Document ID: EPA-HQ-OAR-2003-0062-0243
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-04-25T04:00Z

A.	Executive Order 12866:  Regulatory Planning and Review

  SEQ CHAPTER \h \r 1 Under section 3(f)(1) of Executive Order (EO)
12866 (58 FR 51735, October 4, 1993), this action is an “economically
significant regulatory action.”  Implementation of the PM2.5 NAAQS is
likely to have an annual effect on the economy of $100 million or more. 
Accordingly, EPA submitted this action to the Office of Management and
Budget (OMB) for review under EO 12866 and any changes made in response
to OMB recommendations have been documented in the docket for this
action.  For clarity, we note that the estimated costs and benefits of
implementing the 1997 PM2.5 NAAQS are not created by this rule, because
the Clean Air Act requires state implementation of the 1997 PM2.5
standards (through state development of plans with enforceable
requirements for sources) on a statutory timetable regardless of whether
EPA issues this rule interpreting the statutory requirements.  The rule
reflects the statutory requirements and does not add further costs.

In addition, as part of the “Regulatory Impact Analysis for
Particulate Matter National Ambient Air Quality Standards (September
2006),” EPA prepared an assessment of the estimated costs and benefits
associated with attaining the 1997 PM2.5 NAAQS in 2015, incremental to
currently promulgated federal and state programs including for example
the Clean Air Interstate Rule, the Nonroad Diesel Rule, and other
programs.  This analysis is included as Appendix A of the report and is
available in the docket for this action and on EPA’s website at:   
HYPERLINK
"http://www.epa.gov/ttn/ecas/regdata/RIAs/Appendix%20A--2015%20Analysis.
pdf" 
http://www.epa.gov/ttn/ecas/regdata/RIAs/Appendix%20A--2015%20Analysis.p
df .  This illustrative analysis finds that the estimated monetized
benefits of attaining the 1997 standards in 2015 are between $43 billion
and $97 billion annually, and the estimated monetized costs are $6.7
billion annually.  The RIA states:  “Note that because this analysis
was intended to compare costs and benefits of attaining alternative
standards by fixed dates, it did not attempt to identify for each
designated PM2.5 area measures that may be needed to meet subpart 1
Clean Air Act requirements, such as reasonably available measures and
attainment as expeditiously as practicable.  It is expected that
additional costs and benefits will begin to accrue in earlier years as
states comply with these requirements.” 

B.	Paperwork Reduction Act

The information collection requirements in this rule have been submitted
for approval to the Office of Management and Budget (OMB) under the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq.  In a separate Federal
Register notice published today, EPA is requesting comment on the
information collection requirements of this rule.  The information
collection requirements are not enforceable until OMB approves them.  

	The data collected from the State or local air agency respondents will
include the required SIP elements prescribed in CAA sections 110 and
part D, subpart 1 of title I for Implementation plans and the
requirements in this Implementation Rule (40 CFR 51.1000 – 51.1012). 
The PM2.5 SIP will contains rules and other requirements designed to
achieve the NAAQS by the deadlines established under the CAA, and it
also contains a demonstration that the State’s requirements will in
fact result in attainment.  The SIP must meet the requirements in
subpart 1 to adopt RACM, RACT, and provide for RFP toward attainment for
the period prior to the area’s attainment date.  

The Agency anticipates additional administrative burden during the 3
year period of the ICR for State governments and the Agency of 630,000
hours and 69,300 hours, respectively.  Fifty percent of the hours are
expended in the first year with the remainder evenly divided between the
second and third years of the ICR period.  Tribes are not required to
conduct attainment demonstrations or submit the RFP, RACT, or RACM
requirements.  

The present value of the total additional costs for State governments,
the respondents,  is estimated at $33.4 million for the 3 year period. 
On an equivalent annual basis that is $12.7 million per year during the
3 year period of the ICR.  The present value of the Agency
administrative cost burden is estimated at $3.7 million dollars for the
3 year period.  This is equivalent to an equal annual stream of costs of
$1.4 million per year during the three year period. 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.  When this ICR is approved by
OMB, the Agency will publish a technical amendment to 40 CFR part 9 in
the Federal Register to display the OMB control number for the approved
information collection requirements contained in this final rule.

C.	Regulatory Flexibility Act

	The Regulatory Flexibility Act (RFA) generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities.  Small entities include small businesses, small organizations,
and small governmental jurisdictions.  

For purposes of assessing the impacts of this final action on small
entities, small entity is defined as: (1) a small business as defined by
the Small Business Administration’s (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000; or (3) a small organization that is any
not-for-profit enterprise that is independently owned and operated and
is not dominant in its field.

	After considering the economic impacts of this final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities and it is not
necessary to prepare a regulatory flexibility analysis in conjunction
with this final rule.  The final rule governing SIPs will not directly
impose any requirements on small entities.  Rather, this rule interprets
the obligations established in the CAA for States to submit
implementation plans in order to attain the PM2.5 NAAQS. 

D. 	Unfunded Mandates Reform Act  tc \l2 "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
1 year.  Before promulgating an EPA rule for which a written statement
is needed, EPA is required by section 205 of the UMRA to identify and
consider a reasonable number of regulatory alternatives, and adopt the
least costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule.  The provisions of section 205 do
not apply when they are inconsistent with applicable law.  Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.  Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan.  The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.

	This rule contains no Federal mandate that may result in expenditures
of $100 million or more for State, local, and Tribal governments, in the
aggregate, or the private sector in any 1 year.  The estimated
administrative burden hours and costs associated with implementing the
PM2.5 NAAQS are estimated in the ICR for this rule.  The estimated costs
presented there for States totals $33.4 million for a three-year period.
 Thus, this rule is not subject to the requirements of section 202 and
205 of the UMRA.  The EPA consulted with governmental entities affected
by this rule and has determined that this rule contains no regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments.  

	The CAA imposes the obligation for States to submit SIPs to implement
the PM2.5 NAAQS.  In this rule, EPA is merely providing an
interpretation of those requirements.  However, even if this rule did
establish an independent requirement for States to submit SIPs, it is
questionable whether a requirement to submit a SIP revision would
constitute a Federal mandate in any case.  The obligation for a State to
submit a SIP that arises out of section 110 and section 172 (part D) of
the CAA is not legally enforceable by a court of law, and at most is a
condition for continued receipt of highway funds.  Therefore, it is
possible to view an action requiring such a submittal as not creating
any enforceable duty within the meaning of section 421(5)(9a)(I) of UMRA
(2 U.S.C. 658(a)(I)).  Even if it did, the duty could be viewed as
falling within the exception for a condition of Federal assistance under
section 421(5)(a)(i)(I) of UMRA (2 U.S.C. 658(5)(a)(i)(I)).

E.  Executive Order 13132: Federalism  tc \l2 "Executive Order 13132:
Federalism 

	Executive Order 13132, entitled “Federalism” (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
“meaningful and timely input by State and local officials in the
development of regulatory policies that have Federalism implications.”
 “Policies that have Federalism implications” is defined in the
Executive Order to include regulations that have “substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.”

	 At the time of proposal, EPA concluded that the proposed rule would
not have any federalism implications.  The EPA stated that the proposed
rule would 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.  The CAA establishes
the scheme whereby States take the lead in developing plans to meet the
NAAQS.  This rule clarifies the statutory obligations of States in
implementing the PM2.5 NAAQS.  However, EPA recognized that States would
have a substantial interest in this rule and any corresponding revisions
to associated SIP requirements.  As described in section D, above (on
UMRA), EPA previously determined the costs to States to implement the
PM2.5 NAAQS to be $33.4 million.  This rule clarifies the statutory
obligations of States in implementing the PM2.5 NAAQS.  Finally, the CAA
establishes the scheme whereby States take the lead in developing plans
to meet the NAAQS.  This final rule would not modify the relationship of
the States and EPA for purposes of developing programs to implement the
NAAQS. 

Therefore, in the spirit of Executive Order 12132, and consistent with
EPA policy to promote communications between EPA and State and local
governments, EPA held a number of calls with representatives of State
and local air pollution control agencies and hosted a public hearing in
Washington, DC in November 2005. The EPA considered the comments from
State and local governments in developing the final rule.

	Therefore, EPA concludes that 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.The
final rule will not modify the relationship of the States and EPA for
purposes of developing programs to implement the NAAQS.  The rule does
not alter the relationship between the Federal government and the States
regarding the establishment and implementation of air quality
improvement programs as codified in the CAA.  Finally, as noted above in
section ED on UMRA, this rule does not impose significant costs on
State, local, or Tribal governments or the private sector.  (EPA
estimates the costs to States to implement the PM2.5 NAAQS to be $33.4
million.)  Thus, Executive Order 13132 does not apply to this rule.

F.	Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments  tc \l2 "Executive Order 13175: Consultation and
Coordination with Indian Tribal Governments 

	Executive Order 13175, entitled "Consultation and Coordination with
Indian Tribal Governments" (65 FR 67249, November 9, 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."  This final rule does not have "Tribal
implications" as defined in Executive Order 13175.  This rule concerns
the requirements for State and tribal implementation plans for attaining
the PM2.5 air quality standards.  The CAA provides for States to develop
plans to regulate emissions of air pollutants within their
jurisdictions.  The Tribal Air Rule (TAR) under the CAA gives Tribes the
opportunity to develop and implement CAA programs such as programs to
attain and maintain the PM2.5 NAAQS, but it leaves to the discretion of
the Tribe the decision of whether to develop these programs and which
programs, or appropriate elements of a program, they will adopt. 

Although Executive Order 13175 does not apply to this rule, EPA did
reach out to Tribal leaders and environmental staff in developing this
rule.  From 2001 – 2004, the EPA supported a National Designations
Workgroup to provide a forum for tribal professionals to give input to
the designations process.  In 2006, EPA supported a national "Tribal Air
call" which provides an open forum for all Tribes to voice concerns to
EPA about the NAAQS implementation process, including the PM2.5 NAAQS. 
In these meetings, EPA briefed call participants and Tribal
environmental professionals gave input as the rule was under
development. Furthermore, in December 2005, EPA sent individualized
letters to all federally recognized Tribes about the proposal to give
Tribal leaders the opportunity for consultation.   

	This final rule does not have Tribal implications as defined by
Executive Order 13175.  It does not have a substantial direct effect on
one or more Indian Tribes, since no Tribe has implemented a CAA program
to attain the PM2.5 NAAQS at this time.  The EPA notes that even if a
Tribe were implementing such a plan at this time, while the rule might
have Tribal implications with respect to that Tribe, it would not impose
substantial direct costs upon it, nor would it preempt Tribal law.

	Furthermore, this rule does not affect the relationship or distribution
of power and responsibilities between the Federal government and Indian
Tribes.  The CAA and the TAR establish the relationship of the Federal
government and Tribes in developing plans to attain the NAAQS, and this
rule does nothing to modify that relationship.  As this rule does not
have Tribal implications, Executive Order 13175 does not apply.

G.	Executive Order 13045: Protection of Children from Environmental
Health and Safety Risks tc \l2 "Executive Order 13045: Protection of
Children from Environmental Health and Safety Risks 

	EO 13045, “Protection of Children from Environmental Health 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 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 subject to EO 13045 because it is economically
significant as defined in EO 12866, and we believe that the
environmental health risk addressed by this action may have a
disproportionate effect on children.  This rule implements a previously
promulgated health-based Federal standard – the PM2.5 NAAQS. The NAAQS
constitute uniform, national standards for PM pollution; these standards
are designed to protect public health with an adequate margin of safety,
as required by CAA section 109.  However, the protection offered by
these standards may be especially important for children because
children, along with other sensitive population subgroups such as the
elderly and people with existing heart or lung disease, are potentially
susceptible to health effects resulting from PM exposure.  Because
children are considered a potentially susceptible population, we have
carefully evaluated the environmental health effects of exposure to PM
pollution among children.  These effects and the size of the population
affected are summarized in section 9.2.4 of the Criteria Document and
section 3.5 of the Staff Paper.

 H. 	Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use tc \l2 "Executive Order 13211: Actions That
Significantly Affect Energy Supply, Distribution, or Use 

	This final rule is not a “significant energy action” as defined in
Executive Order 13211, “Actions 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 rule is not a “significant
energy action,” because it does not establish requirements that
directly affect the general public and the public and private sectors,
but, rather, interprets the statutory requirements that apply to States
in preparing their SIPs.  The SIPs themselves will likely establish
requirements that directly affect the general public, and the public and
private sectors.

I.	National Technology Transfer Advancement Act tc \l2 "National
Technology Transfer Advancement Act 

	Section 12(d) of the National Technology Transfer 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 (VCS) 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 VCS bodies.  The NTTAA directs EPA to provide Congress,
through OMB, explanations when the Agency decides not to use available
and applicable VCS.

This final rulemaking does not involve technical standards.  Therefore,
EPA is not considering the use of any VCS. The EPA will encourage the
States and Tribes to consider the use of such standards, where
appropriate, in the development of their implementation plans. tc \l2
"Executive Order 12898: Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations 

J.	Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations	

	EO 12898 (59 FR 7629 (Feb. 16, 1994) establishes Federal executive
policy on environmental justice.  Its main provision directs Federal
agencies, to the greatest extent practicable and permitted by law, to
make environmental justice part of their mission by identifying and
addressing, as appropriate, disproportionately high and adverse human
health or environmental effects of their programs, polices and
activities on minority populations and low-income populations in the
United States. 

	The EPA has determined that the final rule should not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected poplations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or
low-income population.  The health and environmental risks associated
with fine particles were considered in the establishment of the PM2.5
NAAQS.  The level is designed to be protective with an adequate margin
of safety.  This final rule provides a framework for improving
environmental quality and reducing health risks for areas that may be
designated nonattainment.

K.	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 to the United
State.  The EPA will submit a report containing the 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. 804(2). 
This rule will be effective [INSERT DATE 60 DAYS FROM PUBLICATION].	

J.	Petitions for Judicial Review tc \l2 "L.  Petitions for Judicial
Review 

	Under section 307(b)(1) of the Act, petitions for judicial review of
this action must be filed in the United States Court of Appeals for the
District of Columbia Circuit by [INSERT DATE 60 DAYS FROM DATE OF
PUBLICATION].  Filing a petition for reconsideration by the
Administrator of this final rule does not affect the finality of this
rule for the purposes of judicial review nor does it extend the time
within which a petition for judicial review may be filed, and shall not
postpone the effectiveness of such 

rule or action.  This action may not be challenged later in proceedings
to enforce its requirements.  See Act section 307(b)(2).

K.	Judicial Review

	Under sections 307(d)(1)(E) and 307(d)(1)(V) of the CAA, the
Administrator determines that this action is subject to the provisions
of section 307(d).  Section 307(d)(1)(V) provides that the provisions of
section 307(d) apply to "such other actions as the Administrator may
determine."  While the Administrator did not make this determination
earlier, the Administrator believes that all of the procedural
requirements, e.g., docketing, hearing and comment periods, of section
307(d) have been complied with during the course of this rulemaking.

 See 62 FR 38652-38760, National Ambient Air Quality Standards for
Particulate Matter, Final Rule; also 40 CFR Part 50.