[Federal Register: May 29, 2008 (Volume 73, Number 104)]
[Rules and Regulations]
[Page 30746-30749]
[DOCID:fr29my08-6]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0032; Directorate Identifier 2007-NM-314-AD;
Amendment 39-15538; AD 2008-11-15]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model 717-200
Airplanes; Model DC-9-10 Series Airplanes; Model DC-9-20 Series
Airplanes; Model DC-9-30 Series Airplanes; Model DC-9-40 Series
Airplanes; Model DC-9-50 Series Airplanes; Model DC-9-81 (MD-81), DC-9-
82 (MD-82), DC-9-83 (MD-83), and DC-9-87 (MD-87) Airplanes; Model MD-88
Airplanes; and Model MD-90-30 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
McDonnell Douglas airplanes identified above. This AD requires revising
the FAA-approved maintenance program, or the Airworthiness Limitations
(AWLs) section of the Instructions for Continued Airworthiness, as
applicable, to incorporate new AWLs for fuel tank systems to satisfy
Special Federal Aviation Regulation No. 88 requirements. This AD
results from a design review of the fuel tank systems. We are issuing
this AD to prevent the potential for ignition sources inside fuel tanks
caused by latent failures, alterations, repairs, or maintenance
actions, which, in combination with flammable fuel vapors, could result
in a fuel tank explosion and consequent loss of the airplane.

DATES: This AD is effective July 3, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 3,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood
Boulevard, Long Beach, California 90846, Attention: Data and Service
Management, Dept. C1-L5A (D800-0024).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Serj Harutunian, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
McDonnell Douglas Model 717-200 airplanes; Model DC-9-10 series
airplanes; Model DC-9-20 series airplanes; Model DC-9-30 series
airplanes; Model DC-9-40 series airplanes; Model DC-9-50 series
airplanes; Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83), and
DC-9-87 (MD-87) airplanes; Model MD-88 airplanes; and Model MD-90-30
airplanes. That NPRM was published in the Federal Register on January
18, 2008 (73 FR 3422). That NPRM proposed to require revising the FAA-
approved maintenance program, or the Airworthiness Limitations (AWLs)
section of the Instructions for Continued Airworthiness (ICA), as
applicable, to incorporate new AWLs for fuel tank systems to satisfy
Special Federal Aviation Regulation No. 88 requirements.

Changes Made to This AD

    For standardization purposes, we have revised this AD in the
following ways:
     We have added a new paragraph (i) to this AD to specify
that no alternative inspections, inspection intervals, or critical
design configuration control limitations (CDCCLs) may be used unless
they are part of a later approved revision of the Boeing Twinjet
Special Compliance Items Report, MDC-92K9145, Revision G, dated June 7,
2007 (hereafter referred to as ``Report MDC-92K9145''), or unless they
are approved as an alternative method of compliance (AMOC). Inclusion
of this paragraph in the AD is intended to ensure that the AD-mandated
airworthiness limitations changes are treated the same as the
airworthiness limitations issued with the original type certificate.
     We have revised Note 1 of this AD to clarify that an
operator must request approval for an AMOC if the operator cannot
accomplish the required inspections because an airplane has been
previously modified, altered, or repaired in the areas addressed by the
required inspections.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the five commenters.

Request To Revise Note 1

    Boeing requests that we revise Note 1 of the NPRM to clarify the
intent of the note. Boeing states that Note 1 of the NPRM might be
misinterpreted to mean that the AWLs of Report MDC-92K9145 must be
revised to reflect modifications, alterations, or repairs that are
initiated by an operator and outside of Boeing's design cognizance and
responsibility. Boeing requests that we revise Note 1 as follows:
     Replace the words ``revision to'' with ``a deviation
from'' in the last sentence.
     Delete the words ``(g), (h), or'' and ``as applicable''
from the last sentence.
    As stated previously, we have clarified the language in Note 1 of
this AD for standardization with other similar ADs. The language the
commenter requests that we change does not appear in the revised note.
Therefore, no additional change to this AD is necessary in this regard.

Request To Clarify Approval of Component Maintenance Manual (CMM)
Changes

    Boeing requests that we revise the heading and certain wording for
the ``Changes to Component Maintenance Manuals (CMMs) Cited in Fuel
Tank System AWLs'' section of the NPRM. Boeing believes that section
was intended to address situations where an operator chooses to deviate
from the procedures in the CMM referenced in Report MDC-92K9145. Boeing
states that its proposed changes are intended to clarify that only
deviations proposed by an operator require approval of the Manager, Los
Angeles Aircraft Certification Office (ACO), FAA. Boeing further states
that wording in the NPRM could be interpreted to mean that approval of
a CMM in its entirety, including any future CMM revisions by Boeing,
would require direct approval of the Manager, Los Angeles ACO, or
governing regulatory authority.

Specifically, Boeing requests that we revise that section as follows:
     Revise the heading to ``Deviations from Component
Maintenance Manuals (CMMs) Cited in Fuel Tank System AWLs.''
     Revise the third sentence to state that the Manager, Los
Angeles ACO, must approve ``any deviations from'' the CMMs ``as defined
in Report MDC-92K9145.''
     Replace the words ``revision of'' with ``deviation from''
in the fourth sentence.
     Revise the fourth sentence to state that those CMMs ``as
defined in Report MDC-92K9145'' will be handled like a change to the
AWL itself.
     Delete the entire last sentence.
    We agree that clarification is necessary. Our intent is that any
deviation from the CMMs as defined in Report MDC-92K9145 must be
approved by the Manager, Los Angeles ACO, or the governing regulatory
authority, before those deviations can be used. However, we have not
changed the AD as suggested by the commenter, since the ``Changes to
Component Maintenance Manuals (CMMs) Cited in Fuel Tank System AWLs''
section of the NPRM is not retained in this AD.

Request To Identify Additional Service Information

    The Air Transport Association (ATA), on behalf of its member Delta
Airlines (DAL), requests that we revise the NPRM to identify the
affected airplane maintenance manual (AMM), structural repair manual
(SRM), and standard wiring practices manual (SWPM) sections for each
CDCCL and AWL inspection. DAL states that Appendixes B, C, and D of
Report MDC-92K9145 do not fully identify all manuals that require
revision to incorporate the requirements of the given appendix, but
that the information is available in a cross-reference document that
Boeing has made available on the Internet at https://
www.myboeingfleet.com/.
    DAL notes that the ``Ensuring Compliance With Fuel Tank System
AWLs'' section of the NPRM indicates that Boeing has revised the
applicable manuals to address AWLs and to include notes about CDCCLs.
However, DAL has reviewed the applicable manuals and notes that certain
information specified in Report MDC-92K9145 is not present. For
example, although MD-90 CDCCL 28-3 specifies to use only connector part
number 14158-2 when rebuilding or repairing a pump conduit assembly in
accordance with chapter 28-20-7 of the Boeing overhaul manual, this
requirement is not included in the SWPM or CMM 28-20-07, or identified
as a CDCCL in the CMM.
    We disagree with revising this AD as requested by the commenter.
Boeing formatted Report MDC-92K9145 to provide specific information,
where appropriate, concerning the limitations and necessary actions to
maintain CDCCLs and AWL inspections. This revised service information
is readily available to affected operators; therefore, there is no need
to be more specific in this AD. No change to this final rule is
necessary in this regard.

Request To Allow Continued Use of Existing Inventory Parts

    The ATA, on behalf of its member American Airlines, submitted a
comment objecting to the language in Report MDC-92K9145 that controls
maintenance to the standards specified in the referenced CMMs without
deviation according to a FAA-approved service bulletin. American
Airlines states that this proposed requirement will mandate the removal
of long-standing, proven parts substitutions and repair techniques
developed by the operator in accordance with processes and procedures
approved by the FAA. American Airlines also states that proposed
requirement might also make obsolete certain test instruments and
procedures developed by operators. American Airlines asserts that,
without federally-regulated parts supply chains with price controls,
the proposed process makes it impossible for operators to ensure that
they have multiple sources for parts that can be obtained at reasonable
prices. American Airlines states that, in order to ensure that CMM-
approved parts cannot be interchanged with other approved substitute
parts, operators will be forced into expensive redesigns of their
inventory systems, or special procedures to permanently segregate parts
for those specified CMMs. American Airlines states that the cost of
incorporating the proposed requirements of the NPRM will far exceed the
estimated cost specified in the NPRM.
    We infer the commenters request that we allow operators to continue
to use alternative parts inventory and test equipment for repair and
overhaul of their fuel system components and interchange these parts,
which might be different than the parts identified in the approved CMM.
We disagree with this request. While the commenters are correct about
the restrictions included in the referenced service information,
operators may always take advantage of alternatives by requesting that
those alternatives be evaluated and approved in accordance with the
provisions of paragraph (k) of this AD. No change to this AD is
necessary in this regard.

Request To Allow Minor Fuel Pump Repairs Without FAA-Approval

    The ATA, on behalf of its member Northwest Airlines (NWA), requests
we revise the NPRM to specify that fuel pump repairs that are minor do
not require FAA approval, and that existing FAA-approved repairs and
parts manufacturer approval (PMA) parts do not require re-approval by
the FAA. NWA states that CDCCL 28-2 severely limits or eliminates NWA's
ability to use Part 121 authority to customize the particular CMM with
NWA-developed repairs that use alternate PMA materials and vendors.
    We disagree with revising this AD as suggested by the commenters.
The intent of this AD and Special Federal Aviation Regulation No. 88
(``SFAR 88,'' Amendment 21-78, and subsequent Amendments 21-82 and 21-
83) is to define CDCCLs, and the repair and overhaul of fuel system
components in accordance with the limitations specified in Report MDC-
92K9145. The impetus to declare overhaul and repair of certain fuel
tank system components as CDCCLs arose from in-service pump failures
that resulted from repairs not done according to the original equipment
manufacturer (OEM) procedures. Therefore, all changes, whether minor or
major, must be approved by the Manager, Los Angeles ACO. NWA did not
identify any PMAs that would require re-approval. Any existing or
future PMAs, or deviations from the approved CMMs, can be requested by
the AMOC process.

Request To Revise Estimated Costs

    The ATA, on behalf of its members DAL and NWA, disagrees with the
``Costs of Compliance'' section of the NPRM. DAL estimates that it will
take at least 40 hours to document and implement the changes to the
ICA, rather than 1 hour as proposed in the NPRM. DAL also notes that
the ``Costs of Compliance'' section of the NPRM does not include the
labor time required for accomplishing the required repetitive
inspections. NWA states it overhauled and repaired 75 fuel pumps in
2007, and that it estimates that compliance with CDCCL 28-2 will add
about $1,000 to the cost of each overhauled/repaired fuel pump.
    We infer that the commenters request that we revise the ``Costs of
Compliance'' section of this AD. We agree that, for certain operators,
there might be a one-time cost associated with changing over from
existing repair/

overhaul procedures to the CMM procedures approved under SFAR 88.
However, we disagree with including the costs in this AD for complying
with the CDCCLs. The economic analysis of an AD is limited only to the
cost of actions actually required by the rule. It does not consider the
costs of ``on-condition'' actions (that is, actions needed to correct
an unsafe condition) because, regardless of AD direction, those actions
would be required to correct an unsafe condition identified in an
airplane and ensure operation of that airplane in an airworthy
condition, as required by the Federal Aviation Regulations. No change
is necessary in this regard.
    We also disagree with increasing the estimated work-hours for
incorporating new AWLs for fuel tank systems into the FAA-approved
maintenance program, or AWLs section of the ICA, as applicable. While
some individual operators may take longer to accomplish the
requirements, others may not. Our cost estimate is based on an average
of expected costs for all operators. We also disagree with including
the cost of accomplishing the repetitive AWL inspections, since they
are not directly required by this AD. This AD only requires the change
to the maintenance program, or AWLs of the ICA, as applicable. The
operating rules require the repetitive inspections once the maintenance
program/ICA is changed. No change to this AD is necessary in this
regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 780 airplanes of U.S. registry. We
also estimate that it takes about 1 work-hour per product to comply
with this AD. The average labor rate is $80 per work-hour. Based on
these figures, we estimate the cost of this AD to the U.S. operators to
be $62,400, or $80 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-11-15 McDonnell Douglas: Amendment 39-15538. Docket No. FAA-
2008-0032; Directorate Identifier 2007-NM-314-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective July 3, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all McDonnell Douglas Model 717-200
airplanes; Model DC-9-11, DC-9-12, DC-9-13, DC-9-14, DC-9-15, and
DC-9-15F airplanes; Model DC-9-21 airplanes; Model DC-9-31, DC-9-32,
DC-9-32 (VC-9C), DC-9-32F, DC-9-33F, DC-9-34, DC-9-34F, and DC-9-32F
(C-9A, C-9B) airplanes; Model DC-9-41 airplanes; Model DC-9-51
airplanes; Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83),
and DC-9-87 (MD-87) airplanes; Model MD-88 airplanes; and Model MD-
90-30 airplanes; certificated in any category.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these limitations is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance (AMOC)
according to paragraph (k) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Unsafe Condition

    (d) This AD results from a design review of the fuel tank
systems. We are issuing this AD to prevent the potential for
ignition sources inside fuel tanks caused by latent failures,
alterations, repairs, or maintenance actions, which, in combination
with flammable fuel vapors, could result in a fuel tank explosion
and consequent loss of the airplane.

Compliance

    (e) Comply with this AD within the compliance times specified,
unless already done.

Service Information Reference

    (f) The term ``Report MDC-92K9145,'' as used in this AD, means
the Boeing Twinjet Special Compliance Items Report, MDC-92K9145,
Revision G, dated June 7, 2007.

Revise the FAA-Approved Maintenance Program

    (g) For Model DC-9-11, DC-9-12, DC-9-13, DC-9-14, DC-9-15, and
DC-9-15F airplanes; Model DC-9-21 airplanes; Model DC-9-31, DC-9-32,
DC-9-32 (VC-9C), DC-9-32F, DC-9-33F, DC-9-34, DC-9-34F, and DC-9-32F
(C-9A, C-9B) airplanes; Model DC-9-41 airplanes; Model DC-9-51
airplanes; and Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-
83), and DC-9-87 (MD-87) airplanes: Before December 16, 2008, revise
the FAA-approved maintenance program to incorporate the information
specified in Appendixes B, C, and D of

Report MDC-92K9145. Accomplishing the revision in accordance with a
later revision of Report MDC-92K9145 is an acceptable method of
compliance if the revision is approved by the Manager, Los Angeles
Aircraft Certification Office (ACO), FAA.

Revise the Airworthiness Limitations (AWLs) Section

    (h) For Model 717-200, Model MD-88, and Model MD-90-30
airplanes: Before December 16, 2008, revise the AWLs section of the
Instructions for Continued Airworthiness (ICA) to incorporate the
information specified in Appendixes B, C, and D of Report MDC-
92K9145. Accomplishing the revision in accordance with a later
revision of Report MDC-92K9145 is an acceptable method of compliance
if the revision is approved by the Manager, Los Angeles ACO.

No Alternative Inspections, Inspection Intervals, or Critical Design
Configuration Control Limitations (CDCCLs)

    (i) After accomplishing the actions specified in paragraph (g)
or (h) of this AD, as applicable, no alternative inspections,
inspection intervals, or CDCCLs may be used unless the inspections,
intervals, or CDCCLs are part of a later revision of Report MDC-
92K9145 that is approved by the Manager, Los Angeles ACO; or unless
the inspections, intervals, or CDCCLs are approved as an AMOC in
accordance with the procedures specified in paragraph (k) of this
AD.

No Reporting Requirement

    (j) Although Report MDC-92K9145 specifies to submit certain
information to the manufacturer, this AD does not require that
action.

Alternative Methods of Compliance (AMOCs)

    (k)(1) The Manager, Los Angeles ACO, FAA, ATTN: Serj Harutunian,
Aerospace Engineer, Propulsion Branch, ANM-140L, 3960 Paramount
Boulevard, Lakewood, California 90712-4137; telephone (562) 627-
5254; fax<PHONE_NUMBER>; has the authority to approve AMOCs for
this AD, if requested using the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Material Incorporated by Reference

    (l) You must use the Boeing Twinjet Special Compliance Items
Report, MDC-92K9145, Revision G, dated June 7, 2007, to do the
actions required by this AD, unless the AD specifies otherwise.
    (1) The document contains the following errors:
    (i) The Index of Page Changes specifies incorrect revision
levels for certain pages. The revision levels specified on each page
are correct.
    (ii) There are three sets of pages (six pages total) with the
same page numbers in Appendix C (i.e., pages C1 and C2). The first
set of page numbers (i.e., Appendix C title page and Twinjet
Airworthiness Limitation Instructions (ALIs)) is correct. The second
set of page numbers (i.e., ALI 20-2) is incorrect. Those pages
should be identified as page numbers C6 and C7 as specified in the
Index of Page Changes. The third set of page numbers (i.e., ALI 20-
3) is also incorrect. Those pages should be identified as page
numbers C8 and C9 as specified in the Index of Page Changes.
    (iii) None of the pages are dated. The issue date for each
revision is specified in the Index of Page Changes.
    (2) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood
Boulevard, Long Beach, California 90846, Attention: Data and Service
Management, Dept. C1-L5A (D800-0024).
    (4) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on May 15, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-11502 Filed 5-28-08; 8:45 am]

BILLING CODE 4910-13-P


August 30, 2006

Document Control Office (DCO)

Office of Pollution Prevention and Toxics (OPPT)

US Environmental Protection Agency

1200 Pennsylvania Ave., NW

Washington DC 20460-0001

ATTN: Preliminary Assessment Information Reporting (PAIR) rule/8(a)
Auto-ITC

RE:	Docket EPA-HQ-OPPT-2005-0014: Request for withdrawal of CAS #
68603-84-9, 68937-70-2, and 68937-72-4 from PAIR rule

As specified in Unit IV of the TSCA Section 8(a) preliminary assessment
information reporting (PAIR) rule published on August 16, 2006 (FR
71:47122-47130), Aliphatic Acids Consortium hereby requests removal of
CAS # 68603-84-9 (Carboxylic acids, C5-9), 68937-70-2 (Carboxylic acids,
C6-18 and C8-15-di-), and 68937-72-4 (Carboxylic acids, di-, C4-11) from
the PAIR rule.

CAS # 68603-84-9 (Carboxylic acids, C5-9), 68937-70-2 (Carboxylic acids,
C6-18 and C8-15-di-), 68937-72-4 (Carboxylic acids, di-, C4-11) are
already sponsored by the Aliphatic Acids Consortium through the
International Council of Chemical Associations (ICCA) Global Initiative
on High Production Volume Chemicals.  This commitment for sponsorship
includes providing Screening Information Data Sets (SIDS) through the
OECD HPV Chemical Program.  The Consortium is in the document
development stage and intends to submit the required data by SIAM 25.

The Consortium understands that EPA has been working on the PAIR rule
during the time the Consortium was preparing the documentation, which is
why CAS #68603-84-9, 68937-70-2, 68937-72-4 were inadvertently included
in the published rule.  However, since this material has already been
volunteered under the OECD HPV Chemical Program, we respectively request
that CAS #68603-84-9, 68937-70-2, and 68937-72-4 be removed from the
PAIR rule.

Please do not hesitate to contact Kathleen Stanton, at The Soap and
Detergent Association<PHONE_NUMBER>;   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>; 1500 K Street, NW,
Washington DC 20005) if you have any questions.

Sincerely,

Kathleen Stanton

Associate Director, Scientific Affairs

1500 K Street, N.W., Suite 300, Washington, D.C. 20005 ● (202)
347-2900 ●<PHONE_NUMBER> ● www.cleaning101.com

  PAGE  2  of   NUMPAGES  2

-

R

a

}

…

Ø

500 K Street, N.W., Suite 300, Washington, D.C. 20005 ●<PHONE_NUMBER>
●<PHONE_NUMBER> ● www.cleaning101.com

The Soap and Detergent Association


Hi Scott, as far as I know, we do not have a complete and formalized
list of facilities that are subject to each of our rules.  We normally
search various databases and trade association lists to compile lists.
 As long as your state agency has delegating authority of the Title V
program and you have made them aware of the changes, you should be fine
from a compliance standpoint.  If you should receive anything from EPA,
please respond with the updated information and send in copies of your
current permit or permit application verifying the modifications.  Let
me know if you have any other questions.

Rochelle Boyd, Environmental Engineer

U.S. Environmental Protection Agency

Office of Air Quality Planning and Standards

Sector Policies and Programs Division

109 T.W. Alexander Drive, RTP, NC 27711

Mail Drop D243-02

Ph:<PHONE_NUMBER>   Fax:<PHONE_NUMBER>

Email<EMAIL_ADDRESS>
Rochelle,

 The Loxcreen Company in Hayti Missouri is an Aluminum Extrusion
Manufacturing Facility. Our Missouri Plant Number is 0045, Our FIPS
County Number is 155. Loxcreen currently operates under the Title V (
Major) Missouri Part 70 Permit.  In 2009 due to the economy’s
economic impact Loxcreen made reorganized changes to its production
status. Part of that change was to shutdown the ReMelt Facility which
operates under the (secondary aluminum)RRR MACT. There has been no
activity at ReMelt since December of 2009. There are no personnel and
electrical power and gas lines have also been removed.  There is no
intent to reopen this unit. The Missouri Operating Permit has an
expiration date of April 16, 2011 therefore I have started the renewal
process. The Renewal application will not have Re-Verbatory furnace as
part of the new permit. After permit consultation with The Missouri
Department Of Natural Resources it was suggested to request from EPA to
be removed from the secondary aluminum MACT (RRR ).

  Could you Please help locate the proper procedure for completing this
removal?

  Thank You,

  Scott Patterson

Loxcreen Company Inc.

Hayti, Missouri 63851

Environmental Services Mgr.

Phone<PHONE_NUMBER>-ext 18

Fax<PHONE_NUMBER>

Cell<PHONE_NUMBER>

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>


[Federal Register: November 14, 2007 (Volume 72, Number 219)]
[Rules and Regulations]
[Page 63994-63997]
[DOCID:fr14no07-13]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0305; FRL-8156-6]

Isoxadifen-ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate; CAS
Reg. No. 163520-33-0) and its metabolite 4,5-dihydro-5,5,diphenyl-3-
isoxazolecarboxylic acid when used as an inert ingredient (safener) in
or on corn, sweet, kernel plus cob with husks removed; corn, sweet,
forage; corn, sweet, stover; corn, pop, grain; corn, pop, stover; and
corn, oil. EPA is also revising existing tolerances for residues of
isoxadifen-ethyl in or on corn, field, forage and corn, field, hay, and
removing the seasonal application rate specification from existing
tolerances. Interregional Research Project Number 4 (IR-4) and Bayer
CropScience requested certain tolerance amendments for the inert
ingredient safener isoxadifen-ethyl under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 14, 2007. Objections and
requests for hearings must be received on or before January 14, 2008,
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-2005-0305. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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 either 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
Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tracy Ward, Registration Division
(7505P), 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 an electronic copy of this Federal
Register document through the electronic docket 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 pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, 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-2005-0305 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 January 14, 2008.
    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-2005-0305, 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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 and Statutory Findings

    EPA received several petitions requesting new tolerances and
amendments to existing tolerances for the inert ingredient (safener)
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate; CAS
Reg. No. 163520-33-0). The most recent final rule that established
tolerances for this safener was published in the Federal Register (69
FR 29882) on May 26, 2004 (http://www.epa.gov/fedrgstr/EPA-PEST/2004/May/Day-26/p11561.htm
). That final rule provides a description of the

toxicity data and risk assessments for isoxadifen-ethyl, and the reader
is referred to it for additional information. The new petitions
received by the Agency are summarized below.
    In the Federal Register of January 18, 2006 (81 FR 2926) (FRL-7750-
1), the Agency issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a announcing the filing of pesticide petition (PP 5E6962) by
Bayer CropScience, 2 Alexander Drive, Research Triangle Park, NC 27709.
The petition requested an increase in the tolerances under 40 CFR
180.570 for residues of isoxadifen-ethyl and its metabolite 4,5-
dihydro-5,5, diphenyl-3-isoxazolecarboxylic acid when used as an inert
ingredient (safener) in or on the food commodities corn, field, forage
at 0.20 parts per million (ppm) (increased from existing tolerance of
0.10 ppm) and corn, field, stover at 0.40 ppm (increased from existing
tolerance of 0.20 ppm). No substantive comments were received for this
Notice.
    The Agency also issued a notice in the April 4, 2007 Federal
Register (72 FR 163552) announcing the filing of pesticide petition (PP
5E7007) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ
08902-3390. The petition requested the establishment of tolerances for
residues of isoxadifen-ethyl and its metabolite in or on corn, sweet,
kernel plus cob with husks removed (K+CWHR) at 0.05 ppm; corn, sweet,
forage at 0.40 ppm; corn, sweet, stover at 0.40 ppm; corn, pop, grain
at 0.02 ppm; and corn, pop, stover at 0.40 ppm. No comments were
received for this Notice.
    In the same Federal Register of April 4, 2007, it was also noted
that the seasonal application rates could be removed from the existing
tolerances under 40 CFR 180.570. Seasonal application rates are not
necessary when numerical tolerances are already established. No
comments were received for this Notice.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) of the FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....'' These provisions were added to the FFDCA by the
Food Quality Protection Act (FQPA) of 1996.

III. Risk Characterization and Conclusion

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major

identifiable subgroups of consumers, including infants and children.
The nature of the toxic effects caused by isoxadifen-ethyl are
discussed in this unit. EPA has sufficient data to assess the hazards
of and make a determination on aggregate exposure for the chemical.
    The following provides a brief summary of the risk assessment and
conclusions for the Agency's review of isoxadifen-ethyl. The Agency's
full decision document and risk assessments for this action are
available on EPA's Electronic Docket at http://www.regulations.gov/

under docket number EPA-HQ-OPP-2005-0305. For the full toxicity data
and information on which this risk assessment is based, the reader is
referred to a Final Rule establishing tolerances for isoxadifen-ethyl
that published in the May 26, 2004 Federal Register (69 FR 29882).

A. Human Health

    The Agency reviewed the available information on isoxadifen-ethyl
submitted by the petitioners as well as additional information
available to EPA. The toxicity database is sufficient for isoxadifen-
ethyl. Isoxadifen-ethyl has low acute oral, dermal and inhalational
toxicity to rats. It is non-irritating to rabbit skin, moderately
irritating to the eye, and is a skin sensitizer in guinea pigs. The
chemical did not produce systemic toxicity in a subchronic dermal
toxicity study up to the limit dose. Isoxadifen-ethyl tested negative
overall for mutagenicity, and it was classified as ``not likely to be a
human carcinogen.'' In subchronic and chronic oral toxicity studies,
kidney and liver effects and decreased body weight and weight gain were
observed. Concerning developmental toxicity, the Agency concluded that
there is no concern for increased susceptibility in offspring. For
additional information on the human health toxicity data for
isoxadifen-ethyl, see the docket and the Federal Register of May 26,
2004 (69 FR 29882).

B. Exposure Assessment

    The Agency conducted a dietary exposure assessment using the
Dietary Exposure Evaluation Model-Food Consumption Intake Database
(DEEM-FCIDTM) for all uses requested by the petitioners.
Dietary food and drinking water exposures from the inert ingredient
safener use of isoxadifen-ethyl are low for all population subgroups,
and therefore, not of concern. The highest dietary exposure value
estimated was 2.3% of the chronic population adjusted dose (PAD) for
infants (<  1 year old).
    The Agency conducted a residential exposure assessment. Residential
dermal and inhalation exposures for the general population (including
toddlers) are also not of concern given that the estimated margins of
exposure (MOEs) range from 790 to 1,500. Isoxadifen-ethyl is currently
in pesticide formulations applied by professional pesticide applicators
to commercial and residential lawns, recreational facilities, etc.
There are no non-pesticidal uses of this chemical. Therefore, no
further aggregate assessment is necessary. For additional information
on the exposure assessment for isoxadifen-ethyl, see the docket and the
Federal Register of May 26, 2004 (69 FR 29882).

C. Safety Factor for Infants and Children

    Section 408 of the FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans. The toxicity database is
sufficient for isoxadifen-ethyl and potential exposure is adequately
characterized based on modeling. In terms of hazard, there are low
concerns and no residual uncertainties regarding prenatal and/or
postnatal toxicity. Accordingly, EPA concludes that the additional
tenfold safety factor for the protection of infants and children is
unnecessary. For additional information on the Safety Factor
determination for infants and children for isoxadifen-ethyl, see the
docket and the Federal Register of May 26, 2004 (69 FR 29882).

D. Cumulative Exposure

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to isoxadifen-ethyl and any other substances, and the
chemical does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that isoxadifen-ethyl has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
http://www.epa.gov/pesticides/cumulative.

E. Other Considerations

    1. Analytical methods. Adequate enforcement methodology is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>For the
complete description of Analytical Methods for isoxadifen-ethyl, see
the docket and the Federal Register of May 26, 2004 (69 FR 29882).
    2. International tolerances. There are no Codex tolerances
established for isoxadifen-ethyl. Canada has established a Maximum
Residue Limits for isoxadifen-ethyl on corn, field, grain at 0.08 ppm.

F. Determination of Safety and Conclusions

    The Agency is granting the requested tolerances for isoxadifen-
ethyl and its metabolite on corn, field, forage at 0.20 ppm and corn,
field, stover at 0.40 ppm. Although the petitioner requested tolerances
in or on corn, sweet, kernal plus cob with husk removed at 0.05 ppm;
corn, sweet, forage at 0.40 ppm; corn, sweet, stover at 0.40 ppm; corn,
pop, grain at 0.02 ppm; and corn, pop, stover at 0.40 ppm, based on the
Agency's review of the data and information available for isoxadifen-
ethyl, including toxicity endpoints and previously submitted field
trial data, the Agency is granting tolerances for these uses under 40
CFR 180.570 as follows: corn, sweet, kernal plus cob with husk removed
at 0.04 ppm; corn, sweet, forage at 0.30 ppm; corn, sweet, stover at
0.45 ppm; corn, pop, grain at 0.04 ppm; and corn, pop, stover at 0.25
ppm. In addition, based on the results of the risk assessment, the
Agency is lowering the current tolerance on corn, field, grain to 0.08
ppm (from the established 0.10 ppm) and establishing an exemption for
corn, oil at 0.50 ppm. A new field corn processing study is needed if
the petitioner wishes to remove the corn, oil tolerance.
    Finally, the Agency is removing the seasonal application rates from
the existing tolerance expression of 40 CFR

180.570. Seasonal application rates are not necessary when numerical
tolerances are already established.
    Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm to the general population,
including infants and children, from aggregate exposure to residues of
isoxadifen-ethyl and its metabolite. Accordingly, EPA finds that the
tolerances described above for residues of isoxadifen-ethyl and its
metabolite will be safe. EPA is establishing tolerances for residues of
isoxadifen-ethyl and its metabolite when it is used as an inert
ingredient safener in pesticide formulations.

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to the Agency. The
Office of Management and Budget (OMB) has exempted these types of
actions 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, this rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). 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., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000) do not apply to this rule. In addition, This rule does not 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).
    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 104-113, section 12(d) (15 U.S.C. 272
note).

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: November 5, 2007.
Lois Rossi,
Director, Registration Division, 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 180.570 is amended by revising paragraph (a) to read as
follows:

Sec.  180.570  Isoxadifen-ethyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate, (CAS
No. 163520-33-0), and its metabolite: 4,5-dihydro-5,5-diphenyl-3-
isoxazolecarboxylic acid, when used as an inert ingredient (safener) in
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, grain.........................................         0.08
Corn, field, forage........................................         0.20
Corn, field, stover........................................         0.40
Corn, oil..................................................         0.50
Corn, pop, grain...........................................         0.04
Corn, pop, stover..........................................         0.25
Corn, sweet, forage........................................         0.30
Corn, sweet, kernel plus cob with husk removed.............         0.04
Corn, sweet, stover........................................         0.45
------------------------------------------------------------------------

    (2) Tolerances are established for the residues of isoxadifen-ethyl
(3-isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-, ethyl ester
(CAS No. 164520-33-0)), and its metabolites 4,5-dihydro-5,5-diphenyl-3-
isoxazolecarboxylic acid and [beta]-hydroxy-[beta]-
benzenepropanenitrile when used as an inert ingredient (safener) in or
on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Rice, grain................................................         0.10
Rice, hulls................................................         0.50
Rice, straw................................................         0.25
------------------------------------------------------------------------

[FR Doc. E7-22223 Filed 11-13-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 88, Number 80 (Wednesday, April 26, 2023)]
[Notices]
[Pages 25398-25399]
[FR Doc No: 2023-08739]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3409-036]

Boyne USA, Inc.; Notice of Application Accepted for Filing and
Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Temporary variance of license requirement.
    b. Project No.: 3409-036.
    c. Date Filed: April 17, 2023.
    d. Applicant: Boyne USA, Inc.
    e. Name of Project: Boyne River Hydroelectric Project.
    f. Location: The project is located on the Boyne River in
Charlevoix County, Michigan and does not occupy Federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Tyler Prange, Area Manager, Boyne Mountain
Resort, Boyne USA, Inc.<PHONE_NUMBER>, [email protected].
    i. FERC Contact: Brian Bartos,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and protests
is May 19, 2023.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, MD 20852. The first page of any filing should
include docket number P-3409-036. Comments emailed to Commission staff
are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee requests Commission
approval, through December 31, 2023, for a temporary variance of the
run of river (ROR) requirements at the Boyne Project, as required by
Article 25 of the amended project license. The licensee is requesting
the variance to perform an 11-foot drawdown of the project reservoir in
order to complete necessary maintenance of the hydropower generation
system, maintenance of the intake canal, and work to the left
embankment to bring factors of safety into compliance with the
Commission's guidelines. The temporary variance from ROR requirements
would only be necessary during the drawdown and refill periods; ROR
operation would be maintained in between. The licensee anticipates the
drawdown process to take approximately one month and would initiate
drawdown after May 15, 2023. The proposed refill of the impoundment
would occur over a period of two weeks in late summer or late fall of
2023 and would maintain a

minimum release equivalent to the 95 percent exceedance flow
(approximately 30 cubic feet per second). Additionally, the licensee
provided a mitigation plan in its application for potentially stranded
organisms, including mussels, for all bottomlands exposed during the
drawdown, as well as proposed measures to protect endangered species
potentially occurring at the project, per resource agency
recommendations.
    l. Locations of the Application: The Commission provides all
interested persons an opportunity to view and/or print the contents of
this document via the internet through the Commission's website at
http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number
excluding the last three digits in the docket number field to access
the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and
issuances related to this or other pending projects. Agencies may
obtain copies of the application directly from the applicant. For
assistance, contact the Federal Energy Regulatory Commission at
[email protected] or call toll free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 385.2010.

    Dated: April 19, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-08739 Filed 4-25-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Page 40103]
[FR Doc No: 2014-16259]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-R04-OW-2014-0453; FRL 9913-57-OW]

Public Water System Supervision Program Revision for the State of
Mississippi

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Notice of tentative approval.

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

SUMMARY: Notice is hereby given that the State of Mississippi is
revising its approved Public Water System Supervision Program.
Mississippi has adopted the following rules: Long Term 1 Enhanced
Surface Water Treatment Rule, Long Term 2 Enhanced Surface Water
Treatment Rule, Stage 2 Disinfectants and Disinfection Byproducts Rule,
Lead and Copper Rule Short-Term Regulatory Revisions and
Clarifications, and Ground Water Rule. The EPA has determined that
Mississippi's rules are no less stringent than the corresponding
Federal regulations. Therefore, the EPA is tentatively approving this
revision to the State of Mississippi's Public Water System Supervision
Program.

DATES: Any interested person may request a public hearing. A request
for a public hearing must be submitted by August 11, 2014, to the
Regional Administrator at the EPA Region 4 address shown below. The
Regional Administrator may deny frivolous or insubstantial requests for
a hearing. However, if a substantial request for a public hearing is
made by August 11, 2014, a public hearing will be held. If no timely
and appropriate request for a hearing is received and the Regional
Administrator does not elect to hold a hearing on her own motion, this
tentative approval shall become final and effective on August 11, 2014.
Any request for a public hearing shall include the following
information: The name, address and telephone number of the individual,
organization or other entity requesting a hearing; a brief statement of
the requesting person's interest in the Regional Administrator's
determination and a brief statement of the information that the
requesting person intends to submit at such hearing; and the signature
of the individual making the request or, if the request is made on
behalf of an organization or other entity, the signature of a
responsible official of the organization or other entity.

ADDRESSES: All documents relating to this determination are available
for inspection between the hours of 8:30 a.m. and 4:30 p.m., Monday
through Friday, at the following offices: Mississippi State Department
of Health, Bureau of Public Water Supply, 570 East Woodrow Wilson
Drive, Jackson, Mississippi 39216; and the U.S. Environmental
Protection Agency Region 4, Safe Drinking Water Branch, 61 Forsyth
Street SW., Atlanta, Georgia 30303.

FOR FURTHER INFORMATION CONTACT: Dale Froneberger, EPA Region 4, Safe
Drinking Water Branch, by mail at the Atlanta address given above, by
telephone at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>    EPA Analysis: On August 29, 2012, the State of Mississippi
submitted a request that the Region approve a revision to the State's
Safe Drinking Water Act Public Water System Supervision Program to
include the authority to implement and enforce the Long Term 1 Enhanced
Surface Water Treatment Rule, the Long Term 2 Enhanced Surface Water
Treatment Rule, the Stage 2 Disinfectants and Disinfection Byproducts
Rule, and the Lead and Copper Rule Short-Term Regulatory Revisions and
Clarifications. On November 6, 2012, the State of Mississippi submitted
a request that the Region approve a revision to the State's Safe
Drinking Water Act Public Water System Supervision Program to include
the authority to implement and enforce the Ground Water Rule. For the
requests to be approved, the EPA must find the State Rules codified at
15 Miss. Admin. Code Pt. 20, Subpt. 72, Ch. 1., to be no less stringent
than the Federal Rules codified at 40 CFR Part 141, Subpart T--Enhanced
Filtration and Disinfection--Systems Serving Fewer Than 10,000 People;
40 CFR part 141, Subpart W--Enhanced Treatment for Cryptosporidium; 40
CFR part 141, Subpart L--Disinfectant Residuals, Disinfection
Byproducts, and Disinfection Byproduct Precursors; 40 CFR Part 141,
Subpart U--Initial Distribution System Evaluations; 40 CFR part 141,
Subpart V--Stage 2 Disinfection Byproducts Requirements; 40 CFR part
141, Subpart I--Control of Lead and Copper; and 40 CFR Part 141,
Subpart S--Ground Water Rule. The EPA reviewed the applications using
the Federal statutory provisions (Section 1413 of the Safe Drinking
Water Act), Federal regulations (at 40 CFR part 142), State
regulations, rule crosswalks, and EPA regulatory guidance to determine
whether the requests for revision are approvable. The EPA determined
that the Mississippi regulations are no less stringent than the
corresponding Federal regulations.
    EPA Action: The EPA is tentatively approving this revision. If the
EPA does not receive a timely and appropriate request for a hearing and
the Regional Administrator does not elect to hold a hearing on her own
motion, this tentative approval will become final and effective on
August 11, 2014.

    Authority: Section 1413 of the Safe Drinking Water Act, as
amended (1996), and 40 CFR Part 142.

    Dated: June 16, 2014.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2014-16259 Filed 7-10-14; 8:45 am]
BILLING CODE 6560-50-P


OMB Control Number: 2060 0498 Pending Expiration Date: 6/ 30/ 06 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS II CONTROLLED SUBSTANCE TRANSFERS OF PRODUCTION ALLOWANCES, CONSUMPTION ALLOWANCES, ARTICLE 5 ALLOWANCES, OR EXPORT PRODUCTION ALLOWANCES ( Sec 82.23)

SECTION 1 TRANSFEROR IDENTIFICATION 1.1 Date of Submission 1.2 Number of Transactions Reported 1.3 Number of Pages Submitted 1.4 Company Information Company Name Street Address City State Zip Code 1.5 Company Contact Identification Reporting Company Contact Person Phone Number Fax Number E mail Address 1.6 Signature of Reporting Company Representative I certify under penalty of law that I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment.

Name Title Signature Date SEND COMPLETED FORMS TO: For U. S. Postal Service:

Tracking System Program Manager Stratospheric Protection Division U. S. EPA ( 6205J) 1200 Pennsylvania Avenue, NW Washington, DC 20460 For Private Courier:

Tracking System Program Manager Stratospheric Protection Division U. S. EPA ( 6205J) 1310 L Street, NW, 8th Floor Washington, DC 20005 The public reporting and recordkeeping burden for this collection of information is estimated to average 4.5 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

Pending EPA ICR NUMBER 2014.03, Revised 4/ 06 OMB Control Number: 2060 0498 Pending Expiration Date: 6/ 30/ 06 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS II CONTROLLED SUBSTANCE TRANSFERS OF PRODUCTION ALLOWANCES, CONSUMPTION ALLOWANCES, ARTICLE 5 ALLOWANCES, OR EXPORT PRODUCTION ALLOWANCES ( Sec 82.23)

SECTION 2 TRANSACTION RECORD ( Reproduce additional sheets as needed)

TRANSACTION #

2.1 Transferee Identification Transferee Company Name Transferee Contact Person Street Address City State Zip Code Phone Number Fax Number Type of Allowance Being Transferred ( check only one) Production Consumption Article 5 Export Production 2.2 Type of Allowances Transferred ( check only one) Current Year Allowances Baseline Year Allowances 2.3 HCFC Transferring From 2.4 ODP 2.5 Quantity of HCFC Allowances in Section 2.3 Being Transferred ( kg)

2.6 Calculated Level of HCFC in Section 2.3 Being Transferred ( Section 2.4 x Section 2.5)

2.7 HCFC Transferring To 2.8 ODP 2 .9 Amount of Offset ( 0.001 x Section 2.5) ( kg)

2.10 Number of Allowances Subtracted from Transferor's Balance of HCFC Allowances ( Section 2.5 + Section 2.9) ( kg)

2.11 Quantity of HCFC Allowances in Section 2.7 Being Received ( Section 2.6 / Section 2.8) ( kg)

Pending EPA ICR NUMBER 2014.03, Revised 4/ 06 OMB Control Number: 2060 0498 Pending Expiration Date: 6/ 30/ 06 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS II CONTROLLED SUBSTANCE TRANSFERS OF PRODUCTION ALLOWANCES, CONSUMPTION ALLOWANCES, ARTICLE 5 ALLOWANCES, OR EXPORT PRODUCTION ALLOWANCES ( Sec 82.23)

SECTION 3 ALLOWANCE BALANCE SUMMARY 3.1 Balance of Unexpended HCFC Allowances Prior to Transfers Reported A B C D E Chemical Name Balance of Unexpended Production Allowances Balance of Unexpended Consumption Allowances Balance of Unexpended Article 5 Allowances Balance of Unexpended Export Production Allowances HCFC 22 HCFC 141b HCFC 142b Pending EPA ICR NUMBER 2014.03, Revised 4/ 06


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (7/1/2007)

EPA Registration Division contact: Julie Chao, Insecticide-Rodenticide Branch Team 1;<PHONE_NUMBER>

Syngenta Crop Protection, Inc., PO Box 18300, Greensboro, NC 27419

Petition Number 9F7657

	EPA has received a pesticide petition (9F7657) from Syngenta Crop Protection, Inc., PO Box 18300, Greensboro, NC 27419 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.565 by establishing a tolerance for residues of  thiamethoxam {3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-imine}(CAS Reg. No. 153719-23-4) and its metabolite [N-(2-chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine] in or on peanut (0.05 ppm) and peanut, hay (0.25 ppm).   EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The primary metabolic pathways of thiamethoxam in plants (corn, rice, pears, and cucumbers) were similar to those described for animals, with certain extensions of the pathway in plants.  Parent compound and CGA-322704 were the major residues in all crops.  The metabolism of thiamethoxam in plants and animals is understood for the purposes of the proposed tolerance.  Parent thiamethoxam and the metabolite, CGA-322704, are the residues of concern for tolerance setting purposes.

	2. Analytical method. Syngenta Crop Protection, Inc. has submitted practical analytical methodology for detecting and measuring levels of thiamethoxam in or on raw agricultural commodities.  This method is based on crop specific cleanup procedures and determination by liquid chromatography with either UV or MS detections.  The limit of detection (LOD) for each analyte of this method is 1.25 ng injected for samples analyzed by UV and 0.25 ng injected for samples analyzed by MS, and the limit of quantification (LOQ) is 0.005 ppm for milk and juices, and 0.01 ppm for all other substrates.

	3. Magnitude of residues. Syngenta Crop Protection, Inc. has submitted complete residue data for thiamethoxam on peanut (representing peanut nutmeat and hay).

B. Toxicological Profile

	1. Acute toxicity.  The acute oral LD50 for thiamethoxam in the rat is 1563 mg/kg body weight.  The acute dermal LD50 of thiamethoxam is >2000 mg/kg body weight.  Thiamethoxam is non-toxic at atmospheric concentrations of 3.72 mg/l.  Thiamthoxam is minimally irritating to the eye, non-irritating to skin and is not a dermal sensitizer.

In an acute neurotoxicity study in rats (OPPTS 870.6200a), the NOAEL was 100 mg/kg/day with a NOAEL of 500 mg/kg/day based on drooped palpebral closure, decrease in rectal temperature and locomotor activity and increase in forelimb grip strength (males only).  At higher dose levels, mortality, abnormal body tone, ptosis, impaired respiration, tremors, longer latency to first step in the open field, crouched over posture, gait impairment, hypo-arousal, decreased number of rears, uncoordinated landing during the righting reflex test, slight lacrimation (females only) and higher mean average input stimulus value in the auditory startle response test (males only).

	2. Genotoxicty. In gene mutation studies with S. typhimurium and E. coli (OPPTS 870.5100 and 870.5265, there was no evidence of gene mutation when tested up to 5000 g/plate and there was no evidence of cytoxicity.

In a gene mutation study with chinese hamster V79 cells at HGPRT focus (OPPTS 870.5300) there was no evidence of gene mutation when tested up to the solubility limit.

In a CHO cell cytogenetics study (OPPTS 870.5375) there was no evidence of chromosomal aberrations when tested up to cytotoxic or solubility limit concentrations.

An in vivo mouse bone marrow micronucleus study (OPPTS 870.5395) was negative when tested up to levels of toxicity in whole animals; however, no evidence of target cell cytoxicity.  A UDS assay (OPPTS 870.5550) was negative when tested up to precipitating concentrations.

	3. Reproductive and developmental toxicity. A prenatal developmental study in the rat (OPPTS 870.3700a) resulted in Maternal and Developmental NOAELs of 30 mg/kg/day and 200 mg/kg/day, respectively.  The maternal LOAEL is 200 mg/kg/day based on decreased body weight, body weight gain and food consumption.  The developmental LOAEL was 750 mg/kg/day based on decreased fetal body weight and an increased incidence of skeletal anomalies.

A prenatal developmental study in the rabbit (OPPTS 870.3700b) resulted in maternal and developmental NOAELs of 50 mg/kg/day.  The maternal and developmental LOAEL is 150 mg/kg/day.  The maternal LOAEL is based on maternal deaths, hemorrhagic discharge, decreased body weight and food intake during the dosing period.  The developmental LOAEL is based on decreased fetal body weights, increased incidence of post-implantation loss and a slight increase in the incidence of skeletal anomalies/variations.

In a reproduction and fertility effects study in rats (OPPTS 870.3800) the Parental/sytemic NOAEL is 1.84 (males), 202.06 (females) mg/kg/day; the reproductive NOAEL is 0.61 (males), 202.06 (females) mg/kg/day and the offspring NOAEL is 61.25 (males), 79.20 (females) mg/kg/day.  The parental /sytemic LOAEL is 61.25 (males), not determined (females) mg/kg/day based on inscreased incidence of hyaline change in renal tubules in F0 and F1 males.  The reproductive LOAEL is 1.84 (males), not determined (females) mg/kg/day based on increased incidence and severity of tubular atrophy observed in testes of the F1 generation males.  The offspring LOAEL is 158.32 (males), 202.06 (females) mg/kg/day based on reduced body weight gain during lactation period in all litters.

	4. Subchronic toxicity. A 90 day oral toxicity study in rats (OPPTS 870.3100) resulted in a NOAEL of 1.74 (males, 92.5 (females) mg/kg/day.  The LOAEL is 17.4 (male), 182.1 (female) mg/kg/day based on increased incidence of hyaline change or renal tubules epithelium (males), fatty change in adrenal gland of females, liver changes in females, all at the LOAEL. A 90 day oral toxicity in mice (OPPTS 870.3100) resulted in a NOAEL of 1.41 (males, 19.2 (females) mg/kg/day.  The LOAEL was 14.3 (male) 231 (female) mg/kg/day based on increased incidence of hepatocellular hypertrophy.  At higher dose levels: decrease in body weight and body weight gain, necrosis of individual hepatocytes, pigmentation of Kupffer cells, and lymphocytic infiltration of the liver in both sexes; slight hematologic effects and decreased absolute and relative kidney weights in males; and ovarian atrophy, decreased ovary and spleen weights and increased liver weights in females.

In a 90 day oral toxicity in dogs (OPPTS 870.3150), the NOAEL is 8.23 (males), 9.27 (females) mg/kg/day.  The LOAEL is 32.0 (male), 33.9 (female) mg/kg/day based on slightly prolonged prothrombin times and decreased plasma albumin and A/G ration (both sexes; decreased calcium levels and ovary weights and delayed maturation in the ovaries (female); decreased cholesterol and phospholipid levels, testis weights, spermatogenesis, and spermatic giant cells in testes (male).

In a 28 day dermal study in rats (OPPTS 870.3200) the NOAEL was 250 (male), 60 (female) mg/kg/day.  The LOAEL was 1000 (male), 250 (female) mg/kg/day based on increased plasma glucose, triglyceride levels, and alkaline phosphatase activity and inflammatory cell infiltration in the liver and necrosis if single hepatocyts in females and hhaline change in renal tubules and a very slight reduction in body weight in males.  At higher dose levels in females, chronic tubular lesions in the kidneys and inflammatory cell infiltration in the adrenal cortex were observed.

In a subchronic neurotoxicity screening study in rats  (OPPTS 870.6200b) the NOAEL was 95.4 (male), 216.4 (female) mg/kg/day, both at the highest dose tested.  The LOAEL was not determined.  No treatment related observations at any dose level.  LOAEL was not achieved.  May not have been tested at sufficient high dose levels; however, a new study is not required because the weight of evidence from other toxicity studies indicates no evidence of concern.

	5. Chronic toxicity.  In a chronic toxicity study in dogs (OPPTS 870.4100) the NOAEL was 4.05 (male), 4.49 (female) mg/kg/day.  The LOAEL was 21.0 (male), 24.6 (female) mg/kg/day based on increase in creatinine in both sexes, transient decease in food consumption in females, and occasional increase in urea levels, decrease in ALT, and atrophy of seminiferous tubules in males.

In a mouse carcinogenicity study (OPPTS 870.4200) the NOAEL was 2.63 (male), 3.68 (female) mg/kg/day.  The LOAEL was 63.8 (male), 87.6 (female) mg/kg/day based on hepatocyte hypertrophy, single cell necrosis, inflammatory cell infiltration, pigment deposition, foci of cellular alteration, hyperplasia of Kupffer cells and increased mitotic activity, also an increase in the incidence of hepatocellular adenoma (both sexes).  At higher doses, there was an increase in the incidence of hepatocellular adenocarcinoma (both sexes) and the number of animals with multiple tumors, evidence of carcinogenicity.

In a combined carcinogenicity study in rats (OPPTS 870.4300) the NOAEL was 21.0 (male), 50.3 (female) mg/kg/day.  The LOAEL was 63.0 (male), 255 (female) mg/kg/day based on the increased incidence of lymphocytic infiltration of the renal pelvis and chronic nephropathy in males and decreased body weight gain, slight increase in the severity of hemosiderosis of the spleen, foci of cellular alteration in liver and chronic tubular lesions in kidney in females.  No evidence of carcinogenicity.

In a hepatic cell proliferation study in mice, the NOAEL was 16 (male), 20 (female) mg/kg/day.  The LOAEL was 72 (male), 87 (female) mg/kg/day based on proliferative activity of hepatocytes.  At higher dose levels, increases in absolute and relative liver weights, speckled liver, haptocellular glycogenisis/fatty change, heptocellular necrosis, apoptosis and pigmentation were observed.

In a  28 day feeding study to assess replicative DNA synthesis in the amle rat, the NOAEL was 711 mg/kg/day.  The LOAEL was not established.  Immunohistochemical staining of the liver sections from control and high dose animals for proliferating cell nuclear antigen gave no indication for a treatment related increase in the fraction of DNA synthesizing hepatocytes in S-phase.  CGA-293343 did not stimulate hepatocyte cell proliferation in male rats.

In a special study to assess liver biochemistry in the mouse, the NOAEL was 17 (male), 20 (female) mg/kg/day.  The LOAEL was 74 (male), 92 (female) mg/kg/day based on marginal to slight increases in absolute and relative liver weights, a slight increase in the microsomal protein content of the livers, moderate increases in the cytochrome P450 content, slight to moderate increases in the activity of several microsomal enzymes, slight to moderate induction of cystolic glutathion S-transfer activity.  Treatment did not affect peroxisomal fatty acid -oxidation.

	6. Animal metabolism. The metabolism of thiamethoxam in rats and livestock animals is adequately understood.  The residues of concern have been determined to be parent thiamethoxam and its metabolite [N-(2-chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine] expressed as thiamethoxam.

	7. Metabolite toxicology. For most risk assessment purposes, residues of the metabolite corrected for molecular weight are considered to be toxicologically equivalent to parent thiamethoxam.  However, EPA has determined that the metabolite should not be included in the cancer risk assessment.

	8. Endocrine disruption. There are no specific studies requested by the Endocrine Disruptor Screening Program (EDSP) at this time because endocrine effects have been well characterized in an acceptable 2-generation reproduction study with a clear NOAEL and LOAEL, and the chronic reference dose (cRfD) selected for thiamethoxam risk assessments is considered protective of the observed endocrine effects.

C. Aggregate Exposure

	1. Dietary exposure. Tier I acute, and Tier III chronic aggregate risk assessments were performed for thiamethoxam using the Dietary Exposure Evaluation Model (DEEM-FCID[TM], version 2.16) from Exponent.  All consumption data for these assessments was taken from the USDA's Continuing Survey of Food Intake by individuals (CSFII) with the 1994-96 consumption database and the Supplemental CSFII children's survey (1998) consumption database.  In the Tier I acute assessment, in addition to established tolerances (40 CFR 180.565) for the combined residues of thiamethoxam (CGA293343) and its metabolite (CGA322704) in or on a variety of raw agricultural commodities including meat and milk.  These exposure assessments also included the proposed crop tolerance for seed treatment use on peanuts (0.05 ppm).  Percent of crop treated values were conservatively estimated to be 100% for all registered and proposed uses.  Field trial residue values were used in the Tier III chronic assessments where thiamethoxam was applied at the maximum intended use rate and samples were harvested at the minimum pre-harvest interval (PHI) to obtain the maximum expected residues.  Calculated percent crop treated (%CT) values were incorporated in these chronic Tier III assessments.  Drinking water estimates were incorporated directly into the dietary exposure assessments using the highest estimated drinking water concentrations (EDWCs) for surface and ground water.

	i. Food. Acute Exposure.  The thiamethoxam acute food risk assessment was performed for all population subgroups using an acute reference dose of 0.35 mg/kg-bw/day based upon a developmental neurotoxicity study in rats with a no observed adverse effect level (NOAEL) of 34.5 mg/kg/day and an uncertainty factor of 100X.  The 100X safety factor includes intra- and inter-species variations.  No additional FQPA safety factor was applied.  For the purpose of aggregate risk assessment, the exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup.  In addition, exposure was expressed as a percent of the acute reference dose (%aRfD).  At the 95[th] percentile, acute (food only) exposure to the U.S. population resulted in a MOE of 2,466 (4.0% of the aRfD of 0.35 mg/kg-bw/day).  The most exposed sub-population was children (1-2 years old) with a MOE of 1,256 (7.8% of the aRfD of 0.35 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures below 100% of the aRfD, Syngenta believes that there is a reasonable certainty that no harm will result from dietary (food only) exposure to residues arising from all current and proposed uses of thiamethoxam. Chronic Exposure.  The thiamethoxam chronic dietary food risk assessment was performed for all population subgroups using a chronic reference dose of 0.012 mg/kg-bw/day based upon a two generation reproduction study in rats with a no observed adverse effect level (NOAEL) of 1.2 mg/kg/day and an uncertainty factor of 100X.  The 100X safety factor includes intra- and inter-species variations.  No additional FQPA safety factor was applied.  For the purpose of aggregate risk assessment, the exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup.  In addition, exposure was expressed as a percent of the chronic reference dose (%RfD).  Chronic (food only) exposure to the U.S. population resulted in a MOE of 9,592 (1.0% of the RfD of 0.012 mg/kg-bw/day).  The most exposed sub-population was children (1-2 years old) with a MOE of 4,069 (2.5% of the RfD of 0.012 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from dietary (food only) exposure to residues arising from the current and proposed uses of thiamethoxam.

Cancer.  A quantitative risk assessment using a cancer endpoint was not performed.

	ii. Drinking water. [The Estimated Drinking Water Concentrations (EDWCs) of thiamethoxam were determined using Tier l screening models, SCI-GROW which estimates pesticide concentration in ground water, FIRST which estimates pesticide concentration in surface water (for proposed peanut use only), and for aquatic uses, a modified Tier I Rice Model and Provisional Cranberry Model which estimates pesticide concentration in tail water from rice paddies and cranberry bogs, respectively.  EDWCs of thiamethoxam from the currently registered uses plus the proposed seed treatment use on peanuts were determined.   The highest ground water EDWC resulting from SCI-GROW modeling was 4.12 ppb (acute and chronic) based on the currently registered use on grapes.  The highest surface water EDWCs resulted from the currently registered rice use.  The modified Tier I Rice model provided a surface water acute EDWC of 147.72 ppb and a chronic EDWC of 12.62 ppb (adjusted for a 0.87 Percent Cropped Area (PCA) factor).  Since the surface water EDWCs exceed the ground water EDWC, the surface water values were used for risk assessment purposes and will be considered protective for any ground water concentration concerns.     Acute Exposure from Drinking Water.  The acute surface water EDWC of 147.72 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the acute drinking water exposures.  Exposure contributions at the 95%-ile of exposures were determined by taking the difference between the aggregate (food + drinking water) exposures and the food (alone) exposures for each population subgroup.  Acute drinking water exposure U.S. population resulted in a MOE of 7,058 (1.4% of the acute RfD of 0.35 mg/kg-bw/day).  The most exposed sub-population was all infants (<1 year old) with a MOE of 1,596 (6.2% of the aRfD of 0.35 mg/kg/day).  Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the acute RfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute drinking water exposure to residues arising from the current and proposed uses for thiamethoxam.

Chronic Exposure from Drinking Water.  The chronic surface water EDWC of 12.62 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the chronic drinking water exposures.  Chronic drinking water exposure to the U.S. population resulted in a MOE of 4,511 (2.2% of the chronic RfD of 0.012 mg/kg-bw/day).  Chronic drinking water exposure to the most exposed sub-population (infants, <1 year old) resulted in a MOE of 1,376 (7.3% of the chronic RfD of 0.012 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the chronic RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic drinking water exposure to residues arising from the current and proposed use  for thiamethoxam.

	2. Non-dietary exposure. A residential exposure and risk assessment was performed for thiamethoxam using the recently revised endpoints and uncertainty factors established by the EPA.  The residential exposure and risk assessment was performed for thiamethoxam uses on turf and ornamentals using the Meridian 0.33G and 25WG labels.  Based on these Meridian labels, there is a potential for residential handler exposure from consumers making applications to home lawns and ornamentals.  There is also a potential for post-application residential exposure to adults and children re-entering treated lawns and to adults playing golf on treated turf.  The following endpoints were used for these residential risk assessments:  NOAEL = 1.2 mg/kg/day (for adults, from a two generation oral reproduction study in rats) and NOAEL = 60 mg/kg/day (for children 1-6, from a short-term dermal from a 28-day dermal study in rats).  The post-application residential MOE for children (1-6 years) from turfgrass use of Meridian 25 WG is 1,347, which exceeds the residential risk arising from the turfgrass use Meridian 0.33G (MOE = 1,650).  The resultant combined short-term MOEs were1,347 (total post-application risk) and 2,111 (combined post-application and handler risk) for children (1-6 years) and adults (20-49 years), respectively.  Both children (1-6 years) and adults (20-49 years) MOEs are above the Benchmark MOE of 100 and thus do not exceed the EPA's level of concern.

D. Cumulative Effects

	 Cumulative Exposure to Substances with a Common Mechanism of Toxicity.  Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity".  Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to thiamethoxam and any other substances and thiamethoxam does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, the EPA has not assumed that thiamethoxam has a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. The acute dietary exposure analysis (food plus water) showed that exposure from all established and proposed thiamethoxam tolerances would result in a MOE of 1,827 (5.4% of the aRfD of 0.35 mg/kg-bw/day) for the general U.S. population, which exceeds the Benchmark MOE of 100.  The chronic dietary exposure analysis (food plus water) showed that exposure from all registered and proposed thiamethoxam tolerances resulted in a MOE of 3,068 (3.3% of the chronic RfD of 0.012 mg/kg-bw/day) for the general U.S. population, which also exceeds the Benchmark MOE of 100.  For the short-term aggregate exposure analysis the corresponding food, water and residential MOEs were aggregated using the inverse MOE approach.  The short-term aggregate (food, drinking water, and residential) MOE was 1,937 for adults (20-49 years old), which exceeds the Benchmark MOE of 100.  Based on the completeness and reliability of the toxicity data supporting these petitions, Syngenta believes that there is a reasonable certainty that no harm will result from aggregate exposure to residues arising from all current and proposed thiamethoxam uses, including anticipated dietary exposure from food, water, and all other types of non-occupational exposures.

	2. Infants and children. The acute dietary exposure analysis (food plus water) showed that exposure from all established and proposed thiamethoxam uses would result in a MOE of 943 (10.4% of the aRfD of 0.35 mg/kg-bw/day) for the most sensitive population subgroup, infants <1 year old, which exceeds the Benchmark MOE of 100.  The chronic aggregate dietary (food plus water) exposure analysis showed that exposure from all established and proposed thiamethoxam uses would result in a MOE of 1,158 (8.6% of the chronic RfD of 0.012 mg/kg-bw/day) for the most sensitive population subgroup, infants <1 year old, which exceeds the Benchmark MOE of 100.  For the short-term aggregate exposure analysis the corresponding food, water and residential MOEs were aggregated using the inverse MOE approach.  The short-term aggregate (food, drinking water, and residential) MOE was 1,221 for the children (1-6 years), which exceeds the Benchmark MOE of 100.  Based on the completeness and reliability of the toxicity data supporting these petitions, Syngenta believes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to residues arising from all current and proposed thiamethoxam tolerances, including anticipated dietary exposure from food, water, and all other types of non-occupational exposures.

F. International Tolerances

	There are currently no Maximum Residue Limits (MRLs) set for thiamethoxam for crops by the Codex Alimentarius Commission.  International MRLs for the insecticide thiamethoxam have been established for various agricultural commodities in a number of countries including Argentina, Australia, Belarus, Brazil, Canada, Czech Republic, Denmark, Denmark, Estonia, Georgia, Great Britain (UK), Greece, Hungary, India, Israel, Italy, Korea (South), Latvia, Moldova, Netherlands, New Zealand, Russia, Serbia and Montenegro, Slovak Republic, Slovenia, South Africa, Spain, Switzerland, Taiwan, Ukraine, and United States.


[Federal Register Volume 88, Number 111 (Friday, June 9, 2023)]
[Notices]
[Page 37913]
[FR Doc No: 2023-12297]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-40, OMB Control No. 3235-0313]

Submission for OMB Review; Comment Request; Extension: Rule 203-2
& Form ADV-W

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for extension of the previously approved
collection of information discussed below.
    The title for the collection of information is ``Rule 203-2 (17 CFR
275.203-2) and Form ADV-W (17 CFR 279.2) under the Investment Advisers
Act of 1940 (15 U.S.C. 80b).'' Rule 203-2 under the Investment Advisers
Act of 1940 establishes procedures for an investment adviser to
withdraw its registration or pending registration with the Commission.
Rule 203-2 requires every person withdrawing from investment adviser
registration with the Commission to file Form ADV-W electronically on
the Investment Adviser Registration Depository (``IARD''). The purpose
of the information collection is to notify the Commission and the
public when an investment adviser withdraws its pending or approved SEC
registration. Typically, an investment adviser files a Form ADV-W when
it ceases doing business or when it is ineligible to remain registered
with the Commission.
    The potential respondents to this information collection are all
investment advisers registered with the Commission or have applications
pending with the Commission. The Commission has estimated that
compliance with the requirement to complete Form ADV-W imposes a total
burden of approximately 0.75 hours (45 minutes) for an adviser filing
for full withdrawal and approximately 0.25 hours (15 minutes) for an
adviser filing for partial withdrawal. Based on historical filings, the
Commission estimates that there are approximately 769 respondents
annually filing for full withdrawal and approximately 647 respondents
annually filing for partial withdrawal. Based on these estimates, the
total estimated annual burden would be 739 hours ((769 respondents x
.75 hours) + (647 respondents x .25 hours)).
    Rule 203-2 and Form ADV-W do not require recordkeeping or records
retention. The collection of information requirements under the rule
and form are mandatory. The information collected pursuant to the rule
and Form ADV-W are filings with the Commission. These filings are not
kept confidential. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
    Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
by July 10, 2023 to (i) [email protected] and
(ii) David Bottom, Director/Chief Information Officer, Securities and
Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC
20549, or by sending an email to: [email protected].

    Dated: June 5, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-12297 Filed 6-8-23; 8:45 am]
BILLING CODE 8011-01-P