Ethylene Oxide Emissions Standards for Sterilization Facilities, 17712-17720 [06-3314]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 67 (Friday, April 7, 2006)]
[Unknown Section]
[Pages 17712-17720]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3314]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2003-0197, FRL-8054-6]
RIN 2060-AK09


Ethylene Oxide Emissions Standards for Sterilization Facilities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final decision.

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SUMMARY: This action finalizes our decision not to revise the Ethylene 
Oxide Emission Standards for Sterilization Facilities, originally 
promulgated on December 6, 1994. Within 8 years of promulgating these 
standards, the Clean Air Act directs us to assess the risk and to 
promulgate more stringent standards if necessary to protect public 
health with an ample margin of safety and to prevent adverse 
environmental effects. Also, within 8 years of promulgating the 
national emission standards, the Clean Air Act requires us to review 
and revise the standards as necessary, taking into account developments 
in practices, processes, and control technologies. Today's action 
reflects our findings that after conducting these risk and technology 
reviews, no additional control requirements are warranted.

DATES: Effective Date: April 7, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-OAR-2003-0197. All documents in the docket are listed on the 
https://www.regulations.gov Web site. Although listed in the index, some 
information is not publicly available, e.g., confidential business 
information 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 through https://www.regulations.gov or in hard copy at 
the Air and Radiation Docket, EPA/DC, EPA West, Room B-102, 1301 
Constitution Ave., NW., Washington, DC. The Public Facility is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the Air and Radiation Docket is 
(202) 566-1742.

FOR FURTHER INFORMATION CONTACT: General and Technical Information. Mr. 
David Markwordt, Office of Air Quality Planning and Standards, Sector 
Policies and Programs Division, Coatings and Chemicals Group (E-143-
01), Environmental Protection Agency, Research Triangle Park, North 
Carolina 27711, telephone (919) 541-0837, facsimile number (919) 685-
3195, electronic mail (e-mail) address: markwordt.david@epa.gov.
    Residual Risk Assessment Information. Mr. Mark Morris, Office of 
Air Quality Planning and Standards, Health and Environmental Impacts 
Division, Sector Based Assessment Group (C539-02), Environmental 
Protection Agency, Research Triangle Park, North Carolina 27711, 
telephone (919) 541-5470, 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:

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            Category                  NAICS a         (SIC b)             Examples of regulated entities
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Industry........................          329112          (3841)  Operations at major and area sources that
                                          339113          (3842)   sterilize or fumigate medical supplies,
                                          325412          (2834)   pharmaceuticals, and spice.
                                          311942          (2099)
                                          311423          (2034)
Federal/State/ local/tribal
 governments.
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a North American Industry Classification System.
b Standard Industrial Classification.

    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 final decision will also be available on 
the WWW through the Technology Transfer Network (TTN). Following 
signature, a copy of the final decision will be posted on the TTN's 
policy and guidance page for newly proposed or promulgated rules at the 
following address: https://www.epa.gov/ttn/oarpg/. The TTN provides 
information and technology exchange in various areas of air pollution 
control.

[[Page 17713]]

    Judicial Review. Under Clean Air Act (CAA) section 307(b)(1), 
judicial review of this final decision is available only by filing a 
petition for review in the United States Court of Appeals for the 
District of Columbia Circuit by June 6, 2006. Under section 
307(d)(7)(B) of the CAA, only an objection to a rule or procedure 
raised with reasonable specificity during the period for public comment 
can be raised during judicial review. Moreover, under section 307(b)(2) 
of the CAA, the requirements established by the final decision may not 
be challenged separately in civil or criminal proceedings brought to 
enforce these requirements.
    Section 307(d)(7)(B) of the CAA further provides that ``[o]nly an 
objection to a rule or procedure which was raised with reasonable 
specificity during the period for public comment (including any public 
hearing) may be raised during judicial review.'' This section also 
provides a mechanism for us to convene a proceeding for 
reconsideration, ``[i]f the person raising an objection can demonstrate 
to the EPA that it was impracticable to raise such objection within 
[the period for public comment] or if the grounds for such objection 
arose after the period for public comment (but within the time 
specified for judicial review) and if such objection is of central 
relevance to the outcome of the rule.'' Any person seeking to make such 
a demonstration to us should submit a Petition for Reconsideration to 
the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios 
Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a 
copy to both the person(s) listed in the preceding FOR FURTHER 
INFORMATION CONTACT section and the Associate General Counsel for the 
Air and Radiation Law Office, Office of General Counsel (Mail Code 
2344A), U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20004.
    Outline. The information presented in this preamble is organized as 
follows:

I. Background
    A. What Is the Statutory Authority for These Actions?
    B. What Did We propose?
II. Risk and Technology Review Final Decision
III. Summary of Comments and Responses
IV. 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 and Advancement Act
    J. Congressional Review Act

I. Background

A. What Is the Statutory Authority for These Actions?

    Section 112 of the CAA establishes a comprehensive regulatory 
process to address hazardous air pollutants (HAP) from stationary 
sources. In implementing this process, we have identified categories of 
sources emitting one or more of the HAP listed in the CAA, and ethylene 
oxide sterilization facilities are identified as both major and area 
source categories. Section 112(d) requires 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 for HAP (NESHAP) must reflect the maximum 
reductions of HAP achievable (after considering cost, energy 
requirements, and nonair health and environmental impacts) and are 
commonly referred to as maximum achievable control technology (MACT) 
standards. We promulgated the National Emission Standards for Ethylene 
Oxide Commercial Sterilization and Fumigation Operations Facilities at 
59 FR 62585 on December 6, 1994 (Ethylene Oxide Sterilization NESHAP). 
As for area sources, we established MACT standards for certain emission 
points pursuant to section 112(d)(2) and generally available control 
technology (GACT) standards for other emission points pursuant to 
section 112(d)(5).
    In what is referred to as the technology review, we are required 
under section 112(d)(6) of the CAA to review these technology-based 
standards no less frequently than every 8 years. Further, if we 
conclude that a revision is necessary, we have the authority to revise 
these standards, taking into account ``developments in practices, 
processes, and control technologies.''
    The residual risk review is described in section 112(f) of the CAA. 
Section 112(f)(2) requires us to determine for each section 112(d) 
source category, except area source categories for which we issued a 
GACT standard, whether the NESHAP protects public health with an ample 
margin of safety (AMOS). If the NESHAP 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,'' we 
must decide whether additional reductions are necessary to provide an 
ample margin of safety. As part of this decision, we may consider 
costs, technological feasibility, uncertainties, or other relevant 
factors. We must determine whether more stringent standards are 
necessary to prevent adverse environmental effect (defined in section 
112(a)(7)) as ``any significant and widespread adverse effect, which 
may reasonably be anticipated to wildlife, aquatic life, or other 
natural resources, including adverse impacts on populations of 
endangered or threatened species or significant degradation of 
environmental quality over broad areas,'' but in making this decision 
we must consider cost, energy, safety, and other relevant factors.

B. What Did We Propose?

    We promulgated the Ethylene Oxide Sterilization NESHAP in 1994. On 
October 24, 2005 (70 FR 61406), we proposed not to revise the Ethylene 
Oxide Sterilization NESHAP and requested public comments on the 
residual risk and technology review for the Ethylene Oxide 
Sterilization NESHAP.

II. Risk and Technology Review Final Decision

    In our proposal, we presented the analysis and conclusions on 
residual risk and technology review, concluding that the maximum 
individual cancer risk for this source category already meets the level 
we generally consider acceptable, and that further control requirements 
would achieve, at best, minimal emission and risk reductions at a very 
high cost from emission vents controlled with MACT at both major and 
area sources. Further, the analyses showed that both the chronic 
noncancer and acute risks from this source category are below their 
respective relevant health thresholds, and that there are no adverse 
impacts to the environment (i.e., ecological risks). As a result, we 
concluded 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 NESHAP MACT requirements for 
the

[[Page 17714]]

ethylene oxide major and area source categories.
    In the technology review, we concluded that additional controls at 
existing sources would achieve, at best, minimal emission and risk 
reductions at a very high cost. Additionally, we did not identify any 
significant developments in practices, processes, or control 
technologies since promulgation of the original standards in 1994 which 
represent the best controls that can be implemented nationally. Thus, 
we proposed no additional controls under the technology review under 
CAA section 112(d)(6).
    We conclude in this rulemaking, as proposed, that there is not a 
need to revise the Ethylene Oxide Sterilization NESHAP under the 
provisions of CAA section 112(f) or 112(d)(6).

III. Summary of Comments and Responses

    The proposal provided a 45-day comment period ending December 8, 
2005. We received comments from eight commenters. Commenters included 
three State agencies, one State and local agency association, three 
industry trade associations, and one coalition of trade associations. 
We have considered the public comments as discussed below and did not 
find that the comments changed any of our determinations.

1. Source Category Risk Approach

    Comment: One commenter disagreed that EPA can utilize approaches 
different from that specified in the Benzene NESHAP. The commenter 
believes that EPA misinterpreted the CAA legislative history stating 
that EPA could read section 112(f)(2)(B) as directing it to use the 
interpretation set out in the Benzene NESHAP or use approaches 
affording the same level of protection. According to the commenter, EPA 
must use only the Benzene NESHAP approach and cannot use any other 
approach by relying on a Senate manager's statement that EPA should 
interpret the section 112(f)(2)(B) 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 Benzene 
NESHAP.
    Response: In the proposed rule, EPA followed the approach set out 
in National Emission Standards for Hazardous Air Pollutants (NESAHP): 
Benzene Emissions from Maleic Anhydride Plants, Ethylbenzene/Styrene 
Plants, Benzene Storage Vessels, Benzene Equipment Leaks, and Coke By-
Product Recovery Plants, 54 FR 38044 (September 14, 1989). EPA used the 
two-step decision process of first determining a level of acceptable 
risk followed by finding an ample margin of safety. As the commenter 
concedes EPA's approach is fully consistent with the Benzene NESHAP 
approach and therefore acceptable. Since, in this instance, EPA did not 
use any other approach, the comment is not applicable to this 
particular rulemaking.
    Comment: One commenter stated that Congress was clear in requiring 
EPA to evaluate only the risks from an individual source category or 
subcategory in establishing residual risk standards. The commenter 
stated EPA should not include the risk from area sources in determining 
whether risks from the major source category exceeds the one-in-a-
million risk trigger under section 112(f)(2) or in making judgments on 
acceptable risk and ample margin of safety for major sources.
    Response: We listed separate source categories for major and area 
commercial sterilization facilities under section 112(c) of the CAA, 
and we agree with the commenter that a separate determination of 
acceptable risk and ample margin of safety should be made for each 
source category under section 112(f) of the CAA. Our risk assessment 
for commercial sterilization facilities includes risk estimates for all 
known sources, including mostly major sources and the area sources with 
the highest emissions. Only two area sources have estimated cancer risk 
greater than 1 in 1 million (highest is 20 in 1 million), and no area 
sources have modeled ethylene oxide concentrations near the reference 
concentration. For additional information on our risk assessment of 
area sources see section III.2.
    In the preamble to the proposed rule, we stated that risks were 
acceptable considering all known sources (major and area sources) and 
that an ample margin of safety was achieved without control 
requirements beyond those in the current standards. Although the 
preamble to the proposed rule does not discuss separate determinations 
of acceptability and ample margin of safety for major and areas source 
categories, our conclusions would not have changed whether we had 
considered all sources together, or separately for major sources and 
area sources.
    Comment: One commenter stated that EPA did not comprehensively 
consider the plants' impacts because it did not consider all HAP 
emissions or all source categories at the facilities. The commenter 
stated that in considering only a portion of the facilities' emissions, 
the determination of low-risk is based on a distorted and unrealistic 
view of their impact. The commenter included an example of a facility 
that uses and emits methyl bromide from its sterilization operations.
    Response: In general, there is much less co-location of commercial 
sterilization operations with other industrial processes than there is 
for the typical source category. Many facilities are contract 
sterilizers with no co-location. In some cases, there is co-location of 
commercial sterilizers with other processes, such as pharmaceuticals 
production. We do not have sufficiently detailed information to analyze 
the possibility of controls on the various specific sources within a 
facility but outside the commercial sterilizer source category. As a 
result, we could not evaluate the existing levels of control or the 
potential for applying additional controls at the facilities where HAP 
emissions from other sources contribute to the risk. Therefore, we did 
not consider emissions from co-located sources in our decision to 
require no additional controls because we did not have the control cost 
and feasibility data necessary to do so. Our position on the potential 
consideration of co-located source categories is fully discussed in the 
coke oven final rule (70 FR 19995-19998).
    Regarding emissions of methyl bromide, we searched the 1999 
National Emissions Inventory (NEI) for the 76 identified ethylene oxide 
sterilization facilities to determine which emit both ethylene oxide 
and methyl bromide. According to the NEI data base, only two of the 
facilities emit both HAP. One of the facilities emits so little methyl 
bromide that the risk estimates would not be significantly different if 
methyl bromide were considered. The other facility emits more methyl 
bromide than ethylene oxide (about 2 to 3 times as much). However, 
because there is no cancer unit risk estimate for methyl bromide, the 
emissions of methyl bromide would not affect our cancer risk estimate 
(3 in 1 million). Considering effects other than cancer, the reference 
concentration for chronic inhalation exposures to methyl bromide is 
approximately six times lower than that of ethylene oxide. 
Consequently, the methyl bromide emissions could result in an increase 
in our estimate of the hazard index for the facility by as much as a 
factor of 20 (assuming similar source release parameters like stack 
height, etc.). This is not a concern because our current estimate of 
the hazard index is 0.001, and a factor greater than 1000 would be 
necessary before a hazard index of 1 would be exceeded. Therefore, even 
considering these emissions would not change our regulatory decision.

[[Page 17715]]

    Comment: One commenter stated EPA should not conduct a separate 
technology review for ethylene oxide sources under section 112(d)(6). 
The commenter believes that once EPA has made a residual risk 
determination under section 112(f), emissions from the category are 
``safe,'' and the Agency must find a revision of the MACT standard 
under section 112(d)(6) is unnecessary. Another commenter urges EPA to 
avoid expenditure of resources by conducting further analysis geared to 
tightening control requirements when an AMOS has already been provided 
by a protective standard.
    Response: As discussed in the preamble to the proposed rule, we 
performed a separate technology review for both the area and major 
source categories under section 112(d)(6), but recommended no changes 
to the NESHAP. It is possible that future advances in control 
technologies for this source category could allow for meaningful 
emission reductions at a reasonable cost. We believe that the 
technology review required under section 112(d)(6) was appropriate 
here.
    Comment: One commenter believes that there is no mechanism to 
revisit section 112(f) assessments and, therefore, that the risk 
assessment should be corrected to account for reasonably foreseeable 
changes that could result in increased risk, such as new residences 
being built closer to the facility, or increases in actual emissions 
within the current permit limitations.
    Response: We disagree with the commenter's assertion that there is 
no mechanism to revisit risks from the source category, and that, 
therefore, the risk assessment must include consideration of 
foreseeable changes that may occur in the future. We have the authority 
to revisit (and revise, if necessary) any rulemaking if there is 
sufficient evidence that changes within the affected industry or 
significant improvements to science suggests the public is exposed to 
significant increases in risk as compared to the risk assessment 
prepared for the rulemaking (e.g., CAA section 301).

2. Area Source Category--MACT and GACT

    Comment: One commenter stated that EPA has discretion to not 
regulate MACT or GACT area sources under section 112(f). One commenter 
stated that EPA has the discretion under section 112(f)(5) of the CAA 
to avoid residual risk analysis for area sources subject to GACT, 
regardless of whether such sources are subject to both MACT and GACT 
under section 112(d). The commenter reasoned that since the CAA does 
not require residual risk analysis of area sources subject to GACT 
only, area sources subject to more stringent requirements under both 
MACT and GACT should also not require analysis. Two commenters stated 
that EPA should not omit sources subject to GACT from the residual risk 
analysis because it could result in serious underestimation of the 
health risks from area sources. One commenter believes that both 
section 112(d) and 112(f) of the CAA were satisfied when area sources 
were addressed under section 112(d)(5); since GACT controls alone would 
have been sufficient for EPA to avoid a residual risk review, clearly 
requiring both MACT and GACT controls obviates the need for any further 
Agency review of these area sources under both 112(d) and 112(f).
    Response: For area source ethylene oxide sterilizers, EPA issued 
MACT standards under section 112(d)(2) for sterilizer vents and chamber 
exhaust vents and GACT standards for aeration room vents. EPA undertook 
a section 112(f)(2) analysis for area source emissions standards that 
were issued as MACT standards and exercised its discretion under 
section 112(f)(5) to not do an 112(f)(2) analysis for those emission 
points for which GACT standards were established. EPA appreciates the 
responses to its question regarding the range of discretion that the 
Agency has under section 112(f)(5) and will consider the points made by 
commenters in developing future relevant proposals. However, for 
purposes of this rulemaking, EPA believes that it exercised its 
discretion appropriately by conducting a 112(f)(2) analysis for those 
emission points subject to MACT standards.

3. Risk Analysis Assumptions

    Comment: Two commenters stated that EPA must use the best available 
science to establish a cancer unit risk estimate for ethylene oxide, 
and that it is scientifically indefensible for EPA to use the 
California Environmental Protection Agency cancer unit risk factor in 
risk assessments when more recent epidemiological data exist. One 
commenter states that the basis for the California unit risk factor 
(mononuclear leukemia in female rats) is not relevant to humans. One 
commenter states that a sound scientific estimate of the cancer unit 
risk for ethylene oxide has been derived by Kirman, et al. \1\ based 
partly on two epidemiological studies 2 3 that include 
exposure estimates for more than 20,000 workers. Two commenters stated 
that EPA should plan to reevaluate the risks associated with this 
source category whenever the new cancer risk estimate is made final, 
regardless of whether or not the final rule has been published.
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    \1\ Kirman, C.R., et al. 2004. Addressing nonlinearity in the 
exposure-response relationship for a genotoxic carcinogen: cancer 
potency estimates for ethylene oxide. Risk Anal. 24(5):1165-83.
    \2\ Steenland, K.L., et al. 1991. Mortality among workers 
exposed to ethylene oxide. New England Journal of Medicine, 
324(20):1402-1407.
    \3\ Teta, M.J., et al. 1993. Mortality study of ethylene oxide 
workers in chemical manufacturing: A 10-year update. British Journal 
of Industrial Medicine, 50:704-709.
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    Response: In estimating potential excess cancer risk associated 
with ethylene oxide sterilizers, EPA has considered all available, 
credible, and relevant information. In 1985, the EPA health assessment 
for ethylene oxide \4\ concluded, based on the information available at 
that time, that ethylene oxide is ``probably carcinogenic to humans,'' 
and derived a cancer unit risk estimate. California EPA subsequently 
relied on the EPA assessment in developing their cancer unit risk 
estimate using the same rat study as basis.5 6 The 
California EPA assessment received concurrence from their Scientific 
Review Panel.\7\ In 1994, the International Agency for Research on 
Cancer categorized ethylene oxide in their Group 1 (Carcinogenic to 
Humans). In 2000, the United States Department of Health and Human 
Services revised its listing for ethylene oxide to ``known to be a 
human carcinogen'' in the Ninth Report on Carcinogens.\8\ Support for 
this listing includes epidemiological evidence from studies of workers 
exposed to ethylene oxide and animal studies. Cancer in both human and 
animal studies has included multiple sites, including reported 
associations with leukemia.\9\
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    \4\ USEPA. 1985. Health Assessment Document for Ethylene Oxide, 
EPA/600/8-84/009F. Office of Health and Environmental Assessment, 
Washington, DC.
    \5\ CARB. 1987. Staff Report: Initial Statement of Reasons For 
Proposed Rulemaking and Report of the Scientific Review Panel. 
California Air Resources Board. https://www/oehha.ca.gov/air/toxic 
contaminants /pdf1/ethylene% 20oxide.pdf.
    \6\ CalEPA. 2005. Technical Support Document for Describing 
Available Cancer Potency Factors. California Environmental 
Protection Agency, Office of Environmental Health Hazard Assessment. 
Air Toxicology and Epidemiology Section. https://www.oehha.ca.gov/
air/hot_ spots/pdf/May2005 Hotspots.pdf.
    \7\ CARB. op. cit.
    \8\ DHHS. 2000. Report on Carcinogens, Eleventh Edition; United 
States Department of Health and Human Services, Public Health 
Service, National Toxicology Program.
    \9\ DHHS, op. cit.

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[[Page 17716]]

    EPA is currently developing an updated cancer assessment for 
ethylene oxide (https://cfpub.epa.gov/ iristrac/index. 
cfm?fuseaction=viewChemical. showChemical &iris& --sub--id= 897). EPA's 
updated cancer assessment for ethylene oxide will consider all relevant 
literature and studies including the Kirman, et al. paper and the 
epidemiological studies referred to in the comment. However, until 
completion of that assessment and given the peer review status of the 
work done by the State of California, the California EPA unit risk 
estimate must be considered to be the best-available science and has 
therefore been used in assessing cancer risk for this rulemaking.
    The EPA cancer assessment will not receive external peer review 
until mid-2006, which is after the promulgation date of the residual 
risk rule for this source category. Our authority to revisit any 
rulemaking is addressed in Section III.1.
    Comment: Several commenters stated that Acute Exposure Guideline 
Levels (AEGL), Emergency Response Planning Guidelines (ERPG), and 
Immediately Dangerous to Life or Health (IDLH) values should not be 
used in assessing the risk from acute exposures to ethylene oxide 
because these values were developed for accidental release planning and 
are not appropriate for assessing daily human exposure scenarios. One 
commenter stated that EPA's acute assessment discounted the use of the 
National Institute of Occupational Safety and Health (NIOSH) 10-minute 
ceiling value of 5 parts per million (ppm) (9 mg/m\3\), and noted that 
EPA's maximum acute exposure estimate for this source category (23 mg/
m\3\) exceeds the NIOSH value. Two of the commenters stated that EPA's 
new acute reference concentration value for ethylene oxide should be 
used when it becomes available.
    Response: We are continuing to evaluate the role of acute health 
effects in our section 112(f) analysis. In any event, we have concluded 
that this source category does not present acute health risks that 
warrant further regulation. Our authority to revisit any rulemaking is 
addressed in Section III.1.
    Comment: Three commenters stated that EPA should consider the risks 
from chronic exposure at facility property boundaries instead of at the 
geographic centroids of census blocks. The commenters state that census 
blocks can be large and that the point of maximum impact can be far 
from the census block centroid.
    Response: We believe that, in a national-scale assessment of 
lifetime inhalation exposures and health risks from a category of 
facilities, it is appropriate to identify exposure locations where an 
individual may reasonably be expected to spend a majority of his or her 
lifetime. Further, we believe that it is appropriate to use census 
block information on where people actually reside, rather than points 
on a fence-line, to locate the estimation of exposures and risks to 
individuals living near such facilities.
    Census blocks are the finest resolution available for the 
nationwide population data set (as developed by the U.S. Census 
Bureau); each is typically comprised of approximately 40 people or 
about 10 households. In our risk assessments, we use the geographic 
centroid of each census block containing at least one person to 
represent the location where all the people in that census block live. 
The census block centroid with the highest estimated exposure then 
becomes the location of maximum exposure, and the entire population of 
that census block experiences the maximum individual risk. In some 
cases, since actual residence locations may be closer to or farther 
from facility emission points, this may result in an overestimate or 
underestimate of the actual chronic risks. However, given the 
relatively small dimensions of census blocks in densely-populated areas 
and the relatively large number of sources being assessed for any given 
source category, we believe that these uncertainties are small and do 
not bias our estimates of maximum individual risks for a source 
category.
    Comment: One commenter stated that the risk assessment for ethylene 
oxide sterilization facilities lacks a reliable facility-specific 
inventory of emissions. The commenter stated that EPA did not acquire 
the ethylene oxide usage records and emissions data needed to perform 
the residual risk assessment, but instead relied on industry-supplied 
data from the Toxics Release Inventory (TRI) and the National Emissions 
Inventory (NEI). The commenter implied that EPA should have requested 
data from facilities under its authority under section 114 of the CAA. 
The commenter strongly recommend that the EPA re-conduct this residual 
risk assessment by requiring the sources subject to this proposed 
rulemaking to report five years of usage data and/or throughput data. 
The EPA should then select the maximum usage value to calculate 
emissions for each facility in the residual risk assessment based on 
the current percent control requirement prescribed by the NESHAP. One 
commenter stated that EPA's risk assessment considered only actual 
reported emissions instead of potential emissions. The commenter stated 
that since facility emissions (and associated impacts) could increase 
over time for a variety of reasons EPA should have considered the risks 
based on potential emissions. Two commenters stated residual risk 
assessments must be performed on allowable emissions to fully 
understand the potential public health implications for a source 
category.
    Response: Our position on the use of allowable emissions is fully 
discussed in the final Coke Oven Batteries NESHAP (70 FR 19998-19999).
    We used reported emissions (from the National Emissions Inventory 
database and company reports) for the ethylene oxide source category 
risk analysis. The reported emissions are a mix of actual, allowable, 
and potential emissions, but we do not have the necessary information 
to distinguish between the types of data reported. While we generally 
recognize that most facilities over comply with the MACT requirements 
(thus, actual emissions are lower than allowable), we do not have data 
to determine the degree of over compliance that facilities are 
achieving or reporting. For example, chamber exhaust emissions in some 
cases may be lower because they are controlled by some States although 
not by EPA because of the safety issue discussed in the proposal. The 
removal of chamber exhaust vent controls by the States would likely 
result in a significant increase in risk. However, as discussed in 
section III.3, we have no basis to change conclusions presented in the 
proposal and will not impose controls on chamber exhaust emissions for 
either new or existing facilities.
    The commenter also recommended we use the authority under section 
114 of the CAA to gather data rather than use data bases like the TRI 
or data submitted by the facility but not under authority of the CAA. 
Since the data ultimately is supplied by the facility we believe the 
data is comparable to data gathered under section 114. The commenter 
also recommended we base rule-making on 5 years of data. The commenter 
provided no basis which demonstrates modeled results based on the 
previous 5 years are any more representative of risks than those based 
on the most recent emission estimates.

[[Page 17717]]

4. Additional Issues

    Comment: One commenter stated EPA concludes that ``further controls 
would not meaningfully reduce emissions from emission vents'' but 
indicates that the Agency is aware that the State of California's 
requirement for the main sterilizer vent is 99.9 percent as contrasted 
with the 99 percent MACT requirement. The Agency therefore requests 
further data from the public in the form of five questions dealing 
primarily with technology and costs. (70 FR 61408) EPA does not clearly 
set out what decision criteria will be applied to the information that 
the public is being asked to supply. The commenter also stated that EPA 
does not explicitly state the decision criteria used in making ample 
margin of safety decisions under the residual risk program. 
Specifically, the commenter stated that for ethylene oxide 
sterilization facilities, the EPA did not explicitly state that 
incremental emission control costs were compared to incremental risk 
reductions in making the ample margin of safety decision, as it has in 
past rulemakings such as the Benzene NESHAP and radionuclide standards. 
The commenter also stated that the public would better understand and 
accept EPA's ample margin of safety decisions if EPA were to better 
educate the public regarding its estimated risk estimates and the 
contribution of stationary sources to the overall risk. One commenter 
stated EPA indicates that the agency had considered increasing the 
emission reduction limit to 99.9 percent in the national emission 
standards but that ``we do not have data to confirm that facilities are 
capable of achieving 99.9 percent on a continuous basis'' (70 FR 
61409). The commenter encouraged EPA to review state data on this 
source category, including information from New York and New Jersey, 
indicating that such levels are achievable. Another commenter stated 
that EPA needs to re-evaluate the control technologies and exemptions 
from the current NESHAP. The emissions of ethylene oxide from the 
largest fugitive sources evaluated in the residual risk assessment 
equates to over 28 tons per year. The EPA should assess the risk 
reductions associated with the additional control percentages on the 
sterilizer chamber vent and aeration room vents for sources which use 
between 1 and less than 10 tons and 10 tons or greater per year of 
ethylene oxide.
    Response: EPA stated in the proposal, ``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.'' We used the same decision 
criteria today to address the data submitted in response to the 
proposal. The EPA does not have definitive criteria such as a specific 
cost effectiveness value which dictates the final outcome.
    We solicited comments concerning both the control effectiveness and 
costs associated with increasing the performance limit to 99.9 percent. 
The summary test data submitted by the commenters lend support to the 
technical feasibility of complying with a higher limit for the main 
sterilizer vent. Commenters did not supply data supporting continuous 
compliance with a higher limit.
    Many of the outlet concentrations are reported at the detection 
limit. This implies the measurement devices were showing zero 
concentration of ethylene oxide in the outlet stream. Because both the 
1990s and 2000s data show no ethylene oxide in the outlet stream, we 
believe there isn't a measurable difference in the control efficiencies 
of the tested devices.
    We did not receive comments addressing the safe control of 
emissions from the chamber exhaust vent. As we stated in the 
``Memorandum: Technology Review and Residual Risk Data Development for 
the Ethylene Oxide Commercial Sterilization NESHAP'' (Docket  
EPA -HQ -OAQ- 2003-0197 -0027): ``Many, if not all, source facilities 
utilize a chamber exhaust fan while personnel are removing product from 
the sterilization chamber. This fan removes ethylene oxide off-gassing 
from the product. The Ethylene Oxide Commercial Sterilization and 
Fumigation NESHAP promulgated in 1994 (59 FR 62585) required control of 
the chamber exhaust vent. In 1997 there were a series of explosions 
associated with control of the chamber exhaust vent (62 FR 64736). We 
subsequently reassessed the control requirements and removed the 
requirement to control the chamber exhaust in November 2001 (66 FR 
55577); the Agency continues to believe that the action taken in 2001 
is reasonable and we have found no safe way to impose controls on the 
chamber exhaust vents. Approximately 1 percent of the ethylene oxide 
used in the process is emitted through the chamber exhaust vent.''
    Therefore, we have no basis to change conclusions presented in the 
proposal and will not impose controls on chamber exhaust emissions for 
either new or existing facilities.
    To assess the risk reduction associated with increasing the 
stringency of the standard for the main sterilizer vent from 99 to 99.9 
percent emission reduction, we looked at the five facilities with the 
highest estimated cancer risk (ETO 4, 5, 8, 18, 19, and 27). Only one 
commenter provided cost estimates to retrofit existing facilities to 
comply with a higher standard. This commenter estimated the retrofit 
costs to be approximately one million dollars per facility. Emissions 
from these five facilities range from approximately 0.3 to 4.5 tons per 
year and total 18 tons per year (Docket item EPA -HQ- OAR-2003 -0197--
0003, Table 2). Approximately 12 of the 18 tons are fugitive emissions 
from the chamber exhaust. Residual emissions i.e., emissions after the 
application of emission control devices from the main chamber and 
aeration vents for the five facilities with the highest estimated 
cancer risk (ETO 4, 5, 8, 18, 19, and 27) range from approximately 0 to 
1.6 tons per year, and are 4 tons per year in total (Docket item EPA-
HQ-OAR-2003-0197--0003 Table 2). Based on a $1 million capital 
investment per facility, a 7 percent discount rate, and a 10-year 
capital recovery period, the average cost per ton of emissions reduced 
for the five facilities is approximately $35,000. These estimates 
assume facilities complying with the 99 percent limit do not in 
practice achieve a higher efficiency than 99 percent and there are zero 
emissions from control devices complying with the 99.9 percent limit.
    To test the commenter's assertion that more stringent controls on 
the main and aeration vents would reduce risk levels, we remodeled the 
five facilities with the highest estimated cancer risk (ETO 4, 5, 8, 
18, 19, and 27) with the assumption that main vent and aeration vent 
emissions are essentially zero after a 99.9 percent reduction and we 
compared the results to the baseline risks estimates. The risks 
(estimated to one significant figure) changed for only one facility, 
for which the maximum individual risk was reduced from 90 in 1 million 
to 80 in 1 million. Although we did not remodel all facilities, similar 
results would be expected for the other facilities because of the high 
chamber exhaust emissions relative to the emissions from the main vent 
and aeration vent after 99 percent control. Therefore, for existing 
major sources we conclude in our ample margin of safety decision that 
further controls would achieve minimal emission and risk reductions at 
a very high cost.
    For existing sources under the 8 year review, in the proposal we 
stated, ``Because the three vents associated

[[Page 17718]]

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.'' The analysis presented above for the five 
facilities with the highest risk support the conclusion presented in 
the proposal.
    As stated above we believe for new main sterilizer vent and 
aeration control, increasing the stringency of the control limit from 
99 to 99.9 percent achieves only a minimal reduction in risk. 
Therefore, EPA does not find it necessary to increase the control limit 
for new facilities.
    Comment: One commenter stated EPA appropriately concluded that 
changes to the standard are not required to satisfy section 112(f) of 
the CAA. However, the commenter stated EPA did not provide sufficient 
data in the preamble to the document on the AMOS analysis that led to 
this conclusion, including its cost versus risk-reduction benefit 
analysis for a possible increase in the EO reduction requirements from 
99 percent to 99.9 percent.
    Response: As we stated in the proposal, we did not find any new 
technology or alternative controls for any vents for commercial EO 
sterilizers. We also found no data to support the addition of down 
stream control devices to existing controls as a way of further 
reducing emissions. We, therefore, concluded that further controls 
would achieve minimal reductions at a high cost. While we were aware of 
more stringent control limits at the State level, we stated in the 
proposal that we did not have data to confirm that all facilities are 
capable of meeting a more stringent level and solicited both control 
and cost data. Based on the data received from commenters we performed 
a risk assessment which confirmed our earlier qualitative conclusion.
    Comment: One commenter stated EPA's language suggests that the 
decision criterion is whether further reductions would ``meaningfully 
reduce emissions or risks.'' (70 FR 61408) The commenter stated that 
introducing the term ``meaningfully reduce'' without further explaining 
it is potentially misleading to the public. They were further troubled 
by the continued insertion of the word ``emissions'' in this 
formulation of the decision criteria as reinforced by the specific 
questions asked in this Federal Register notice.
    Response: EPA presented, in the proposal, its analysis and 
conclusions on residual risk and technology review. Under section 
112(d)(6), EPA is required to review the MACT standards and revise them 
as necessary taking into account developments in practices, processes 
and control technologies, no less frequently than every 8 years. 
Section 112(f)(2) requires us to determine for each source category 
whether the NESHAP protect public health with an ample margin of safety 
and prevent an adverse environmental effect. After reviewing and 
analyzing data under both these sections, EPA concluded that further 
controls would not meaningfully reduce emissions or risks. EPA reached 
this conclusion because the maximum individual cancer risk for this 
source category is already at the level we generally consider 
acceptable and that further controls would achieve minimal risk 
reduction at a very high cost. In addition, our conclusion referred to 
both emissions and risk because EPA's analysis included both the 
technology review and a residual risk determination.
    Comment: One commenter stated EPA's CAA section 112(d)(6) review of 
the source category correctly concluded that the NESHAP standards did 
not need to be revised. However, the commenter stated that EPA reached 
this conclusion after conducting an independent technology review 
instead of basing it on the conclusions of EPA's CAA section 112(f)(2) 
analysis, which showed that the source category achieves an AMOS that 
is not limited by cost or technological feasibility concerns. The 
commenter believes that EPA should have based its determination that 
further controls under 112(d)(6) are not required through the 112(f) 
AMOS determination. According to the commenter, EPA did not need to 
conduct a separate technology review because it considered the need for 
additional controls in its AMOS analysis. The commenter goes on to 
state that where the AMOS is based in large part on cost or technical 
feasibility concerns, which according to the commenter was not the case 
with EO sterilizer facilities, then further future review under CAA 
section 112(d)(6) may remain viable and additional controls may not be 
precluded if feasible control measures are identified. Further, the 
commenter states that in evaluating whether action is necessary under 
CAA section 112(d)(6), EPA should not apply a ``bright line'' 1 in 1 
million standard for cancer risks, nor a similar ``bright line'' 
standard for non-cancer risks.
    Response: Section 112(d)(6) of the CAA requires EPA to review, and 
revise as necessary (taking into account developments in practices, 
processes, and control technologies), emission standards promulgated 
under section 112 no less often than every 8 years. We disagree, 
therefore, that the Agency did not need to conduct a separate 
technology review because it considered, among other factors, the need 
for additional controls under its 112(f) analysis. As we noted in the 
preamble to the Coke Ovens residual risk rule, the findings that 
underlie a section 112(f) determination should be key factors in making 
any subsequent section 112(d)(6) determinations. However, as the word 
``subsequent'' indicates, we believe that we are obligated to perform 
the initial section 112(d)(6) analysis. Because the timing for the 
initial section 112(d)(6) analysis coincides with those of the residual 
risk analysis, it is appropriate for the Agency to conduct both 
analyses at the same time and for the results of the risk analysis to 
impact future section 112(d)(6) technology reviews. However, we agree 
with the commenters that a revision is not necessarily required under 
section 112(d)(6) even if cancer risks are greater than or equal to 1 
in 1 million. For example, it may be the case that a technology review 
is performed, but no change in the standard results from that review. 
In the preamble to the residual risk rule for Coke Ovens, we have 
applied a similar logic to the need for subsequent technology revisions 
under section 112(d)(6). As we stated in the Coke Ovens rule, if the 
ample margin of safety analysis for a section 112(f) standard shows 
that the remaining risk for non-threshold pollutants falls below 1 in 1 
million and for threshold pollutants falls below a similar threshold of 
safety, then further revision should not be needed because an ample 
margin of safety has already been assured.
    We generally agree that where an AMOS is based on cost or technical 
feasibility future review under Sec.  112(d)(6) may require additional 
controls if feasible control measures are identified. If the 
availability and/or costs of technology are part of the rationale for 
the ample margin of safety determination, it is reasonable to conclude 
that changes in those costs or in the availability of technology could 
alter our conclusions regarding the ample margin of safety. For this 
reason, we agree that revisions may be

[[Page 17719]]

appropriate if the ample margin of safety established by the residual 
risk process considers cost or technical feasibility. In the EO 
proposal, we noted that while some states required the facilities to 
meet a more stringent standard, we believed that the costs and 
feasibility concerns for implementing such a standard did not make 
adopting this standard a reasonable alternative. In addition, we noted 
in the preamble to the EO proposal that EPA had evaluated new 
technologies and alternatives during our investigation of the safety 
issue regarding chamber exhaust vents and concluded that controls on 
those vents were not technologically feasible and additional controls 
on these vents were limited because of the safety issues. [For a full 
discussion of the safety issues, see 66 FR Notice 55577.]

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), we 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.
    Pursuant to the terms of Executive Order 12866, OMB has notified us 
that it considers this a ``significant regulatory action'' within the 
meaning of the Executive Order. We have submitted this action to OMB 
for review. 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. 
However, OMB has previously approved the information collection 
requirements for the national emissions standards under the provisions 
of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned 
OMB control number 2060-0283, EPA ICR number 1666.06. A copy of the OMB 
approved Information Collection Request (ICR) may be obtained from 
Susan Auby, Collection Strategies Division; U.S. Environmental 
Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC 
20460 or by calling (202) 566-1672.
    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 our 
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
    We have established a public docket for this action, which includes 
the ICR, under Docket ID number EPA-HQ-OAR-2003-0197, which can be 
found in https://www.regulations.gov. Today's final 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 rule on small 
entities, small entity is defined as: (1) A small business as defined 
by the Small Business Administrations' regulations at 13 CFR 121.201; 
(2) a small governmental jurisdiction that is a government of a city, 
county, town, school district or special district with a population of 
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not 
dominant in its field.
    After considering the economic impacts of today's final decision on 
small entities, we have concluded that this action will not have a 
significant economic impact on a substantial number of small entities. 
We are taking no further action at this time to revise the national 
emission standards. Thus, the final decision will not impose any 
requirements on small entities. Today's final decision on the residual 
risk assessment and technology review for the national emission 
standards imposes no additional burden on facilities impacted by the 
national emission standards.

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, we 
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 a rule for which a written statement is 
needed, section 205 of the UMRA generally requires us 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 us 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 we establish any regulatory requirements that may 
significantly or uniquely affect small governments, including tribal 
governments, we 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

[[Page 17720]]

governments to have meaningful and timely input in the development of 
regulatory proposals with significant Federal intergovernmental 
mandates, and informing, educating, and advising small governments on 
compliance with the regulatory requirements.
    We have determined that today's final 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 final decision is not 
subject to the requirements of sections 202 and 205 of the UMRA. In 
addition, today's final 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 
final 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 us 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 final 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 
final 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 us 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 final 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 final decision.

G. Executive Order 13045: Protection of Children From Environmental 
Health & 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 we have reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, we 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 final decision is not subject to the Executive Order 
because it is not economically significant as defined in Executive 
Order 12866, and because, as explained earlier, 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 final decision is not an ``economically 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 final decision is not likely to have any adverse energy 
impacts.

I. National Technology Transfer and Advancement Act

    Under section 12(d) of the National Technology Transfer and 
Advancement 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 final decision does not involve technical standards. 
Therefore, the requirements of the NTTAA are not applicable.

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. We will submit a report containing this final decision 
and other required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the final decision in the Federal Register. A major 
rule cannot take effect until 60 days after it is published in the 
Federal Register.