[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Notices]
[Pages 30725-30727]
[FR Doc No: 2011-13060]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0320]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study on Consumer Responses to Whole
Grain Labeling Statements on Food Packages

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a study entitled: ``Experimental Study on
Consumer Responses to Whole Grain Labeling Statements on Food
Packages.''

DATES: Submit either electronic or written comments on the collection
of information by July 25, 2011.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the

docket number found in brackets in the heading of this document. For
access to the docket to read background documents or comments received,
go to http://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.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER>.

I. Background

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Experimental Study on Consumer Responses to Whole Grain Labeling
Statements on Food Packages, 21 U.S.C. 393(d)(2)(C)--(OMB Control
Number 0910--New)

    The Nutrition Labeling and Education Act (NLEA), which amended the
Food, Drug and Cosmetic Act, requires most foods to bear nutrition
labeling (i.e., the Nutrition Facts), and requires food labels that
bear nutrient content claims and certain health messages to comply with
specific requirements. There are three different types of claims
(health claims, nutrient content claims, and structure/function claims)
that the food industry can voluntarily use on food labels. Although
they are regulated differently, they all must be truthful and not
misleading (Ref. 1).
    In the past 30 years, whole-grain consumption has been greatly
promoted by government agencies and scientific communities as an
important part of a healthy diet (Refs. 2 and 3). For example, the
newly-released ``Dietary Guidelines for Americans 2010'' recommends
Americans eat fewer refined grains, and consume more nutrient-dense
whole grains instead (Ref. 4). At the same time, whole grain labeling
statements, such as ``Made With Whole Grain,'' on food products have
also become more prevalent in recent years (Ref. 5). Given the variety
of whole-grain statements on food products and the importance of whole
grains in maintaining a healthy diet, it is important for policy makers
to gain a better understanding of how consumers interpret these
statements.
    Several studies indicate that consumers may have difficulties in
understanding the meaning of whole grains or recognizing whole-grain
foods (Refs. 6 to 8). Research also suggests consumer product
perceptions and purchase decisions can be influenced by labeling
statements and different labeling statements may have different
influences (Refs. 9 and 10). The majority of existing studies focus on
whole grain intake or the relationships between whole grain and disease
prevention. There is a lack of systematic investigation of consumers'
understanding of different whole-grain labeling statements. We are
aware of at least one existing study related to the statements (Ref.
11). However, the study did not compare consumer reactions to various
whole-grain statements. Therefore, the FDA, as part of its effort to
promote public health, plans to use the proposed study to explore and
compare consumer responses to food labels that use whole grains
labeling statements.
    Specifically, the study plans to examine: (1) Consumer judgments
about a food product including its nutritional attributes, overall
healthiness, and health benefits; (2) consumer judgments about a label
in terms of its credibility in conveying the product's nutritional
attributes and its helpfulness in making product purchasing decisions;
(3) consumer perceptions about differences between different
statements, such as ``Made with Whole Grain,'' ``Contains Whole
Grain,'' and ``Whole Grain;'' (4) consumer extrapolation of whole grain
statements beyond the scope of the statements themselves (i.e., halo
effects); and (5) how whole grain statements influence consumer use of
the Nutrition Facts.
    The proposed collection of information is a controlled randomized
experimental study. The study will use a 15-minute Web-based survey to
collect information from 2,700 English-speaking adult members of an
online consumer panel maintained by a contractor. The study will aim to
produce a sample that reflects the U.S. Census on gender, education,
age, and ethnicity/race.
    The study will randomly assign each participant to view two label
images from a set of food labels that will be created for the study and
systematically varied in the: (1) Whole grain labeling statements; (2)
nutritional profiles (differing by the amount of fiber); (3) ingredient
lists (differing by the ranking order of whole grain wheat on the
list); and (4) featured product (e.g., bread, cereal, and breakfast
bars). With regard to claims, the study will focus on examples of whole
grain statements that can be found on food packages. All label images
will be mock-ups resembling food labels that may be found in the
marketplace. Images will show product identity (e.g., bread), but not
any real or fictitious brand name. The study will provide interested
participants access to the Nutrition Facts, but not together with a
product image.
    The survey will ask its participants to view two label images one
at a time and answer questions about their perceptions and reactions
related to each of the products and labels. Product perceptions (e.g.,
healthiness, potential health benefits, levels of whole grains and
fiber amount) and label perceptions (e.g., helpfulness and credibility)
will constitute the measures of responses in the experiment. To help
understand the data, the survey will also collect information about
participants' backgrounds, such as consumption, purchase history,
perception, and familiarity with a category of food; awareness and
knowledge of nutrients and substances; health literacy; and health
status and demographic characteristics.
    The study is part of the agency's continuing effort to enable
consumers to make informed dietary choices and construct healthful
diets. Results of the study will be used primarily to enhance the
agency's understanding of how whole grains claims and other related

labeling statements on food packages may affect how consumers perceive
a product or a label, which may in turn affect their dietary choices.
Results of the study will not be used to develop population estimates.
    To help design and refine the questionnaire, FDA plans to conduct
cognitive interviews by screening 72 panelists in order to obtain 9
participants in the interviews. Each screening is expected to take 5
minutes (0.083 hour) and each cognitive interview is expected to take
one hour. The total for cognitive interview activities is 15 hours (6
hours + 9 hours). Subsequently, we plan to conduct pretests of the
questionnaire before it is administered in the study. We expect that
1,600 invitations, each taking 2 minutes (0.033 hour), will need to be
sent to panelists to have 200 of them complete a 15-minute (0.25 hour)
pretest. The total for the pretest activities is 103 hours (53 hours +
50 hours). For the survey, we estimate that 21,600 invitations, each
taking 2 minutes (0.033 hour) to complete, will need to be sent to the
consumer panel to have 2,700 of its members complete a 15-minute (0.25
hour) questionnaire. The total for the survey activities is 1,388 hours
(713 hours + 675 hours). Thus, the total estimated burden is 1,506
hours. FDA's burden estimate is based on prior experience with research
that is similar to this proposed study.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden  per
        Portion of study            respondents   responses  per     responses     response (in     Total hours
                                                     respondent                     hours) \2\
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener....              72               1              72            5/60               6
Cognitive interview.............               9               1               9               1               9
Pretest invitation..............           1,600               1           1,600            2/60              53
Pretest.........................             200               1             200           15/60              50
Survey invitation...............          21,600               1          21,600            2/60             713
Survey..........................           2,700               1           2,700           15/60             675
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,506
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

II. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20857, under Docket No. FDA-2011-N-0320 and may
be seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday. We have verified all Web site addresses, but we are not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.

1. U.S. Food and Drug Administration, ``Claims That Can Be Made for
Conventional Foods and Dietary Supplements,'' September 2003,
available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm.
2. Cleveland, L. E., A.J. Moshfegh, A.M. Albertson, and J.D.
Goldman, ``Dietary intake of whole grains,'' Journal of the American
College of Nutrition, 19, 331S-338S, 2000.
3. Kantor, L. S., J.N. Variyam, J.E. Allshouse, J.J. Putnam, and
B.H. Lin, ``Choose a variety of grains daily, especially whole
grains: A challenge for consumers,'' Journal of Nutrition, 131,
473S-486S, 2001.
4. U.S. Department of Agriculture and U.S. Department of Health and
Human Services. ``Executive Summary of Dietary Guidelines for
Americans, 2010,'' January 2011, available at http://www.cnpp.usda.gov/Publications/DietaryGuidelines/2010/PolicyDoc/ExecSumm.pdf.
5. Supermarket News, ``Report: Whole Grains Gain Momentum,''
September 2010, available at http://supermarketnews.com/news/whole_grains_0917/#.
6. Arvola, A., L.L[auml]hteenm[auml]ki, M. Dean, M. Vassallo, M.
Winkelmann, E. Claupein, A. Saba, and R. Shepherd, ``Consumers'
beliefs about whole and refined grain products in the UK, Italy and
Finland,'' Journal of Cereal Science, 46, 197-206, 2007.
7. Kantor, L. S., J.N. Variyam, J.E. Allshouse, J.J. Putnam, and
B.H.Lin, ``Choose a variety of grains daily, especially whole
grains: A challenge for consumers,'' Journal of Nutrition, 131,
473S-486S, 2001.
8. Marquart, L., K.L. Wiemer, J.M. Jones, and B.Jacob, ``Whole grain
health claims in the U.S.A. and other efforts to increase whole-
grain consumption,'' Proceedings of the Nutrition Society, 62, 151-
159, 2003.
9. Drichoutis, A.C., P. Lazaridis, and R.M. Nayga, ``Consumers' Use
of Nutritional Labels: A Review of Research Studies and Issues,''
Academy of Marketing Science Review, 2006(9), 2006.
10. Willis, Josephine M., and K.G. Grunert, ``A Review of Research
on Consumer Response to Nutrition Information on Food Packaging,''
2007.
11. Kellogg Co. ``A Survey of Consumers' Whole Grain & Fiber
Consumption Behaviors, and the Perception of Whole Grain Foods as a
Source of Dietary Fiber,'' 2010. FDA Docket No. 2006-D-0298, July
2010, available at http://www.regulations.gov/#!documentDetail;D=FDA-2006-D-0298-0016.

    Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13060 Filed 5-25-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 219 (Wednesday, November 13, 2013)]
[Proposed Rules]
[Pages 67999-68002]
[FR Doc No: 2013-27066]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0319]
RIN 1625-AA09

Drawbridge Operation Regulation; Gulf Intracoastal Waterway,
Treasure Island, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to change the operating schedule that
governs the Treasure Island Causeway Bridge, mile 119.0, Treasure
Island, Florida. The Treasure Island Bridge is a double-leaf bascule
bridge that provides a vertical clearance of 21 feet in the closed
position. The Treasure Island Bridge crosses the Gulf Intracoastal
Waterway at mile 119.0, Treasure Island, Pinellas County, Florida.
Changing the schedule from on signal to three times an hour during the
week and twice an hour on the weekends and Federal holidays between the
hours of 7 a.m. and 7 p.m. will reduce vehicle traffic issues caused by
the bridge openings. Between 7 p.m. and 7 a.m. the bridge will continue
to open only on signal.

DATES: Comments and related material must reach the Coast Guard on or
before February 11, 2014.

ADDRESSES:  You may submit comments identified by docket number USCG-
2013-0319 using any one of the following methods:
    (1) Federal Rulemaking Portal: http://www.regulations.gov.

    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments. To avoid duplication, please use only one of these
three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email, Mr. Michael Lieberum, Chief Operations Section,
Seventh Coast Guard District Bridge Branch at<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
proposed rulemaking (USCG-2013-0319), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online at http://www.regulations.gov, or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online, it will be considered received by the Coast Guard when
you successfully transmit the comment. If you fax, hand deliver, or
mail your comment, it will be considered as having been received by the
Coast Guard when it is received at the Docket Management Facility. We
recommend that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that we can
contact you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2013-0319] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit them by mail
and would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2013-0319) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC, 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

A. Basis and Purpose

    The City of Treasure Island has requested a change to the Treasure
Island Causeway Bridge regulation due to an increase in vehicle traffic
in this area. Based on the bridge logs this bridge opens on average
less than twice an hour on signal. Scheduled openings at regular
intervals between 7 a.m. and 7 p.m. would reduce the vehicle traffic
back-ups caused by the opening of the bridge. Motorists will be able to
better judge when the bridge will be open, and this will lead to less
vehicle congestion on the surface streets surrounding the bridge.

B. Discussion of Proposed Rule

    The current operating regulation governing the Treasure Island
Causeway Bridge 33 CFR 117.5 requires the bridge to open on signal. The
proposed schedule would have the bridge open at regular intervals
between the hours of 7 a.m. and 7 p.m. The intervals will occur three
times an hour during the week and twice an hour on the weekends. The
Coast Guard does not anticipate longer bridge opening periods due to an
accumulation of vessels, since the bridge currently opens less than
twice an hour on average.

C. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    This action will have a minor impact on vessels transiting the Gulf
Intracoastal Waterway in the vicinity of Treasure Island, Florida and
will still meet the reasonable needs of navigation. This action is
designed to improve vehicle traffic flow in downtown Treasure Island.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations

that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities. This proposed rule would affect
the following entities, some of which might be small entities: the
owners or operators of vessels needing to transit the bridge daily from
7 a.m. to 7 p.m. This proposed rule would change the regulations from
one signal to three times an hour during the week and twice an hour on
weekends and Federal holidays which should not have a substantial
impact on any vessel traffic.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rulemaking would
have a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this proposed rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this proposed rule. If the rulemaking would
affect your small business, organization, or governmental jurisdiction
and you have questions concerning its provisions or options for
compliance, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT, above. The Coast Guard will not retaliate against
small entities that question or complain about this proposed rule or
any policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
rulemaking elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, 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.

 12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a
preliminary determination that this action is one of a category of
actions which do not individually or cumulatively have a significant
effect on the human environment. This proposed rule simply promulgates
the operating regulations or procedures for drawbridges. This rule is
categorically excluded, under figure 2-1, paragraph (32(e), of the
Commandant Instruction. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
proposed rule.

List of Subjects in 33 CFR Part 117

    Bridges.
    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.287, revise paragraph (g) to read as follows:

Sec.  117.287  Gulf Intracoastal Waterway.

* * * * *
    (g) The draw of the Treasure Island Causeway bridge, mile 119.0
shall open on signal except that from 7 a.m. to 7 p.m. the draw need
open on the hour, 20 minutes after the hour and 40 minutes after the
hour Monday through Friday and on the quarter hour and three quarter
hour on Saturday, Sunday and Federal holidays.
* * * * *

    Dated: October 3, 2013.
J.H. Korn,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2013-27066 Filed 11-12-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Notices]
[Pages 72717-72719]
[FR Doc No: 2015-29689]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0386; FRL-9937-03]

Pesticide Registration Review; Draft Human Health and Ecological
Risk Assessments for Sulfonylureas; Notice of Availability and Request
for Comment; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of comment period.

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

SUMMARY: EPA issued a notice in the Federal Register of September 25,
2015, concerning the publication of draft human health and ecological
risk assessments for the registration review of 22 sulfonylurea
chemicals and certain other non-sulfonylurea chemicals. This document
extends the comment period for 30 days for only the chemicals listed in
the Table in this document, from November 24, 2015 to December 24,
2015. The comment period is being extended in response to comments
received by the Agency requesting additional time to review the

sulfonylurea risk assessment documents.

DATES: Comments, identified by docket identification (ID) numbers in
the Table must be received on or before December 24, 2015.

ADDRESSES: Follow the detailed instructions provided under ADDRESSES in
the Federal Register document of September 25, 2015 (80 FR 57812) (FRL-
9933-68).

FOR FURTHER INFORMATION CONTACT: Persons listed with individual
chemicals in the Table.

SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register document of September 25,
2015 (80 FR 57812) (FRL-9933-68). In that document, a public comment
period opened on EPA's draft human health and ecological risk
assessments for the registration review of certain members of a group
of pesticides known collectively as sulfonylureas, as well as various
non-sulfonylurea chemicals. This extension on the comment period is
being requested for the sulfonylurea chemicals listed in the Table,
rather than all the chemicals that were included in the document that
published in the Federal Register of September 25, 2015. EPA is
extending the comment period, which was set to end on November 24,
2015, to December 24, 2015.

             Table--Chemicals With Extended Comment Periods
------------------------------------------------------------------------
                                                       Chemical review
  Registration review case        Docket ID No.      manager and contact
        name and No.                                     information
------------------------------------------------------------------------
Bensulfuron-methyl, 7216....  EPA-HQ-OPP-2011-0663  Moana Appleyard,
<EMAIL_ADDRESS>(703) 308-
                                                     8175.
Chlorimuron-ethyl, 7403.....  EPA-HQ-OPP-2010-0478  Wilhelmena
                                                     Livingston,
<EMAIL_ADDRESS>(703)
                                                     308-8025.
Chlorsulfuron, 0631.........  EPA-HQ-OPP-2012-0878  Miguel Zavala,
<EMAIL_ADDRESS>(703) 347-0504.
Flazasulfuron, 7271.........  EPA-HQ-OPP-2011-0994  Ricardo Jones,
<EMAIL_ADDRESS>(703) 347-0493.
Foramsulfuron, 7252.........  EPA-HQ-OPP-2012-0387  Jose Gayoso,
<EMAIL_ADDRESS>                                                     ,<PHONE_NUMBER>.
Halosulfuron-methyl, 7233...  EPA-HQ-OPP-2011-0745  Brittany Pruitt,
<EMAIL_ADDRESS>(703) 347-
                                                     0289.
Imazosulfuron, 7281.........  EPA-HQ-OPP-2015-0625  Caitlin Newcamp,
<EMAIL_ADDRESS>(703) 347-
                                                     0325.
Iodosulfuron-methyl-sodium,   EPA-HQ-OPP-2012-0717  Katherine St. Clair,
 7253<EMAIL_ADDRESS>(703) 347-
                                                     8778.
Mesosulfuron-methyl, 7277...  EPA-HQ-OPP-2012-0833  Jolene Trujillo,
<EMAIL_ADDRESS>(303) 312-
                                                     6579.
Metsulfuron-methyl, 7205....  EPA-HQ-OPP-2011-0375  Katherine St. Clair,
<EMAIL_ADDRESS>(703) 347-
                                                     8778.
Nicosulfuron, 7227..........  EPA-HQ-OPP-2012-0372  Miguel Zavala,
<EMAIL_ADDRESS>(703) 347-0504.
Orthosulfamuron, 7270.......  EPA-HQ-OPP-2011-0438  Khue Nguyen,
<EMAIL_ADDRESS>                                                     ,<PHONE_NUMBER>.
Primisulfuron-methyl, 7220..  EPA-HQ-OPP-2011-0844  Christina Scheltema,
<EMAIL_ADDRESS>(703) 308-
                                                     2201.
Prosulfuron, 7235...........  EPA-HQ-OPP-2011-1010  Wilhelmena
                                                     Livingston,
<EMAIL_ADDRESS>(703)
                                                     308-8025.
Rimsulfuron, 7218...........  EPA-HQ-OPP-2012-0178  Jose Gayoso,
<EMAIL_ADDRESS>                                                     ,<PHONE_NUMBER>.
Sulfometuron-methyl, 3136...  EPA-HQ-OPP-2012-0433  Caitlin Newcamp,
<EMAIL_ADDRESS>(703) 347-
                                                     0325.
Sulfosulfuron, 7247.........  EPA-HQ-OPP-2011-0434  Kelly Ballard,
<EMAIL_ADDRESS>(703) 305-8126.
Thifensulfuron-methyl, 7206.  EPA-HQ-OPP-2011-0171  Brittany Pruitt,
<EMAIL_ADDRESS>(703) 347-
                                                     0289.
Triasulfuron, 7221..........  EPA-HQ-OPP-2012-0115  Margaret Hathaway,
<EMAIL_ADDRESS>(703) 305-
                                                     5076.
Tribenuron-methyl, 7217.....  EPA-HQ-OPP-2010-0626  Brittany Pruitt,
<EMAIL_ADDRESS>(703) 347-
                                                     0289.
Trifloxysulfuron-Sodium,      EPA-HQ-OPP-2013-0409  Kelly Ballard,
 7208<EMAIL_ADDRESS>(703) 305-8126.
Triflusulfuron-methyl, 7236.  EPA-HQ-OPP-2012-0605  Matthew Manupella,
<EMAIL_ADDRESS>(703) 347-
                                                     0411.
------------------------------------------------------------------------

    To submit comments, or access the docket, please follow the
detailed instructions provided under ADDRESSES in the Federal Register
document of September 25, 2015. If you have questions on individual
chemicals, consult the person listed in the Table.

    Authority: 7 U.S.C. 136 et seq.

    Dated: November 13, 2015.
Michael Goodis,
Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2015-29689 Filed 11-19-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 29, 2009 (Volume 74, Number 81)]
[Notices]
[Page 19609]
[DOCID:fr29ap09-145]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, April
30, 2009 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
April 30, 2009 will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an
enforcement nature; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: April 23, 2009.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-9704 Filed 4-28-09; 8:45 am]


[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Rules and Regulations]
[Pages 19793-19795]
[FR Doc No: 2022-07263]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0008; Project Identifier MCAI-2021-00882-R;
Amendment 39-21985; AD 2022-06-19]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Leonardo S.p.a. Model AW109SP helicopters. This AD was prompted by
reports of corrosion inside the hoist support assembly (boom assembly)
(affected part) that affects both the huck bolt heads (blind bolt
fasteners) and the support surface. This AD requires repetitive
inspections of the external and internal surfaces of each affected part
for cracking and corrosion and, depending on the findings,
accomplishment of corrective actions, as specified in a European Union
Aviation Safety Agency (EASA) AD, which is incorporated by reference.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective May 11, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 11,
2022.

ADDRESSES: For EASA material incorporated by reference (IBR) in this
final rule, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find the EASA material on the EASA website
at https://ad.easa.europa.eu. You may view this material at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. It is also available
in the AD docket at https://www.regulations.gov by searching for and
locating Docket No. FAA-2022-0008.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0008; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
EASA AD, any comments received, and other information. The address for
Docket Operations is 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: Andrea Jimenez, Aerospace Engineer,
COS Program Management Section, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0179, dated July 27, 2021 (EASA
AD 2021-0179), to correct an unsafe condition for Leonardo S.p.A.
Helicopters, formerly Finmeccanica S.p.A., AgustaWestland S.p.A., and
Agusta S.p.A., Model AW109SP helicopters, all serial numbers.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Leonardo S.p.a.
Model AW109SP helicopters. The NPRM published in the Federal Register
on January 21, 2022 (87 FR 3241). The NPRM was prompted by reports of
corrosion inside the hoist support assembly affecting both the huck
bolt heads and the support surface. Investigation of the root cause for
the corrosion is ongoing. The NPRM proposed to require repetitive
inspections of the external and internal surfaces of each affected part
for cracking and corrosion and, depending on the findings,
accomplishment of corrective actions, as specified in EASA AD 2021-
0179.
    The FAA is issuing this AD to address corrosion on the hoist
support assembly. This condition, if not addressed, could affect the
structural integrity of the hoist support assembly, leading to in-
flight detachment of the hoist support and consequent damage to the
helicopter, and injury to hoisted persons. See EASA AD 2021-0179 for
additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these helicopters. Except for minor editorial changes,
this AD is adopted as proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0179 requires repetitive inspections of the external
and internal surfaces of each affected part for cracking and corrosion
and, depending on the findings, accomplishment of corrective actions.
If there is no evidence of corrosion on the interior surface of the
boom torque tube or on the huck bolt heads, the corrective actions
include spraying the interior surface with corrosion preventative
compound around the hulk bolt heads from the forward and aft ends of
the boom torque tube, and installing new tube plugs on both ends of the
boom torque tube. If there is superficial corrosion on the interior
surface of the boom torque tube or on the hulk bolt heads, the
corrective actions include cleaning the corrosion, spraying the
interior surface with corrosion preventative compound, and installing
new tube plugs on both ends of the boom torque tube. If corrosion is
found that is not superficial corrosion, the corrective action is
repair or replacement of the boom torque tube.
    If cracking is observed on the external surface of the hoist
support assembly the corrective action is replacement of the hoist
support assembly. If only corrosion is found on the external surface of
the hoist support assembly the corrective actions include cleaning the
hoist support assembly.
    EASA AD 2021-0179 also allows installing an affected part, provided
certain instructions are followed.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Interim Action

    The FAA considers this AD to be an interim action. If final action
is later identified, the FAA might consider further rulemaking.

Costs of Compliance

    The FAA estimates that this AD affects 40 helicopters of U.S.
Registry. The FAA estimates the following costs to comply with this AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Action                          Labor cost          Parts cost            Cost per product                 Cost on U.S.  operators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspecting............................  0.50 work-hour x $85 per            $0  $42.50 per inspection cycle........  $1,700 per inspection cycle.
                                         hour = $42.50 per
                                         inspection cycle.
Installing new boom torque tube plugs.  0.25 work-hour x $85 per         5,044  $5,065.25..........................  $202,610.
                                         hour = $21.25.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements that are required based on the results of the inspection.
The agency has no way of determining the number of aircraft that might
need these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Cleaning boom torque tube interior or exterior  0.25 work-hour x $85 per hour =               $0          $21.25
                                                 $21.25.
Replacing boom torque tube....................  6 work-hours x $85 per hour =             39,500          40,010
                                                 $510.
Replacing hoist support assembly..............  6.50 work-hours x $85 per hour =          44,864       45,416.50
                                                 $552.50.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the repairs specified in this AD.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators.

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.
    The FAA is 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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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:

2022-06-19 Leonardo S.p.a.: Amendment 39-21985; Docket No. FAA-2022-
0008; Project Identifier MCAI-2021-00882-R.

(a) Effective Date

    This airworthiness directive (AD) is effective May 11, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Leonardo S.p.a. Model AW109SP
helicopters, certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 2560, Emergency
Equipment.

(e) Unsafe Condition

    This AD was prompted by reports of corrosion inside the hoist
support assembly (boom assembly) (affected part) that affects both
the huck bolt heads (blind bolt fasteners) and the support surface.
The FAA is issuing this AD to address corrosion on the hoist support
assembly. This condition, if not addressed, could affect the
structural integrity of the hoist support assembly, leading to in-
flight detachment of the hoist support and consequent damage to the
helicopter, and injury to hoisted persons.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0179, dated July 27, 2021 (EASA AD 2021-0179).

(h) Exceptions to EASA AD 2021-1079

    (1) Where EASA AD 2021-0179 requires compliance in terms of
flight hours, this AD requires using hours time-in-service.
    (2) Where EASA AD 2021-0179 refers to its effective date, this
AD requires using the effective date of this AD.
    (3) Where the service information referenced in EASA AD 2021-
0179 specifies discarding parts, this AD requires removing those
parts from service.
    (4) Where the service information referenced in EASA AD 2021-
0179 specifies returning a part to the manufacturer, this AD
requires removing that part from service.
    (5) Where the service information referenced in EASA AD 2021-
0179 specifies submitting photographs to the manufacturer, this AD
does not require that action.
    (6) Where the service information referenced in EASA AD 2021-
0179 specifies attaching a label to the hoist support assembly, this
AD does not require that action.
    (7) Where paragraph (2) of EASA AD 2021-0179 specifies
contacting Leonardo S.p.a. for corrective action instructions, this
AD requires replacing or repairing before further flight using a
method approved by the Manager, General Aviation and Rotorcraft
Section, International Validation Branch, FAA; or EASA; or Leonardo
S.p.a.'s EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (8) This AD does not mandate compliance with the ``Remarks''
section of EASA AD 2021-0179.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2021-0179
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Special Flight Permit

    Special flight permits may be permitted provided that there are
no passengers on board.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (l) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    For more information about this AD, contact Andrea Jimenez,
Aerospace Engineer, COS Program Management Section, Operational
Safety Branch, Compliance & Airworthiness Division, FAA, 1600
Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-
7330; email [email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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) European Union Aviation Safety Agency (EASA) AD 2021-0179,
dated July 27, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0179, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find the
EASA material on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket at https://www.regulations.gov by searching
for and locating Docket No. FAA-2022-0008.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on March 10, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-07263 Filed 4-5-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 231 (Friday, November 30, 2012)]
[Notices]
[Pages 71464-71466]
[FR Doc No: 2012-28943]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68287; File No. SR-NASDAQ-2012-131]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify the Listing Requirements for Other Securities Listed Under Rule
5730

November 26, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on November 16, 2012, The NASDAQ

Stock Market LLC (``Nasdaq'' or ``Exchange'') filed with the Securities
and Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to modify the listing requirements for Other
Securities listed under Rule 5730. The text of the proposed rule change
is below. Proposed new language is in italics; proposed deletions are
in brackets.\3\
---------------------------------------------------------------------------

    \3\ Changes are marked to the rule text that appears in the
electronic manual of Nasdaq found at http://nasdaqomx.cchwallstreet.com.
---------------------------------------------------------------------------

5730. Listing Requirements for Securities Not Otherwise Specified
[Above] (Other Securities)

(a) Initial Listing Requirements

    (1) Nasdaq will consider listing on the Global Market any security
not otherwise covered by the criteria in the Rule 5400 or 5700 Series,
provided the instrument is otherwise suited to trade through the
facilities of Nasdaq. Such securities will be evaluated for listing
against the following criteria:
    (A) No change.
    (B) For equity securities, there [There] must be:
    (i) a minimum of 400 holders of the security[, provided, however,
that if the instrument is traded in $1,000 denominations, there must be
a minimum of 100 holders.]; and
    (ii) a minimum public distribution of 1,000,000 trading units.
However, if the instrument is redeemable at the option of the holders
thereof on at least a weekly basis, these requirements shall not apply.
    (C) [For equity securities listed pursuant to this paragraph, there
must be a minimum public distribution of 1,000,000 trading units.
    (D)] The aggregate market value/principal amount of the security
shall be at least $4 million.
    (2)-(3) No change.
    (b) No Change.
* * * * *

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

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

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

1. Purpose
    Nasdaq Rule 5730 provides rules for listing ``Other Securities,''
which are not described elsewhere in Nasdaq's listing requirements.\4\
Generally, this rule allows the listing of innovative securities of
substantially-sized companies, which are not readily categorized under
the traditional listing standards. It is not intended to accommodate
the listing of securities that raise significant new regulatory issues,
which would require a separate rule filing submitted pursuant to
Section 19(b) of the Act and Rule 19b-4 thereunder.\5\
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release No. 32988 (September 29,
1993), 58 FR 52124 (October 6, 1993) (SR-NASD-93-15). This order
approved the predecessor to current Nasdaq Rule 5730 while Nasdaq
was a facility of the NASD, now FINRA.
    \5\ 15 U.S.C. 78s(b) and 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    The issuer of a security listed under Rule 5730 must have assets in
excess of $100 million, stockholders' equity of at least $10 million,
and income of at least $1 million; assets in excess of $200 million and
stockholders' equity of at least $10 million; or assets in excess of
$100 million and stockholders' equity of at least $20 million.\6\ In
addition, the security generally must have a minimum of 400 holders, an
aggregate market value/principal amount of at least $4 million, and, in
the case of equity securities, there must be a minimum public
distribution of 1 million trading units.\7\ Prior to the trading of a
security under this rule, Nasdaq evaluates the nature and complexity of
the issue and, if appropriate, distributes a circular to the membership
providing guidance regarding member firm compliance responsibilities
and requirements when handling transactions in such securities.\8\
---------------------------------------------------------------------------

    \6\ Rule 5730(a)(1)(A).
    \7\ Rule 5730(a)(1)(B), (C) and (D). A security traded in one
thousand dollar denominations must only have 100 holders.
    \8\ Rule 5730(a)(3).
---------------------------------------------------------------------------

    This rule was based on a rule of the New York Stock Exchange
(``NYSE'')\9\ and is also similar to a rule of NYSE MKT.\10\ Nasdaq now
proposes changes to Rule 5730 to more closely align that rule with
those other markets' rules.
---------------------------------------------------------------------------

    \9\ See Section 703.19 of the NYSE Listed Company Manual.
    \10\ See Section 107 of the NYSE MKT Company Guide.
---------------------------------------------------------------------------

    Specifically, the proposed rule change would modify the holder
requirement so that it applies only to equity securities, and thereby
eliminate the holder requirement for listing debt securities. In this
way, the revised rule will more closely track the NYSE's requirement,
which does not impose a holder requirement on such listings.\11\ In
addition, Nasdaq proposes to adopt an exception adopted by NYSE MKT to
the holder and public distribution requirements for securities that are
redeemable at the option of their holders on at least a weekly
basis.\12\ Finally, Nasdaq also proposes to change the title of the
rule, to clarify its applicability to only securities that do not
otherwise have specific listing standards, wherever they may be in the
rulebook.
---------------------------------------------------------------------------

    \11\ The proposed rule change would also remove the 100 holder
requirement for securities that trade in $1,000 denominations
because such securities are debt securities, which would no longer
be subject to the holder requirement.
    \12\ Securities Exchange Act Release No. 55733 (May 10, 2007),
72 FR 27602 (May 16, 2007) (SR-Amex-2007-34).
---------------------------------------------------------------------------

b. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\13\ in general, and with
Section 6(b)(5) of the Act,\14\ in particular, in that the proposal is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Specifically,
Nasdaq notes that the proposed changes will conform Rule 5730 with the
rules of other national securities exchanges, while continuing to limit
the availability of the rule to more financially substantial companies,
which can satisfy the assets, equity, income, and other requirements of
Rule 5730(a). In addition, Nasdaq is unaware

of any problems related to the trading of instruments that have
qualified under the other markets' lower holder and distribution
requirements.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. Instead, the
proposed rule change will allow Nasdaq to list securities that can
already be listed on other exchanges, thereby increasing competition
with other national securities exchanges.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \15\ and Rule 19b-
4(f)(6) thereunder.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    The Exchange has requested the Commission to waive the 30-day
operative delay period to allow the proposed rule change to become
operative upon filing.\17\ The Commission believes it is consistent
with the public interest to waive the 30-day operative delay. The
proposed rule change is substantially similar in all material respects
to Section 703.19 of the NYSE Listed Company Manual and Section 107A(b)
of the NYSE MKT Listed Company Guide, and each policy issue raised by
the proposed rule change (i) has been considered by the Commission in
approving the other exchanges' rules and (ii) is resolved in a manner
generally consistent with the approved rules. As such, the Commission
believes that the proposal presents no novel regulatory issues. Waiver
of the operative delay will allow the Exchange to list certain
securities that can already be listed and traded on other exchanges
without undue delay. Therefore, the Commission grants such waiver and
designates the proposal operative upon filing.\18\
---------------------------------------------------------------------------

    \17\ As required under Rule 19b-4(f)(6)(iii), the Exchange
provided the Commission with written notice of its intent to file
the proposed rule change along with a brief description and the text
of the proposed rule change, at least five business days prior to
the date of filing of the proposed rule change, or such shorter time
as designated by the Commission.
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-NASDAQ-2012-131 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-NASDAQ-2012-131. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Web site (http://www.sec.gov/rules/sro.shtml). Copies
of the submission, all subsequent amendments, all written statements
with respect to the proposed rule change that are filed with the
Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of Nasdaq. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File No. SR-NASDAQ-2012-131 and should be submitted on
or before December 21, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-28943 Filed 11-29-12; 8:45 am]
BILLING CODE 8011-01-P


EPA Registration Division contact: Barbara Madden<PHONE_NUMBER>

Interregional Research Project Number 4 and Dow AgroSciences

PP# 6E7086

	EPA has received a pesticide petition (6E7086) from Interregional Research Project #4 (IR-4), Rutgers, The State University of New Jersey, 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 180.544 by establishing a tolerance for residues of methoxyfenozide in or on the raw agricultural commodities Vegetable, tuberous and corm, except potato, subgroup 1D at 0.02 parts per million (ppm); Bushberries subgroup 13B at 3.0 ppm; Juneberry at 3.0 ppm; Lingonberry at 3.0 ppm, Salal at 3.0 ppm; Aronia berry at 3.0 ppm;  Blueberry, lowbush at 3.0 ppm; Buffalo currant at 3.0 ppm; Chilean guava at 3.0 ppm; European barberry at 3.0 ppm; Highbush cranberry at 3.0 ppm; Honeysuckle at 3.0 ppm; Jostaberry at 3.0 ppm; Native currant at 3.0 ppm; Sea buckthorn at 3.0 ppm; Bean, dry, seed at 0.15 ppm; Grass, forage, fodder and hay, group 17, forage at 18.0 ppm; Grass, forage, fodder and hay, group 17, hay at 30.0 ppm; Peanut at 0.02 ppm;  Peanut, hay at 60 ppm; Peanut, oil at 0.09 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The qualitative nature of methoxyfenozide residues in plants and animals is adequately understood and was previously published in the Federal Register of July 5, 2000 (65 FR 41355) (FRL-6497-5).

	2. Analytical method. Adequate enforcement methods are available for determination of methoxyfenozide residues in plant commodities.  The available Analytical Enforcement Methodology was previously reviewed in the Federal Register of September 20, 2002 (67 FR 59193).

	3. Magnitude of residues. Complete residue data for methoxyfenozide on sweet potato; blueberry; dry bean; grasses; and peanut have been submitted by IR-4.   The requested tolerances are adequately supported.

B. Toxicological Profile

	1. Acute toxicity.  The toxicological profile and endpoints for methoxyfenozide which supports this petition to establish tolerances were previously published in the Federal Register of August 31, 2005 (70 FRL-7732-3.)

	2. Genotoxicty. The toxicological profile and endpoints for methoxyfenozide which supports this petition to establish tolerances were previously published in the Federal Register of August 31, 2005 (70 FRL-7732-3.).

	3. Reproductive and developmental toxicity. The toxicological profile and endpoints for methoxyfenozide which supports this petition to establish tolerances were previously published in the Federal Register of August 31, 2005 (70 FRL-7732-3.).

	4. Subchronic toxicity. The toxicological profile and endpoints for methoxyfenozide which supports this petition to establish tolerances were previously published in the Federal Register of August 31, 2005 (70 FRL-7732-3.)

	5. Chronic toxicity. The toxicological profile and endpoints for methoxyfenozide which supports this petition to establish tolerances were previously published in the Federal Register of August 31, 2005 (70 FRL-7732-3.)

	6. Animal metabolism. The toxicological profile and endpoints for methoxyfenozide which supports this petition to establish tolerances were previously published in the Federal Register of August 31, 2005 (70 FRL-7732-3.)

	7. Metabolite toxicology. The toxicological profile and endpoints for methoxyfenozide which supports this petition to establish tolerances were previously published in the Federal Register of August 31, 2005 (70 FRL-7732-3.)

	8. Endocrine disruption. The toxicological profile and endpoints for methoxyfenozide which supports this petition to establish tolerances were previously published in the Federal Register of August 31, 2005 (70 FRL-7732-3.).

C. Aggregate Exposure

	1. Dietary exposure. Assessments were conducted to evaluate potential risks due to chronic and acute dietary exposure of the U.S. population subgroups to residues of methoxyfenozide.  These analyses cover all registered crops, as well as, uses pending with the Agency, active and proposed section 18 uses, and proposed IR-4 minor uses.  There are no registered residential nonfood uses of methoxyfenozide.

	i. Food. a.  Acute risk.  No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on methoxyfenozide including the acute neurotoxicity study in rats, the developmental toxicity study in rats and the developmental toxicity study in rabbits.  Since no acute toxicological endpoints were established, the acute aggregate risk is expected to be negligible.

b.  Chronic assessments were conducted to evaluate potential risks due to chronic dietary exposure of the U.S. population and selected population subgroups to residues of methoxyfenozide.  These analyses cover all registered crops, uses pending with the EPA, active and proposed Section 18 uses and new proposed IR-4 uses.  Dow AgroSciences used the Dietary Exposure Evaluation Model™ (DEEM-FCID, ver. 2.03, Exponent, Inc., Washington, DC-20036) software for conducting a chronic dietary (food) risk analysis.  DEEM is a dietary exposure analysis system that is used to estimate exposure to a pesticide chemical in foods comprising the diets of the U.S. population, including population subgroups.  DEEM contains food consumption data as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals (CSFII) conducted in 1994-1996 and 1998 and food translation to RACs, as indicated by EPA/USDA FCID recipe set as of August, 2002.  Dow AgroSciences assumed for a tier-I analysis that 100% of crops would be treated and will contain methoxyfenozide residues at the tolerance level.

The dietary exposure analysis is proceeding from Intrepid® current and proposed labels, assuming the worst case use patterns, summarized in Section B – Amount, Frequency and Time of Application of Methoxyfenozide, of the current NOF.

Some of the currently proposed uses are involving crops commonly used as feed for livestock: grass, forage and hay, and peanut hay.  Therefore, an estimated animal dietary burden was conducted, in order to confirm that the new uses proposed on grass and peanut will not trigger residue levels above the current tolerances on meat and poultry food commodities.  The methodology used by Dow AgroSciences followed EPA’s OPPTS 860.1000 guidelines for residue chemistry test guidelines (ref. 5 ).  A summary of the estimated dietary intake for beef and dairy cattle, and also for poultry, is presented in Table 1.

 Table 1.  Estimated Dietary Intake for Beef and Dairy Cattle and Poultry from Methoxyfenozide’s Current and Proposed Uses on Feed-crops

 The maximum total intake estimated from all existing and proposed used on field feed crops was compared with the doses tested in the feeding study conducted by Rohm & Haas with methoxyfenozide on dairy cattle (TR-34-98-95) and submitted previously to the agency.  Residue were calculated in milk (cream and skim), muscle, fat, liver and kidney of dairy cattle by extrapolating residues on dairy cattle from the dose tested at 53.6 ppm and for beef cattle from the dose tested at 183 ppm.  All residue levels in muscle, fat, liver, kidney and milk were found to be below the current tolerances for all meat commodities.  A summary of the residue estimated by this assessment in meat, fat, kidney and milk of dairy and beef cattle is presented in Table 2.

Table 2. Estimated Residue in Dairy and Beef Food Commodities from Current and Proposed Uses of Methoxyfenozide on Feed-crops

Feeding Study ( TR-34-98-95)

Dairy Cattle

 	MILK 	CREAM 	Skim milk 	Muscle 	* Kidney  	* Liver 	Fat

Dose (ppm) 	mean 	mean 	mean 	mean 	mean 	mean 	mean

0 	0 	0 	0 	0 	0 	0 	0

16.5 	0.003 	 	 	ND 	ND 	0.02 	ND

53.6 	0.004 	 	 	ND 	0.01 	0.066 	0.008

183 	0.028 	0.12 	0.005 	0.007 	0.068 	0.276 	0.041

74.5

 	0.00556 	0 	0 	0.002 	0.014 	0.091735 	0.011

118.6 	0.018 	0.078 	0.003 	0.005 	0.044 	0.178872 	0.027

US – Tolerance 	0.1 	0.1 	0.1 	0.02 	0.1 	0.4 	0.5

LOQ = 0.01 mg/kg

LOD = 0.003 mg/kg

Dairy Max. Estimated Residue < US Tolerances

Beef Max. Estimated Residue < US Tolerances

* Liver, kidney include parent + RH-1518

Residue on poultry muscle, fat, liver and eggs, were also calculated based on maximum intake from current and proposed treated feed and findings of the feeding study conducted by Rohm & Haas on laying hens (TR-34-00-33) and previously submitted to the agency. The calculation extrapolated residue from the highest dose tested in the feeding study.  A summary of the maximum expected residue in muscle, fat, liver and eggs is presented in Table 3.

Table 3. Estimated Residue in Poultry Food Commodities from Current and Proposed Uses of Methoxyfenozide on Feed-crops

Poultry Feeding  (TR-34-00-33)

Hens

 	eggs 	whole body 	l muscle 	d muscle 	ab fat 	sub fat 	liver *

Dose (ppm) 	mean 	mean 	mean 	mean 	mean 	mean 	mean

0 	0 	 	0 	0 	0 	0 	0

2.37 	ND 	 	ND 	 	ND 	 	0.003

7.58 	0.0057 	 	ND 	 	ND 	 	0.016

23.49 	0.009 	 	ND 	 	ND 	 	0.031

75.2 	0.029 	0 	0.005 	 	0.005 	 	0.098

estimated max. intake)

(

US Tolerance 	0.02 	 	0.02 	 	0.02 	 	0.1

LOQ = 0.01 mg/kg

LOD = 0.003 mg/kg

ND considered at 1/2 LOD

Liver and eggs* includes parent + RH-1518

The maximum level of residues were estimated to be below the current tolerances for all poultry commodities, with the exception of eggs. Considering the overly conservative assumptions of this tier-1 assessment, real exposure in eggs from treated feed, might still comply with the current tolerance.  However, based on the findings of this assessment the current tolerance on eggs is requested to be increased from 0.02 ppm to 0.03 ppm.

The actual dietary food exposure was calculated by the DEEM 2.03 model.  It is a straight tier-I assessment considering residues at tolerance levels for all current and proposed uses.

Consumption patterns include results from CSFII 1994 and 1998 for US-general population and subgroups by age groups from infants to elderly.  The chronic tox-endpoint was the cRfD = 0.1 mg/kg-bw/day, published in the Federal Register of August 31, 2005 (70 FRL-7732-3).  The published FQPA SF = 1x for methoxyfenozide and therefore the cPAD = 0.1 mg/kg/day.  The tier-I exposure was found to occupy up to 24.9% of the chronic population adjusted dose (PAD) for US-general population and 43.1% of PAD for the most highly exposed population subgroup, children 1 to 6 years old.  These results should be viewed as conservative (health protective) risk estimates.  Refinements such as use of percent crop-treated information and/or anticipated residue values would yield lower estimates of chronic dietary exposure. A summary of the findings of the tier-I dietary risk assessment is presented in Table 4.

Table 4.  Chronic Dietary Risk for Methoxyfenozide Current and Proposed Uses as Assessed by DEEM 2.03 (Tier I )

Population Subgroup 	Exposure milligram/kilogram/day (mg/kg/day)  Percent of chronic Population Adjusted Dose   (% cPAD)

U.S. population - (Total) 	0.0249 	24.9

All infants (<1-year) 	0.0278 	27.8

Nursing infants  	0.0141 	14.1

Non-nursing infants 	0.0329 	32.9

Children 1 to 6 years old 	0.0431 	43.1

Children 7 to 12 years old 	0.0263 	26.3

Females 13+ (nursing) 	0.0291 	29.1

Non-Hispanic/non-White/non-Black 	0.0364 	36.5

Percent chronic PAD - (Exposure divided by chronic cPAD) x 100%.  The subgroups listed are:

1. The U.S. population (total)

2. Those for infants and children

3. The most highly exposed of the females sub-groups, in this case Females 13+ (nursing)

4. The most highly exposed of the remaining subgroups, in this case Non-Hispanic/non-white/non-black.

	ii. Drinking Water. There are no water-related exposure data from monitoring to complete a quantitative drinking water exposure analysis and risk assessment for methoxyfenozide.  Screening level exposure levels to water were estimated from EPA’s water models (ref 6).  Index Drinking Water Reservoir model (FIRST) was used to calculate estimated the environmental concentrations (EECs) for surface water.  The screening concentration in ground water was estimated by using the model Screening Concentrations in GROund Water (SCI-GROW), an empirical model based upon actual monitoring data collected for a number of pesticides that serve as benchmarks.  These models take into account the use patterns and the environmental profile of a pesticide, but do not include consideration of the impact that processing 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 at this stage is to provide a coarse screen for assessing whether a pesticide likely to be present in drinking water at concentrations which would exceed human health levels of concern.

A drinking water level of comparison (DWLOC) is the concentration of a pesticide in drinking water that would be acceptable as a theoretical upper limit in light of total aggregate exposure to that pesticide from food, water, and residential uses.  HED uses DWLOCs internally in the risk assessment process as a surrogate measure of potential exposure associated with pesticide exposure through drinking water.  In the absence of monitoring data for a pesticide, the DWLOC is used as a point of comparison against the conservative EECs provided by computer modeling (SCI-GROW, FIRST, GENEEC, PRZM/EXAMS).

a.  Acute exposure and risk.  Because no acute dietary endpoint was established, Dow AgroSciences concludes that there is a reasonable certainty of no harm from acute exposure from drinking water.

b.  Chronic exposure and risk.  Tier I screening-level exposure assessments can be conducted using the simulation models SCI-GROW and FIRST to generate EECs for ground and surface water, respectively.  The modeling was conducted based on the environmental profile and the maximum seasonal application rate proposed across current and proposed labels for Intrepid®: 0.25 lb ai/acre, for maximum 4 applications per season, with at least 7 days intervals.  FIRST was used to generate the surface water EECs, because it is commonly used for tier-I risk assessments.

The EECs estimated in ground-water by Sci-Grow 2.3 for chronic exposureis 2.2 parts per billion (ppb). A summary report as produced by the Sci-Grow 2.3 model is included in Table 5.

Table 5. Summary Report of EEC Estimated in Ground-water by SCI-GROW 2.3.

SciGrow version 2.3  	 	Chemical:methoxyfenozide	 	5/19/2006  14:29:39

Application  rate (lb/acre)    	Number of  applications 	Total Use

(lb/acre/yr) 	Koc

(ml/g)    	Soil Aerobic  metabolism (days)

0.250           	      4.0          	1.000       	2.00E+02   	336.0

 	 	groundwater screening cond (ppb) =   2.26E+00

The concentration for chronic exposure from surface-water was estimated by the screening model FIRST  as an EEC = 15.8 parts per billion (ppb) (based on the FIRST, annual average concentration).  A summary report as produced by FIRST model is presented in Table 6.

Table 6. Summary Report of EEC Estimated in Surface-water by the FIRST model.

   RUN No.   1 FOR methoxyfenozide  ON   veggies, b    * INPUT VALUES *

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

    RATE (#/AC)   No.APPS &   SOIL  SOLUBIL  APPL TYPE  %CROPPED INCORP

     ONE(MULT)    INTERVAL    Koc   (PPM )   (%DRIFT)     AREA    (IN)

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

   .250(   .979)   4   7     200.0    3.3   AERIAL(16.0)  83.0    .0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

    336.00        2          N/A     77.00- 9548.00   150.00    147.68

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB))    Ver 1.0 AUG 1, 2001

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

             63.970                     15.790

The DWLOCs for assessing chronic aggregate dietary risk can be back-calculated by subtracting from the cRfD the amount of the estimated dietary exposure.  A summary of the DWLOC calculated for different sub-population groups is presented in Table 7.

Table 7.  DWLOC for Chronic Exposure from Methoxyfenozide’s Current and Proposed Uses

Population subgroup 	Chronic PAD (mg/kg/ day)  	Food exposure (mg/kg/ day) 	Maximum DW- water exposure (mg/kg/ day) 	DWLOC (mg /L) 	SCI-GROW (mg/L) 	FIRST annual average (mg/L)

U.S. population (total) 	0.1 	0.0249 	0.0751 	2.63 	0.002 	0.016

Females 13+ (nursing) 	0.1 	0.0291 	0.0709 	2.13 	0.002 	0.016

Non-nursing  < 1 year old 	0.1 	0.0329 	0.0671 	0.67 	0.002 	0.016

Children 1-6 years old 	0.1 	0.043 	0.057 	0.57 	0.002 	0.016

Children 7 - 12 years old 	0.1 	0.0263 	0.0737 	0.74 	0.002 	0.016

Notes:

Maximum water exposure (mg/kg/d) = chronic PAD (mg/kg/d) - chronic food exposure (mg/kg/d).

DWLOC (mg/L) = Maximum water exposure (mg/kg/d) x body weight (kg) / water consumed daily (L/Day).

Body weights (kg) for adults is 70, for females 13+ is 60 kg, and for children is 10 kg.

Drinking water consumption is 2 liters per day for adults and 1 liter per day for children.]

The range of the calculated DWLOC varies from 570 ppb for the most highly exposed population subgroup (children 1-6 years old) to 2,630 ppb for the U.S. population (48 contiguous States - all seasons).  Therefore, DWLOC is at least 35 times higher than the EEC estimated in drinking water by high screening level models.

The SCI-GROW and FIRST chronic EECs are lower than the Agency’s level of comparison (the DWLOC value for each population subgroup) for methoxyfenozide residues in drinking water as a contribution to chronic aggregate exposure.  Dow AgroSciences thus concludes with reasonable certainty that residues of methoxyfenozide in drinking water will not contribute significantly to the aggregate chronic human health risk and that the chronic aggregate exposure from methoxyfenozide residues in food and drinking water will not exceed the Agency’s level of concern (100% of the chronic PAD) for chronic dietary aggregate exposure by any population subgroup.  EPA generally has no concern for exposures below 100% of the chronic PAD, because it is a level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to the health and safety of any population subgroup.  This risk assessment is considered high confidence, conservative, and very protective of human health.]

	2. Non-dietary exposure. Methoxyfenozide is not currently registered for use on any residential non-food sites.  Therefore, there is no non-dietary acute, chronic, short- or intermediate-term exposure.

D. Cumulative Effects

	Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether methoxyfenozide has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment.  Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, methoxyfenozide does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, therefore, it is assumed that methoxyfenozide does not have a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. Using the DEEM exposure assumptions described in this unit, Dow AgroSciences has concluded that the aggregate exposure to methoxyfenozide from the current and proposed new tolerances will utilize 24.9% of the chronic PAD for the U.S. population.  If potable water is aggregated to the dietary exposure, at the maximum residue level estimated by EPA’s model FIRST (0.016 ppm), the aggregate exposure to US-population is slightly increasing from 24.9 to 25.3 % PAD. EPA generally has no concern for exposures below 100% of the chronic PAD because the chronic PAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health.  Despite the potential for exposure to methoxyfenozide in drinking water, the aggregate exposure is not expected to exceed 100% of the chronic PAD.  Dow AgroSciences concludes that there is a reasonable certainty that no harm will result to US-general population from aggregate exposure to methoxyfenozide residues.

	2. Infants and children. In assessing the potential for additional sensitivity of infants and children to residues of methoxyfenozide, EPA considered data from developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study in the rat.  The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure during gestation.  Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity.

FFDCA section 408 provides that EPA shall apply an additional ten-fold safety factor 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 determines that a different margin of safety will be safe for infants and children.  Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis, or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.  EPA believes that reliable data support using the standard uncertainty factor (UF = 100 for combined interspecies and intraspecies variability) and no additional safety factor is required for the calculation of MOE for any of the population sub-groups.

The toxicology data base available for methoxyfenozide included acceptable developmental toxicity studies in both rats and rabbits as well as a 2-generation reproductive toxicity study in rats.  The data provided no indication of increased sensitivity of rats or rabbits to in utero and/or postnatal exposure to methoxyfenozide.  There is a complete toxicity data base for methoxyfenozide and the exposure data are complete or are estimated based on data/assumptions that reasonably accounts for potential exposures.  Based on the completeness of the data base and the lack of prenatal and postnatal toxicity, EPA determined that an additional safety factor was not needed for the protection of infants and children (FQPA SF = 1x).

Since no acute toxicological endpoints were established, the acute aggregate risk is considered to be negligible.  Using the exposure assumptions described in this report, Dow AgroSciences has concluded that chronic dietary exposure to methoxyfenozide from the existing and proposed new tolerances will utilize 43.1% of the cPAD for infants and children.  If exposure from drinking water is aggregated to the dietary exposure, at the maximum residue level estimated by EPA’s model FIRST (0.016 ppm), the aggregate exposure to children 1-6 is slightly increasing from 43.1 to 43.5 % PAD. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health.  Despite the potential for exposure to methoxyfenozide in drinking water, Dow AgroSciences does not expect the aggregate exposure to exceed 100% of the cPAD.  Short and intermediate term risks are judged to be negligible due to the lack of significant toxicological effects observed.  Based on these risk assessments, Dow AgroSciences concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to methoxyfenozide residues.

F. International Tolerances

	There are several countries around the globe that have established tolerances/ MRLs for methoxyfenozide. The most extensive list has been published by Codex (25 food commodities). Among others countries, Canada, Australia, Brazil, United Kingdom, and several other European countries have MRL’s established for residues of methoxyfenozide.  A summary of the comparative MRLs from leading countries which establish local MRLs is presented in Table 8. By comparing them, it is concluded that the MRLs established by different agencies are incompatible.  The difference may be originated by diverse good agricultural practices used for efficacious pest control, different guidelines for conducting field crop residue studies and different calculation methods to propose tolerances.  Based on the current situation, the U.S. tolerance levels cannot be re-considered in order to harmonize with MRLs from other countries, and therefore the incompatibility will persist.

Table 8. Comparative International and National MRL’s for Methoxyfenozide as Reported by Homologa Database on 5-18-06.

CTRY 	CROP_GROUP 	CROP 	AMOUNT 	UNIT

BRA 	CEREALS 	CORN 	0.5000	PPM

BRA 	OILSEEDS: SOYBEAN 	SOYBEANS 	0.0500	PPM

BRA 	NON-FOOD: COTTON 	COTTON 	0.5000	PPM

BRA 	VEG: FRUIT-SOLANACEAE 	TOMATOES 	0.1000	PPM

CAN 	FRUIT: POME-FRUIT 	LOQUAT/MEDLAR-JAPANESE 	1.5000	PPM

CAN 	FRUIT: POME-FRUIT 	CRAB-APPLES 	1.5000	PPM

CAN 	FRUIT: MISCELLENIUS 	MAYHAW 	1.5000	PPM

CAN 	FRUIT: POME-FRUIT 	APPLES 	1.5000	PPM

CAN 	FRUIT: POME-FRUIT 	PEARS 	1.5000	PPM

CAN 	FRUIT: POME-FRUIT 	PYRUS-PYRIFOLIA/ORIENTAL-PEAR 	1.5000	PPM

CAN 	FRUIT: POME-FRUIT 	QUINCE 	1.5000	PPM

AUS 	OILSEEDS: OTHER 	COTTONSEED 	3.0000	PPM

AUS 	VEG: FRUIT-SOLANACEAE 	TOMATOES 	3.0000	PPM

GBR 	CEREALS 	CORN 	0.1000	PPM

GBR 	OILSEEDS: SOYBEAN 	SOYBEANS 	1.0000	PPM

GBR 	OILSEEDS: OTHER 	COTTONSEED 	2.0000	PPM

GBR 	FRUIT: POME-FRUIT 	APPLES 	2.0000	PPM

GBR 	FRUIT: POME-FRUIT 	PEARS 	2.0000	PPM

GBR 	FRUIT: STONE-FRUIT 	PEACHES/NECTARINES 	0.5000	PPM

GBR 	FRUIT: MISCELLENIUS 	KIWI 	1.0000	PPM

$

'

=

>

K

V

X

!X

Y

k

v

w

x

‡

’

”

¡

¬

®

¿

Ê

Ë

Ì

Þ

é

ë

ö

"

&

(

[

]

ò

ò

ò

ò

ò

ò

ò

d

d

d

d

	”

kd

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

摧ᓚ"欀걤

	”

	”

摧ᓚ"欀੤

	”

摧ᓚ"欀륤

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

	”

2.0000	PPM

CDX 	VEG: FRUIT-SOLANACEAE 	TOMATOES 	2.0000	PPM

CDX 	VEG: STALK&STEM 	CELERY 	15.0000	PPM

CDX 	VEG: LEAFY&FRESH-HERBS 	LETTUCE-HEAD 	15.0000	PPM

CDX 	VEG: LEAFY&FRESH-HERBS 	LETTUCE-LEAF 	30.0000	PPM

CDX 	FRUIT: GRAPES-TABLE/VINE 	GRAPES: WINE 	1.0000	PPM

]

{<P>}

{<E T=’03'>}

{</E>}

{<P>}

{<E T=’03'>}

{</E>}

{<P>}

{<P>}

{<E T=’03'>}

{</E>}

{<P>