[Federal Register: May 14, 2009 (Volume 74, Number 92)]
[Rules and Regulations]
[Page 22693-22696]
[DOCID:fr14my09-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 51 and 52

[EPA-HQ-OAR-2003-0064; FRL-8904-5]
RIN 2060-AP49

Prevention of Significant Deterioration (PSD) and Nonattainment
New Source Review (NSR): Aggregation

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action on a rule that amends and delays the effective date for the rule
addressing ``aggregation'' under the Prevention of Significant
Deterioration (PSD) and the nonattainment New Source Review
(nonattainment NSR) programs (collectively, ``NSR''). The ``NSR
Aggregation Amendments'' were published in the Federal Register on
January 15, 2009, and described when a source must combine nominally-
separate physical changes and changes in the method of operation for
the purpose of determining whether they are a single change resulting
in a significant emissions increase.
    On January 30, 2009, the Natural Resources Defense Council (NRDC)
submitted a petition for reconsideration (the ``NRDC Petition'') of the
NSR Aggregation Amendments. In response to the NRDC Petition, EPA
announced on February 13, 2009, that it would convene a reconsideration
proceeding for the NSR Aggregation Amendments and would delay the
effective date of the rule from February 17, 2009 until May 18, 2009.
On March 18, 2009, EPA proposed an additional delay of the effective
date and solicited comment on the duration of the additional delay.
    By this rule, EPA is delaying the effective date of the NSR
Aggregation Amendments for an additional 12 months, which will allow
for sufficient time to conduct the reconsideration proceeding. The new
effective date of the rule is May 18, 2010.

DATES: The effective date of FR Doc. E9-815, published in the Federal
Register on January 15, 2009 (74 FR 2376), and delayed on February 13,
2009 (74 FR 7284), is further delayed to May 18, 2010.

ADDRESSES: Docket: The final rule, the petition for reconsideration,
comments on the March 18, 2009 proposal, and all other documents in the
record for the NSR Aggregation rulemaking are in Docket ID. No. EPA-HQ-
OAR-2003-0064. All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air and Radiation Docket
and Information Center, EPA/DC, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744.

FOR FURTHER INFORMATION CONTACT: Mr. David J. Svendsgaard, Air Quality
Policy Division, Office of Air Quality Planning and Standards (C504-
03), U.S. Environmental Protection Agency, Research Triangle Park, NC
27711, telephone<PHONE_NUMBER>, fax number<PHONE_NUMBER>, e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    Entities potentially affected by this action include sources in all
industry groups and state, local, and tribal governments.

B. How is this preamble organized?

    The information presented in this preamble is organized as follows:

I. General Information
    A. Does this action apply to me?
    B. How is this preamble organized?
II. Background
III. Summary of Public Comments Received
IV. Additional Twelve Month Delay of Effectiveness
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Analysis
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12899: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act
    L. Judicial Review
VI. Statutory Authority

II. Background

    On January 15, 2009, the EPA (we) issued a final rule amending our
PSD and nonattainment NSR regulations implementing the definition of
``modification'' in the Clean Air Act (CAA) 111(a)(4). The amendments
addressed when a source must combine (aggregate) nominally-separate
physical changes and changes in the method of operation (known as
``activities'') for the purpose of determining whether they are a
single change resulting in a significant emission increase. The
amendments retained the rule language for aggregation but interpreted
that rule text to mean that sources and permitting authorities should
combine emissions when activities are ``substantially related.'' The
rule also adopted a rebuttable presumption that activities at a plant
can be presumed not to be substantially related if they occur three or
more years apart. Collectively, this rulemaking is known as the ``NSR
Aggregation Amendments.'' For further information on the NSR
Aggregation Amendments, please see 74 FR 2376 (January 15, 2009).
    On January 30, 2009, NRDC submitted a petition for reconsideration
of the NSR Aggregation Amendments as provided for in CAA
307(d)(7)(B).\1\\\ Under that CAA provision, the Administrator may
commence a reconsideration proceeding if the petitioner raises an
objection to a rule that was impracticable to raise during the comment
period or if the grounds for the objection arose after the comment
period. In either case, the objection must be of central relevance to
the outcome of the rule. The Administrator may stay the effectiveness
of the rule for up to three months during such reconsideration.
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    \1\ John Walke, Natural Resources Defense Council, EPA-HQ-OAR-
2003-0064-0116.1.
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    On February 13, 2009, we issued notices announcing the convening of
a

reconsideration proceeding in response to the NRDC petition and an
administrative stay of the NSR Aggregation Amendments, which delayed
the effective date of the NSR Aggregation Rule for 90 days from
February 17, 2009 until May 18, 2009. See 74 FR 7193 and 74 FR 7284
(February 13, 2009).
    As noted above, our authority to delay the effective date of a rule
solely under the Administrator's discretion is limited to three months.
On occasion, however, we have found three months to be insufficient to
complete the necessary steps in the reconsideration process. Therefore,
when we have issued similar administrative stays in the past, it has
often been our practice to also propose an additional extension of the
stay of effectiveness through a rulemaking process. An additional
extension enables us to take comment on issues that are in question and
complete any revisions of the rule that become necessary as a result of
the reconsideration process.
    Since we expect to take comment on a broad range of legal and
policy issues as part of the NSR Aggregation Amendments
reconsideration, on March 18, 2009 (74 FR 11509), we proposed to
further delay the effective date of the NSR Aggregation Amendments
until November 18, 2009. We also solicited comment on longer periods
for a delay of effectiveness: (1) Until February 18, 2010, and (2) May
18, 2010.

III. Summary of Public Comments Received

    We received five comments from interested parties on our March 18,
2009 proposal to delay the effective date of the NSR Aggregation
Amendments. Most of the commenters requested that we not further delay
the effective date of the rule after May 18, 2009. These commenters
expressed concerns that sources need more clarity and certainty on the
issue of aggregation, and leaving the NSR Aggregation Amendments in
place during the reconsideration proceeding would provide greater
clarity to sources even if we ultimately decide to change the rule.
    While it is understandable that commenters may perceive a need for
more clarity in the program, we are concerned that making effective a
rule that may later change may actually result in more confusion for
both sources and permitting authorities. We also are concerned that
portions of the legal basis for the final rule did not undergo comment
solicitation, so we would be remiss to let the rule become effective
prior to letting the public comment fully on the basic authority for
the rule. Furthermore, a few of the issues raised in the NRDC Petition
demonstrate that there are aspects of the final rule that still cause
confusion, such as whether states must adopt the new rule and whether
SIPs must be amended. These issues were not adequately addressed in the
final rule. An additional delay of effectiveness that allows us to
address these defects is necessary and prudent.
    One commenter claimed it would be inappropriate for EPA to use
section 705 of the Administrative Procedures Act (APA) to further
postpone the effective date of the rule. However, because we do not
rely on that statutory provision for this extension notice, the
question is not relevant to this rule.
    This commenter also suggested that the January 21, 2009 memorandum
from the Director of the Office of Management and Budget (OMB) created
an outside limit of 60 days for reconsideration of rules published
prior to January 20, 2009.\2\ However, nothing in the OMB memorandum
supersedes the procedural and substantive requirements of the CAA. For
example, section 307(d) provides the public the procedural right to
present oral testimony and a minimum period for parties to comment on
the testimony. The time frame allowed by the statute would be difficult
to reconcile with the period in the memorandum.
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    \2\ OMB Memorandum M-09-08, ``Implementation of Memorandum
Concerning Regulatory Review'' (January 21, 2009). See http://
www.whitehouse.gov/omb/assets/agencyinformation_memoranda_2009_
pdf/m09-08.pdf.
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    Another commenter stated we lack authority to extend the effective
date more than 90 days under the specific provisions of CAA section
307(d). The commenter argues that we can only amend the effective date
in a new ``substantive'' rulemaking. We disagree with the commenter's
analysis of the statute.
    First, the provision allowing for a three month stay of
effectiveness of the rule is an authority that either a court or EPA
may use at its discretion without notice or an opportunity for comment.
While CAA section 307(d)(7)(B) provides that this type of a stay may
not ``exceed three months,'' this limitation is best understood as
applying to the plenary authority to grant a stay without notice and
comment. There is nothing in this CAA provision indicating that it
strips EPA of the authority to amend any provision it establishes
through notice and comment rulemaking by a subsequent notice and
comment rulemaking. See National Cable & Telecomms. Ass'n v. Brand X
Internet Servs., 125 S. Ct. 2688, 2700 (2005). That is the procedure we
have undertaken in this action.
    Second, the commenter recognizes that a new ``substantive'' rule
following the rulemaking procedures of CAA section 307(d) could shift
an effective date. We find no distinction in CAA section 307(d) between
what the commenter terms a ``substantive'' amendment and an amendment
modifying when the rule becomes effective, especially when such a
rulemaking is completed before the original rule becomes effective. The
commenter's interpretation of the statute would require as a matter of
law the irrational result that EPA would have to allow a defective rule
to nevertheless go into effect even if it could complete a rulemaking
revising the effective date in time, or if it could not complete a
potentially more complicated rulemaking amendment to address the rule's
shortcomings in the same amount of time. However, EPA need not even
have to find that a rule is defective before it can undertake notice
and comment to revise any part of the rule, as long as the basis for
the revisions is reasonable. Thus, like any other provision of a CAA
section 307(d) rule, we are authorized to change the effective date of
the final rule through rulemaking.
    While most commenters were opposed to a further extension of the
effective date of the NSR Aggregation Amendments, we note that one
commenter concurred entirely with the objections raised in the NRDC
petition and specifically pointed out a lack of tribal outreach in the
development of the rule. The commenter requested a delay of three
months to allow for tribal outreach, and a notice-and-comment
rulemaking before a final action on aggregation takes effect. Since the
issue of state, local, and tribal involvement under Executive Order
12866 will be addressed as part of our reconsideration proceeding, we
will fully respond to this commenter's concern through our
reconsideration.

IV. Additional Twelve Month Delay of Effectiveness

    As noted above, we solicited comment on three potential periods of
delay for the effective date of the NSR Aggregation Amendments. We now
believe that allowing 12 additional months is more appropriate than a
delay of six months, which was the preferred option at proposal, or
nine months. This schedule allows for drafting and publishing a notice
that focuses comment on specific issues to be reconsidered, provides a
sufficient

opportunity for public comment on the reconsideration in accordance
with the requirements of CAA section 307(d), and gives us an
opportunity to evaluate and respond to such comments.
    We note that, over the recent past, reconsideration of NSR
rulemakings like the Equipment Replacement Provision required nearly a
year between the notice opening the comment period for reconsideration
and the final action on reconsideration. See 69 FR 40278 (July 1, 2004)
(opening of comments) and 70 FR 33838 (June 10, 2005) (final action).
Given the degree of complexity with the issues under review here, the
likelihood of significant public interest in this reconsideration, and
our experience from recent NSR reconsiderations, we believe the delay
we are adopting today is consistent with a realistic and achievable
schedule for the reconsideration. While it is possible that we may
require less time to complete the reconsideration, we believe extending
the effective date by a full 12 months is reasonable and prudent.
    Section 553(d) of the APA, 5 U.S.C. Chapter 5, generally provides
that rules may not take effect earlier than 30 days after they are
published in the Federal Register. EPA is issuing this final rule under
section 307(d)(1) of the CAA, which states: ``The provisions of section
553 through 557 * * * of Title 5 shall not, except as expressly
provided in this section, apply to actions to which this subsection
applies.'' Thus, section 553(d) of the APA does not apply to this rule.
EPA is nevertheless acting consistently with the policies underlying
APA section 553(d) in making this rule effective on May 14, 2009. APA
section 553(d) provides an exception when the agency finds good cause
exists for a period less than 30 days before effectiveness. We find
good cause exists to make this rule effective upon publication because
doing so alleviates any potential confusion and implementation
difficulties that could arise were the NSR Aggregation Amendments to go
into effect for a 30 day period and then be stayed during
reconsideration or modified as a result of the reconsideration process.
    The effective date of the NSR Aggregation Amendments, FR Doc. E9-
815, published in the Federal Register on January 15, 2009 (74 FR
2376), is hereby delayed to May 18, 2010.

V. Statutory and Executive Order Reviews

A. Executive Order 12866--Regulatory Planning and Review

    This final action is not a ``significant regulatory action'' under
the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993)
and is therefore not subject to review under the EO.

B. Paperwork Reduction Act

    This final action does not impose any new information collection.
However, OMB has previously approved the information collection
requirements contained in the existing NSR regulations (40 CFR parts 51
and 52) under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq., and has assigned OMB control number 2060-0003. The OMB
control numbers for EPA's regulations in 40 CFR are listed in 40 CFR
part 9.

C. Regulatory Flexibility Analysis

    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 APA 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, a ``small entity'' is defined as: (1) A small business as
defined by the Small Business Administration's regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district, or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this final rule on small
entities, I certify that this final action will not have a significant
economic impact on a substantial number of small entities. This rule
will not impose any requirements on small entities.

D. Unfunded Mandates Reform Act

    This final action contains no Federal mandates under the provisions
of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2
U.S.C. 1531-1538 for state, local, or tribal governments or the private
sector. This final action will not increase the burden imposed upon
reviewing authorities. Therefore, this final action is not subject to
the requirements of sections 202 and 205 of the UMRA.
    This final action is also not subject to the requirements of
section 203 of the UMRA because it contains no regulatory requirements
that might significantly or uniquely affect small governments. As
described above, this final action does not impose any new requirements
on small governments.

E. Executive Order 13132--Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by state and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the states, on the relationship between the national
government and the states, or on the distribution of power and
responsibilities among the various levels of government.''
    This final action 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. This action simply stays the
effective date of the January 15, 2009 rule for an additional 12
months, pending a reconsideration proceeding. Thus, Executive Order
13132 does not apply to this final action.

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

    This final action does not have tribal implications, as specified
in Executive Order 13175 (65 FR 67249, November 9, 2000). This action
simply stays the effective date of the January 15, 2009 rule for an
additional 12 months, pending a reconsideration proceeding. Thus,
tribal governments should not experience added burden from this final
action, nor should their laws be affected with respect to
implementation of this final action. Thus, Executive Order 13175 does
not apply to this final action.

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

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
final action is not subject to Executive Order 13045 because it does
not establish an

environmental standard intended to mitigate health or safety risks.

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

    This final action is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001) because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 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 (for example, 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.
    This final action does not involve technical standards; therefore,
EPA did not consider the use of any voluntary consensus standards.

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

    Executive Order 12898 (59 FR 7629, February 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,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final action will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. Therefore, Executive Order 12898 does not apply to this
final action.

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 of the
United States. EPA submitted 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 final action is not a ``major rule'' as defined by 5
U.S.C. 804(2). Therefore, this final action will be effective on May
14, 2009.

L. Judicial Review

    Under CAA section 307(b), judicial review of this final action is
available only by filing a petition for review in the U.S. Court of
Appeals for the District of Columbia Circuit on or before July 13,
2009. Under CAA section 307(d)(7)(B), only those objections to the
final rule that were raised with specificity during the period of
public comment may be raised during judicial review. Moreover, under
CAA section 307(b)(2), the requirements established by this final rule
may not be challenged separately in any civil or criminal proceedings
brought by EPA to enforce these requirements.

VI. Statutory Authority

    The statutory authority for this action is provided by sections
307(d)(7)(B), 101, 111, 114, 116, and 301 of the CAA as amended (42
U.S.C. 7401, 7411, 7414, 7416, and 7601). This notice is also subject
to section 307(d) of the CAA (42 U.S.C. 7407(d)).

List of Subjects

40 CFR Part 51

    Environmental protection, Administrative practice and procedure,
Air pollution control, Baseline emissions, Intergovernmental relations,
Aggregation, Major modifications, Reporting and recordkeeping
requirements.

40 CFR Part 52

    Environmental protection, Administrative practice and procedure,
Air pollution control, Baseline emissions, Incorporation by reference,
Intergovernmental relations, Aggregation, Major modifications,
Reporting and recordkeeping requirements.

    Dated: May 8, 2009.
Lisa P. Jackson,
Administrator.
[FR Doc. E9-11271 Filed 5-13-09; 8:45 am]

BILLING CODE 6560-50-P


New BART + CAIR New BART+ CAIR+ CAMR Difference State Name SO2 SO2 SO2 Alabama 255 260 5 District of Columbia 0 0 0 Florida 167 167 0 Georgia 259 241  18 Illinois 244 245 1 Indiana 383 377  6 Iowa 164 163  1 Kentucky 282 264  18 Louisiana 62 62 0 Maryland 24 43 19 Michigan 392 394 2 Minnesota 85 85 0 Mississippi 86 86 0 Missouri 269 266  2 New York 52 49  4 North Carolina 145 125  21 Ohio 239 272 32 Pennsylvania 150 141  9 South Carolina 142 106  36 Tennessee 163 191 28 Texas 362 373 11 Virginia 118 95  23 West Virginia 119 111  8 Wisconsin 151 151 0 Grand Total 4,314 4,267  47 New BART + CAIR New BART+ CAIR+ CAMR Difference State Name NOx NOx NOx Alabama 49 49 0 District of Columbia 0 0 0 Florida 61 61 0 Georgia 67 67 0 Illinois 66 66 0 Indiana 86 82  4 Iowa 44 52 8 Kentucky 78 77  1 Louisiana 30 32 3 Maryland 14 14 0 Michigan 88 94 5 Minnesota 40 40 1 Mississippi 12 8  4 Missouri 62 70 8 New York 37 24  13 North Carolina 51 51 0 Ohio 86 93 7 Pennsylvania 80 74  5 South Carolina 36 37 0 Tennessee 27 27 0 Texas 161 159  2 Virginia 40 40 1 West Virginia 44 40  5 Wisconsin 39 41 2 Grand Total 1,299 1,299 0 New BART New BART + CAIR Difference NOx NOx NOx State Name Thousand tons Thousand tons Thousand tons Alabama 107 49  58 District of Columbia 0 0 0 Florida 133 61  71 Georgia 94 67  27 Illinois 89 66  23 Indiana 182 86  96 Iowa 71 44  27 Kentucky 110 78  33 Louisiana 40 30  10 Maryland 24 14  10 Michigan 95 88  6 Minnesota 57 40  17 Mississippi 31 12  19 Missouri 72 62  10 New York 47 37  9 North Carolina 56 51  5 Ohio 178 86  92 Pennsylvania 149 80  70 South Carolina 38 36  1 Tennessee 76 27  48 Texas 179 161  19 Virginia 61 40  21 West Virginia 85 44  41 Wisconsin 65 39  26 Grand Total 2,041 1,299  742 Old BART Old BART + CAIR Difference NOx NOx NOx State Name Thousand tons Thousand tons Thousand tons Alabama 111 49  62 District of Columbia 0 0 0 Florida 120 61  59 Georgia 77 66  11 Illinois 86 65  21 Indiana 166 84  82 Iowa 51 39  12 Kentucky 91 64  27 Louisiana 38 30  8 Maryland 24 12  12 Michigan 85 85 0 Minnesota 50 37  13 Mississippi 19 12  7 Missouri 66 58  8 New York 44 34  10 North Carolina 56 49  7 Ohio 169 80  89 Pennsylvania 123 77  46 South Carolina 34 36 2 Tennessee 83 27  56 Texas 181 160  21 Virginia 61 38  23 West Virginia 90 44  46 Wisconsin 47 32  15 Grand Total 1872 1239  633 2 Summary of Differences Between Old analysis and New Analysis for NOx Difference Between New BART Difference Between Old BART State Name and New CAIR + BART and Old CAIR + BART Alabama  58  62 District of Columbia 0 0 Florida  71  59 Georgia  27  11 Illinois  23  21 Indiana  96  82 Iowa  27  12 Kentucky  33  27 Louisiana  10  8 Maryland  10  12 Michigan  6 0 Minnesota  17  13 Mississippi  19  7 Missouri  10  8 New York  9  10 North Carolina  5  7 Ohio  92  89 Pennsylvania  70  46 South Carolina  1 2 Tennessee  48  56 Texas  19  21 Virginia  21  23 West Virginia  41  46 Wisconsin  26  15 Grand Total  742  633 CAIR + BART gets the same or more reductions than BART for all States in the New Analysis Overall, CARI + BART gets more NOx reductions in the New Analysis 3 New BART New BART + CAIR Difference SO2 SO2 SO2 State Name Thousand tons Thousand tons Thousand tons Alabama 227 255 29 District of Columbia 0 0 0 Florida 228 167  61 Georgia 273 259  15 Illinois 333 244  89 Indiana 1,140 383  757 Iowa 193 164  29 Kentucky 519 282  237 Louisiana 36 62 26 Maryland 80 24  56 Michigan 251 392 141 Minnesota 152 85  67 Mississippi 29 86 57 Missouri 249 269 20 New York 140 52  88 North Carolina 101 145 44 Ohio 1,113 239  874 Pennsylvania 343 150  193 South Carolina 160 142  18 Tennessee 580 163  417 Texas 279 362 83 Virginia 205 118  87 West Virginia 394 119  275 Wisconsin 105 151 46 Grand Total 7,131 4,314  2,816 Old BART Old BART + CAIR Difference SO2 SO2 SO2 State Name Thousand tons Thousand tons Thousand tons Alabama 272 255  17 District of Columbia 0 0 0 Florida 159 167 8 Georgia 205 249 44 Illinois 280 239  41 Indiana 1128 353  775 Iowa 96 125 29 Kentucky 307 271  36 Louisiana 31 62 31 Maryland 84 24  60 Michigan 219 385 166 Minnesota 114 72  42 Mississippi 25 86 61 Missouri 184 245 61 New York 131 41  90 North Carolina 91 139 48 Ohio 1100 202  898 Pennsylvania 372 133  239 South Carolina 120 106  14 Tennessee 566 161  405 Texas 257 352 95 Virginia 217 116  101 West Virginia 402 116  286 Wisconsin 58 132 74 Grand Total 6418 4031  2387 4 Summary of Differences Between Old analysis and New Analysis for SO2 Difference Between New BART Difference Between Old BART State Name and New CAIR + BART and Old CAIR + BART Alabama 29  17 District of Columbia 0 0 Florida  61 8 Georgia  15 44 Illinois  89  41 Indiana  757  775 Iowa  29 29 Kentucky  237  36 Louisiana 26 31 Maryland  56  60 Michigan 141 166 Minnesota  67  42 Mississippi 57 61 Missouri 20 61 New York  88  90 North Carolina 44 48 Ohio  874  898 Pennsylvania  193  239 South Carolina  18  14 Tennessee  417  405 Texas 83 95 Virginia  87  101 West Virginia  275  286 Wisconsin 46 74 Grand Total  2,816  2387 Overall, CAIR+ BART gets more SO2 reductions than BART in the new analysis than in the old analsyis In 15 States, CAIR + BART gets the same or greater reductions than BART in the new analysis In 7 States where CAIR + BART does not get greater reductions than BART, the difference in the new analsysis is less than the difference in the old analysis Alabama is the only State in which CAIR + BART achieved less reductions than BART in both analysis and the difference between CAIR + BART and BART is greater in the new aanlysis than the old analysis 5 2015 Emissions Dec 04 BART Dec 04 BART New BART New BART Dec 04 CAIR + BART Dec 04 CAIR + BART New CAIR + BART New CAIR + BART AR, DE, NJ included for annual for PM AR, DE, NJ included for PM State Name Total SO2 ( MTons) Total NOx ( MTons) Total SO2 ( MTons) Total NOx ( MTons) Total SO2 ( MTons) Total NOx ( MTons) Total SO2 ( MTons) Total NOx ( MTons)

Alabama 272 111 227 107 255 49 255 49 District of Columbia 0 0 0 0 0 0 0 0 Florida 159 120 228 133 167 61 167 61 Georgia 205 77 273 94 249 66 259 67 Illinois 280 86 333 89 239 65 244 66 Indiana 1128 166 1,140 182 353 84 383 86 Iowa 96 51 193 71 125 39 164 44 Kentucky 307 91 519 110 271 64 282 78 Louisiana 31 38 36 40 62 30 62 30 Maryland 84 24 80 24 24 12 24 14 Michigan 219 85 251 95 385 85 392 88 Minnesota 114 50 152 57 72 37 85 40 Mississippi 25 19 29 31 86 12 86 12 Missouri 184 66 249 72 245 58 269 62 New York 131 44 140 47 41 34 52 37 North Carolina 91 56 101 56 139 49 145 51 Ohio 1100 169 1,113 178 202 80 239 86 Pennsylvania 372 123 343 149 133 77 150 80 South Carolina 120 34 160 38 106 36 142 36 Tennessee 566 83 580 76 161 27 163 27 Texas 257 181 279 179 352 160 362 161 Virginia 217 61 205 61 116 38 118 40 West Virginia 402 90 394 85 116 44 119 44 Wisconsin 58 47 105 65 132 32 151 39 Grand Total 6418 1872 7131 2041 4031 1239 4314 1299 6 New CAIR + BART + Hg New CAIR + BART + Hg Total SO2 ( MTons) Total NOx ( MTons)

260 49 0 0 167 61 241 67 245 66 377 82 163 52 264 77 62 32 43 14 394 94 85 40 86 8 266 70 49 24 125 51 272 93 141 74 106 37 191 27 373 159 95 40 111 40 151 41 4267 1299 7


[Federal Register: April 1, 2008 (Volume 73, Number 63)]
[Notices]
[Page 17354-17355]
[DOCID:fr01ap08-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

The Essentials of Food and Drug Administration Medical Device
Regulations: A Primer for Manufacturers and Suppliers; Public Seminar

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice of public seminar.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Devices
and Radiological Health and Office of Regulatory Affairs, in
cooperation with AdvaMed's Medical Technology Learning Institute, is
announcing a series of three seminars on FDA medical device
regulations. These 2-day seminars, which are designed to address the
training needs of startup and small device manufacturers and their
suppliers, will include both industry and FDA perspectives and a
question and answer period.

    Dates: The seminars are planned for the following dates:
    1. April 8 and 9, 2008, in Rosemont, IL 60018. Details about dates
are posted on AdvaMed's Web site at: www.Advamedmtli.org/Chicago.\1\
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    \1\ FDA has verified the Web site addresses, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.
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    2. May 13 and 14, 2008, Bethesda, MD 20852. Details about dates are
posted on AdvaMed's Web site at www.Advamedmtli.org/Bethesda.
    3. June 17 and 18, 2008, Queens, NY. Details about dates are posted
on AdvaMed's Web site at: www.Advamedmtli.org/New York.
    Locations: The seminars are planned for the following locations:
    1. April 8 and 9, 2008, Westin O'Hare, 6100 North River Rd.,
Rosemont, IL 60018. Details about location sites are posted on
AdvaMed's Web site at: www.Advamedmtli.org/Chicago.
    2. May 13 and 14, 2008, Marriott Bethesda North Conference Center,
White Flint Auditorium, 5101 Marinelli Rd., North Bethesda, MD 20852.
Details about location sites are posted on AdvaMed's Web site at:
www.advamedmtli.org/Bethesda.
    3. June 17 and 18, 2008, Crowne Plaza New York-LaGuardia, 104-04-
Ditmars Blvd., East Elmhurst, NY 11369. Details about location sites
are posted on AdvaMed's Web site at: www.advamedmtli.org/NewYork.
    Contact: For FDA: William Sutton, Division of Small Manufacturers,
International and Consumer Assistance, Center for Devices and
Radiological Health (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850,
800-638-2041, ext. 125, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>    For AdvaMed: Veronica Allen,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>    Registration: The registration fee for a limited number of FDA
employees is waived. Send registration information (including name,
title, firm name, address, telephone, and fax number) and the
registration fee of $525 per person to AdvaMed, contact Veronica Allen,
202-434-7231, FAX:<PHONE_NUMBER>. Payment forms accepted are major
credit card (MasterCard, Visa, or American Express) or company check.
If you wish to pay by check, contact Veronica Allen at
<EMAIL_ADDRESS>    To register via the Internet, go to www.AdvaMed.org. The latest
information on dates/venue sites will be posted on this Web site at:
www.advamedmtli.org/Chicago, www.admedmtli.org/Bethesda, and
www.advamedmtli.org/NewYork (FDA has verified the Web site addresses,
but is not responsible for changes to the Web sites after this document
publishes in the Federal Register).
    For more information on the meeting, or for questions on
registration, contact Veronica Allen (see Contact).
    Attendees are responsible for their own accommodations. For further
hotel information and driving directions, go to the registration Web
site.
    The registration fee will be used to offset the expenses of hosting
the conference, including meals (breakfast and a lunch), refreshments,
meeting rooms, and training materials. It also includes a networking
reception on the evening of the first day of each seminar.
    Space is limited; therefore, interested parties are encouraged to
register early. There will be no onsite registration.
    If you need special accommodations due to a disability, please
contact Veronica Allen (see Contact) at AdvaMed as soon as possible.

SUPPLEMENTARY INFORMATION:  The ``Essentials of FDA Medical Device
Regulations: A Primer for Manufacturers and Suppliers'' seminar helps
fulfill the Department of Health and Human Services' and FDA's
important mission to protect the public health by educating new
entrepreneurs on the essentials of FDA device regulations. FDA has made
education of the medical device community a high priority to assure the
quality of products reaching the marketplace and to increase the rate
of voluntary industry compliance with regulations.
    The seminar helps to implement the objectives of section 903 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA Plan
for Statutory Compliance, which includes working more closely with
stakeholders and ensuring access to needed scientific and technical
expertise. The seminar also furthers the goals of the Small Business
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing
outreach activities by Government agencies directed at small
businesses.
    The following topics, as well as others, will be discussed at the
seminar:
     Doing business in a regulated industry;
     Organizational structure of FDA;
     Overview of the quality system regulation;
     Design controls;
     Documents, records, and change control;
     Purchasing controls and acceptance activities;
     Production and process control;
     Corrective and preventive actions;
     Complaints, medical device reports, corrections, and
recalls;
     Compliance issues;
     Management responsibility;
     Interacting with FDA--Where do you go for assistance?
     General question and answer session;
     Manufacturers and suppliers--the chain regulatory
responsibility;
     Reimbursement of medical technology;
     The AdvaMed code of ethics; and
     Fraud and abuse.

    Dated: March 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 08-1085 Filed 3-28-08; 11:48 am]

BILLING CODE 4160-01-S