[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Proposed Rules]
[Pages 61404-61411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21187]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[OAR-2003-0197; FRL -7987-5]
RIN 2060-AK09
Ethylene Oxide Emissions Standards for Sterilization Facilities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed decision; request for public comment.
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SUMMARY: On December 6, 1994, we promulgated Ethylene Oxide Emission
Standards for Sterilization Facilities (59 FR 62585). The national
emission standards limit and control hazardous air pollutants (HAP)
that are known or suspected to cause cancer or have other serious
health or environmental effect.
Section 112(f)(2) of the Clean Air Act (CAA) directs EPA to assess
the risk remaining (residual risk) after the application of national
emission standards controls and revise as necessary to protect public
health. Also, CAA section 112(d)(6) requires us to review and to revise
the national emission standards as necessary by taking into account
developments in practices, processes, and control technologies. The
proposal announces a decision and requests public comments on the
residual risk assessment and technology review for the national
emission standards. We are proposing no further action at this time to
revise the national emission standards.
DATES: Comments. Comments must be received on or before December 8,
2005. Public Hearing. If anyone contacts EPA requesting to speak at a
public hearing by November 8, 2005, a public hearing will be held
approximately 20 days following publication of this notice in the
Federal Register.
ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2003-
0197 (Legacy Docket A-88-03), by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Agency Web site: http://www.epa.gov/edocket. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow the on-line instructions for
submitting comments.
E-mail: [email protected].
Fax: (202) 566-1741.
Mail: Air Docket, EPA, Mailcode: 6102T, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460. Please include a total of two
copies.
Hand Delivery: EPA, 1301 Constitution Avenue, NW., Room
B102, Washington, DC 20460. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. OAR-2003-0197
(Legacy Docket A-88-03). The 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.epa.gov/edocket, 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 EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the Federal
regulations.gov Web sites are ``anonymous access'' systems, 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 EDOCKET or 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 EDOCKET index
at http://www.epa.gov/edocket. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in EDOCKET or in hard
copy at the Air and Radiation Docket, EPA/DC, EPA West, Room B102, 1301
Constitution Avenue, 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.
Public Hearing. If a public hearing is held, it will begin at 10
a.m. and will be held at the EPA's campus in Research Triangle Park,
North Carolina, or at an alternate facility nearby. Persons interested
in presenting oral testimony or inquiring as to whether a public
hearing is to be held should contact Mr. David Markwordt, Policy
Planning and Standards Group, Emission Standards Division, U.S. EPA
(C439-04), Research Triangle Park, NC 27711, telephone (919) 541-0837.
FOR FURTHER INFORMATION CONTACT: For additional information on this
proposed decision, review the reports listed in the SUPPLEMENTARY
INFORMATION section.
General and technical information. Mr. David Markwordt, EPA, Office
of Air Quality Planning and Standards, Emission Standards Division,
Policy Planning and Standards Group (C439-04), Research Triangle Park,
North Carolina 27711, telephone (919) 541-0837, facsimile number (919)
541-0942, electronic mail (e-mail) address: [email protected].
Residual risk assessment information. Mr. Mark Morris, EPA, Office
of Air Quality Planning and Standards, Emission Standards Division,
Risk and Exposure Assessment Group (C404-01), Research Triangle Park,
North Carolina 27711, telephone (919) 541-5416, facsimile number (919)
541-0840, electronic mail (e-mail) address: [email protected].
SUPPLEMENTARY INFORMATION:
Regulated Entities. The regulated categories and entities affected
by the national emission standards include:
[[Page 61405]]
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Category NAICS* Examples of regulated entities
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Industry.............................. 3841, 3842.................... Medical suppliers.
2834, 5122, 2831, 2833........ Pharmaceuticals.
2099, 5149, 2034, 2035, 2046.. Spice manufacturers.
7399, 7218, 8091.............. Contract sterilizers.
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* North American Information Classification System.
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by the
national emission standards. To determine whether your facility would
be affected by the national emission standards, you should examine the
applicability criteria in 40 CFR 63.360. If you have any questions
regarding the applicability of the national emission standards to a
particular entity, consult either the air permit authority for the
entity or your EPA regional representative as listed in 40 CFR 63.13.
Worldwide Web (WWW). In addition to being available in the docket,
an electronic copy of today's proposed decision will also be available
on the WWW through the Technology Transfer Network (TTN). Following
signature, a copy of the proposed decision 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.
Reports for Public Comment. We have prepared two summary memoranda
covering the rationale for the proposed decision and the residual risk
analyses. These memoranda are entitled: ``Technology Review and
Residual Risk Development for the Ethylene Oxide Commercial
Sterilization NESHAP,'' and ``Residual Risk Assessment for the Ethylene
Oxide Commercial Sterilization Source Category.'' Both reports are in
the Docket No. OAR-2003-0197 (Legacy Docket A-88-03). See the preceding
Docket section for docket information and availability.
Outline
The information presented in this preamble is organized as follows:
I. Background
A. What is the statutory authority for these actions?
B. What is our approach for developing residual risk standards?
C. What are the current standards?
D. What are the results of the residual risk assessment?
E. What are our conclusions regarding the need for more
stringent standards under section 112(f)(2)?
F. How are we addressing GACT at area sources for purposes of
section 112(f)?
G. What are the results of the technology review?
II. 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 & Safety Risks
H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer Advancement Act
I. Background
A. What is the statutory authority for these actions?
Section 112 of the CAA establishes a two-stage regulatory process
to address emissions of HAP from stationary sources. In the first
stage, after EPA has identified categories of sources emitting one or
more of the HAP listed in the CAA, section 112(d) calls for us to
promulgate national technology-based emission standards for sources
within those categories that emit or have the potential to emit any
single HAP at a rate of 10 tons or more per year or any combination of
HAP at a rate of 25 tons or more per year (known as ``major sources''),
as well as for certain ``area sources'' emitting less than those
amounts. These technology-based national emission standards must
reflect the maximum reductions of HAP achievable (after considering
cost, energy requirements, and non-air health and environmental
impacts) and are commonly referred to as maximum achievable control
technology (MACT) standards.
For area sources, CAA section 112(d)(5) provides that in lieu of
MACT, the Administrator may elect to promulgate standards or
requirements which provide for the use of generally available control
technologies or management practices and such standards are commonly
referred to as generally available control technology (GACT) standards.
On December 6, 1994 (59 FR 62585), we promulgated national emission
standards for Ethylene Oxide Commercial Sterilization and Fumigation
Operations. In that final rule, we set MACT for major sources under
section 112(d)(2). As for area sources, we established MACT standards
for certain emission points pursuant to section 112(d)(2) and GACT
standards for other emission points pursuant to section 112(d)(5).
Section 112(d)(6) provides that EPA review these technology-based
standards and revise them ``as necessary (taking into account
developments in practices, processes and control technologies)'' no
less frequently than every 8 years.
The second stage in standard setting is described in section 112(f)
of the CAA. 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 to emitting sources, and recommendations as to legislation
regarding such remaining risk. EPA prepared and submitted the
``Residual Risk Report to Congress,'' EPA-453/R-99-001, in March 1999.
The Congress did not act on any of the recommendations in the report,
triggering the second stage of the standard-setting process, the
residual risk phase.
Section 112(f)(2) requires us to determine for each section 112(d)
source category whether the national emission standards protect public
health with an ample margin of safety. If the national emission
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 one in one million,'' EPA must promulgate residual risk
standards for the source category (or subcategory) as necessary to
provide an ample margin of safety. EPA must also
[[Page 61406]]
adopt more stringent standards to prevent an adverse environmental
effect (defined in section 112(a)(7) as ``any significant and
widespread adverse effect * * * to wildlife, aquatic life, or natural
resources * * *.''), but must consider cost, energy, safety, and other
relevant factors in doing so.
Section 112(f)(5) expressly provides, however, that EPA is not
required to conduct any review under section 112(f) or promulgate any
emissions limitations under that subsection for any area source listed
pursuant to section 112(c)(3) for which EPA has issued GACT standards.
Thus, although EPA has discretion to conduct a residual risk review
under section 112(f) for area sources for which it has established
GACT, it is not required to do so. See CAA section 112(f)(5).
B. What is our approach for developing residual risk standards?
Following our initial determination that the individual most
exposed for the emissions category considered exceeds a 1-in-1 million
lifetime excess cancer risk, our approach to developing residual risk
standards is based on a two-step determination of acceptable risk and
ample margin of safety. The first step, consideration of acceptable
risk, is only a starting point for the analysis that determines the
final standards. The second step determines the ample margin of safety
which corresponds to the levels at which the standards are set.
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) refers positively to the
interpretation of these terms in our 1989 rulemaking (54 FR 38044,
September 14, 1989), ``National Emission Standards for Hazardous Air
Pollutants (NESHAP): Benzene Emissions from Maleic Anhydride Plants,
Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene Equipment
Leaks, and Coke By-Product Recovery Plants,'' (Benzene NESHAP). We read
CAA section 112(f)(2)(B) as essentially directing us to use the
interpretation set out in that notice \1\ or to utilize approaches
affording at least the same level of protection.\2\ We likewise
notified Congress in its Residual Risk Report that we intended to use
the Benzene NESHAP approach in making CAA section 112(f) residual risk
determinations.\3\
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\1\ This reading is confirmed by the Legislative History to CAA
section 112(f); see, e.g., ``A Legislative History of the Clean Air
Act Amendments of 1990,'' vol. 1, page 877 (Senate Debate on
Conference Report).
\2\ Legislative History, vol. 1, p. 877, stating, ``* * * the
managers intend that the Administrator shall interpret this
requirement [to establish standards reflecting an ample margin of
safety] in a manner no less protective of the most exposed
individual than the policy set forth in the Administrator's benzene
regulations * * *.''
\3\ ``Residual Risk Report to Congress,'' March 1999, EPA-453/R-
99-001, page ES-11.
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In the Benzene NESHAP (54 FR 38044-45, September 14, 1989), 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 a
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.
As explained more fully in our Residual Risk Report to Congress,
these goals are not ``rigid line[s] for acceptability,'' but rather
broad objectives to be weighed ``with a series of other health measures
and factors.'' \4\
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\4\ Id.
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C. What are the current standards?
The Ethylene Oxide Emission Standards for Sterilization Facilities
were promulgated on December 6, 1994 (59 FR 62585) and cover ethylene
oxide, the only HAP emitted from the sterilization/fumigation process.
The national emission standards regulate both major and area sources;
the emission points regulated are the main sterilization and aeration
room vents. The standards for major sources require that sources reduce
main sterilization and aeration room vent emissions by 99 percent. The
standards for area sources require that sources reduce main
sterilization vent emissions by 99 percent.
During the development of the national emission standards, we
estimated that there were approximately 188 facilities nationwide, of
which 47 were major sources. Usually, these operations are not located
at facilities with other types of HAP-emitting sources. The majority of
sterilization facilities process on a contract basis, but some medical
supply and spice manufacturers sterilize their own products. We
estimated that the national emission standards would reduce emissions
of ethylene oxide by 1,000 tons annually.
D. What are the results of the residual risk assessment?
Pursuant to CAA section 112(f)(2), we prepared a risk assessment to
determine the residual risk posed by ethylene oxide sterilization
facilities after implementation of the ethylene oxide national emission
standards. The number of facilities in the source category has
decreased since the development of the national emission standards for
various reasons, including industry consolidation. We developed a list
of 76 facilities that currently comprises both the major and area
source categories, based on information primarily from the following
three sources: (1) The 1999 National Emissions Inventory (NEI), (2) the
2000 Toxics Release Inventory (TRI), and (3) the Ethylene Oxide
Sterilization Association (EOSA). We used these data sources for
emissions and emission point release parameters in dispersion modeling.
As stated previously, consistent with section 112(f)(2), EPA must
determine for each section 112(d) source category whether the MACT
standards protect public health with an ample margin of safety. Because
MACT and GACT are both required of some area sources, risk attributed
to GACT emission points are included in the overall modeled risks for
MACT. Therefore, the risks presented below are higher than just those
risks attributed solely to emission points for which we established
MACT in 1994.
Using the above-noted information, we modeled ambient
concentrations near these facilities and calculated the risk of
possible chronic cancer and noncancer health effects and evaluated
whether acute exposures might exceed relevant health thresholds. We
found that individual lifetime cancer risks exceeded 1-in-1 million in
areas near 44 of the 76 modeled sources, and approximately 250,000
people live in these areas. Individual lifetime cancer risks exceeded
10-in-1 million in areas near 19 sources, and approximately 7,300
people live in these areas. The highest calculated individual lifetime
cancer risk was 90-in-1 million at one facility.
An EPA assessment for ethylene oxide is currently under way. The
EPA has not yet completed a full evaluation of the data on which it
will determine an EPA cancer unit risk estimate for ethylene oxide. The
EPA is also developing an acute reference exposure value for ethylene
oxide. The schedule for both of these actions can be found at: http://cfpub.epa.gov/iristrac.
[[Page 61407]]
Under section 112(o)(7) of the CAA, we are required to issue
revised cancer guidelines prior to the promulgation of the first
residual risk rule under section 112(f) (an implication being that we
should consider these revisions in the various residual risk rules). We
have issued revised cancer guidelines and also supplemental guidance
which deal specifically with assessing the potential added
susceptibility from early-life exposure to carcinogens. The
supplemental guidance provides an approach for adjusting risk estimates
to incorporate the potential for increased risk due to early-life
exposures to chemicals that are thought to be carcinogenic by a
mutagenic mode of action. We are currently evaluating the available
scientific information associated with ethylene oxide to see if ``age
dependent adjustment factors'' should be applied when assessing cancer
risk for early-life exposures which cause cancer through a mutagenic
mode. If the scientific information indicates that it is appropriate to
apply age dependent adjustment factors, then we will reassess the risks
from exposure to ethylene oxide prior to the promulgation of the final
rule.
Estimated annual cancer incidence rates were also calculated from
predicted individual cancer risks for the people reported to reside in
the U.S. census blocks within the modeled area around each facility
(i.e., within 50 kilometers). For the 44 facilities for which estimated
maximum individual cancer risk is greater than 1-in-1 million, the
summed estimated annual cancer incidence is 0.01 cases per year. Across
all 76 modeled facilities, the total estimated annual incidence is 0.04
cases per year. We estimated that values presented here are incremental
rates based on modeled concentrations and 2000 U.S. census data, and
they should not be interpreted as actual cancer incidence rates derived
from observations of disease occurrence over time (such as cancer
incidence rates that may be reported based on epidemiological studies).
The highest chronic noncancer hazard index was 0.03. This means
that the highest lifetime exposures to ethylene oxide were only 3
percent of the chronic noncancer reference concentration (RfC).
Finally, we found that acute exposures, which were calculated by
assuming the maximum hourly emissions rate and worst-case
meteorological conditions, did not exceed any of the relevant health
thresholds for acute effects for ethylene oxide.
We also consider an adverse environmental effect as a part of a
residual risk assessment. Regarding the inhalation exposure pathway for
terrestrial mammals, we conclude that human toxicity values for the
inhalation pathway are generally protective of terrestrial mammals.
Because the maximum cancer and noncancer hazards to humans from
inhalation exposure are relatively low, we expect no significant and
widespread adverse effects to terrestrial mammals from inhalation
exposure to ethylene oxide from commercial sterilization facilities.
Some HAP which are persistent and bioaccumulative can also pose
risks via pathways other than inhalation (e.g., by depositing to the
ground and entering the food chain). The EPA has developed a list of
persistent, bioaccumulative, and toxic (PBT) HAP based on information
from the Pollution Prevention program, the Great Waters program, the
TRI, and additional analysis conducted by the Office of Air Quality
Planning and Standards. Ethylene oxide is not on the list of PBT.
Consequently, we conclude the noninhalation risks to be minimal, and we
conclude that a quantitative risk assessment for multipathway exposures
is unnecessary.
The details of this analysis can be found in our ``Memorandum: Data
and Assumptions Used for the Screening-level Residual Risk Analysis of
the Commercial Ethylene Oxide Sterilizers and Fumigators Source
Category'' and the supporting ``Memorandum: Residual Risk Assessment
for Ethylene Oxide Commercial Sterilization Source Category.'' See
``Reports for Public Comment'' in the SUPPLEMENTARY INFORMATION section
above for information on obtaining these reports.
E. What are our conclusions regarding the need for more stringent
standards under section 112(f)(2)?
In the first step of the decision-making process under section
112(f)(2), the determination of acceptability, we note that the maximum
individual excess lifetime cancer risk associated with any facility
with MACT is less than what we would normally consider as the upper
limit of acceptable risk (i.e., less than 100-in-1 million).\5\
Therefore, we are satisfied that these sources represent acceptable
risk without the need for further more stringent controls.
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\5\ Although we conducted a risk assessment which included
emissions from those vents for which we set GACT in 1994, we are
exercising our discretion under section 112(f)(5) not to undertake
the section 112(f)(2) analysis for those GACT emission points.
See CAA sections 112(f)(2)(A), (B) and (f)(5). The discussion in
this section of the preamble, therefore, is limited to those
emission points for which we established MACT in 1994.
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In the second step of the ample margin of safety framework under
section 112(f)(2), we consider setting standards at a level which may
be equal to, or lower than, the acceptable risk level and which
protects public health with an ample margin of safety. In making the
determination, we considered the estimate of health risk and other
health information along with additional factors relating to the
appropriate level of control, including costs and economic impacts of
controls, technological feasibility, uncertainties, and other relevant
factors.
Because our conservative risk estimates suggest facilities in the
category continue to pose risks exceeding 1-in-1 million after the
application of MACT, we considered additional controls, such as new
technology or alternative controls, to reduce emissions and associated
risks. In 2001, while investigating the safety issue associated with
chamber exhaust vents, we did not find any new technology or
alternative controls for any of the vents--chamber, sterilizer or
aeration room vents. We also found no data to support the addition of
down stream control devices to existing control means as a way of
further reducing emissions. This discussion can be found in our
``Memorandum: Technology Review and Residual Risk Data Development for
the Ethylene Oxide Commercial Sterilization NESHAP.'' We concluded that
further controls would not meaningfully reduce emissions from emission
vents controlled with MACT at both major and area sources.
While no additional control measures for emission vents controlled
with MACT have been identified that would result in a meaningful
reduction of emissions, we are aware of existing State rules which have
control limits exceeding the 99 percent MACT requirement. The State of
California's emissions reductions requirement for the main sterilizer
vent is 99.9 percent; this requirement was enacted prior to
promulgation of the Federal requirements.
We do not have data to confirm that all facilities are capable of
achieving 99.9 percent on a continuous basis. In 1994, in support of
the Federal control limit, we concluded both rules are sufficiently
stringent to require application of the same technologies. We concluded
it reasonable to assume the same technologies perform similarly, i.e.,
those facilities outside of California are on average likely to achieve
emissions reductions similar to
[[Page 61408]]
those in California. We concluded that tightening the current standards
would not meaningfully reduce risks.
The EPA requests comments specifically addressing our conclusion
that the tightening of the current standards would not meaningfully
reduce emissions or risks. Both EPA's and California's rules require a
test to demonstrate compliance with the emissions reductions limit and
continuous monitoring of the control equipment to ensure proper
operation and maintenance. Initial compliance tests are performed one
time and on a very narrow set of operating conditions. The test results
are too limited to determine if there are any meaningful differences in
control technology lifetime performance associated with a 99 percent
and 99.9 percent performance limit. Specifically, there are several
questions on which we are requesting public comment:
Are there available test data demonstrating achievability
of 99.9 percent emissions reductions on a continuous basis for the main
sterilizer vent?
Are there available test data demonstrating a meaningful
difference in lifetime control performance between the same technology
when it is subject to either the 99 or 99.9 percent emissions
reductions requirement?
Are there available test data demonstrating all similar
existing control technology is capable of achieving 99.9 percent
emissions reductions on a continuous basis?
Are there available data showing the variance in long-term
performance for similar technology complying with the 99 or 99.9
percent emissions reductions limit?
Are there additional costs associated with increasing the
percent reduction from 99 to 99.9 percent?
We also considered prohibiting the use of ethylene oxide for new
facilities, which would necessitate the use of an alternative
sterilization process. The Food and Drug Administration (FDA) has
primary authority to regulate the use of sterilization methods. The FDA
issued guidance (510(k) Sterility Review Guidance K90-1, August 30,
2002 (``FDA Guidance'')) to facilitate nontraditional sterilization
methods. The FDA stated in the guidance that the FDA ``has had little
or no experience with these methods for achieving sterilization and is
concerned about a manufacturer's ability to successfully use such
methods without adversely affecting the sterility assurance level * *
*.'' If the use of ethylene oxide were prohibited, manufacturers of
products requiring sterilization would have to reconsider the device
and packaging material, its compatibility with the nontraditional
sterilizing agent, the packaging configuration, the ability of the
nontraditional sterilant to penetrate the packaging, the cost, and
availability. Because these nontraditional sterilization methods are
less known, manufacturers would have to submit to FDA their validation
data for review. Nontraditional sterilization operations cannot be used
to sterilize materials until they have been validated. Prohibiting the
use of ethylene oxide carries the risk of creating a void where some
products may not be able to be sterilized until newer systems are
designed and validated. Until such time as these nontraditional
sterilization techniques may be used under FDA rules, these techniques
are not considered available for the purpose of reducing emissions.
Radiation (gamma and electron beam) can be used to sterilize many
products. Radiation sterilization has been used for about half of the
products sterilized in the U.S. However, these sterilization techniques
are limited in their applications. For example, gamma radiation has
potentially damaging effects on products, particularly those products
that contain polymers. And, radiation technology is completely
different from chamber sterilization. Ethylene oxide and radiation
technologies (both gamma and e-beam) share no common equipment. Any
conversion would involve scrapping the ethylene oxide chambers and the
related specialized equipment and systems, and likely displacing the
existing workforce. Additionally, the ethylene oxide sterilization
facility would not meet requirements for a radiation facility. To
construct a radiation facility, special shielding (huge concrete/lead
shields) and storage pools need to be incorporated into the design of
both the building and the process.
As stated previously, further controls for emission vents
controlled with MACT at both major and area sources do not meaningfully
reduce emissions or the corresponding risks. Further, the review has
shown that both the noncancer and acute risks from this source category
are below their relevant health thresholds. As a result, we conclude
that no additional control should be required because an ample margin
of safety (considering cost, technical feasibility, and other factors)
has been achieved by the national emission standards.
Thus, we conclude that the level of risk resulting from the limits
in the national emission standards is acceptable for these source
categories, and that changes to the national emission standards are not
required to satisfy section 112(f) of the CAA.
As discussed above, the EPA is developing a cancer unit risk
estimate for ethylene oxide. If the EPA value becomes available before
the promulgation of the final rule, we will reevaluate whether the
risks are acceptable and whether an ample margin of safety has been
achieved.
F. How are we addressing GACT at area sources for purposes of section
112(f)?
As noted above, section 112(f)(5) provides that EPA may, but is not
required to, conduct any review under section 112(f) or promulgate any
emissions limitations under that subsection for any area source for
which an emissions standard is promugated as GACT. The CAA clearly
permits EPA to review area source emissions under section 112(f)(2),
even when the agency issued GACT standards under section 112(d)(5)
during its initial review. What is less clear is what the approach
should be when the agency has ``mixed'' its emission standards (i.e.,
issued both MACT and GACT standards) for an area source category. In
this instance, for example, EPA has issued MACT standards, under
section 112(d)(1), for sterilizer vents and chamber exhaust vents; and
GACT standards, under section 112(d)(5), for aeration room vents. This
leaves open the question of which emissions points should be reviewed
under a subsequent section 112(f)(2) review. In this instance, EPA has
undertaken an analysis under section 112(f)(2) for the area emissions
standards that were issued as MACT standards, but the Agency has
exercised its discretion and chosen not to perform an section 112(f)(2)
analysis for those emissions points for which we established GACT. The
Agency may have other alternatives legally available, however. For
example, because the Administrator is not required to perform a
residual risk analysis for any area source category when the Agency has
previously promulgated ``an emissions standard'' pursuant to section
112(d)(5), it is at least arguable that, by using the singular article
``an,'' Congress intended to permit the Agency discretion to decline to
review the area source category, in its entirety, under section
112(f)(2) in appropriate ``mixed'' cases. The Agency seeks comment on
the Agency's range of discretion under section 112(f)(5) and
suggestions on what factors should guide decisions about its approach
in future rulemakings.
[[Page 61409]]
G. What are the results of the technology review?
Section 112(d)(6) of the CAA requires us to review and revise as
necessary (taking into account developments in practices, processes,
and control technologies) emission standards promulgated under this
section no less often than every 8 years. In the course of our review,
we investigated emission control levels and the potential for
additional emissions reductions from existing affected facilities
within the ethylene oxide commercial sterilization source category.
Because the three vents associated with these facilities (i.e., the
main sterilization, aeration room, and chamber exhaust emission vents)
are the same for both major and area sources, the conclusions
concerning technology apply to both source categories. We found that
additional controls for emission vents controlled with either MACT or
GACT would achieve at best, minimal emission and risk reductions at a
very high cost. In our review, we did not identify any significant
developments in practices, processes, or control technologies since
promulgation of the national emission standards in 1994.
For new major sources where MACT requires emissions reductions of
99 percent, we considered increasing the emissions reductions limit to
99.9 percent in the national emission standards. A new limit would only
apply to affected new sources (a new facility for the standards), while
existing sources would still be subject to the current limits. As
stated previously, we do not have data to confirm that facilities are
capable of achieving 99.9 percent on a continuous basis. Therefore, the
99 percent emissions reductions requirement of the national emission
standards is considered to be the best control level in practice
nationally. We conclude that the new source standard for the emissions
reductions limit should be kept the same as that for existing, and that
no further revisions to the National Emission Standards for Ethylene
Oxide Sterilization Facilities are needed.
In the original generally GACT determination for new area sources,
no control requirements were established due to the high cost (59 FR
10598-99). In our review, we did not identify any significant
developments in practices, processes, or control technologies since
promulgation of the national emission standards in 1994 which would
reduce the costs of applying controls to new area sources.
Because the national emission standards continue to represent the
best controls that can be implemented nationally, we are proposing not
to revise the National Emission Standards for Ethylene Oxide
Sterilization Facilities under CAA section 112(f) or 112(d)(6).
II. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA
must determine whether a regulation is ``significant'' and, therefore,
subject to Office of Management and Budget (OMB) review and the
requirements of the Executive Order. The Executive Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may:
(1) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal government communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligations of
recipients thereof; or
(4) Raise novel or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in the Executive
Order.
It has been determined that today's proposed decision is a
``significant regulatory action'' under the terms of Executive Order
12866 because it raises novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in the Executive Order. Therefore, today's proposed decision was
submitted to OMB for review. However, today's proposed decision will
result in no additional cost impacts beyond those estimated for the
current national emission standards. Changes made in response to OMB
suggestions or recommendations will be documented in the public record.
B. Paperwork Reduction Act
This action does not impose any new information collection burden
under the provisions of the Paperwork Reduction Act, 44 U.S.C. et seq.
Today's proposed decision will not change the burden estimates from
those developed and approved for the national emission standards. In
1994, OMB approved the information collection requirements for the
national emission standards under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq., and assigned OMB control number
2060-0283.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
EPA has established a public docket for this action, which includes
the ICR, under Docket ID number OAR 2003-0197, which can be found in
http://www.epa.gov/edocket. Today's proposed decision will not change
the burden estimates from those developed and approved in 1994 for the
national emission standards.
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 today's proposed decision
on small entities, small entity is defined as: (1) A small business
whose parent company has fewer than 100 or 1,500 employees, or a
maximum of $5 million to $18.5 million in revenues, depending on the
size definition for the affected North American Industry Classification
System (NAICS) code; (2) a small governmental jurisdiction that is a
government of a city, county, town, school district or special district
with a
[[Page 61410]]
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. It should be noted that the small
business definition applied to each industry by NAICS code is that
listed in the Small Business Administration (SBA) size standards (13
CFR 121).
After considering the economic impacts of today's proposed decision
on small entities, I certify that the decision will not have a
significant economic impact on a substantial number of small entities.
The proposed decision will not impose any requirements on small
entities. Today's proposal announces a decision and requests public
comments on the residual risk assessment and technology review for the
national emission standards and imposes no additional burden on
facilities impacted by the national emission standards. We are
proposing no further action at this time to revise the national
emission standards. We continue to be interested in the potential
impacts of the proposed decision on small entities and welcome comments
on issues related to such impacts.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures by State, local, and tribal governments, in
aggregate, or by the private sector, of $100 million or more in any 1
year. Before promulgating an EPA rule for which a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation of why that
alternative was not adopted.
Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
The EPA has determined that today's proposed decision does not
contain a Federal mandate that may result in expenditures of $100
million or more to State, local, and tribal governments in the
aggregate, or to the private sector in any 1 year. Therefore, today's
proposed decision is not subject to the requirements of sections 202
and 205 of the UMRA. In addition, today's proposed decision does not
significantly or uniquely affect small governments because it contains
no requirements that apply to such governments or impose obligations
upon them. Therefore, today's proposed decision is not subject to
section 203 of the UMRA.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
Today's proposed decision does not have substantial direct effects
on the States, on the relationship between the national government and
the States, or on the distribution of power and responsibilities among
the various levels of government, as specified in Executive Order
13132. Thus, the requirements of the Executive Order do not apply to
today's proposed decision.
F. Executive Order 13175, Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.''
Today's proposed decision does not have tribal implications. 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 Executive Order 13175.
Thus, Executive Order 13175 does not apply to today's proposed
decision.
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, EPA must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by the Agency.
Today's proposed decision is not subject to the Executive Order
because it is not economically significant as defined in Executive
Order 12866 and because the Agency does not have reason to believe the
environmental health or safety risk addressed by this action present a
disproportionate risk to children.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
Today's proposed decision 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. Further, we have concluded that today's
proposed decision is not likely to have any adverse energy impacts.
I. National Technology Transfer and Advancement Act of 1995
Under section 12(d) of the National Technology Transfer and
Advancement
[[Page 61411]]
Act of 1995 (NTTAA), Public Law No. 104-113, all Federal agencies are
required to use voluntary consensus standards (VCS) in their regulatory
and procurement activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, business practices) developed or adopted by one or
more voluntary consensus bodies. The NTTAA requires Federal agencies to
provide Congress, through annual reports to OMB, with explanations when
the agency does not use available and applicable VCS.
Today's proposed decision does not involve technical standards.
Therefore, the requirements of the NTTAA are not applicable.
List of Subjects in 40 CFR Part 63
Environmental protection, Administrative practice and procedures,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.
Dated: October 18, 2005.
Stephen L. Johnson,
Administrator.
[FR Doc. 05-21187 Filed 10-21-05; 8:45 am]
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