[Federal Register Volume 76, Number 244 (Tuesday, December 20, 2011)]
[Proposed Rules]
[Pages 78869-78871]
[FR Doc No: 2011-32561]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2011-0627; FRL-9608-5]

Approval and Promulgation of Implementation Plans and
Designations of areas for Air Quality Planning Purposes; Missouri and
Illinois; St. Louis Nonattainment Area; Determination of Attainment by
Applicable Attainment Date for the 1997 Annual Fine Particulate
Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to determine, pursuant to the Clean Air Act
(CAA), that the bi-state St. Louis, Missouri-Illinois, fine particulate
(PM2.5) nonattainment area (hereafter referred to as ``the
St. Louis area'' or ``the area'') has attained the 1997 annual
PM2.5 national ambient air quality standards (NAAQS) by its
applicable attainment date of April 5, 2010. This proposed
determination is based on quality-assured and certified monitoring data
for the 2007-2009 monitoring period. Based on this data, EPA previously
determined on May 23, 2011, that the area attained the 1997 standards,
and EPA suspended certain planning requirements for the area based on
that determination. EPA is now proposing to find that the St. Louis
area attained the 1997 annual PM2.5 NAAQS by its applicable
attainment date. EPA is proposing this action because it is consistent
with the CAA and its implementing regulations.

DATES: Comments must be received on or before January 19, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2011-0627, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Steven Brown, Atmospheric Section, Air Planning and
Development Branch, Air and Waste Management Division, U.S.
Environmental Protection Agency, Region 7, 901 North 5th Street, Kansas
City, Kansas 66101.
    5. Hand Delivery or Courier: Steven Brown, Atmospheric Section, Air
Planning and Development Branch, Air and Waste Management Division,
U.S. Environmental Protection Agency, Region 7, 901 North 5th Street,
Kansas City, Kansas 66101. Such deliveries are only accepted during the
Regional Office normal hours of operation, and special arrangements
should be made for deliveries of boxed information. The Regional Office
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2011-0627. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at the Atmospheric Section, Air Planning and Development
Branch, Air Waste and Management Division, U.S. Environmental
Protection Agency, Region 7, 901 North 5th Street, Kansas City, Kansas
66101. EPA requests that if at all possible, you contact the person
listed in the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection. The Regional Office's official hours of business are Monday
through Friday, 8:30 to 4:30, excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: In Region 7, Steven Brown, Atmospheric
Section, Air Planning And Development Branch, Air and Waste Management
Division, U.S. Environmental Protection Agency, Region 7, 901 North 5th
Street, Kansas City, Kansas 66101. Steven Brown may be reached by
telephone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>In Region 5, John Summerhays, Attainment Planning
and Maintenance Section, Air Programs Branch (AR 18J), U.S.
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604. The telephone number is<PHONE_NUMBER>. Mr.
Summerhays can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?
II. What is the background for this action?
III. What is the air quality in the St. Louis area for the 1997
annual PM2.5 NAAQS for the 2007-2009 monitoring period?
IV. What is the proposed action, and what is the effect of this
action?
V. Statutory and Executive Order Reviews

I. What action is EPA taking?

    Based on EPA's review of the quality-assured and certified
monitoring data for 2007-2009, and in accordance with section 179(c)(1)
of the CAA, EPA proposes to determine that the St. Louis area has
attained the 1997 annual PM2.5 NAAQS by the applicable
attainment date of April 5, 2010. The St. Louis area is comprised of
Jefferson County, Franklin County, St. Louis County, St. Louis City,
and St. Charles in Missouri, and Madison, Monroe and St. Clair
Counties, and Baldwin Township in Randolph County in Illinois.
    It is important to distinguish between two different types of
attainment determinations that EPA makes for areas that are designated
nonattainment. Both types require notice-and-comment rulemaking.
    (1) Determinations of attainment by an area's attainment date, and
    (2) Determinations of attainment for purposes of suspending the
State's obligation to submit certain planning SIPs linked to
attainment.
    This proposed action is with respect to Type 1 above. The CAA
requires EPA to determine whether a nonattainment

area has attained the standard as of its applicable attainment date.
These determinations of attainment provide a historical snapshot--they
evaluate attainment only as of an area's attainment deadline, and are
issued to comply with section 181(b)(2)of the CAA for ozone and
sections 172 and 179 of the CAA for PM2.5. Determinations of
attainment by an attainment deadline are separate and independent of
the second type of attainment determinations, as described below.
    On May 23, 2010, EPA published a final rulemaking making a
determination that the St. Louis area attained the 1997 annual
PM2.5 NAAQS based on quality-assured, quality controlled and
certified ambient air monitoring data for the 2007-2009 monitoring
period and thereby suspended the requirements for the St. Louis area to
submit an attainment demonstration and associated reasonably available
control measures (RACM), a reasonable further progress (RFP) plan,
contingency measures, and other planning State Implementation Plan
(SIP) revisions related to attainment of the 1997 annual
PM2.5 NAAQS so long as the area continues to attain the 1997
Annual PM2.5 NAAQS. See 76 FR 29652. Further information
regarding that action is available in the notice proposing that action,
published on March 7, 2011, at 76 FR 12302.
    Today's proposed action merely makes a determination that the St.
Louis area has attained the 1997 annual PM2.5 NAAQS by its
applicable attainment date. This action is not a re-proposal of the
prior attainment determination or of the effects of suspending the
requirements for the St. Louis area to submit an attainment
demonstration and associated RACM, an RFP plan, contingency measures,
and other planning SIP revisions related to attainment of the standard.
More information regarding the 1997 annual PM2.5 NAAQS and
the area's attainment of that NAAQS is available at 76 FR 29652 (May
23, 2011). A detailed discussion of EPA's review of the monitoring data
showing attainment of the standard can be found in the March 7, 2011
proposed action and the May 23, 2011 final action.

II. What is the background for this action?

    On January 5, 2005, EPA designated the St. Louis area as
nonattainment for the 1997 annual PM2.5 NAAQS. (70 FR 944)
The designation was effective April 5, 2005. Section 172(a) of the CAA
requires a state to achieve attainment no later than 5 years from the
nonattainment designation. Thus, the St. Louis area had an applicable
attainment date of April 5, 2010. Pursuant to section 179(c) of the
CAA, EPA is required to make a determination whether the area attained
the standard by its applicable attainment date. Specifically, section
179(c)(1) of the CAA reads as follows: ``As expeditiously as
practicable after the applicable attainment date for any nonattainment
area, but not later than 6 months after such date, the Administrator
shall determine, based on the area's air quality as of the attainment
date, whether the area attained the standard by that date.'' Today's
action makes this determination.

III. What is the air quality in the St. Louis area for the 1997 annual
PM2.5 NAAQS for the 2007-2009 monitoring period?

    Under EPA regulations at 40 CFR 50.7, the 1997 annual primary and
secondary PM2.5 standards are met when the annual arithmetic mean
concentration, as determined in accordance with 40 CFR part 50,
Appendix N, is less than or equal to 15.0 micrograms per cubic meter
([mu]g/m3) at all relevant monitoring sites in the subject area.
    EPA reviewed the ambient air monitoring data for the St. Louis area
in accordance with the provisions of 40 CFR part 50, Appendix N. All
data considered have been quality-assured, certified, and recorded in
EPA's Air Quality System database. This review addresses air quality
data collected in the 3-year period from 2007-2009. The 3-year period
from 2007-2009 provides the latest 3-year set of data that EPA may use
to determine whether the St. Louis area attained the standard by its
applicable attainment date of April 5, 2010.

                    Table 1--Annual Average Concentrations in the St. Louis area (2007-2009)
         [Annual PM2.5 design values for Saint Louis area monitors with complete data for 2007 to 2009]
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                                                                                Annual design
            State                     County               Monitor             Site name        value  2007-2009
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IL..........................  Madison...............       17-119-1007  23rd and Madison......              14.1
                                                           17-119-2009  1700 Annex St.........              12.5
                              ......................       17-119-3007  54 N. Walcott.........              12.5
                              Randolph..............       17-157-0001  ......................              11.4
                              Saint Clair...........       17-163-0010  13th and Tudor........              13.3
                                                           17-163-4001  1500 Caseyville Ave...              12.5
MO..........................  City of Saint Louis...       29-510-0007  Broadway..............              12.8
                                                           29-510-0085  Blair Street..........              12.7
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    As shown above in Table 1, during the 2007-2009 design period, the
St. Louis area met the 1997 annual PM2.5 NAAQS. The official
annual design value for the St. Louis area for the 2007-2009 period is
14.1 [mu]g/m\3\. More detailed information on the monitoring data for
the St. Louis area during the 2007-2009 design period is provided in
EPA's March 7, 2011, proposed rulemaking, and EPA's May 23, 2011, final
rulemaking regarding the determination of attainment for the St. Louis
area for the 1997 annual PM2.5 NAAQS. See 76 FR 12302 and 76
FR 29652.

IV. What is the proposed action, and what is the effect of this action?

    This action is a proposed determination that the St. Louis area has
attained the 1997 annual PM2.5 NAAQS by its applicable
attainment date of April 5, 2010, consistent with the CAA section
179(c)(1). Finalizing this proposed action would not constitute a
redesignation of the St. Louis area to attainment of 1997 annual
PM2.5 NAAQS under section 107(d)(3) of the CAA because EPA
would not have yet approved a maintenance plan for the St. Louis area
as required under CAA section 175A, nor a determination that the St.
Louis area has met all other requirements for redesignation under the
CAA. Even if EPA finalizes today's proposed action, the designation
status

of the St. Louis area will remain nonattainment for the 1997 annual
PM2.5 NAAQS until such time as EPA determines that the CAA
requirements for redesignation to attainment are met, and takes action
to finalize that determination through a redesignation.

V. Statutory and Executive Order Reviews

    This action proposes to make a determination of attainment based on
air quality, and would not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed determination that the St. Louis area
attained the 1997 annual average PM2.5 NAAQS by its
applicable attainment date does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIPs are not approved to apply in Indian country located in
the states, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Air pollution control, Environmental protection, Particulate
matter, Reporting and recordkeeping requirements.

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

    Dated: November 1, 2011.
Mark Hague,
Acting Regional Administrator, Region 7.
    Dated: December 9, 2011.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2011-32561 Filed 12-19-11; 8:45 am]
BILLING CODE 6560-50-P


CLEMASTINE FUMARATE- clemastine fumarate orally disintegrating tablet

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CLEMASTINE FUMARATE ORALLY DISINTEGRATING TABLETS, USP  Rx only

 DESCRIPTION

Clemastine belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1- methylpyrrolidine fumarate (1:1).

 C21H26C1NO.C4H4O4 M.W. 459.97

Each tablet for oral administration contains 2.68 mg of clemastine fumarate, USP.

Inactive ingredients: TBD.

CLINICAL PHARMACOLOGY

Clemastine fumarate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. The inherently long duration of antihistaminic effects of clemastine fumarate has been demonstrated in wheal and flare studies. In normal human subjects who received histamine injections over a 24-hour period, the antihistaminic activity of clemastine reached a peak at 5 to 7 hours, persisted for 10 to 12 hours and, in some cases, for as long as 24 hours. Pharmacokinetic studies in man utilizing 3H and 14C labeled compound demonstrates that: clemastine is rapidly and nearly completely absorbed from the gastrointestinal tract, peak plasma concentrations are attained in 2 to 4 hours, and urinary excretion is the major mode of elimination.

INDICATIONS AND USAGE

Clemastine Fumarate Orally Disintegrating Tablets USP, 2.68 mg are indicated for the relief of symptoms

associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Orally Disintegrating Tablets USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.

It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.

CONTRAINDICATIONS

 Usage in Nursing Mothers

Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

Usage in Lower Respiratory Disease

Antihistamines should not be used to treat lower respiratory tract symptoms including asthma.

Antihistamines are also contraindicated in the following conditions:

Hypersensitivity to clemastine fumarate or other antihistamines of similar chemical structure.

Monoamine oxidase inhibitor therapy (see Drug Interactions section).

WARNINGS

Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction.

Usage in Children

Safety and efficacy of clemastine fumarate have not been established in children under the age of 12 years.

Usage in Pregnancy

Experience with this drug in pregnant women is inadequate to determine whether there exists a potential for harm to the developing fetus.

Usage with CNS Depressants

Clemastine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).

Usage in Activities Requiring Mental Alertness

Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Usage in the Elderly (approximately 60 years or older)

 Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

 PRECAUTIONS

 Clemastine fumarate should be used with caution in patients with: history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, and hypertension.

 Drug Interactions

 MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

 ADVERSE REACTIONS

 Transient drowsiness, the most common adverse reaction associated with clemastine fumarate, occurs relatively frequently and may require discontinuation of therapy in some instances.

 Antihistaminic Compounds

 It should be noted that the following reactions have occurred with one or more antihistamines and, therefore, should be kept in mind when prescribing drugs belonging to this class, including clemastine. The most frequent adverse reactions are italicized.      General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose, and throat.      Cardiovascular System: Hypotension, headache, palpitations, tachycardia, extrasystoles.      Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.      Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.      GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.      GU System: Urinary frequency, difficult urination, urinary retention, early menses.      Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

 OVERDOSAGE

 Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms: dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur.

 If vomiting has not occurred spontaneously the conscious patient should be induced to vomit. This is best done by having him drink a glass of water or milk after which he should be made to gag. Precautions against aspiration must be taken, especially in infants and children.

If vomiting is unsuccessful gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand. Isotonic and 1/2 isotonic saline is the lavage solution of choice.

Saline cathartics, such as milk of magnesia, by osmosis draw water into the bowel and therefore, are valuable for their action in rapid dilution of bowel content.

 Stimulants should not be used.

Vasopressors may be used to treat hypotension.

DOSAGE AND ADMINISTRATION

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.

Clemastine Fumarate Orally Disintegrating Tablets 2.68 mg

The maximum recommended dosage is one tablet three times daily. Many patients respond favorably to a single dose which may be repeated as required, but not to exceed three tablets daily.

HOW SUPPLIED

Clemastine Fumarate Orally Disintegrating Tablets USP, 2.68 mg are TBD.  NDC: TBD.

Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).