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and by adding a new paragraph (h) to
read as follows:

ENVIRONMENTAL PROTECTION
AGENCY

§ 51.373

40 CFR Part 63

Implementation deadlines.

*

*
*
*
*
(b) For areas newly required to
implement basic I/M as a result of
designation under the 8-hour ozone
standard, the required program shall be
fully implemented no later than 4 years
after the effective date of designation
and classification under the 8-hour
ozone standard.
*
*
*
*
*
(d) For areas newly required to
implement enhanced I/M as a result of
designation under the 8-hour ozone
standard, the required program shall be
fully implemented no later than 4 years
after the effective date of designation
and classification under the 8-hour
ozone standard.
(e) [Reserved]
*
*
*
*
*
(h) For areas newly required to
implement either a basic or enhanced
I/M program as a result of being
designated and classified under the
8-hour ozone standard, such programs
shall begin OBD testing on subject OBDequipped vehicles coincident with
program start-up.
*
*
*
*
*
[FR Doc. 06–3317 Filed 4–6–06; 8:45 am]
BILLING CODE 6560–01–P

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

Ethylene Oxide Emissions Standards
for Sterilization Facilities
Environmental Protection
Agency (EPA).
ACTION: Final decision.
AGENCY:

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 http://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

Category

NAICS a

Industry .......................................................................................................

329112
339113
325412
311942
311423

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 http://
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.

Regulated
Entities. The regulated categories and
entities affected by the national
emission standards include:

SUPPLEMENTARY INFORMATION:

(SIC b)

Examples of regulated entities

(3841)
(3842)
(2834)
(2099)
(2034)

Operations at major and area
sources that sterilize or fumigate
medical
supplies,
pharmaceuticals, and spice.

Federal/State/ local/tribal governments.
a North

American Industry Classification System.
Industrial Classification.

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b Standard

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

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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

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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: http://
www.epa.gov/ttn/oarpg/. The TTN
provides information and technology
exchange in various areas of air
pollution control.

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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

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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,

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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

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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).

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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

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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

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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 colocation. In some cases, there is colocation 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 colocated 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.

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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

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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
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.

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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.
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
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.
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. http://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. http://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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EPA is currently developing an
updated cancer assessment for ethylene
oxide (http://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 mid2006, 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/m3), and
noted that EPA’s maximum acute
exposure estimate for this source
category (23 mg/m3) 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.

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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 reconduct 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

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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.

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Federal Register / Vol. 71, No. 67 / Friday, April 7, 2006 / Rules and Regulations
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 reevaluate 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

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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.

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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

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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

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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

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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
§ 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

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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.]

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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.

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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
http://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

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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

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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.

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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

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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.

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.

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.

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. This
action is not a ‘‘major rule’’ as defined
by 5 U.S.C. 804(2). The final decision
becomes effective on April 7, 2006.

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

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List of Subjects in 40 CFR Part 63
Environmental protection,
Administrative practice and procedures,
Air pollution control, Intergovernmental
relations, Reporting and recordkeeping
requirements.
Dated: March 31, 2006.
Stephen L. Johnson,
Administrator.
[FR Doc. 06–3314 Filed 4–6–06; 8:45 am]
BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2003–0161, FRL–8054–2]
RIN 2060–AK23

National Emission Standards for
Magnetic Tape Manufacturing
Operations
Environmental Protection
Agency (EPA).
ACTION: Final action.
AGENCY:

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07APR1