information on title V burdens and costs from the ICRs for part 70 and
71 (docket items 80 and 81), to evaluate the impact of title V on these
categories of area sources, including limitations on this information,
and the assumptions we made for them concerning title V burdens and
costs. Also, in the proposal, we acknowledged that these sources would
generally have fewer emissions units, that their operations are less
complex, and they would be simpler to permit, and we took these facts
into consideration in our analyses. During the public comment period,
no one submitted any information related to the area source categories
to substantiate their claims that title V burdens and costs would not
be significant for these area sources. Our review of comments and
further consideration of these issues has not led us to a contrary view
from the proposal. Thus, we find that factor two supports title V
exemptions for the categories of area sources addressed in today's
final rule.
    Also relevant to factor two and three in the proposal, one
commenter said that the EPA ignored Clean Air Act provisions designed
to limit title V costs for small sources, while another commenter said
States agencies are expected to have resources to meet this workload
and fees to offset costs. Section 502(b)(3)(A) of the Act requires
title V sources to pay annual fees, while section 507(f) of the Act,
concerning SBAP, provides that the permitting authority may reduce any
fee required under this Act to take into account the financial
resources of small business stationary sources. In response, title V
fees vary greatly from State to State, but because area sources have
small emissions by definition and most State agencies charge emissions-
based fees (on a per ton basis), fees would not comprise a substantial
portion of the overall costs and burdens for these area sources. As the
EPA explained in the proposal, there are many other burdens and costs
of title V, unrelated to fees, such that whether fees are reduced or
not, significant burdens and cost of title V would remain for these
area sources. Section 502(b)(3)(A) of the Act requires fees to be
charged that are sufficient to cover all reasonable (direct and
indirect) costs required to develop and administer the title V program.
However, there are practical limitations on the ability of State
agencies, tribes, and EPA to increase fees and provide additional
resources for title V implementation, especially in a relatively short
period of time. In many States, fee increases must typically be
approved by the State legislature within the State budget process, and
this may lead to significant delays in implementing new fee schedules
to meet new demands. This limitation could lead to significant, albeit
temporary, impairment of the title V programs for major sources, given
the large workload a requirement to permit

these area sources would impose on State agencies. For example, if all
these area sources were required to be permitted, up to 38,000 title V
permit applications would be due by December 9, 2005, and title V
permits for these sources would have to be issued or denied within 18
months of receipt of the applications, as required by section 503(a)
and 503(c) of the Act.
    Also relevant to factor two, one commenter pointed out that
difficulties in obtaining compliance assistance from State agencies
will be temporary. In response, EPA notes that even though such
difficulties may be temporary, they would come at a critical time for
sources and permitting authorities. For example, immediately upon
becoming subject to title V, an area source which does not typically
have employees trained in such matters, would need to quickly become
familiar with the critical and pressing step of completing and
submitting a permit application, required under Sec.  70.5 and Sec.
71.5. Since such applications are provided by individual permitting
agencies, access to the agency to obtain assistance and guidance on
completing the forms will be essential for area sources in order for
them to complete and submit them by the mandatory deadline, currently
December 9, 2005, in most jurisdictions. See 64 FR 69637, December 14,
1999, (setting the deadline of December 9, 2004 for deferrals to end).
In addition, before applications are distributed to area sources,
certain agencies may need to translate forms and other information into
foreign languages, which in the EPA's experience, is often needed for
small businesses, such as dry cleaners, in large urban communities, but
not typically necessary for major sources. [For example, see a fact
sheet developed for dry cleaners in Vietnamese, docket item 96 and the
equivalent form in English, docket item 97.]
    Another commenter thinks the title V costs would not be significant
for area sources because they would merely be passed on to consumers.
In response, no economic data for these categories of area sources were
submitted by the commenter or otherwise available to the EPA to support
this point, and any such assertion is entirely speculative. Costs
cannot necessarily be passed on to consumers in highly competitive
industries, or where there are highly price-responsive consumers. EPA
believes that these situations may exist for these sources, and that
passing prices on to consumers may, therefore, not be feasible for
them. The commenter provided no information on competition in these
industries, or on price-responsiveness of their consumers to support
his assertions.

D. What Is Our Analysis of Factor Four for the Final Rule?

    Commenters opposed to the EPA's reliance on the fourth factor in
the proposal, whether adequate oversight could achieve high compliance
with the NESHAP without title V, cited perceived flaws in the State
survey (docket item 02), including that it does not contain
representative data, that it has missing data, and that this missing
data means that existing compliance with the NESHAP is not high. The
proposal explained that information in the docket, including the State
survey, shows that many permitting authorities have alternative
compliance oversight programs that result in high NESHAP compliance
without title V. During the public comment period, the EPA received
comments from State and local agencies confirming this point. [See
docket items 11, 16, 59, 61, and 65]. The EPA undertook the survey to
collect information we thought would be relevant in our consideration
of possible title V exemptions, and we believe State and local agencies
made reasonable efforts to complete it. There is no definition for
``high'' compliance in the Act or EPA regulations, nor did the EPA
suggest one to State agencies. States are primarily responsible for
enforcement of the vast majority of Act requirements, including NESHAP,
through delegation of EPA responsibilities, approved State programs,
the SIP process, and other mechanisms, and we give considerable weight
to their judgement on questions concerning the compliance status of
sources. Moreover, even without such input from States, the EPA would
have reached the same conclusion regarding high compliance absent title
V because NESHAP are based on section 112 of the Act, which imposes
stringent compliance requirements, independent of title V, and because
States and EPA have adequate authority and actual implementation and
enforcement programs in place sufficient to assure compliance with
NESHAP, independent of title V.
    Also concerning factor four of the proposal, one commenter said
they believe Congressional intent was that these exemptions would only
apply when a reasonable alternative to title V permitting is actually
in place and achieving results, specifically citing the 1990
legislative history that the EPA ``is authorized to exempt sources from
the new permit program if the exemption would be consistent with the
Act's purposes. For example, the EPA may exempt certain small but
numerous sources from the requirement to obtain a permit if a
reasonable alternative is developed.'' S. Rep. No. 101-228, at 349
(1990). In response, the plain wording of the Senate Report is that it
is an ``example'' of a justification for a title V exemption. Title V
does not require EPA to develop such alternative programs as a
prerequisite to granting exemptions. In any event, as described below,
we believe there is existing authority in the Act and actual
implementation and enforcement programs in place, as required under
section 112, that are sufficient to assure compliance with these
NESHAP, and thus, high compliance can be achieved with the NESHAP
without title V in all jurisdictions where such sources may reside in
the nation.
    First. Statutory programs of implementation and enforcement of
NESHAP are conducted by EPA under the authority of sections 112, 113,
and 114 of the Act, while State and local agencies or tribes may be
granted delegation of this responsibility under section 112(l) of the
Act (implemented through subpart E of part 63). The EPA has primary
responsibility for implementation and enforcement of all NESHAP under
section 112 of the Act in all parts of the nation. Section 112(l)
allows EPA to delegate to State or local agencies or tribes certain of
its implementation and enforcement duties for NESHAP, based on a State
request to do so, and satisfaction of certain criteria. There are
several types of delegations, including ``straight delegation,'' which
is adoption of the NESHAP without change, or the delegate agency may
establish a program or rules to operate in place of the NESHAP,
provided the program or rules are ``no less stringent'' than the
NESHAP, and the delegate agency has adequate authority and resources to
implement and enforce the delegated NESHAP (under all delegation
options). Section 63.91(d) defines criteria that State and local
agencies or tribes are required to meet prior to approval of requests
for any type of NESHAP delegation, including that the request contain:
(1) Written findings from the Attorney General (or General Counsel for
local agencies and tribes) that they have certain legal authorities
concerning enforcement and compliance, (2) a copy of the State
statutes, regulations, and requirements that grant authority for them
to implement and enforce the NESHAP, (3) a demonstration that they have
adequate resources to implement and enforce all aspects of their NESHAP
program, except for authorities retained by EPA, and (4) a plan that
assures expeditious

compliance by all sources subject to the program. Also, depending on
the type of delegation requested, Sec. Sec.  63.92 through 63.95, and
Sec.  63.97 specify additional approval criteria. [Also, see section
112(l)(5), and the final rule for subpart E, 58 FR 62262, November 26,
1993, amended by 65 FR 55810, September 14, 2000]. In addition, under
section 112(l)(6) EPA has authority to withdraw its approval of a
delegation, or approval of an equivalent program or rule, if the
delegate agency is not adequately implementing or enforcing the NESHAP;
and under section 112(l)(7) EPA may enforce any NESHAP, including those
it has delegated. Thus, even if a State does not have adequate
authority to implement and enforce any NESHAP in their jurisdiction,
EPA does have such authority, consequently, there can be no gap in
implementation and enforcement for NESHAP that apply to area sources in
any jurisdiction. [For example, see EPA's final rule approving the
request of Indiana for delegation of all NESHAP for all sources not
covered by the State's part 70 program, 62 FR 36460, July 8, 1997,
docket item 98.]
    Second. The EPA has general authority for enforcement of NESHAP
under section 113, including authority to (1) issue an order requiring
compliance or assessing an administrative penalty; (2) bring a civil
action seeking to enjoin violations or the assessment of penalties; or
(3) bring a criminal action to punish knowing violations. Section 114
allows the EPA to determine if violations have occurred through
inspection, auditing, monitoring, recordkeeping, reporting, and entry
onto premises.
    Third. All States have established non-title V permitting programs,
which may include operating and preconstruction permitting programs for
minor sources, under section 110(a)(2)(C) of the Act. However, the EPA
notes that several States have reported that their non-title V permits
do not currently include NESHAP, so such permits would not always be
immediately available for this purpose. Although some State agencies
have established permitting programs under State law that include
NESHAP for area sources, some have not, either because they do not have
explicit State authority, or they have State authority, but they have
chosen to not implement such a program so far. See the State survey
(docket item 02), where States noted that they issue non-title V
permits for certain of these area sources.
    Fourth. All States and EPA are required to establish a small
business assistance program (SBAP) under section 507 of the Act. These
programs are required to assist small business with technical and
environmental compliance assistance, and they are not limited to title
V sources. Any activities for non-title V sources conducted by a SBAP
may be funded by non-title V fees at State option, and EPA matching
grants under section 105 of the Act may also be used for this
purpose.\8\ State SBAP programs are required by section 507 to provide
information on compliance methods, to have a small business ombudsman,
to provide assistance in determining applicable requirements and
permitting requirements under the Act, and to refer sources to
compliance auditors, or at State option, provide auditors for small
sources. [For example, see docket item 91, a fact sheet concerning an
SBAP implemented by a local air pollution control district.]
---------------------------------------------------------------------------

    \8\ For more on the use of matching grants, see a August 4, 1993
memorandum from John S. Seitz, Director, Office of Air Quality
Planning and Standards, U.S. EPA, ``Reissuance of Guidance on Agency
Review of State Fee Schedules for Operating Permit Programs under
Title V,'' and a July 21, 1994 memorandum from Mary D Nichols,
Assistant Administrator for Air and Radiation, U.S. EPA,
``Transition to Funding Portions of State and Local Air Programs
with Permit Fees Rather than Federal Grants.''
---------------------------------------------------------------------------

    Finally. States may have voluntary compliance assistance programs
in place for NESHAP requirements, such as the environmental results
programs (ERP) or other similar programs. The EPA has encouraged States
to adopt voluntary programs in the past, and the ERP, in particular,
has been successful in assisting small sources with compliance in
fourteen States across nine business-dominated sectors, including dry
cleaners in Massachusetts and Michigan. See 70 FR 15260. In addition to
the State survey, which includes information concerning State
permitting programs, inspection, and compliance assistance programs,
several permitting agencies submitted comments to describe their
alternative programs for non-title V sources in additional detail. [See
State and local comments, docket items 11, 16, 59, 61, and 65.]
Importantly, no comments were received from State agencies saying that
they would not be able to ensure compliance for these area sources if
we promulgate title V exemptions for them.

E. Are These Exemptions Consistent With the Legislative History of The
Act?

    Several commenters expressed concern that exemptions from title V
would adversely affect public health, welfare, or the environment by
weakening air quality standards, increasing HAP emissions, and by
increasing morbidity in human populations, and that this would be
inconsistent with the legislative history of section 502(a).
    In response, section 112 of the Act, which authorizes NESHAP, is
the primary vehicle under the Act for HAP reduction, not title V. See
sections 112(b)(2), 112(c)(3), 112(d), 112(f), and 112(k) of the Act.
For an overview of the EPA's national effort to regulate air toxics
under section 112, see a July 19, 1999 notice (64 FR 38705), which
includes a description of the EPA's integrated urban air toxics
strategy, a strategy to address public health risks posed by air toxics
from the large number of smaller area sources in urban areas. Today's
rulemaking is not exempting any area sources from any section 112
requirements, such as those described in the July 19 notice, and
section 112 gives the EPA, or its delegate agency, responsibility to
implement and enforce section 112 standards, independent of title V.
Thus, consistent with the legislative history and the EPA's analysis
for each category of area sources addressed in this rulemaking, title V
exemptions for these particular area sources will not thwart or in any
way interfere with the implementation and enforcement of section 112 of
the Act, and today's action should not adversely affect public health.
    The EPA does not believe HAP increases will occur from title V
exemptions for these area sources. The Act does not require emission
reductions through title V permits. As we explained in the proposal (70
FR 15255), the EPA's outreach in recent years has shown that several
State agencies believe, in their experience, implementing emissions
standards for area sources through permits did not result in increased
compliance with the emissions standards. EPA has evaluated the extent
to which title V could improve compliance for these NESHAP, and EPA
believes that successful implementation at such sources is better
achieved through compliance assistance efforts, such as compliance
outreach and education programs, rather than title V permits.
    One commenter asserted that title V permitting will not divert
resources from more significant sources because the Act requires State
and local agencies to charge adequate fees to cover the costs of the
title V program, including the costs of small business assistance
programs under section 507 of the Act, and adequate personnel to
administer the program, and because fees may be reduced for small
sources. This commenter apparently was taking issue with EPA's
statement in the proposal

that ``requiring permitting of area sources will likely cause, at least
in the first few years of implementation, permitting authorities to
shift resources away from assuring compliance for major sources with
existing permits to issuing new permits for area sources. This has the
potential, at least temporarily, to reduce the overall effectiveness of
the States' title V permit programs, which could potentially adversely
affect public health, welfare, or the environment.'' In response, EPA
notes that there are practical limitations on the ability of State
agencies, tribes, and EPA to increase fees and provide additional
resources for title V implementation, especially in a relatively short
period of time. As we described in the proposal (70 FR 15255), in many
States, fee increases must typically be approved by the State
legislature within the State budget process, and this may lead to
significant delays in implementing new fee schedules to meet new title
V demands. This limitation could lead to significant, albeit temporary,
impairment of the title V program for major sources, given the large
workload a requirement to permit these area sources would impose on
State agencies. For example, if all these area sources were required to
be permitted, up to 38,000 title V permit applications would be due by
December 9, 2005, and title V permits for these sources would have to
be issued or denied within 18 months of receipt of the applications, as
required by section 503(a) and 503(c) of the Act.

F. Is It Reasonable for EPA To Rely on the Information Cited in Support
of the Proposal?

    Several commenters complained about the information EPA collected
to support the findings of the proposal, particularly the State survey,
concluding that it was so flawed that the findings are arbitrary and
capricious under the APA or otherwise inconsistent with administrative
rulemaking requirements. We disagree. In developing the proposal, EPA
sought and relied on information from State agencies on the level of
oversight and compliance rates for the area sources addressed in
today's proposal. The results are summarized for each category of area
sources in the State survey (docket item 02). The EPA also sought input
from State small business ombudsmen and several trade associations, and
they responded with information on the area sources and compliance
assistance programs currently available to them. This information is
also in the docket. See docket items 03, 06, and 08.
    We have collected information we believe is useful and appropriate
under the statute to establish a rational basis for evaluating whether
the area sources addressed in today's rule satisfy the exemption
criteria of section 502(a) of the Act. We summarized our outreach
efforts and we collected cost and economic data, which we placed in the
docket prior to the proposal. We considered all information available
to us for this rulemaking, including that submitted during the public
comment period, in making our exemption findings. Also see section X
below for additional discussion of how this rulemaking satisfies
administrative rulemaking requirements.
    As to comments that the State survey is not complete, we believe
much of the missing information can be explained by two factors: (1)
State agency participation was voluntary, and (2) some States have more
or less of these area sources, so experience with them varies. We did
not base our decisions on missing data but on the data we have and our
judgement as air quality experts, and we did not assume any particular
meaning for missing data. Commenters had an opportunity to submit what
they consider to be more complete or accurate information on compliance
rates and the oversight activities of State agencies for these area
sources during the comment period, but they did not do so.
    Also, concerning information on burdens and costs of title V, for
the current ICR, we provided the public with our draft analysis of
burdens and costs under title V, including for general permits, and we
received no comments.

G. Are Permits Necessary To Define Monitoring for Chrome
Electroplaters?

    One commenter stated that the monitoring requirements of the chrome
electroplating NESHAP vary based on the type of control technique
employed and the range of acceptable values, or a minimum and maximum,
for each monitoring parameter at each area source, and that it would be
useful for the public, regulatory agencies, and the source for its
specific obligations to be spelled out in a permit.
    The chrome electroplating NESHAP has extensive requirements for
monitoring, recordkeeping, and reporting, including for monitoring
system performance tests, and a written report to document the results
of the performance test, which will document the monitoring techniques
employed and the parameter ranges that show compliance. The NESHAP
requires the source to conduct the performance tests needed to define
the monitoring parameters that assure compliance by the source with its
emissions limitations or standards, and this report is submitted to EPA
or a delegate agency with such responsibilities, as defined at Sec.
63.347(f), so neither the source or the regulatory agency will be
confused about the specific monitoring that applies to area sources,
absent a title V permit. Also, there is independent authority for
public disclosure of information related to compliance with NESHAP
under section 114(c) of the Act, which does not rely on title V for
implementation. Public disclosure authority under section 114(c) of the
Act extends to all information collected under NESHAP, even information
required to be kept on-site, rather than submitted directly, except for
trade secrets which may not be released to the public. Thus, if a
member of the public wants information on compliance with the NESHAP,
he or she may get it from the agency responsible for implementation and
enforcement of the NESHAP (either EPA, or the State or local agency, or
tribe), whether there is a title V permit or not. In addition, State or
local agencies, or tribes, are required to submit, as part of their
delegation request, a written finding by the State Attorney General (or
General Counsel for local agencies and tribes) that the State has legal
authority ``to request information from regulated sources regarding
their compliance status,'' under Sec.  63.91(d)(3)(i)(B), and legal
authority ``to inspect sources and any records required to determine a
source's compliance status,'' under Sec.  63.91(d)(3)(i)(C). Therefore,
title V is not necessary for State and local authorities to obtain
compliance information from regulated sources. While it is helpful for
the public, regulatory agencies, and the source for the specific
requirements to be defined in a permit, we do not believe it is
necessary for adequate compliance to occur, and we believe we have
shown in today's final rule that title V would be unnecessarily
burdensome on these area sources.

H. May Degreasers Be Exempted When There Are Multiple Applicable
Requirements?

    One commenter supports an exemption for degreasers, but only when
they are not subject to other applicable requirements. They think the
compliance requirements of the NESHAP will be substantially equivalent
to title V only when the source is subject to only this NESHAP and the
source is not subject to other NESHAP. In response, the EPA does not
agree with this comment for the

following reasons. First, there are cases where more than one NESHAP
for which a title V exemption is being finalized applies to degreasers,
for example, where a degreaser is located at a chrome electroplater.
But the requirements of the chrome electroplating and degreasing NESHAP
do not significantly overlap for the emission units at such facilities,
so this would not present a significant problem of complexity that
would justify the burdens associated with issuing title V permits for
such sources. Second, such concerns are largely offset by the relative
simplicity of the emission control requirements of the degreaser
NESHAP, which involves primarily work practice standards. For example,
lids are required to be kept on containers at all times when not in
use. However, EPA notes that where a degreaser is otherwise subject to
title V, it will not be exempt from permitting. Thus, because
degreasers are often collocated with major sources, as an adjunct to
the primary activity occurring at the major source, many degreasers
will be included in the major source permit for the collocated major
source. This is so because, as we have clarified elsewhere in this
preamble, major source permits must include all applicable
requirements, and these exemptions are only for title V requirements at
area sources.

I. Are the Compliance Requirements of the EO Sterilizer and Secondary
Aluminum NESHAP Substantially Equivalent to Title V?

    One commenter opined that the compliance requirements of the EO
sterilizer and secondary aluminum NESHAP are not substantially
equivalent to the compliance requirements of title V with respect to
our analysis of factor one for area sources subject to these NESHAP
because the EPA has no data to show how many sources employ continuous
monitoring methods, and even if continuous methods are used, the
reporting is not equivalent to title V reporting. Also, the commenter
pointed out that the EO sterilizer and secondary aluminum NESHAP do not
require an annual compliance certification (as does title V), and that
this is another reason why the compliance requirements of the NESHAP
and title V are not substantially equivalent as EPA proposed. Also,
responding to a specific request of the proposal for input on the value
of annual compliance certifications and the threat of enforcement for
false certification for area sources subject to these NESHAP, the
commenter said that completing a compliance certification will be
important in bringing about better compliance because the act of
signing one is not taken lightly and will produce positive results,
including greater compliance efforts, and the submittal of more
compliance plans.
    In the proposal, we compared the compliance requirements of the EO
sterilizer and secondary aluminum NESHAP with those of title V, and we
stated for both that the recordkeeping and reporting requirements are
substantially equivalent (the first factor), when sources employ
continuous monitoring methods to assure proper operation and
maintenance of control equipment, such as when sources use thermal
oxidizers for emission controls. Also, we said that sources that use
scrubbers as emission controls under both of these NESHAP employ
noncontinuous monitoring methods, and thus, the recordkeeping and
reporting requirements for them would not be substantially equivalent
to the compliance requirements of title V. Although we were not certain
of the number of area sources that employ continuous monitoring methods
under either of the two NESHAP, we stated a belief that most sources
would employ such methods, and we asked for comment on the percentage
of sources that employ them. See the March 25, 2005 proposal's
discussion of EO sterilizers (70 FR 15256) and secondary aluminum (70
FR 15258).
    For the final rule, we reviewed the EO sterilizer and secondary
aluminum NESHAP once again, and we now conclude that sources with
scrubbers are required to conduct ``continuous'' monitoring under the
NESHAP. Also, both of these NESHAP require sources that conduct
``continuous'' monitoring to submit excess emissions and continuous
monitoring system performance report and summary reports to assess
their compliance status on a semiannual basis, consistent with Sec.
63.10(e)(3). These NESHAP require these reports for sources that use
scrubbers for emissions controls, the same as they require them for
sources that use thermal oxidizers as emissions controls. Under the two
NESHAP, these reports provides compliance information that is
substantially equivalent to the requirements of Sec. Sec.
70.6(a)(3)(iii) and 71.6(a)(3)(iii) for deviation reports and six-month
monitoring reports (see explanation below). [Also, see discussion of
factor one for these area sources in sections IV.A, IV.E and IV.F, and
more on why title V monitoring and the monitoring in these NESHAP are
equivalent in section VIII.E.]
    The compliance information already required to be reported by these
two NESHAP is substantial, and similar to that required in annual
compliance certifications under title V [see Sec. Sec.  70.6(c)(5) and
71.6(c)(5)]. Also, the compliance reports required by the two NESHAP
require certification by a responsible official, which is defined
similarly in the two programs [see Sec.  63.2, and Sec. Sec.  70.2 and
71.2]. For these reasons, we conclude that the lack of an annual
compliance certification report under title V will not have a
significant impact on compliance for these NESHAP.
    Also, in response to the comment that the act of signing the
compliance certifications is valuable because it produces positive
compliance results and that these results will be lost if we exempt
these area sources from title V, we disagree that the title V
exemptions will have this effect for these NESHAP. We conclude this in
today's final rule because the EO sterilizer and secondary aluminum
NESHAP both require the excess emissions and continuous monitoring
system performance report and summary reports (described above) to be
certified by a responsible official, similar to how this is done for
title V. [See the requirements for certification by responsible
official of Sec.  63.363(a)(3) for EO sterilizers and Sec.
63.10(e)(3)(v) for secondary aluminum.]
    In the final rule, we conclude that the overall differences in
compliance requirements, after considering all monitoring,
recordkeeping, and reporting requirements, including the lack of annual
compliance certification, are not great enough to have a significant
impact on compliance for the EO sterilizer and secondary aluminum
NESHAP, and we conclude that the compliance requirements of the NESHAP
and title V rules are substantially equivalent. Thus, our analysis of
factor one for the final rule is that it supports a finding that title
V is ``unnecessary'' for compliance for area sources subject to the EO
sterilizer and secondary aluminum NESHAP, consistent with the
``unnecessarily burdensome'' criterion of section 502(a) of the Act.

J. Are the Proposed Revisions to EO Sterilizer NESHAP Appropriate?

    Several commenters were concerned that the proposed revision to
Sec.  63.360(f) would redefine what an ``area source'' is under the EO
sterilizer NESHAP, resulting in fewer area sources. Also, they stated
that the proposed rule change is inconsistent with the definition of
``major source'' and ``area source'' in section 112 of the Act, and

that it contradicts the proposed wording of Table 1 of Sec.  63.360,
which exempts ``area sources'' regardless of EO usage. Another
commenter recommended that the rule language be revised to be
consistent with parallel rule language for other subparts, which refers
to ``area sources.''
    In the final rule, Sec.  63.360(f) has been revised to specify that
exemptions from title V are for ``area sources,'' rather than ``sources
using less than 10 tons [of EO],'' as we proposed. The intent of the
proposal was to exempt area sources subject to the NESHAP from title V,
not to change the applicability of the NESHAP. The EPA's March 2004
implementation guidance for this NESHAP (docket item 88) is clear that
the definition of ``area source'' is the definition of Sec.  63.2,
which is based on actual emissions or potential to emit, and this
definition should be used for title V purposes under the NESHAP.\9\
Also, the guidance explains that usage of EO is the basis for
applicability of the emission standards for various types of vents,
under the NESHAP. Nevertheless, we are changing the rule language today
to clarify that ``area sources'' subject to this standard are exempted
from title V, and this change will not affect the NESHAP requirements
that apply to any existing sources. With this change, Sec.  63.360(f)
is now also consistent with Table 1 of Sec.  63.360, in the same
subpart, and with the rule language of subparts M, N, T and RRR, that
also refers to ``area sources.''
---------------------------------------------------------------------------

    \9\ U.S. EPA, Office of Air Quality Planning and Standards, EPA-
456/R-97-004, September 1997 (Updated March 2004), Ethylene Oxide
Commercial Sterilization and Fumigation Operations NESHAP
Implementation Document.
---------------------------------------------------------------------------

K. Are Title V Permits Allowed for Area Sources Exempted From Title V?

    Several commenters disagreed with the EPA's proposed approach of
not allowing permitting authorities to issue title V permits to area
sources that EPA has exempted from title V. These commenters did not
agree with EPA's proposed reading of section 502(a), 506(a), and 116 of
the Act as requiring this result. Also, they did not agree that
existing title V permits for such sources should be terminated,
suspended, or revoked after exemptions from title V take effect.
    Several commenters opined that EPA's proposed approach is
inconsistent with section 502(a) of the Act. The proposal explains that
section 502(a) of the Act grants the Administrator alone discretion to
define the universe of area sources subject to title V. It follows that
once the EPA exempts area sources through rulemaking, they may not be
permitted under title V. No other provision of the Act is more specific
on this matter than section 502(a). Similarly, an existing title V
permit for an area source that has been exempted from title V must be
revoked, terminated, or denied because the permit would conflict with
our interpretation of section 502(a) of the Act. We also believe
allowing title V permitting for area sources we have exempted would be
an obstacle to the implementation of title V both because of the
confusion and frustration such a situation would cause for the area
sources, based on the common sense meaning of the term ``exemption,''
and because State efforts at title V permitting would be better spent
addressing major sources and non-exempt area sources.
    Several commenters were concerned that EPA's interpretation of
section 502(a) of the Act is illegal because it conflicts with section
506(a), which allows States to have ``additional permitting
requirements not inconsistent with this chapter.'' In light of the
structure of section 502(a), EPA believes that section 506(a) is best
read as allowing States to establish additional permitting requirements
for sources that are already subject to title V permitting. Thus, under
the EPA's interpretation, there is no conflict between the two sections
because section 502(a) of the Act defines what sources must get a
permit, while section 506(a) of the Act allows States flexibility in
establishing permit requirements for sources properly subject to the
program.
    Several commenters stated that EPA's proposed reading of section
502(a) is illegal because it conflicts with section 116, which allows
States to issue title V permits to exempted area sources. We explained
in the proposal that section 116 of the Act allows State agencies to
issue non-title V permits to area sources that have been exempted from,
or are outside the scope of, the title V program. However, even if the
Act were ambiguous in this regard, EPA would exercise its discretion in
interpreting the Act to reach the same result. The EPA would do so to
avoid confusion for area sources, as described above, and to achieve
the policy benefits associated with having States direct their title V
efforts to major sources and non-exempt area sources.

L. Does This Rulemaking Disregard Cost Estimates for General Permits?

    Several commenters were concerned that we disregarded prior
estimates of title V costs for general permits and they believe that
these estimates show that title V costs would be sufficiently low that
title V would not be ``unnecessarily burdensome'' for the area sources
addressed in the proposal.
    In the discussion of burdens and cost of title V permitting in the
proposal (section II.A of the proposal), we stated that we did not have
specific estimates for the burdens and costs associated with general
permits for sources, but we described certain source activities
associated with the part 70 and 71 rules that would apply to sources,
whether they have a general or standard permit. Also, in section III of
the proposal we said that general permits would reduce burdens to some
extent for area sources but that the potential burden and cost
reductions would not be sufficient to alter our findings that title V
would be significant for area sources. To explain this last point in
more detail in the proposal, we reviewed each of the four factors we
used in our exemption analysis with respect to general permits, and we
concluded that title V will be ``unnecessarily burdensome'' for area
sources that are issued general permits, rather than standard permits.
(See 70 FR 15254 and 15258-15259.)
    One commenter pointed to a regulatory impact analysis (RIA) for
operating permits issued in 1992, saying we should have used the
estimate of $154 per year in that document in analyzing the costs
associated with general permits. In response, the RIA (Regulatory
Impact Analyses and Regulatory Flexibility Act Screening for Operating
Permits Regulations, U.S. EPA, Office of Air Quality Planning and
Standards, EPA-450/2-91-011, June 1992) did contain an estimate of $154
for the total annual costs for general permits, but it is inaccurate
and outdated because it was not based on actual implementation
experience, such as the cost estimates contained in the more recent
2004 ICR, which is based on actual implementation experience, and which
suggests significantly higher costs for general permits, on the order
of half the cost of standard permits (see more on the 2004 ICR below).
The part 70 rule was not effective until July 21, 1992, and
consequently, no State title V programs were approved until December of
1994, and no part 70 permits were issued in any jurisdiction until late
1996. [Also, the part 71 rule was not effective until July 31, 1996].
    One commenter said we disregarded information in the current ICR
for part 70 (issued in 2004), including ``re-application of general
permits'' at 2 burden hours for each title V source with a general
permit, compared to the estimate of ``permit renewal'' at 200 burden
hours for each title V source with a standard permit, which they
believe shows that title V costs for area

sources with general permits would not be significant (thus, not
``burdensome'' for them). In response, it was an oversight for us to
refer in the proposal to cost estimates in the 2000 ICR for part 70,
when an updated one, the 2004 ICR, was available; however, the 2004 ICR
does not support the commenter's claim that title V costs would not be
significant for these area sources. We referenced the 2000 ICR in our
proposal as indicating an average title V cost of $7,700 per source per
year, and noted that there were no specific estimates for general
permits. Similarly, the 2004 ICR indicates an average title V cost of
$7,300 per source per year, and, although it contains specific
estimates of title V costs for certain activities required for sources
with general permits, it does not provide specific estimates of title V
costs for all activities that would occur for such sources. For
example, the 2004 ICR lists twelve different activities that title V
sources would experience (see table 2, average source burden by
activity, page 16). The ICR lists all activities that may apply to a
typical source, not all that will necessarily apply to every source.
For example, there are burden hour estimates for three different types
of permit revisions, but not all sources may need any of these permit
revisions in any given year. The commenter is correct that the activity
of ``re-application of general permits'' at 2 burden hours per year
would only apply to sources with general permits, and that another
activity, ``permit renewal'' at 200 burden hours per year, would only
apply to sources with standard permits. Both of these activities
reflect the requirements of title V for sources to prepare permit
applications for permit renewals, which for general permits, may be
streamlined, compared to standard permits. [See Sec.  70.6(d)(2), which
allows applications for general permits, including permit renewal
applications, to ``deviate from the requirements of Sec.  70.5,'' which
applies for standard permits.] However, title V sources are subject to
many other activities the commenter did not acknowledge. For example,
another activity listed in the table, ``prepare monitoring reports'' at
80 hours per source per year, would apply to sources with general
permits and standard permits. [See the assumption section of the ICR
(page 36), which specifies that ``[a]ll sources with issued permits
(including those covered by general permits) will report monitoring
data semi-annually and compliance certifications annually.''] Also, the
2004 ICR is silent with respect to whether the remaining activities in
the table would be required of sources with general permits, but many
of them would apply to such sources because Sec.  70.6(d) requires
general permits to ``comply with all requirements applicable to other
part 70 permits.'' Certain of these remaining activities may be
streamlined or simplified for sources with general permits, compared to
sources with standard permits, but the ICR does not provide different
burden hour estimates to acknowledge these differences. For example,
sources with general permits would have to prepare an initial permit
application when they apply for coverage under the general permit,
consistent with Sec.  70.6(d)(2), but the ICR lists the activity of
``prepare application'' at 300 hours per source per year, without
estimating the potential reduction in burdens and costs that may occur
through streamlined permit applications for general permits. Although
the information in the 2004 ICR is more detailed, our analysis for the
final rule results in the same conclusion as our review of the 2000 ICR
for the proposal: That title V costs would be somewhat lower for
sources with general permits, compared to sources with standard
permits. Thus, the view of the commenter that title V costs would not
be significant for area sources with general permits is not supported
by the 2004 ICR.
    Another commenter criticized our reference in the proposal of the
$7,700 average cost estimate for title V sources, taken from the 2000
ICR, because that value reflects an average from among all sources,
including the biggest industrial facilities in the country, and the
costs to a smaller source obtaining either an individual or general
permit should be less. In response, EPA agrees that costs for area
sources are likely to be lower than the average cost of issuing all
title V permits to all sources, for the reasons indicated by the
commenter. EPA referenced the average cost of title V for all sources
in the proposal because the cost estimates of the ICRs are the best
estimates of title V costs available, even though they suffer from the
limitations noted by the commenter. EPA's assessment of costs and
burdens of title V for area sources covered by today's rule assumed
that costs would be lower than the average for all sources, but still
significant in light of the characteristics of the area sources. The
2004 ICR estimates average annual title V costs for all sources at
$7,300, and it also does not provide all the information one would need
to determine specific costs for area sources, whether they have general
or standard permits.
    Each ICR developed by EPA is based on the best information
available to the Agency at the time it is prepared, such that more
realistic estimates of burdens and costs for title V sources in general
would be found in more recent ICRs, as implementation experience is
gained. In addition, each ICR is approved by OMB for a set period of
time in the future (typically three years), until the next ICR is
approved, or the current ICR is extended.
    EPA relied to some extent on the information in the ICRs for this
rulemaking because it is the best information available on title V
burdens and costs and no one submitted any better information to
analyze title V burdens and costs for these area sources. EPA has
conducted outreach and provided a 60-day public comment period to
collect information on the costs and burdens for these sources for this
rulemaking, and we provided a similar opportunity for the current ICR.
No one submitted, or cited to, any more accurate and complete cost
estimates for general permits under title V than those available to
EPA. See the notice of March 23, 2004 (69 FR 13524) soliciting comment
on the current ICR (Attachment 1 of the current ICR).

IX. Effective Date of Today's Final Rule Under the Administrative
Procedure Act

    Section 553(d) of the Administrative Procedure Act (APA) generally
provides that rules may not take effect earlier than 30 days after they
are published in the Federal Register. However, section 553(d)(1) of
the APA, provides that a substantive rule which grants or recognizes an
exemption or relieves a restriction, may take effect earlier. Today's
final rule grants an exemption from title V permitting requirements for
a large number of area sources, so we make this final rule effective
immediately.

X. 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 regulatory action is ``significant'' and therefore
subject to Office of Management and Budget (OMB) review and the
requirements of the Executive Order. The Order defines a ``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,
adversely affecting in a material way the economy, a sector of the
economy,

productivity, competition, jobs, the environment, public health or
safety in State, local, or tribal governments or 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 entitlement, grants,
user fees, or loan programs of the rights and obligations of recipients
thereof; or
    4. Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    Under Executive Order 12866, it has been determined that this rule
is a ``significant regulatory action'' because it raises important
legal and policy issues. As such, this rule was submitted to OMB for
review. Because this rule exempts area sources that would be subject to
title V requirements absent this final rule, this final rule reduces
burdens on area sources, and thus it is not economically significant.
Also, area sources subject to the secondary lead NESHAP are already
subject to title V (since their earlier deferral has expired) and this
final rule does not change this, so this final rule does not change
burdens for them. The final rule does not impose any burdens and
therefore a detailed economic analysis is unnecessary.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
Instead, it reduces such burdens by exempting a large number of area
sources from title V requirements. However, the information collection
requirements in the existing regulations (parts 70 and 71) were
previously approved by OMB under the requirements of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. The existing ICR for part 70 is
assigned EPA ICR number 1587.06 and OMB control number 2060-0243; for
part 71, the EPA ICR number is 1713.05 and the OMB control number is
2060-0336. 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 20004 or by calling<PHONE_NUMBER>. Burden means
the total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or
for a federal agency. This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information. An agency may not conduct or
sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations in 40 CFR are listed in
40 CFR part 9.

C. Regulatory Flexibility Act (RFA)

    The RFA generally requires an Agency to conduct a regulatory
flexibility analysis of any rule subject to notice and comment
requirements 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 not-for-profit
enterprises, 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 that meets
the Small Business Administration size standards for small businesses
found in 13 CFR 121.201; (2) a small governmental jurisdiction that is
a government of a city, country, 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 rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may certify that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic effect
on all of the small entities subject to the rule.
    This rule reduces economic impacts on small entities by exempting
certain categories of ``non-major'' industrial sources from the
permitting requirements under title V of the Clean Air Act (Act). These
sources tend to be smaller businesses and there are estimated at up to
38,000 small entities. They are currently subject to title V permitting
(40 CFR parts 70 and 71) under previous rulemaking actions, and they
will remain subject to these requirements until we exempt them. We have
therefore concluded that today's final rule will relieve regulatory
burden for these affected small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating a rule for which a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least-costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply where they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least-
costly, most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, EPA must have developed
under section 203 of the UMRA a small government agency plan. The plan
must provide for notifying potentially affected small governments,
enabling officials of affected small governments to have meaningful and
timely input in the development of our regulatory proposals with
significant federal intergovernmental mandates, and informing,
educating, and advising small governments on compliance with the
regulatory requirements.
    Today's rule contains no federal mandates under the regulatory
provisions of title II of the UMRA for

State, local, or tribal governments or the private sector. Today's
final rule imposes no enforceable duty on any State, local or tribal
governments or the private sector. This final rule exempts a large
number of sources from title V operating permit programs, which will
reduce the duties government entities with title V programs would be
required to perform and it will remove the requirement for many private
sector entities to obtain operating permits under title V programs.
Therefore, today's action is not subject to the requirements of
sections 202 and 205 of the UMRA.
    In addition, EPA has determined that this final rule contains no
regulatory requirements that might significantly or uniquely affect
small governments. This final rule exempts a large number of area
sources from the requirement to obtain operating permits under title V.
As such it also removes the requirements for small governments with
approved operating permit programs to issue permits to those area
sources. Therefore, today's final rule is not subject to the
requirements of section 203 of the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. Today's rule will not impose any
new requirements under title V of the Clean Air Act, and it will not
affect the ability of States to issue non-title V permits to these area
sources, if they so choose. Accordingly, it will not substantially
alter the overall relationship or distribution of powers between
governments for the part 70 and part 71 operating permits programs.
Thus, Executive Order 13132 does not apply to this final rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, ``Consultation and Coordination with Indian
Tribal Governments (65 FR 67249, November 6, 2000), requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the federal government and the Indian tribes, or
on the distribution of power and responsibilities between the federal
government and Indian tribes.''
    This final rule does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, 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.
Today's action does not significantly or uniquely affect the
communities of Indian tribal governments. As discussed above, today's
action imposes no new requirements on Indian tribal governments under
title V of the Clean Air Act. Accordingly, the requirements of
Executive Order 13175 do not apply to this rule.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    Executive Order 13045, ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency 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.
    This final rule is not subject to the Executive Order because it is
not economically significant as defined in Executive Order 12866 and
because the Agency does not have reason to believe the environmental
health or safety risks addressed by this action present a
disproportionate risk to children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This final rule is not a ``significant energy action,'' as defined
in Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), because it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy. This
final rule exempts a large number of small sources from the obligation
to obtain an operating permit under title V of the Clean Air Act and is
not likely to have any adverse energy effects.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law No. 104-113, Section 12(d) (15 U.S.C.
272 note), directs EPA to use voluntary consensus standards in its
regulatory 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, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
    The NTTAA does not apply to this final rule because it does not
involve technical standards. Therefore, EPA did not consider the use of
any voluntary consensus standards.

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 rule 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 rule 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. Sec.  804(2). This rule will be effective December
19, 2005.

List of Subjects

40 CFR Part 63

    Administrative practice and procedure, Air pollution control,
Hazardous substances, Intergovernmental relations, Reporting and
recordkeeping requirements.

40 CFR Part 70

    Administrative practice and procedure, Air pollution control,
Intergovernmental relations, Reporting and recordkeeping requirements.

40 CFR Part 71

    Administrative practice and procedure, Air pollution control,
Reporting and recordkeeping requirements.

    Dated: December 9, 2005.
Stephen L. Johnson,
Administrator.

0
For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as set forth below.

PART 63--[AMENDED]

0
1. The authority citation for part 63 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart M--[Amended]

0
2. Section 63.320 is amended by revising paragraph (k) to read as
follows:

Sec.  63.320  Applicability.

* * * * *
    (k) If you are an owner or operator of an area source subject to
this subpart, you are exempt from the obligation to obtain a permit
under 40 CFR part 70 or 71, provided you are not required to obtain a
permit under 40 CFR 70.3(a) or 71.3(a) for a reason other than your
status as an area source under this subpart. Notwithstanding the
previous sentence, you must continue to comply with the provisions of
this subpart applicable to area sources.

Subpart N--[Amended]

0
3. Section 63.340 is amended by revising paragraph (e) to read as
follows:

Sec.  63.340  Applicability and designation of source.

* * * * *
    (e) If you are an owner or operator of an area source subject to
this subpart, you are exempt from the obligation to obtain a permit
under 40 CFR part 70 or 71, provided you are not required to obtain a
permit under 40 CFR 70.3(a) or 71.3(a) for a reason other than your
status as an area source under this subpart. Notwithstanding the
previous sentence, you must continue to comply with the provisions of
this subpart applicable to area sources.

0
4. Table 1 to Subpart N is amended by revising the entry for Sec.
63.1(c)(2) to read as follows:

  Table 1 to Subpart N of Part 63.--General Provisions Applicability to
                                Subpart N
------------------------------------------------------------------------
                                    Applies to
 General provisions reference       subpart N             Comment
------------------------------------------------------------------------

                              * * * * * * *
Sec.   63.1(c)(2).............  Yes..............  Sec.   63.340(e) of
                                                    Subpart N exempts
                                                    area sources from
                                                    the obligation to
                                                    obtain Title V
                                                    operating permits.

                              * * * * * * *
------------------------------------------------------------------------

Subpart O--[Amended]

0
5. Section 63.360 is amended by:
0
a. Revising the entry for Sec.  63.1(c)(2) in Table 1; and
0
b. Revising paragraph (f).
    The revisions read as follows:

Sec.  63.360  Applicability.

* * * * *

                    Table 1 of Section 63.360.--General Provisions Applicability to Subpart O
----------------------------------------------------------------------------------------------------------------
                                                               Applies to sources
             Reference                 Applies to using 10    using 1 to 10 tons in            Comment
                                       tons in subpart O a         subpart O a
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
63.1(c)(2).........................                        Yes                       Sec.   63.360(f) exempts
                                                                                area sources subject to
                                                                                this subpart from the
                                                                                obligation to obtain Title
                                                                                V operating permits.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (f) If you are an owner or operator of an area source subject to
this subpart, you are exempt from the obligation to obtain a permit
under 40 CFR part 70 or 71, provided you are not required to obtain a
permit under 40 CFR 70.3(a) or 71.3(a) for a reason other than your
status as an area source under this subpart. Notwithstanding the
previous sentence, you must continue to comply with the provisions of
this subpart applicable to area sources.
* * * * *

Subpart T--[Amended]

0
6. Section 63.460 is amended by adding paragraph (h) to read as
follows:

Sec.  63.460  Applicability and designation of source.

* * * * *
    (h) If you are an owner or operator of an area source subject to
this subpart, you are exempt from the obligation to obtain a permit
under 40 CFR part 70 or 71, provided you are not required to obtain a
permit under 40 CFR 70.3(a) or 71.3(a) for a reason other than your

status as an area source under this subpart. Notwithstanding the
previous sentence, you must continue to comply with the provisions of
this subpart applicable to area sources.

Sec.  63.468  [Amended]

0
7. Section 63.468 is amended by removing and reserving paragraph (j).
0
8. Appendix B to Subpart T is amended by revising the entry for Sec.
63.1(c)(2) to read as follows:

               Appendix B to Subpart T of Part 63.--General Provisions Applicability to Subpart T
----------------------------------------------------------------------------------------------------------------
                                                  Applies to subpart T
             Reference              ------------------------------------------------           Comment
                                               BCC                     BVI
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Sec.   63.1(c)(2)..................  Yes...................  Yes...................  Subpart T, Sec.   63.460(h)
                                                                                exempts area sources
                                                                                subject to this subpart
                                                                                from the obligation to
                                                                                obtain Title V operating
                                                                                permits.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

Subpart RRR--[Amended]

0
9. Section 63.1500 is amended by revising paragraph (e) to read as
follows:

Sec.  63.1500  Applicability.

* * * * *
    (e) If you are an owner or operator of an area source subject to
this subpart, you are exempt from the obligation to obtain a permit
under 40 CFR part 70 or 71, provided you are not required to obtain a
permit under 40 CFR 70.3(a) or 71.3(a) for a reason other than your
status as an area source under this subpart. Notwithstanding the
previous sentence, you must continue to comply with the provisions of
this subpart applicable to area sources.
* * * * *

0
10. Appendix A to Subpart RRR is amended by revising the entry for
Sec.  63.1(c)(2) to read as follows:

             Appendix A to Subpart RRR of Part 63.--General Provisions Applicability to Subpart RRR
----------------------------------------------------------------------------------------------------------------
              Citation                     Requirement           Applies to RRR                Comment
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Sec.   63.1(c)(2)..................  ......................  Yes...................  Sec.   63.1500(e) exempts
                                                                                area sources subject to
                                                                                this subpart from the
                                                                                obligation to obtain Title
                                                                                V operating permits.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

PART 70--[AMENDED]

0
1. The authority citation for part 70 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

0
2. Section 70.3 is amended as follows:
0
a. By revising paragraph (a) introductory text.
0
b. By removing and reserving paragraph (b)(3).
0
c. By revising paragraph (b)(4) introductory text.

Sec.  70.3  Applicability.

    (a) Part 70 sources. A State program with whole or partial approval
under this part must provide for permitting of the following sources:
* * * * *
    (b) * * *
    (4) The following source categories are exempted from the
obligation to obtain a part 70 permit:
* * * * *

PART 71--[AMENDED]

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Sec.  71.3  [Amended]

0
2. Section 71.3 is amended by removing and reserving paragraph (b)(3).

[FR Doc. 05-24072 Filed 12-16-05; 8:45 am]

BILLING CODE 6560-50-P


From: " Fulmer, Kevin" < KMF@ adem. state. al. us Sent: 05/ 29/ 03 12: 08 PM To: Lynn Dail/ RTP/ USEPA/ US@ EPA cc: Subject: RE: Residual Risk Project with Magnetic Tape facility: Sony, Dothan, AL AFTER FURTHER INVESTIGATION BY SONY OFFICIALS, IT WAS FOUND THAT THERE WERE ADDITIONAL COBALT THAT WAS BEING ASSIGNED TO EMISSIONS THAT COULD BE ACCOUNTED F OR. THIS HAS BEEN UPDATED IN THE ATTACHED SPREADSHEET FOR EMISSIONS. PLEASE CO NTACT ME IF YOU HAVE ????

BYE!!!!!!! KEVIN M. FULMER KMF@ ADEM. STATE. AL. US ( 334) 271 7861 ( See attached file: AME COBALT EMMISION SUMMARY REPORT revised. xls)


This file set contains Appendices C and D of the memorandum from Katie Hanks and Kevin McGinn, USEPA, and Cybele Brockmann, RTI International to the PCWP Docket File titled, "Regulatory Options for Combustion-Related HAP From Plywood and Composite Wood Products Direct-Fired Dryers." December 8, 2022


[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3611-3614]
[DOCID:fr21ja09-86]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0008]

Draft Guidance for Industry on Citizen Petitions and Petitions
for Stay of Action Subject to Section 505(q) of the Federal Food, Drug,
and Cosmetic Act; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Citizen
Petitions and Petitions for Stay of Action Subject to Section 505(q) of
the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug
Administration Amendments Act of 2007 (FDAAA) added new provisions to
the Federal Food, Drug, and Cosmetic Act (the act) addressing the
agency's treatment of certain citizen petitions and petitions for stay
of agency action (collectively, petitions), as well as related
applications. The draft guidance describes how FDA will determine if
the new provisions apply to a particular petition and how FDA will
determine if a petition would delay approval of a pending abbreviated
new drug application (ANDA) or 505(b)(2) application. The draft
guidance also describes how FDA will interpret the requirements that
such petitions include a certification and that supplemental
information or comments to such petitions include a verification. The
draft guidance also addresses the relationship between the review of
petitions and pending ANDAs and 505(b)(2) applications for which the
agency has not yet made a decision on approvability.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance,
including comments regarding the proposed collection of information, by
March 23, 2009.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Nancy Boocker, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Citizen Petitions and Petitions for Stay of Action Subject
to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' The
draft guidance provides information regarding FDA's current thinking on
interpreting section 914 of Title IX of FDAAA (Public Law 110-85).
Section 914 of FDAAA added new section 505(q) to the act (21 U.S.C.
355(q)) and governs certain citizen petitions and petitions for stay of
agency action that request that FDA take any form of action related to
a pending application submitted under section 505(b)(2) or 505(j) of
the act. The draft guidance describes FDA's interpretation of section
505(q) of the act regarding how the agency will determine if: (1) The
provisions of section 505(q) addressing the treatment of citizen
petitions and petitions for stay of agency action (collectively,
petitions) apply to a particular petition and (2) a petition would
delay approval of a pending ANDA or a 505(b)(2) application. The draft
guidance also describes how FDA will interpret the provisions of
section 505(q) requiring that: (1) A petition include a certification
and (2) supplemental information or comments to a petition include a
verification. Finally, the draft guidance addresses the relationship
between the review of petitions and pending ANDAs and 505(b)(2)
applications for which the agency has not yet made a decision on
approvability.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on citizen
petitions and petitions for stay of action that are subject to section
505(q) of the act. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA),
Federal agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information set forth
in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Citizen Petitions and Petitions for Stay of Action Subject
to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.
    Description of Respondents: Respondents to this collection of
information as it is related to citizen petitions are individuals or
households, State or local governments, not-for-profit institutions,
and businesses or other for-profit institutions or groups. Respondents
to this collection of information as it is related to petitions for
stay of agency action are persons who choose to file a petition for an
administrative stay of action.
    Burden Estimate: FDA is requesting public comment on estimates of
annual submissions from these respondents, as required by section
505(q) of the act and described in this draft guidance. Section
505(q)(1)(H) of the act requires that citizen petitions and petitions
for stay of agency action that are subject to section 505(q) include a
certification to be considered for review by FDA. Section 505(q)(1)(I)
of the act requires that supplemental information or comments to such
citizen petitions and petitions for stay of agency action include a
verification to be accepted for review by FDA. The draft guidance
describes our current thinking on the interpretation of these
requirements. The draft guidance sets forth the criteria the agency
will use in determining if the provisions of section 505(q) apply to a
particular citizen petition or petition for stay of agency action. One
of the criteria for a citizen petition or petition for stay of agency
action to be subject to section 505(q) of the act is that a related
ANDA or 505(b)(2) application is pending at the time the citizen
petition or petition for stay is submitted. Because petitioners or
commenters may not be aware of the existence of a pending ANDA or
505(b)(2) application, the draft guidance recommends that all
petitioners challenging the approvability of a possible ANDA or
505(b)(2) application include the certification required in section
505(q)(1)(H) of the act and that petitioners and commenters submitting
supplements or comments, respectively, to a citizen petition or
petition for stay of action challenging the approvability of a possible
ANDA or 505(b)(2) application include the verification required in
section 505(q)(1)(I) of the act. The draft guidance also recommends
that if a petitioner submits a citizen petition or petition for stay of
agency action that is missing the required certification but is
otherwise within the scope of section 505(q) of the act and the
petitioner would like FDA to review the citizen petition or petition
for stay of agency action, the petitioner should submit a letter
withdrawing the deficient petition and submit a new petition that
contains the required certification.
    FDA currently has OMB approval for the collection of information
entitled, ``General Administrative Procedures: Citizen Petitions;
Petition for Reconsideration or Stay of Action; Advisory Opinions''
(OMB Control Number 0910-0183). This collection of information
includes, among other things: (1) The format and procedures by which an
interested person may submit to FDA, in accordance with Sec.  10.20 (21
CFR 10.20), a citizen petition requesting the Commissioner of Food and
Drugs (Commissioner) to issue, amend, or revoke a regulation or order,
or to take or refrain from taking any other form of administrative
action (Sec.  10.30(b) (21 CFR 10.30(b))); (2) the submission of
written comments on a filed citizen petition (Sec.  10.30(d)); (3) the
submission of a supplement or amendment to or a letter to withdraw a
filed citizen petition (Sec.  10.30(g)); (4) the format and procedures
by which an interested person may request, in accordance with Sec.
10.20, the Commissioner to stay the effective date of any
administrative action (Sec.  10.35(b) (21 CFR 10.35(b))); and (5) the
submission of written comments on a filed petition for administrative
stay of action (Sec.  10.35(c)). This information collection includes
citizen petitions, petitions for administrative stay of action,
comments to petitions, supplements to citizen petitions, and letters to
withdraw a citizen petition, as described above, that are subject to
section 505(q) of the act and described in the draft guidance.
    Under section 505(q) of the act and the draft guidance, the
following information would be submitted to FDA but is not currently
approved by OMB under the PRA:
    1. The certification required under section 505(q)(1)(H) of the act
for citizen petitions that are subject to section 505(q) and/or that
are challenging the approvability of a possible ANDA or 505(b)(2)
application. Although the submission of a certification for citizen
petitions is approved under OMB Control Number 0910-0183, the
certification would be broadened under section 505(q) of the act and
the draft guidance.
    2. The certification required under section 505(q)(1)(H) of the act
for petitions for stay of action that are subject to section 505(q)
and/or that are challenging the approvability of a possible ANDA or
505(b)(2) application.
    3. The verification required under section 505(q)(1)(I) of the act
for comments to citizen petitions.
    4. The verification required under section 505(q)(1)(I) of the act
for comments to petitions for stay of agency action.
    5. The verification required under section 505(q)(1)(I) of the act
for supplements to citizen petitions.
    6. Supplements to petitions for stay of agency action and the
verification required under section 505(q)(1)(I) of the act.
    7. The letter submitted by a petitioner withdrawing a deficient
petition for stay of agency action that is missing the required
certification but is otherwise within the scope of section 505(q) of
the act.
    Section 505(q)(1)(B) and (C) of the act and the draft guidance
state that if FDA determines that a delay in approval of an ANDA or
505(b)(2) application is necessary based on a petition subject to
section 505(q) of the act, the applicant may submit to the petition
docket clarifications or additional data to allow FDA to review the
petition promptly. This information collection is not included in this
analysis because it is approved under OMB Control Number 0910-0001 (21
CFR 314.54, 314.94, and 314.102).
    Based on FDA's knowledge of citizen petitions and petitions for
stay of agency action subject to section 505(q) of the act that have
been submitted since September 27, 2007, as well as the agency's
familiarity with the time needed to prepare a certification and a

verification, our estimates for this information collection are as
follows:
    1. The certification currently submitted for a citizen petition
would be broadened under section 505(q) of the act and the draft
guidance. FDA estimates that it will receive annually approximately 25
certifications under section 505(q)(1)(H) of the act for citizen
petitions that are subject to section 505(q) and/or that are
challenging the approvability of a possible ANDA or 505(b)(2)
application. FDA estimates that approximately 19 respondents will
submit these certifications and that each certification will take
approximately 30 minutes to prepare.
    2. FDA estimates that it will receive annually approximately three
certifications under section 505(q)(1)(H) of the act for petitions for
stay of action that are subject to section 505(q) and/or that are
challenging the approvability of a possible ANDA or 505(b)(2)
application. FDA estimates that approximately three respondents will
submit these certifications and that each certification will take
approximately 30 minutes to prepare.
    3. FDA estimates that it will receive annually approximately 12
verifications required under section 505(q)(1)(I) of the act for
comments to citizen petitions. FDA estimates that approximately nine
respondents will submit these verifications, and that each verification
will take approximately 30 minutes to prepare.
    4. FDA estimates that it will receive annually approximately two
verifications required under section 505(q)(1)(I) of the act for
comments to petitions for stay of agency action. FDA estimates that
approximately two respondents will submit these verifications and that
each verification will take approximately 30 minutes to prepare.
    5. FDA estimates that it will receive annually approximately 10
verifications required under section 505(q)(1)(I) of the act for
supplements to citizen petitions. FDA estimates that approximately
seven respondents will submit these verifications and that each
verification will take approximately 30 minutes to prepare.
    6. FDA estimates that it will receive annually approximately one
supplement to petitions for stay of agency action as described under
section 505(q)(1)(I) of the act, that approximately one respondent will
submit this supplement, and that each supplement will take
approximately 6 hours to prepare. FDA estimates that it will receive
annually approximately one verification required under section
505(q)(1)(I) of the act for supplements to petitions for stay of agency
action, that approximately one respondent will submit this
verification, and that each verification will take approximately 30
minutes to prepare.
    7. FDA estimates that it will receive annually approximately one
letter from petitioners withdrawing a deficient petition for stay of
agency action that is missing the required certification but is
otherwise within the scope of section 505(q) of the act. FDA estimates
that approximately one respondent will submit this letter and that the
letter will take approximately 30 minutes to prepare.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Number of        Annual Frequency       Total annual        Hours per
                                                           Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification for citizen petitions                                    19                  1.32                 25                0.5               12.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification for petitions for stay of agency action                   3                     1                  3                0.5                1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Verification for comments to citizen petitions                          9                  1.33                 12                0.5                6.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Verification for comments to petitions for stay of                      2                     1                  2                0.5                1.0
 agency action
--------------------------------------------------------------------------------------------------------------------------------------------------------
Verification for supplements to citizen petitions                       7                  1.43                 10                0.5                5.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplements to petitions for stay of agency action and                  1                     1                  1                6.5                6.5
 the verification for the supplement
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter withdrawing a petition for stay of agency                        1                     1                  1                0.5                0.5
 action
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours                                                                                33.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Therefore, the estimated annual reporting burden for this
information collection is 33 hours.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: January 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-937 Filed 1-16-09; 8:45 am]

BILLING CODE 4160-01-S