[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Rules and Regulations]
[Pages 60112-60114]
[FR Doc No: 2017-27277]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2017-N-6484]

Medical Devices; Obstetrical and Gynecological Devices;
Classification of the Fetal Head Elevator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the fetal head elevator into class II (special controls). The special
controls that apply to the device type are identified in this order and
will be part of the codified language for the fetal head elevator's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective December 19, 2017. The classification
was applicable on July 27, 2017.

FOR FURTHER INFORMATION CONTACT: David Birsen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G623, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the fetal head elevator as class
II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by reducing regulatory burdens by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to

these devices as ``postamendments devices'' because they were not in
commercial distribution prior to the date of enactment of the Medical
Device Amendments of 1976, which amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On November 20, 2015, Safe Obstetrics Systems, Ltd., submitted a
request for De Novo classification of the Fetal Pillow. FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on July 27, 2017, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 884.4350. We have named
the generic type of device fetal head elevator, and it is identified as
a prescription device consisting of a mechanism that elevates the fetal
head to facilitate delivery during a Caesarean section.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

       Table 1--Fetal Head Elevator Risks and Mitigation Measures
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            Identified risks                   Mitigation measures
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Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Sterilization validation, Shelf
                                          life testing, and Labeling.
Fetal injury due to device failure.....  Non-clinical performance
                                          testing, Shelf life testing,
                                          and Labeling.
Maternal injury due to device failure..  Non-clinical performance
                                          testing, Shelf life testing,
                                          and Labeling.
Use error..............................  Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.
    At the time of classification, fetal head elevators are for
prescription use only. Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR
801.5, as long as the conditions of 21 CFR 801.109 are met (referring
to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information

found in other FDA regulations. These collections of information are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in the guidance document ``De Novo
Classification Process (Evaluation of Automatic Class III
Designation)'' have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; and the collections of information
in 21 CFR part 801, regarding labeling, have been approved under OMB
control number 0910-0485.

List of Subjects in 21 CFR Part 884

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
884 is amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for part 884 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  884.4350 to subpart E to read as follows:

Sec.  884.4350   Fetal head elevator.

    (a) Identification. A fetal head elevator is a prescription device
consisting of a mechanism that elevates the fetal head to facilitate
delivery during a Caesarean section.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of patient-
contacting components of the device.
    (3) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
    (4) Non-clinical performance data must demonstrate that the device
performs as intended under anticipated conditions of use. The following
performance characteristics must be tested:
    (i) Reliability testing of device deployment and retrieval under
relevant use conditions must be conducted.
    (ii) Testing of the maximum force applied to the fetal head in an
anatomic model must be conducted.
    (iii) Testing of uniform application of the elevator mechanism on
the fetal head must be conducted.
    (5) Labeling must include the following:
    (i) Contraindication for use in the presence of active genital
infection;
    (ii) Specific instructions regarding the proper placement and use
of the device; and
    (iii) A shelf life.

    Dated: December 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27277 Filed 12-18-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Rules and Regulations]
[Pages 10344-10346]
[FR Doc No: 2014-03422]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0090; Directorate Identifier 2014-CE-003-AD;
Amendment 39-17761; AD 2014-04-03]
RIN 2120-AA64

Airworthiness Directives; Pacific Aerospace Limited Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Pacific Aerospace Limited Model 750XL airplanes. This AD results from
mandatory continuing airworthiness information (MCAI) issued by the
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as broken control column attachment bolts. We are issuing
this AD to require actions to address the unsafe condition on these
products.

DATES: This AD is effective February 25, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 25,
2014.
    We must receive comments on this AD by April 11, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Pacific
Aerospace

Limited, Hamilton Airport, Private Bag 3027 Hamilton 3240, New Zealand;
telephone: +64 7 843 6144; fax: +64 7 843 6134; email:
<EMAIL_ADDRESS>Internet: http://www.aerospace.co.nz/. You may
view this referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0090; 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 street address for the Docket Office (telephone
(800) 647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The Civil Aviation Authority (CAA), which is the airworthiness
authority for New Zealand, has issued AD DCA/750XL/15, dated January
29, 2014 (referred to after this as ``the MCAI''), to correct an unsafe
condition for all Pacific Aerospace Limited Model 750XL airplanes. The
MCAI states:

    This emergency AD with effective date 30 January 2014 is
prompted by reports of finding broken control column attachment
bolts on two 750 XL aircraft.
    Investigation revealed the bolt failures may be due to possible
over-tightening of the control column attachment bolt to reduce
control column play in the pivot fork (socket). Pacific Aerospace
subsequently issued MSP PACSB/XL/070 issue 1, dated 24 January 24,
2014 to replace affected bolts, washers and nuts within the next 10
hours TIS, and to caution operators and maintainers that over-
tightening may reduce the life of the bolt. This AD mandates the
requirements in PACSB/XL/070 to prevent failure of the control
column attachment bolt which could result in control column
detachment and loss of aircraft control.

You may examine the MCAI on the Internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2014-0090.

Relevant Service Information

    Pacific Aerospace Limited has issued Mandatory Service Bulletin
PACSB/XL/070, Issue 1, dated January 24, 2014. The actions described in
this service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of this AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are issuing this AD because we
evaluated all information provided by the State of Design Authority and
determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
failure of the control column attachment bolt could result in control
column detachment, which could cause loss of control. Therefore, we
determined that notice and opportunity for public comment before
issuing this AD are impracticable and that good cause exists for making
this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2014-0090; Directorate
Identifier 2014-CE-003-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD will affect 17 products of U.S. registry.
We also estimate that it will take about 1.5 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost about $100 per product.
    Based on these figures, we estimate the cost of this AD on U.S.
operators to be $3,867.50, or $227.50 per product.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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

    We determined that 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 the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and

    (4) 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    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:

2014-04-03 Pacific Aerospace Limited: Amendment 39-17761; Docket No.
FAA-2014-0090; Directorate Identifier 2014-CE-003-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective February 25,
2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pacific Aerospace Limited Model 750XL
airplanes, all serial numbers, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted from mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as broken control
column attachment bolts. We are issuing this AD to prevent failure
of the control column attachment bolt, which could result in control
column detachment and cause loss of control.

 (f) Actions and Compliance

    Unless already done, within the next 10 hours time-in-service
after February 25, 2014 (the effective date of this AD), replace the
left hand and the right hand control column attachment bolts
following the Accomplishment Instructions in Pacific Aerospace
Limited Mandatory Service Bulletin PACSB/XL/070, Issue 1, dated
January 24, 2014.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>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.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(h) Related Information

    Refer to MCAI Civil Aviation Authority (CAA) AD DCA/750XL/15,
dated January 29, 2014, for related information. You may examine the
MCAI on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2014-0090.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Pacific Aerospace Limited Mandatory Service Bulletin PACSB/
XL/070, Issue 1, dated January 24, 2014.
    (ii) Reserved.
    (3) For Pacific Aerospace Limited service information identified
in this AD, contact Pacific Aerospace Limited, Hamilton Airport,
Private Bag 3027 Hamilton 3240, New Zealand; telephone: +64 7 843
6144; fax: +64 7 843 6134; email<EMAIL_ADDRESS>Internet:
http://www.aerospace.co.nz/.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference 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/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri on February 10, 2014.
Steven W. Thompson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-03422 Filed 2-24-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Proposed Rules]
[Page 11563-11570]
[DOCID:fr08mr06-25]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0325; FRL-7750-8]

Ethylenediaminetetraacetic Acid Chemicals: Exemptions from the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY:  The Agency is proposing to establish 16 new and amend three
existing exemptions from the requirement of a tolerance for residues of
various ethylenediaminetetraacetic acid (EDTA) chemicals in or on raw
agricultural commodities when used as inert ingredients in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA). This regulation eliminates the need to establish a maximum
permissible level for residues of these EDTA chemicals.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPP-2005-0325, must be received on or before May 8, 2006.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0325, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/.

Follow the on-line instructions for submitting comments.
     Agency Website: EDOCKET, EPA's electronic public and
comment system was replaced on November 25, 2005, by an enhanced
federal-wide electronic docket management and comment system located at
http://www.regulations.gov/. Follow the on-line instructions.

     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460-0001, Attention: Docket ID Number EPA-HQ-OPP-2005-
0325.
     Hand Delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID Number EPA-HQ-OPP-2005-0325. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0325. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov/, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov your
e-mail address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage athttp://www.epa.gov/epahome/dockets.html.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically in http://www.regulations.gov or hard copy at the Public

Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. This 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:  Kathryn Boyle, Registration Division
(7505C), 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 and Other
Related Information?

    In addition to using 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/. A

frequently updated electronic version of 40 CFR part 180 is available
on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

C. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date, and page number).
    ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

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

    This proposed rule is issued under section 408 of FFDCA, 21 U.S.C.
346a, as amended by the Food Quality Protection Act of 1996 (FQPA)
(Public Law 104-170). Section 408(e) of FFDCA authorizes EPA to
establish, modify, or revoke tolerances, or exemptions from the
requirement of a tolerance for residues of pesticide chemicals in or on
raw agricultural commodities and processed foods.

III. What Action is the Agency Taking?

    The Agency is proposing to establish 16 new and amend three
existing tolerance exemptions for several EDTA chemicals. Currently,
there are three tolerance exemptions for EDTA chemicals in 40 CFR
180.910: Disodium

zinc ethylenediaminetetraacetate dihydride, ethylenediaminetetraacetic
acid, and ethylenediaminetetraacetic acid, tetrasodium salt. These
exemptions are being amended to reflect a common nomenclature, add CAS
Reg. Nos., and/or a 5% limitation of all EDTA chemicals in the
pesticide product.
    The tolerance exemptions for the tetrasodium salt and the disodium
zinc are considered to be for both the hydrated and anhydrous forms.
Thus, three of the new tolerance exemptions are for the hydrated forms
of the tetrasodium salt and the disodium zinc salt.
    The EDTA chemicals are a group of man-made chelating (binding)
agents with a preferred affinity for heavier metals such as lead,
mercury, cadmium, zinc, and aluminum. EDTA's ability to complex, bind,
and remove such metals is used commercially to either promote or
inhibit chemical reactions, depending on the application. EDTA has also
been used under medical supervision to treat heavy metal poisoning.
Large doses of EDTA (or one of its salts) function to scavenge the
heavy metals from the body. EDTA preferentially binds with the heavy
metal present with the resultant complex then being excreted.
    The EDTA chemicals which are the subject of this proposed rule, the
nomenclature which will be used and the CAS Reg. Nos. are in the Table
below. These chemicals were selected based on information in the
Agency's files which indicate use in pesticide products applied to
food-use sites.

----------------------------------------------------------------------------------------------------------------
                          EDTA Chemical                                             CAS Reg. No.
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA)                                                                   60-00-4
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) calcium disodium salt                                             62-33-9
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) disodium copper (II) salt                                      14025-15-1
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) disodium copper (II) salt,                                     61916-40-3
 dihydrate
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) disodium copper (II) salt,                                     73637-19-1
 trihydrate
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) disodium manganese (II)                                        15375-84-5
 salt
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) disodium manganese (I)                                         73637-20-4
 salt, dihydrate
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) disodium salt                                                    139-33-3
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) disodium salt, dihydrate                                        6381-92-6
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) disodium zinc salt                                             14025-21-9
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) disodium zinc salt,                                            73513-47-0
 dihydrate
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) monosodium salt                                                17421-79-3
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) sodium iron (III) salt                                         15708-41-5
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) sodium salt                                                     7379-28-4
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) tetrapotassium salt                                             5964-35-2
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt                                                  64-02-8
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt,                                              13235-36-4
 tetrahydrate
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt,                                              67401-50-7
 trihydrate
----------------------------------------------------------------------------------------------------------------
Ethylenediaminetetraacetic acid (EDTA) tripotassium salt                                              17572-97-3
----------------------------------------------------------------------------------------------------------------

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of 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 these
EDTA chemicals are summarized in this unit.
    The data considered in this assessment included information located
by the Office of Pesticide Programs on the internet, studies conducted
by the National Toxicology Program (NTP) and the National Cancer
Institute (NCI), several work products produced by the Cosmetic
Ingredient Review, several evaluations by the World Health
Organization, and articles from open literature. The Agency's overall
conclusions are as follows; however, greater detail on the Agency's
review and evaluation of these EDTA chemicals are in the EDTA Science
Assessment, which is posted as a support document in the docket for
this action (see http://www.regulations.gov/). It is noted that the

Agency's review and evaluation covered a large group of 25 EDTA
chemicals in which the available data from all of the chemicals was
``pooled'' for use as surrogate data.
    As a group, the EDTA chemicals are not acutely toxic via the oral
route of exposure. They are mild skin irritants and severe eye
irritants.
    Mutagenicity studies such as the mouse lymphoma study were negative
for EDTA and its salts except for a few positive tests when
administered with sterile distilled water. Genotoxicity studies for
EDTA and its salts were

mixed positive and negative results, depending on assay type and cell
type.
    Trisodium EDTA was tested in a 2-year carcinogenicity study by the
NCI. Their conclusions indicated that there were no compound-related
signs of chemical toxicity, and tumor incidence was not related to
treatment. This study was re-evaluated in 2003 with the conclusion that
``there is no concern for EDTA with regard to carcinogenicity.''
    The Agency has evaluated 15 of the EDTA chemicals through the use
of structure-activity-relationship (SAR) assessments. With one
exception, these evaluations indicate no absorption of the EDTA
chemicals through the skin, but predicted good absorption through the
lungs and GI tract. The exception was EDTA, per se, which is expected
to be absorbed through all routes of exposure. The Team performing the
SARs indicated a low to moderate concern for human health effects. All
concerns noted were considered to be due to the chelation and eventual
excretion of metals such as calcium, magnesium, iron, and zinc in the
mammalian body.
    Other reviews indicate that EDTA is not totally absorbed when
ingested. Various sources rate the absorption as poor to good with the
upper limit on absorption being defined numerically as 20%. Elimination
occurs mainly by the kidneys (95%) with some (5%) via the bile.
    Various EDTA chemicals have been tested in repeated dose toxicity
studies which included doses of up to 5% of the diet. Only diarrhea and
lowered food consumption were reported in animals given 5% disodium
EDTA. Taken together, all of the repeated dose toxicity studies
reviewed indicate that the greatest risk in the mammalian body will
occur when the EDTA attempts to scavenge the trace metals used and
required by the body. The repeated conclusion of the various studies is
that rats fed a low percent of an EDTA chemical in the diet with
adequate minerals showed no signs of toxicity. The various
developmental studies indicate that developmental effects will occur if
the EDTA chemicals remove the necessary trace metals from the maternal
body, so that none are available for the developing fetus.
    The Agency's review and evaluation of EDTA and its various salts
indicates that adverse effects occur only in the presence of mineral
deficiencies. In fact, the toxic effects of EDTA are considered to be
related to metal deficiencies, especially a deficiency of zinc.
However, two critical pieces of information informed the Agency's
evaluation of EDTA. Two developmental toxicity studies were performed
using disodium EDTA. The Agency has reviewed the toxicological
literature on both of these studies. In one study, rats were maintained
on de-ionized water (water containing no trace minerals) and a semi-
purified diet, and housed in nonmetallic caging. The test animals
displayed both maternal and developmental effects. In another very
similar study, rats that were maintained on tap water displayed no such
effects. Thus, the availability of trace metals, particularly zinc, in
the diet and drinking water work to prevent deficiencies.
    Thus, test animals can consume large amounts of EDTA (up to 5% of
the diet) with no adverse effects, provided that the trace metals
needed by the body, are also included in the diet.

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary exposure

    1. Food additive uses. EDTA is used extensively as a food additive
to sequester trace metals that catalyze the oxidation of oils,
vitamins, and unsaturated fats that cause rancidity, flavor changes,
and discoloration. For the calcium disodium salt of EDTA an acceptable
daily intake of 2.5 milligram/kilogram (mg/kg) was established by the
Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1973.
    In the U.S., in food the permissible levels of the calcium disodium
salt of EDTA, as specified in 21 CFR 172.120, range from 25 to 800 ppm.
Use of calcium disodium EDTA as a food additive is permitted for direct
addition to food for human consumption, as long as (1) the quantity of
the substance added to food does not exceed the amount reasonably
required to accomplish its intended physical, nutritive, or other
technical effect in food, and (2) any substance intended for use in or
on food is of appropriate food grade, and is prepared and handled as a
food ingredient.
    Disodium EDTA can also be used as a food additive for direct
addition to food for human consumption in specified foods, as specified
under 21 CFR 172.135.
    For sodium iron EDTA, a provisional maximum tolerance daily intake
of 0.8 mg/kg/bodyweight was established by the Joint FAO/WHO Committee.
    In 1981, an article in a toxicology journal reported that the
maximum human consumption of EDTA and its salts in foods was on the
order of 0.4 mg/kg/day.
    2. Food contact surface sanitizing solutions. The disodium and
tetrasodium salts of EDTA are used in food contact surface sanitizing
solutions, as specified in 40 CFR 180.940. A screening-level exposure
estimate of this use was performed for the tetrasodium salt. The
estimated exposure is 0.005 mg/kg/day.
    3. In pesticide products applied to agricultural crops. The Agency
is proposing to place a limitation of 5% of total EDTA in pesticide
products. This limit was based on information in the Agency's files. To
account for possible food residues as a result of application of an
inert ingredient in a pesticide product, the Agency has developed a
screening-level model for predicting dietary exposure to inert
ingredients. The model assumes that the inert ingredients are used on
all crops and 100% of all crops are ``treated'' with the inert
ingredient. The results of the model are considered to over-estimate
exposure to an inert ingredient in a pesticide product. The model is
scalable and can be adjusted to account for lower percent in
formulations. The scaled estimate for use of EDTA chemicals with a
limitation of 5% in the formulation is 0.006 mg/kg/day.

B. Drinking Water

    EDTA is a strong organic acid (approximately 1,000 times stronger
than acetic acid). It has a high affinity for alkaline-earth ions (for
example, calcium and magnesium) and heavy-metal ions (for example, lead
and mercury). This affinity generally results in the formation of
highly stable and soluble complexes. The EDTA chemicals are soluble in
water, have low sorption to soil and sediments, have no significant
vapor pressure, and have a biodegradation half-life of weeks to months.
While EDTA chemicals are slow to degrade, aerobic biodegradation
(mineralization to carbon dioxide and water) is the dominant mechanism.
The rate of biodegradation of EDTA in soils is reported to vary
depending upon environmental factors such as pH, temperature, soil
classification, organic matter, and types and population of microbes.
    There are significant releases of EDTA to the environment in
domestic sewage (from use in detergents, soaps, and

cleaning products) and industrial effluents (bleaching of textiles and
paper; processing of photographic material; electroplating; bottle
cleaning; and industrial cleaning of pipe and tank systems). Detergent
preparations are probably the predominant source of EDTA found in
domestic sewage, contributing an estimated 100 micrograms/Liter ([mu]g/
L) to the total concentration of EDTA in average sewage streams, with
smaller amounts probably originating from food and other consumer
products.
    After treatment, the effluent from sewage treatment plants is
released to streams, rivers, and lakes, and is further diluted by the
receiving waters. According to Toxnet (see http://toxnet.nlm.nih.gov)

ethylenediamine tetraacetic acid has been detected in ground water
(ranging from 5 to 25 [mu]g/L), and drinking water derived from surface
water (10 to 45 [mu]g/L).
    Using 45 [mu]g/L, the estimated exposure via drinking water is 1.5
[mu]g/kg/day or 0.0015 mg/kg/day for adult females and 4.5 [mu]g/kg/day
or 0.0045 mg/kg/day for children.

C. Other Non-Occupational

    Several EDTA chemicals are used as chelating agents in cosmetics.
Examples of products containing EDTA chemicals include: bubble baths,
bath soaps and detergents, deodorants, facial makeups and lotions,
colognes and toilet waters, hair products (shampoos, rinses,
conditioners, dyes and colors), nail basecoats and undercoats, and nail
creams and lotions. EDTA chemicals are also used in cleaning products
and laundry detergents and to control the interactions of trace metals
in pharmaceuticals, metal working, pulp and paper processing, rubber
and polymer chemistry, and textile processing and dyeing.The available
information indicates that the non-food uses of EDTA are more prevalent
than the food-uses. The information in the Agency's files indicates
that pesticide products applied to residential use sites generally
contain less than 1% of EDTA in the formulated product.
    Using this information on percents in formulation, the Agency has
estimated short-term screening level dermal exposure estimates for EDTA
chemicals using both EDTA, per se, and the tetrasodium salt of EDTA.
Since the screening level estimates were identical for both of these
chemicals, they can serve as surrogate estimates for all the EDTA
chemicals. Note that inhalation exposure estimates are not used since
the vapor pressure of EDTA chemicals is so low.
     For a typical cleaning product, the estimated exposure
estimate is 0.028 mg/kg/day
     For a typical laundry detergent, the estimated exposure
estimate is 0.0088 mg/kg/day
     For a cosmetic product, the estimated exposure is 0.0008
mg/kg/day
    These modeled exposure estimates indicate that the exposures that
could occur from the use of these EDTA chemicals in either residential
pesticidal or consumer non-pesticidal products are less than the levels
at which an adverse effect could occur.

VI. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance or tolerance
exemption, the Agency consider ``available information'' concerning the
cumulative effects of a particular chemical's residues and ``other
substances that have a common mechanism of toxicity.''
    Unlike other pesticide chemicals 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 ethylene
diaminetetraacetic acid and its various salts. The EDTA chemicals are a
structurally-related group of chemicals, that travel through the
mammalian body and are excreted. For the purposes of this tolerance
action, therefore, EPA has not assumed that these chemical substances
have 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 the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

VII. Safety Factor for Infants and Children

    FFDCA section 408 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 unless EPA concluded that a different
margin of safety will be safe for infants and children.
    EDTA chemicals are chelating agents or scavengers. Their function
is to locate and then bind to metals. Many metals (iron, zinc,
manganese) are required in the mammalian body in trace amounts for
proper functioning of the mammalian body. Lack of these metals, and
most particularly zinc, can lead to severe effects.
    Various salts of EDTA have been tested in several developmental
toxicity studies. Based on developmental studies in lab rodents, EDTA
and salts should not posed a developmental concern. Results of a
developmental study indicate no developmental effects are likely in
rodents at doses up to 1,000 mg/kg/day. Adequate minerals in the diet
and administration of tap water prevented possible developmental
effects of EDTA during pregnancy. In a different developmental toxicity
study, developmental effects observed in lab rodents were likely due to
animals maintained on deionized water and a semi-purified diet, and
housed in nonmetallic caging. It is unlikely that infants and children
would be exposed to concentrations as high as the lab rodents studied.
The maximum human consumption of EDTA and its salts in foods was
reported to be on the order of 0.4 mg/kg/day. Infants and children,
also, generally drink tap water instead of deionized or distilled
water.
    EDTA is also used therapeutically in adults and pregnant women. A
therapeutic dose of 1.2 to 2.0 grams per day is generally given to
adults. Information is also available indicating EDTA treatment of
pregnant women is possible without affecting the development of the
fetus. Treatments of EDTA to pregnant women include 75 mg/kg/day
calcium disodium EDTA for 7 days and 1 gram twice a day for 3 days,
under medical supervision. Healthy, normal infants were delivered 4
weeks and 8 days after chelation therapy, respectively.
    EPA also believes there would be a very low exposure of infants to
EDTA. First, premature or very young infants ingest only formula or
breast milk. (It is generally recommended that infants not consume
solid food until 4 to 6 months of age). Regulation of infant formulas
is under the purview of the FDA (http://www.fda.gov/fdac/features/596_baby.html
). Calcium disodium EDTA, disodium EDTA, and tetrasodium EDTA

are used as direct food additives (21 CFR 172.120, 172.135, and
178.1010, respectively). However, all manufacturers of infant formula
must begin with safe food ingredients, which are approved either
generally as safe or approved as food additives for use in infant
formula. Neither EDTA nor the salts of EDTA are currently approved by
the FDA for use in infant formula. Therefore, infants consuming only
infant formula or breast

milk would be exposed to very low amounts of EDTA. Second, even if
young infants were to be fed some solid food, given the characteristics
of EDTA and its salts, residues are not likely to be present at
concentrations for potential sensitivity. Once past this several month
time-period, there is no longer a concern for potential sensitivity to
infants and children. Older infants, like adults, process EDTA through
well understood metabolic pathways.
    The comparison of two developmental toxicity studies performed
using disodium EDTA clearly indicates that the presence of trace metals
in the drinking water and diet, particularly zinc, work to prevent
deficiencies. Based on this information concerning both toxicity and
exposure, a safety factor analysis has not been used to assess the risk
of ethylenediaminetetraacetic acid (EDTA) and its various salts. For
the same reasons, the additional tenfold safety factor for the
protection of infants and children is unnecessary.

VIII. Determination of Safety for U.S. Population, and Infants and
Children

    Based on the available toxicity data on ethylenediaminetetraacetic
acid (EDTA) and its various salts, with particular emphasis on the
comparison of the findings in the two developmental toxicity studies;
the reviews and evaluations conducted by NTP, NCI, and WHO; the
knowledge that trace metal supplementation occurs via the food and
drinking water consumed by human beings; and considering the estimated
exposures of the wide-spread existing uses of
ethylenediaminetetraacetic acid (EDTA) and its various salts which are
less than levels at which adverse effects were noted, EPA concludes
that there is a reasonable certainty of no harm from aggregate exposure
to residues of ethylenediaminetetraacetic acid (EDTA) and its various
salts. EPA finds that establishing exemptions from the requirement of a
tolerance for ethylenediaminetetraacetic acid (EDTA) and its various
salts with the following limitation ``The concentration of all EDTA
chemicals is not to exceed 5% in the formulated pesticide product''
will be safe for the general population including infants and children.

IX. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemicals (both
inert and active ingredients), ``may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect. . .'' EPA has been working with interested
stakeholders to develop a screening and testing program as well as a
priority setting scheme. As the Agency proceeds with implementation of
this program, further testing of products containing
ethylenediaminetetraacetic acid and its various salts for endocrine
effects may be required.

B. Analytical Method(s)

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

C. Existing Exemptions

    There are three existing tolerance exemptions for
ethylenediaminetetraacetic acid, disodium zinc
ethylenediaminetetraacetate dihydride, and ethylenediaminetetraacetic
acid, tetrasodium salt in 40 CFR 180.910. These are the tolerance
exemptions proposed for amendment as a result of this action. There are
four existing tolerance exemptions for the disodium and tetrasodium
EDTA salts in 40 CFR 180.940. These four exemptions are not the subject
of this action.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance or
tolerance exemption for ethylenediamine tetraacetic acid and its
various salts, nor have any CODEX Maximum Residue Levels (MRLs) been
established for any food crops at this time.

X. Conclusions

    Accordingly, EPA proposes to establish 16 new and amend three
existing exemptions from the requirement of a tolerance for residues of
various ethylenediaminetetraacetic acid (EDTA) chemicals in or on raw
agricultural commodities when used as inert ingredients in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest. The concentration of all EDTA chemicals is
not to exceed 5% in the formulated pesticide product.

XI. Statutory and Executive Order Reviews

    This rule proposes to amend three existing and establish 16 new
exemptions from the requirement of a tolerance under section 408(e) of
FFDCA. The Agency is acting on its own initiative. 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 proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed 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). This proposed
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). The Regulatory Flexibility Act (RFA) (5 U.S.C.
601 et seq.) Generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant impact on a substantial number of small entities. The
Agency hereby certifies that this proposed action will not have
significant negative economic impact on a substantial number of small
entities. Establishing exemptions from the requirement of a pesticide
tolerance, as is proposed, is in effect the removal of a regulatory
restriction on pesticide residues in food and thus such an action will
not have any negative economic impact on any entities, including small
entities. In addition, the Agency has determined that this action will
not have a substantial direct effect on States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various

levels of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This proposed rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this proposed rule does not have any
``tribal implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

    Dated: February 27, 2006.
Lois Ross,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 180--[AMENDED]

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

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

    2. Section 180.910, in the table, is amended by removing the entry
for Disodium zinc ethylenediaminetetraacetate dihydride; by revising
the entries for ethylenediaminetetraacetic acid and
ethylenediaminetetraacetic acid (EDTA) tetrasodium salt and adding
alphabetically the remaining entries as set forth below to read as
follows:

Sec.  180.910  Inert ingredients used pre-and post-harvest; exemptions
from the requirement of a tolerance.

------------------------------------------------------------------------
        Inert Ingredient                Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Ethylenediaminetetraacetic acid   The concentration   Sequestrant
 (EDTA) (CAS Reg. No.60-00-4)      of all EDTA
                                   chemicals is not
                                   to exceed 5% in
                                   the formulated
                                   pesticide product.
Ethylenediaminetetraaceticacid    Do................  Do.
 (EDTA) calcium disodium salt
 (CAS Reg. No.62-33-9)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) disodiumcopper (II) salt
 (CAS Reg. No. 14025-15-1)
Ethylenediaminetetraaceticacid    Do................  Do.
 (EDTA) disodiumcopper (II)
 salt, dihydrate(CAS Reg. No.
 61916-40-3)
Ethylenediaminetetraaceticacid    Do................  Do.
 (EDTA) disodium copper (II)
 salt, trihydrate(CAS Reg. No.
 73637-19-1)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) disodiummanganese (II)
 salt (CAS Reg. No. 15375-84-5)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) disodiummanganese (I)
 salt, dihydrate (CAS Reg. No.
 73637-20-4)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) disodium salt(CAS Reg.
 No. 139-33-3)
Ethylenediaminetetraaceticacid    Do................  Do.
 (EDTA) disodium salt, dihydrate
 (CAS Reg. No. 6381-92-6)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) disodium zincsalt (CAS
 Reg. No. 14025-21-9)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) disodium zinc salt,
 dihydrate (CAS Reg. No.73513-47-
 0)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) monosodiumsalt (CAS Reg.
 No. 17421-79-3)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) sodium iron(III) salt
 (CAS Reg. No. 15708-41-5)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) sodium salt(CAS Reg. No.
 7379-28-4)
Ethylenediaminetetraaceticacid    Do................  Do.
 (EDTA) tetrapotassiumsalt (CAS
 Reg. No. 5964-35-2)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) tetrasodium salt(CAS
 Reg. No. 64-02-8)
Ethylenediaminetetraacetic acid   Do................  Do.
 (EDTA) tetrasodium salt,
 tetrahydrate (CAS Reg. No.
 13235-36-4)
Ethylenediaminetetraaceticacid    Do................  Do.
 (EDTA) tetrasodium salt,
 trihydrate (CAS Reg. No.67401-
 50-7)
Ethylenediaminetetraacetic acid   The concentration   Sequestrant
 (EDTA) tripotassium salt (CAS     of all EDTA
 Reg. No. 17572-97-3)              chemicals is not
                                   to exceed 5% in
                                   the formulated
                                   pesticide product.
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 06-2106 Filed 3-7-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 162 (Monday, August 22, 2011)]
[Rules and Regulations]
[Pages 52215-52217]
[FR Doc No: 2011-21313]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0187; Directorate Identifier 2011-NE-07-AD;
Amendment 39-16784; AD 2011-18-02]
RIN 2120-AA64

Airworthiness Directives; General Electric Company CF34-10E2A1;
CF34-10E5; CF34-10E5A1; CF34-10E6; CF34-10E6A1; CF34-10E7; and CF34-
10E7-B Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above with certain part number (P/N) fan rotor spinners
installed. This AD requires removing from service certain fan rotor
blade retainers, and removing from service the fan rotor spinner
support that was installed with those fan rotor blade retainers. This
AD was prompted by a fan rotor spinner support found cracked at the
attachment lugs. We are issuing this AD to prevent high-cycle fatigue
cracking of the fan rotor spinner support attachment lugs, leading to
separation of the fan rotor spinner assembly, uncontained failure of
the engine, and damage to the airplane.

DATES: This AD is effective September 26, 2011.

ADDRESSES: For service information identified in this AD, contact GE-
Aviation, M/D Rm. 285, One Neumann Way, Cincinnati, OH 45215, phone:
513-552-3272; e-mail<EMAIL_ADDRESS>You may review copies of the
referenced service information at the FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA. For
information on the availability of this material at the FAA, call 781-
238-7125.

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 (phone:<PHONE_NUMBER>) is 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: John Frost, Aerospace Engineer, Engine
Certification Office, FAA, 12 New England Executive Park, Burlington,
MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on May 11, 2011 (76 FR
27282). Investigation of a General Electric Company CF34-10E turbofan
engine experiencing high fan frame vibrations led to removal of the fan
rotor spinner. Eight of the twelve attachment lugs on the fan rotor
spinner support were found cracked. The cause of the vibration was
determined to be a non-synchronous vibration induced by a spinner
redesign that removed an interference between the fan blade retainers
and the spinner. That NPRM proposed to require removing from service
certain fan rotor blade retainers, and removing from service the fan
rotor spinner support that was installed with those fan rotor blade
retainers. We are issuing this AD to prevent high-cycle fatigue
cracking of the fan rotor spinner support attachment lugs, leading to
separation of the fan rotor spinner assembly, uncontained failure of
the engine, and damage to the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received one comment which is presented below.

Request for Compliance Clarification

    One commenter, Regionla Compagnie Aerienne Europeene, requests that
we clarify the AD as to what parts are allowed to be reinstalled when
affected parts are removed for either scheduled or unscheduled
maintenance before the AD compliance time is reached.
    We do not agree. When the affected parts are removed from the
engine, paragraphs (h) and (i) of this AD are clear that those parts
are not to be reinstalled into the engine. Any FAA-approved part except
those prohibited by paragraphs (h) and (i), is eligible for
installation. We did not change the AD.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed.

Costs of Compliance

    We estimate that this AD will affect 164 engines installed on
airplanes of U.S. registry. We also estimate that it will take about 2
work-hours per engine to perform the actions required by this AD, and
that the average labor rate is $85 per work-hour. If all removed parts
get replaced, required parts will cost about $10,458 per engine. Based
on these figures, we estimate the total cost of the AD to U.S.
operators to be $1,742,992.

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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    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 airworthiness
directive (AD):

2011-18-02 General Electric Company: Amendment 39-16784 ; Docket No.
FAA-2011-0187; Directorate Identifier 2011-NE-07-AD.

Effective Date

    (a) This AD is effective September 26, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to General Electric Company (GE) CF34-
10E2A1; CF34-10E5; CF34-10E5A1; CF34-10E6; CF34-10E6A1; CF34-10E7;
and CF34-10E7-B turbofan engines, with a fan rotor spinner part
number (P/N) 2050M34G03; 2050M34G04; 2050M34G05; 2050M34G06;
2437M60G01; or 2437M60G02, installed.

Unsafe Condition

    (d) This AD was prompted by a fan rotor spinner support found
cracked at the

attachment lugs. We are issuing this AD to prevent high-cycle
fatigue cracking of the fan rotor spinner support attachment lugs,
leading to separation of the fan rotor spinner assembly, uncontained
failure of the engine, and damage to the airplane.

Compliance

    (e) Comply with this AD within 1,800 hours-in-service after the
effective date of this AD, unless already done.

Removal of Fan Rotor Blade Retainers

    (f) Remove from service the 24 fan rotor blade retainers, P/N
2050M56P02.

Removal of Fan Rotor Spinner Support

    (g) Remove from service the fan rotor spinner support that
operated with the fan rotor blade retainers removed in paragraph (f)
of this AD.

Installation Prohibition

    (h) After the effective date of this AD, do not install any fan
rotor blade retainer, P/N 2050M56P02, into any engine. Do not
attempt to repair, make serviceable, or re-install, this part.
    (i) After the effective date of this AD, do not install any fan
rotor spinner support removed in paragraph (g) of this AD, into any
engine. Do not attempt to repair, make serviceable, or re-install,
this part.

Alternative Methods of Compliance (AMOCs)

    (j) The Manager, Engine Certification Office, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19.

Related Information

    (k) For more information about this AD, contact John Frost,
Aerospace Engineer, Engine Certification Office, FAA, 12 New England
Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: 781-
238-7199; e-mail<EMAIL_ADDRESS>    (l) Refer to GE Service Bulletin No. CF34-10E S/B 72-0186, for
related information. Contact GE-Aviation, M/D Rm. 285, One Neumann
Way, Cincinnati, OH 45215, phone:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>for a copy of this service information. You may
review copies of the referenced service information at the FAA,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on August 15, 2011.
Peter A. White,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2011-21313 Filed 8-19-11; 8:45 am]
BILLING CODE 4910-13-P


The planning outputs from the seven steps of the DQO Process fit into the requirements for implementation of a QAPP. The relationships among systematic planning, the DQO Process, and, for example, the elements of a UFP-QAPP are shown below in Table C-3. Several EPA organizations have accepted the UFP-QAPP as an alternative quality document to the EPA QAPP described in Annex B. The use of the UFP-QAPP or any other alternative QAPP document is subject to the approval of the EPA organization responsible for the work.

                          Step 1. State the Problem.
               Define the problem that necessitates the study,
     identify the planning team, examine the budget, and set the schedule.

                    Step 2. Identify the Goal of the Study.
     State how environmental data will be used in meeting objectives and
solving the problem, identify the study questions, and define alternative outcomes.

                     Step 3. Identify Information Inputs.
        Identify data and information needed to answer study questions.

                  Step 4. Define the Boundaries of the Study.
        Specify the target population and characteristics of interest,
        define spatial and temporal limits, and the scale of inference.

                    Step 5. Develop the Analytic Approach.
       Define the parameter of interest, specify the type of inference,
         and develop the logic for drawing conclusions from findings.

              Step 6. Specify Performance or Acceptance Criteria.

           Select the resource-effective sampling and analysis plan
                      that meets the performance criteria
                                  Estimation
Develop performance criteria for new data being collected or acceptance criteria for existing data being considered for use.
                                Decision Making
Specify probability limits for false rejection and false acceptance decision errors.

                 Step 7. Develop the Plan for Obtaining Data.
           Select the resource-effective sampling and analysis plan
                     that meets the performance criteria.

                          Figure C-1. The DQO Process

Table C-2. The Elements of a Uniform Federal Policy Quality Assurance Project Plan (UFP-QAPP)

                     A. Project Management and Objectives
A1   Title and Approval Page
A2	Document Format and Table of Contents
A3	Distribution List and Sign-off Sheet
A4	Project Organization
A5 	Project Planning/Problem Definition
A6   Project Quality Objectives and
       Measurement Performance Criteria
A7   Secondary Data Evaluation
A8   Project Overview and Schedule

                        B. Measurement/Data Acquisition
B1	Sampling Tasks
B2	Analytical Tasks
B3	Sample Collection Documentation

B4	Quality Control (QC) Samples
B5    Data Management Tasks
                            C. Assessment/Oversight
C1	Assessments and Response Actions
C3   Final Project Report
C2   QA Management Reports

                                D. Data Review
D1	Overview
D2	Data Review Steps (Verification/Validation)
D3   Streamline Data Review

Table C-3. The Relationship between Systematic Planning, the DQO Process, and a UFP-QAPP
    Systematic Planning
          DQO Process
         Elements of a UFP-QAPP
Organization
Step 1: Define the problem
A1 - A5
Schedule
Step 1: Define the problem
A4, A8, C3
Project Goal
Step 2: Identify goals
Step 3: identify information
            needed for the study
A4, A6
Quality Assurance
Step 3: Identify information
            needed for the study
B2  -  B5
Data Needs
Step 4: Define boundaries
Step 5: Develop the analytic
            approach
A6, B1
Criteria
Step 6: Specify performance
            or acceptance criteria
A7, B1, C1, D1 - D2
Data Collection
Step 7: Develop the plan for
            obtaining data
A7 - A8, B1
Analysis
Step 7: Develop the plan for
            obtaining data
B1, A7, C1 - C2, D3


[Federal Register: September 6, 2006 (Volume 71, Number 172)]
[Notices]
[Page 52591-52592]
[DOCID:fr06se06-116]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Rule 20a-1; SEC File No. 270-132; OMB Control No. 3235-0158.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3520) 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 of the collection of
information is ``Rule 20a-1 under the Investment Company Act of 1940,
Solicitation of Proxies, Consents and Authorizations.''
    Rule 20a-1 (17 CFR 270.20a-1) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) requires that the solicitation of a
proxy, consent, or authorization with respect to a security issued by a
registered investment company (``fund'') be in compliance with
Regulation 14A (17 CFR 240.14a-1 et seq.), Schedule 14A (17 CFR
240.14a-101), and all other rules and regulations adopted under section
14(a) of the Securities Exchange Act of 1934 (15 U.S.C. 78n(a)). It
also requires a fund's investment adviser, or a prospective adviser, to
transmit to the person making a proxy solicitation the information
necessary to enable that person to comply with the rules and
regulations applicable to the solicitation.
    Regulation 14A and Schedule 14A establish the disclosure
requirements applicable to the solicitation of proxies, consents and
authorizations. In particular, Item 22 of Schedule 14A contains
extensive disclosure requirements for fund proxy statements. Among
other things, it requires the disclosure of information about fund fee
or expense increases, the election of directors, the approval of an
investment advisory contract and the approval of a distribution plan.
    The Commission requires the dissemination of this information to
assist investors in understanding their fund investments and the
choices they may be asked to make regarding fund operations. The
Commission does not use the information in proxies directly, but
reviews proxy statement filings for compliance with applicable rules.
    It is estimated that funds file approximately 1,565 proxy
solicitations annually with the Commission. That figure includes
multiple filings by some funds. The total annual reporting and
recordkeeping burden of the collection of information is estimated to
be approximately 166,203 hours (1,565 responses x 106.2 hours per
response).
    Rule 20a-1 does not involve any recordkeeping requirements.
Providing the information required by the rule is mandatory and
information provided under the rule will not be 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.

    General comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or via e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312, or via e-mail
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: August 30, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-14697 Filed 9-5-06; 8:45 am]

BILLING CODE 8010-01-P