[Federal Register: September 16, 2009 (Volume 74, Number 178)]
[Rules and Regulations]
[Page 47451-47457]
[DOCID:fr16se09-7]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0251; FRL-8431-7]

Ametryn, Amitraz, Ammonium Soap Salts of Higher Fatty Acids,
Bitertanol, Coppers, et al.; Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is revoking certain tolerances/tolerance exemptions for
the fungicides pentachloronitrobenzene and triadimenol; the herbicides
ametryn, fluazifop-p-butyl, and prometryn; the insecticides amitraz and
mineral oil; the defoliant/desiccant sodium chlorate; and the
fungicide/algicide/herbicide coppers. Also, EPA is modifying certain
tolerances for the fungicide bitertanol and the insecticide malathion.
In addition, EPA is establishing new tolerances/tolerance exemptions
for the fungicides coppers and pentachloronitrobenzene; the herbicide
prometryn; the insecticide malathion; and the defoliant/desiccant
sodium chlorate; and revising the tolerance expression for the ammonium
salts of higher fatty acids (ammonium soap salts). The regulatory
actions finalized in this document are in follow-up to the Agency's
reregistration program under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and tolerance reassessment program under the
Federal Food, Drug, and Cosmetic Act (FFDCA), section 408(q).

DATES: This regulation is effective September 16, 2009. Objections and
requests for hearings must be received on or before November 16, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0251. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Pesticide Re-evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in

accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2009-0251 in the subject line on the first page of your submission. All
requests must be in writing, and must be mailed or delivered to the
Hearing Clerk on or before November 16, 2009.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2009-0251, by one of the following methods.
    Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
    Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
    Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of May 13, 2009 (74 FR 22478) (FRL-8412-3),
EPA issued a proposal to revoke, modify, and establish specific
tolerances/tolerance exemptions for residues of the fungicides
bitertanol, coppers, pentachloronitrobenzene and triadimenol; the
herbicides ametryn, fluazifop-p-butyl, and prometryn; the insecticides
amitraz, malathion, and mineral oil; the defoliant/desiccant sodium
chlorate; and the fungicide/algicide/herbicide coppers; and to revise
the tolerance expression for the ammonium salts of higher fatty acids
(ammonium soap salts). Also, the proposal of May 13, 2009 (74 FR 22478)
provided a 60-day comment period which invited public comment for
consideration and for support of tolerance retention under FFDCA
standards.
    In this final rule, EPA is revoking, modifying, and establishing
specific tolerances/tolerance exemptions for residues of ametryn,
amitraz, bitertanol, coppers, fluazifop-p-butyl, malathion, mineral
oil, pentachloronitrobenzene, prometryn, sodium chlorate, and
triadimenol in or on commodities listed in the regulatory text of this
document, and revising the tolerance expression for the ammonium soap
salts of higher fatty acids (C8-C18 saturated;
C8-C12 unsaturated).
    EPA is finalizing these tolerance actions in order to implement the
tolerance recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). As part of these processes, EPA is required to
determine whether each of the amended tolerances meets the safety
standard of FFDCA. The safety finding determination of ``reasonable
certainty of no harm'' is discussed in detail in each Reregistration
Eligibility Decision (RED) and Report on FQPA Tolerance Reassessment
Progress and Interim Risk Management Decision (TRED) for the active
ingredient. REDs and TREDs recommend the implementation of certain
tolerance actions, including modifications, to reflect current use
patterns, to meet safety findings and change commodity names and
groupings in accordance with new EPA policy. Printed copies of many
REDs and TREDs may be obtained from EPA's National Service Center for
Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH
45242-2419; telephone number: 1-800-490-9198; fax number: 1-513-489-
8695; Internet at http://www.epa.gov/ncepihom and from the National
Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield,
VA 22161; telephone number: 1-800-553-6847 or<PHONE_NUMBER>; Internet
at http://www.ntis.gov. Electronic copies of REDs and TREDs are
available on the Internet at http://www.regulations.gov and http://
www.epa.gov/pesticides/reregistration/status.htm.
    In this final rule, EPA is revoking certain tolerances and/or
tolerance exemptions because either they are no longer needed or are
associated with food uses that are no longer registered under FIFRA in
the United States. Those instances where registrations were canceled
were because the registrant failed to pay the required maintenance fee
and/or the registrant voluntarily requested cancellation of one or more
registered uses of the pesticide active ingredient. The tolerances
revoked by this final rule are no longer necessary to cover residues of
the relevant pesticides in or on domestically treated commodities or
commodities treated outside but imported into the United States. It is
EPA's general practice to issue a final rule revoking those tolerances
and tolerance exemptions for residues of pesticide active ingredients
on crop uses for which there are no active registrations under FIFRA,
unless any person in comments on the proposal indicates a need for the
tolerance or tolerance exemption to cover residues in or on imported
commodities or legally treated domestic commodities.
    EPA has historically been concerned that retention of tolerances
that are not necessary to cover residues in or on legally treated foods
may encourage misuse of pesticides within the United States.
    Generally, EPA will proceed with the revocation of these tolerances
on the grounds discussed in Unit II.A. if one of the following
conditions applies:
    1. Prior to EPA's issuance of a FFDCA section 408(f) order
requesting additional data or issuance of a FFDCA section 408(d) or (e)
order revoking the tolerances on other grounds, commenters retract the
comment identifying a need for the tolerance to be retained.
    2. EPA independently verifies that the tolerance is no longer
needed.
    3. The tolerance is not supported by data that demonstrate that the
tolerance meets the requirements under FQPA.
    In response to the proposal published in the Federal Register of
May 13, 2009 (74 FR 22478), EPA received no comments during the 60-day
public comment period.
    EPA did not propose in a notice for comment to revise the tolerance
nomenclature for malathion, in 40 CFR 180.111(a)(1) from alfalfa to
alfalfa, forage and alfalfa, hay; bean to bean, dry seed and bean,
succulent; corn, grain, postharvest to corn, field, grain, postharvest
and corn, pop, grain, postharvest; salsify (including tops) to salsify,
roots and salsify, tops; and turnip, tops to turnip, greens, as is
current Agency practice. However, section 553(b)(3)(B) of the
Administrative Procedure Act provides that notice and comment is not
necessary ``when the agency for good cause finds (and incorporates the
finding and a brief statement of reasons therefore in the rules issued)
that notice and public procedure thereon are impracticable,
unnecessary, or contrary to the public interest.'' Consequently, for
good cause, EPA is revising the tolerance terminology in 40 CFR
180.111(a)(1) from alfalfa to alfalfa,

forage and alfalfa, hay; bean to bean, dry seed and bean, succulent;
corn, grain, postharvest to corn, field, grain, postharvest and corn,
pop, grain, postharvest; salsify (including tops) to salsify, roots and
salsify, tops; and turnip, tops to turnip, greens. Notice and comment
are unnecessary because revising the terminology has no practical
impact on the use of or exposure to malathion in or on that commodity
and is made such that the tolerance terminology will conform to current
Agency practice.
    On June 3, 2009 (74 FR 26527) (FRL-8417-9), EPA published a final
rule that made minor revisions to commodity terminologies throughout 40
CFR part 180, including revisions for exemptions from the requirement
of a tolerance for sodium chlorate in 40 CFR 180.1020. Among these
revisions in 40 CFR 180.1020, ``corn, forage'' was replaced by ``corn,
field, forage''; ``corn, fodder'' was replaced by ``corn, field,
stover'' and ``corn, pop, stover''; ``peas, southern'' was replaced by
``cowpea, forage''; ``cowpea, hay''; and ``cowpea, seed''; ``peppers,
chili'' was replaced by ``pepper, chili.'' No revision had been made
for ``sorghum, forage.'' However, ``peas, southern'' should have been
replaced by ``pea, southern''; ``pepper, chili'' should have been
replaced by ``pepper, nonbell''; and revisions of ``corn, forage'' and
``corn, fodder'' should have included ``corn, sweet, forage'' and
``corn, sweet, stover,'' respectively. In the Federal Register of May
13, 2009 (74 FR 22478), EPA proposed amendments to commodity
terminology for sodium chlorate in 40 CFR 180.1020 and among them
included ``corn, forage'' to ``corn, field, forage'' and ``corn, sweet,
forage''; ``corn, fodder'' to ``corn, field, stover''; ``corn, pop,
stover''; and ``corn, sweet, stover''; ``peas, southern'' to ``pea,
southern''; ``pepper, chili'' to ``pepper, nonbell'' ``sorghum,
forage'' to ``sorghum, grain, forage'' and ``sorghum, forage, forage'';
``soybeans'' to ``soybean, seed''; as well as other commodity
terminology revisions. As a result of the final rule of June 3, 2009
(74 FR 26527), EPA is revising the current commodity terminologies for
sodium chlorate in 40 CFR 180.1020 in this final rule by removing
``cowpea, forage''; ``cowpea, hay''; and ``cowpea, seed'' and replacing
them with ``pea, southern''; replacing ``pepper, chili'' with ``pepper,
nonbell''; establishing ``corn, sweet, forage'' and ``corn, sweet,
stover''; and revising ``sorghum, forage'' to ``sorghum, grain,
forage'' and ``sorghum, forage, forage''; as proposed in the rule of
May 13, 2009 (74 FR 22478). Also, consistent with most of the commodity
revisions for sodium chlorate proposed on May 13, 2009 (74 FR 22478),
EPA is maintaining current commodity terminologies, finalized by the
rule of June 3, 2009 (74 FR 26527), in 40 CFR 180.1020 for ``bean, dry,
seed''; ``corn, field, forage''; ``corn, field, grain''; ``corn, field,
stover''; ``corn, pop, grain''; ``corn, pop, stover''; ``cotton,
undelinted seed''; ``flax, seed''; ``grain, aspirated fractions'';
``guar, seed''; ``potato''; ``rice, grain''; ``safflower, seed'';
``sorghum, grain, grain''; ``sorghum, grain, stover''; ``soybean,
forage''; ``soybean, hay''; ``soybean, seed''; and ``sunflower, seed.''
    The Agency did not receive any specific comments, during the 60-day
comment period, on the following pesticide active ingredients: ametryn,
amitraz, bitertanol, coppers, fluazifop-p-butyl, malathion, mineral
oil, pentachloronitrobenzene, prometryn, sodium chlorate, triadimenol,
and ammonium soap salts of higher fatty acids (C8-
C18 saturated; C8-C12 unsaturated).
Therefore, in addition to revising the tolerance nomenclature for
specific tolerances for malathion as described in this final rule, and
revising specific commodity terminologies for sodium chlorate as
described in this final rule, EPA is finalizing the amendments proposed
concerning the pesticide active ingredients in the Federal Register of
May 13, 2009 (74 FR 22478). For a detailed discussion of the Agency's
rationale for the establishments, revocations, and modifications to the
tolerances, refer to the proposed rule of May 13, 2009 (74 FR 22478).

B. What is the Agency's Authority for Taking this Action?

    EPA may issue a regulation establishing, modifying, or revoking a
tolerance under FFDCA section 408(e). In this final rule, EPA is
establishing, modifying, and revoking tolerances to implement the
tolerance recommendations made during the reregistration and tolerance
reassessment processes, and as follow-up on canceled uses of
pesticides. As part of these processes, EPA is required to determine
whether each of the amended tolerances meets the safety standards under
FFDCA. The safety finding determination is found in detail in each
post-FQPA RED and TRED for the active ingredient. REDs and TREDs
recommend the implementation of certain tolerance actions, including
modifications to reflect current use patterns, to meet safety findings,
and change commodity names and groupings in accordance with new EPA
policy. Printed and electronic copies of the REDs and TREDs are
available as provided in Unit II.A.
    EPA has issued REDs for ametryn, coppers, malathion, aliphatic
solvents (mineral oil), pentachloronitrobenzene, prometryn, inorganic
chlorates (sodium chlorate), and soap salts (includes ammonium salts of
higher fatty acids), and TREDs for amitraz, bitertanol, fluazifop-p-
butyl, and triadimenol. REDs and TREDs contain the Agency's evaluation
of the database for these pesticides, including statements regarding
additional data on the active ingredients that may be needed to confirm
the potential human health and environmental risk assessments
associated with current product uses, and REDs state conditions under
which these uses and products will be eligible for reregistration. The
REDs and TREDs recommended the establishment, modification, and/or
revocation of specific tolerances. RED and TRED recommendations such as
establishing or modifying tolerances, and in some cases revoking
tolerances, are the result of assessment under the FFDCA standard of
``reasonable certainty of no harm.'' However, tolerance revocations
recommended in REDs and TREDs that are made final in this document do
not need such assessment when the tolerances are no longer necessary.
    EPA's general practice is to revoke tolerances for residues of
pesticide active ingredients on crops for which FIFRA registrations no
longer exist and on which the pesticide may therefore no longer be used
in the United States. EPA has historically been concerned that
retention of tolerances that are not necessary to cover residues in or
on legally treated foods may encourage misuse of pesticides within the
United States. Nonetheless, EPA will establish and maintain tolerances
even when corresponding domestic uses are canceled if the tolerances,
which EPA refers to as ``import tolerances,'' are necessary to allow
importation into the United States of food containing such pesticide
residues. However, where there are no imported commodities that require
these import tolerances, the Agency believes it is appropriate to
revoke tolerances for unregistered pesticides in order to prevent
potential misuse.
    When EPA establishes tolerances for pesticide residues in or on raw
agricultural commodities, the Agency gives consideration to possible
pesticide residues in meat, milk, poultry, and/or eggs produced by
animals that are fed agricultural products (for example, grain or hay)
containing pesticides residues (40 CFR 180.6). If there is no
reasonable expectation of finite pesticide residues

in or on meat, milk, poultry, or eggs, then tolerances do not need to
be established for these commodities (40 CFR 180.6(b) and 180.6 (c)).

C. When Do These Actions Become Effective?

    With the exception of certain tolerances for ametryn and
triadimenol for which EPA is revoking with specific expiration/
revocation dates, the Agency is revoking, modifying, and establishing
specific tolerances/tolerance exemptions, and revising specific
tolerance terminologies effective on the date of publication of this
final rule in the Federal Register. With the exception of the specific
tolerances regarding ametryn and triadimenol for which EPA is revoking
with specific expiration/revocation dates, specific copper tolerances
associated with treated pear wrappers and potable water for which EPA
is revoking because they are no longer needed or applicable, and
tolerances/tolerance exemptions that are considered by EPA to no longer
be significant food/feed items or whose commodity use is covered by
another tolerance/tolerance exemption (including conversion of interim
tolerances for pentachloronitrobenzene to permanent tolerances), the
Agency believes that existing stocks of pesticide products labeled for
the uses associated with the revoked tolerances/tolerance exemptions
have been completely exhausted and that treated commodities have had
sufficient time for passage through the channels of trade. EPA is
revoking ametryn tolerances on banana; corn, sweet, forage; corn,
sweet, kernel plus cob with husks removed; and corn, sweet, stover with
expiration/revocation dates of June 16, 2010; and triadimenol
tolerances on sorghum, grain, forage; sorghum, grain, grain; and
sorghum, grain, stover with expiration/revocation dates of September
11, 2010. The Agency believes that these revocation dates allow users
to exhaust stocks and allow sufficient time for passage of treated
commodities through the channels of trade.
    Any commodities listed in the regulatory text of this document that
are treated with the pesticides subject to this final rule, and that
are in the channels of trade following the tolerance revocations, shall
be subject to FFDCA section 408(1)(5), as established by FQPA. Under
this unit, any residues of these pesticides in or on such food shall
not render the food adulterated so long as it is shown to the
satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA.
    2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates that the
pesticide was applied to such food.

III. Are There Any International Trade Issues Raised by this Final
Action?

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international Maximum Residue Limits (MRLs) established
by the Codex Alimentarius Commission, as required by section 408(b)(4)
of FFDCA. The Codex Alimentarius is a joint U.N. Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level in a notice published for public
comment. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual REDs and TREDs, and in the
Residue Chemistry document which supports the RED and TRED, as
mentioned in the proposed rule cited in Unit II.A. Specific tolerance
actions in this rule and how they compare to Codex MRLs (if any) is
discussed in Unit II.A.

IV. Statutory and Executive Order Reviews

    In this final rule, EPA establishes tolerances under FFDCA section
408(e), and also modifies and revokes specific tolerances established
under FFDCA section 408. The Office of Management and Budget (OMB) has
exempted these types of actions (i.e., establishment and modification
of a tolerance and tolerance revocation for which extraordinary
circumstances do not exist) from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, entitled Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations as required by Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any other Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-13, section 12(d) (15 U.S.C. 272
note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), the Agency previously assessed whether establishment of
tolerances, exemptions from tolerances, raising of tolerance levels,
expansion of exemptions, or revocations might significantly impact a
substantial number of small entities and concluded that, as a general
matter, these actions do not impose a significant economic impact on a
substantial number of small entities. These analyses for tolerance
establishments and modifications, and for tolerance revocations were
published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR
66020) (FRL-5753-1), respectively, and were provided to the Chief
Counsel for Advocacy of the Small Business Administration. Taking into
account this analysis, and available information concerning the
pesticides listed in this rule, the Agency hereby certifies that this
final rule will not have a significant economic impact on a substantial
number of small entities. In a memorandum dated May 25, 2001, EPA
determined that eight conditions must all be satisfied in order for an
import tolerance or tolerance exemption revocation to adversely affect
a significant number of small entity importers, and that there is a
negligible joint probability of all eight conditions holding
simultaneously with respect to any particular revocation. (This Agency
document is available in the docket of the proposed rule, as mentioned
in Unit

II.A.). Furthermore, for the pesticides named in this final rule, the
Agency knows of no extraordinary circumstances that exist as to the
present revocations that would change EPA's previous analysis. In
addition, the Agency has determined that this action will not have a
substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 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 rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000). Executive Order 13175, 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 rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 2, 2009.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.111 is amended by revising the table in paragraph
(a)(1), redesignating paragraphs (a)(2) through (a)(5) as paragraphs
(a)(4) through (a)(7), respectively, and adding new paragraphs (a)(2)
and (a)(3), and by revising newly designated paragraph (a)(6) to read
as follows:

Sec.  180.111  Malathion; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................          135
Alfalfa, hay...............................................          135
Almond, hulls..............................................           50
Almond, postharvest........................................            8
Apple......................................................            8
Apricot....................................................            8
Asparagus..................................................            8
Avocado....................................................            8
Barley, grain, postharvest.................................            8
Bean, dry seed.............................................            8
Bean, succulent............................................            8
Beet, garden, roots........................................            8
Beet, garden, tops.........................................            8
Beet, sugar, roots.........................................            1
Beet, sugar, tops..........................................            8
Blackberry.................................................            8
Blueberry..................................................            8
Boysenberry................................................            8
Carrot, roots..............................................            8
Chayote, fruit.............................................            8
Chayote, roots.............................................            8
Cherry.....................................................            8
Chestnut...................................................            1
Clover, forage.............................................          135
Clover, hay................................................          135
Corn, field, forage........................................            8
Corn, field, grain, postharvest............................            8
Corn, pop, grain, postharvest..............................            8
Corn, sweet, forage........................................            8
Corn, sweet, kernel plus cob with husks removed............            2
Cowpea, forage.............................................          135
Cowpea, hay................................................          135
Cranberry..................................................            8
Cucumber...................................................            8
Currant....................................................            8
Date, dried fruit..........................................            8
Dewberry...................................................            8
Eggplant...................................................            8
Fig........................................................            8
Flax, seed.................................................          0.1
Garlic, bulb...............................................            8
Gooseberry.................................................            8
Grape......................................................            8
Grapefruit.................................................            8
Guava......................................................            8
Hazelnut...................................................            1
Hop, dried cones...........................................            1
Horseradish................................................            8
Kumquat....................................................            8
Leek.......................................................            8
Lemon......................................................            8
Lentil, seed...............................................            8
Lespedeza, hay.............................................          135
Lime.......................................................            8
Loganberry.................................................            8
Lupin, seed................................................            8
Mango......................................................            8
Melon......................................................            8
Mushroom...................................................            8
Nectarine..................................................            8
Nut, macadamia.............................................            1
Oat, grain, postharvest....................................            8
Okra.......................................................            8
Onion, bulb................................................            8
Onion, green...............................................            8
Orange.....................................................            8
Papaya.....................................................            1
Parsnip....................................................            8
Passionfruit...............................................            8
Pea........................................................            8
Pea, field, hay............................................            8
Pea, field, vines..........................................            8
Peach......................................................            8
Peanut, hay................................................          135
Peanut, postharvest........................................            8
Pear.......................................................            8
Pecan......................................................            8
Pepper.....................................................            8
Peppermint, tops...........................................            8
Pineapple..................................................            8
Plum.......................................................            8
Plum, prune................................................            8
Potato.....................................................            8
Pumpkin....................................................            8
Quince.....................................................            8
Radish.....................................................            8

Raspberry..................................................            8
Rice, grain, postharvest...................................            8
Rice, wild.................................................            8
Rutabaga...................................................            8
Rye, grain, postharvest....................................            8
Safflower, seed............................................          0.2
Salsify, roots.............................................            8
Salsify, tops..............................................            8
Shallot, bulb..............................................            8
Sorghum, grain, forage.....................................            8
Sorghum, grain, grain, postharvest.........................            8
Soybean, forage............................................          135
Soybean, hay...............................................          135
Soybean, seed..............................................            8
Soybean, vegetable, succulent..............................            8
Spearmint, tops............................................            8
Squash, summer.............................................            8
Squash, winter.............................................            8
Strawberry.................................................            8
Sunflower, seed, postharvest...............................            8
Sweet potato, roots........................................            1
Tangerine..................................................            8
Tomato.....................................................            8
Trefoil, forage............................................          135
Trefoil, hay...............................................          135
Turnip, greens.............................................            8
Turnip, roots..............................................            8
Vegetable, brassica, leafy, group 5........................            8
Vegetable, leafy, except brassica, group 4.................            8
Vetch, hay.................................................          135
Walnut.....................................................            8
Wheat, grain, postharvest..................................            8
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the
insecticide malathion (O,O-dimethyl dithiophosphate of diethyl
mercaptosuccinate) and its metabolite, malaoxon (O,O-dimethyl
thiophosphate of diethyl mercaptosuccinate), in or on the following
food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, straw..............................................           50
Corn, field, stover........................................         30.0
Cotton, undelinted seed....................................         20.0
Grass, forage..............................................          200
Grass, hay.................................................          270
Oat, forage................................................          4.0
Oat, straw.................................................           50
Rye, forage................................................          4.0
Rye, straw.................................................           50
Watercress.................................................          0.2
Wheat, forage..............................................          4.0
Wheat, straw...............................................           50
------------------------------------------------------------------------

    (3) Tolerances are established for residues of the insecticide
malathion (O,O-dimethyl dithiophosphate of diethyl mercaptosuccinate),
in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................            4
Cattle, meat\1\............................................            4
Cattle, meat byproducts\1\.................................            4
Egg........................................................          0.1
Goat, fat..................................................            4
Goat, meat\1\..............................................            4
Goat, meat byproducts\1\...................................            4
Hog, fat...................................................            4
Hog, meat\1\...............................................            4
Hog, meat byproducts\1\....................................            4
Horse, fat.................................................            4
Horse, meat\1\.............................................            4
Horse, meat byproducts\1\..................................            4
Milk, fat..................................................          0.5
Poultry, fat...............................................            4
Poultry, meat\1\...........................................            4
Poultry, meat byproducts\1\................................            4
Sheep, fat.................................................            4
Sheep, meat\1\.............................................            4
Sheep, meat byproducts\1\..................................            4
------------------------------------------------------------------------
\1\ The tolerance level shall not be exceeded in any cut of meat or in
  any meat byproducts from cattle, goat, hog, horse, poultry, or sheep.

* * * * *
    (6) Malathion may be safely used for the control of insects during
the drying of grape (raisins) in compliance with paragraph (a)(4) of
this section by incorporation into paper trays in amounts not exceeding
100 milligrams per square foot.
* * * * *

Sec.  180.136  [Removed]

0
3. Section 180.136 is removed.

Sec.  180.149  [Removed]

0
4. Section 180.149 is removed.

0
5. Section 180.222 is amended by revising the table in paragraph (a),
and by revising paragraph (d) to read as follows:

Sec.  180.222  Prometryn; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Carrot, roots\1\...........................................          0.1
Celery.....................................................          0.5
Cotton, gin byproducts.....................................          1.0
Cotton, undelinted seed....................................         0.25
Pea, pigeon, seed..........................................         0.25
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of April 10, 1998 for use on
  carrots.

* * * * *
     (d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent residues of the herbicide prometryn, 2,4-
bis(isopropylamino)-6-methylthio-s-triazine, in or on the following
food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, forage.............................................          0.3
Barley, hay................................................          1.0
Barley, straw..............................................          0.3
Oat, forage................................................          0.3
Oat, hay...................................................          1.0
Oat, straw.................................................          0.3
Rye, forage................................................          0.3
Rye, hay...................................................          1.0
Rye, straw.................................................          0.3
Triticale, forage..........................................          0.3
Triticale, hay.............................................          1.0
Triticale, straw...........................................          0.3
Wheat, forage..............................................          0.3
Wheat, hay.................................................          1.0
Wheat, straw...............................................          0.3
------------------------------------------------------------------------

0
6. Section 180.258 is amended by revising the table in paragraph (a) to
read as follows:

Sec.  180.258  Ametryn; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
Banana........................................         0.25      6/16/10
Corn, field, forage...........................          0.1         None
Corn, field, grain............................         0.05         None
Corn, field, stover...........................         0.05         None
Corn, pop, grain..............................         0.05         None
Corn, pop, stover.............................         0.05         None
Corn, sweet, forage...........................          0.5      6/16/10
Corn, sweet, kernel plus cob with husks                0.25      6/16/10
 removed......................................
Corn, sweet, stover...........................          0.5      6/16/10
Pineapple.....................................         0.05         None
Sugarcane, cane...............................         0.05         None
------------------------------------------------------------------------

* * * * *

Sec.  180.287  [Amended]

0
7. Section 180.287 is amended by removing the entry for ``pear'' from
the table in paragraph (a).

0
8. Section 180.291 is revised to read as follows:

Sec.  180.291  Pentachloronitrobenzene; tolerances for residues.

    (a) General. Tolerances are established for the combined residues
of the fungicide pentachloronitrobenzene (PCNB) and its metabolites
pentachloroaniline (PCA), and pentachlorothioanisole (PCTA), in or on
the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean.......................................................          0.1

Brassica, head and stem, subgroup 5A.......................          0.1
Cotton, undelinted seed....................................          0.1
Garlic, bulb...............................................          0.1
Peanut.....................................................          1.0
Potato.....................................................          0.1
Soybean, forage............................................         0.02
Soybean, hay...............................................         0.02
Soybean, seed..............................................         0.02
Vegetable, fruiting, group 8...............................          0.1
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
     (c) Tolerances with regional registrations. Tolerances with
regional registrations, as defined in Sec.  180.1(m), are established
for the combined residues of the fungicide pentachloronitrobenzene
(PCNB) and its metabolites pentachloroaniline (PCA), and
pentachlorothioanisole (PCTA), in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Collards...................................................          0.2
Kale.......................................................          0.2
Mustard, greens............................................          0.2
------------------------------------------------------------------------

     (d) Indirect or inadvertent residues. [Reserved]

Sec.  180.319  [Amended]

0
9. Section 180.319 is amended by removing the entire entry for
``pentachloronitrobenzene'' from the table.

Sec.  180.411  [Amended]

0
10. Section 180.411 is amended by removing the entry for ``spinach''
from the table in paragraph (a).

0
11. Section 180.450 is amended by revising the table in paragraph (a)
to read as follows:

Sec.  180.450  Beta-(4-Chlorophenoxy)-[alpha]-(1,1-dimethylethyl)-1H-
1,2,4-triazole-1-ethanol; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Banana\1\.......................................        0.2         None
Barley, grain...................................       0.05         None
Barley, straw...................................        0.2         None
Corn, field, forage.............................       0.05         None
Corn, field, grain..............................       0.05         None
Corn, field, stover.............................       0.05         None
Corn, pop, grain................................       0.05         None
Corn, pop, stover...............................       0.05         None
Corn, sweet, forage.............................       0.05         None
Corn, sweet, kernel plus cob with husks removed.       0.05         None
Corn, sweet, stover.............................       0.05         None
Cotton, undelinted seed.........................       0.02         None
Oat, forage.....................................        2.5         None
Oat, grain......................................       0.05         None
Oat, straw......................................        0.2         None
Rye, forage.....................................        2.5         None
Rye, grain......................................       0.05         None
Rye, straw......................................        0.1         None
Sorghum, grain, forage..........................       0.05      9/11/10
Sorghum, grain, grain...........................       0.01      9/11/10
Sorghum, grain, stover..........................       0.01      9/11/10
Wheat, forage...................................        2.5         None
Wheat, grain....................................       0.05         None
Wheat, straw....................................        0.2         None
------------------------------------------------------------------------
\1\ There are no U.S. registrations for banana (whole) as of September
  22, 1993.

* * * * *

0
12. Section 180.457 is revised to read as follows:

Sec.  180.457  Bitertanol; tolerances for residues.

    (a) General. A tolerance is established for the residues of the
fungicide bitertanol, [beta]-([1,1'-biphenyl]-4-yloxy)-[alpha]-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on the following raw
agricultural commodity:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Banana\1\..................................................          0.5
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of April 1, 1992.

     (b) Section 18 emergency exemptions. [Reserved]
     (c) Tolerances with regional registrations. [Reserved]
     (d) Indirect or inadvertent residues. [Reserved]

Sec.  180.538  [Removed]

0
13. Section 180.538 is removed.

0
14. Section 180.1020 is revised to read as follows:

Sec.  180.1020  Sodium chlorate; exemption from the requirement of a
tolerance.

    Sodium chlorate is exempted from the requirement of a tolerance for
residues when used as a defoliant or desiccant in accordance with good
agricultural practice on the following crops:

Bean, dry, seed
Corn, field, forage
Corn, field, grain
Corn, field, stover
Corn, pop, grain
Corn, pop, stover
Corn, sweet, forage
Corn, sweet, stover
Cotton, undelinted seed
Flax, seed
Grain, aspirated fractions
Guar, seed
Pea, southern
Pepper, nonbell
Potato
Rice, grain
Rice, straw
Safflower, seed
Sorghum, forage, forage
Sorghum, grain, forage
Sorghum, grain, grain
Sorghum, grain, stover
Soybean, forage
Soybean, hay
Soybean, seed
Sunflower, seed
Wheat, grain

0
15. Section 180.1021 is amended by revising paragraph (b) to read as
follows:

Sec.  180.1021  Copper; exemption from the requirement of a tolerance.

* * * * *
    (b) The following copper compounds are exempt from the requirement
of a tolerance when applied (primarily) as a fungicide to growing crops
using good agricultural practices:

------------------------------------------------------------------------
                Copper compounds                       CAS Reg. No.
------------------------------------------------------------------------
Basic copper carbonate (malachite).............                1184-64-1
Copper ammonia complex.........................               16828-95-8
Copper ethylenediamine complex.................               13426-91-0
Copper hydroxide...............................               20427-59-2
Copper octanoate...............................               20543-04-8
Copper oxychloride.............................                1332-65-6
Copper oxychloride sulfate.....................                8012-69-9
Copper salts of fatty and rosin acids..........                9007-39-0
Copper sulfate basic...........................                1344-73-6
Copper sulfate pentahydrate....................                7758-99-8
Cuprous oxide..................................                1317-19-1
------------------------------------------------------------------------

* * * * *

0
16. Section 180.1284 is revised to read as follows:

Sec.  180.1284  Ammonium salts of higher fatty acids (C8-
C18 saturated; C8-C12 unsaturated);
exemption from the requirement of a tolerance.

    Ammonium salts of C8-C18 saturated and
C8-C12 unsaturated higher fatty acids are
exempted from the requirement of a tolerance for residues in or on all
food commodities when used in accordance with good agricultural
practice.

[FR Doc. E9-22022 Filed 9-15-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Notices]
[Page 46147]
[FR Doc No: 2012-18942]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

57th Meeting: RTCA Special Committee 186, Automatic Dependent
Surveillance Broadcast (ADS-B)

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Meeting Notice of RTCA Special Committee 186, Automatic
Dependent Surveillance Broadcast (ADS-B).

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

SUMMARY: The FAA is issuing this notice to advise the public of the
57th meeting of RTCA Special Committee 186, Automatic Dependent
Surveillance Broadcast (ADS-B)

DATES: The meeting will be held August 23, 2012, from 9 a.m.-5 p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1150 18th Street
NW., Suite 910, MacIntosh-NBAA Room and Colson Board Room, Washington,
DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a) (2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 186. The agenda will
include the following:

August 23, 2012

 Chairman's Introductory Remarks
 Review of Meeting Agenda
 Review/Approval of the Fifty-Sixth Meeting Summary, RTCA Paper
No. 142-12/SC186-321
 EUROCAE WG-51--Status & Activities
 FAA Surveillance and Broadcast Services (SBS) Program--Status
 Working Group Reports
     WG-1--Operations and Implementation--no report
     WG-2--TIS-B MASPS--no report
     WG-3--1090 MHz MOPS--no report
     WG-4--Application Technical Requirements--Status
    [ssquf] Traffic Situation Awareness with Alerts (TSAA)
    [ssquf] Flight-deck Interval Management (FIM)
     WG-5--UAT MOPS--no report
     WG-6--Combined ADS-B & ASA MASPS--no report
    [ssquf] ATSSA MASPS published in June by RTCA as DO-338
 Date, Place and Time of Next Meeting
 New Business
 Other Business
     Aircraft-level Flight Crew Alerting on ADS-B Equipment
Failures
 Review Action Items/Work Programs
 Adjourn Plenary
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on July 27, 2012.
Kathy Hitt,
Management Analyst, Business Operations Branch, Federal Aviation
Administration.
[FR Doc. 2012-18942 Filed 8-1-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Page 12068]
[FR Doc No: 2013-03963]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Device Good Manufacturing Practice Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (Agency or FDA). The
meeting will be open to the public.
    Name of Committee: Device Good Manufacturing Practice Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 11, 2013, from 8
a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is<PHONE_NUMBER>.
    Contact Person: Natasha Facey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg
66, rm. 1544, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On April 11, 2013, the committee will discuss the potential
effects of extreme weather and natural disasters on medical device
manufacturing chain processes and marketed medical device safety and
quality. The committee will further discuss how to optimize the use of
FDA's current regulatory framework to address risks and vulnerabilities
to the manufacturing chain resulting from extreme weather conditions.
Future steps may be identified to help industry mitigate or better
tolerate challenges to the manufacturing chain as a result of extreme
weather conditions. In a separate Federal Register notice, FDA is
seeking additional broad public input about the effects of extreme
weather on medical device safety and quality.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 4, 2013. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 p.m. Oral presentations from
industry, professional organizations, and societies that have an
interest in this topic will be scheduled between approximately 1 p.m.
and 2 p.m. Those individuals interested in making formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before March 27, 2013. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by March 29,
2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Committee Management Staff, at<EMAIL_ADDRESS>or 301-
796-5966, at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 14, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-03963 Filed 2-20-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33249-33250]
[FR Doc No: 2014-13457]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72313; File No. SR-NYSEMKT-2014-48]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Rule
900.3NY(d)(3) in Order To Delete Reserve Orders and References Thereto
From the Rules

June 4, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on May 23, 2014 NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Rule 900.3NY(d)(3) in order to
delete Reserve Orders and references thereto from the rules. The text
of the proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange hereby proposes to amend Rule 900.3NY(d)(3) to delete
``Reserve Order'' as an order type. The proposed rule change mirrors a
similar deletion by the NASDAQ Options Market (``NOM'').\4\ Reserve
Orders are limit orders that have both a displayed size as well as an
additional non-displayed amount. Both the displayed and non-displayed
portions of a Reserve Order are available for potential execution
against incoming orders. If the displayed portion of a Reserve Order is
fully executed, the System will replenish the displayed portion from
the reserve up to the size of the original displayed amount. A new
timestamp is created for the replenished portion of the order each time
it is replenished from reserve, while the reserve portion retains the
time-stamp of its original entry. Due to a lack of demand for Reserve
Orders, the Exchange proposes to discontinue functionality supporting
the order type. Accordingly, the Exchange proposes to delete the
definition of Reserve Order from Rule 900.3NY(d)(3).
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 65873 (December 2,
2011); 76 FR 76786 (December 8, 2011) (SR-NASDAQ-2011-164).
---------------------------------------------------------------------------

    The Exchange also proposes to make corresponding amendments to
Rules 935NY Commentary .06, 964NY(b)(2)(A), 964NY(c)(2)(A),
964NY(c)(2)(D), 964NY(c)(2)(E)(iii) and 971.1NY(c)(5)(E) in order to
remove references to Reserve Orders. No substantive changes are being
proposed to these rules themselves. The Exchange will announce the
implementation date of this change through a Trader Update.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \5\ of the
Securities Exchange Act of 1934 (the ``Act''), in general, and furthers
the objectives of Section 6(b)(5),\6\ in particular, in that it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, and to remove impediments to and perfect the mechanism of a
free and open market and a national market system. Specifically, the
Exchange believes that, by eliminating a little-used order type and
making corresponding changes to the rules, the proposal will remove
impediments to and perfect the mechanisms of a free and open market and
add transparency and clarity to the Exchange's rules. The Exchange
further believes that deleting corresponding references to a deleted
order type also removes impediments to and perfects the mechanism of a
free and open market by ensuring that members, regulators and the
public can more easily navigate the Exchange's rulebook and better
understand the orders types available for trading on the Exchange.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Specifically, the Exchange
believes that the proposed rule change will relieve a burden on
competition by following another options market in no longer offering a
seldom used rule type. In doing so, the proposed rule change will also
serve to promote regulatory clarity and consistency, thereby reducing
burdens on the marketplace and facilitating investor protection.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) \7\ of the Act and Rule 19b-4(f)(6) \8\ thereunder.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to provide the Commission with written notice
of its intent to file the proposed rule change, along with a brief
description and text of the proposed rule change, at least five
business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \9\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2014-48 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2014-48. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2014-48, and should
be submitted on or before July 1, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-13457 Filed 6-9-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Proposed Rules]
[Pages 61140-61141]
[FR Doc No: 2015-25834]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0280; FRL-9935-41-Region 9]

Revisions to California State Implementation Plan; Bay Area Air
Quality Management District; Stationary Source Permits; Reopening of
Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; reopening of comment period.

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

SUMMARY: EPA is reopening the comment period on a proposed limited
approval and limited disapproval published on August 28, 2015 (80 FR
52236).

DATES: Any comments on this proposal must arrive by November 12, 2015.

ADDRESSES: Submit comments, identified by Docket ID Number EPA-R09-OAR-
2015-0280, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Gerardo Rios (Air-3), U.S. Environmental
Protection Agency, Region 9, 75 Hawthorne Street, San Francisco, CA
94105-3901. Deliveries are only accepted during the Regional Office's
normal hours of operation.
    Instructions: All comments 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 Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an anonymous access system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. 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.
    Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region 9, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed at www.regulations.gov, some
information may be publicly available only at the hard copy location
(e.g., copyrighted material, large maps), and some may not be publicly
available in either location (e.g., CBI). To inspect the hard copy
materials, please schedule an appointment during normal business hours
with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Shaheerah Kelly, EPA Region 9, (415)
947-4156<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 28, 2015, EPA proposed a limited
approval and limited disapproval of the following rules for the Bay
Area Air Quality Management District (BAAQMD) portion of the California
State Implementation Plan (SIP).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
           Regulation & Rule No.                       Rule title            Adopted/amended       Submitted
----------------------------------------------------------------------------------------------------------------
Regulation 2, Rule 1 (2-1).................  Permits, General Requirements           12/19/12            4/22/13
Regulation 2, Rule 2 (2-2).................  Permits, New Source Review...           12/19/12            4/22/13
----------------------------------------------------------------------------------------------------------------

    The proposed rule provided a 30-day public comment period. In
response to a request from BAAQMD submitted by letter on September 21,
2015, EPA is reopening the comment period for an additional 45 days.

    Dated: September 28, 2015.
 Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2015-25834 Filed 10-8-15; 8:45 am]
 BILLING CODE 6560-50-P