[Federal Register Volume 73, Number 203 (Monday, October 20, 2008)]
[Proposed Rules]
[Pages 62384-62408]
From the Federal Register Online via the Government Publishing 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:
http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
E-mail: [email protected].
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
http://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 http://www.regulations.gov or e-mail. The http://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 http://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 http://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 http://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: [email protected]. 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: [email protected]. 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: [email protected].
SUPPLEMENTARY INFORMATION: Regulated Entities. Categories and entities
potentially affected by this notice include:
[[Page 62385]]
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Examples of
Category NAICS \1\ code potentially
regulated entities
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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.
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\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 http://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: http://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 http://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:
[email protected], 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).
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\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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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\
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\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.
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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.
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\4\ Quoted text is from the Benzene NESHAP preamble, pages 38045
and 38046.
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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.
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\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: http://www.epa.gov/ttn/atw/degrea/halopg.html.
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\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.
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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).
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\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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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.
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\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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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.
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\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.
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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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 http://www.census.gov/acs/www/.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\15\ New York State Department of Health, Trichloroethene Air
Criteria Document, October 2006, page 1, http://www.health.state.ny.us/environmental/chemicals/trichloroethene/docs/cd_tce.pdf.
\16\ NYS DOH toxicological review document. http://www.health.state.ny.us/environmental/chemicals/trichloroethene/docs/cd_tce.pdf.
---------------------------------------------------------------------------
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.
http://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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
Cancer risk results control
------------------------------------------------------------------------
Estimated maximum individual lifetime cancer risk (per 100
million) \1\.........................................
Estimated annual cancer incidence \2\................. 0.55
------------------------------------------------------------------------
Estimated lifetime cancer risk (per million) persons
------------------------------------------------------------------------
100
>= 10 to < 100........................................ 82,000
>= 1 to < 10.......................................... 8,000,000
Total Pop >= 1........................................ 8,082,100
-----------------
Total Population Living within 50 km of any 200,000,000
Halogenated Solvent Cleaner......................
------------------------------------------------------------------------
Estimated lifetime cancer risk (per million) facilities
------------------------------------------------------------------------
9
>= 10 to < 100........................................ 86
>= 1 to < 10.......................................... 394
< 1 (only carcinogen emitters)........................ 802
< 1 (including sources emitting non-carcinogens) \3\.. 1,411
-----------------
Estimated total number of facilities \4\.......... 1,900
------------------------------------------------------------------------
\1\ Estimated maximum individual lifetime cancer risks are rounded to
one significant figure.
\2\ Estimated annual cancer incidence and population counts have been
rounded to two or three significant figures where appropriate.
\3\ Includes 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).
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.
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.
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-in-1 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
[[Page 62393]]
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 cost-effectiveness 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 cost-effectiveness 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 cost-effectiveness 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. 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,
cost-effectiveness, incremental cost-effectiveness, or net benefits.
Indeed, with regard to the consideration of cost-effectiveness and
incremental cost-effectiveness, 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,
cost-effectiveness and incremental cost-effectiveness 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 cost-effectiveness 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 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 cost-effectiveness 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 cost-effectiveness 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
[[Page 62394]]
accordance with the framework established in the Benzene NESHAP. With
regard to comparing cost or cost-effectiveness 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' cost-effectiveness 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 category-specific 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)
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 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).
---------------------------------------------------------------------------
\19\ Escalation in costs is calculated using the CPI-U (ftp://ftp.bls.gov/pub/special.requests/cpi/cpiai.txt).
---------------------------------------------------------------------------
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 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 standard-setting 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 statutorily-mandated
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
[[Page 62395]]
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 sector-specific 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 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 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 re-examined 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
[[Page 62396]]
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 re-evaluation 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 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 3-year 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
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 non-HAP, nPB. One of these two facilities also
indicated an ability to achieve eight
[[Page 62397]]
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.
---------------------------------------------------------------------------
\20\ 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.
---------------------------------------------------------------------------
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 2-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 co-proposed 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 facilities
indicated was not possible--and include:
Installing CAD and vacuum-to-vacuum 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
[[Page 62398]]
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 co-proposed 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 non-HAP 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 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 re-evaluated 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 aerospace manufacturing and
maintenance facilities.
iii. Continuous Web Cleaning Machines \21\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Petitioners also allege that the EPA failed to provide any
explanation as to why several alternative reduction measures, such as
either vacuum-to-vacuum 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
[[Page 62399]]
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 3-year 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 re-evaluation and our belief that a
relative reduction limit is more suitable than an 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 re-evaluated 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 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 non-cancer air criterion developed by the NYS DOH
was used to characterize non-cancer 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.
[[Page 62400]]
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 organ-specific 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 Option 1 Option 2 Option 3
----------------------------------------------------------------------------------------------------------------
MIR (in-1 million).............................. 100 ~50 ~50 ~50
>100 in-1 million *............................. 100 0 0 0
>=10 to <100 in-1 million *..................... 82,000 7,500 6,600 5,700
>=1 to <10 in-1 million *....................... 8,000,000 2,100,000 2,087,500 1,946,500
Emissions Reduced (tons/yr)..................... 0 1,681 2,601 3,188
Emissions Remaining (tons/yr)................... 4,200 2,535 1,615 1,028
Maximum Non-cancer HI........................... 0.2-7.0 0.2-2.0 0.05-1.0 0.05-1.0
Cancer Incidence (cases/yr)..................... 0.55 0.36 0.35 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
Industry group Emission limit incidence after control Cases avoided/ Tons reduced
(cases/yr) (cases/yr) year
----------------------------------------------------------------------------------------------------------------
General Degreaser Population 60,000 kg/yr.... 0.45 0.26 0.19 1,592
(not in any other sector).
Narrow Tubing Manufacturing... 60,000 kg/yr.... 0.02 0.007 0.013 920
Continuous Web Cleaning 80 percent 0.03 0.02 0.01 263
Machines (>60,000 kg/yr). overall control
efficiency.
Aerospace Manufacturing and 100,000 kg/yr... 0.05 0.03 0.02 324
Maintenance.
Military maintenance and depot 100,000 kg/yr... 0.0003 0.0001 0.0002 89
----------------------------------------------------------------------------------------------------------------
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 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 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.
[[Page 62401]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 worst-case 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 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-to-vacuum 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 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
add-on 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
[[Page 62402]]
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 2 3
----------------------------------------------------------------------------------------------------------------
Total Capital Costs (Millions)............................... $15.65 $37.58 $49.89
Net Annualized Costs (Millions).............................. $1.50 $3.73 $5.19
Operation and Maintenance Costs (Millions)................... $0.76 $1.88 $2.61
Solvent Savings (Millions)................................... ($3.65) ($4.00) ($4.96)
Total Annual Costs * (Millions).............................. ($1.38) $1.60 $2.83
Emissions Reduced (tons/yr).................................. 1,681 2,601 3,058
Cancer Cases Avoided/yr...................................... 0.19 0.20 0.23
Cost Effectiveness of Control ($/ton)........................ ($821) $616 $927
Incremental Cost effectiveness (compared to next least ($7.0) $293 $41
stringent option) (Millions $/case avoided).................
----------------------------------------------------------------------------------------------------------------
* 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 80 percent
equivalent for overall control
general for continuous 100,000 kg MC 100,000 kg/yr
degreaser 60,000 kg/yr MC web cleaning equivalent for MC equivalent
Emission limit population equivalent for machines at aerospace for military
(does not narrow tubing facilities manufacture and maintenance and
include named emitting maintenance depot
sectors) >60,000 kg/yr
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Capital Costs (Millions)..................................... $15.7 $21.92 $3.29 $9.02 $0.54
Net Annualized Costs (Millions).................................... $1.45 $2.23 $0.63 $0.87 $0.06
Operation and Maintenance Costs (Millions)......................... $0.72 $1.11 $0.31 $0.44 $0.04
Solvent Savings (Millions)......................................... ($3.50) ($0.36) ($0.34) ($0.68) ($0.16)
Million Thousand Thousand Thousand Thousand
Total Annual Costs * (Millions).................................... ($1.32) $2.97 $0.60 $0.63 $0.06
Emissions Reduced (tons/yr)........................................ 1,621 920 290 324 89
Cost of Control ($/ton)............................................ ($832) $3,238 $2,774 $1,933 ($625)
Cost per Case Avoided (Millions)................................... ($7.0) $596 $177 $31 ($56)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 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) 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.
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
[[Page 62403]]
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
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 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.
[[Page 62404]]
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 cost-
effectiveness/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 cost-effectiveness/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-
to-vacuum machines or solvent switching were not available control
options for 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 re-assessed 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 non-HAP 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 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.
[[Page 62405]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
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.
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). 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
[[Page 62406]]
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.
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
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 energy-generating
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 (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 6-digit 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
[[Page 62407]]
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.
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.
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 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.
[[Page 62408]]
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 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
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