[Federal Register Volume 88, Number 86 (Thursday, May 4, 2023)]
[Notices]
[Pages 28541-28545]
[FR Doc No: 2023-09396]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2022-0223; FRL-10924-01-OCSPP]

Cancellation Order for Certain Chlorpyrifos Registrations and
Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) hereby announces its
final cancellation order for the cancellations and amendments
voluntarily requested by the registrants and accepted by the Agency, of
the products in Table 1 and Table 2 of Unit I, pursuant to the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA). This final
cancellation order follows a December 13, 2022, Federal Register Notice
of Receipt of Requests from the registrants listed in Table 3 of Unit
I, to voluntarily cancel or amend these product registrations. In the
December 13, 2022 notice, EPA indicated that it would issue a final
order implementing the cancellations, unless the Agency received
substantive comments within the 30-day comment period that would merit
its further review of these requests, or unless the registrants
withdrew their requests. The Agency received three comments on the
notice regarding registrations containing the ingredient chlorpyrifos,
which are summarized in Unit III.B. EPA's responses to these comments
and its determination that these comments do not merit further review
of these cancellation and amendment requests are included in Unit
III.C. None of the registrants withdrew their request for these
voluntary cancellations or amendments. Accordingly, EPA hereby grants
the requested cancellations and amendments shown in this cancellation
order. Any distribution, sale, or use of existing stocks of these
products subject to this cancellation order is permitted only in
accordance with the terms of this order.

DATES: The cancellations and amendments are effective May 4, 2023.

FOR FURTHER INFORMATION CONTACT: Patricia Biggio, Pesticide Re-
Evaluation Division (7508M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2022-0223, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.

II. What action is the Agency taking?

    This document announces the cancellations and amendments through
termination of certain uses, as requested by registrants, of products
registered under FIFRA section 3 (7 U.S.C. 136a). These registrations
are listed in sequence by registration number in Table 1 and Table 2 of
this Unit.

                                         Table 1--Product Cancellations
----------------------------------------------------------------------------------------------------------------
            Registration No.                Company No.          Product name             Active ingredients
----------------------------------------------------------------------------------------------------------------
1381-243................................            1381  Tundra Supreme............  Chlorpyrifos Bifenthrin.
62719-34................................           62719  Lorsban 15G...............  Chlorpyrifos.
62719-79................................           62719  LOCK-ON...................  Chlorpyrifos.
62719-220...............................           62719  Lorsban-4E................  Chlorpyrifos.
62719-221...............................           62719  Lorsban 50W in Water        Chlorpyrifos.
                                                           Soluble Packets.
62719-254...............................           62719  Dursban 4E-N..............  Chlorpyrifos.
62719-301...............................           62719  Lorsban 75WG..............  Chlorpyrifos.
62719-353...............................           62719  Dursban F Insecticidal      Chlorpyrifos.
                                                           Chemical.
62719-355...............................           62719  Dursban R Insecticidal      Chlorpyrifos.
                                                           Chemical.
62719-575...............................           62719  Cobalt....................  Chlorpyrifos gamma-
                                                                                Cyhalothrin.
62719-591...............................           62719  Lorsban advanced..........  Chlorpyrifos.
62719-615...............................           62719  Cobalt advanced...........  Chlorpyrifos.
83222-20................................           83222  CPF 4E....................  Chlorpyrifos.
83222-34................................           83222  CPF 15G...................  Chlorpyrifos.
----------------------------------------------------------------------------------------------------------------

                     Table 2--Chlorpyrifos Registrations With Specific Uses To Be Terminated
----------------------------------------------------------------------------------------------------------------
           Registration No.               Company No.          Product name            Uses to be terminated
----------------------------------------------------------------------------------------------------------------
11678-58..............................           11678  Pyrinex Chlorpyrifos       Food uses: Agricultural Crops
                                                         Insecticide.               [Terrestrial Food Crop,
                                                                                Greenhouse Food Crop]:
                                                                                Alfalfa; apple; asparagus;
                                                                                banana; beet (sugar, garden/
                                                                                table, including crops grown
                                                                                for seed); blueberry;
                                                                                Brassica (cole) leafy
                                                                                vegetables (bok choy,
                                                                                broccoli, broccoli raab,
                                                                                Brussels sprouts, cabbage,
                                                                                cauliflower, Chinese
                                                                                cabbage, collards, kale,
                                                                                kohlrabi); caneberries;
                                                                                cherimoya; cherries (sour,
                                                                                sweet); citrus fruits, corn
                                                                                (field corn, sweet corn
                                                                                (including corn grown for
                                                                                seed)); cotton; cranberry;
                                                                                cucumber; date; feijoa; fig;
                                                                                grape; kiwifruit; leek;
                                                                                legume vegetables (succulent
                                                                                or dried), mint; nectarine;
                                                                                onion (dry bulb); peach;
                                                                                peanut; pear; pepper; plum;
                                                                                prune; pumpkin; radish
                                                                                (including crops grown for
                                                                                seed); rutabaga; sapote;
                                                                                seed and pod vegetables;
                                                                                sorghum (milo); strawberry;
                                                                                sugarcane; sunflower; sweet
                                                                                potato; tree nuts, turnip;
                                                                                wheat; seed treatment.
                                                                                Commercial Livestock Housing:
                                                                                Cattle ear tags, poultry
                                                                                houses, turkey barns, swine
                                                                                barns, and dairy barns.
                                                                                Nonfood uses: Tobacco.
66222-19..............................           66222  Chlorpyrifos 4E AG.......  Food uses: Alfalfa, apple
                                                                                tree trunk, asparagus,
                                                                                cherries, citrus fruits
                                                                                (calmondin, chironja, citrus
                                                                                citron, citrus hybrids,
                                                                                grapefruit, kumquat, lemons,
                                                                                limes, mandarin, tangerine,
                                                                                oranges, pummelo, Satsuma
                                                                                mandarin, tangelo, tangor,
                                                                                and other citrus fruit),
                                                                                cranberries, figs, grapes;
                                                                                legume vegetables including
                                                                                adzuki bean, asparagus bean,
                                                                                bean, blackeyed pea, broad
                                                                                bean (dry and succulent),
                                                                                catjang, chickpea, Chinese
                                                                                longbean, cowpea, crowder
                                                                                pea, dwarf pea, edible pod
                                                                                pea, English pea, fava bean,
                                                                                field bean, field pea,
                                                                                garbanzo bean, garden pea,
                                                                                grain lupin, green pea,
                                                                                guar, hyacinth bean,
                                                                                jackbean, kidney bean,
                                                                                lablab bean, lentil, lima
                                                                                bean, moth bean, mung bean,
                                                                                navy bean, pea, pigeon pea,
                                                                                pinto bean, rice bean,
                                                                                runner bean, snap bean, snow
                                                                                pea, southern pea, sugar
                                                                                snap pea, sweet lupin, sword
                                                                                bean, tepary bean, urd bean,
                                                                                wax bean, white lupin, white
                                                                                sweet lupin, yardlong bean;
                                                                                mint (peppermint and
                                                                                spearmint), plums, prunes,
                                                                                nectarines, peaches,
                                                                                almonds, onions, peanuts,
                                                                                pears, sorghum, soybeans,
                                                                                strawberries, sugar beets,
                                                                                sunflowers, sweet potatoes,
                                                                                tree fruits, tree nuts,
                                                                                almonds, filberts, pecans,
                                                                                walnuts; almond, pecan,
                                                                                walnut orchard floors;
                                                                                vegetables, Brassica (cole)
                                                                                leafy vegetable (bok choy),
                                                                                cauliflower, broccoli,
                                                                                Brussels sprouts, cabbage,
                                                                                Chinese cabbage, collards,
                                                                                kale, kohlrabi, turnips,
                                                                                radishes, rutabagas, wheat,
                                                                                cotton; seed treatment.
                                                                                Nonfood uses: Tobacco.

66222-233.............................           66222  Vulcan...................  Food uses: Alfalfa, apple,
                                                                                citrus fruits: calamondin,
                                                                                chironja, citrus citron,
                                                                                citrus hybrids, grapefruit,
                                                                                kumquat, lemons, limes,
                                                                                mandarin (tangerine),
                                                                                oranges, pummelo, Satsuma
                                                                                mandarin, tangelo, tangor,
                                                                                citrus orchard floors, corn
                                                                                (field and sweet) (including
                                                                                corn grown for seed),
                                                                                cotton, cranberries, figs,
                                                                                grapes; legume vegetables,
                                                                                including adzuki bean,
                                                                                asparagus bean, bean,
                                                                                blackeyed pea, broad bean
                                                                                (dry and succulent),
                                                                                catjang, chickpea, Chinese
                                                                                longbean, cowpea, crowder
                                                                                pea, dwarf pea, edible pod
                                                                                pea, English pea, fava bean,
                                                                                field bean, field pea,
                                                                                garbanzo bean, garden pea,
                                                                                grain lupin, green pea,
                                                                                guar, hyacinth bean,
                                                                                jackbean, kidney bean,
                                                                                lablab bean, lentil, lima
                                                                                bean, moth bean, mung bean,
                                                                                navy bean, pea, pigeon pea,
                                                                                pinto bean, rice bean,
                                                                                runner bean, snap bean, snow
                                                                                pea, southern pea, sugar
                                                                                snap pea, sweet lupin, sword
                                                                                bean, tepary bean, urd bean,
                                                                                wax bean, white lupin, white
                                                                                sweet lupin, yardlong bean;
                                                                                mint (peppermint and
                                                                                spearmint), nectarines,
                                                                                peaches, almonds, onions
                                                                                (dry bulb), peanuts, pears,
                                                                                sorghum, soybeans,
                                                                                strawberries, sugar beets,
                                                                                sunflowers, sweet potatoes,
                                                                                tree fruits and nuts:
                                                                                almond, cherry, nectarine,
                                                                                peach, pear, plum, prune,
                                                                                walnut, filberts; almond,
                                                                                pecan, and walnut orchard
                                                                                floors; vegetables:
                                                                                cauliflower, broccoli,
                                                                                broccoli raab, Brussels
                                                                                sprouts, cabbage, Chinese
                                                                                cabbage, collards, kale,
                                                                                kohlrabi, rutabaga, turnips,
                                                                                radish, wheat; seed
                                                                                treatment.
                                                                                Nonfood uses: Tobacco.
----------------------------------------------------------------------------------------------------------------

          Table 3--Registrants of Cancelled or Amended Products
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          EPA company No.                 Company name and address
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11678.............................  ADAMA US, 3120 Highwoods Boulevard,
                                     Suite 100, Raleigh, NC 27604.
66222.............................  ADAMA US, 3120 Highwoods Boulevard,
                                     Suite 100, Raleigh, NC 27604.
62719.............................  Corteva Agriscience, LLC, 9330
                                     Zionsville Road, Indianapolis, IN
                                     46268.
1381..............................  Winfield Solutions, LLC, 1080 County
                                     Rd., F West, MS5705, P.O. Box
                                     64589, St. Paul, MN 55164.
83222.............................  Winfield Solutions, LLC, 1080 County
                                     Rd., F West, MS5705, P.O. Box
                                     64589, St. Paul, MN 55164.
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III. Public Comments

A. Brief History

    In August 2021, EPA issued a rule in the Federal Register on August
30, 2021 (86 FR 48315) (FRL-5993-04-OCSPP) revoking chlorpyrifos
tolerances on the grounds that the chlorpyrifos tolerances were not
safe. Pursuant to the procedures set forth in FFDCA section 408(g)(2),
objections to, requests for evidentiary hearings on those objections,
and/or requests for stays of the Final Rule were filed on or before the
close of the objections period on October 29, 2021. EPA issued an Order
published in the Federal Register on February 28, 2022 (87 FR 11222)
(FRL-5993-05-OCSPP) denying all objections to, requests for hearing on
those objections, as well as requests for stay of the Final Rule (the
Denial Order).
    As a result, chlorpyrifos tolerances expired on February 28, 2022
per the Final Rule. Once the tolerances expired, use of pesticide
products containing chlorpyrifos on food or feed crops would result in
adulterated food, which cannot be sold in interstate commerce. After
EPA alerted registrants of chlorpyrifos products of the lack of
tolerances and the options for their products, several registrants
submitted requests to voluntarily cancel their chlorpyrifos pesticide
products. The notice for this action was published for comment in the
Federal Register on December 13, 2022 (87 FR 76191) (FRL-10469-01-
OCSPP). The 30-day public comment period closed on January 12, 2023.

B. Summary of Comments Received

    During the public comment period, EPA received three comments in
response to the December 13, 2022 notice. The comments can be found in
the docket for this action, identified by docket identification (ID)
number EPA-HQ-OPP-2022-0223, available at https://www.regulations.gov
and are briefly summarized here. One comment was submitted by the
American Sugarbeet Growers Association, U.S. Beet Sugar Association,
and the Beet Sugar Development Foundation. A second comment was
submitted by a private citizen, and a third comment was submitted
anonymously and was not substantive.
    The comment from the American Sugarbeet Growers Association, U.S.
Beet Sugar Association, and the Beet Sugar Development Foundation
opposed the voluntary cancellation of the products in the December 13,
2022 notice of receipt for this action. In particular, these commenters
specified concerns that the voluntary cancellation of chlorpyrifos
registrations and termination of certain uses is premature while there
is ongoing litigation regarding the Final Rule and Denil Order in the
United States Court of Appeals for the Eighth Circuit, Red River Valley
Sugarbeet Growers Ass'n et al., v. Regan, et al., Nos. 22-1422, 22-1530
(8th Cir.). These commenters also specified concerns that sugarbeet
growers will suffer irreparable harm because the loss of chlorpyrifos
as a pest management tool will result in substantial increased costs,
lost profits, decreased crop yields, and a larger environmental impact
from more frequent use of less effective alternatives.
    The comment from the private citizen specified concerns about
allowing the export of chlorpyrifos outside of the

United States as well as purchasing produce and foodstuffs that may
have been treated with substances that are prohibited from application
to food in the United States, like chlorpyrifos.

C. EPA Response to Comments

    Regarding the comments submitted by the American Sugarbeet Growers
Association, U.S. Beet Sugar Association, and the Beet Sugar
Development Foundation, the cancellations and amendments requested by
the registrants listed in Table 3 are appropriate at this time because
registrants have a right under section 6(f)(1) of FIFRA to at any time
request that EPA cancel or amend their registrations to terminate one
or more uses. 7 U.S.C. 136d(f)(1)(A). The registrant may request
voluntary cancellation of a pesticide product registration at any time
for many reasons, including lack of interest in maintaining the
registration or the pesticide no longer being marketed.
    EPA cannot compel registrants to maintain a registration
indefinitely if they request to voluntarily cancel it. The resolution
and timing of the litigation in the Eighth Circuit is unknown, and
therefore, retention of the registrations could subject registrants to
additional maintenance fees and responsibilities for those
registrations, for which the registrants requested cancellation or
amendment. See, e.g., 40 CFR part 152, subpart G (registrant
responsibilities); 7 U.S.C. 136a-1(i)(1) (maintenance fee obligations);
7 U.S.C. 136e (production reporting requirements); 7 U.S.C. 136f
(recordkeeping requirements).
    Moreover, retention of these registrations will not make
chlorpyrifos products available for use as the commenters desire. EPA
issued a rule in the Federal Register revoking chlorpyrifos tolerances
on August 30, 2021 (86 FR 48315) (FRL-5993-04-OCSPP). Chlorpyrifos
tolerances expired six months later with the issuance of the Order
published in the Federal Register on February 28, 2022 (87 FR 11222)
(FRL-5993-05-OCSPP). The revocation of the tolerances means that
application of chlorpyrifos to food crops will result in adulterated
food which cannot be shipped in interstate commerce. While cancellation
of the 14 products in Table 1 and amendment of three products in Table
2 does not terminate the last of the chlorpyrifos products registered
in the United States, these products (and other remaining chlorpyrifos
products) cannot be applied to food crops that will be shipped in
interstate commerce.
    Regarding the comment from the private citizen, EPA regulates both
the import and export of pesticides, but the Agency does not have
jurisdiction over the use of pesticides outside of the United States.
FIFRA Section 17(a) allows for the distribution of unregistered
pesticides produced solely for export, as long as certain conditions
are met (7 U.S.C. 136o(a)). Otherwise, all registered pesticides that
are exported to other countries must bear the product label approved by
EPA. For additional information on importing or exporting chlorpyrifos,
please consult EPA's web page on Importing and Exporting Pesticides at
https://www.epa.gov/pesticides/international-activities-related-pesticides.
    Any pesticide residues in or on food that is imported into the
United States must be covered by a tolerance or exemption from the
requirement of a tolerance, just the same as any pesticide residues
applied to food in the United States. Since there are no current
tolerances for residues of chlorpyrifos in or on food, food containing
chlorpyrifos residues cannot be imported into the United States, unless
the chlorpyrifos residues on that food fall within the Channels of
Trade guidance for chlorpyrifos residues that the U.S. Food and Drug
Administration (FDA) released last year. This guidance is available at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-channels-trade-policy-human-food-commodities. FDA has stated in its channels of
trade policy that it intends to subject the importation of any food
bearing a residue (within the former tolerance) of a pesticide chemical
for which a tolerance has been revoked, suspended, or modified to the
same enforcement approach as for domestic food.
    For the reasons above, EPA has determined that these comments do
not merit further review or a denial of the cancellations and
amendments described in Tables 1 and 2 of Unit I.

IV. The Cancellation Order

    Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)(1)), EPA hereby
approves the requested cancellations and amendments of the
registrations identified in Table 1 and Table 2 of Unit I. Accordingly,
the Agency hereby orders that the product registrations identified in
Table 1 of Unit I. are cancelled.
    The cancellations and amendments addressed in this Order are
effective May 4, 2023. Any distribution, sale, or use of existing
stocks of the products identified in Tables 1 and 2 of Unit I. in a
manner inconsistent with any of the provisions for disposition of
existing stocks set forth in Unit V. will be a violation of FIFRA.

V. What is the Agency's authority for taking these actions?

    Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a
registrant of a pesticide product may at any time request that any of
its pesticide registrations be cancelled or amended to terminate one or
more registered uses. FIFRA further provides that, before acting on the
request, EPA must publish a notice of receipt of any such request in
the Federal Register.
    Section 6(f)(1)(B) of FIFRA (7 U.S.C. 136d(f)(1)(B)) requires that
before acting on a request for voluntary cancellation, EPA must provide
a 30-day public comment period on the request for voluntary
cancellation or use termination. Following the public comment period,
the EPA Administrator may approve such a request. The notice for this
action was published for comment in the Federal Register on December
13, 2022 (87 FR 76191) (FRL-10469-01-OCSPP). The 30-day public comment
period closed on January 12, 2023.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action.
    Because all chlorpyrifos tolerances expired on February 28, 2022,
use of chlorpyrifos in or on food will result in adulterated food,
which cannot be delivered into interstate commerce. Such use would be
inconsistent with the provisions of FIFRA. EPA is allowing use of
existing stocks of chlorpyrifos products identified in Tables 1 and 2
until those existing stocks are exhausted, only for non-food uses
identified on the existing labels, as long as such use is consistent
with the label. All other use of existing stocks of these chlorpyrifos
products are prohibited.
    None of the registrants listed in this order have requested any
continued sale of existing stocks of the registrations subject to this
cancellation order; however, Adama and Corteva have requested that EPA
allow for the return of existing stocks that are in the hands of end
users and distributors to the respective registrant. Because sale and
distribution of chlorpyrifos products for use on food is inconsistent
with the purposes of FIFRA, all sale and distribution of the
chlorpyrifos products identified in Table 1 and Table 2 of Unit

I. is prohibited, except for export consistent with FIFRA section 17 (7
U.S.C. 136o); for proper disposal; or consistent with the terms of the
individual return program agreements EPA has approved for Adama and
Corteva. The return program agreements were approved by the Agency on
April 19, 2023. Adama and Corteva were notified of the approval of
their return program agreements on April 20, 2023.
    Additional information regarding chlorpyrifos return programs for
Adama and Corteva may be found in https://www.regulations.gov/docket/EPA-HQ-OPP-2021-0523 or by contacting the registrants at: Adama (866)
406-6262; [email protected] and Corteva<PHONE_NUMBER>.

    Dated: April 28, 2023.
Mary Elissa Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2023-09396 Filed 5-3-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69731-69732]
[FR Doc No: 2013-27759]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70879; File No. SR-Phlx-2013-108]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
an Extension of a Pilot Program for SPY Position and Exercise Limits

November 14, 2013.
    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 5, 2013, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``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 extend the pilot program for another
fourteen (14) month time period, which was set to expire fourteen
months after approval, to eliminate position limits for options on the
SPDR[supreg] S&P 500[supreg] exchange-traded fund (``SPY ETF'' or
``SPY''),\3\ which list and trade under the symbol SPY (``SPY Pilot
Program'').
---------------------------------------------------------------------------

    \3\ ``SPDR[supreg],'' ``Standard & Poor's[supreg],''
``S&P[supreg],'' ``S&P 500[supreg],'' and ``Standard & Poor's 500''
are registered trademarks of Standard & Poor's Financial Services
LLC. The SPY ETF represents ownership in the SPDR S&P 500 Trust, a
unit investment trust that generally corresponds to the price and
yield performance of the SPDR S&P 500 Index.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings,
at the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the 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
    The purpose of the proposed rule change is to amend Rule 1001,
entitled ``Position Limits,'' to extend the current pilot which expires
on December 4, 2013 for an additional fourteen (14) month time period
to February 4, 2015 (``Extended Pilot''). At this time, not all self-
regulatory organizations (``SROs'') have adopted similar rules
eliminating position limits on SPY. As a result, market participants
that are members of such SROs are required to comply with the more
restrictive SPY position limits and there has been no trading on Phlx
wherein a position limit has not applied with respect to SPY.
    This filing does not propose any substantive changes to the SPY
Pilot Program. In proposing to extend the SPY Pilot Program, the
Exchange reaffirms its consideration of several factors that supported
the original proposal of the SPY Pilot Program, including (1) the
availability of economically equivalent products and their respective
position limits; (2) the liquidity of the option and the underlying
security; (3) the market capitalization of the underlying security and
the related index; (4) the reporting of large positions and
requirements surrounding margin; and (5) the potential for market on
close volatility.
    The Exchange also states that it is not filing a report with this
extension request, which report is due at this time pursuant to the
current pilot.\4\ As noted above, the Exchange does not have any data
to report because as explained herein there has been no trading on its
market wherein a position limit has not applied with respect to SPY.
---------------------------------------------------------------------------

    \4\ The Exchange noted in its original SPY Pilot Program that it
would file a report analyzing the first twelve months of the SPY
Pilot Program within thirty (30) days of the end of the twelve (12)
month time period (``Pilot Report''). See Securities Exchange Act
Release No. 67999 (October 5, 2012), 77 FR 62295 (October 12, 2012)
(SR-Phlx-2012-122).
---------------------------------------------------------------------------

    As with the original proposal to establish the SPY Pilot Program,
the Exchange represents that a Pilot Report will be submitted within
thirty (30) days of the end of the first twelve (12) month time period
of the Extended Pilot and would analyze that period. The Pilot Report
will detail the size and different types of strategy employed with
respect to positions established as a result of the elimination of
position limits in SPY. In addition, the report will note whether any
problems resulted due to the no limit approach and any other
information that may be useful in evaluating the effectiveness of the
Extended Pilot. The Pilot Report will compare the impact of the SPY
Pilot Program, if any, on the volumes of SPY options and the volatility
in the price of the underlying SPY shares, particularly at expiration
during the Extended Pilot. In preparing the report the Exchange will
utilize various data elements such as volume and open interest. In
addition the Exchange will make available to Commission staff data
elements relating to the effectiveness of the Spy Pilot Program.
    Conditional on the findings in the Pilot Report, the Exchange will
file with the Commission a proposal to extend the pilot program, adopt
the pilot program on a permanent basis or terminate the pilot. If the
Pilot Program is not extended or adopted on a permanent basis by the
expiration of the Extended Pilot, the position limits for SPY would
revert to limits in effect at the commencement of the SPY Pilot
Program.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \5\ in general, and furthers the objectives of Section
6(b)(5) of the Act \6\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, 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.
---------------------------------------------------------------------------

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

    The Exchange believes that its proposal to extend the SPY Pilot
Program would be beneficial to market participants, including market
makers, institutional investors and retail investors, by permitting
them to establish greater positions when pursuing their investment
goals and needs.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

In this regard and as indicated above, the Exchange notes that the rule
change is being proposed as a competitive response to similar filings
by other options exchanges. The Exchange believes this proposed rule
change is necessary to permit fair competition among the options
exchanges and to establish uniform positions for a multiply listed
options class.

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

    No written comments were either solicited or received.

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

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

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

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \9\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \10\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay. The
Exchange believes that waiver of the 30-day operative delay is
appropriate and will benefit market participants because immediate
operability will allow the SPY Pilot Program to continue without
interruption. The Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest. Therefore, the Commission hereby waives the 30-day operative
delay and designates the proposal operative upon filing.\11\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ 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 the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2013-108 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 Number SR-Phlx-2013-108. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2013-108 and should be
submitted on or before December 11, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-27759 Filed 11-19-13; 8:45 am]
BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: October 06, 2005 SUBJECT: Imazaquin: Residential Exposure Assessment and Recommendations for the Tolerance Reassessment Eligibility Decision ( TRED)

FROM: Seyed Tadayon, Chemist Reregistration Branch III Health Effect Division ( 7509C)

THRU: William Donovan, Acting Branch Senior Scientist Reregistration Branch III Health Effect Division ( 7509C)

TO: Susan Stanton, Risk Assessor Reregistration Branch III Health Effect Division ( 7509C)

PC Code: 128848 DP Barcode: D302942 The attached assessment shows the non occupational ( residential) exposure and risk estimates for imazaquin to support HED's tolerance reassessment eligibility decision ( TRED). Page 2 of 25 Table of Contents 1.0 EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2.0 BACKGROUND INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2.1 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2.2 Criteria for Conducting Exposure Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2.3 Summary of Toxicity Concerns Related to Residential Exposures . . . . . . . . . . . . . . . . . 4 2.4 FQPA Safety Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.5 Incident Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 2.6 Summary of Physical and Chemical Properties of imazaquin . . . . . . . . . . . . . . . . . . . . . 7 2.7 Summary of Use Pattern and Formulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3.0 RESIDENTIAL EXPOSURE AND RISKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3.1 Residential Handler Exposures and Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3.1.1 Handler Exposure Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3.1.2 Data and Assumptions For Handler Exposure Scenarios . . . . . . . . . . . . . . . . . . 8 3.1.3 Residential Handler Exposure and Non Cancer Risk Estimates . . . . . . . . . . . . 10 3.1.4 Residential Handler Exposure and Risk Estimates for Cancer . . . . . . . . . . . . . 11 3.1.5 Summary of Risk Concerns and Data Gaps for Handlers . . . . . . . . . . . . . . . . 11 3.1.6 Recommendations For Refining Residential Handler Risk Assessment . . . . . . . 11 3.2 Residential Postapplication Exposures and Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 3.2.1 Residential Postapplication Exposure Scenarios . . . . . . . . . . . . . . . . . . . . . . . 12 3.2.2 Data and Assumptions for Residential Postapplication Exposure Scenarios . . . 12 3.2.3 Residential Postapplication Exposure and Noncancer Risk Estimates . . . . . . . 13 3.2.4 Residential Postapplication Exposure and Risk Estimates for Cancer . . . . . . . 17 3.2.5 Summary of Residential Postapplication Risk Concerns and Data Gaps . . . . . 17 3.2.6 Recommendations For Refining Residential Postapplication Risk Assessment . 17 3.3 Spray Drift from Agricultural Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Page 3 of 25 1.0 EXECUTIVE SUMMARY This document supports the Tolerance Reassessment Eligibility Decision ( TRED) for imazaquin and addresses risks resulting from non occupational ( residential) exposures only. Occupational exposures will not be addressed in this document.

At this time, products containing imazaquin are intended for both occupational and nonoccupational uses. Imazaquin is a selective herbicide used in the post emergent control of grasses in agricultural, ornamental, residential and recreational ( golf courses) settings. Imazaquin has occupational uses that will not be addressed in this TRED. The imazaquin end use products are formulated as liquid concentrates and ready to use liquids formulations.

In residential settings, imazaquin is used on residential turfgrass, on ornamentals, and for golf courses. The current maximum application rate for application to residential turfgrass is 0.5 pounds active ingredient per acre by lawn care operators ( LCOs), and 0.38 pounds active ingredient per acre by homeowner application. The maximum application rate for application to residential ornamentals and turf spot treatment is 0.006 pounds active ingredient per gallon.

Short term exposures ( defined as exposures from 1 to 30 days in duration) may occur for residents applying imazaquin products and for residents exposed to imazaquin following applications in residential settings. Intermediate and long term exposures are not anticipated for residential handling or postapplication exposures. For short, intermediate and long term dermal and inhalation a NOAEL of 25 mg/ kg/ day ( 1000 ppm) based on body weight loss, clinical chemistry/ hematology differences, slight anemia and the presence of skeletal muscle myopathy at a dose of 125 mg/ kg/ day ( 5000 ppm) was selected. For inhalation assessment, 100% absorption of inhaled imazaquin in the atmosphere is assumed. For dermal assessment, 50% dermal absorption is assumed. The same end point ( 25 mg/ kg/ day) was selected for incidental oral ingestion.

The exposure and risk for residential handlers were assessed using the revised draft Standard Operating Procedures ( SOPs) for Residential Exposure Assessment and the 2001 Recommended Revisions by the Science Advisory Council for Exposure ( Policy # 12). Exposures were estimated using surrogate unit exposure values from the Outdoor Residential Exposure Task Force ( ORETF) data base.

Short term postapplication exposures may occur following applications at residential sites. Residential exposures were estimated based on HED's 1997 draft Standard Operating Procedures for Residential Exposure Assessments and the 2001 Recommended Revisions by the Science Advisory Council for Exposure ( Policy # 12). Short term risks estimated for Handler and postapplication exposure do not exceed HED's level of concern for any of the assessed scenarios.

2.0 BACKGROUND INFORMATION Page 4 of 25 2.1 Purpose This document supports the Tolerance Reassessment Eligibility Decision ( TRED) document for imazaquin and addresses risks resulting from non occupational ( residential) exposures only. Occupational exposures and risks are not addressed in this document.

2.2 Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For imazaquin, both criteria are met.

2.3 Summary of Toxicity Concerns Related to Residential Exposures Short term Dermal and inhalation ( non cancer)

Short term exposures ( defined as exposures from 1 to 30 days in duration) may occur for residents applying imazaquin products and for residents exposed to imazaquin following applications in residential settings. For short  term dermal and short term inhalation a NOAEL of 25 mg/ kg/ day ( 1000 ppm) based on body weight loss, clinical chemistry/ hematology differences, slight anemia and the presence of skeletal muscle myopathy at a dose of 125 mg/ kg/ day ( 5000 ppm) was selected. For inhalation assessment, 100% absorption of the inhaled imazaquin in the atmosphere is assumed. For dermal assessment, 50% dermal absorption is assumed.

Intermediate term and Long term ( Chronic) Dermal and Inhalation ( noncancer)

The same endpoint of concern was chosen for intermediate term and long term dermal and inhalation exposures as was chosen for short term dermal and inhalation exposures. No Intermediate term or long term exposures are expected for residential use patterns, therefore, no risks were assessed.

Short term Oral Ingestion ( non cancer)

For short  term oral ingestion assessment a NOAEL of 25 mg/ kg/ day ( 1000 ppm) based on body weight loss, clinical chemistry/ hematology differences, slight anemia and the presence of skeletal muscle myopathy at a dose of 125 mg/ kg/ day ( 5000 ppm) was selected.

Dermal Absorption A dermal penetration study was not available. When the NOAEL of 1000 mg/ kg/ day for the rabbit 21 day dermal toxicity study was compared with the LOAEL for body weight effects in the rabbit oral prenatal developmental toxicity study a crude estimate of 50% dermal absorption was made. It is noted that a LOAEL for the rabbit oral study is being compared with a NOAEL Page 5 of 25 for a dermal study when LOAEL for both studies should normally be compared. However, since no LOAEL for the rabbit dermal study was established, the highest dose tested ( 1000 mg/ kg/ day) is being compared for a conservative estimate based on the possibility that toxicity may develop at doses slightly higher than the NOAEL. Otherwise the default assumption of 100% dermal absorption would have to be assumed for imazaquin since there is no dermal absorption study.

Non cancer Level of Concern ( LOC)

HED's level of concern for imazaquin exposures is 100   a margin of exposure ( MOE) less than 100 exceeds HED's level of concern for residential scenarios. The level of concern is based on 10X to account for interspecies extrapolation to humans from the animal test species and 10X to account for intraspecies sensitivity.

Aggregation The dermal and inhalation margins of exposure were combined for the imazaquin risk assessment, because the toxicity endpoints for the dermal and inhalation routes of exposure are the same.

Cancer Imazaquin is classified as not likely to be carcinogenic to humans, based on the lack of evidence of carcinogenicity in mice rats or dogs.

Acute Toxicity Imazaquin is classified as category IV for acute oral, and category III for dermal, and inhalation toxicity. It is classified as category IV for eye irritation potential and skin irritation potential. Results were negative for dermal sensitization in guinea pigs.

Table 1 Acute Toxicity Profile  Imazaquin Guideline No. Study Type MRID( s) Results Toxicity Category 870.1100 Acute oral [ rat] 00144178* 00144180* 00144617* LD50 = > 5000 mg/ kg IV 870.1200 Acute dermal [ rabbit] 00144178* 00144180* 00144617* LD50 > 2000 mg/ kg III 870.1300 Acute inhalation [ rat] 00073679* > 5.5 mg/ L ( 4 hours) III Page 6 of 25 870.2400 Acute eye irritation [ rabbit] 00144178* 00144180* 00144617* Non irritating IV 870.2500 Acute dermal irritation [ rabbit] 00144178* 00144180* 00144617* Mildly irritating IV 870.2600 Skin sensitization [ guinea pig] 00073680* Negative  not a sensitizer A summary of toxicological endpoints for imazaquin is presented in Table 2.

Table 2. Summary of Toxicological Doses and Endpoints for Imazaquin Use in Human Residential Risk Assessments Exposure Scenario Dose Used in Risk Assessment, UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Incidental Oral Short Term ( 1  30 days) NOAEL = 25 mg/ kg/ day acceptable MOE = 100 ( residential, FQPA SF = 1). Chronic toxicity  dog LOAEL = 125 mg/ kg/ day based on weight loss, slight anemia, evidence of skeletal muscle myopathy and supporting hematology/ clinical chemistry differences Incidental Oral Intermediate Term ( 1  6 months) NOAEL = 25 mg/ kg/ day acceptable MOE = 100 ( residential, FQPA SF = 1) Same as above Dermal  all exposures. NOAEL = 25 mg/ kg/ day. Assume 50% dermal absorption. acceptable MOE = 100 Same as above Inhalation  all exposures. NOAEL = 25 mg/ kg/ day Assume 100% absorption. acceptable MOE = 100 ( occupational) acceptable MOE = 100 ( residential, FQPA SF = 1) Same as above Cancer ( oral, dermal, inhalation) Classification: no evidence of carcinogenicity in mice or rats. " Not Likely To Be Carcinogenic To Humans" was evaluated by imazaquin risk assessment team.

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, MOE = margin of exposure.

2.4 FQPA Safety Factor The imazaquin risk assessment team evaluated the potential for increased susceptibility of infants and children from exposure to imazaquin as required by the Food Quality Protection Act Page 7 of 25 ( FQPA) of 1996 according to the 2002 OPP 10x Guidance Document. Based on the hazard data, the team concluded that the special FQPA SF can be removed ( 1X), since there are no concerns and not residual uncertainties for pre and/ or postnatal toxicity.

2.5 Incident Reports See a separate memo from J Blondell 2.6 Summary of Physical and Chemical Properties of Imazaquin See product chemistry chapter.

2.7 Summary of Use Pattern and Formulations Imazaquin is formulated as soluble concentrate and ready to use liquid concentrate. It is registered for use in a variety of agricultural, occupational and residential scenarios. However, this assessment addresses risk resulting from non occupational ( residential) exposures only. Occupational exposures will not be addressed in this document. Imazaquin is registered for use by residential applicators therefore, risks to residential handlers will be assessed as well as postapplication risks to residential populations. Table 3 summarizes the use patterns that could impact nonoccupational ( residential) populations.

Table 3. Summary of Maximum Application Rates for Imazaquin Uses in Residential Settings Target Application Rate Application Equipment Area Treated Daily Commercial Uses at Residential Sites Lawn Turf* 0.38 lb ai/ A Garden Hose end sprayer 0.5A Ornamental or shade trees 0.006 lb ai/ gal Hand Held Pump Sprayer 1 gal Lawn Turf ( spot treatment) 0.006 lb ai/ gal Ready to Use Sprayer 1 gal * For all post application activities an application rate of 0.5 lb ai/ A ( commercial rate applied by LCOs) is used in this assessment.

3.0 RESIDENTIAL EXPOSURE AND RISKS Residential Handler Exposures and Risks 3.1.1 Handler Exposure Scenarios It has been determined that exposure to pesticide handlers is likely during the residential use of imazaquin in a variety of outdoor environments, including on lawns and ornamentals. The anticipated use patterns and current labeling indicate several residential handler exposure scenarios based on the types of equipment and techniques that can potentially be used to make Page 8 of 25 imazaquin applications. The quantitative exposure/ risk assessment developed for residential handlers is based on these scenarios.

Mixer/ Loader/ Applicators: ( 1) Liquid Concentrate: Hose end Sprayer ( ORETF data) ( 2) Liquid Concentrate: Hand Held Pump Sprayer ( ORETF data) ( 3) Liquid Concentrate: Ready to Use Sprayer ( ORETF data)

3.1.2 Data and Assumptions For Handler Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing the residential handler risk assessments. Each assumption and factor is detailed below. In addition to these factors, unit exposure values were used to calculate risk estimates. Mostly, the unit exposure value was taken from the Outdoor Residential Exposure Task Force ( ORETF) studies Assumptions and Factors: The assumptions and factors used in the risk calculations include:

C HED always considers the maximum application rates allowed by labels in its risk assessments. If additional information such as average or typical rates are available, these values also may be used to allow risk managers to make a more informed risk management decision. Average/ typical application rates were not available for residential scenarios.

C Residential risk assessments are based on estimates of what homeowners would typically treat, such as the size of a lawn. The factors used for the imazaquin assessment were from the Health Effects Division Science Advisory Committee Policy 12: Recommended Revisions To The Standard Operating Procedures For Residential Exposure Assessment which was completed on February 22, 2001, and on professional judgement. The daily volumes handled and area treated used in each residential scenario are provided in Table 3.

Residential Handler Exposure Studies: No chemical specific data were submitted for use in the residential handler risk assessment. The unit exposure values that were used in this assessment were based on PHED database and Outdoor Residential Exposure Task Force studies. Summaries of the studies are presented below:

ORETF Hose End Sprayer Study: A mixer/ loader/ applicator study was performed by the Outdoor Residential Exposure Task Force ( ORETF) using diazinon as a surrogate compound to determine " generic" exposures to individuals applying a pesticide to turf with a dial type hose end sprayer. Dermal and inhalation exposures were estimated using whole body passive dosimeters and breathing zone air samples on OVS tubes. Inhalation exposure was calculated using an assumed respiratory rate of 17 liters per minute for light work ( NAFTA, 1999), the actual sampling time for each individual, and the pump flow rate. All results were normalized for Page 9 of 25 pounds active ingredient handled. A total of 30 replicates were monitored throughout the study. Diazinon ( 25% emulsifiable concentrate) was applied by homeowners to actual residential lawns at a site in Maryland. A target application rate of 4 pounds active ingredient was used for all replicates. Each replicate monitored the test subject treating 5,000 ft2 of turf and handling a total of 0.5 lb ai/ replicate. The exposure periods ( mixing/ loading/ applying) averaged seventy five minutes. Dermal exposure was measured using inner and outer whole body dosimeters, hand washes, face/ neck washes, and personal air monitoring devices. In general, concurrent lab spikes produced mean recoveries in the range of 87 103 percent. Adjustment for recoveries from field fortifications ( 79 104%) were performed on each dosimeter section or sample matrix for each study participant, using the mean recovery for the closest field spike level for each matrix and correcting the value to 100 percent. The unit exposures are presented below in Table 4. [ Note the data were found to be lognormally distributed. As a result, all exposures are geometric means.]

Table 4: Unit Exposures Obtained From ORETF Hose End Sprayer Studies ( MRID 449722 01)

Type Dermal: Short Pants, Short Sleeves ( mg ai/ lb handled) Inhalation ( µ g ai/ lb handled)

Hose end ( Mix your own) 11 17 All unit exposures are geometric means.

ORETF Hand Held Pump Sprayer ( MRID # 444598 01): The data collected reflect the dermal and respiratory exposure of homeowners mixing, loading and applying RP 2 Liquid ( 21%), a carbaryl end use product. Applications were made by volunteers to two 18 foot rows of tomatoes and one 18 foot row of cucumber. The only test field was located in Florida. For this study, RP 2 Liquid ( 21%) exposures were monitored using hose end sprayers and low pressure handwand sprayers. Exposures to Sevin ® 10 Dust, using a separate duster device that required transfer from the package and Sevin ® Ready To Use Insect Spray ( RTU) in a trigger sprayer package were also monitored. Exposure for each spray method/ product combination was monitored using 40 handlers ( replicates). Of the 40 replicates per spray method/ product combination, 20 wore household latex gloves and 20 performed tasks without gloves. The 20 dust product replicates loaded the dusters and applied without gloves only.

Each replicate opened the end use product, added it to the application implement ( except the RTU product), adjusted the setting and applied it to the vegetable rows. After application to the vegetable rows, dosimeters were collected. Inhalation exposure was monitored with personal air sampling pumps with OVS tubes attached to the shirt collar in the breathing zone. Dermal exposure was assessed by extraction of carbaryl from inner and outer 100 percent cotton dosimeters, face/ neck wipes, and glove and hand washes. The inner and outer dosimeters were segmented into: lower and upper arms, lower and upper legs, front and back torso.

Field fortification recoveries for passive dosimeters averaged 84.3 percent for inner and 77.7 percent for outer dosimeters. Face and neck wipe fortifications average 84.8 percent. Handwash and Inhalation OVS tube field fortification averaged > 90 percent. Inner and outer Page 10 of 25 dosimeter and face and neck wipe residues were adjusted for field fortification results. Handwash and inhalation residues were not adjusted.

Laboratory method validation for each matrix fell within the acceptable range of 70 to 120 percent. The limit of quantitation ( LOQ) was 1.0 µ g/ sample for all media except the inhalation monitors where the LOQ was 0.01 µ g/ sample. The limit of detection ( LOD) was 0.5 µ g/ sample for all media except the inhalation monitors where the LOD was 0.005 µ g/ sample.

Dermal exposure was determined by adding the values from the bare hand rinses, face/ neck wipes to the outer dosimeter lower legs and lower arms plus the inner dosimeter front and rear torso, upper legs, lower legs, lower arms, and upper arms. This accounts for the residential handlers with barehands wearing short sleeved shirt and short pants. Unit exposures for this scenario in each application method are presented below in Table 5. [ Note: The geometric mean values were used for risk assessment purposes.]

Table 5: Unit Exposure Values Obtained From ORETF Study ( ( MRID 444598 01)

Scenario Monitored Dermal Unit Exposure ( mg ai/ lb handled) Inhalation Unit Exposure ( µ g ai / lb handled)

Hand Held Pump Spray 38 9 Ready to Use Spray 54 67 All unit exposures are geometric means.

3.1.3 Residential Handler Exposure and Non Cancer Risk Estimates Residential risk assessments must include the determination of an appropriate Food Quality Protection Act ( FQPA) safety factor to be applied to the overall safety factor or level of concern. In the case of imazaquin, it was decided that the factor should be 1X. Therefore, the overall uncertainty factor applied to imazaquin for residential handler risk assessments is 100, which is based on the FQPA safety factor of 1X along with the 10X for inter species extrapolation, and the 10X for intra species sensitivity.

Dermal and inhalation potential doses for residential handlers are calculated as follows:

Exposure Dose ( mg/ kg/ day) = UE x AR x A x AB BW Where, UE = unit exposure from ORETF study data ( mg/ lb ai or µ g/ lb ai) AR = maximum application rate ( lb ai/ acre or lb ai/ gal) A = maximum area treated ( acres/ day or gal/ day) AB = absorption value ( Dermal absorption 50% inhalation absorption = 100%) BW = body weight ( 70 kg)

For handler short term exposure, the margin of exposure ( MOE) was calculated as follows:

Inhalation MOE = NOAEL ( 25 mg/ kg/ day) Page 11 of 25 Inhalation Exposure Dose Dermal MOE= NOAEL ( 25 mg/ kg/ day) Dermal Exposure Dose MOE TOTAL = 1 ( 1/ Dermal MOE ) + ( 1/ Inhalation MOE)

Noncancer Risk Summary: All of the noncancer risk calculations for residential imazaquin handlers completed in this assessment are included in Table 6. The results of the residential handler noncancer risk assessment indicate that none of the residential handler risks exceed HED's level of concern ( i. e., MOEs are all greater than 100).

Table 6: Summery of Residential Handler Noncancer Risks from Imazaquin Exposure Scenario Target Application Rate Area Treated Daily MOE ( HED's level of concern = 100)

Dermal Inhalation Dermal + Inhalation Mixer/ Loader/ Applicator Mixing/ Loading/ Applying Liquid Concentrates with Hose End Sprayer ( Residential ORETF data) ( 1) Turf 0.38/ A 0.5 acre 1700 550000 1700 Mixing/ Loading/ Applying Liquid Concentrates with a Hand Held Pump ( ORETF ) sprayer( 2) Ornamental or shade trees 0.006 lb ai/ gal 1 gal 15400 12500000 15400 Applying Ready to Use sprayer ( ORETF)( 3) Turf 0.006 lb ai/ gal 1 gal 11000 15625000 11000 3.1.4 Residential Handler Exposure and Risk Estimates for Cancer Residential handler cancer risks are not assessed, since no toxicological endpoint of concern for cancer was selected.

3.1.5 Summary of Risk Concerns and Data Gaps for Handlers Noncancer risks ( i. e., MOEs) associated with the residential handler scenarios do not exceed HED's level of concern of 100.

HED has no data to assess exposures from applications using a sprinkling can. Therefore, ORETF residential hose end data were used in the assessment as a surrogate.

3.1.6 Recommendations For Refining Residential Handler Risk Assessment In order to refine this residential risk assessment, more data on actual use patterns including rates, timing, and areas treated would better characterize imazaquin risks.

3.2 Residential Postapplication Exposures and Risks Page 12 of 25 HED uses the term " postapplication" to describe exposures to individuals that occur as a result of being in an environment that has been previously treated with a pesticide. Imazaquin can be used in many areas that can be frequented by the general population including residential areas ( e. g., home lawns). As a result, individuals can be exposed by entering these areas if they have been previously treated.

3.2.1 Residential Postapplication Exposure Scenarios Individuals of varying ages can potentially be exposed to imazaquin when they are in areas that have been previously treated. Postapplication exposure scenarios were developed for each residential setting where imazaquin can be used. The scenarios assessed include:

Residential Adults: these individuals are members of the general population that are exposed to chemicals by engaging in activities at their residences ( e. g., in their lawns) and also in areas not limited to their residence ( e. g., golf courses or parks) previously treated with a pesticide. These kinds of exposures are attributable to a variety of activities and are usually addressed by HED in risk assessments by considering a representative activity as the basis for the exposure calculation.

Residential Children: children are members of the general population that can also be exposed in their residences ( e. g., on lawns and other residential turfgrass areas). These kinds of exposures are attributable to a variety of activities such as playing outside. Toddlers have been selected as the sentinel ( representative) population for turf. Children are addressed by HED in risk assessments by considering representative activities for each age group in an exposure calculation.

3.2.2 Data and Assumptions for Residential Postapplication Exposure Scenarios A series of assumptions and exposure factors served as the basis for completing the residential postapplication risk assessments. The assumptions and factors used in the risk calculations are consistent with current Agency policy for completing residential exposure assessments ( i. e., SOPs For Residential Exposure Assessment). The values used in this assessment include:

C The body weight of an average adult ( 70 kilograms) is used for assessing dermal risks to adults.

C HED combines risks resulting from exposures to individual applications when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. For imazaquin, HED has combined risks ( i. e., MOEs) for turf scenarios involving toddlers   dermal plus hand to mouth plus object to mouth plus soil ingestion.

C Exposures to adults and children on treated turf have been addressed using the latest HED standard operating procedures for this scenario including: Page 13 of 25 < A dermal absorption value of 50% was used for estimating risk in this assessment.

< 5 percent of the application rate has been used to calculate the day zero TTR residue levels used for assessing risks from dermal and hand to mouth exposures, since imazaquin specific turf transferable residue study data are not available;

< 20 percent of the application rate has been used to calculate the day zero residue levels used for assessing risks from object to mouth behaviors ( a higher percent transfer has been used for object to mouth behaviors, because it involves a teething action believed to be more analogous to DFR/ leaf wash sample collection where 20 percent is also used);

< the transfer coefficients used are those presented during the 1999 Agency presentation before the FIFRA Science Advisory Panel that have been adopted in routine practice by HED;

< 3 year old toddlers are expected to weigh 15 kilograms ( representing an average weight from years one to six);

< hand to mouth exposures are based on a frequency of 20 events/ hour and a surface area per event of 20 cm2, representing the palmar surfaces of three fingers;

< saliva extraction efficiency is 50 percent meaning that every time the hand goes in the mouth approximately ½ of the residues on the hand are removed;

< object to mouth exposures are based on a 25 cm2 surface area;

< exposure durations for turfgrass scenarios are estimated to be 2 hours based on information in HED's Exposure Factors Handbook;

< soil residues are contained in the top centimeter and soil density is 0.67 mL/ gram; and < dermal, hand and object to mouth, and soil ingestion are combined to represent an overall risk from exposure to turf.

C Postapplication residential risks are based on maximum application rates or values specified in the SOPs For Residential Exposure Assessment.

C The Jazzercize approach is the basis for the dermal transfer coefficients from turfgrass as described in HED's Series 875 guidelines, SOPs For Residential Exposure Assessment, and the 1999 FIFRA SAP Overview document.

3.2.3 Residential Postapplication Exposure and Noncancer Risk Estimates Noncancer risks were calculated using the Margin of Exposure ( MOE) approach, which is a ratio of the body burden to the toxicological endpoint of concern. Exposures were calculated by considering the potential sources of exposure ( i. e., TTRs on lawns), then calculating dermal and nondietary ingestion exposures. Page 14 of 25 Nondietary Ingestion Exposure From Treated Turf: Nondietary ingestion exposure from treated turf were calculated using the following equations. These values were then used to calculate MOEs.

Estimating Turf Transferrable Residues and Dislodgeable Foliar Residues To estimate turf transferrable residue ( TTR) values when no chemical specific TTR, HED assumes that 5 percent of the turf application rate is available for transfer on day 0. Then HED converts the application rate ( in pounds active ingredient per acre) to micrograms per square centimeter using conversion factors.

TTR = AR x F x CF2 x CF 3 where: AR = application rate F = fraction of ai available on turf CF2 = weight unit conversion factor to convert the lbs ai in the application rate to ug for TTR value ( 4.54E8 ug/ lb) CF3 = area unit conversion factor to convert the surface are units ( acres) in the application rate to cm2 for the TTR value ( 2.47E 8 acre/ cm2)

Dermal Exposure from Treated Lawns ( adult and toddler)

The approach used to calculate the dermal exposures that are attributable to exposure from contacting treated lawns is:

ADD = ( TTR0 * ET * TC * DA * CF1) / BW Where: ADD = average daily dose ( mg/ kg/ day); TTRt = turf transferable residue on day " 0" ( µ g/ cm2); ET = exposure time ( 2 hr/ day) for lawn and ( 4 hr. day) for golf; TC = transfer coefficient ( 14,500 cm2/ hr for adults and 5,200 cm2/ hr for toddlers for high contact lawn activities; 500 cm2/ hr for golf or mowing); DA = dermal absorption factor ( 50% for high contact lawn activities ( high exposure) and golfing or mowing ( low exposure)); CF1 = weight unit conversion factor to convert µ g units to mg for the daily exposure ( 0.001 mg/ µ g); and BW = body weight ( 70 kg for adults and 15 kg for toddlers).

Hand to mouth Transfer of Pesticide Residues on Lawns ( toddler)

The approach used to calculate the nondietary ingestion exposures that are attributable to hand to mouth behavior on treated turf is:

ADD = ( TTR0 * SA * FQ * ET * SE * CF1) / BW Where: ADD = average daily dose ( mg/ kg/ day); TTRt = turf transferable residue on day " 0" ( µ g/ cm2 ); SA = surface area of the hands ( 20 cm2/ event); Page 15 of 25 FQ = frequency of hand to mouth activity ( 20 events/ hr); ET = exposure time ( 2 hr/ day); SE = extraction by saliva ( 50%); CF1 = weight unit conversion factor to convert µ g units in the TTR value to mg for the daily exposure ( 0.001 mg/ µ g); and BW = body weight ( 15 kg).

Object to mouth Transfer of Pesticide Residues on Lawns ( toddler)

The approach used to calculate exposures that are attributable to object to mouth behavior on treated turf that is represented by a child mouthing on a handful of turf is:

ADD = ( TTR0 * IgR* CF1) / BW Where: ADD = average daily dose ( mg/ kg/ day); TTRt = turf transferable residue on day " 0" ( µ g/ cm2); IgR = ingestion rate of grass ( 25 cm2/ day); CF1 = weight unit conversion factor to convert the µ g of residues on the grass to mg to provide units of mg/ day ( 1E 3 mg/ µ g); and BW = body weight ( 15 kg).

Incidental Ingestion of Soil from Pesticide Treated Residential Areas ( toddler)

The approach used to calculate exposures that are attributable to soil ingestion is:

ADD = SR * IgR * CF1/ BW where: ADD = Average daily l dose rate on day " t" ( mg/ day) SR = soil residue on day " t" ( Fg/ g) IgR = ingestion rate of soil ( mg/ day) CF1 = weight unit conversion factor to convert the Fg of residues on the soil to grams to provide units of mg/ day ( 1E 6 g/ Fg) and SR = AR * F * ( 1 D) t * CF2 * CF3 * CF4 where: AR = application rate ( lbs ai/ ft2 or lb ai/ acre) F = fraction of ai available in uppermost cm of soil ( fraction/ cm) D = fraction of residue that dissipates daily ( unitless) t = postapplication day on which exposure is being assessed CF2 = weight unit conversion factor to convert the lbs ai in the application rate to Fg for the soil residue value ( 4.54E8 Fg/ lb) CF3 = area unit conversion factor to convert the surface area units ( ft2) in the application rate to cm2 for the SR value ( 1.08E 3 ft2/ cm2 or 2.47E 8 acre/ cm2 if the application rate is per acre) CF4 = volume to weight unit conversion factor to convert the volume units ( cm3) to weight units for the SR value ( 0.67 cm3/ g soil)

Adults Page 16 of 25 Table 7 presents the imazaquin postapplication MOE values calculated for adults after applications to golf courses, to established lawns and to lawns slated for renovation. All MOEs are $ 100 on the day of application.

Table 7. Adult Residential Risk Estimates for Postapplication Exposure to imazaquin Exposure Scenario Route of Exposure Application Rate ( lb ai/ acre) MOE at Day 0 ( HED's level of concern = 100)

High Contact Lawn Activities Dermal 0.5 430 Mowing Turf 12500 Golf Course 6250 Toddler ( 3 year old)

Risks ( MOEs) to toddlers were calculated for postapplication risks following the application of imazaquin to established home lawns and to lawns slated for renovation. Table 8 summarizes the risk assessment for toddlers. All MOEs are greater than HED's level of concern of 100 on day 0.

Table 8. Toddler Residential Postapplication Risk Estimates for Imazaquin Exposure Scenario Route of Exposure Application Rate ( lb ai/ acre) MOE on Day 0 ( HED's level of concern = 100)

Residential Turf ( High Contact Activities) Dermal 0.5 260 Hand to Mouth Activity on Turf Oral 3400 Object to Mouth Activity on Turf 13400 Incidental Soil Ingestion 1000000 Combined Risk Assessment for Residential Scenarios HED combines risk values resulting from separate postapplication exposure scenarios when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. Table 9 presents a summary of the combined MOE estimates.

The combined risk assessment for exposures to toddlers following home lawn applications was calculated:

Combined MOE = NOAEL/( ADDhand to mouth + ADDobject to mouth + ADDincidental soil ingestion + ADDdermal) Page 17 of 25 The results of the combined postapplication risk assessment for toddlers indicates that the combined risks to toddlers on day 0 following applications to established lawns and to lawns slated for renovation are greater than HED's level of concern of 100 ( i. e., MOE = 260).

Table 9: Imazaquin Residential Scenarios for Combined Risk Estimates Postapplication Exposure Scenario Margins of Exposure ( MOEs) ( HED's level of concern = 100)

ADD ( mg/ kg/ day) Combined Non Dietary Risk Toddler Risks following spray applications to lawns Hand to Mouth 0.007 260 Object to Mouth 0.0019 Incidental Soil Ingestion 0.00003 High Contact Dermal 0.10 3.2.4 Residential Postapplication Exposure and Risk Estimates for Cancer Residential postapplication cancer risks were not assessed for imazaquin, since no toxicological endpoint of concern was selected for cancer.

3.2.5 Summary of Residential Postapplication Risk Concerns and Data Gaps HED considered a number of exposure scenarios for products that can be used in the residential environment representing different segments of the population including toddlers, youth aged children, and adults. Short term noncancer MOEs were calculated for all scenarios. Cancer risks were not calculated, since no toxicological endpoint for cancer was selected. In residential settings, HED does not use restricted entry intervals or other mitigation approaches to limit postapplication exposures, because they are viewed as impractical and not enforceable. As such, risk estimates on the day of application are the key concern.

In the assessment for residential postapplication exposure and risk, HED has no postapplication risk concerns following the use of imazaquin in residential settings.

3.2.6 Recommendations For Refining Residential Postapplication Risk Assessment In order to refine this residential assessment, data on actual use patterns including rates, timing, and the kinds of tasks performed are required to better characterize imazaquin risks. 3.3 Spray Drift from Agricultural Uses HED has concerns for the potential for children's exposure in the home as a result of agricultural uses of imazaquin. Environmental concentrations of imazaquin in homes may result from spray drift, track in, or from redistribution of residues brought home on the farm worker's clothing. Potential routes of exposure for children may include incidental ingestion and dermal contact with residues on carpets/ hard surfaces. Further research into children's exposures resulting from agricultural uses of pesticides are being conducted by the Agency's Office of Research and Development through the STAR ( Science to Achieve Results) grant program. The STAR program can be accessed at http:// es. epa. gov/ ncerqa/ grants/ Modifications to this assessment shall be incorporated as updated guidance becomes available. This will include expanding the scope of the residential exposure assessments by developing guidance for characterizing exposures from other sources not addressed such as from spray drift and exposures to farm worker children. Page 19 of 25 IMAZAQUIN APPENDIX POSTAPPLICATION EXPOSURE AND RISK CALCULATIONS Page 20 of 25 Appendix Table 1: Residential Handler Noncancer Risks from Imazaquin Exposure Scenario Target Application Ratea Area Treated Dailyb Dermal Unit Exposure ( mg/ lb ai) Inhalation Unit Exposure ( Ug/ lb ai) Dermal Dose d ( mg/ kg/ day) Inhalation Dose e ( mg/ kg/ day) MOE ( HED's level of concern = 100)

Dermalf Inhalation g Dermal +

Inhalation h Mixer/ Loader/ Applicator Mixing/ Loading/ Applying Liquid Concentrates with Hose End Sprayer ( Residential ORETF data) ( 1) Turf 0.38/ A 0.5 acre 11 17 0.015 0.000046 1700 550000 1700 Mixing/ Loading/ Applying Liquid Concentrates with a Hand Held Pump ( ORETF ) sprayer( 2) Ornamental 0.006 lb ai/ gal 1 gal 38 2.7 0.0016 0.0000002 15400 12500000 15400 Applying Ready to Use sprayer ( ORETF)( 3) Turf 0.006 lb ai/ gal 1 gal 54 19 0.0023 0.0000016 11000 15625000 11000 Footnotes a Application rates are the maximum application rates determined from EPA registered labels for imazaquin.

b Amount handled per day values are EPA estimates.

c Attire is short sleeve shirt, short pants, and no gloves and no respirator.

d Dermal Dose = application rate x area treated x dermal unit exposure x % DA ( 50) ÷ 70 e. Inhalation Dose = application rate x area treated x inhalation unit exposure ÷ 70 f. Dermal MOE = NOAEL ( 25mg/ kg/ day) / dermal daily dose ( mg/ kg/ day),

g. Inhalation MOE = NOAEL ( 25 mg/ kg/ day) / inhalation daily dose ( mg/ kg/ day)

h MOE TOTAL = 1 ( 1/ Dermal MOE ) + ( 1/ Inhalation MOE) Page 21 of 25 Appendix Table 2  Oral Exposure from Hand to Mouth Activity on Imazaquin Treated Turf Exposure Scenario Application Rate ( lb ai/ acre) Percent active ingredient dislodgeable Surface area ( cm2) Hand to Mouth ( events/ hr) Extraction by Saliva Exposure Time Body Weight ( kg) Average Daily Dose ( mg/ kg/ day) Oral MOE ( HED's level of concern = 100)

Hand to Mouth ( turf) 0.5 5% 20 20 50% 2 15 0.007 3400 Oral Dose ( mg/ kg/ day) = AR ( lb ai) x CF1 x CF2 x CF3 x F x SA ( cm2) x EXT x FQ( events/ hr) x ET( hrs/ day) x ( 0.001mg/ µ g)

BW ( kg)

Where:

Dose = oral dose on day of application ( mg/ kg/ day)

AR = application rate ( lb ai/ A)

CF1 = conversion factor to convert µ g to mg ( 1.00 x 10 3 µ g/ mg)

CF2 = weight unit conversion factor to convert the lbs ai in the application rate to µ g for the soil residue value ( 4.54 x 108 µ g/ lb)

CF3 = area unit conversion factor to convert the surface area units ( acres) in the application rate to cm2 for the SR value ( 2.47 x 10 8 acre/ cm2)

F = fraction of residue dislodgeable from wet hands ( unitless)

SA = surface area of 1 to 3 fingers ( cm2)

EXT = extraction rate by saliva ( unitless)

FQ = frequency of hand to mouth events ( events/ hour)

ET = exposure duration ( hours/ day)

BW = body weight ( kg)

Assumptions:

SA  The surface area of 1 to 3 finger is 20 cm2 FQ  The frequency of hand to mouth events is 20 events per hour F  The fraction of residue dislodgeable from wet hands is 5%

EXT  The extraction rate by saliva is 50%.

ET  The time spent outdoors is 2 hours/ day MOE = NOAEL ( 25g/ kg/ day) ÷ Dermal Dose Page 22 of 25 Appendix Table 3  Oral Exposure from Mouthing Imazaquin Treated Turf Exposure Scenario Application Rate ( lb ai/ acre) Percent Active Ingredient Dislodgeable Surface Area ( cm2) Body Weight ( kg) Average Daily Dose ( mg/ kg/ day) Oral MOE ( HED's level of concern =

100)

Object ( turf) to Mouth 0.5 20% 25 15 0.0019 13400 Oral Dose ( mg/ kg/ day) = AR ( lb ai) x CF1 x CF2 x CF3 x F x SA ( cm2)

BW ( kg)

Where:

Dose = oral dose on day of application ( mg/ kg/ day)

AR = application rate ( lb ai/ A)

CF1 = conversion factor to convert µ g to mg ( 1.00 x 10 3 µ g/ mg)

CF2 = weight unit conversion factor to convert the lbs ai in the application rate to µ g for the soil residue value ( 4.54 x 108 µ g/ lb)

CF3 = area unit conversion factor to convert the surface area units ( acres) in the application rate to cm2 for the SR value ( 2.47 x 10 8 acre/ cm2)

F = fraction of residue dislodgeable from wet hands ( unitless)

SA = surface area of 1 to 3 fingers ( cm2/ day)

BW = body weight ( kg)

Oral MOE = NOAEL ( 25 mg/ kg/ day) ÷ Daily Dose Assumptions:

SA  The surface area of 1 to 3 finger is 25 cm2/ day F  The fraction of residue dislodgeable from wet hands is 20% Page 23 of 25 Appendix Table 4  Oral Exposure from Incidental Soil Ingestion Exposure Scenario Application Rate ( lb ai/ acre) % of rate in uppermost 1 cm of soil Body Weight ( kg) Ingestion Rate ( IgR)

( mg/ day) Average Daily Dose mg/ kg/ day Oral MOE ( HED's level of concern = 100)

Soil Ingestion 0.5 100% 15 100 0.00003 1000000 Oral Dose = AR ( lb ai/ A) x F ( 1.0/ cm) x IgR( mg/ day) x CF1( 4.54E 8 µ g/ lb) x CF2 ( 2.47E 8 A/ cm2) x CF3 ( 0.67 cm3/ g) x CF4 ( 1E 6 g/ µ g)

BW ( kg)

Where:

Dose = oral dose on day of application ( mg/ kg/ day)

AR = application rate ( lb ai/ A)

F = fraction or residue retained on uppermost 1 cm of soil IgR = ingestion rate of soil ( mg/ day)

CF1 = weight unit conversion factor to convert the lbs ai in the application rate to µ g for the soil residue value ( 4.54 x 108 µ g/ lb)

CF2 = area unit conversion factor to convert the surface area units ( acres) in the application rate to cm2 for the SR value ( 2.47 x 10 8 acre/ cm2)

CF3 = volume to weight unit conversion factor to convert the volume units ( cm3) to weight units for the soil residue value ( 0.67 cm3/ g soil)

CF4 = weight unit conversion factor to convert the µ g of residues on the soil to grams to provide units of mg/ day ( 1E 6 g/ µ g)

BW = body weight ( kg)

MOE = NOAEL ( 25 mg/ kg/ day) ÷ Daily Dose Assumptions:

F  The fraction or residue retained on uppermost 1 cm of soil is 100 percent based on soil incorporation into top 1 cm of soil after application ( 1.0/ cm)

IgR  The ingestion rate of soil is 100 mg/ day Page 24 of 25 Appendix Table 5  Dermal Exposure from Imazaquin Treated Turfgrass Exposure Scenario Application Rate ( lb ai/ acre) Hours of Exposure Body Weight ( kg) Percent available TTR ( µ g/ cm2)

( normalized)

DAT 0 Transfer Coefficient ( cm2/ hr) Dermal Absorption (%) Absorbed Dermal Dose ( mg/ kg/ day) Dermal MOE ( HED's level of concern = 100)

High Contact Lawn Activities Adult 0.5 2 70 5% 0.549 14,500 50 0.06 430 Toddler 2 15 5% 0.549 5,200 50 0.1 260 Mowing Turf Adult 2 70 5% 0.050 500 50 0.002 12500 Golf Course Adults 4 70 5% 0.050 500 50 0.004 6250 Dermal Dose ( mg/ kg/ day) = TTR ( µ g/ cm2) x 0.001 ( mg/ µ g) x TC ( cm2/ hr) x ET ( hr/ day) x DA (%)

BW ( kg)

Where:

Dose = Dermal exposure at on day of application attributable for activity in a previously treated area ( mg/ kg/ day)

TTR = Turf Transferable Residue on day of application ( µ g/ cm2)

TC = Transfer Coefficient;

ET = Exposure Time ( hours);

DA = Dermal Absorption; and BW = Body Weight ( 70 kg)

TTR ( µ g/ cm2) = AR ( lb ai/ acre) x CF1( 4.54E 8 µ g/ lb) x CF2 ( 2.47E 8 A/ cm2) x PA Where:

AR = Application rate ( lb ai/ acre)

CF1 = weight unit conversion factor to convert the lbs ai in the application rate to µ g for the soil residue value ( 4.54 x 108 µ g/ lb)

CF2 = area unit conversion factor to convert the surface area units ( acres) in the application rate to cm2 for the SR value ( 2.47 x 10 8 acre/ cm2)

PA = Percent available (%)

Assumptions:

TC  The assumed transfer coefficients ( TCs) for adults and children performing short term high contact activities on treated turf are 14,500 and 5,200, respectively. Golfing, mowing and other low contact activities were assumed to have a TC of 500 µ g/ cm2. Page 25 of 25 ET  The exposure time for high contact activities on residential lawns is 2 hours. The exposure time for golfers is 4 hours. The exposure time for mowing is 2 hours.

DA  The dermal absorption is 50%


[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Proposed Rules]
[Page 55802]
[FR Doc No: 2015-23333]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0146]
RIN 0910-AH23

User Fee Program To Provide for Accreditation of Third-Party
Auditors/Certification Bodies To Conduct Food Safety Audits and To
Issue Certifications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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SUMMARY: The Food and Drug Administration (FDA or we) is correcting a
document that appeared in the Federal Register of July 24, 2015,
entitled ``User Fee Program for Accreditation of Third-Party Auditors/
Certification Bodies To Conduct Food Safety Audits and To Issue
Certifications.'' That document proposed amending the document,
``Accreditation of Third-Party Auditors/Certification Bodies to Conduct
Food Safety Audits and to Issue Certifications,'' and proposed
establishing a reimbursement (user fee) program to assess fees and
require reimbursement for the work performed to establish and
administer the system for the Accreditation of Third-Party Auditors
under the FDA Food Safety Modernization Act (FSMA). The document was
published with an incorrect RIN. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Charlotte Christin, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In FR Doc. 2015-18141, in the Federal
Register of July 24, 2015 (80 FR 43987), appearing on page 43987, in
the second column, the RIN number heading is corrected to read ``RIN
0910-AH23.''

    Dated: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23333 Filed 9-16-15; 8:45 am]
 BILLING CODE 4164-01-P