Document ID: EPA-HQ-OAR-2003-0197-0001
Agency: epa
Document Type: Proposed Rule
Title: Ethylene Oxide Emission Standards for Sterilization Facilities
Posted Date: 2005-10-24T04:00Z

[Federal Register: October 24, 2005 (Volume 70, Number 204)]
[Proposed Rules]               
[Page 61404-61411]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc05-21]                         

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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: a-and-r-docket@epa.gov.
     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: markwordt.david@epa.gov.
    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: morris.mark@epa.gov.

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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