[Federal Register: July 6, 2007 (Volume 72, Number 129)]
[Notices]
[Page 37010-37012]
[DOCID:fr06jy07-65]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0037; FRL-8135-7]

Pesticide Registration Review; New Dockets Opened for Review and
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has established registration review dockets for the
following pesticides: 1-Methyl-3, 5, 7-Triaza-1-Azoniatricyclodecane
Chloride (Busan 1024), Case number 5026; and 2,4-Imidazolidinedione,
Case number 5020. With this document, EPA is opening the public comment
period for these registration reviews. Registration review is EPA's
periodic review of pesticide registrations to ensure that each
pesticide continues to satisfy the statutory standard for registration,
that is, the pesticide can perform its intended function without
unreasonable adverse effects on human health or the environment.
Registration review dockets contain information that will assist the
public in understanding the types of information and issues that the
Agency may consider during the course of registration reviews. Through
this program, EPA is ensuring that each pesticide's registration is
based on current scientific and other knowledge, including its effects
on human health and the environment.

DATES: Comments must be received on or before October 4, 2007.

ADDRESSES: Submit your comments identified by the docket identification
(ID) number for the specific pesticide of interest provided in the
table in Unit III.A., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket'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>.
    Instructions: Direct your comments to the docket ID numbers listed
in the table in Unit III.A. For the pesticides you are commenting on.
EPA's policy is that all comments received will be included in the
docket without change and may be made available on-line 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 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.
    Docket: All documents in the docket are listed in the docket index
available at regulations.gov. 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. Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material,

is not placed on the Internet and will be publicly available only in
hard copy form. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in

hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For information about the pesticides
included in this document, contact the specific Chemical Review
Managers for these pesticides as identified in the table in Unit III.A.
    For general questions on the registration review program, contact
Kennan Garvey, Special Review and Reregistration Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-7106; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farmworker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. 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. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
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 document by docket ID 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. Authority

    EPA is initiating its reviews of the pesticides identified in this
document pursuant to section 3(g) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations
for Registration Review published in the Federal Register of August 9,
2006, and effective on October 10, 2006 (71 FR 45719) (FRL-8080-4). You
may also access the Procedural Regulations for Registration Review on
the Agency's website at http://www.epa.gov/fedrgstr/EPA-PEST/2006/August/Day-09/p12904.htm.
 Section 3(g) of FIFRA provides, among other

things, that the registrations of pesticides are to be periodically
reviewed. The goal is a review of a pesticide's registration every 15
years. Under FIFRA section 3(a), a pesticide product may be registered
or remain registered only if it meets the statutory standard for
registration given in FIFRA section 3(c)(5). When used in accordance
with widespread and commonly recognized practice, the pesticide product
must perform its intended function without unreasonable adverse effects
on the environment; that is, without any unreasonable risk to man or
the environment, or a human dietary risk from residues that result from
the use of a pesticide in or on food.

III. Registration Reviews

A. What Action is the Agency Taking?

    As directed by FIFRA section 3(g), EPA is periodically reviewing
pesticide registrations to assure that they continue to satisfy the
FIFRA standard for registration--that is, they can still be used
without unreasonable adverse effects on human health or the
environment. The implementing regulations establishing the procedures
for registration review appear at 40 CFR part 155. A pesticide's
registration review begins when the Agency establishes a docket for the
pesticide's registration review case and opens the docket for public
review and comment. At present, EPA is opening registration review
dockets for the cases identified in the following table.

               Table--Registration Review Dockets Opening
------------------------------------------------------------------------
                                                       Chemical Review
  Registration Review Case     Pesticide Docket ID   Manager, Telephone
       Name and Number               Number            Number, E-Mail
                                                           Address
------------------------------------------------------------------------
1-Methyl-3, 5, 7-Triaza-1-    EPA-HQ-OPP-2006-0243  K. Avivah Jakob,
 Azoniatricyclodecane<PHONE_NUMBER>,
 Chloride (Busan 1024); Case<EMAIL_ADDRESS> 5026                                                v
------------------------------------------------------------------------
2,4-Imidazolidinedione; Case  EPA-HQ-OPP-2006-0244  Diane Isbell, (703)
 5020                                                308-8154,
<EMAIL_ADDRESS>------------------------------------------------------------------------

B. Docket Content

    1. Review dockets. The registration review dockets contain
information that the Agency may consider in the course of the
registration review. The Agency may include information from its files
including, but not limited to, the following information:
     An overview of the registration review case status.
     A list of current product registrations and registrants.
     Federal Register notices regarding any pending
registration actions.
     Federal Register notices regarding current or pending
tolerances.
     Risk assessments.
     Bibliographies concerning current registrations.
     Summaries of incident data.
     Any other pertinent data or information.
    Each docket contains a document summarizing what the Agency
currently knows about the pesticide case and a preliminary work plan
for anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
Agency is asking that interested persons identify any additional
information they believe the Agency should consider during the
registration reviews of these pesticides. The Agency identifies in each
docket the areas where public comment is specifically requested, though
comment in any area is welcome.
    2. Other related information. More information on these cases,
including the active ingredients for each case, may be located in the
registration review schedule on the Agency's website at http://www.epa.gov/oppsrrd1/registration_review/schedule.htm.
 Information on

the Agency's registration review program and its implementing
regulation may be seen at http://www.epa.gov/oppsrrd1/registration_review
.

     3. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
     As provided in 40 CFR 155.58, the registration review
docket for each pesticide case will remain publicly accessible through
the duration of the registration review process; that is, until all
actions required in the final decision on the registration review case
have been completed.

List of Subjects

    Environmental protection, Pesticides and pests, antimicrobials,
Busan 1024, 2,4-Imidazolidinedione.

    Dated: June 26, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-12869 Filed 7-5-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39047-39048]
[FR Doc No: 2021-15646]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0424]

Medical Devices; Exemption From Premarket Notification: Powered
Patient Transport, All Other Powered Patient Transport; Extension of
Comment Period

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice that appeared in the
Federal Register of June 15, 2021. In the notice, FDA requested
comments by August 16, 2021. The Agency is taking this action in
response to a correction to the notice's docket number that appeared in
the Federal Register of June 30, 2021, to allow interested persons time
to submit comments in response to the corrected notice.

DATES: FDA is extending the comment period on the notice published June
15, 2021 (86 FR 31722). Submit either electronic or written comments by
August 30, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 30, 2021. The https://www.regulations.gov

electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of August 30, 2021. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-P-0424 for ``Medical Devices; Exemption from Premarket
Notification: Powered Patient Transport, All Other Powered Patient
Transport.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dan Reed, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1526, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 15, 2021,
FDA published a notice with a 60-day comment period requesting comments
by August 16, 2021. Comments on the notice will inform FDA's response
to a petition requesting exemption from premarket notification
requirements for powered patient transport, all other powered patient
transport.
    In the Federal Register of June 30, 2021, FDA corrected the docket
number associated with the notice (86 FR 34770). FDA has considered the
requirements associated with receipt of a petition requesting exemption
from premarket notification requirements under section 510(m) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)). Due to the
correction to the docket number, the Agency is extending the comment
period for the notice, until August 30, 2021. The Agency believes that
an extension allows adequate time for interested persons to submit
comments from the date of the correction to the notice issued June 30,
2021, without delaying our consideration of these important issues.

    Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15646 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Page 63174]
[FR Doc No: 2016-22015]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14504-001]

FFP Project 121, LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document, and Approving Use of
the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 14504-001.
    c. Date Filed: July 26, 2016.
    d. Submitted By: Rye Development, LLC on behalf of FFP Project 121,
LLC.
    e. Name of Project: New Cumberland Locks and Dam Hydroelectric
Project.
    f. Location: At the existing Army Corps of Engineers' New
Cumberland Locks and Dam on the Ohio River in Jefferson County, Ohio
and Hancock County, West Virginia. The project would occupy United
States lands administered by the U.S. Army Corps of Engineers.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Applicant Contact: Mr. Erik Steimle, Vice President--
Development, Rye Development, LLC, 334 NW 11th Ave., Portland, OR
97209;<PHONE_NUMBER>; email<EMAIL_ADDRESS>    i. FERC Contact: Andy Bernick at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. FFP Project 121, LLC filed its request to use the Traditional
Licensing Process on July 26, 2016. FFP Project 121, LLC provided
public notice of its request on July 29 through August 4, 2016. In a
letter dated September 6, 2016, the Director of the Division of
Hydropower Licensing approved FFP Project 121, LLC's request to use the
Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service under section 7 of the Endangered
Species Act and the joint agency regulations thereunder at 50 CFR, Part
402; and NOAA Fisheries under section 305(b) of the Magnuson-Stevens
Fishery Conservation and Management Act and implementing regulations at
50 CFR 600.920. We are also initiating consultation with the Ohio and
West Virginia State Historic Preservation officers, as required by
section 106, National Historic Preservation Act, and the implementing
regulations of the Advisory Council on Historic Preservation at 36 CFR
800.2.
    l. With this notice, we are designating FFP Project 121, LLC as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act; and consultation pursuant to section 106 of the
National Historic Preservation Act.
    m. FFP Project 121, LLC filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: September 6, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-22015 Filed 9-13-16; 8:45 am]
BILLING CODE 6717-01-P


<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS

<EPA Registration Division contact:  Sidney Jackson<PHONE_NUMBER>>

<Interregional Research Project Number 4 (IR-4) >

<Pesticide Petition Number: 1E7881>

<	EPA has received a pesticide petition (PP # 1E7881) from Interregional Research Project Number 4 (IR-4), 500 College Road East,  Suite 201 W, Princeton, NJ 08540 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 180.566 by establishing a tolerance for combined residues of the insecticide fenpyroximate (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-  5-phenoxy-1H-pyrazol-4-yl)  methylene] amino]oxy]methyl]  benzoate and its Z-isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5- phenoxy-1H-  pyrazol-4-yl)methylene]  amino]oxy]  methyl]benzoate in or on the raw agricultural commodities:  Avocado at 0.20 parts per million (ppm), Sapote, black at 0.20 ppm, Canistel at 0.20 ppm, Sapote, mamey at 0.20 ppm, Mango at 0.20 ppm, Papaya at 0.20 ppm, Sapodilla at 0.20 ppm, Star apple at 0.20 ppm, Bean, snap, succulent, at 0.40 ppm, and Tea, plucked leaves at 15 ppm.  Revisions to the existing tolerances are the following:  Cucumber at 0.25 ppm, Fruit, citrus, citrus, group 10-10 tolerance at 0.60 ppm, Vegetable, fruiting, group 8-10 tolerance at 0.20 ppm, and Fruit, pome, group 11-10 tolerance at 0.40 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 support granting of the petition. Additional data may be needed before EPA rules on the petition.

>

<A. Residue Chemistry>

<	1. Plant metabolism. The metabolism of fenpyroximate and z-isomer has been studied in cotton, apples, grapes, and citrus and is well understood. The major residue in plants is fenpyroximate and z-isomer, with very low levels of several degradates. Metabolism in plants involves hydrolysis of the ester and methyleneamino ether links, N-demethylation, oxidation, and conjugation of the polar metabolites.

	2. Analytical method. Based upon the metabolism of fenpyroximate in plants and the toxicology of the parent and metabolites, quantification of the parent, fenpyroximate and the z-isomer, combined as fenpyroximate is sufficient to determine toxic residues in plants. As a result an enforcement method has been developed which involves extraction of fenpyroximate from crops with acetone, filtration, partitioning and cleanup, and analysis by gas chromatography using a nitrogen/phosphorous detector. The method has undergone independent laboratory validation as required by PR Notice 88-5 and 96-1.

>

<	3. Magnitude of residues. Magnitude of residues in crops-

Field residue trials meeting EPA study requirements have been conducted at the maximum label rate for avocado, cucumbers, tea, and snap beans2.  Results from these trials demonstrate that the highest fenpyroximate and z-isomer residues found will not exceed the proposed tolerances when the product is applied following the proposed use directions.

<B. Toxicological Profile>

<

1.  An extensive battery of toxicology studies has been conducted with fenpyroximate.  EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk  The nature of the toxic effects caused by fenpyroximate is discussed in Unit III.A. of the Final Rule on Fenpyroximate Pesticide Tolerance published in the Federal Register on April 10, 2001 (66 FR 18561) (FRL-6773-2).   An assessment of toxic effects caused by fenpyroximate including the toxicological endpoints of concern is also discussed in Unit III.A. and Unit III B. of the Federal Register dated June 10, 2004   (FRL-7362-9) (89 FR 32457).

<	2. Animal metabolism. The qualitative nature of the residues of fenpyroximate and its z-isomer, in animals is adequately understood. Fenpyroximate was not metabolized to volatiles to any significant degree.  The majority of either benzyl or pyrazole labels (approximately 70 % to 92 %) is excreted in the feces. Urinary excretion accounts for less (approximately 9 % to 18 %) of the label.  Thus, feces and urine are the major routes of excretion for fenpyroximate.  Tissue did not accumulate fenpyroximate or its metabolites to any great extent.  The greatest levels of label were in liver, kidneys, adrenals, and fat (to a lesser degree).  In blood, nearly all of the label is in the plasma.

	3. Metabolite toxicology. No toxicologically significant metabolites were detected in plant or animal metabolism studies for cotton, apples, or or grapes.

8. Endocrine disruption. Chronic, lifespan, and multigenerational bioassays in mammals and acute and subchronic studies on aquatic organisms and wildlife did not reveal any endocrine effects for fenpyroximate.  Any endocrine related effects would have been detected in this comprehensive series of required tests.  The probability of any such effect due to agricultural uses of fenpyroximate is negligible.

>

<C. Aggregate Exposure>

<	1. Dietary exposure. Acute and chronic dietary risk analyses were conducted to estimate to potential fenpyroximate residues in/on the following crops: avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla, bell and non-bell peppers, cantaloupe and other melons, cotton, cranberries, eggplant, grape, grape raisins, okra, snap beans, cucumbers, strawberries, tomatoes, citrus fruits, hops, mint, pome fruits, tree nuts, tea, and meat, milk, and honey using LifeLine™ version 4.3.  Residue estimates for water consumption were based on PRZM3/EXAMs and SCIGROW models and exposure assessments using LifeLineTM version 5.0.

	i. Food. The acute dietary exposure was based on the following assumptions: residues at tolerance levels, 100% crop treated, and LifeLine™ version 5.0, default processing factors for all registered/proposed commodities/processed fractions except for the following noted fractions (Tier 1).  A processing factor of 0.11 was used apple, grape, pear, and tomato for juice based on processing study data and 0.06 x for orange juice. No processing factors were used for oils since they were adequately represented by tolerance levels.  The acute dietary aPAD (acute population adjusted dose) was set at 0.05 mg/kg/day for females aged 13-50 years old based on a developmental toxicity study in rats that had an oral NOEL of 5 mg/kg/day.  The chronic dietary exposure was based on the following assumptions:  Residues at tolerance levels, 100% crop treated, and using USDA survey data where available.  A processing factor of 0.11 was used for juice based on processing study data. The chronic dietary cPAD (chronic Population Adjusted Dose) was determined to be 0.01 mg/kg/day for the general population, based on an oral NOAEL of 0.97 mg/kg/day in the two-year rat chronic/oncogenicity study.  The resultant safety factor used to establish the cPAD was 100.  There was not likely any evidence of carcinogenicity.

	ii. Drinking water. The residue of concern in drinking water was determined to be fenpyroximate and its z-isomer.  There are no established maximum contaminant levels or health advisory levels for residues of fenpyroximate in drinking water.  In the absence of comprehensive water monitoring data, the Agency uses the FQPA Index Reservoir Screening Tool or the Pesticide Root ZoneModel/Exposure Analysis Modeling System (PRZM/EXAMS) to produce estimates of pesticide concentrations in an index resevoir.   The SCI-GROW model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern.

The estimated drinking water concentrations (EDWCs) in surface water were determined using the Tier II PRZM (Pesticide Root Zone Model) and EXAMS (Exposure Analysis Modeling System (PE4-PL, version 01).  PRZM is used to simulate pesticide transport as a result of runoff and erosion and spray drift from an agricultural field and EXAMS estimates environmental fate and transport of pesticides in surface water.  The EPA estimated that the EWDCs of fenpyroximate for acute exposures are estimated to be 8.74 parts per billion (ppb) for surface water and 0.001 ppb for ground water.  For chronic exposures for non-cancer assessments are estimated to be 0.51 ppb for surface water and 0.001 ppb for ground water.    Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.  For acute dietary risk assessment, the water concentration value of 8.74 ppb was used while for chronic dietary risk assessment, the water concentration of 0.51 ppb was used to assess the contribution to drinking water.  The actual drinking water values would be much lower than the levels predicted in the hypothetical, small, stagnant farm pond model since drinking water derived from surface water would normally be treated before consumption. Based on these analyses, the contribution of water to the dietary risk estimate is negligible. Therefore, based on the dietary and drinking water assessments, aggregate exposure to residues of fenpyroximate and its z-isomer in food and water can be considered to be negligible.

 >

<	2. Non-dietary exposure.  The term residential exposure is used in this document to refer to non-occupational, non-dietary exposure (e.g. for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fenpyroximate is not registered for use on any sites that would result in residential exposure.

>

<D. Cumulative Effects

Fenpyroximate is a mitochondrial electron transport inhibitor acting at Site I, which is similar to pyridaben, but quite different than other established acaricides.  All relevant toxicological data has been provided to the EPA.  A determination has not been made that fenpyroximate has a common mechanism of toxicity with other substances.  Fenpyroximate does not appear to produce a common toxic metabolite with other substances. Therefore, for the purposes of this notice of filing, there should be no consideration of cumulative risk that would require assessment.

>

<E. Safety Determination>

<	1. U.S. population.

 i. Acute risk.  Using the conservative assumptions discussed above, based on the completeness and reliability of the toxicity data, it is concluded that aggregate exposure to the proposed uses of fenpyroximate will occupy at most 12. 1 % of the acute reference dose of females (13-49).

>

ii. Chronic Risk.  Based on the toxicology data base and available information on anticipated residues, the chronic dietary exposure to the U.S. Population (total) was estimated to be  24.5 % of the estimated chronic population adjusted dose (cPAD).

<

2. Infants and children. Chronic exposure to food and water to children from 1-2 years old, the highest exposed population subgroup, was 75.2 % of the cPAD.  EPA has determined that reliable data support the uncertainty factor (100 for intraspecies variability) for fenpyroximate.  EPA deemed an additional FQPA safety factor is not necessary to be protective of infants and children.  EPA generally has no concern for exposures below 100% of the cPAD. The Agency has considered the potential aggregate exposure from food, water and non-occupational exposure routes and has concluded aggregate exposure is not expected to exceed 100% of the chronic reference dose, and consequently, has determined there is a reasonable certainty that no harm will occur to infants and children from aggregate exposure to residues of fenpyroximate.

>

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>

 PAGE

 PAGE   5


[Federal Register: December 8, 2008 (Volume 73, Number 236)]
[Rules and Regulations]
[Page 74348-74349]
[DOCID:fr08de08-3]

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

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 760

[Docket No. 080220216-81424-03]
RIN 0694-AD59

Conforming Changes to Certain End-User/End-Use Based Controls in
the EAR; Clarification of the Term ``Transfer'' and Related Terms as
Used in the EAR; Correction

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Correcting amendment.

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

SUMMARY: The Bureau of Industry and Security (BIS) published a final
rule in the Federal Register on Tuesday, November 18, 2008 (73 FR
68321) that amended the Export Administration Regulations (EAR) to,
among other things, clarify that the terms ``transferred'' and
``transfer'', in the context of two sections of the EAR, meant
``assigned to'' and ``assignment'', respectively. That final rule
contained one inadvertent error in the amendatory instruction used for
revising one of those two sections. This error in the amendatory
instruction led to one sentence of the revised regulatory text to not
be revised as was intended in the regulatory text of that final rule.
This document corrects that amendatory instruction error by revising
that one sentence from that section.

DATES: Effective Date: This rule is effective: December 8, 2008.

ADDRESSES: Written comments on this rule may be sent to the Federal
Register eRulemaking Portal: http://www.regulations.gov, or by e-mail
to<EMAIL_ADDRESS>Include RIN 0694-AD59 in the subject
line of the message. Comments may be submitted by mail or hand delivery
to Timothy Mooney, Office of Exporter Services, Regulatory Policy
Division, Bureau of Industry and Security, U.S. Department of Commerce,
14th St. & Pennsylvania Avenue, NW., Room H2705, Washington, DC 20230,
ATTN: RIN 0694-AD59; or by fax to<PHONE_NUMBER>.
    Send comments regarding the collection of information to Jasmeet
Seehra, Office of Management and Budget (OMB), by e-mail to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>; and to the Regulatory
Policy Division, Bureau of Industry and Security, U.S. Department of
Commerce, 14th St. & Pennsylvania Avenue, NW., Room H2705, Washington,
DC 20230.

FOR FURTHER INFORMATION CONTACT: Timothy Mooney, Office of Exporter
Services, Bureau of Industry and Security, U.S. Department of Commerce;
by telephone:<PHONE_NUMBER>; or by fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On November 18, 2008, the final rule, Conforming Changes to Certain
End-User/End-Use Based Controls in the EAR; Clarification of the Term
``Transfer'' and Related Terms as Used in the EAR was published in the
Federal Register (73 FR 68321). The amendments in that rule included a
revision to paragraph (b)(4)(viii) in Section 760.1 (Definitions). The
November 18 rule intended to revise the first three sentences of
paragraph (b)(4)(viii), but because of an inadvertent error in the
amendatory instruction the third sentence of that paragraph was not
revised as was intended in the regulatory text of that final rule. This
rule corrects that amendatory instruction error by revising the third
sentence of paragraph (b)(4)(viii).

Savings Clause

    Shipments of items removed from eligibility for a License Exception
or export or reexport without a license (NLR) as a result of this
regulatory action that were on dock for loading, on lighter, laden
aboard an exporting or reexporting carrier, or en route aboard a
carrier to a port of export or reexport, on November 18, 2008, pursuant
to actual orders for export or reexport to a foreign destination, may
proceed to that destination under the previous eligibility for a
License Exception or export or reexport without a license (NLR) so long
as they are exported or reexported before December 30, 2008. Any such
items not actually exported or reexported before midnight, on December
30, 2008, require a license in accordance with this rule.
    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as extended by the Notice of July 23, 2008,
73 FR 43603 (July 25, 2008), has continued the Export Administration
Regulations in effect under the International Emergency Economic Powers
Act.

Rulemaking Requirements

    1. This final rule has been determined to be not significant for
purposes of E.O. 12866.
    2. Notwithstanding any other provision of law, no person is
required

to respond to, nor shall any person be subject to a penalty for failure
to comply with a collection of information, subject to the requirements
of the Paperwork Reduction Act, unless that collection of information
displays a currently valid Office of Management and Budget Control
Number. This final rule involves a collection of information subject to
the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). This
collection has been approved by the Office of Management and Budget
under control number 0694-0088, ``Multi-Purpose Application,'' which
carries a burden hour estimate of 58 minutes for a manual or electronic
submission. This final rule is expected to have a minimal increase on
the total number of license applications submitted to BIS. Send
comments regarding these burden estimates or any other aspect of these
collections of information, including suggestions for reducing the
burden, to Jasmeet Seehra, Office of Management and Budget (OMB), and
to the Regulatory Policy Division, Bureau of Industry and Security as
indicated in the ADDRESSES section of this rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined under E.O. 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public participation, and a delay in effective date, are inapplicable
because this regulation involves a military and foreign affairs
function of the United States (5 U.S.C. 553(a)(1)). Further, no other
law requires that a notice of proposed rulemaking and an opportunity
for public comment be given for this final rule. Because a notice of
proposed rulemaking and an opportunity for public comment are not
required to be given for this rule under the Administrative Procedure
Act or by any other law, the analytical requirements of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Therefore,
this regulation is issued in final form. Although the formal comment
period closed on June 17, 2008, public comments on this regulation are
welcome on a continuing basis. Comments should be submitted to one of
the addresses listed in the ADDRESSES section of the preamble of this
final rule.

List of Subjects in 15 CFR Part 760

    Boycotts, Exports, Reporting and recordkeeping requirements.

0
Accordingly, part 760 of the Export Administration Regulations (15 CFR
parts 730-774) is corrected by making the following correcting
amendment:

PART 760--[CORRECTED]

0
1. The authority citation for 15 CFR part 760 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of July
23, 2008, 73 FR 43603 (July 25, 2008).

0
2. Section 760.1 is amended by revising the third sentence of paragraph
(b)(4)(viii) to read as follows:

Sec.  760.1  Definitions.

* * * * *
    (b) * * *
    (4) * * *
    (viii) * * * A, a U.S. national who will reside in Y, has agreed to
the assignment provided he is able to retain his insurance, pension,
and other benefits. * * *
* * * * *

    Dated: December 3, 2008.
Bernard Kritzer,
Director, Office of Exporter Services.
[FR Doc. E8-29012 Filed 12-5-08; 8:45 am]

BILLING CODE 3510-33-P