COVERED
Final
14 SPONSORING AGENCY CODE
EPA/200/04
i 5. SUPPLEMENTARY NOTES
16. ABSTRACT
The EPA proposed a Federal plan for hospital/medical/infectious waste incinerators on July 6, 1999, This
report summarizes and responds to the comments EPA received on the proposed Federal plan.
17. KEY WORDS AND DOCUMENT ANALYSIS
a. DESCRIPTORS
Air Pollution
Pollution Control
Emission Guidelines
Federal Plan
Hospital/Medieal/Infectious Waste Incinerators
18. DISTRIBUTION STATEMENT
Release Unlimited
b. IDENTIFIERS/OPEN ENDED TERMS c. COSATI Field/Group
Air Pollution Control
Solid Waste
Medical Waste
Hospital Waste
Infectious Waste
Incineration
1 9. SECURITY CLASS (Report) 2 L NO. OF PAGES
Unclassified 1 7
20. SECURITY CLASS (Page) 22. PRICE
Unclassified
EPA Form 2220-1 (Rev. 4-77)
PREVIOUS EDITION IS OBSOLETE
Form ,wpd
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