National Emission Standards for Halogenated Solvent Cleaning, 62384-62408 [E8-24013]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2002–0009; FRL–8727–5]
RIN 2060–AP07
National Emission Standards for
Halogenated Solvent Cleaning
Environmental Protection
Agency (EPA).
ACTION: Proposed Notice of
Reconsideration and Request for Public
Comment.
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AGENCY:
SUMMARY: On May 3, 2007, EPA
promulgated the final rule titled:
National Air Emission Standards for
Hazardous Air Pollutants: Halogenated
Solvent Cleaning (the Halogenated
Solvent Cleaning rule) pursuant to
sections 112(d)(6) and 112(f) of the
Clean Air Act. The Halogenated Solvent
Cleaning rule set facility-wide emission
limits for certain halogenated solvent
cleaning machines and a May 3, 2010,
compliance deadline.
Following promulgation of the
Halogenated Solvent Cleaning rule, the
Administrator received several petitions
for reconsideration, pursuant to Clean
Air Act section 307(d)(7)(B). The
purpose of this notice is to initiate a
process for responding to certain issues
raised in the petitions. We are
requesting comment on the particular
issues for which we are granting
reconsideration, and those issues are
identified, in detail, below. Specifically,
we are requesting comment on the
revised risk assessment, our use of the
2002 National Emissions Inventory data
in lieu of the 1999 National Emissions
Inventory data, which was used at
proposal, our ample margin of safety
determination under Clean Air Act
section 112(f)(2), our determination
under Clean Air Act section 112(d)(6),
and the compliance deadline.
DATES: Comments. Comments must be
received on or before December 4, 2008.
Public Hearing. If anyone contacts
EPA requesting to speak at a public
hearing by October 30, 2008, a public
hearing will be held November 4, 2008.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OAR–2002–0009, by one of the
following methods:
• https://www.regulations.gov. Follow
the on-line instructions for submitting
comments.
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• E-mail: a-and-r-docket@epa.gov.
• Fax: (202)566–1741.
• Mail: Air and Radiation Docket,
EPA, Mailcode: 6102T, 1200
Pennsylvania Ave., NW., Washington,
DC 20460. Please include a duplicate
copy, if possible. We request that a
separate copy of each public comment
also be sent to the contact person listed
below (see FOR FURTHER INFORMATION
CONTACT).
• Hand Delivery: In person or by
courier, deliver comments to: EPA
Docket Center (2822T), EPA West
Building, Room 3334, 1301 Constitution
Ave., NW., Washington, DC 20004. Such
deliveries are only accepted during the
Docket’s normal hours of operation and
special arrangements should be made
for deliveries of boxed information. We
request that a separate copy of each
public comment also be sent to the
contact person listed below (see FOR
FURTHER INFORMATION CONTACT).
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OAR–2002–
0009. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be confidential business
information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or e-mail. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
www.regulations.gov, your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
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encryption, and be free of any defects or
viruses.
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available either
electronically in https://
www.regulations.gov or in hard copy at
the EPA Docket Center, Docket ID No.
EPA–HQ–OAR–2002–0009, EPA West
Building, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the Air and Radiation
Docket is (202) 566–1742.
For
questions about this proposed action,
contact Mr. H. Lynn Dail, Office of Air
Quality Planning and Standards, Sector
Policies and Programs Division, Natural
Resources and Commerce Group (E143–
03), U.S. Environmental Protection
Agency, Research Triangle Park, NC
27711; telephone number: (919) 541–
2363; fax number: (919) 541–3470; and
e-mail address: dail.lynn@epa.gov. For
specific information regarding the
modeling methodology, contact Ms.
Elaine Manning, Office of Air Quality
Planning and Standards, Health and
Environmental Impacts Division, Sector
Based Assessment Group (C539–02),
U.S. Environmental Protection Agency,
Research Triangle Park, NC 27711;
telephone number: (919) 541–5499; fax
number: (919) 541–0840; and e-mail
address: manning.elaine@epa.gov. For
information about the applicability of
these national emission standards for
hazardous air pollutants (NESHAP) to a
particular entity, contact Mr. Scott
Throwe, Office of Enforcement and
Compliance Assurance, U.S.
Environmental Protection Agency,
Washington, DC, (202) 564–7013; and email address: throwe.scott@epa.gov.
FOR FURTHER INFORMATION CONTACT:
Regulated
Entities. Categories and entities
potentially affected by this notice
include:
SUPPLEMENTARY INFORMATION:
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Category
NAICS 1 code
Examples of potentially regulated entities
Industry ................................
Any of numerous industries using halogenated solvent
cleaning, primary affected industries include those in
NAICS Codes beginning with: 331 (primary metal
manufacturing), 332 (fabricated metal manufacturing),
333 (machinery manufacturing), 334 (computer and
electronic product manufacturing), 335 (electrical
equipment, appliance, and component manufacturing); 336 (transportation equipment manufacturing); 337 (furniture and related products manufacturing); and 339 (misc. manufacturing).
..........................................................................................
Operations at sources that are engaged in solvent
cleaning
using
methylene
chloride
(MC),
perchloroethylene (PCE), or trichloroethylene (TCE).
Federal, State, local, and
tribal government.
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1 North
Operations at sources that are engaged in solvent
cleaning using MC, PCE, or TCE.
American Industry Classification System.
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this proposed action. This
action proposes to require an owner or
operator of a facility that is subject to
the 1994 NESHAP for Halogenated
Solvent Cleaning (40 CFR part 63.460 of
subpart T) to operate under certain
specific emission limits. If you have any
questions regarding the applicability of
this proposal to a particular entity,
consult the person listed in the
preceding FOR FURTHER INFORMATION
CONTACT section.
Submitting Comments/CBI. Direct
your comments to Docket ID No. EPA–
HQ–OAR–2002–0009. Do not submit
CBI to EPA through https://
www.regulations.gov or e-mail. Instead,
send or deliver information identified as
CBI only to the following address: Mr.
Roberto Morales, OAQPS Document
Control Officer (C404–02), U.S.
Environmental Protection Agency,
Office of Air Quality Planning and
Standards, Research Triangle Park, NC
27711, Attention Docket ID No. EPA–
HQ–OAR–2002–0009. Clearly mark the
part or all of the information that you
claim to be CBI. For CBI information on
a disk or CD–ROM that you mail to Mr.
Morales, mark the outside of the disk or
CD–ROM as CBI and then identify
electronically within the disk or CD–
ROM the specific information that is
claimed as CBI.
In addition to one complete version of
the comment that includes information
claimed as CBI, a copy of the comment
that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket. If you
submit a CD–ROM or disk that does not
contain CBI, mark the outside of the
disk or CD–ROM clearly that it does not
contain CBI. Information not marked as
CBI will be included in the public
docket and EPA’s electronic public
docket without prior notice.
If you have any questions about CBI
or the procedures for claiming CBI,
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please consult the person identified in
the FOR FURTHER INFORMATION CONTACT
section. Information marked as CBI will
not be disclosed except in accordance
with procedures set forth in 40 CFR part
2. Worldwide Web (WWW). In addition
to being available in the docket, an
electronic copy of this proposed action
will also be available on the WWW
through the Technology Transfer
Network (TTN). Following signature, a
copy of the proposed action will be
posted on the TTN’s policy and
guidance page for newly proposed or
promulgated rules at the following
address: https://www.epa.gov/ttn/oarpg/.
The TTN provides information and
technology exchange in various areas of
air pollution control.
Additional information is available in
section I of this preamble and on the
Halogenated Solvents Cleaning Web
page at https://www.epa.gov/ttn/atw/
rrisk/rtrpg.html. This information
includes source category descriptions
and detailed emissions and other data
that were used as inputs to the risk
assessments.
Public Hearing. If anyone contacts
EPA requesting to speak at a public
hearing concerning the particular issues
for which we are granting
reconsideration by October 30, 2008, we
will hold a public hearing at 10 a.m. at
EPA’s Campus located at 109 T.W.
Alexander Drive in Research Triangle
Park, NC, or an alternate site nearby on
November 4, 2008. Persons interested in
presenting oral testimony should
contact Ms. Joan C. Rogers, Natural
Resources and Commerce Group (E143–
03), Sector Policies and Programs
Division, EPA, Research Triangle Park,
NC 27711, telephone number: (919)
541–4487, e-mail address:
rogers.joanc@epa.gov, by October 30,
2008. Persons interested in attending
the public hearing should also call Ms.
Rogers to verify the time, date, and
location of the hearing. A public hearing
will provide interested parties the
opportunity to present data, views, or
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arguments concerning the proposed
standards.
Outline. The information presented in
this Preamble is organized as follows:
I. Background
A. What is the statutory authority for
regulating hazardous air pollutants?
B. What is the Halogenated Solvent
Cleaning rule?
C. What have we been asked to reconsider?
II. Proposed Response to the Petitions for
Reconsideration
A. What is our proposed action?
B. What is the reason for our proposed
action?
III. Discussion of Issues Subject to
Reconsideration
A. Baseline Risk Assessment and Decision
on Acceptable Risk
B. Decision on Ample Margin of Safety
C. Clean Air Act Section 112(d)(6) Review
D. Compliance Schedule
IV. Proposed Regulatory Text
V. Impacts
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
I. National Technology Transfer
Advancement Act
J. Executive Order 12898: Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations
I. Background
A. What is the statutory authority for
regulating hazardous air pollutants?
Section 112 of the Clean Air Act
(CAA) establishes a two-stage regulatory
process to address emissions of
hazardous air pollutants (HAP) from
stationary sources. In the first stage,
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after EPA has identified categories of
sources emitting one or more of the HAP
listed in section 112(b) of the CAA,
section 112(d) of the CAA calls for us
to promulgate NESHAP for those
sources: ‘‘Major sources’’ are those that
emit or have the potential to emit any
single HAP at a rate of 10 tons or more
per year or 25 tons or more per year of
any combination of HAP. For major
sources, the technology-based standards
must reflect the maximum degree of
emission reductions of HAP achievable
(after considering cost, energy
requirements, and non-air quality health
and environmental impacts) and are
commonly referred to as maximum
achievable control technology (MACT)
standards.
The MACT floor is the minimum
control level allowed for NESHAP and
is defined under section 112(d)(3) of the
CAA. For new sources, the MACT floor
cannot be less stringent than the
emission control that is achieved in
practice by the best-controlled similar
source. The MACT standards for
existing sources can be less stringent
than standards for new sources, but it
cannot be less stringent than the average
emission limitation achieved by the
best-performing 12 percent of existing
sources in the category or subcategory
(or the best-performing five sources for
categories or subcategories with fewer
than 30 sources). In developing MACT
standards, we must also consider
control options that are more stringent
than the floor. We may establish
standards more stringent than the floor
based on the consideration of the cost of
achieving the emission reductions, any
non-air quality health and
environmental impacts, and energy
requirements.
EPA is then required to review these
technology-based standards and to
revise them ‘‘as necessary (taking into
account developments in practices,
processes, and control technologies)’’ no
less frequently than every 8 years, under
CAA section 112(d)(6). In this proposal,
we are publishing the results of our 8year technology review for the
halogenated cleaning solvent source
category.
The second stage in standard-setting
focuses on reducing any remaining
‘‘residual’’ risk according to CAA
section 112(f). This provision requires,
first, that EPA prepare a Report to
Congress discussing (among other
things) methods of calculating risk
posed (or potentially posed) by sources
after implementation of the MACT
standards, the public health significance
of those risks, the means and costs of
controlling them, actual health effects to
persons in proximity of emitting
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sources, and recommendations as to
legislation regarding such remaining
risk. EPA prepared and submitted this
report (Residual Risk Report to
Congress, EPA–453/R–99–001) in March
1999. Congress did not act in response
to the report, thereby triggering EPA’s
obligation under CAA section 112(f)(2)
to analyze and address residual risk.
CAA section 112(f)(2) requires us to
determine for source categories subject
to certain CAA section 112(d) standards
whether the emission limitations
provide an ample margin of safety to
protect public health. If the MACT
standards for HAP ‘‘classified as a
known, probable, or possible human
carcinogen do not reduce lifetime excess
cancer risks to the individual most
exposed to emissions from a source in
the category or subcategory to less than
1-in-1 million,’’ EPA must promulgate
residual risk standards for the source
category (or subcategory) as necessary to
provide an ample margin of safety to
protect public health. EPA must also
adopt more stringent standards, if
necessary, to prevent an adverse
environmental effect,1 but must
consider cost, energy, safety, and other
relevant factors in doing so. In a
residual risk rulemaking under section
112(f)(2), EPA may adopt standards
equal to the existing MACT standards
(NRDC v. EPA, 529 F.3d 1077, 1083
(D.C. Cir. 2008).
Section 112(f)(2) of the CAA expressly
preserves our use of the two-step
process for developing standards to
address residual risk and our
interpretation of ‘‘ample margin of
safety’’ developed in the National
Emission Standards for Hazardous Air
Pollutants: Benzene Emissions from
Maleic Anhydride Plants, Ethylbenzene/
Styrene Plants, Benzene Storage Vessels,
Benzene Equipment Leaks, and Coke
By-Product Recovery Plants (Benzene
NESHAP) (54 FR 38044, September 14,
1989). See NRDC v. EPA, 529 F.3d 1077
D.C. Cir. 2008). The first step in the
residual risk process is the
determination of acceptable risk. The
second step provides for an ample
margin of safety to protect public health,
which is the level at which the
standards are set (unless a more
stringent standard is required to
prevent, taking into consideration costs,
energy, safety, and other relevant
1 ‘‘Adverse
environmental effect’’ is defined in
CAA Section 112(a)(7) as any significant and
widespread adverse effect, which may be
reasonably anticipated to wildlife, aquatic life, or
natural resources, including adverse impacts on
populations of endangered or threatened species or
significant degradation of environmental quality
over broad areas.
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factors, an adverse environmental
effect).
The terms ‘‘individual most exposed,’’
‘‘acceptable level,’’ and ‘‘ample margin
of safety’’ are not specifically defined in
the CAA. However, CAA section
112(f)(2)(B) directs us to use the
interpretation set out in the Benzene
NESHAP. See also, A Legislative History
of the Clean Air Act Amendments of
1990, volume 1, p. 877 (Senate debate
on Conference Report). We notified
Congress in the Residual Risk Report to
Congress that we intended to use the
Benzene NESHAP approach in making
CAA section 112(f) residual risk
determinations (EPA–453/R–99–001, p.
ES–11).
In the Benzene NESHAP, we stated as
an overall objective:
* * * in protecting public health with an
ample margin of safety, we strive to provide
maximum feasible protection against risks to
health from hazardous air pollutants by (1)
protecting the greatest number of persons
possible to an individual lifetime risk level
no higher than approximately 1-in-1 million;
and (2) limiting to no higher than
approximately 1-in-10 thousand (i.e., 100-in1 million) the estimated risk that a person
living near a facility would have if he or she
were exposed to the maximum pollutant
concentrations for 70 years.
We also stated that, ‘‘The EPA also
considers incidence (the number of
persons estimated to suffer cancer or
other serious health effects as a result of
exposure to a pollutant) to be an
important measure of the health risk to
the exposed population. Incidence
measures the extent of health risk to the
exposed population as a whole, by
providing an estimate of the occurrence
of cancer or other serious health effects
in the exposed population.’’ The EPA
went on to conclude that ‘‘estimated
incidence would be weighed along with
other health risk information in judging
acceptability.’’ As explained more fully
in our Residual Risk Report to Congress,
EPA does not define ‘‘rigid line(s) of
acceptability,’’ but considers rather
broad objectives to be weighed with a
series of other health measures and
factors (EPA–453/R–99–001, p. ES–11).
The determination of what represents an
‘‘acceptable’’ risk is based on a judgment of
‘‘what risks are acceptable in the world in
which we live’’ (54 FR 38045, quoting the
Vinyl Chloride decision at 824 F.2d 1165)
recognizing that our world is not risk-free.
In the Benzene NESHAP, we stated
that ‘‘EPA will generally presume that if
the risk to (the maximum exposed)
individual is no higher than
approximately 1-in-10 thousand, that
risk level is considered acceptable.’’ We
discussed the maximum individual
lifetime cancer risk as being ‘‘the
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estimated risk that a person living near
a plant would have if he or she were
exposed to the maximum pollutant
concentrations for 70 years.’’ We
explained that this measure of risk ‘‘is
an estimate of the upperbound of risk
based on conservative assumptions,
such as continuous exposure for 24
hours per day for 70 years.’’ 2 We
acknowledge that maximum individual
lifetime cancer risk ‘‘does not
necessarily reflect the true risk, but
displays a health-protective risk level
which is an upper bound that is
unlikely to be exceeded.’’ 3
Understanding that there are both
benefits and limitations to using
maximum individual lifetime cancer
risk as a metric for determining
acceptability, we acknowledged in the
1989 Benzene NESHAP that
‘‘consideration of maximum individual
risk * * * must take into account the
strengths and weaknesses of this
measure of risk.’’ 4 Consequently, the
presumptive risk level of 100-in-1
million (1-in-10 thousand) provides a
benchmark for judging the acceptability
of maximum individual lifetime cancer
risk, but does not constitute a rigid line
for making that determination.
The EPA also explained in the 1989
Benzene NESHAP the following:
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In establishing a presumption for MIR 5,
rather than rigid line for acceptability, the
Agency intends to weigh it with a series of
other health measures and factors. These
include the overall incidence of cancer or
other serious health effects within the
exposed population, the numbers of persons
exposed within each individual lifetime risk
range and associated incidence within,
typically, a 50 kilometer (km) exposure
radius around facilities, the science policy
assumptions and estimation uncertainties
associated with the risk measures, weight of
the scientific evidence for human health
effects, other quantified or unquantified
health effects, effects due to co-location of
facilities, and co-emission of pollutants.
In some cases, these health measures
and factors taken together may provide
a more realistic description of the
magnitude of risk in the exposed
population than that provided by
maximum individual lifetime cancer
risk alone.
As explained in the Benzene
NESHAP, ‘‘(e)ven though the risks
judged ‘‘acceptable’’ by EPA in the first
step of the Vinyl Chloride inquiry are
already low, the second step of the
inquiry, determining an ‘‘ample margin
2 Quoted text is from the Benzene NESHAP
preamble, pages 38045 and 38046.
3 Quoted text is from the Benzene NESHAP
preamble, pages 38045 and 38046.
4 Quoted text is from the Benzene NESHAP
preamble, pages 38045 and 38046.
5 MIR is the maximum individual cancer risk.
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of safety,’’ again includes consideration
of all of the health factors, and whether
to reduce the risks even further. In the
second step, EPA strives to provide
protection to the greatest number of
persons possible to an individual
lifetime risk level no higher than
approximately 1 in 1 million. In the
ample margin decision, the EPA again
considers all of the health risk and other
health information considered in the
first step. Beyond that information,
additional factors relating to the
appropriate level of control will also be
considered, including costs and
economic impacts of controls,
technological feasibility, uncertainties,
and any other relevant factors.
Considering all of these factors, the EPA
will establish the standard at a level that
provides an ample margin of safety to
protect the public health, as required by
section 112.’’
B. What is the Halogenated Solvent
Cleaning rule?
On December 2, 1994, we
promulgated national emission
standards for halogenated solvent
cleaning machines 6 (59 FR 61801,
December 2, 1994) (1994 NESHAP), to
control emissions of the halogenated
solvents MC, PCE, TCE, 1,1,1,trichloroethane (TCA), carbon
tetrachloride, chloroform, and
halogenated solvent blends or their
vapors from halogenated solvent
cleaning machines, pursuant to Section
112(d) of the CAA. The standards,
which can be found in 40 CFR Subpart
T, include multiple alternatives that
allow maximum compliance flexibility.
The final rule is available in the docket
for this rulemaking. It can also be
accessed at: https://www.epa.gov/ttn/
atw/degrea/halopg.html.
Carbon tetrachloride and chloroform
are no longer used in this source
category. The Montreal Protocol, a
multi-national treaty signed on
September 16, 1987, phased out the
6 Halogenated solvent cleaning does not
constitute a distinct industrial category, but is an
integral part of many major industries. The five 3digit NAICS Codes that use the largest quantities of
halogenated solvents for cleaning are NAICS 337
(furniture and related products manufacturing),
NAICS 332 (fabricated metal manufacturing),
NAICS 335 (electrical equipment, appliance, and
component manufacturing), NAICS 336
(transportation equipment manufacturing), and
NAICS 339 (miscellaneous manufacturing).
Additional industries that use halogenated solvents
for cleaning include NAICS 331 (primary metals),
NAICS 333 (machinery), and NAICS 334 (electronic
equipment manufacturing). Non-manufacturing
industries such as railroad (NAICS 482), bus
(NAICS 485), aircraft (NAICS 481), and truck
(NAICS 484) maintenance facilities; automotive and
electric tool repair shops (NAICS 811); and
automobile dealers (NAICS 411) also use
halogenated solvent cleaning machines.
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production and use of these
chlorofluorocarbons by January 1, 1996.
The Montreal Protocol also phased out
the production and use of TCA.
Although production and use of TCA
has been phased out since 1998, an
exemption to the phase-out allows
facilities with essential products or
activities to continue their use of TCA,
and facilities with non-essential
activities or products to continue the
use of their remaining TCA stockpiles
until depleted. A declining quantity of
TCA continued to be used until 2002,
when all production of TCA ceased, and
eventually, facilities used TCA
stockpiles until depleted. Since January
1, 2002, TCA has not been
manufactured for domestic use in the
United States.
Halogenated solvent cleaning
machines use MC, PCE, TCE and TCA
to remove soils such as grease, oils,
waxes, carbon deposits, fluxes, and tars
from metal, plastic, fiberglass, printed
circuit boards, and other surfaces.
Halogenated solvent cleaning is
typically performed prior to processes
such as painting, plating, inspection,
repair, assembly, heat treatment, and
machining. Types of halogenated
solvent cleaning machines include, but
are not limited to, batch vapor, in-line
vapor, in-line cold, and batch cold
solvent cleaning machines. Buckets,
pails, and beakers with capacities of 7.6
liters (2 gallons) or less are not
considered halogenated solvent cleaning
machines.
In May 2007, we promulgated the
Halogenated Solvent Cleaning rule (72
FR 25138), which established revised
standards that further limit emissions of
MC, TCE and PCE from facilities
engaged in halogenated solvent
cleaning, pursuant to CAA section
112(f). Specifically, we promulgated a
facility-wide emission limit of 60,000
kilograms per year (kg/yr) MC
equivalent 7 that applied to all
halogenated solvent cleaning machines
with the exception of halogenated
solvent cleaning machines used by the
following industries: Facilities that
manufacture narrow tubing, facilities
that use continuous web cleaning
machines, aerospace manufacturing and
maintenance facilities, and military
maintenance and depot facilities. We
also promulgated a facility-wide
emission limit of 100,000 kg/yr MC
7 All emission limits and emission rates in the
assessments were converted to MC equivalents
based on the relative cancer potency of the HAP
emitted. The cancer potency-weighted MC
equivalent emission rate was calculated as the
estimated emissions for the HAP in kg/yr or lb/yr
times the unit risk estimate (URE) for the HAP
divided by the URE for MC.
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equivalent for halogenated solvent
cleaning machines used at military
maintenance and depot facilities. We
required existing facilities to comply
with the revised standards by May 3,
2010, which is three years after the
effective date of the Halogenated
Solvent Cleaning rule. Further, with
regard to halogenated solvent cleaning
machines used by facilities that
manufacture narrow tubing, facilities
that use continuous web cleaning
machines, and aerospace manufacturing
and maintenance facilities we found,
after considering risks, associated
compliance costs and the availability of
control measures, that the 1994
NESHAP reduces risk to acceptable
levels, provides an ample margin of
safety to protect public health, and
prevents adverse environmental effects.
We also reviewed the 1994 NESHAP as
required by CAA section 112(d)(6).
C. What have we been asked to
reconsider?
Following promulgation of the
Halogenated Solvent Cleaning rule, the
Administrator received several
petitions 8 for reconsideration
(Petitions), under CAA section
307(d)(7)(B). Generally, petitioners
claimed that the Halogenated Solvent
Cleaning rule contained legal
interpretations and information that are
of central relevance to the final rule that
were not sufficiently reflected at
proposal, and that they, therefore, did
not have adequate opportunity to
provide input during the designated
public comment period. Further,
petitioners claimed that additional
information on compliance measures
had become available since the close of
the public comment period for the
Halogenated Solvent Cleaning rule, and
that this new information is also of
central relevance to the Halogenated
Solvent Cleaning rule.
On August 15, 2007, EPA informed
petitioners of its intent to initiate notice
and comment rulemaking to address the
Petitions. We also informed petitioners
that the particular issues for
reconsideration and the specifics of the
reconsideration process would be
addressed in a forthcoming Federal
Register notice. Additionally, we denied
the request to stay the effectiveness of
the Halogenated Solvent Cleaning rule
pending completion of the
reconsideration proceedings. (These
8 These petitions for reconsideration were filed by
the Commonwealth of Pennsylvania Department of
Environmental Protection, Natural Resources
Defense Council, Citizens for Pennsylvania’s Future
and Sierra Club, several State and federal legislators
and the Governor of the Commonwealth of
Pennsylvania (petitioners).
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letters are in the docket for this
rulemaking.)
Finally, petitioners challenged the
Halogenated Solvent Cleaning rule in
the Court of Appeals for the District of
Columbia Circuit.9 Because we intended
to initiate notice and comment
rulemaking to address the Petitions, the
Court has granted our request to hold
the litigation in abeyance. The Court has
directed the parties to the litigation to
file Motions to Govern Further
Proceedings by November 3, 2008.
II. Proposed Response to the Petitions
for Reconsideration
A. What is our proposed action?
In this action, we are proposing to
find that the risk associated with the
1994 NESHAP for the halogenated
solvent cleaning source category is
acceptable within the meaning of
Section 112(f). We are also proposing
various regulatory options that would
provide an ample margin of safety to
protect public health and prevent
adverse environmental effects. These
proposed requirements would apply to
owners and operators of halogenated
solvent cleaning machines that are
subject to the 1994 NESHAP. We are
proposing these requirements under
both CAA sections 112(d)(6) and
112(f)(2). For existing sources that were
not subject to the emission reduction
requirements in the Halogenated
Solvent Cleaning rule,10 we are
proposing a 2-year compliance deadline
from the date of publication of the final
rule in the Federal Register. As to those
sources that were subject to emission
reduction requirements in the
Halogenated Solvent Cleaning rule,11 if
the final rule on reconsideration
changes those requirements and makes
them more stringent, we propose that
these sources have two years from the
9 Commonwealth of Pennsylvania Department of
Environmental Protection v. EPA, No. 07–1129
(D.C. Cir.); Citizens for Pennsylvania’s Future and
Sierra Club v. EPA, No. 07–1255 (D.C. Cir.); Natural
Resources Defense Council v. EPA, No. 07–1256
(D.C. Cir.). These cases have since been
consolidated.
10 These sources include halogenated solvent
cleaning machines used by facilities that
manufacture narrow tubing, facilities that
manufacture specialized products requiring
continuous web cleaning machines, and aerospace
manufacturing and maintenance facilities.
11 These sources include halogenated solvent
cleaning machines at military maintenance and
depot facilities and the general population of
halogenated solvent cleaning machines. The general
population of halogenated solvent cleaning
machines includes all halogenated solvent cleaning
machines, except those machines used by facilities
that manufacture narrow tubing, facilities that
manufacture specialized products requiring
continuous web cleaning, aerospace manufacturing
and maintenance facilities, and military
maintenance and depot facilities.
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date of publication of the final rule to
comply with the requirements of the
final rule. We believe that such an
extension is appropriate to allow the
affected facilities time to meet the more
stringent emission limitations.
We are seeking public comment on all
aspects of this proposed reconsideration
rule. As noted above, the issues
identified below are the ones for which
we are granting reconsideration. We will
convey our decision as to any other
issues raised in the reconsideration
petitions no later than the date by which
we take final action on the issues
discussed in this action.
B. What is the reason for our proposed
action?
On August 17, 2006, pursuant to CAA
section 112(f), we proposed revised
standards (71 FR 47670, August 17,
2006) (August 2006 Proposal) to further
limit emissions of MC, TCE and PCE
from facilities engaged in halogenated
solvent cleaning. We co-proposed
emission limits of 25,000 kg/yr MC
equivalent and 40,000 kg/yr MC
equivalent to provide an ample margin
of safety to protect public health and
prevent adverse environmental effects.
The August 2006 proposal also
identified other levels of emission
reductions, including the 60,000 and
100,000 kg/yr MC equivalent levels. 71
FR 47680–81. We indicated that we
expected to finalize one of the two coproposed options, and that the
standards finalized would apply to the
entire source category in addition to the
1994 NESHAP requirements. We also
proposed a compliance deadline for
existing sources of two years after the
effective date of the final rule.
Industry, States, solvent
manufacturers, industry trade
associations and district air associations
submitted comments in response to our
August 2006 proposal. Industry’s
comments were primarily submitted by
the aerospace manufacturing and
maintenance industry, the narrow
tubing manufacturing industry, facilities
that use continuous web cleaning
machines, and military maintenance
and depot facilities. Comments focused
on associated compliance costs,
technical feasibility, and the proposed
compliance deadline. In response to
these comments, we issued a Notice of
Data Availability (NODA), on December
14, 2006 (71 FR 75182), requesting
specific information on compliance
costs, technical feasibility, and
compliance deadlines as they related to
halogenated solvent machines used by
the above-referenced industries.
Responses to the NODA provided
significant data and information that led
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EPA to re-evaluate the data and
assumptions used to estimate risks,
costs and technical feasibility of
compliance with the co-proposed
emission limits.
In the Halogenated Solvent Cleaning
rule, we presented our re-evaluation of
risks, costs and technical feasibility of
compliance with the co-proposed
emission limits. As a result of our reevaluation, we promulgated a facilitywide emission limit of 60,000 kg/yr MC
equivalent for all halogenated solvent
cleaning machines with the exception of
halogenated solvent cleaning machines
used by facilities that manufacture
narrow tubing, facilities that use
continuous web cleaning machines,
aerospace manufacturing and
maintenance facilities, and military
maintenance and depot facilities. We
determined that this emission limit
would provide an ample margin of
safety to protect health and prevent
adverse environmental effects. For all
halogenated solvent cleaning machines
used at military maintenance and depot
facilities, we promulgated a facilitywide emission limit of 100,000 kg/yr
MC equivalent that would provide an
ample margin of safety to protect health
and prevent adverse environmental
effects. We also set a compliance
deadline of three years from the
effective date of the Halogenated
Solvent Cleaning rule. Finally, with
regard to facilities that use continuous
web cleaning machines and halogenated
solvent cleaning machines used by
facilities that manufacture narrow
tubing and aerospace manufacturing
and maintenance facilities, we found
that the current level of control required
by the 1994 NESHAP reduces HAP
emissions to levels that provide an
ample margin of safety to protect public
health and prevent any adverse
environmental effects.
As noted earlier above, following
promulgation of the Halogenated
Solvent Cleaning rule, the
Administrator received several petitions
for reconsideration, under CAA Section
307(d)(7)(B). In general, petitioners
alleged that the following issues
appeared for the first time in the
Halogenated Solvent Cleaning rule,
making it impracticable to raise
objections during the period provided
for public comment: The 60,000 kg/yr
MC equivalent limit for the general
population of halogenated solvent
cleaning machines; the 100,000 kg/yr
MC equivalent limit for halogenated
solvent cleaning machines used by
military maintenance and depot
facilities; EPA’s decision to use in
support of its risk assessment, data from
the 2002 National Emissions Inventory
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(NEI) as opposed to data from the 1999
NEI; EPA’s conclusion that the 1994
NESHAP reduces risk to acceptable
levels and provides an ample margin of
safety to protect public health for
aerospace manufacturing and
maintenance facilities, facilities that
manufacture narrow tubing, and
facilities that use continuous web
cleaning machines; EPA’s technical
feasibility and cost analyses in the final
rule; and the 3-year compliance period
for existing sources.
Petitioners also provided information
on technical feasibility that was not
otherwise available to EPA at the time
of promulgation of the Halogenated
Solvent Cleaning rule. That information
shows certain facilities that manufacture
narrow tubing either taking steps or
planning to take steps to reduce HAP
emissions at their facilities. This
information is discussed in greater
detail below.
In response to the petitions, we are
reconsidering various issues, and those
issues are described in detail below.
III. Discussion of Issues Subject to
Reconsideration
A. Baseline Risk Assessment and
Decision on Acceptable Risk
In addition to the general issues
raised above, petitioners raised several
specific issues relating to the baseline
risk assessment and EPA’s decision on
acceptable risk.
Before discussing the issues on which
we are granting reconsideration, we
would like to clarify a
misunderstanding that was revealed to
us in the Petitions. Specifically, certain
petitioners contend that by removing
facilities that use continuous web
cleaning machines, and halogenated
solvent cleaning machines used by
facilities that manufacture narrow
tubing, aerospace manufacturing and
maintenance, and military maintenance
and depot facilities in the risk
assessments for the Halogenated Solvent
Cleaning rule, we failed to consider the
health risks from the entire source
category and thus, that the Halogenated
Solvent Cleaning rule deviated from the
Benzene NESHAP (54 FR 38044,
September 14, 1989) framework and
CAA Section 112(f)(2)(B). Petitioners
also contend that the risks associated
with the source category are ‘‘gross
underestimates of actual risks’’ because
of our removal of this subset of sources.
One petitioner asserts that because the
risk assessment at proposal showed the
baseline maximum individual risk
(MIR) as 200-in-1 million with 0.40
annual cancer incidences, as compared
to 100-in-1 million and 0.55 annual
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62389
cancer incidences presented in the
Halogenated Solvent Cleaning rule, the
resulting 38 percent increased cancer
incidence was not subject to public
comment. The petitioner further
contends that cancer risks would have
increased beyond 38 percent but for the
exemptions of certain halogenated
solvent cleaning machines that had a
further effect of removing the
Collegeville, PA, population from the
population risk distribution.
However, contrary to petitioners
understanding, we performed a risk
assessment for the entire halogenated
solvent cleaning machines source
category both for the August 2006
Proposal (71 FR 47670) and for the
Halogenated Solvent Cleaning rule (72
FR 25138). Our re-evaluation of risks
involved the re-assessment of the risks
for the entire category using both the
1999 and the 2002 NEI inventory
(discussed in greater detail, below),
which was not available at the time of
the August 2006 Proposal, but was
available for the Halogenated Solvent
Cleaning rule. The preamble and risk
assessment also provided separate
analyses for each of the industry sectors
(facilities that manufacture narrow
tubing, aerospace manufacturing and
maintenance, military maintenance and
depots, facilities that use continuous
web cleaning machines) and the subset
of remaining facilities not included in
one of these four sectors that make up
the halogenated solvent cleaning source
category. This approach allowed us to
compare the risk contribution of each
sector to the overall risks presented by
the facilities in the halogenated solvent
source category. In this way, we were
able to show the contribution of each
sector’s risk to the risk from the entire
category. Therefore, contrary to
petitioners’ allegations, our re-analyses
of the risks in the Halogenated Solvent
Cleaning rule did not exclude a subset
of the halogenated solvent cleaning
machines source category and therefore,
did not understate or fail to consider a
portion of the risks associated with the
entire source category.
With regard to the issues on which
EPA is granting reconsideration, one
petitioner states that we failed to
consider the risk assessment prepared
by the Commonwealth of Pennsylvania
Department of Environmental Protection
(PADEP),12 and that our maximum
12 In addition to raising the PADEP risk
assessment in their Petitions, Petitioners identified
certain other documents dated after the close of the
public comment period, which they argue are of
central relevance to the Halogenated Solvent
Cleaning rule. If the Petitioners believe that these
documents are relevant to the issues on which we
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individual cancer risk level of 70-in-1
million associated with the narrow
tubing industry was erroneous given the
associated risks of 160-in-1 million
indicated by PADEP’s risk assessment.
Another petitioner contends that the
certain assumptions underlying EPA’s
risk assessment for the Halogenated
Solvent Cleaning rule are erroneous. In
support of its position, the petitioner
cites EPA’s use of census block
centroids to predict MIR. The petitioner
argues that EPA should have estimated
risk at the nearest residence and that
EPA’s census block approach may have
resulted in an underprediction of risk.
We reviewed the risk assessment
prepared by the PADEP, and we
disagree with their conclusion that our
estimated MIR risk level associated with
the narrow tubing industry is erroneous.
The PADEP risk assessment was based
on ambient monitoring data collected in
2004. (PADEP continues to collect
ambient data on TCE in the Collegeville,
PA, area.) From 2004 to 2007, the
annual average TCE concentrations
measured over the 4 years ranged from
0.6 micrograms per cubic meter (µg/m3)
to 1.5 µg/m3 (avg. = 0.9 µg/m3) at the
Evansberg, PA site and 1.2 µg/m3 to 1.3
µg/m3 (avg. = 1.3 µg/m3) at the Trappe,
PA, site. We extended our risk
assessment, which was based on
dispersion modeling of TCE emissions
from the two Collegeville, PA,
halogenated solvent cleaning facilities
in the 2002 NEI emissions inventory, to
estimate TCE concentrations of 0.8 µg/
m3 and 1.4 µg/m3 at the Evansberg and
Trappe monitoring sites, respectively.
Thus, from an ambient air concentration
perspective, the two risk assessments
are consistent. The risk assessments
differ, however, because TCE exposures
were assessed using different cancer
unit risk estimates (URE) for TCE.
Following the long-established EPA
policy, we used the California EPA
(CalEPA) inhalation URE for TCE. In
contrast, PADEP used a unit risk value
for TCE developed by EPA in a draft
report issued in 2001. That draft report
was subjected to peer review by the
EPA’s Science Advisory Board, and the
Board raised several important issues.
As a result of the Science Advisory
Board’s input on the draft report, EPA
asked the National Academy of Sciences
(NAS) to examine issues critical to
developing an objective, realistic, and
scientifically-based health assessment of
TCE. The NAS released their report in
are granting reconsideration in this rule, we invite
petitioners to submit the documents to EPA during
the public comment period. We will consider such
documents at the same time we consider all
significant comments received during the comment
period for this action.
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17:55 Oct 17, 2008
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2006, providing EPA further insight as
they develop a revised health risk
assessment for TCE. EPA never finalized
the 2001 draft report because of the
significant issues raised by the Science
Advisory Board and NAS. Thus,
PADEP’s use of EPA’s draft 2001 TCE
risk assessment neither satisfies the
basic requirements of our peer review
policy, nor is the draft 2001 TCE risk
assessment currently endorsed by the
EPA’s Office of Research and
Development.
In addition, PADEP used an oral
cancer slope value from the draft TCE
document instead of the inhalation
value derived in that document, and
extrapolated the oral cancer slope factor
for use in their inhalation risk
assessment. Use of such an
extrapolation is considered substantially
inferior to use of values developed
directly from inhalation data. PADEP’s
use of the draft extrapolated URE in
their assessment resulted in the
estimation of a maximum individual
cancer risk of 160-in-1 million at the
Trappe site, a risk which is
approximately 50 times higher than
what the EPA risk assessment indicates
for that location. Thus, while both risk
assessments are consistent with respect
to the estimates of ambient TCE
concentrations around these monitoring
sites, there is a significant difference in
the estimation of individual cancer risk.
The difference results from PADEP
using a cancer potency value that would
not be considered acceptable under
EPA’s Information Quality Guidelines
because it did not withstand a rigorous
scientific peer review.
Several petitioners stated that the
EPA’s decision to use available data
from the 2002 NEI, instead of data from
the 1999 NEI as proposed, appeared for
the first time in the Halogenated Solvent
Cleaning rule, making it impracticable
to raise objections during the period
provided for public comment.
Based on public comments on our
August 2006 Proposal, our risk
assessment for the entire source
category that was presented in the
Halogenated Solvent Cleaning rule used
the 2002 NEI database instead of the
1999 NEI database as presented at
proposal. The 2002 NEI database was
unavailable at proposal. Further, since
receipt of the petitions, we have
conducted additional risk assessments
using facility emissions from both the
1999 and 2002 NEI, explicitly assessing
the risks separately for each of the
industry sectors identified above at
various levels of control, similar to our
August 2006 Proposal and the
Halogenated Solvent Cleaning rule. In
this way, we have been able to show the
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contribution of each sector’s risk to the
risk from the entire source category. The
1999 NEI contains information for 1,167
halogenated solvent cleaning facilities,
out of which 743 emit carcinogenic
HAP. The 2002 NEI contains
information for 1,080 halogenated
solvent cleaning facilities, out of which
734 emit carcinogenic HAP. Considering
the uncertainties associated with the
development of emission inventories,
we consider neither the 1999 nor the
2002 NEI to be accurate in an absolute
sense. Rather, we consider them to be
our best estimates of annual snapshots
of emissions for this source category.
For each base year risk assessment, we
scale-up the modeled results to reflect
what we believe to be the true number
of facilities in the source category,
approximately 1,900. Given our
knowledge of the NEI database and as a
result of meetings with industry we
believe that 1,900 is a better estimate of
the number of sources in the source
category.
To develop an estimate of facilities
currently operating, EPA asked State
and EPA regional source category
contacts for estimates of the number of
cleaning machines in their jurisdictions.
As a result of that effort, EPA concluded
that there were 3,821 halogenated
solvent cleaning machines nationwide.
EPA also determined that there was on
average about two machines per facility,
therefore, EPA estimated a total of 1,932
solvent cleaning facilities currently
existing nationwide. Therefore, for the
development of this rule, the number of
sources in this source category was
assumed to be about 3,800 cleaning
machines located at 1,900 facilities
nationwide. This estimate is based on
information collected by EPA in 1998
and in 2005. If the scale-up had not
been implemented the cost and HI
results would be reduced by 56 percent
(given that the scale-up factor is 1.76)
relative to the number of facilities and
may not truly represent the affected
universe. We request comment on the
use of the scale-up to accurately
represent the universe of sources.
In addition, the Johnson and Capel
(1992) population mobility model,13
used to develop the population risk
distribution for the Halogenated Solvent
Cleaning rule, was updated subsequent
to promulgation of that rule. The
updated model reflects the use of more
recent Surveys of Income and Program
13 Ted Johnson and Jim Capel. 1992. A Monte
Carlo Approach to Simulating Residential
Occupancy Periods and Its Application to the
General U.S. Population, EPA–450/3–92–011, U.S.
Environmental Protection Agency, Research
Triangle Park, N.C. (This information has been
placed in the docket for this rule).
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Participation (SIPP) data and a newer,
more complete modeling approach. The
new model randomly selects subjects
from the U.S. Census Bureau’s
American Community Survey
database,14 and estimates time already
spent in the residence, future time to be
spent in the residence, and future length
of life. These estimates are then
combined to predict the total time, past
and future, that the subject would
occupy the current residence. Results
are then compared with SIPP residence
time data and adjusted to compensate
for ‘‘residential inertia’’ (i.e., a tendency
in the SIPP data for long-term residents
to have lower-than-expected move
rates). As a result of this update to the
modeling approach, the baseline
population risk estimates in this
preamble differ somewhat from those
presented in the Halogenated Solvent
Cleaning rule. This preamble (section
III) presents risk estimates based on the
2002 NEI. We believe the 2002 NEI is
likely to provide more accurate
estimates of current emissions from the
source category (compared to the 1999
NEI), reflecting known decreases in
solvent demand and use.
Since promulgation of the
Halogenated Solvent Cleaning rule, we
have also become aware of a newer
assessment for non-cancer effects of TCE
developed by the New York State
Department of Health (NYS DOH). The
NYS DOH states that their ‘‘air
criterion,’’ is ‘‘essentially equivalent to
an United States Environmental
Protection Agency’s (US EPA, 2002a)
reference concentration (RfC) * * * or
an Agency for Toxic Substances and
Disease Registry’s (ATSDR, 1996)
chronic minimal risk level (MRL) * * *
.’’ 15 In addition to evaluating a number
of studies which look at numerous
different toxicological endpoints, the
NYS DOH air criterion relies on a 1993
study which evaluated clinical
neurological effects (as measured by
coordination tests) in 99 Danish
workers. For 70 of these workers, the
dominant exposure was TCE, while for
25 of the workers the dominant
exposure was to CFC 113. Air exposures
were extrapolated from measurements
of the urinary metabolite TCA.
Limitations of this study include some
uncertainty about the actual long-term
exposure levels of the workers to TCE
during their employment, and that 25 of
14 U.S. Census Bureau, 2007. American
Community Survey. Available online at https://
www.census.gov/acs/www/.
15 New York State Department of Health,
Trichloroethene Air Criteria Document, October
2006, page 1, https://www.health.state.ny.us/
environmental/chemicals/trichloroethene/docs/
cd_tce.pdf.
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the 99 subjects were exposed primarily
to CFC 113. The NYS DOH assessment
is limited by gaps in the data on
developmental effects and
immunotoxicity, and concerns about
adequacy of methods for evaluating
health risks to children (limitations it
shares with the CalEPA assessment).
The results of the scientific review are
described in the NYS DOH toxicological
review document.16
The CalEPA inhalation reference
exposure level (REL) 17 used in the risk
assessment for this proposal and our
previous assessment was based on a
1973 study of 19 workers who
experienced symptoms of drowsiness,
fatigue, headache, and eye irritation.
CalEPA identified the use of human
exposure data from workers exposed
over a period of years as a strength of
the REL. The lack of reproductive and
developmental toxicity studies and the
lack of a no effect level were identified
as major areas of uncertainty. Both
CalEPA and NYS DOH had an external
peer review process and allowed for
public comment before finalizing their
respective assessments. The NYS DOH
assessment was finalized in 2006 and
the CalEPA assessment was finalized in
2000.
Non-cancer risk results were derived
using the NYS DOH TCE air criterion as
well as using the CalEPA value in the
additional risk assessments completed
since promulgation of the Halogenated
Solvent Cleaning rule. The results of our
additional risk assessments are
summarized in section III of this
preamble and the complete
documentation is available in the docket
for this rulemaking. In this action, we
are providing this additional risk
analysis and are soliciting comment on
it, including comments on the use of the
NYS DOH air criterion. We note that we
received no comments recommending
use of the NYS DOH TCE air criterion
either in comment on the proposed rule,
in comment on the NODA, or in any of
the petitions for reconsideration
submitted to the EPA.
The additional risk assessment
conducted in support of this proposal
reaffirms our baseline risk analysis that
was presented in the Halogenated
Solvent Cleaning rule. The results are
summarized in Table 1, below.
Specifically, the analysis confirms that:
(1) The baseline MIR for the entire
source category is approximately 100-in16 NYS DOH toxicological review document.
https://www.health.state.ny.us/environmental/
chemicals/trichloroethene/docs/cd_tce.pdf.
17 California EPA, 1999. Chronic toxicity
summary: Trichloroethylene. Office of
Environmental Health Hazard Assessment. https://
www.oehha.ca.gov/air/chronic_rels/pdf/79016.pdf.
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1 million and (2) the total cancer
incidence associated with the source
category is approximately 0.55 cases per
year. The updated population risk
distribution at baseline emission levels
shows that 100 people are exposed to
risk levels at or above 100-in-1 million,
82,000 people are estimated to have
risks between 10-in-1 million and 100in-1 million, and 8,000,000 people are
estimated to have risks between 1-in-1
million and 10-in-1 million. These
values can be compared to the baseline
risk estimates that we presented in the
Halogenated Solvent Cleaning rule, i.e.,
about 25 people exposed to risks at or
above 100-in-1 million, about 22,000
people at estimated risks between 10-in1 million and 100-in-1 million risk
level, and about 4,000,000 people at
estimated risks between 1-in-1 million
and 10-in-1 million.
Additionally, in our previous risk
assessment for the Halogenated Solvent
Cleaning rule, the maximum hazard
index (HI) was 0.2 (this HI is associated
with the compound TCA), and there
were no facilities with a HI greater than
1. However, if we were to use the NYS
DOH air criterion for TCE mentioned
above, rather than the CalEPA REL and
apply the national scaling factor 18 we
estimate that there are ten facilities with
HI greater than 1 and a maximum HI of
7. A chronic HI less than or equal to 1
indicated that there is no appreciable
risk of adverse effects. Although, a
chronic HI greater than 1 raises concern
over potential toxicity, the numerical
magnitude of the HI must be interpreted
in the context of the supporting
information. Thus, we examined these
ten HI values greater than 1 in the
context of uncertainties and additional
supporting information. In the risk
assessment document used to support
the August 2006 proposal, we stated
that the approach used then (and in all
subsequent risk analyses for this source
category) was a reasonable one which
was more likely to over-predict risks
than under-predict them. When we
consider the distribution of the
population at different HI levels, we see
that out of a total exposed population of
approximately 6 million people living
around the ten facilities, only 2,000
people are estimated to be exposed to
concentrations whose HI values exceed
1. Further, when the underlying
information for the NY value is
considered, we see that the NYS DOH
air criterion incorporates a significant
18 The 2002 NEI contained 1,080 facilities and we
estimate that there are a nationwide total of 1,900
facilities in this source category, we scale up the
facility population by a factor of 1.76 to obtain an
estimated total of facilities for the HI analysis.
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degree of health protection in its use of
a composite uncertainty factor of 1000.
The range of maximum HI values (0.2 to
7) resulting from consideration of
reference values from both CalEPA and
NYS DOH is indicative of the range of
uncertainty in the toxicity estimates for
TCE. When the NYS DOH value is used,
the maximum HI is 7; however, when
the CalEPA value is used, the maximum
HI becomes 0.2 and the 0.2 value is no
longer driven by TCE emissions, but by
TCA emissions. Thus, considering that
our models would tend to overestimate
risk, the limited number of people living
around these ten facilities whose
exposures correspond to HI values
above 1, and the health-protective
factors inherent in the derivation of the
NY central nervous system value, we
conclude that the chronic non-cancer
risks estimated around these ten
facilities using the NY criteria value and
associated with the baseline scenario
are, in this case, acceptable. We are
seeking comment on whether the
scaling factor applied to the narrow
tubing facilities and population
exposed, as discussed earlier, is
appropriate in this case.
We have not conducted any
additional assessment of environmental
risks for this source category. The record
established in the Halogenated Solvent
Cleaning rule is sufficient to conclude
that ‘‘no adverse environmental effects,’’
as defined in CAA section 112(a)(7), are
associated with the emissions from
these sources. After considering all of
these health risk measures and factors in
this action, we are again concluding that
the risks associated with the 1994
NESHAP are acceptable.
TABLE 1—ESTIMATED BASELINE CANCER RISK, POPULATION RISK DISTRIBUTION, AND ESTIMATED NUMBER OF FACILITIES
AT VARIOUS RISK LEVELS USING NEI 2002 DATA: SCALED TO NATIONAL LEVEL—ALL HALOGENATED SOLVENT
CLEANING FACILITIES
Baseline
no control
Cancer risk results
Estimated maximum individual lifetime cancer risk (per million) 1 ..................................................................................................
Estimated annual cancer incidence 2 ..............................................................................................................................................
100
0.55
Estimated lifetime cancer risk (per million) # persons
≥ 10 to < 100 ...................................................................................................................................................................................
≥ 1 to < 10 .......................................................................................................................................................................................
Total Pop ≥ 1 ...................................................................................................................................................................................
100
82,000
8,000,000
8,082,100
Total Population Living within 50 km of any Halogenated Solvent Cleaner ............................................................................
200,000,000
Estimated lifetime cancer risk (per million) # facilities
≥ 10 to < 100 ...................................................................................................................................................................................
≥ 1 to < 10 .......................................................................................................................................................................................
< 1 (only carcinogen emitters) .........................................................................................................................................................
< 1 (including sources emitting non-carcinogens) 3 ........................................................................................................................
9
86
394
802
1,411
Estimated total number of facilities 4 ........................................................................................................................................
1,900
1 Estimated
maximum individual lifetime cancer risks are rounded to one significant figure.
annual cancer incidence and population counts have been rounded to two or three significant figures where appropriate.
facilities with cancer risk < 1 plus 609 (346 scaled up) of the Year 2002 facilities that emit only the non-carcinogen 1,1,1-trichloroethane (TCA).
4 Represents the total number of facilities in this category. This facility count should equal the sum of facilities with any MIR greater than or
equal to 1 and the number of facilities with less than 1 (including sources emitting non-carcinogens).
2 Estimated
3 Includes
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B. Decision on Ample Margin of Safety
Petitioners raised a number of issues
related to the approach and information
that we used in making the ample
margin of safety determination in the
Halogenated Solvent Cleaning rule. In
the following sections we summarize
and address these issues. In addition,
the following sections present
regulatory options that we are proposing
in this action, as well as health
information, cost information, and other
relevant factors that support an ample
margin of safety analysis for those
options. Finally, this section provides
reasons why EPA might choose one
option over another in our final action.
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1. What is the approach used in making
the ample margin of safety
determination?
Petitioners raised a number of issues
pertaining to EPA’s overall approach to
conducting ample margin of safety
analyses and making ample margin of
safety determinations, and we address
these issues in this section of the
preamble. The petitioners also raise a
number of points directed at EPA’s
obligations and discretion under the
CAA, as well as our exercise of those
obligations and that discretion. Issues
raised by petitioners that pertain to
more specific topics or analyses related
to our ample margin of safety
determination are addressed later in this
notice.
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Several petitioners contend that our
finding for facilities that manufacture
narrow tubing that the 1994 NESHAP
provides an ample margin of safety to
protect public health is arbitrary and
capricious because it rests on an
‘‘erroneous assumption that the MIR
from (narrow tubing) facilities is 70-in1 million’’ given that PADEP risk data
indicated risks of 160-in-1 million
associated with the same facilities in the
Collegeville, PA area. As discussed in
the previous section, we believe that the
PADEP risk assessment is in error, and
instead rely on our estimated baseline
MIR for the narrow tubing industry of
70-in-1 million. One petitioner also
contended that ‘‘(d)espite the principle
articulated by EPA in the Benzene
NESHAP that residual risk standards
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should ‘protect the greatest number of
persons possible to an individual
lifetime risk level no higher than
approximately 1-in-1 million,’ ’’ the
Halogenated Solvent Cleaning rule
failed to demonstrate that it reduced
risk in this manner. Petitioners further
claim that consideration of costeffectiveness of controls in making an
ample margin of safety finding is
unlawful and does not conform to the
Benzene NESHAP approach. For
example, one petitioner stated that
‘‘EPA claims that ‘incremental’
reductions in risk that would result
from the 40,000 kg/yr instead of the
60,000 kg/yr are not cost-effective.’’
Petitioners argue that cost and costeffectiveness are different concepts and
CAA section 112(f)(2)(B) does not
contemplate basing the ample margin of
safety analysis on cost-effectiveness.
The petitioner stated that EPA’s reliance
on cost-effectiveness changes the
inquiry from whether the residual risk
standards provide an ample margin of
safety to protect public health, as
intended by Congress, to a far more
discretionary inquiry of whether
controls measures are cost-effective.
Petitioners claim that CAA section
112(f)(2)(B) does not contemplate basing
the ample margin of safety analysis on
cost-effectiveness, suggesting that EPA
inappropriately and impermissibly
considered cost-effectiveness as well as
incremental cost-effectiveness (as
opposed to just cost) in making our
ample margin of safety determination.
EPA disagrees with the petitioners
and contends that the CAA
contemplates consideration of costeffectiveness in ample margin of safety
determinations. The Benzene NESHAP,
which is incorporated into CAA section
112(f)(2) by reference, explains that in
the second step of the ample margin of
safety analysis we consider all of the
health risks and other health
information considered in the first
step—determining what level of risk is
acceptable. The Benzene NESHAP goes
on to explain that in the second step; in
the ample margin of safety decision, we
consider additional factors relating to
the appropriate level of control,
including costs and economic impacts
of controls, technological feasibility,
uncertainties and other relevant factors.
To reiterate, in the second step of the
ample margin of safety determination,
we adopt standards at the level that
provides an ample margin of safety to
protect public health. That level may be
equal to or more stringent than the
acceptable risk level. The EPA’s
authority to consider such factors was
affirmed in NRDC v. EPA, 529 F.3d.
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1077, 1083 (D.C. Cir. 2008), which
stated:
* * * subsection 112(f)(2)(B) expressly
incorporates EPA’s interpretation of the
Clean Air Act from the Benzene standard,
complete with a citation to the Federal
Register. In that rulemaking, EPA set forth its
standard for benzene ‘‘at a level that provides
an ‘ample margin of safety’ in consideration
of all health information * * * as well as
other relevant factors including costs and
economic impacts, technological feasibility,
and other factors relevant to each particular
decision.’’ 54 FR 38045. (Emphasis in
original).
In discussing the second step of the
ample margin of safety analysis in the
Benzene NESHAP, the EPA stated that
other relevant factors, aside from cost
and feasibility, could include, but are
not limited to, impact on the national
economy, small business impacts, costeffectiveness, incremental costeffectiveness, or net benefits. Indeed,
with regard to the consideration of costeffectiveness and incremental costeffectiveness, the Benzene NESHAP
states that:
Because the court (in Vinyl Chloride) has
specifically sanctioned the consideration of
costs as well as feasibility of controls, it is
clear that Vinyl Chloride does not require
imposition of the maximum feasible controls
without regard to cost or effectiveness. (54 FR
38057).
The EPA further stated in the Benzene
NESHAP that:
* * * EPA concluded that all the relevant
health, technological and economic
information should be considered in making
the ample margin of safety decision.
Accordingly, EPA rejects the position that the
maximum feasible control technologies
should be applied in all cases and accepts the
position that an analysis of incremental risk
reduction benefits versus incremental costs
of additional controls be performed to help
determine if additional control is warranted.
(54 FR 38061).
Based on the foregoing, the EPA can
consider, among other things, costeffectiveness and incremental costeffectiveness in the second step of the
ample margin of safety decision.
Petitioners contend that even if CAA
section 112(f)(2)(B) allows for
consideration of cost-effectiveness, the
EPA failed to provide a reasoned
explanation supporting its cost
conclusions in the Halogenated Solvent
Cleaning rule. In particular, the
petitioners argue that the EPA has not
explained why the cost and costeffectiveness values estimated by the
EPA for options that were assessed in
the rule, but ultimately rejected, were
unacceptable. Petitioners also contend
that in the past the EPA has
promulgated other rules where
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estimates of cost or cost-effectiveness
are within the range of those for options
rejected in the Halogenated Solvent
Cleaning rule. For example, Petitioners
assert that a $3,600/ton costeffectiveness is well within range of
cost-effectiveness that the EPA has
found acceptable in the past for less
toxic pollutants. Petitioners also
question why a cost-effectiveness of
$3,400/ton and $2,000/ton for facilities
that use continuous web cleaning
machines and aerospace manufacturing
and maintenance facilities, respectively,
is not reasonable. Petitioners further
contend that a cost-effectiveness of
$520/ton and annualized costs of $1.2
million for the proposed 25,000 kg/yr
MC equivalent limit and $74/ton and
annualized costs of $130,000 for the
proposed 40,000 kg/yr MC equivalent
limit are well within the range of costs
the EPA has found acceptable in the
past. Some petitioners also contend that
the EPA failed to calculate costs of 30
percent TCE reduction as indicated in
response to comments at proposal by
one facility that manufactures narrow
tubing.
The EPA’s rationale supporting its
ample margin of safety decision was set
forth in the Halogenated Solvent
Cleaning rule. Consistent with the
Benzene NESHAP, after determining
that risks were acceptable, the EPA
weighed the health information
evaluated in the acceptability
determination and other relevant factors
as specified in the Benzene NESHAP to
determine the appropriate level of
control to provide an ample margin of
safety (e.g., see excerpts from the EPA’s
analysis in the Halogenated Solvent
Cleaning rule, below). As noted above,
the Benzene NESHAP is inherently and
necessarily flexible regarding what
factors the EPA might consider, and
how they might be weighed, in our
ample margin of safety analysis, stating
that ‘‘* * * EPA believes the relative
weight of the many factors that can be
considered in selecting an ample margin
of safety can only be determined for
each specific source category. This
occurs mainly because technological
and economic factors (along with the
health-related factors) vary from source
category to source category.’’ (54 FR
38061).
Concerning the petitioners’ assertion
that the EPA did not explain why the
magnitude of certain cost and costeffectiveness values that supported the
EPA’s decision were unacceptable, and
the petitioner’s contention that these
values are in fact similar to values
estimated for other pollutants in
previous rulemakings, the EPA affirms
that we conducted our analysis in
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accordance with the framework
established in the Benzene NESHAP.
With regard to comparing cost or costeffectiveness values to values in past
rules, the EPA points out that the
Benzene NESHAP specifically
discourages such a practice: ‘‘(EPA)
does not intend to use ‘bright-line’ costeffectiveness ratios to make the ample
margin of safety decision but rather will
consider such information with all the
other relevant information available for
this decision.’’ (54 FR 38061). Further,
as explained above, the Benzene
NESHAP provides that the ample
margin of safety analysis is a categoryspecific determination (‘‘the relative
weight of the many factors that can be
considered in selecting an ample margin
of safety can only be determined for
each specific source category’’)
reflecting the consideration of a number
of factors, all of which may be weighed
differently for different source
categories such that comparisons of the
magnitudes of factors are rendered
meaningless.
The EPA also clearly explained how
we determined ample margin of safety
and why the minimal risk reductions
achieved by the options we ultimately
rejected in the Halogenated Solvent
Cleaning rule did not warrant the
disproportionate costs. For example, in
addition to other detailed results, we
stated in the Halogenated Solvent
Cleaning rule that:
The finding regarding an ‘ample margin of
safety’ is based on a consideration of the
relatively small reductions in health risks
likely to result from the feasible emission
reductions we evaluated, the additional costs
required to achieve further control, the lack
of technically feasible control options for
these sectors, and the time required to
comply with any requirements. (72 FR
25146)
and
Therefore, we believe that a requirement
for these facilities to meet a 100,000 kg/yr
MC equivalent emission limit is technically
feasible, provides an annual and long-term
cost savings, provides an ample margin of
safety to protect public health and prevents
adverse environmental effects. (72 FR 25145)
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and
After considering revisions to the risk and
cost estimates presented at proposal, we
believe that the 60,000 kg/yr MC equivalent
emission limit for those halogenated solvent
cleaning machines not identified as being in
use by one of the four sectors discussed in
section II, above, protects public health with
an ample margin of safety and prevents
adverse environmental effects. Specifically,
the 60,000 kg/yr level reduces 90 percent of
the HAP emissions reduced at the 40,000 kg/
yr level. The 60,000 kg/year emission limit
achieves reductions in MIR and cancer
incidence that are similar to those expected
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at the 25,000 kg/yr and 40,000 kg/yr emission
levels. The incremental reduction in
emissions with a 40,000 kg/yr level instead
of 60,000 kg/yr imposes an incremental cost
of $1.5 million per year. The incremental cost
per ton of this reduction is roughly $9,000/
ton.
Moreover, in comparing the 40,000 kg/yr
and the 60,000 kg/yr emission limits, the
incremental cost per cancer case avoided,
$73 million/case, is substantial, supporting
our conclusion that the $60,000 kg/yr
emission limit provides an ample margin of
safety consistent with the Benzene NESHAP.
(72 FR 25145)
Moreover, contrary to the petitioners’
claims, an analysis such as the one we
provided in the Halogenated Solvent
Cleaning rule is consistent with, and
more comprehensive than, similar
analyses presented in the Benzene
NESHAP. For example, one ample
margin of safety analysis in the Benzene
NESHAP offered the conclusion that:
* * * this control option will reduce
benzene emissions by 70 to 90 Mg/yr, which
represents less than an additional one
percent reduction over the uncontrolled
level. The cost of this additional emission
reduction (and consequent risk reduction)
would be about $200,000/yr (1982 dollars).
While this additional cost is small, it is
disproportionately large in comparison to the
small additional emission and risk reduction
achieved. (54 FR 38050)
While it is ultimately irrelevant (for the
reasons stated above), the EPA notes
that annualized costs rejected in the
Benzene NESHAP itself—$200,000 per
year in 1982 dollars, or approximately
$430,000 19 per year in 2007 dollars—
are even less than the cost estimates for
options that the EPA rejected that are
cited by the petitioners (e.g., see above
where the petitioner cites $600,000;
$630,000, and $700,000 per year).
Petitioners cite to the Benzene
NESHAP, arguing ‘‘that residual risk
standards should ‘protect the greatest
number of persons possible to an
individual lifetime risk level no higher
than approximately 1-in-1 million.’ ’’
Petitioners focus, however, on one facet
of the Benzene NESHAP in isolation,
without accounting for the fact that the
EPA evaluates various factors as part of
the ample margin of safety
determination. Specifically, the Benzene
NESHAP states that ‘‘* * * EPA strives
to provide maximum feasible protection
against risks to health from hazardous
air pollutants by (1) protecting the
greatest number of persons possible to
an individual lifetime risk level no
higher than approximately 1 in 1
million and (2) limiting (maximum
individual risk, the MIR) to no higher
19 Escalation in costs is calculated using the
CPI–U (ftp://ftp.bls.gov/pub/special.requests/cpi/
cpiai.txt).
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than approximately 1 in 10 thousand
* * *’’ (54 FR 38044–38045). The
Benzene NESHAP continues with an
explicit statement that
‘‘(i)mplementation of these goals is by
means of a two-step standard-setting
approach’’ (54 FR 38045), which the notice
explains further in greater detail. As
described in this preamble (and in the
Halogenated Solvent Cleaning rule), the EPA
has implemented the two-step standardsetting approach to achieve these goals. As an
additional note, the EPA points out that the
Benzene NESHAP is unambiguous that
‘‘* * * it is clear that * * * (the court) does
not require imposition of the maximum
feasible controls without regard to cost or
effectiveness’’ (54 FR 38057).
Petitioners further claim that
category-wide residual risk standards
must be set for the entire source
category, but that the EPA’s rule
exempted certain machines. First, the
EPA would like to reiterate that we did
not ‘‘exempt’’ machines in our
Halogenated Solvent Cleaning rule. The
EPA implemented the statutorilymandated two-step Benzene NESHAP
framework and ultimately re-adopted
the 1994 NESHAP for certain segments
of the source category. Our authority to
re-adopt the NESHAP in our residual
risk rulemaking was recently affirmed
by the United States Court of Appeals
for the District of Columbia Circuit in
NRDC v. EPA, 529 F.3d 1077 (D.C. Cir.
2008). In that case, the court stated that
‘‘If EPA determines that the existing
technology-based standards already
provide an ‘ample margin of safety,’
then the agency is free to readopt those
standards during a residual risk
rulemaking.’’ In this rule, we have
adhered to the two-step approach set
forth in the Benzene NESHAP, and we
are proposing a range of regulatory
options.
2. Overview of Options Examined
Similar to the approach taken in our
August 2006 Proposal and discussed in
the Halogenated Solvent Cleaning rule,
we have evaluated a range of regulatory
options and have assessed the residual
risk reductions that could be achieved if
post-MACT HAP emissions were
controlled further. These options
incorporate MC equivalent based
emission limits because we continue to
believe that such emission limits (e.g.,
as promulgated in the Halogenated
Solvent Cleaning rule that is the subject
of this reconsideration) may provide an
opportunity for additional risk
reduction. These options were derived
from information on the availability and
feasibility of specific emission control
technologies or practices, and are
expressed as maximum facility-wide
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emission limits and requirements that
would apply to the total emissions from
all of a facility’s solvent cleaning
machines that are subject to the 1994
NESHAP. This proposal also reflects our
investigations of information received
subsequent to promulgation of the
Halogenated Solvent Cleaning rule and
our belief based on that information that
certain emission limits could be
achieved through both solvent
switching and traditional technologies
and practices for some sectors of the
category. We have produced additional
risk and cost analyses to support the
evaluation of these proposed regulatory
options.
We recognize that some commenters
may either endorse aspects of one or
more of the proposed regulatory options
or advocate for a combination of the
options in ways other than presented in
this proposal. Specifically, comments
that we receive may lead us to conclude
that the most appropriate regulatory
approach would be one that combines
sector-specific alternatives from
different options. This proposal seeks to
allow such an approach by providing
the risk (Table 3, section III) and cost
(Table 5, section III) estimates that
correspond to each of the sector-specific
alternatives that make up the broader
options (Options 1, 2, and 3) we are
proposing. The estimated risk
reductions and associated costs for
Options 1, 2 and 3 are presented in
Tables 2 and 4 below. This approach
differs from our August 2006 Proposal
where we explicitly solicited comments
on only two co-proposed options,
although we had also developed six
emission levels to evaluate reductions
in residual risk if post-MACT emissions
(i.e., baseline emissions) were
controlled further from this source
category. Thus, we are soliciting
comments on options 1 through 3, and
any combination of the proposed sectorspecific options identified in this
proposal. Our decision on the final
regulatory approach will reflect the
comments we receive. The options are
summarized below:
i. Proposed Option 1
A 60,000 kg/yr MC equivalent limit
would be applicable to sources
associated with the general population
of halogenated solvent cleaning
machines. A 100,000 kg/yr MC
equivalent limit would be applicable to
halogenated solvent cleaning machines
located at military maintenance and
depot facilities. With respect to facilities
that use continuous web cleaning
machines, halogenated solvent cleaning
machines used by facilities that
manufacture narrow tubing, and
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halogenated solvent cleaning machines
used by aerospace manufacturing and
maintenance facilities, we are proposing
to re-adopt the 1994 NESHAP under
CAA section 112(f)(2) because we are
proposing that the current level of
control called for by the 1994 NESHAP
reduces HAP emissions to levels that
present an acceptable level of risk,
provide an ample margin of safety to
protect public health, and prevent any
adverse environmental effects. (This
option represents the standards
promulgated in the Halogenated Solvent
Cleaning rule.)
ii. Proposed Option 2
A 60,000 kg/yr MC equivalent limit
would be applicable to sources
associated with the general population
of halogenated solvent cleaning
machines and halogenated solvent
cleaning machines used by facilities that
manufacture narrow tubing. A 100,000
kg/yr MC equivalent limit would be
applicable to halogenated solvent
cleaning machines located at military
maintenance and depot facilities. With
respect to facilities that use continuous
web cleaning machines, and
halogenated solvent cleaning machines
used by aerospace manufacturing and
maintenance facilities, we are proposing
to re-adopt the 1994 NESHAP under
CAA section 112(f)(2) because we are
proposing that the current level of
control called for by the 1994 NESHAP
reduces HAP emissions to levels that
present an acceptable level of risk,
provide an ample margin of safety to
protect public health, and prevent any
adverse environmental effects.
iii. Proposed Option 3
A 60,000 kg/yr MC equivalent limit
would be applicable to sources
associated with the general population
of halogenated solvent cleaning
machines and halogenated solvent
cleaning machines used by facilities that
manufacture narrow tubing. A 100,000
kg/yr MC equivalent limit would be
applicable to halogenated solvent
cleaning machines used by aerospace
manufacturing and maintenance
facilities and halogenated solvent
cleaning machines located at military
maintenance and depot facilities.
Facilities that use continuous web
cleaning machines that exceed 60,000
kg/yr MC equivalent HAP emissions
would have to achieve 80 percent
overall control efficiency for those units.
3. How Did the EPA Establish the
Proposed Regulatory Options?
This section describes our
determination that the above proposed
regulatory options are technically
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feasible. Additionally, section III
discusses human health risks and costs
associated with these options. Similar to
our August 2006 Proposal and our May
3, 2007 final rule, we have also reexamined and re-evaluated the impacts
to small businesses associated with the
alternative emission limits based on
supporting information from the
Halogenated Solvent Cleaning rule
(contained in the docket for that rule)
and information we received after
promulgation of the Halogenated
Solvent Cleaning rule. Our discussion of
the small business impacts of this action
are presented in section VI of this
preamble.
Several petitioners contend that we
did not evaluate all of the control
options provided in response to our
August 2006 Proposal and subsequent
NODA. However, the EPA did carefully
evaluate specific comments from
commenters on costs, on results, on
technical compatibility with products
and technical feasibility. While
commenters identified specific control
options, most indicated implementing
such controls were not feasible because
of physical limitations of the facility or
the proposed compliance timeframes.
Petitioners also provided information
indicating that certain manufacturers in
the narrow tube industry, after the close
of the comment period for our August
17, 2006 proposal, either instituted or
began planning the installation of
various control measures that would
have achieved the emission limitations
that the EPA co-proposed in August
2006 and contend that this information
was of central relevance to the outcome
of the Halogenated Solvent Cleaning
rule. Petitioners further contend that we
excluded available alternative control
measures without providing an
explanation in the Halogenated Solvent
Cleaning rule, that we frequently set
technology-forcing standards, and that
recognizing the responses by the
affected industries regarding
compliance difficulty is not an excuse
for our failure to set a standard. In the
May 3, 2007 rule, the EPA set a final
standard according to section 112(f)(2)
and 112(d)(6) and provided
explanations for that final standard. In
response to the petitioners comment on
setting technology-forcing standards, the
EPA is bound by CAA section 112(f)(2)
to make an ample margin of safety
decision according to the Benzene
NESHAP and not to extend this
authority in setting technology-forcing
standards. In summary, petitioners
contend that the requirements
promulgated in the Halogenated Solvent
Cleaning rule were not a logical
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outgrowth of the August 2006 Proposal
and December 2006 NODA.
As part of this reconsideration effort,
we have re-analyzed our conclusions on
risk, cost, technical feasibility, and
compliance deadlines made in the
Halogenated Solvent Cleaning rule. In
this action and in response to the
petitions we reassessed the regulatory
options for halogenated solvent cleaning
machines used by facilities that
manufacture narrow tubing, aerospace
manufacturing and maintenance,
military maintenance and depot
facilities, facilities that use continuous
web cleaning machines, and for all other
halogenated solvent cleaning machines
that are not included in these named
sectors.
This proposal is based on supporting
data and information from the
Halogenated Solvent Cleaning rule
(contained in the docket for that rule)
and data and information received since
promulgation of the Halogenated
Solvent Cleaning rule. Data and
information received since
promulgation of the Halogenated
Solvent Cleaning rule indicates the
availability of control measures that
would enable certain facilities in the
narrow tube industry and certain
facilities that use continuous web
cleaning machines to achieve HAP
emission reductions that we did not
believe feasible when we finalized the
Halogenated Solvent Cleaning rule. In
some cases, this proposal reflects a reevaluation of the information on
availability of control measures that we
received in response to both the August
17, 2006 proposal and subsequent
NODA, in light of information that we
received since we promulgated the
Halogenated Solvent Cleaning rule.
As in the final Halogenated Solvent
Cleaning rule, today’s proposal
recognizes that certain facilities might
be able to use control measures that
include retrofit technologies, such as a
carbon adsorption device (CAD), and
vacuum-to-vacuum machines, switching
from HAP to non-HAP solvents, such as
n-propyl bromide (nPB), changes to the
manufacturing process, and instituting
emission reduction programs. Further,
this proposal recognizes and reflects the
differences between facilities that use
continuous web cleaning machines and
batch cleaning machines, and
acknowledges comments on the August
2006 Proposal and subsequent NODA
indicating that control efficiency
requirements rather than straight
emission limits are a preferable
approach for expressing emission
limitations for facilities that use
continuous web cleaning machines
because continuous web cleaning
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machines must control emissions at
both entry and exit points. These
comments from some facilities that use
continuous web cleaning machines
suggested that their emission capture
systems could be modified within a 3year period to achieve an 80 percent
overall control efficiency, over
uncontrolled emission levels. Control
efficiency requirements rather than
straight emission limits are a preferable
approach for expressing emission
limitations for facilities that use
continuous web cleaning machines,
which is the same conclusion that we
made in the final Halogenated Solvent
Cleaning rule. In this action, we also are
soliciting comments on whether CAD or
emission capture systems operating at
high efficiency would provide an
opportunity for facilities that use
continuous web cleaning machines to
control up to 80 percent of their
emissions. We note that although the
final Halogenated Solvent Cleaning rule
also considered, but ultimately rejected,
such an option, the option in today’s
proposal (described in more detail
below) would restrict this requirement
to facilities emitting over 60,000 kg/yr
MC equivalent HAP emissions.
i. Narrow Tube Manufacturing Facilities
Petitioners contend that we failed to
consider and evaluate various
compliance options for the facilities that
manufacture narrow tubing despite
responses and comments we received
on both our August 17, 2006 proposal
and NODA. Specifically:
• Petitioners cite comments and
responses to both the August 17, 2006
proposal and the subsequent NODA
from several facilities that manufacture
narrow tubing indicating the likelihood
of 25 percent TCE emission reductions
through installation of CAD and a
capture and control system. The EPA
considered this comment in our final
rule (see 72 FR 25154) and concluded
that while reductions may be obtained,
the industry, through their comments,
was unable to research, design and
implement the necessary technological
controls within the compliance period
and the EPA’s proposed costs.
• Petitioners cite responses by
various facilities that manufacture
narrow tubing indicating an ability to
achieve emission reductions ranging
from either 25–35 percent or 50–95
percent through installation of emission
control devices and changes in
production processes. The EPA
considered this comment in developing
our final rule and concluded that while
reductions may be obtained through
solvent switching and installation of
controls, the narrow tube manufacturing
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industry, through their comments,
indicated that there was inadequate
research available to the industry to
warrant solvent switching. They
indicated the research, design and
implementation could not be
accomplished within the EPA’s
proposed compliance period and would
exceed the EPA’s proposed costs.
• Petitioners also cite responses
indicating the ability of one particular
facility to reduce TCE emissions from
68.4 tons per year (tpy) to 52 tpy. The
EPA considered this comment in
developing our final rule (see 72 FR
25154) and concluded that the industry,
through their comments, was unable to
research, design and implement the
necessary technological controls within
the compliance period and EPA’s
proposed costs. Petitioners further argue
that we should have investigated the
feasibility of establishing a 100,000 kg/
yr MC equivalent emission limit given
the response of one facility that
manufactures narrow tubing indicating
the ability to meet this level within five
years of promulgation. The EPA did not
develop this option for two reasons:
First, Congress limits the EPA’s ability
to impose compliance periods that
exceed three years, and, second, the
industrial sector commented that they
simply could not implement the
necessary technology within the 3-year
compliance period permitted by
Congress and within the cost parameters
the EPA assumed in the August 17, 2006
proposal.
Subsequent to promulgation of the
Halogenated Solvent Cleaning rule,
Petitioners provided information to the
EPA indicating that this industrial
sector may, in fact, be capable of
complying with the co-proposed limits
in our August 17, 2006 proposal within
the 3-year compliance period provided
in the Halogenated Solvent Cleaning
rule. Petitioners also provided
information indicating that subsequent
to the close of the comment period of
the Halogenated Solvent Cleaning rule
various facilities that manufacture
narrow tubing either installed control
devices or were in advanced planning
stages to install control devices that
would enable them to achieve either of
our August 17, 2006 co-proposed
emission limits. Specifically,
subsequent to promulgation of the
Halogenated Solvent Cleaning rule, one
facility that manufactures narrow tubing
has installed vacuum-to-vacuum
machines. Two other facilities that
manufacture narrow tubing have
switched from solvent HAP to a nonHAP, nPB. One of these two facilities
also indicated an ability to achieve eight
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percent and 22 percent TCE emission
reductions through reconfiguration of
two flush degreasers and use of
reformulated materials, respectively.20
Petitioners also provided information
indicating that the other of the two
facilities was in advanced installation
stages for CAD and a capture and
control system that would likely achieve
30 percent TCE reduction. This
information and supporting
documentation have been placed in the
docket for this rulemaking.
As explained earlier, our August 17,
2006 proposal would have required all
owners and operators of all halogenated
solvent cleaning machines to comply
with either 25,000 kg/yr or 40,000 kg/yr
MC equivalent facility-wide emission
limit. We assumed compliance with
these limits could be achieved by
installation of control technologies,
such as vacuum-to-vacuum machines
and CAD, and switching solvents, either
from PCE to TCE or TCE to MC. We also
assumed compliance would be achieved
through retrofit technologies such as
freeboard ratios, working mode covers
and freeboard refrigeration devices. In
commenting on our August 17, 2006
proposal, various facilities that
manufacture narrow tubing indicated
that further HAP control that would be
required by the co-proposed standards
would likely be achieved only through
installation of expensive technology,
and that such technologies had yet to be
proven either effective or reliable for
their manufacturing processes. They
also expressed concerns over the
proposed compliance period.
Additionally, several facilities that
manufacture narrow tubing that use PCE
indicated that solvent switching was an
unsuitable compliance option because
they were bound to their customers’
procedural requirements for the higher
vapor temperature of PCE and thus, that
both TCE and MC, which have lower
vapor pressure temperature, would be
inadequate for proper cleaning.
Although some facilities that
manufacture narrow tubing indicated
the possibility of switching solvents
from TCE to nPB, they also stated that
it had yet to be proven as a degreaser
and thus, had yet to be approved as an
alternative solvent by many original
equipment manufacturers. They further
indicated that such approval processes
would likely be beyond the proposed 220 EPA notes that in this case the facility’s permit
does not identify a specific reformulated material
that would be used to achieve 22 percent TCE
emissions reduction. In addition, materials
reformulation specified in the facility’s permit
could be implemented to reduce TCE emissions
from an activity that is not in the source category
addressed in today’s notice.
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year compliance period. Some facilities
that manufacture narrow tubing also
described their halogenated solvent
cleaning machines as unique due to
their large size and capacity and
indicated the non-availability of
vacuum-to-vacuum machines as a
result.
As explained above, subsequent to
our evaluation of these comments, we
issued a NODA that requested
additional information on costs,
compliance deadlines and technical
feasibility for halogenated solvent
cleaning at facilities that manufacture
narrow tubing. In response, most
facilities that manufacture narrow
tubing reiterated and expanded upon
the reasons why they were unable to
comply with the 25,000 kg/yr and
40,000 kg/yr MC equivalent co-proposed
limits due to technological factors, costs
and compliance deadline constraints.
The facilities that manufacture narrow
tubing did, as noted by the petitioners
and described at the beginning of this
section, outline those emission
reduction measures they believed they
could achieve. Because we were
persuaded by their assertions, we found,
after re-evaluating risks, associated
compliance costs and availability of
control measures, that the 1994
NESHAP both reduces risk to acceptable
levels and provides an ample margin of
safety to protect public health for
halogenated solvent cleaning machines
used by facilities that manufacture
narrow tubing. In the final Halogenated
Solvent Cleaning rule the EPA also
considered, but ultimately rejected in
our ample margin of safety analysis, a
compliance option that would have
required a 10 percent reduction in HAP
emissions from facilities that
manufacture narrow tubing. We
believed this reduction could feasibly be
achieved by facilities that manufacture
narrow tubing within the compliance
period through installation of side
chambers, however the estimated risk
reductions were small in comparison to
the cost.
We are now aware, however, that
since promulgation of the Halogenated
Solvent Cleaning rule, at least four out
of 17 facilities that manufacture narrow
tubing have either implemented or
instituted plans to install control
measures and HAP reduction
techniques that would likely achieve
either of the August 17, 2006 coproposed limits, i.e., 25,000 kg/yr and
40,000 k/yr MC equivalent limits. These
control measures and HAP emission
reduction techniques have been
implemented within the compliance
period—which earlier comments by the
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facilities indicated was not possible—
and include:
• Installing CAD and vacuum-tovacuum machines (installed by the
facilities that manufacture narrow
tubing that indicated uniqueness of
their halogenated solvent cleaning
machines due to size, in their comments
on the August 17, 2006 proposal),
• Switching to nPB (a non-HAP
solvent), and
• Manufacturing process changes
such as cleaning smaller bundles of
tubes and/or allowing product to remain
in the machine for a longer duration to
allow complete condensation of the
solvent vapors before removal.
These accomplishments are applauded
by the EPA, yet appear to be in direct
conflict with the comments submitted
on the August 17, 2006 proposal and
subsequent NODA.
We are also aware that at least four
facilities would not need to install any
additional controls in order to comply
with these proposed regulatory options.
The remaining nine facilities continue
to use HAP solvents and operate in
accordance with the 1994 NESHAP. We
believe the techniques and technologies
employed by the four facilities that
manufacture narrow tubing may be used
by the remaining facilities to achieve
further emission reductions to comply
with the emission limit of 60,000 kg/yr
MC equivalent.
In light of the information that was
otherwise not available to the EPA at the
time of promulgation of the Halogenated
Solvent Cleaning rule, we have
reviewed and revised our conclusions
on technical feasibility, the compliance
deadline and compliance costs
associated with meeting the August 17,
2006 co-proposed limits. With the
activities completed by these facilities
that manufacture narrow tubing, we
believe that the remaining facilities that
manufacture narrow tubing nationwide,
most with lower total emissions than
the facilities mentioned above, could
achieve reductions in emissions within
a 2-year compliance period and at a
potentially reasonable cost. Therefore,
as discussed in section III of this
Preamble, we are proposing two
regulatory options that would be
applicable to halogenated solvent
cleaning machines in use at facilities
that manufacture narrow tubing. We are
soliciting comments on the proposed
regulatory options as they relate to
facilities that manufacture narrow
tubing.
ii. Aerospace Manufacturing and
Maintenance Facilities
Petitioners contend that the
Halogenated Solvent Cleaning rule does
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not provide any explanation as to why
vacuum-to-vacuum technology and
retrofit technologies such as freeboard
ratios, working mode covers and
freeboard refrigeration devices cannot
be used by aerospace manufacturing and
maintenance facilities. One petitioner
stated that there was no explanation for
the rejection of vacuum-to-vacuum
technology as a control option for
aerospace manufacturing and
maintenance facilities even though the
Halogenated Solvent Cleaning rule
indicated that such technology was in
use by ‘‘similar’’ aerospace
manufacturing and maintenance
facilities.
In response to both our August 17,
2006 proposal, and subsequent NODA,
aerospace manufacturing and
maintenance facilities indicated an
inability to comply with our coproposed limits due to technical
infeasibility, associated compliance
costs and the limited proposed
compliance deadline. Some facilities
indicated a 5-year minimum compliance
period would be required because they
would need to investigate technology
and protocol changes called for by the
proposed 40,000 kg/yr MC equivalent
limit. With regard to vacuum-to-vacuum
technology, aerospace manufacturers
indicated that vacuum-to-vacuum
technology was extremely expensive
and had not been proven effective or
reliable for the operations at aerospace
manufacturing and maintenance
facilities. With regard to solvent
switching, those aerospace
manufacturing and maintenance
facilities that use PCE stated that
switching to either TCE or MC would be
an unsuitable compliance option
because of incompatibility issues and
lower vapor pressure. Other facilities
also stated that they may be able to
switch from a HAP solvent to a nonHAP solvent such as nPB, but indicated
that nPB solvent was untested in their
industry. They also stated that changing
solvents involved a rigorous approval
process by the original equipment
manufacturers and the Federal Aviation
Administration in order to ensure that
safety and quality criteria continue to be
met and that such process would likely
be beyond the 2-year proposed
compliance deadline. We note, in
general, that the bulk of comments
indicated an inability to implement
these control measures within the
proposed 2-year compliance period at
the costs presented in our August 17,
2006 proposal.
In the Halogenated Solvent Cleaning
rule, we evaluated costs alone for the
60,000 kg/yr MC equivalent emission
limit and both risks and costs for the
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100,000 kg/yr and 250,000 kg/yr MC
equivalent levels for aerospace
manufacturing and maintenance, but
rejected these options based on our
conclusion that they were either not
cost-effective or the costs were
disproportionate given the emission
reductions achieved. We also rejected
these options because the industry
strongly indicated necessary emission
control actions could not be achieved
within the compliance timeframe.
Additionally, similar to the facilities
that manufacture narrow tubing, we
were persuaded by the industry’s
responses and information, and after our
re-evaluation of compliance costs,
technical feasibility and risks, we
determined that the current level of
control provided by the 1994 NESHAP
for the aerospace manufacturing and
maintenance industry both reduces HAP
emissions to levels that present an
acceptable risk and provides an ample
margin of safety to protect public health.
Since receiving the petitions, we have
re-evaluated our treatment of the
responses to the NODA by aerospace
manufacturing and maintenance
facilities. Specifically, we have reevaluated responses we received from
various aerospace manufacturing and
maintenance facilities indicating the
availability of compliance options that
include various work practices and
installing larger or additional CAD
systems, and vacuum-to-vacuum
machines and switching from a HAP
solvent to nPB. We have also learned
that certain aerospace manufacturing
and maintenance facilities are testing
nPB as a compliance approach to HAP
emission reductions. We currently do
not have sufficient information that
would allow us to conclude definitively
that nPB switching is a viable
compliance option for this industry
primarily because we are aware of
material compatibility concerns.
Therefore, we do not believe that we can
extrapolate the use of nPB by facilities
that manufacture narrow tubing to the
aerospace manufacturing and
maintenance facilities. We have thus
calculated compliance costs for the
aerospace manufacturing and
maintenance facilities using HAP
solvent switching, retrofitting of
machines, vacuum-to-vacuum machines
and CAD using the same assigned costs
used in the Halogenated Solvent
Cleaning rule, which were based on
costs provided in public comments. As
discussed in section III of this preamble,
we are proposing a range of regulatory
options that would be applicable on a
facility-wide basis for all halogenated
solvent cleaning machines in use at
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aerospace manufacturing and
maintenance facilities.
iii. Continuous Web Cleaning
Machines 21
Petitioners also allege that the EPA
failed to provide any explanation as to
why several alternative reduction
measures, such as either vacuum-tovacuum machines or solvent switching
are not available control options for
facilities that use continuous web
cleaning machines.
As explained earlier, in response to
both our August 17, 2006 proposal, and
subsequent NODA, the EPA received
significant comments from some
facilities that use continuous web
cleaning machines identifying
numerous compliance issues presented
by the co-proposed limits. Responses
included that switching from either PCE
or TCE to MC was not an available
compliance option due to the fact that
MC is incompatible with certain metals,
and production processes, has a lower
boiling point, and stringent worker
safety OSHA requirements. Some
facilities also indicated that installation
of vacuum-to-vacuum machines was not
a compliance option due to the
differences between the continuous web
cleaning process and other batch
cleaning operations. They stated that the
1994 NESHAP, in recognition of these
differences, prescribed compliance
options for facilities that use continuous
web cleaning machines that were
different from other halogenated solvent
cleaning machines. They requested that
we set different compliance
requirements that would be based on
overall control efficiency rather than an
emission limit, in light of the fact that
they could not comply with either of the
proposed emission limits in the August
2006 proposed rule. They maintained
that attaining a degree of control rather
than meeting an emission limit was a
more appropriate measure of their
emission reduction capability. They also
indicated that they had installed CAD,
which can operate at about 99 percent
control efficiency, and that they could
possibly achieve an overall effectiveness
of 80 percent control efficiency (the
21 Continuous web cleaners are a subset of in-line
cleaners that are used to clean products such as
films, sheet metal, and wire in rolls or coils. They
are semi-enclosed, with emission points where the
workload enters and exits the machine. Squeegee
rollers reduce carry out emissions by removing
excess solvent from the exiting workload. The
workload is uncoiled and conveyorized throughout
the cleaning machine at speeds in excess of 11 feet
per minute and recoiled or cut as it exits the
machine. Emission points are similar to emission
points from other in-line cleaners. Also some
continuous web machines have exhaust systems
that are similar to those used with some in-line
cleaners.
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1994 NESHAP requires 70 percent
overall control efficiency).
Similar to our treatment of
comparable assertions by both facilities
that manufacture narrow tubing and
aerospace manufacturing and
maintenance facilities, we were
persuaded by these assertions, and in
the Halogenated Solvent Cleaning rule,
we acknowledged that continuous web
machines are designed differently from
general halogenated solvent cleaning
machines, i.e., batch cleaning machines,
and that it would be both
technologically infeasible and cost
prohibitive for facilities that use
continuous web cleaning machines to
comply with our final promulgated
emission limits. Further, we determined
that their control choices were limited
to installation of CAD, but that CAD
would be insufficient for purposes of
complying with either the proposed or
final promulgated emission limits
because they would likely achieve only
a 10 to 30 percent overall emission
reductions in facility-wide emissions.
72 FR 25155. In our final Halogenated
Solvent Cleaning rule we analyzed and
discussed a regulatory alternative that
would require 80 percent overall control
efficiency for all facilities, but we
ultimately concluded that for facilities
that use continuous web cleaning
machines the current level of control
provided by the 1994 NESHAP both
reduces HAP emissions to levels that
present an acceptable risk and provides
an ample margin of safety to protect
public health.
Since promulgation of the
Halogenated Solvent Cleaning rule, and
receipt of the reconsideration petitions,
we have also re-evaluated our
assumptions on compliance options,
and costs for additional emission
reductions as it relates to facilities that
use continuous web cleaning machines.
In doing so, we have re-examined the
comments submitted on the August 16,
2006 proposal and NODA, where some
facilities that use continuous web
cleaning machines indicated their
preference for tighter control efficiency
as compared to a straight emission limit
and more specifically their comments
that indicated the ability to achieve 80
percent overall control efficiency over
uncontrolled emission levels within a 3year compliance period. (These
comments are in the docket for this
rulemaking.) Facilities that use
continuous web cleaning machines are
currently required to achieve 70 percent
overall control efficiency under the
1994 NESHAP.
This proposal reflects this reevaluation and our belief that a relative
reduction limit is more suitable than an
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emission cap for facilities that use
continuous web cleaning machines.
Under one of the regulatory options
presented in this proposal, six facilities
would be required to reduce emissions
by 33 percent, i.e., ((1 ¥ 70%) ¥ (1 ¥
80%)/(1 ¥ 70%) = 33%). To meet this
proposed emission requirement, we
assumed three facilities could switch
their HAP solvent to nPB (based on the
use of nPB in the narrow tubing
industry). Based on the analysis we
conducted to support the Halogenated
Solvent Cleaning rule we also assumed
that three facilities could install CAD or
automated gates control to comply with
the proposed option. Thus, as earlier
discussed in section III of this preamble,
we are proposing an option that
includes an overall control efficiency of
80 percent for facilities that use
continuous web cleaning machines that
exceed a 60,000 kg/yr MC equivalent
limit.
iv. Military Maintenance and Depot
Facilities
Petitioners also contend that the EPA
announced a final rule that dramatically
departed from the proposed rule by
imposing a 100,000 kg/yr MC equivalent
limit for halogenated solvent cleaning
machines used by military maintenance
and depot facilities. Petitioners contend
that the public was deprived of the
opportunity to comment on this
standard and on the technical, legal and
policy rationale the EPA proffered in the
Halogenated Solvent Cleaning rule.
In response to both our August 17,
2006 proposal and the NODA, military
depot and maintenance facilities
indicated an inability to comply with
either co-proposed limits due to both
technological and compliance deadline
constraints. They indicated, however,
an ability to comply with a 100,000 kg/
yr MC equivalent limit. Persuaded by
these responses, we determined that the
100,000 kg/yr MC equivalent limit for
halogenated solvent cleaning machines
used by military depot and maintenance
facilities would provide an ample
margin of safety in the Halogenated
Solvent Cleaning rule.
Since promulgation of the
Halogenated Solvent Cleaning rule, and
receipt of the petitions, we have also reevaluated our assumptions on
compliance options, and costs for
additional emission reductions as they
relate to military maintenance and
depot facilities. In this action, as
discussed in section III above, for
halogenated solvent cleaning machines
used by military maintenance and depot
facilities we are re-proposing the
100,000 kg/yr MC equivalent emission
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limit option that we finalized in the
Halogenated Solvent Cleaning rule.
v. General Population of Halogenated
Solvent Cleaning Machines
Petitioners stated that the 60,000 kg/
yr MC equivalent level we promulgated
for the general population of
halogenated solvent cleaning machines
was neither proposed nor made
available for public comment. In
reconsideration of the Halogenated
Solvent Cleaning rule, we re-examined
the proposed 40,000 kg/yr and
promulgated 60,000 kg/yr MC
equivalent levels of control for the
general population, retaining the
emission control assumptions (and thus
the risk reduction and cost assumptions)
used in the final rule. As in the
Halogenated Solvent Cleaning rule, our
evaluation is based on the 2002 NEI
data.
Since promulgation of the
Halogenated Solvent Cleaning rule, we
have received no new information that
would lead us to change the facts and
conclusions we presented for either the
40,000 kg/yr MC equivalent level
(which we rejected in the Halogenated
Solvent Cleaning rule) or the 60,000 kg/
yr MC equivalent level. Therefore, in
this action we are proposing a 60,000
kg/yr MC equivalent emission limit as a
regulatory option for the general
degreasing units.
4. Health Information for the Proposed
Options
As previously mentioned, we have
performed additional risk assessments
for this source category since the final
rule was promulgated. In this section,
we provide estimates of the health risk
reductions achieved by each of the
proposed regulatory options for each of
the industry sectors. The estimates were
derived using the same analytical
methodologies which were used to
derive the estimates for the Halogenated
Solvent Cleaning rule, with two
exceptions: (1) The health risk estimates
were derived explicitly (rather than
extrapolated, as was done for the
Halogenated Solvent Cleaning rule) for
each industrial sector as well as for the
total population of facilities; and, (2) in
addition to our use of the CalEPA
chronic REL for TCE, a chronic noncancer air criterion developed by the
NYS DOH was used to characterize noncancer risks for TCE.
While health risks were estimated
using both the 1999 NEI and the 2002
NEI, we only present those derived
using the more recent emission
inventory data. Additional details and
results are provided in the docket for
this rule.
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Table 2 presents a summary of cancer
risk results for the entire source category
at baseline levels and for each of the
proposed control options, indicating
both how the maximum individual
cancer risk level and the population
within various individual risk ranges
vary from option to option. It also shows
the projected emission reductions and
cancer incidence levels associated with
each option, as well as the estimated
maximum non-cancer target organspecific HI values (indicated as a range,
depending on which chronic reference
value is used in the calculation). We
note specifically that the range of
exposures (as indicated by the HI
values) for the baseline and Option 1
scenarios are near the exposure level
where we can say that there is no
appreciable risk of non-cancer health
effects (see previous discussion in this
section). We believe that this result does
not indicate that there should be
concern; rather, we believe it is
indicative of the range of values
associated with the chronic non-cancer
toxicity of TCE. We also note that using
the CalEPA REL there are no facilities
with an HI above 1; however, using the
NYS DOH air criterion, which
incorporates a significant degree of
conservatism in its final estimate, the
only HAP contributing to non-cancer HI
values above 1 becomes TCE. The target
organ system which is most sensitive for
both the CalEPA REL and the NYS DOH
air criterion is the central nervous
system, with symptoms including
dizziness, drowsiness, and confusion at
high enough exposures. Effects to the
liver and immune systems have also
been observed in people at high enough
TCE exposures.
In response to one petitioner’s
assertion that the Halogenated Solvent
Cleaning rule omitted an analysis of the
population exposed to lifetime cancer
risks greater than 1-in-1 million, Table
1, above, presents updated estimates of
this information from the Halogenated
Solvent Cleaning rule while Table 2,
below, provides population risk
information relevant to the different
proposed regulatory options that we are
seeking comment on in this action.
TABLE 2—EFFECT OF THE PROPOSED OPTIONS ON RISK AND EMISSIONS
Options
Baseline
MIR (in-1 million) .............................................................................................
>100 in-1 million * ............................................................................................
≥10 to <100 in-1 million * .................................................................................
≥1 to <10 in-1 million * .....................................................................................
Emissions Reduced (tons/yr) ...........................................................................
Emissions Remaining (tons/yr) ........................................................................
Maximum Non-cancer HI .................................................................................
Cancer Incidence (cases/yr) ............................................................................
Option 1
100
100
82,000
8,000,000
0
4,200
0.2–7.0
0.55
Option 2
~50
0
7,500
2,100,000
1,681
2,535
0.2–2.0
0.36
~50
0
6,600
2,087,500
2,601
1,615
0.05–1.0
0.35
Option 3
~50
0
5,700
1,946,500
3,188
1,028
0.05–1.0
0.32
* Number of people in the specified risk range
Option 1: 60,000 kg/yr MC equivalent
applicable to general population of
halogenated solvent cleaning machines
and 100,000 kg/yr MC equivalent for
halogenated solvent cleaning machines
in use at military maintenance and
depot facilities.
Option 2: 60,000 kg/yr MC equivalent
applicable to facilities that manufacture
narrow tubing and general population of
halogenated solvent cleaning machines
and 100,000 kg/yr MC equivalent for
halogenated solvent cleaning machines
in use at military maintenance and
depot facilities.
Option 3: 60,000 kg/yr MC equivalent
applicable to general population and
facilities that manufacture narrow
tubing; 100,000 kg/yr MC equivalent
applicable to aerospace manufacturing
and maintenance facilities and military
maintenance and depot facilities; and 80
percent overall control efficiency for
facilities that use continuous web
cleaning machines that have emissions
exceeding 60,000 kg/yr MC equivalent.
Table 3 presents a summary of cancer
incidence, cancer incidence reduction,
and emission reductions for the general
population and for each of the industrial
sectors discussed above, for each of the
control options being considered.
TABLE 3—INCIDENCE AND EMISSIONS REDUCTIONS FOR THE SECTOR-SPECIFIC COMPONENTS OF OPTIONS 1, 2, AND 3
Baseline
incidence
(cases/yr)
Incidence after
control
(cases/yr)
Cases avoided/
year
Emission limit
General Degreaser Population (not
in any other sector).
Narrow Tubing Manufacturing .......
Continuous Web Cleaning Machines (>60,000 kg/yr).
Aerospace Manufacturing and
Maintenance.
Military maintenance and depot ....
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Industry group
60,000 kg/yr ...................................
0.45
0.26
0.19
60,000 kg/yr ...................................
80 percent overall control efficiency.
100,000 kg/yr .................................
0.02
0.03
0.007
0.02
0.013
0.01
920
263
0.05
0.03
0.02
324
100,000 kg/yr .................................
0.0003
0.0001
0.0002
After promulgation of the
Halogenated Solvent Cleaning rule, we
became aware that nPB, a non-HAP, had
already been substituted for TCE in at
least two facilities that manufacture
narrow tubing and that it may be a
suitable alternative solvent at other
facilities. As a result, in this proposal
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we have assumed that nPB could and
would be used in both the narrow tube
manufacturing industry and facilities
that use continuous web cleaning
machines. Due to materials
incompatibility, however, we do not
believe we can extrapolate the use of
nPB to the aerospace manufacturing and
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Sfmt 4702
Tons reduced
1,592
maintenance facilities. The HAP
emission reductions, risk reductions,
and costs projected under these’s
proposed regulatory options 2 and 3
rely, and are based, in part, on nPB
substitution for TCE in a specific
number of machines of specific sizes.
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Although nPB is not a HAP, there are
known adverse health effects from
exposures to high levels of nPB,
including effects on the nervous system
(headaches, dizziness, nausea,
numbness in the lower body) based on
studies of exposed workers,22 and
effects on the liver and reproductive
system based on animal tests.23 In its
review of the use of nPB as an
alternative to using solvents which
deplete stratospheric ozone (72 FR
30142, May 30, 2007), the EPA
determined that nPB was an acceptable
substitute in solvent cleaning
applications, but recommended use of
personal protective equipment and
adherence to the capture and
suppression guidelines in the NESHAP
for halogenated solvent cleaning.24 For
example, emission controls previously
used for MC or TCE should remain in
place for worker safety and general
public safety reasons.
In evaluating nPB in a specific use
under the SNAP program, we evaluated
the worst-case level of nPB emissions.
We note that even though this worstcase emission level is higher, by at least
a factor of 4, than the highest-emitting
facility in the halogenated solvents
category, the worst-case impact
estimated under the SNAP program is
still substantially below, by more than
a factor of 10, the derived threshold for
non-cancer effects. This leads us to
conclude that the substitution of nPB for
TCE and/or MC in halogenated solvent
22 Ichihara et al. 2004b. Neurological
Abnormalities in Workers of 1-Bromopropane
Factory, Environmental Health Perspectives
published by the National Institute of
Environmental Health Sciences, National Institute
of Health, U.S. Department of Health and Human
Services, June 2004.
Ichihara et al. 2002. Neurological disorders in
three workers exposed to 1-bromopropane. Journal
of Occupational Health 44:1–7 (2002).
23 WIL. 2001. An Inhalation Two-Generation
Reproductive Toxicity Study of 1–Bromopropane in
Rats. Conducted by Stump D. G. at WIL Research
Laboratories, Inc., Sponsored by Brominated
Solvents Consortium. May 24, 2001.
24 The EPA has addressed the use of nPB as a
solvent in industrial equipment for metals cleaning,
electronics cleaning and precision cleaning under
the Significant New Alternative Policy (SNAP)
Program. Under SNAP, EPA reviews substitutes for
ozone depleting substances to determine if a
substitute would pose a substantially greater risk to
human health or the environment than other
substitutes that are available. See CAA section
612(c), 40 CFR Part 82, subpart G. Specifically,
based on evidence that in solvent cleaning worker
exposure levels were consistently below levels of
concern, EPA concluded that users could use nPB
as safely as other available substitutes. Thus, EPA
found nPB acceptable as a substitute for methyl
chloroform and CFC–113, (72 FR 30142 May 30,
2007). While under SNAP no restrictions were
placed on the use of nPB in the solvent cleaning
end uses addressed in the rule, SNAP approval does
not relieve users from the obligation to comply with
any other regulatory obligations, such as those that
might apply under the 1994 NESHAP.
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cleaners should not pose any health
risks to the general population.
The SNAP final rule stated that for
non-aerosol solvent cleaning, facilities
should follow the guidelines in the
NESHAP for halogenated solvent
cleaning if they are using nPB. The
equipment and procedural changes
described in the NESHAP for
halogenated solvent cleaning can reduce
emissions, reduce solvent losses and
lower the cost of cleaning with organic
solvents.
Based on this information, we
conclude that use of nPB to comply
with the proposed emission limit is
reasonable, and we recommend that
those switching to nPB maintain use of
their current emission controls for
worker and general public safety. In this
notice, we request comment on
additional or new information which
might suggest that this conclusion is
incorrect.
5. Costs and Other Relevant Factors for
the Proposed Options
As discussed earlier in sections I and
III of this preamble, petitioners have
raised several issues on our cost
conclusions in the Halogenated Solvent
Cleaning rule. Since promulgation of the
Halogenated Solvent Cleaning rule, we
have become aware of certain facilities
that manufacture narrow tubing that
have voluntarily investigated and
instituted HAP emission reductions by
installing CAD, vacuum-to-vacuum
machines, switching from HAP solvents
to a non-HAP solvent and
reconfiguration and changing
production processes.
Consequently, we have re-evaluated
our conclusions on costs, availability of
technology and the compliance deadline
for the facility-wide limits in the
Halogenated Solvent Cleaning rule. As
earlier explained in this section,
existing information now leads us to
conclude, in a change from the
Halogenated Solvent Cleaning rule, that
certain affected sources in the narrow
tubing industry can comply with the
proposed limits and requirements
through installation of CAD, vacuum-tovacuum machines, switching from HAP
to non-HAP and improved work
practices and manufacturing process
changes. In addition, we extrapolated
information on compliance measures
that we obtained for the narrow tubing
industry sector to facilities that use
continuous web cleaning machines.
Specifically, we assumed that facilities
that use continuous web cleaning
machines could substitute TCE for nPB.
As noted earlier, however, due to
concerns over materials incompatibility,
we do not believe we can extrapolate
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62401
the information on the use of nPB by
facilities that manufacture narrow
tubing to aerospace manufacturing and
maintenance facilities. Finally, our cost
estimates do not reflect any new
information on available HAP emission
reduction options for both the general
population of halogenated solvent
cleaning machines, the aerospace
manufacturing and maintenance
facilities and military maintenance and
depot facilities.
To estimate the costs of reducing
emissions for individual facilities, the
EPA first calculated the percent
emission reductions necessary for each
facility to comply with the levels being
investigated. Then, control technologies
were applied on a per unit basis to
achieve the percent reduction necessary
to achieve the level. The control
technologies applied varied depending
on the cleaning machine type, the
solvent used, and the percent control
required. As earlier stated, such control
technologies include the replacement of
existing units with vacuum-to-vacuum
machines, solvent switching, and addon controls. This proposal reflects our
investigation of these control options
and a determination of the direct costs
associated with these emission
reduction measures.
Prior to selection of the proposed
emission limits and control efficiency
requirements, we have considered the
costs of each of the emission limits in
providing various degrees of emission
reductions, similar to our August 17,
2006, proposal and our Halogenated
Solvent Cleaning rule. The costs for an
individual facility were then
determined based on the costs
associated with the controls needed to
meet the level and taking into account
any increase or decrease in solvent
costs. We have determined facilities in
each sector of industries engaging in
halogenated solvent cleaning that would
have to add technology measures to
control emissions at the various
emission limits discussed in this
preamble. With regard to the narrow
tube manufacturing industry, we have
applied costs that were incurred by
specific facilities in Pennsylvania for
purposes of meeting various proposed
emission limits. We have also
extrapolated some of these costs to
facilities that use continuous web
cleaning machines (e.g., use of nPB as
a substitute for TCE). We also assumed
that the necessary controls were all high
efficiency and costlier controls. We did
not apply any mid-level controls and
their associated costs for instances
where we had direct compliance costs
to use as examples. In other words,
when estimating costs for the facilities
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that manufacture narrow tubing, the
EPA used cost information provided by
facilities that manufacture narrow
tubing that had already implemented
control technologies, such as CAD,
vacuum-to-vacuum machines, and
switching to nPB. Additionally, costs
and risk estimates were developed for
the narrow tube manufacturing industry
at various percent emission reduction
levels and MC equivalent levels. We
have then applied these associated
direct costs to facilities that use
continuous web cleaning machines
because we have assumed that these
associated direct costs would be a
primary example of costs of complying
with the various proposed emission
limits for any facility with similar
cleaning machines, similar solvent
usage and similar HAP emission
reduction. These applied assumptions
are similar to our cost assumptions in
the August 17, 2006, proposal. To more
fully analyze the implications of the
various emission limits, we re-
calculated the overall and incremental
annualized cost per cancer case avoided
for each proposed option. The results of
our analyses are summarized in Table 4
below. In general, we expect that
facilities that use halogenated solvents
with a higher URE, and as a result have
lower emission limits, would likely
incur higher costs to reduce emissions
to the necessary limit. We are soliciting
comments on these aspects of this
proposal.
TABLE 4—COST ANALYSIS FOR PROPOSED OPTIONS
Option
1
Total Capital Costs (Millions) .................................................................................................
Net Annualized Costs (Millions) ............................................................................................
Operation and Maintenance Costs (Millions) ........................................................................
Solvent Savings (Millions) .....................................................................................................
Total Annual Costs * (Millions) ...............................................................................................
Emissions Reduced (tons/yr) .................................................................................................
Cancer Cases Avoided/yr ......................................................................................................
Cost Effectiveness of Control ($/ton) ....................................................................................
Incremental Cost effectiveness (compared to next least stringent option) (Millions $/case
avoided) ..............................................................................................................................
2
3
$15.65
$1.50
$0.76
($3.65)
($1.38)
1,681
0.19
($821)
$37.58
$3.73
$1.88
($4.00)
$1.60
2,601
0.20
$616
$49.89
$5.19
$2.61
($4.96)
$2.83
3,058
0.23
$927
($7.0)
$293
$41
* Net Annualized Costs plus O&M plus Solvent Savings.
We are also presenting in Table 5 the
associated costs and emission
reductions for the sector-specific control
options in light of the fact that we are
soliciting comments on combinations of
limits other than those represented by
options 1 through 3 presented above in
section III.
TABLE 5—COST ANALYSIS FOR SECTOR-SPECIFIC COMPONENTS OF OPTIONS 1, 2, AND 3
60,000 kg/yr
MC equivalent
for general
degreaser population (does
not include
named sectors)
Emission limit
60,000 kg/yr
MC equivalent
for narrow tubing
80 percent
overall control
for continuous
web cleaning
machines at facilities emitting
>60,000 kg/yr
100,000 kg MC
equivalent for
aerospace manufacture and
maintenance
$15.7
$1.45
$0.72
($3.50)
Million
($1.32)
1,621
($832)
($7.0)
$21.92
$2.23
$1.11
($0.36)
Thousand
$2.97
920
$3,238
$596
$3.29
$0.63
$0.31
($0.34)
Thousand
$0.60
290
$2,774
$177
$9.02
$0.87
$0.44
($0.68)
Thousand
$0.63
324
$1,933
$31
Total Capital Costs (Millions) .....................................
Net Annualized Costs (Millions) .................................
Operation and Maintenance Costs (Millions) ............
Solvent Savings (Millions) ..........................................
Total Annual Costs * (Millions) ...................................
Emissions Reduced (tons/yr) .....................................
Cost of Control ($/ton) ...............................................
Cost per Case Avoided (Millions) ..............................
100,000 kg/yr
MC equivalent
for military
maintenance
and depot
$0.54
$0.06
$0.04
($0.16)
Thousand
$0.06
89
($625)
($56)
mstockstill on PROD1PC66 with PROPOSALS2
* Net Annualized Costs plus O&M plus Solvent Savings.
Other factors relevant to our ample
margin of safety determination include
(but are not limited to) impact on the
national economy, small business
impacts, cost-effectiveness, incremental
cost-effectiveness, or net benefits.
All economic impact estimates
incorporate the scale-up factor of 1.76
applied to affected source populations
and costs. Option 1 is expected to affect
120 ultimate parent entities, and 40 of
these parent entities (one-third of the
total number of ultimate parent entities
affected) are small as defined by the
Small Business Administration (SBA)
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small business size standards. Of these
40 small entities, none have an
annualized cost of greater than one
percent of their sales. Option 2 is
expected to affect 148 ultimate parent
entities, and 52 (or 35 percent) of these
entities are small. Of these 52 small
entities, three have an annualized cost
of greater than one percent of their sales.
Finally, Option 3 is expected to affect
181 ultimate parent entities, and 56 (or
31 percent) of these entities are small.
Of these 56 small entities, three have an
annualized cost of greater than one
percent of their sales.
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6. Ample Margin of Safety Rationale for
Each of the Proposed Options
This section provides the results of
our reconsideration analysis and the
options that the EPA believes suitable
for proposal considering the issues
raised by the petitioners and the
capabilities of the industries affected by
the source category NESHAP
regulations. Specifically, Option 1
proposes the same limits promulgated
in the Halogenated Solvent Cleaning
rule that is the subject of this
reconsideration. Option 2 introduces
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more stringent emission limits (60,000
kg/yr MC equivalent) for the narrow
tube manufacturing industry. Finally,
Option 3 introduces more stringent
limits for aerospace manufacturing and
maintenance facilities (100,000 kg/yr
MC equivalent) and facilities that use
continuous web cleaning machines
(80% overall control efficiency for units
at facilities emitting greater than 60,000
kg/yr MC equivalent).
We recognize that there are significant
differences between these options in
terms of the level of emission
reductions, the number of cancer cases
avoided per year, and the associated
costs of control, but we believe that each
of the options presented provides an
ample margin of safety consistent with
the Benzene framework. We specifically
solicit comment on the information
included in Table 4 above and any other
information relevant to our ample
margin of safety determination.
i. What is our rationale for Option 1?
A 60,000 kg/yr MC equivalent limit
would be applicable to sources
associated with the general population
of halogenated solvent cleaning
machines. A 100,000 kg/yr MC
equivalent limit would be applicable to
halogenated solvent cleaning machines
located at military maintenance and
depot facilities. With respect to facilities
that use continuous web cleaning
machines, and halogenated solvent
cleaning machines used by facilities that
manufacture narrow tubing and
aerospace manufacturing and
maintenance facilities, we are proposing
to readopt the 1994 NESHAP under
CAA section 112(d)(6) and (f)(2)
because, as discussed below, we are
proposing that the current level of
control called for by the 1994 NESHAP
reduces HAP emissions to limits that
present an acceptable level of risk,
provide an ample margin of safety to
protect public health, and prevent any
adverse environmental effects. (This
option represents the standards
promulgated in the Halogenated Solvent
Cleaning rule).
Under this option, the total HAP
emissions would be reduced by 1,681
tpy. We anticipate that about 82
facilities and 98 halogenated solvent
cleaning machines would be affected by
this proposed option. Facilities would
reduce their emissions to meet this
proposed regulatory option by selecting
control options that might include one
or more of the following: (1) Solvent
switching from a HAP solvent with a
higher URE to a HAP solvent with a
lower URE, such as switching from PCE
or TCE to MC; (2) solvent switching
from a HAP solvent to a non-HAP
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solvent; (3) retrofitting additional
freeboard; (4) installing CAD; or (5)
installing vacuum-to-vacuum machines.
We are proposing to conclude that
Option 1 reduces HAP emissions to
levels that present an acceptable level of
risk, provides an ample margin of safety
to protect public health, and prevents
any adverse environmental effects.
When Option 1 is applied to the
facilities in the 2002 NEI database we
estimate that the MIR decreases to about
50-in-1 million with an estimated
reduction in cancer incidence of about
0.19 cases annually, with an annualized
cost savings of $1.3 million, or a cost
savings of about $822 per ton. The
maximum chronic noncancer HI is
lower than the baseline, ranging from
0.2 to 2.0 depending on which
noncancer toxicity value is used in the
assessment. Specifically, using the
CalEPA chronic REL to assess TCE
noncancer hazard, emissions from no
facilities would result in exposures
exceeding an HI of 1. Using the NYS
DOH noncancer criterion to assess TCE
noncancer hazard, emissions from the
five narrow tube manufacturing
facilities would result in exposures
exceeding an HI of 1, the HI value is 2
for each of these facilities. The HIs for
the five other facilities that are above 1
in the baseline using the NYS DOH
noncancer criterion would fall below 1
under this option. In addition,
considering the discussion of the
conservatism associated with the
chronic non-cancer toxicity of TCE
using the NYS DOH criterion (discussed
previously in section III), along with the
additional cost and risk factors
discussed above, we propose that this
option provides an ample margin of
safety to protect public health.
ii. What is our rationale for Option 2?
A 60,000 kg/yr MC equivalent limit
would be applicable to sources
associated with the general population
of halogenated solvent cleaning
machines and halogenated solvent
cleaning machines used by facilities that
manufacture narrow tubing. A 100,000
kg/yr MC equivalent limit would be
applicable to halogenated solvent
cleaning machines located at military
maintenance and depot facilities. With
respect to facilities that use continuous
web cleaning machines, and
halogenated solvent cleaning machines
used by aerospace manufacturing and
maintenance facilities, we are proposing
to re-adopt the 1994 NESHAP under
CAA section 112(d)(6) and (f)(2)
because, as discussed below, we are
proposing that the current level of
control called for by the 1994 NESHAP
reduces HAP emissions to levels that
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62403
present an acceptable level of risk,
provide an ample margin of safety to
protect public health, and prevent any
adverse environmental effects. We
anticipate that about 105 facilities and
150 halogenated solvent cleaning
machines would be subject to this
proposed option. Facilities would
reduce their emissions by selecting
control options that might include one
or more of the following: (1) Solvent
switching from a HAP solvent with a
higher URE to a HAP solvent with a
lower URE, such as switching from PCE
or TCE to MC; (2) solvent switching
from a HAP solvent to a non-HAP
solvent; (3) retrofitting additional
freeboard; (4) installing CAD or; (5)
installing vacuum-to-vacuum machines.
We are proposing to conclude that
Option 2 reduces HAP emissions to
levels that present an acceptable level of
risk, provides an ample margin of safety
to protect public health, and prevents
any adverse environmental effects.
When Option 2 is applied to the
facilities in the 2002 NEI database, the
MIR decreases to about 30-in-1 million
with an estimated reduction in cancer
incidence of about 0.20 cases annually,
and annualized costs of $1.6 million, or
annual costs of about $615 per ton. The
maximum chronic noncancer HI is
reduced from the baseline, to a range of
0.05 to 1 depending on which
noncancer toxicity value is used in the
assessment. The incremental annualized
cost of control options 1 and 2 is about
$3 million. The incremental emission
reduced from Option 1 to Option 2 is
920 tons. Therefore the incremental
cost-effectiveness between Options 1
and 2 is nearly $3,200/ton/year. The
incremental cancer incidence reduction
between options 1 and 2 is 0.01. The
incremental cost-effectiveness/cancer
case avoided is nearly $293 million.
iii. What is our rationale for Option 3?
A 60,000 kg/yr MC equivalent limit
would be applicable to sources
associated with the general population
of halogenated solvent cleaning
machines and halogenated solvent
cleaning machines used by facilities that
manufacture narrow tubing. A 100,000
kg/yr MC equivalent limit would be
applicable to halogenated solvent
cleaning machines used by aerospace
manufacturing and maintenance
facilities and halogenated solvent
cleaning machines located at military
maintenance and depot facilities.
Facilities that use continuous web
cleaning machines that exceed 60,000
kg/yr MC equivalent HAP emissions
would have to achieve 80 percent
overall control efficiency for those units.
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We anticipate that about 130 facilities
and 260 halogenated solvent cleaning
machines would be subject to this
proposed option. Facilities would
reduce their emissions by selecting
control options that might include one
or more of the following: (1) Solvent
switching from a HAP solvent with a
higher URE to a HAP solvent with a
lower URE, such as switching from PCE
or TCE to MC; (2) solvent switching
from a HAP solvent to a non-HAP
solvent; (3) retrofitting additional
freeboard; (4) installing CAD; or (5)
installing vacuum-to-vacuum machines.
We are proposing to conclude that
Option 3 reduces HAP emissions to
levels that present an acceptable level of
risk, provides an ample margin of safety
to protect public health, and prevents
any adverse environmental effects.
When Option 3 is applied to 130
facilities in the 2002 NEI database, the
MIR decreases to about 30-in-1 million
with an estimated reduction in cancer
incidence of about 0.23 cases annually,
and annualized costs of $2.8 million, or
annual costs of about $887 per ton. The
incremental annualized cost of control
Options 2 and 3 is about $1.2 million.
The incremental emission reduced from
Option 2 to Option 3 is 587 tons.
Therefore the incremental costeffectiveness/tons emissions reduced
between Options 2 and 3 is nearly
$2,100/ton/year. The incremental cancer
incidence reduction between Options 2
and 3 is 0.03. The incremental costeffectiveness/cancer case avoided is $41
million.
C. Clean Air Act Section 112(d)(6)
Review
Petitioners also contend that the
Halogenated Solvent Cleaning rule does
not satisfy our obligations under CAA
section 112(d)(6). Several petitioners
state that our review of the 1994
NESHAP failed to consider the
availability of current control
technology, such as CAD, and capture
and control system that could achieve
upwards of 35 percent TCE emissions
reduction by facilities that manufacture
narrow tubing. Petitioners also identify
CAD, and vacuum-to-vacuum machines,
and other control options, such as
solvent switching as compliance options
for halogenated solvent cleaning
machines used by facilities that
manufacture narrow tubing that became
available subsequent to promulgation of
the Halogenated Solvent Cleaning rule.
Further, petitioners allege that we failed
to provide any explanation as to why
several alternative emission reduction
measures, such as either vacuum-tovacuum machines or solvent switching
were not available control options for
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facilities that use continuous web
cleaning machines.
CAA section 112(d)(6) requires the
EPA to review and revise, as necessary
(taking into account developments in
practices, processes, and control
technologies), emission standards
promulgated under CAA section 112(d)
no less often than every eight years. In
light of the petitions, we have reassessed the issue of whether there have
been developments in practices,
processes and control technologies since
issuance of the 1994 NESHAP. We have
also reviewed the information
concerning compliance options
included in the various petitions, as
some of that information was not
available to the EPA at the time of
promulgation of the Halogenated
Solvent Cleaning rule. Additionally, we
have held discussions with industry
representatives on the availability of
control measures and the potential for
additional emission reductions.
We believe that there have been some
developments in control technologies,
practices and processes for the facilities
that manufacture narrow tubing. The
control technologies include the use of
vacuum-to-vacuum technology and
CAD. Other measures include, for
example, switching from HAP to nonHAP cleaners, such as nPB and
manufacturing process changes. We
solicit comment on the extent to which
these control approaches represent
advances in the control of halogenated
solvents for the entire source category or
whether they are relevant only to certain
sectors within the category.
Section 112(d)(6) grants EPA much
discretion to revise the standards ‘‘as
necessary.’’ Thus, although the
specifically enumerated factors that EPA
should consider all relate to technology
(e.g., developments in practices,
processes and control technologies), the
instruction to revise ‘‘as necessary’’
indicates that EPA is to exercise its
judgment in this regulatory decision,
and is not precluded from considering
additional relevant factors, such as costs
and risk. EPA has substantial discretion
in weighing all of the relevant factors in
arriving at the best balance of costs and
emissions reduction and determining
what further controls, if any, are
necessary. This interpretation is
consistent with numerous rulings by the
U.S. Court of Appeals for the DC Circuit
regarding EPA’s approach to weighing
similar enumerated factors under
statutory provisions directing the
agency to issue technology-based
standards. See, e.g. Husqvarna AB v.
EPA, 254 F.3d 195 (DC Cir. 2001). After
weighing all relevant factors, we are
proposing the same regulatory options
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described above for our 112(f)(2)
residual risk analysis. Based on the
information analyzed for the regulatory
options, and discussed in detail above,
we are proposing three options for
emissions standards to satisfy the
requirements of section 112(d)(6)
review:
Proposed Option 1: A 60,000 kg/yr
MC equivalent limit would be
applicable to sources associated with
the general population of halogenated
solvent cleaning machines. A 100,000
kg/yr MC equivalent limit would be
applicable to halogenated solvent
cleaning machines located at military
maintenance and depot facilities. With
respect to facilities that use continuous
web cleaning machines, halogenated
solvent cleaning machines used by
facilities that manufacture narrow
tubing, and halogenated solvent
cleaning machines used by aerospace
manufacturing and maintenance
facilities, we are proposing to re-adopt
the 1994 NESHAP under CAA section
112(f)(2).
Proposed Option 2: A 60,000 kg/yr
MC equivalent limit would be
applicable to sources associated with
the general population of halogenated
solvent cleaning machines and
halogenated solvent cleaning machines
used by facilities that manufacture
narrow tubing. A 100,000 kg/yr MC
equivalent limit would be applicable to
halogenated solvent cleaning machines
located at military maintenance and
depot facilities. With respect to facilities
that use continuous web cleaning
machines, and halogenated solvent
cleaning machines used by aerospace
manufacturing and maintenance
facilities, we are proposing to re-adopt
the 1994 NESHAP under CAA section
112(f)(2).
Proposed Option 3: A 60,000 kg/yr
MC equivalent limit would be
applicable to sources associated with
the general population of halogenated
solvent cleaning machines and
halogenated solvent cleaning machines
used by facilities that manufacture
narrow tubing. A 100,000 kg/yr MC
equivalent limit would be applicable to
halogenated solvent cleaning machines
used by aerospace manufacturing and
maintenance facilities and halogenated
solvent cleaning machines located at
military maintenance and depot
facilities. Facilities that use continuous
web cleaning machines that exceed
60,000 kg/yr MC equivalent HAP
emissions would have to achieve 80
percent overall control efficiency for
those units.
We solicit comments on these
proposed options.
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D. Compliance Schedule
As discussed in section II, one
petitioner stated that the 3-year
compliance period appeared for the first
time in the Halogenated Solvent
Cleaning rule, making it impracticable
to raise objections during the period
provided for public comment. One
petitioner argued that our assumption
that facilities that manufacture narrow
tubing could only achieve a 10 percent
emission reduction within a 3-year
compliance period was unsupported by
the record and unexplained. Another
petitioner argued that CAA section
112(f)(4) is the controlling provision
that addresses compliance deadlines for
existing sources with regard to
standards promulgated under CAA
sections 112(d)(6) and (f)(2).
At proposal, we determined that CAA
section 112(i) was the controlling
provision that addressed compliance
deadlines for existing sources with
regard to standards promulgated under
CAA sections 112(d)(6) and (f)(2). For
existing sources, we proposed a 2-year
compliance deadline from the effective
date of the rule. We were persuaded,
however, by comments on our August
17, 2006 proposal and subsequent
NODA, indicating that additional time
beyond the proposed 2-year compliance
deadline would be needed, and in the
Halogenated Solvent Cleaning rule, we
set a 3-year compliance period for
existing sources, finding that this period
was more appropriate given the time
necessary to implement control
approaches necessary to meet the
emission requirements. Thus, we
promulgated a 3-year compliance
deadline for existing sources from the
effective date of the Halogenated
Solvent Cleaning rule.
In this action, for existing sources that
were not subject to the emission
reduction requirements in the
Halogenated Solvent Cleaning rule,25
we are proposing a 2-year compliance
deadline from the date of publication of
the final rule in the Federal Register. As
to those sources that were subject to
emission reduction requirements in the
Halogenated Solvent Cleaning rule,26 if
the final rule on reconsideration
changes those requirements
significantly and makes them more
stringent, we propose that these sources
have two years from the date of
publication of the final rule to comply
with the requirements of the final rule.
We believe that such an extension is
appropriate to allow the affected
facilities time to meet the more stringent
emission limitations.
In the Halogenated Solvent Cleaning
rule, we identified a conflict between
section 112(i) and section 112(f)(4) of
the Act. To avoid a conflict in these
provisions addressing compliance
deadlines, we interpreted the more
specific and comprehensive set of
provisions in section 112(i) as governing
both CAA section 112(d) and (f)
standards. We maintain this
interpretation in this rule. We note,
however, that the 2-year compliance
deadline proposed in this action is
consistent with an alternative
interpretation of the Act, which
petitioners endorse, that the provisions
of CAA section 112(f)(4) control. CAA
section 112(f)(4) would allow us to grant
a 2-year extension of the compliance
deadline for existing sources, in
addition to the 90-day compliance date
otherwise applicable. We believe that
the proposed 2-year compliance
deadline is necessary for the installation
of controls at existing sources, and
section 112(f)(4) would allow us to grant
such an extension for the installation of
controls. The proposed 2-year
compliance deadline takes into account
that the sources that have already
installed controls appear to have done
so within a two year period. Thus, we
believe that this proposal falls within
the 2-year plus 90-day period that
would be allowed under CAA section
112(f)(4)(A)–(B) and is therefore within
the permissible range of CAA section
112(f)(4), even if that section applies.
We are also soliciting comments on this
aspect of this proposal.
25 These sources include halogenated solvent
cleaning machines used by facilities that
manufacture narrow tubing, facilities that
manufacture specialized products requiring
continuous web cleaning, and aerospace
manufacturing and maintenance facilities.
26 These sources include halogenated solvent
cleaning machines at military maintenance and
depot facilities and the general population of
halogenated solvent cleaning machines.
V. Impacts
For the general population degreasing
sources required to comply with the
60,000 kg/yr MC equivalent emission
limit, the national capital costs to reach
compliance are estimated to be
$15,000,000 with annualized cost
savings of $1.3 million (2007 dollars).
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IV. Proposed Regulatory Text
Given that we are proposing a range
of regulatory options, we have not
prepared proposed regulatory text for
each option. The regulatory text for
Option 1 is, however, set forth in the
Halogenated Solvent Cleaning rule. If
we elect to finalize options 2 or 3 or
some combination thereof, the
regulatory text will follow the
framework set forth in the Halogenated
Solvent Cleaning rule.
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The capital costs for individual facilities
would range from $15,000 to $800,000
with an average cost of about $190,000.
More than 60 percent of the facilities
implementing a control technology
would recognize a cost savings
primarily from solvent savings.
Controlling solvent use is a pollution
prevention approach where emissions
reduction translate into less PCE, TCE
and MC consumption and reduced
operating costs primarily because
facilities would need to purchase less
solvents. Using the 2002 NEI database,
the maximum individual cancer risk is
estimated to be reduced from 100-in-1
million to between 50 and 20-in-1
million, depending on the control
option selected. The options outlined
here are expected to reduce cancer
incidence from a source category wide
baseline of 0.55 cases annually to 0.33
for Option 1, with reductions to 0.33
when continuing to Option 3, resulting
in a range of reduction in cancer
incidence from between 0.19 to 0.22
cases annually, depending upon the
option selected. Additionally, Option 1
is expected to reduce the range of
possible chronic noncancer HI values
from 0.2 to 7 at the baseline, to 0.2 to
2, depending on which noncancer
toxicity value is used in the assessment.
Both Options 2 and 3 result in a
reduction of the range of possible
maximum chronic noncancer HI values
from between 0.2 and 7 at the baseline,
to between 0.05 and 1, depending on
which noncancer toxicity value is used
in the assessment.
The EPA estimates that to comply
with the 100,000 kg/yr MC equivalent
emission limit, military maintenance
and depot facilities are expected to
incur $540,000 in capital costs with
annualized savings of about $56,000.
Using the 2002 NEI database, the
maximum individual cancer risk is
estimated to be reduced from 6-in-1
million to 3-in-1 million. The emission
limit for military maintenance and
depot facilities is expected to reduce
cancer incidence by 0.0002 cases
annually.
The EPA also estimates that to comply
with the 100,000 kg/yr MC equivalent
emission limit, aerospace manufacturing
and maintenance facilities are expected
to incur $9 million in capital costs with
annualized costs of about $626,000.
Using the 2002 NEI database, this
emission limit for aerospace
manufacturing and maintenance
facilities is expected to reduce cancer
incidence by 0.03 cases annually.
The EPA also estimates that to comply
with the 60,000 kg/yr MC equivalent
emission limit, facilities that
manufacture narrow tubing are expected
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to incur $22 million in capital costs
with annualized costs of about $3
million. Using the 2002 NEI database,
this emission limit for facilities that
manufacture narrow tubing is expected
to reduce cancer incidence by 0.005
cases annually.
The EPA further estimates that to
comply with the 80 percent overall
control efficiency, facilities that use
continuous web cleaning machines with
total emissions over the 60,000 kg/yr
MC equivalent thresholds are expected
to incur $3 million in capital costs with
annualized costs of about $601,000.
Using the 2002 NEI database, this
emission limit for facilities that use
continuous web cleaning machines is
expected to reduce cancer incidence by
0.003 cases annually.
VI. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review
Under Executive Order (EO) 12866
(58 FR 51735, October 4, 1993), this
action is a ‘‘significant regulatory
action.’’ EO 12866 gives the Office of
Management and Budget (OMB) the
authority to review regulatory actions
that are categorized as ‘‘significant’’
under section 3(f) of the EO, i.e., those
actions that are likely to result in a rule
that may raise novel legal and policy
issues arising out of mandates in CAA
section 112(f)(2) and 112(d)(6).
Accordingly, EPA submitted this action
to OMB for review under EO 12866 and
any changes made in response to OMB
recommendations have been
documented in the docket for this
action.
In addition, EPA prepared an analysis
of the potential costs and benefits
associated with this action. The
analysis, which is briefly summarized in
section III of this Preamble, is contained
in the Costs Analyses Memorandum,
and has been placed in the docket for
this action.
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B. Paperwork Reduction Act
This action does not impose any new
information collection burden. Owners
or operators will continue to keep
records and submit required reports to
EPA or the delegated State regulatory
authority. Notifications, reports, and
records are essential in determining
compliance and are required, in general,
of all sources subject to the 1994
NESHAP. Owners or operators subject
to the 1994 NESHAP continue to
maintain records and retain them for at
least five years following the date of
such measurements, reports, and
records. Information collection
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requirements that were promulgated on
December 2, 1994, in the Halogenated
Solvent Cleaning NESHAP prior to the
2006 proposed amendments, as well as
the NESHAP General Provisions (40
CFR part 63, subpart A), which are
mandatory for all owners or operators
subject to national emission standards,
are documented in EPA ICR No.
1652.06. OMB has previously approved
the information collection requirements
contained in the existing regulations 40
CFR part 63 Subpart T under the
provisions of the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq. and has
assigned OMB control number 2060–
0273. The OMB control numbers for
EPA’s regulations in 40 CFR are listed
in 40 CFR part 9.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
generally requires an agency to prepare
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements under the
Administrative Procedure Act or any
other statute unless the agency certifies
that the rule will not have a significant
economic impact on a substantial
number of small entities. Small entities
include small businesses, small
organizations, and small governmental
jurisdictions.
For purposes of assessing the impacts
of this rule on small entities, small
entity is defined as: (1) A small business
as defined by the Small Business
Administration’s (SBA) regulations at 13
CFR 121.201; (2) a small governmental
jurisdiction that is a government of a
city, county, town, school district or
special district with a population of less
than 50,000; and (3) a small
organization that is any not-for-profit
enterprise which is independently
owned and operated and is not
dominant in its field.
The companies owning the affected
facilities using halogenated solvents can
be grouped into small and large
categories using SBA general size
standard definitions. Size standards are
based on industry classification codes
(i.e., North American Industrial
Classification System, or NAICS) that
each company uses to identify the
industry or industries in which they
operate. SBA defines a small business in
terms of the maximum employment,
annual sales, or annual energygenerating capacity (for electricity
generating units) of the owning entity.
These thresholds vary by industry and
are evaluated based on the primary
industry classification of the affected
companies. In cases where companies
are classified by multiple NAICS codes,
the most conservative SBA definition
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(i.e., the NAICS code with the highest
employee or revenue size standard) was
used.
As mentioned earlier in this
preamble, facilities across a large
number of industries use halogenated
solvents, therefore a number of size
standards are utilized in this analysis.
For the 41 industries identified at the 6digit NAICS code represented in this
analysis, the employment size standard
varies from 500 to 1,500 employees. The
annual sales standard is as low as four
million dollars and as high as 150
million dollars. The specific SBA size
standard is identified for each affected
industry within the small entity
database created for this economic
analysis.
After considering the economic
impacts of this action on small entities,
we have concluded that this action will
not have a significant economic impact
on a substantial number of small
entities. This certification is based on
the economic impact of this action on
all affected small entities in the entire
halogenated solvent cleaning source
category. Option 1 is expected to affect
120 ultimate parent entities, and 40 of
these parent entities (one-third of the
total number of ultimate parent entities
affected) are small as defined by SBA
small business size standards. Of these
40 small entities none have an
annualized cost of greater than one
percent of their sales. Option 2 is
expected to affect 148 ultimate parent
entities, and 52 (or 35 percent) of these
entities are small. Of these 52 small
entities, three have an annualized cost
of greater than one percent of their sales.
Finally, Option 3 is expected to affect
181 ultimate parent entities, and 56 (or
31 percent) of these entities are small.
Of these 56 small entities, three have an
annualized cost of greater than one
percent of their sales. More information
on these impacts can be found in the
economic impact analysis for this
proposed rule, a document available in
the public docket for this action.
Although this proposed rule will not
have a significant economic impact on
a substantial number of small entities,
EPA nonetheless has tried to reduce the
impact of this rule on small entities.
When developing the proposed rule, we
took special steps to ensure that the
burdens imposed on small entities were
minimal. We conducted several
meetings with industry trade
associations to discuss regulatory
options and the corresponding burden
on industry, such as recordkeeping and
reporting.
Following publication of the proposed
rule, copies of the Federal Register
notice and, in some cases, background
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documents, will be publicly available to
all industries, organizations, and trade
associations that have had input during
the regulation development, as well as
State and local agencies.
We continue to be interested in the
potential impacts of this proposed rule
on small entities and welcome
comments on issues related to such
impacts.
D. Unfunded Mandates Reform Act
This action contains no Federal
mandates under the provisions of Title
II of the Unfunded Mandates Reform
Act of 1995 (UMRA), 2 U.S.C. 1531–
1538 for State, local, or tribal
governments or the private sector. The
action imposes no enforceable duty on
any State, local or tribal governments or
the private sector. [The term
‘‘enforceable duty’’ does not include
duties and conditions in voluntary
Federal contracts for goods and
services.] Therefore, this action is not
subject to the requirements of sections
202 or 205 of the UMRA.
This action is also not subject to the
requirements of section 203 of UMRA
because it contains no regulatory
requirements that might significantly or
uniquely affect small governments.
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E. Executive Order 13132: Federalism
Executive Order (EO) 13132, entitled
‘‘Federalism,’’ (64 FR 43255, August 10,
1999) requires EPA to develop an
accountable process to ensure
‘‘meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications.’’ ‘‘Policies that have
federalism implications’’ is defined in
the EO to include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’
This proposed action does not have
federalism implications. It will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in EO
13132. None of the affected halogenated
solvent cleaning facilities are owned or
operated by State or local governments.
Thus, EO 13132 does not apply to this
proposed action.
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In the spirit of Executive Order 13132,
and consistent with EPA policy to
promote communications between EPA
and State and local governments, EPA
specifically solicits comment on this
proposed rule from State and local
officials.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This proposed action does not have
tribal implications, as specified in
Executive Order 13175 (65 FR 67249,
November 9, 2000). It will not have
substantial direct effects on tribal
governments, on the relationship
between the Federal government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal government and Indian tribes as
specified in EO 13175. Thus, Executive
Order 13175 does not apply to this
proposed action.
EPA specifically solicits additional
comment on this proposed rule from
tribal officials.
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
EPA interprets EO 13045 (62 FR
19885, April 23, 1997) as applying to
those regulatory actions that concern
health or safety risks, such that the
analysis required under section 5–501 of
the Order has the potential to influence
the regulation. This action is not subject
to EO 13045 because it is based solely
on technology performance.
This proposed action is not subject to
the EO because it is not economically
significant as defined in EO 12866; the
Agency believes this action represents
reasonable further efforts to mitigate
risks to the general public, including
effects on children. This conclusion is
based on our assessment of the imposed
emission limits that would reduce
chlorinated solvent impacts on human
health associated with exposures to
halogenated solvent cleaning
operations.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This proposed action is not a
‘‘significant energy action’’ as defined in
Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not likely
to have a significant adverse effect on
the supply, distribution, or use of
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62407
energy. This proposed action will have
a negligible impact on energy
consumption because about 10 percent
of entities using halogenated solvent
cleaning will have to reduce emissions
through a range of activities involving
simple process changes to the
installation of additional emission
control equipment or special low
emitting machines to comply. The cost
of energy distribution should not be
affected by this proposed action at all
since the standards do not affect energy
distribution facilities. We also expect
that there would be no impact on the
import of foreign energy supplies, and
no other adverse outcomes are expected
to occur with regards to energy supplies.
Further, we have concluded that this
proposed action is not likely to have any
significant adverse energy effects.
I. National Technology Transfer
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act (NTTAA) of 1995 (Pub. L. 104–113,
12(d) (15 U.S.C. 272 note), directs EPA
to use voluntary consensus standards
(VCS) in its regulatory activities unless
to do so would be inconsistent with
applicable law or otherwise impractical.
VCS are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by VCS bodies. The NTTAA directs EPA
to provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable VCS.
This proposed action does not involve
technical standards. Therefore, we are
not considering the use of any voluntary
consensus standards.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order 12898 (59 FR 7629,
Feb. 16, 1994) establishes federal
executive policy on environmental
justice. Its main provision directs
federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States.
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EPA has determined that this
proposed rule will not have
disproportionately high and adverse
human health or environmental effects
on minority or low-income populations
because it increases the level of
environmental protection for all affected
populations without having any
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disproportionately high and adverse
human health or environmental effects
on any population, including any
minority or low-income population.
List of Subjects in 40 CFR Part 63
Environmental protection, Air
pollution control, Hazardous
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substances, Reporting and
recordkeeping requirements.
Dated: October 3, 2008.
Stephen L. Johnson,
Administrator.
[FR Doc. E8–24013 Filed 10–17–08; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 73, Number 203 (Monday, October 20, 2008)]
[Proposed Rules]
[Pages 62384-62408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24013]
[[Page 62383]]
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Part II
Environmental Protection Agency
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40 CFR Part 63
National Emission Standards for Halogenated Solvent Cleaning; Proposed
Rule
Federal Register / Vol. 73, No. 203 / Monday, October 20, 2008 /
Proposed Rules
[[Page 62384]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[EPA-HQ-OAR-2002-0009; FRL-8727-5]
RIN 2060-AP07
National Emission Standards for Halogenated Solvent Cleaning
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Notice of Reconsideration and Request for Public
Comment.
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SUMMARY: On May 3, 2007, EPA promulgated the final rule titled:
National Air Emission Standards for Hazardous Air Pollutants:
Halogenated Solvent Cleaning (the Halogenated Solvent Cleaning rule)
pursuant to sections 112(d)(6) and 112(f) of the Clean Air Act. The
Halogenated Solvent Cleaning rule set facility-wide emission limits for
certain halogenated solvent cleaning machines and a May 3, 2010,
compliance deadline.
Following promulgation of the Halogenated Solvent Cleaning rule,
the Administrator received several petitions for reconsideration,
pursuant to Clean Air Act section 307(d)(7)(B). The purpose of this
notice is to initiate a process for responding to certain issues raised
in the petitions. We are requesting comment on the particular issues
for which we are granting reconsideration, and those issues are
identified, in detail, below. Specifically, we are requesting comment
on the revised risk assessment, our use of the 2002 National Emissions
Inventory data in lieu of the 1999 National Emissions Inventory data,
which was used at proposal, our ample margin of safety determination
under Clean Air Act section 112(f)(2), our determination under Clean
Air Act section 112(d)(6), and the compliance deadline.
DATES: Comments. Comments must be received on or before December 4,
2008.
Public Hearing. If anyone contacts EPA requesting to speak at a
public hearing by October 30, 2008, a public hearing will be held
November 4, 2008.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2002-0009, by one of the following methods:
https://www.regulations.gov. Follow the on-line
instructions for submitting comments.
E-mail: a-and-r-docket@epa.gov.
Fax: (202)566-1741.
Mail: Air and Radiation Docket, EPA, Mailcode: 6102T, 1200
Pennsylvania Ave., NW., Washington, DC 20460. Please include a
duplicate copy, if possible. We request that a separate copy of each
public comment also be sent to the contact person listed below (see FOR
FURTHER INFORMATION CONTACT).
Hand Delivery: In person or by courier, deliver comments
to: EPA Docket Center (2822T), EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC 20004. Such deliveries are only
accepted during the Docket's normal hours of operation and special
arrangements should be made for deliveries of boxed information. We
request that a separate copy of each public comment also be sent to the
contact person listed below (see FOR FURTHER INFORMATION CONTACT).
Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2002-0009. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://
www.regulations.gov or e-mail. The https://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through https://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
Docket: All documents in the docket are listed in the https://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in https://www.regulations.gov or in hard copy at the EPA Docket Center,
Docket ID No. EPA-HQ-OAR-2002-0009, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Air and Radiation Docket is
(202) 566-1742.
FOR FURTHER INFORMATION CONTACT: For questions about this proposed
action, contact Mr. H. Lynn Dail, Office of Air Quality Planning and
Standards, Sector Policies and Programs Division, Natural Resources and
Commerce Group (E143-03), U.S. Environmental Protection Agency,
Research Triangle Park, NC 27711; telephone number: (919) 541-2363; fax
number: (919) 541-3470; and e-mail address: dail.lynn@epa.gov. For
specific information regarding the modeling methodology, contact Ms.
Elaine Manning, Office of Air Quality Planning and Standards, Health
and Environmental Impacts Division, Sector Based Assessment Group
(C539-02), U.S. Environmental Protection Agency, Research Triangle
Park, NC 27711; telephone number: (919) 541-5499; fax number: (919)
541-0840; and e-mail address: manning.elaine@epa.gov. For information
about the applicability of these national emission standards for
hazardous air pollutants (NESHAP) to a particular entity, contact Mr.
Scott Throwe, Office of Enforcement and Compliance Assurance, U.S.
Environmental Protection Agency, Washington, DC, (202) 564-7013; and e-
mail address: throwe.scott@epa.gov.
SUPPLEMENTARY INFORMATION: Regulated Entities. Categories and entities
potentially affected by this notice include:
[[Page 62385]]
------------------------------------------------------------------------
Examples of
Category NAICS \1\ code potentially
regulated entities
------------------------------------------------------------------------
Industry.................... Any of numerous Operations at
industries using sources that are
halogenated solvent engaged in solvent
cleaning, primary cleaning using
affected industries methylene chloride
include those in (MC),
NAICS Codes perchloroethylene
beginning with: 331 (PCE), or
(primary metal trichloroethylene
manufacturing), 332 (TCE).
(fabricated metal
manufacturing), 333
(machinery
manufacturing), 334
(computer and
electronic product
manufacturing), 335
(electrical
equipment,
appliance, and
component
manufacturing); 336
(transportation
equipment
manufacturing); 337
(furniture and
related products
manufacturing); and
339 (misc.
manufacturing).
Federal, State, local, and .................... Operations at
tribal government. sources that are
engaged in solvent
cleaning using MC,
PCE, or TCE.
------------------------------------------------------------------------
\1\ North American Industry Classification System.
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
proposed action. This action proposes to require an owner or operator
of a facility that is subject to the 1994 NESHAP for Halogenated
Solvent Cleaning (40 CFR part 63.460 of subpart T) to operate under
certain specific emission limits. If you have any questions regarding
the applicability of this proposal to a particular entity, consult the
person listed in the preceding FOR FURTHER INFORMATION CONTACT section.
Submitting Comments/CBI. Direct your comments to Docket ID No. EPA-
HQ-OAR-2002-0009. Do not submit CBI to EPA through https://
www.regulations.gov or e-mail. Instead, send or deliver information
identified as CBI only to the following address: Mr. Roberto Morales,
OAQPS Document Control Officer (C404-02), U.S. Environmental Protection
Agency, Office of Air Quality Planning and Standards, Research Triangle
Park, NC 27711, Attention Docket ID No. EPA-HQ-OAR-2002-0009. Clearly
mark the part or all of the information that you claim to be CBI. For
CBI information on a disk or CD-ROM that you mail to Mr. Morales, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI.
In addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. If you submit a CD-ROM or disk that does not contain
CBI, mark the outside of the disk or CD-ROM clearly that it does not
contain CBI. Information not marked as CBI will be included in the
public docket and EPA's electronic public docket without prior notice.
If you have any questions about CBI or the procedures for claiming
CBI, please consult the person identified in the FOR FURTHER
INFORMATION CONTACT section. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. Worldwide Web (WWW). In addition to being available in the docket,
an electronic copy of this proposed action will also be available on
the WWW through the Technology Transfer Network (TTN). Following
signature, a copy of the proposed action will be posted on the TTN's
policy and guidance page for newly proposed or promulgated rules at the
following address: https://www.epa.gov/ttn/oarpg/. The TTN provides
information and technology exchange in various areas of air pollution
control.
Additional information is available in section I of this preamble
and on the Halogenated Solvents Cleaning Web page at https://
www.epa.gov/ttn/atw/rrisk/rtrpg.html. This information includes source
category descriptions and detailed emissions and other data that were
used as inputs to the risk assessments.
Public Hearing. If anyone contacts EPA requesting to speak at a
public hearing concerning the particular issues for which we are
granting reconsideration by October 30, 2008, we will hold a public
hearing at 10 a.m. at EPA's Campus located at 109 T.W. Alexander Drive
in Research Triangle Park, NC, or an alternate site nearby on November
4, 2008. Persons interested in presenting oral testimony should contact
Ms. Joan C. Rogers, Natural Resources and Commerce Group (E143-03),
Sector Policies and Programs Division, EPA, Research Triangle Park, NC
27711, telephone number: (919) 541-4487, e-mail address:
rogers.joanc@epa.gov, by October 30, 2008. Persons interested in
attending the public hearing should also call Ms. Rogers to verify the
time, date, and location of the hearing. A public hearing will provide
interested parties the opportunity to present data, views, or arguments
concerning the proposed standards.
Outline. The information presented in this Preamble is organized as
follows:
I. Background
A. What is the statutory authority for regulating hazardous air
pollutants?
B. What is the Halogenated Solvent Cleaning rule?
C. What have we been asked to reconsider?
II. Proposed Response to the Petitions for Reconsideration
A. What is our proposed action?
B. What is the reason for our proposed action?
III. Discussion of Issues Subject to Reconsideration
A. Baseline Risk Assessment and Decision on Acceptable Risk
B. Decision on Ample Margin of Safety
C. Clean Air Act Section 112(d)(6) Review
D. Compliance Schedule
IV. Proposed Regulatory Text
V. Impacts
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
I. National Technology Transfer Advancement Act
J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
I. Background
A. What is the statutory authority for regulating hazardous air
pollutants?
Section 112 of the Clean Air Act (CAA) establishes a two-stage
regulatory process to address emissions of hazardous air pollutants
(HAP) from stationary sources. In the first stage,
[[Page 62386]]
after EPA has identified categories of sources emitting one or more of
the HAP listed in section 112(b) of the CAA, section 112(d) of the CAA
calls for us to promulgate NESHAP for those sources: ``Major sources''
are those that emit or have the potential to emit any single HAP at a
rate of 10 tons or more per year or 25 tons or more per year of any
combination of HAP. For major sources, the technology-based standards
must reflect the maximum degree of emission reductions of HAP
achievable (after considering cost, energy requirements, and non-air
quality health and environmental impacts) and are commonly referred to
as maximum achievable control technology (MACT) standards.
The MACT floor is the minimum control level allowed for NESHAP and
is defined under section 112(d)(3) of the CAA. For new sources, the
MACT floor cannot be less stringent than the emission control that is
achieved in practice by the best-controlled similar source. The MACT
standards for existing sources can be less stringent than standards for
new sources, but it cannot be less stringent than the average emission
limitation achieved by the best-performing 12 percent of existing
sources in the category or subcategory (or the best-performing five
sources for categories or subcategories with fewer than 30 sources). In
developing MACT standards, we must also consider control options that
are more stringent than the floor. We may establish standards more
stringent than the floor based on the consideration of the cost of
achieving the emission reductions, any non-air quality health and
environmental impacts, and energy requirements.
EPA is then required to review these technology-based standards and
to revise them ``as necessary (taking into account developments in
practices, processes, and control technologies)'' no less frequently
than every 8 years, under CAA section 112(d)(6). In this proposal, we
are publishing the results of our 8-year technology review for the
halogenated cleaning solvent source category.
The second stage in standard-setting focuses on reducing any
remaining ``residual'' risk according to CAA section 112(f). This
provision requires, first, that EPA prepare a Report to Congress
discussing (among other things) methods of calculating risk posed (or
potentially posed) by sources after implementation of the MACT
standards, the public health significance of those risks, the means and
costs of controlling them, actual health effects to persons in
proximity of emitting sources, and recommendations as to legislation
regarding such remaining risk. EPA prepared and submitted this report
(Residual Risk Report to Congress, EPA-453/R-99-001) in March 1999.
Congress did not act in response to the report, thereby triggering
EPA's obligation under CAA section 112(f)(2) to analyze and address
residual risk.
CAA section 112(f)(2) requires us to determine for source
categories subject to certain CAA section 112(d) standards whether the
emission limitations provide an ample margin of safety to protect
public health. If the MACT standards for HAP ``classified as a known,
probable, or possible human carcinogen do not reduce lifetime excess
cancer risks to the individual most exposed to emissions from a source
in the category or subcategory to less than 1-in-1 million,'' EPA must
promulgate residual risk standards for the source category (or
subcategory) as necessary to provide an ample margin of safety to
protect public health. EPA must also adopt more stringent standards, if
necessary, to prevent an adverse environmental effect,\1\ but must
consider cost, energy, safety, and other relevant factors in doing so.
In a residual risk rulemaking under section 112(f)(2), EPA may adopt
standards equal to the existing MACT standards (NRDC v. EPA, 529 F.3d
1077, 1083 (D.C. Cir. 2008).
---------------------------------------------------------------------------
\1\ ``Adverse environmental effect'' is defined in CAA Section
112(a)(7) as any significant and widespread adverse effect, which
may be reasonably anticipated to wildlife, aquatic life, or natural
resources, including adverse impacts on populations of endangered or
threatened species or significant degradation of environmental
quality over broad areas.
---------------------------------------------------------------------------
Section 112(f)(2) of the CAA expressly preserves our use of the
two-step process for developing standards to address residual risk and
our interpretation of ``ample margin of safety'' developed in the
National Emission Standards for Hazardous Air Pollutants: Benzene
Emissions from Maleic Anhydride Plants, Ethylbenzene/Styrene Plants,
Benzene Storage Vessels, Benzene Equipment Leaks, and Coke By-Product
Recovery Plants (Benzene NESHAP) (54 FR 38044, September 14, 1989). See
NRDC v. EPA, 529 F.3d 1077 D.C. Cir. 2008). The first step in the
residual risk process is the determination of acceptable risk. The
second step provides for an ample margin of safety to protect public
health, which is the level at which the standards are set (unless a
more stringent standard is required to prevent, taking into
consideration costs, energy, safety, and other relevant factors, an
adverse environmental effect).
The terms ``individual most exposed,'' ``acceptable level,'' and
``ample margin of safety'' are not specifically defined in the CAA.
However, CAA section 112(f)(2)(B) directs us to use the interpretation
set out in the Benzene NESHAP. See also, A Legislative History of the
Clean Air Act Amendments of 1990, volume 1, p. 877 (Senate debate on
Conference Report). We notified Congress in the Residual Risk Report to
Congress that we intended to use the Benzene NESHAP approach in making
CAA section 112(f) residual risk determinations (EPA-453/R-99-001, p.
ES-11).
In the Benzene NESHAP, we stated as an overall objective:
* * * in protecting public health with an ample margin of
safety, we strive to provide maximum feasible protection against
risks to health from hazardous air pollutants by (1) protecting the
greatest number of persons possible to an individual lifetime risk
level no higher than approximately 1-in-1 million; and (2) limiting
to no higher than approximately 1-in-10 thousand (i.e., 100-in-1
million) the estimated risk that a person living near a facility
would have if he or she were exposed to the maximum pollutant
concentrations for 70 years.
We also stated that, ``The EPA also considers incidence (the number
of persons estimated to suffer cancer or other serious health effects
as a result of exposure to a pollutant) to be an important measure of
the health risk to the exposed population. Incidence measures the
extent of health risk to the exposed population as a whole, by
providing an estimate of the occurrence of cancer or other serious
health effects in the exposed population.'' The EPA went on to conclude
that ``estimated incidence would be weighed along with other health
risk information in judging acceptability.'' As explained more fully in
our Residual Risk Report to Congress, EPA does not define ``rigid
line(s) of acceptability,'' but considers rather broad objectives to be
weighed with a series of other health measures and factors (EPA-453/R-
99-001, p. ES-11).
The determination of what represents an ``acceptable'' risk is
based on a judgment of ``what risks are acceptable in the world in
which we live'' (54 FR 38045, quoting the Vinyl Chloride decision at
824 F.2d 1165) recognizing that our world is not risk-free.
In the Benzene NESHAP, we stated that ``EPA will generally presume
that if the risk to (the maximum exposed) individual is no higher than
approximately 1-in-10 thousand, that risk level is considered
acceptable.'' We discussed the maximum individual lifetime cancer risk
as being ``the
[[Page 62387]]
estimated risk that a person living near a plant would have if he or
she were exposed to the maximum pollutant concentrations for 70
years.'' We explained that this measure of risk ``is an estimate of the
upperbound of risk based on conservative assumptions, such as
continuous exposure for 24 hours per day for 70 years.'' \2\ We
acknowledge that maximum individual lifetime cancer risk ``does not
necessarily reflect the true risk, but displays a health-protective
risk level which is an upper bound that is unlikely to be exceeded.''
\3\
---------------------------------------------------------------------------
\2\ Quoted text is from the Benzene NESHAP preamble, pages 38045
and 38046.
\3\ Quoted text is from the Benzene NESHAP preamble, pages 38045
and 38046.
---------------------------------------------------------------------------
Understanding that there are both benefits and limitations to using
maximum individual lifetime cancer risk as a metric for determining
acceptability, we acknowledged in the 1989 Benzene NESHAP that
``consideration of maximum individual risk * * * must take into account
the strengths and weaknesses of this measure of risk.'' \4\
Consequently, the presumptive risk level of 100-in-1 million (1-in-10
thousand) provides a benchmark for judging the acceptability of maximum
individual lifetime cancer risk, but does not constitute a rigid line
for making that determination.
---------------------------------------------------------------------------
\4\ Quoted text is from the Benzene NESHAP preamble, pages 38045
and 38046.
---------------------------------------------------------------------------
The EPA also explained in the 1989 Benzene NESHAP the following:
In establishing a presumption for MIR \5\, rather than rigid
line for acceptability, the Agency intends to weigh it with a series
of other health measures and factors. These include the overall
incidence of cancer or other serious health effects within the
exposed population, the numbers of persons exposed within each
individual lifetime risk range and associated incidence within,
typically, a 50 kilometer (km) exposure radius around facilities,
the science policy assumptions and estimation uncertainties
associated with the risk measures, weight of the scientific evidence
for human health effects, other quantified or unquantified health
effects, effects due to co-location of facilities, and co-emission
of pollutants.
---------------------------------------------------------------------------
\5\ MIR is the maximum individual cancer risk.
In some cases, these health measures and factors taken together may
provide a more realistic description of the magnitude of risk in the
exposed population than that provided by maximum individual lifetime
cancer risk alone.
As explained in the Benzene NESHAP, ``(e)ven though the risks
judged ``acceptable'' by EPA in the first step of the Vinyl Chloride
inquiry are already low, the second step of the inquiry, determining an
``ample margin of safety,'' again includes consideration of all of the
health factors, and whether to reduce the risks even further. In the
second step, EPA strives to provide protection to the greatest number
of persons possible to an individual lifetime risk level no higher than
approximately 1 in 1 million. In the ample margin decision, the EPA
again considers all of the health risk and other health information
considered in the first step. Beyond that information, additional
factors relating to the appropriate level of control will also be
considered, including costs and economic impacts of controls,
technological feasibility, uncertainties, and any other relevant
factors. Considering all of these factors, the EPA will establish the
standard at a level that provides an ample margin of safety to protect
the public health, as required by section 112.''
B. What is the Halogenated Solvent Cleaning rule?
On December 2, 1994, we promulgated national emission standards for
halogenated solvent cleaning machines \6\ (59 FR 61801, December 2,
1994) (1994 NESHAP), to control emissions of the halogenated solvents
MC, PCE, TCE, 1,1,1,-trichloroethane (TCA), carbon tetrachloride,
chloroform, and halogenated solvent blends or their vapors from
halogenated solvent cleaning machines, pursuant to Section 112(d) of
the CAA. The standards, which can be found in 40 CFR Subpart T, include
multiple alternatives that allow maximum compliance flexibility. The
final rule is available in the docket for this rulemaking. It can also
be accessed at: https://www.epa.gov/ttn/atw/degrea/halopg.html.
---------------------------------------------------------------------------
\6\ Halogenated solvent cleaning does not constitute a distinct
industrial category, but is an integral part of many major
industries. The five 3-digit NAICS Codes that use the largest
quantities of halogenated solvents for cleaning are NAICS 337
(furniture and related products manufacturing), NAICS 332
(fabricated metal manufacturing), NAICS 335 (electrical equipment,
appliance, and component manufacturing), NAICS 336 (transportation
equipment manufacturing), and NAICS 339 (miscellaneous
manufacturing). Additional industries that use halogenated solvents
for cleaning include NAICS 331 (primary metals), NAICS 333
(machinery), and NAICS 334 (electronic equipment manufacturing).
Non-manufacturing industries such as railroad (NAICS 482), bus
(NAICS 485), aircraft (NAICS 481), and truck (NAICS 484) maintenance
facilities; automotive and electric tool repair shops (NAICS 811);
and automobile dealers (NAICS 411) also use halogenated solvent
cleaning machines.
---------------------------------------------------------------------------
Carbon tetrachloride and chloroform are no longer used in this
source category. The Montreal Protocol, a multi-national treaty signed
on September 16, 1987, phased out the production and use of these
chlorofluorocarbons by January 1, 1996. The Montreal Protocol also
phased out the production and use of TCA. Although production and use
of TCA has been phased out since 1998, an exemption to the phase-out
allows facilities with essential products or activities to continue
their use of TCA, and facilities with non-essential activities or
products to continue the use of their remaining TCA stockpiles until
depleted. A declining quantity of TCA continued to be used until 2002,
when all production of TCA ceased, and eventually, facilities used TCA
stockpiles until depleted. Since January 1, 2002, TCA has not been
manufactured for domestic use in the United States.
Halogenated solvent cleaning machines use MC, PCE, TCE and TCA to
remove soils such as grease, oils, waxes, carbon deposits, fluxes, and
tars from metal, plastic, fiberglass, printed circuit boards, and other
surfaces. Halogenated solvent cleaning is typically performed prior to
processes such as painting, plating, inspection, repair, assembly, heat
treatment, and machining. Types of halogenated solvent cleaning
machines include, but are not limited to, batch vapor, in-line vapor,
in-line cold, and batch cold solvent cleaning machines. Buckets, pails,
and beakers with capacities of 7.6 liters (2 gallons) or less are not
considered halogenated solvent cleaning machines.
In May 2007, we promulgated the Halogenated Solvent Cleaning rule
(72 FR 25138), which established revised standards that further limit
emissions of MC, TCE and PCE from facilities engaged in halogenated
solvent cleaning, pursuant to CAA section 112(f). Specifically, we
promulgated a facility-wide emission limit of 60,000 kilograms per year
(kg/yr) MC equivalent \7\ that applied to all halogenated solvent
cleaning machines with the exception of halogenated solvent cleaning
machines used by the following industries: Facilities that manufacture
narrow tubing, facilities that use continuous web cleaning machines,
aerospace manufacturing and maintenance facilities, and military
maintenance and depot facilities. We also promulgated a facility-wide
emission limit of 100,000 kg/yr MC
[[Page 62388]]
equivalent for halogenated solvent cleaning machines used at military
maintenance and depot facilities. We required existing facilities to
comply with the revised standards by May 3, 2010, which is three years
after the effective date of the Halogenated Solvent Cleaning rule.
Further, with regard to halogenated solvent cleaning machines used by
facilities that manufacture narrow tubing, facilities that use
continuous web cleaning machines, and aerospace manufacturing and
maintenance facilities we found, after considering risks, associated
compliance costs and the availability of control measures, that the
1994 NESHAP reduces risk to acceptable levels, provides an ample margin
of safety to protect public health, and prevents adverse environmental
effects. We also reviewed the 1994 NESHAP as required by CAA section
112(d)(6).
---------------------------------------------------------------------------
\7\ All emission limits and emission rates in the assessments
were converted to MC equivalents based on the relative cancer
potency of the HAP emitted. The cancer potency-weighted MC
equivalent emission rate was calculated as the estimated emissions
for the HAP in kg/yr or lb/yr times the unit risk estimate (URE) for
the HAP divided by the URE for MC.
---------------------------------------------------------------------------
C. What have we been asked to reconsider?
Following promulgation of the Halogenated Solvent Cleaning rule,
the Administrator received several petitions \8\ for reconsideration
(Petitions), under CAA section 307(d)(7)(B). Generally, petitioners
claimed that the Halogenated Solvent Cleaning rule contained legal
interpretations and information that are of central relevance to the
final rule that were not sufficiently reflected at proposal, and that
they, therefore, did not have adequate opportunity to provide input
during the designated public comment period. Further, petitioners
claimed that additional information on compliance measures had become
available since the close of the public comment period for the
Halogenated Solvent Cleaning rule, and that this new information is
also of central relevance to the Halogenated Solvent Cleaning rule.
---------------------------------------------------------------------------
\8\ These petitions for reconsideration were filed by the
Commonwealth of Pennsylvania Department of Environmental Protection,
Natural Resources Defense Council, Citizens for Pennsylvania's
Future and Sierra Club, several State and federal legislators and
the Governor of the Commonwealth of Pennsylvania (petitioners).
---------------------------------------------------------------------------
On August 15, 2007, EPA informed petitioners of its intent to
initiate notice and comment rulemaking to address the Petitions. We
also informed petitioners that the particular issues for
reconsideration and the specifics of the reconsideration process would
be addressed in a forthcoming Federal Register notice. Additionally, we
denied the request to stay the effectiveness of the Halogenated Solvent
Cleaning rule pending completion of the reconsideration proceedings.
(These letters are in the docket for this rulemaking.)
Finally, petitioners challenged the Halogenated Solvent Cleaning
rule in the Court of Appeals for the District of Columbia Circuit.\9\
Because we intended to initiate notice and comment rulemaking to
address the Petitions, the Court has granted our request to hold the
litigation in abeyance. The Court has directed the parties to the
litigation to file Motions to Govern Further Proceedings by November 3,
2008.
---------------------------------------------------------------------------
\9\ Commonwealth of Pennsylvania Department of Environmental
Protection v. EPA, No. 07-1129 (D.C. Cir.); Citizens for
Pennsylvania's Future and Sierra Club v. EPA, No. 07-1255 (D.C.
Cir.); Natural Resources Defense Council v. EPA, No. 07-1256 (D.C.
Cir.). These cases have since been consolidated.
---------------------------------------------------------------------------
II. Proposed Response to the Petitions for Reconsideration
A. What is our proposed action?
In this action, we are proposing to find that the risk associated
with the 1994 NESHAP for the halogenated solvent cleaning source
category is acceptable within the meaning of Section 112(f). We are
also proposing various regulatory options that would provide an ample
margin of safety to protect public health and prevent adverse
environmental effects. These proposed requirements would apply to
owners and operators of halogenated solvent cleaning machines that are
subject to the 1994 NESHAP. We are proposing these requirements under
both CAA sections 112(d)(6) and 112(f)(2). For existing sources that
were not subject to the emission reduction requirements in the
Halogenated Solvent Cleaning rule,\10\ we are proposing a 2-year
compliance deadline from the date of publication of the final rule in
the Federal Register. As to those sources that were subject to emission
reduction requirements in the Halogenated Solvent Cleaning rule,\11\ if
the final rule on reconsideration changes those requirements and makes
them more stringent, we propose that these sources have two years from
the date of publication of the final rule to comply with the
requirements of the final rule. We believe that such an extension is
appropriate to allow the affected facilities time to meet the more
stringent emission limitations.
---------------------------------------------------------------------------
\10\ These sources include halogenated solvent cleaning machines
used by facilities that manufacture narrow tubing, facilities that
manufacture specialized products requiring continuous web cleaning
machines, and aerospace manufacturing and maintenance facilities.
\11\ These sources include halogenated solvent cleaning machines
at military maintenance and depot facilities and the general
population of halogenated solvent cleaning machines. The general
population of halogenated solvent cleaning machines includes all
halogenated solvent cleaning machines, except those machines used by
facilities that manufacture narrow tubing, facilities that
manufacture specialized products requiring continuous web cleaning,
aerospace manufacturing and maintenance facilities, and military
maintenance and depot facilities.
---------------------------------------------------------------------------
We are seeking public comment on all aspects of this proposed
reconsideration rule. As noted above, the issues identified below are
the ones for which we are granting reconsideration. We will convey our
decision as to any other issues raised in the reconsideration petitions
no later than the date by which we take final action on the issues
discussed in this action.
B. What is the reason for our proposed action?
On August 17, 2006, pursuant to CAA section 112(f), we proposed
revised standards (71 FR 47670, August 17, 2006) (August 2006 Proposal)
to further limit emissions of MC, TCE and PCE from facilities engaged
in halogenated solvent cleaning. We co-proposed emission limits of
25,000 kg/yr MC equivalent and 40,000 kg/yr MC equivalent to provide an
ample margin of safety to protect public health and prevent adverse
environmental effects. The August 2006 proposal also identified other
levels of emission reductions, including the 60,000 and 100,000 kg/yr
MC equivalent levels. 71 FR 47680-81. We indicated that we expected to
finalize one of the two co-proposed options, and that the standards
finalized would apply to the entire source category in addition to the
1994 NESHAP requirements. We also proposed a compliance deadline for
existing sources of two years after the effective date of the final
rule.
Industry, States, solvent manufacturers, industry trade
associations and district air associations submitted comments in
response to our August 2006 proposal. Industry's comments were
primarily submitted by the aerospace manufacturing and maintenance
industry, the narrow tubing manufacturing industry, facilities that use
continuous web cleaning machines, and military maintenance and depot
facilities. Comments focused on associated compliance costs, technical
feasibility, and the proposed compliance deadline. In response to these
comments, we issued a Notice of Data Availability (NODA), on December
14, 2006 (71 FR 75182), requesting specific information on compliance
costs, technical feasibility, and compliance deadlines as they related
to halogenated solvent machines used by the above-referenced
industries. Responses to the NODA provided significant data and
information that led
[[Page 62389]]
EPA to re-evaluate the data and assumptions used to estimate risks,
costs and technical feasibility of compliance with the co-proposed
emission limits.
In the Halogenated Solvent Cleaning rule, we presented our re-
evaluation of risks, costs and technical feasibility of compliance with
the co-proposed emission limits. As a result of our re-evaluation, we
promulgated a facility-wide emission limit of 60,000 kg/yr MC
equivalent for all halogenated solvent cleaning machines with the
exception of halogenated solvent cleaning machines used by facilities
that manufacture narrow tubing, facilities that use continuous web
cleaning machines, aerospace manufacturing and maintenance facilities,
and military maintenance and depot facilities. We determined that this
emission limit would provide an ample margin of safety to protect
health and prevent adverse environmental effects. For all halogenated
solvent cleaning machines used at military maintenance and depot
facilities, we promulgated a facility-wide emission limit of 100,000
kg/yr MC equivalent that would provide an ample margin of safety to
protect health and prevent adverse environmental effects. We also set a
compliance deadline of three years from the effective date of the
Halogenated Solvent Cleaning rule. Finally, with regard to facilities
that use continuous web cleaning machines and halogenated solvent
cleaning machines used by facilities that manufacture narrow tubing and
aerospace manufacturing and maintenance facilities, we found that the
current level of control required by the 1994 NESHAP reduces HAP
emissions to levels that provide an ample margin of safety to protect
public health and prevent any adverse environmental effects.
As noted earlier above, following promulgation of the Halogenated
Solvent Cleaning rule, the Administrator received several petitions for
reconsideration, under CAA Section 307(d)(7)(B). In general,
petitioners alleged that the following issues appeared for the first
time in the Halogenated Solvent Cleaning rule, making it impracticable
to raise objections during the period provided for public comment: The
60,000 kg/yr MC equivalent limit for the general population of
halogenated solvent cleaning machines; the 100,000 kg/yr MC equivalent
limit for halogenated solvent cleaning machines used by military
maintenance and depot facilities; EPA's decision to use in support of
its risk assessment, data from the 2002 National Emissions Inventory
(NEI) as opposed to data from the 1999 NEI; EPA's conclusion that the
1994 NESHAP reduces risk to acceptable levels and provides an ample
margin of safety to protect public health for aerospace manufacturing
and maintenance facilities, facilities that manufacture narrow tubing,
and facilities that use continuous web cleaning machines; EPA's
technical feasibility and cost analyses in the final rule; and the 3-
year compliance period for existing sources.
Petitioners also provided information on technical feasibility that
was not otherwise available to EPA at the time of promulgation of the
Halogenated Solvent Cleaning rule. That information shows certain
facilities that manufacture narrow tubing either taking steps or
planning to take steps to reduce HAP emissions at their facilities.
This information is discussed in greater detail below.
In response to the petitions, we are reconsidering various issues,
and those issues are described in detail below.
III. Discussion of Issues Subject to Reconsideration
A. Baseline Risk Assessment and Decision on Acceptable Risk
In addition to the general issues raised above, petitioners raised
several specific issues relating to the baseline risk assessment and
EPA's decision on acceptable risk.
Before discussing the issues on which we are granting
reconsideration, we would like to clarify a misunderstanding that was
revealed to us in the Petitions. Specifically, certain petitioners
contend that by removing facilities that use continuous web cleaning
machines, and halogenated solvent cleaning machines used by facilities
that manufacture narrow tubing, aerospace manufacturing and
maintenance, and military maintenance and depot facilities in the risk
assessments for the Halogenated Solvent Cleaning rule, we failed to
consider the health risks from the entire source category and thus,
that the Halogenated Solvent Cleaning rule deviated from the Benzene
NESHAP (54 FR 38044, September 14, 1989) framework and CAA Section
112(f)(2)(B). Petitioners also contend that the risks associated with
the source category are ``gross underestimates of actual risks''
because of our removal of this subset of sources. One petitioner
asserts that because the risk assessment at proposal showed the
baseline maximum individual risk (MIR) as 200-in-1 million with 0.40
annual cancer incidences, as compared to 100-in-1 million and 0.55
annual cancer incidences presented in the Halogenated Solvent Cleaning
rule, the resulting 38 percent increased cancer incidence was not
subject to public comment. The petitioner further contends that cancer
risks would have increased beyond 38 percent but for the exemptions of
certain halogenated solvent cleaning machines that had a further effect
of removing the Collegeville, PA, population from the population risk
distribution.
However, contrary to petitioners understanding, we performed a risk
assessment for the entire halogenated solvent cleaning machines source
category both for the August 2006 Proposal (71 FR 47670) and for the
Halogenated Solvent Cleaning rule (72 FR 25138). Our re-evaluation of
risks involved the re-assessment of the risks for the entire category
using both the 1999 and the 2002 NEI inventory (discussed in greater
detail, below), which was not available at the time of the August 2006
Proposal, but was available for the Halogenated Solvent Cleaning rule.
The preamble and risk assessment also provided separate analyses for
each of the industry sectors (facilities that manufacture narrow
tubing, aerospace manufacturing and maintenance, military maintenance
and depots, facilities that use continuous web cleaning machines) and
the subset of remaining facilities not included in one of these four
sectors that make up the halogenated solvent cleaning source category.
This approach allowed us to compare the risk contribution of each
sector to the overall risks presented by the facilities in the
halogenated solvent source category. In this way, we were able to show
the contribution of each sector's risk to the risk from the entire
category. Therefore, contrary to petitioners' allegations, our re-
analyses of the risks in the Halogenated Solvent Cleaning rule did not
exclude a subset of the halogenated solvent cleaning machines source
category and therefore, did not understate or fail to consider a
portion of the risks associated with the entire source category.
With regard to the issues on which EPA is granting reconsideration,
one petitioner states that we failed to consider the risk assessment
prepared by the Commonwealth of Pennsylvania Department of
Environmental Protection (PADEP),\12\ and that our maximum
[[Page 62390]]
individual cancer risk level of 70-in-1 million associated with the
narrow tubing industry was erroneous given the associated risks of 160-
in-1 million indicated by PADEP's risk assessment. Another petitioner
contends that the certain assumptions underlying EPA's risk assessment
for the Halogenated Solvent Cleaning rule are erroneous. In support of
its position, the petitioner cites EPA's use of census block centroids
to predict MIR. The petitioner argues that EPA should have estimated
risk at the nearest residence and that EPA's census block approach may
have resulted in an underprediction of risk.
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\12\ In addition to raising the PADEP risk assessment in their
Petitions, Petitioners identified certain other documents dated
after the close of the public comment period, which they argue are
of central relevance to the Halogenated Solvent Cleaning rule. If
the Petitioners believe that these documents are relevant to the
issues on which we are granting reconsideration in this rule, we
invite petitioners to submit the documents to EPA during the public
comment period. We will consider such documents at the same time we
consider all significant comments received during the comment period
for this action.
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We reviewed the risk assessment prepared by the PADEP, and we
disagree with their conclusion that our estimated MIR risk level
associated with the narrow tubing industry is erroneous. The PADEP risk
assessment was based on ambient monitoring data collected in 2004.
(PADEP continues to collect ambient data on TCE in the Collegeville,
PA, area.) From 2004 to 2007, the annual average TCE concentrations
measured over the 4 years ranged from 0.6 micrograms per cubic meter
([mu]g/m\3\) to 1.5 [mu]g/m\3\ (avg. = 0.9 [mu]g/m\3\) at the
Evansberg, PA site and 1.2 [mu]g/m\3\ to 1.3 [mu]g/m\3\ (avg. = 1.3
[mu]g/m\3\) at the Trappe, PA, site. We extended our risk assessment,
which was based on dispersion modeling of TCE emissions from the two
Collegeville, PA, halogenated solvent cleaning facilities in the 2002
NEI emissions inventory, to estimate TCE concentrations of 0.8 [mu]g/
m\3\ and 1.4 [mu]g/m\3\ at the Evansberg and Trappe monitoring sites,
respectively. Thus, from an ambient air concentration perspective, the
two risk assessments are consistent. The risk assessments differ,
however, because TCE exposures were assessed using different cancer
unit risk estimates (URE) for TCE. Following the long-established EPA
policy, we used the California EPA (CalEPA) inhalation URE for TCE. In
contrast, PADEP used a unit risk value for TCE developed by EPA in a
draft report issued in 2001. That draft report was subjected to peer
review by the EPA's Science Advisory Board, and the Board raised
several important issues. As a result of the Science Advisory Board's
input on the draft report, EPA asked the National Academy of Sciences
(NAS) to examine issues critical to developing an objective, realistic,
and scientifically-based health assessment of TCE. The NAS released
their report in 2006, providing EPA further insight as they develop a
revised health risk assessment for TCE. EPA never finalized the 2001
draft report because of the significant issues raised by the Science
Advisory Board and NAS. Thus, PADEP's use of EPA's draft 2001 TCE risk
assessment neither satisfies the basic requirements of our peer review
policy, nor is the draft 2001 TCE risk assessment currently endorsed by
the EPA's Office of Research and Development.
In addition, PADEP used an oral cancer slope value from the draft
TCE document instead of the inhalation value derived in that document,
and extrapolated the oral cancer slope factor for use in their
inhalation risk assessment. Use of such an extrapolation is considered
substantially inferior to use of values developed directly from
inhalation data. PADEP's use of the draft extrapolated URE in their
assessment resulted in the estimation of a maximum individual cancer
risk of 160-in-1 million at the Trappe site, a risk which is
approximately 50 times higher than what the EPA risk assessment
indicates for that location. Thus, while both risk assessments are
consistent with respect to the estimates of ambient TCE concentrations
around these monitoring sites, there is a significant difference in the
estimation of individual cancer risk. The difference results from PADEP
using a cancer potency value that would not be considered acceptable
under EPA's Information Quality Guidelines because it did not withstand
a rigorous scientific peer review.
Several petitioners stated that the EPA's decision to use available
data from the 2002 NEI, instead of data from the 1999 NEI as proposed,
appeared for the first time in the Halogenated Solvent Cleaning rule,
making it impracticable to raise objections during the period provided
for public comment.
Based on public comments on our August 2006 Proposal, our risk
assessment for the entire source category that was presented in the
Halogenated Solvent Cleaning rule used the 2002 NEI database instead of
the 1999 NEI database as presented at proposal. The 2002 NEI database
was unavailable at proposal. Further, since receipt of the petitions,
we have conducted additional risk assessments using facility emissions
from both the 1999 and 2002 NEI, explicitly assessing the risks
separately for each of the industry sectors identified above at various
levels of control, similar to our August 2006 Proposal and the
Halogenated Solvent Cleaning rule. In this way, we have been able to
show the contribution of each sector's risk to the risk from the entire
source category. The 1999 NEI contains information for 1,167
halogenated solvent cleaning facilities, out of which 743 emit
carcinogenic HAP. The 2002 NEI contains information for 1,080
halogenated solvent cleaning facilities, out of which 734 emit
carcinogenic HAP. Considering the uncertainties associated with the
development of emission inventories, we consider neither the 1999 nor
the 2002 NEI to be accurate in an absolute sense. Rather, we consider
them to be our best estimates of annual snapshots of emissions for this
source category. For each base year risk assessment, we scale-up the
modeled results to reflect what we believe to be the true number of
facilities in the source category, approximately 1,900. Given our
knowledge of the NEI database and as a result of meetings with industry
we believe that 1,900 is a better estimate of the number of sources in
the source category.
To develop an estimate of facilities currently operating, EPA asked
State and EPA regional source category contacts for estimates of the
number of cleaning machines in their jurisdictions. As a result of that
effort, EPA concluded that there were 3,821 halogenated solvent
cleaning machines nationwide. EPA also determined that there was on
average about two machines per facility, therefore, EPA estimated a
total of 1,932 solvent cleaning facilities currently existing
nationwide. Therefore, for the development of this rule, the number of
sources in this source category was assumed to be about 3,800 cleaning
machines located at 1,900 facilities nationwide. This estimate is based
on information collected by EPA in 1998 and in 2005. If the scale-up
had not been implemented the cost and HI results would be reduced by 56
percent (given that the scale-up factor is 1.76) relative to the number
of facilities and may not truly represent the affected universe. We
request comment on the use of the scale-up to accurately represent the
universe of sources.
In addition, the Johnson and Capel (1992) population mobility
model,\13\ used to develop the population risk distribution for the
Halogenated Solvent Cleaning rule, was updated subsequent to
promulgation of that rule. The updated model reflects the use of more
recent Surveys of Income and Program
[[Page 62391]]
Participation (SIPP) data and a newer, more complete modeling approach.
The new model randomly selects subjects from the U.S. Census Bureau's
American Community Survey database,\14\ and estimates time already
spent in the residence, future time to be spent in the residence, and
future length of life. These estimates are then combined to predict the
total time, past and future, that the subject would occupy the current
residence. Results are then compared with SIPP residence time data and
adjusted to compensate for ``residential inertia'' (i.e., a tendency in
the SIPP data for long-term residents to have lower-than-expected move
rates). As a result of this update to the modeling approach, the
baseline population risk estimates in this preamble differ somewhat
from those presented in the Halogenated Solvent Cleaning rule. This
preamble (section III) presents risk estimates based on the 2002 NEI.
We believe the 2002 NEI is likely to provide more accurate estimates of
current emissions from the source category (compared to the 1999 NEI),
reflecting known decreases in solvent demand and use.
---------------------------------------------------------------------------
\13\ Ted Johnson and Jim Capel. 1992. A Monte Carlo Approach to
Simulating Residential Occupancy Periods and Its Application to the
General U.S. Population, EPA-450/3-92-011, U.S. Environmental
Protection Agency, Research Triangle Park, N.C. (This information
has been placed in the docket for this rule).
\14\ U.S. Census Bureau, 2007. American Community Survey.
Available online at https://www.census.gov/acs/www/.
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Since promulgation of the Halogenated Solvent Cleaning rule, we
have also become aware of a newer assessment for non-cancer effects of
TCE developed by the New York State Department of Health (NYS DOH). The
NYS DOH states that their ``air criterion,'' is ``essentially
equivalent to an United States Environmental Protection Agency's (US
EPA, 2002a) reference concentration (RfC) * * * or an Agency for Toxic
Substances and Disease Registry's (ATSDR, 1996) chronic minimal risk
level (MRL) * * * .'' \15\ In addition to evaluating a number of
studies which look at numerous different toxicological endpoints, the
NYS DOH air criterion relies on a 1993 study which evaluated clinical
neurological effects (as measured by coordination tests) in 99 Danish
workers. For 70 of these workers, the dominant exposure was TCE, while
for 25 of the workers the dominant exposure was to CFC 113. Air
exposures were extrapolated from measurements of the urinary metabolite
TCA. Limitations of this study include some uncertainty about the
actual long-term exposure levels of the workers to TCE during their
employment, and that 25 of the 99 subjects were exposed primarily to
CFC 113. The NYS DOH assessment is limited by gaps in the data on
developmental effects and immunotoxicity, and concerns about adequacy
of methods for evaluating health risks to children (limitations it
shares with the CalEPA assessment). The results of the scientific
review are described in the NYS DOH toxicological review document.\16\
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\15\ New York State Department of Health, Trichloroethene Air
Criteria Document, October 2006, page 1, https://
www.health.state.ny.us/environmental/chemicals/trichloroethene/docs/
cd_tce.pdf.
\16\ NYS DOH toxicological review document. https://
www.health.state.ny.us/environmental/chemicals/trichloroethene/docs/
cd_tce.pdf.
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The CalEPA inhalation reference exposure level (REL) \17\ used in
the risk assessment for this proposal and our previous assessment was
based on a 1973 study of 19 workers who experienced symptoms of
drowsiness, fatigue, headache, and eye irritation. CalEPA identified
the use of human exposure data from workers exposed over a period of
years as a strength of the REL. The lack of reproductive and
developmental toxicity studies and the lack of a no effect level were
identified as major areas of uncertainty. Both CalEPA and NYS DOH had
an external peer review process and allowed for public comment before
finalizing their respective assessments. The NYS DOH assessment was
finalized in 2006 and the CalEPA assessment was finalized in 2000.
---------------------------------------------------------------------------
\17\ California EPA, 1999. Chronic toxicity summary:
Trichloroethylene. Office of Environmental Health Hazard Assessment.
https://www.oehha.ca.gov/air/chronic_rels/pdf/79016.pdf.
---------------------------------------------------------------------------
Non-cancer risk results were derived using the NYS DOH TCE air
criterion as well as using the CalEPA value in the additional risk
assessments completed since promulgation of the Halogenated Solvent
Cleaning rule. The results of our additional risk assessments are
summarized in section III of this preamble and the complete
documentation is available in the docket for this rulemaking. In this
action, we are providing this additional risk analysis and are
soliciting comment on it, including comments on the use of the NYS DOH
air criterion. We note that we received no comments recommending use of
the NYS DOH TCE air criterion either in comment on the proposed rule,
in comment on the NODA, or in any of the petitions for reconsideration
submitted to the EPA.
The additional risk assessment conducted in support of this
proposal reaffirms our baseline risk analysis that was presented in the
Halogenated Solvent Cleaning rule. The results are summarized in Table
1, below. Specifically, the analysis confirms that: (1) The baseline
MIR for the entire source category is approximately 100-in-1 million
and (2) the total cancer incidence associated with the source category
is approximately 0.55 cases per year. The updated population risk
distribution at baseline emission levels shows that 100 people are
exposed to risk levels at or above 100-in-1 million, 82,000 people are
estimated to have risks between 10-in-1 million and 100-in-1 million,
and 8,000,000 people are estimated to have risks between 1-in-1 million
and 10-in-1 million. These values can be compared to the baseline risk
estimates that we presented in the Halogenated Solvent Cleaning rule,
i.e., about 25 people exposed to risks at or above 100-in-1 million,
about 22,000 people at estimated risks between 10-in-1 million and 100-
in-1 million risk level, and about 4,000,000 people at estimated risks
between 1-in-1 million and 10-in-1 million.
Additionally, in our previous risk assessment for the Halogenated
Solvent Cleaning rule, the maximum hazard index (HI) was 0.2 (this HI
is associated with the compound TCA), and there were no facilities with
a HI greater than 1. However, if we were to use the NYS DOH air
criterion for TCE mentioned above, rather than the CalEPA REL and apply
the national scaling factor \18\ we estimate that there are ten
facilities with HI greater than 1 and a maximum HI of 7. A chronic HI
less than or equal to 1 indicated that there is no appreciable risk of
adverse effects. Although, a chronic HI greater than 1 raises concern
over potential toxicity, the numerical magnitude of the HI must be
interpreted in the context of the supporting information. Thus, we
examined these ten HI values greater than 1 in the context of
uncertainties and additional supporting information. In the risk
assessment document used to support the August 2006 proposal, we stated
that the approach used then (and in all subsequent risk analyses for
this source category) was a reasonable one which was more likely to
over-predict risks than under-predict them. When we consider the
distribution of the population at different HI levels, we see that out
of a total exposed population of approximately 6 million people living
around the ten facilities, only 2,000 people are estimated to be
exposed to concentrations whose HI values exceed 1. Further, when the
underlying information for the NY value is considered, we see that the
NYS DOH air criterion incorporates a significant
[[Page 62392]]
degree of health protection in its use of a composite uncertainty
factor of 1000. The range of maximum HI values (0.2 to 7) resulting
from consideration of reference values from both CalEPA and NYS DOH is
indicative of the range of uncertainty in the toxicity estimates for
TCE. When the