[Federal Register: October 12, 2007 (Volume 72, Number 197)]
[Notices]
[Page 58142-58143]
[DOCID:fr12oc07-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56617; File No. SR-NASDAQ-2007-083]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Increase the Annual Membership Fee for Nasdaq Members

October 4, 2007.
    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 October 1, 2007, The NASDAQ Stock Market LLC (``Nasdaq'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which items
have been substantially prepared by the Exchange. Nasdaq filed this
proposed rule change pursuant to section 19(b)(3)(A)(ii) of the Act \3\
and Rule 19b-4(f)(2) \4\ thereunder, which renders it effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to increase the annual membership fee for Nasdaq
members under Nasdaq Rule 7001. The text of the proposed rule change is
available at Nasdaq, the Commission's Public Reference Room, and
Nasdaq's Web site, http://www.nasdaq.com.

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

    In its filing with the Commission, Nasdaq 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. Nasdaq has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    Nasdaq is increasing its annual membership fee, which is assessed
on all Nasdaq members as of a date determined by Nasdaq in December of
each year, from $1,200 to $3,000 per year. The fee had initially been
set at a level to ease the transition of the Nasdaq Market Center's
status as a facility of the Financial Industry Regulatory Authority,
Inc. (f/k/a the National Association of Securities Dealers, Inc.) to a
facility of a new self-regulatory organization (``SRO''). Now that
Nasdaq has an established membership base, Nasdaq believes that the fee
increase is warranted to ensure that its annual membership fee funds a
greater portion of the cost of regulating the Nasdaq market. Nasdaq
believes that even with the fee increase, the cost of Nasdaq membership
is generally lower than the cost of membership in other SROs.\5\ In
this regard, it is particularly notable that unlike other SROs, Nasdaq
does not charge annual registration fees for each of a firm's
registered representatives.
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    \5\ See, e.g., New York Stock Exchange Price List 2007 at http://www.nyse.com/pdfs/2007pricelist.pdf
 (itemizing numerous

registration, regulation, and trading rights fees); NASD By-Laws,
Schedule A, Section 1 at http://nasd.complinet.com/nasd/display/display.html?rbid=1189&element_id=1159000126
; Chicago Stock

Exchange Fees and Assessments at http://wallstreet.cch.com/CHXtools/PlatformViewer.asp?SelectedNode=chp_1_1&manual=/CHX/Admin/
 chx-

feesandassessments/.
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2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of section 6 of the Act,\6\ in general, and with section
6(b)(4) of the Act,\7\ in particular, in that it provides for an
equitable allocation of reasonable dues, fees, and other charges among
its members and issuers and other persons using any facility or system
which Nasdaq operates or controls. Nasdaq believes that an increased
annual membership fee is reasonable and equitable method of ensuring
that its annual membership fee funds a greater portion of the cost of
regulating the Nasdaq market, and that the overall cost of Nasdaq
membership is reasonable as compared with the cost of membership in
other SROs.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    The foregoing proposed rule change has become effective upon filing
with the Commission pursuant to section 19(b)(3)(A)(ii) of the Act \8\
and Rule 19b-4(f)(2) thereunder,\9\ in that the proposed rule change
establishes or changes a member due, fee, or other charge imposed by
the SRO. At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
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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 e-mail to<EMAIL_ADDRESS>Please include

File No. SR-NASDAQ-2007-083 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2007-083. This
file number should be included on the subject line if e-mail 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 inspection and copying in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of Nasdaq. All comments received will
be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2007-083 and should be submitted
on or before November 2, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E7-20120 Filed 10-11-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Notices]
[Page 42005]
[FR Doc No: 2021-16550]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92524; File No. SR-FINRA-2021-014]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Designation of a Longer Period for
Commission Action on a Proposed Rule Change Relating to Members' Filing
Requirements Under FINRA Rule 6432 (Compliance With the Information
Requirements of SEA Rule 15c2-11)

July 29, 2021.
    On May 28, 2021, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend members' filing requirements under FINRA
Rule 6432 (Compliance with the Information Requirements of Securities
Exchange Act Rule 15c2-11). The proposed rule change was published for
comment in the Federal Register on June 15, 2021.\3\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Exchange Act Release No. 92139 (June 9, 2021), 86 FR
31774 (June 15, 2021). Comments on the proposed rule change can be
found at: https://www.sec.gov/comments/sr-finra-2021-014/srfinra2021014.htm.
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    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is July 30, 2021. The Commission is extending this 45-day period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change and the comment
received. Accordingly, the Commission, pursuant to Section 19(b)(2) of
the Act,\5\ designates September 13, 2021 as the date by which the
Commission shall either approve or disapprove, or institute proceedings
to determine whether to disapprove, the proposed rule change (File No.
SR-FINRA-2021-014).
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    \5\ Id.
    \6\ 17 CFR 200.30-3(a)(31).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-16550 Filed 8-3-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Page 182]
[FR Doc No: C1-2017-26995]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82273; File No. SR-CBOE-2017-040]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing of Amendment No. 2 to the Proposed Rule Change To Amend the
Schedule of Fees and Assessments To Adopt a Fee Schedule To Establish
Fees for Industry Members Related to the National Market System Plan
Governing the Consolidated Audit Trail

December 11, 2017.

Correction

    In notice document 2017-26995, appearing on pages 59683-59685, in
the issue of Friday, December 15, 2017, please note the following
correction:
    On page 59685, in the second column, in the tenth line from the
top, ``January 5, 2017'' should read ``January 5, 2018''.

[FR Doc. C1-2017-26995 Filed 12-29-17; 8:45 am]
 BILLING CODE 1301-00-D


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                                      OFFICE OF CHEMICAL SAFETY
                                                      AND POLLUTION PREVENTION

MEMORANDUM

DATE:  	September 24, 2012

SUBJECT:	Quinclorac and the Dimethylamine (DMA) Salt of Quinclorac.  Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration Action on Rhubarb and Low Growing Berry except Strawberry, Subgroup 13-07H and the Registration Review Action.

PC Code:  128974 and 028974
DP Barcodes: D404795 and D404914
Decision Numbers:  459055 and 468877
Registration Number:  42750-169
Petition Number:  1E7957
Regulatory Action:  Section 3 and Registration Review
Assessment Type:  Single Chemical/Aggregate
Case Number:  7222
TXR Number:  Not Applicable
CAS Number:  84087-01-4
MRID Number:  Not Applicable
40CFR §180. 463

FROM:	Bonnie Cropp-Kohlligian, Environmental Scientist
            Risk Assessment Branch IV, Health Effects Division (HED) (7509P)

THROUGH:	Thurston Morton, Chemist, Senior Scientist
		Risk Assessment Branch IV, HED (7509P)
			and
		Douglas Dotson, Ph.D., Chemist
		Ideliz Negrón-Encarnación, Ph.D., Chemist
            Dietary Exposure Science Advisory Council (DESAC), HED (7509P)

TO:		Sidney Jackson and Barbara Madden, PM#5
	        	RIMUERB, Registration Division (RD) (7505P)
			and
	        	Erik Kraft and Kable Davis, PM#25
	        	Herbicide Branch, RD (7505P)
			and
		Wilhelmina Livingston, RM#60
		Pesticide Reevaluation Division (PRD) (7508P)
Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model DEEM-FCID, Version 3.16 which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  This dietary survey was conducted from 2003 to 2008.  These analyses were performed to support the Section 3 request for quinclorac uses on rhubarb and low growing berry, except strawberry, subgroup 13-07H and to support Registration Review for quinclorac and the dimethylamine (DMA) salt of quinclorac.  All registered, pending and proposed uses of quinclorac and the DMA salt of quinclorac, as of the date of this memorandum, are included in these assessments.

Tolerances have been established for quinclorac (40CFR §180.463[a]) in livestock and cereal grain commodities.  HED has determined that the use of the DMA salt of quinclorac on cereal grains will not affect the established tolerances for quinclorac on rice, grain sorghum, and wheat.
The residue of concern (ROC), for both tolerance enforcement and risk assessment, is the parent compound, quinclorac.  Both the acute and chronic assessments are highly conservative, and assume 100% crop treated (%CT), along with tolerance-level residues for all agricultural commodities.  Default processing factors from DEEM 7.81 were used (for dried beef and cranberry juice) in the analyses.  Screening-level Tier I modeling was used to estimate drinking water concentrations.

The acute (food + water) dietary risk estimate at the 95[th] percentile of exposure is 1.6% of the acute population adjusted dose (aPAD) for females age 13 to 49.  This is the only population subgroup for which an acute endpoint was selected.

The chronic (food + water) dietary risk estimates are less than or equal to 8.9% of the chronic population adjusted dose (cPAD) for all population subgroups.  All Infants < 1 year of age is the most highly-exposed subgroup, utilizing 8.9% of the cPAD, while the general US population utilizes 3.6% of the cPAD.

Generally, the Agency is concerned when risk estimates exceed 100% of the PAD.  All acute and chronic dietary risk estimates for quinclorac are below HED's level of concern.

Quinclorac was classified in 1992 by the HED Cancer Peer Review committee (CPRC) as a group D carcinogen - not classifiable as to human carcinogenicity- based on recommendation by the EPA Scientific Advisory Panel (TXR# 0010416).  This classification was based on equivocal increase in the incidence of one type of benign tumor (pancreatic acinar cell adenomas) in only one sex and one species of animals (male Wistar rats).   A quantification of cancer risk is not warranted because the chronic RfD will adequately account for all chronic effects, including the observed adenomas, likely to result from exposure to quinclorac.

1.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million. References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  "Available Information on Assessing Exposure from Pesticides, A User's Guide," 21-JUN-2000, web link:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for quinclorac was conducted by W. Drew (6/2/09, DP# 363872).

2.	Residue Information

Reference Memo:  DP#s 397719, 404569, 404569; 9/6/12; S. Hummel (Residue Chemistry Summary Document)
Reference:  Quinclorac Summary Document Registration Review: Initial Docket December 2007 (bioaccumulation)

The qualitative nature of quinclorac residues in plants is considered adequately understood for the currently registered and proposed uses, based on rice, grain sorghum, and wheat metabolism studies.  The qualitative nature of quinclorac residues in livestock is considered adequately understood based on goat and poultry metabolism studies.  In each of these studies, quinclorac was the major residue identified in each commodity.  Based on the above studies, HED has concluded that parent is the only residue of concern in plant and livestock commodities for purposes of the tolerance expression and risk assessment.

Permanent tolerances have been established for quinclorac (40CFR §180.463[a]) in/on livestock and cereal grain commodities.  A time-limited tolerance for a Section 18 emergency exemption has been established for quinclorac (40CFR §180.463[b]) in/in cranberry at 15.0 ppm (expiration/revocation date 12/31/12).

Based on rice, grain sorghum, and wheat side-by-side field trial data comparing residue levels of quinclorac and the dimethylamine (DMA) salt of quinclorac and a comparative study of the dissociation behavior of quinclorac and the DMA salt of quinclorac, HED determined that the use of the DMA salt of quinclorac on cereal grains will not affect the established tolerances for quinclorac on rice, grain sorghum, and wheat (DP#s 378709 and 378710, J. Stokes, 3/25/11).
Under PP#1E7957, Interregional Research Project Number 4 (IR-4) is proposing new uses for quinclorac on rhubarb and low growing berry, except strawberry, crop subgroup 13-07H.  In conjunction with these uses, HED is recommending the tolerances below for residues of quinclorac, including its metabolites and degradates.

      Rhubarb	0.5 ppm
      Low growing berry, except strawberry, crop subgroup 13-07H	1.5 ppm

Cranberry is the representative commodity for low growing berry, except strawberry, crop subgroup 13-07H.  Since the proposed Section 3 use on low growing berry, except strawberry, crop subgroup 13-07H is essentially the same as the Section 18 use on cranberry, HED is recommending for the revocation of the currently established time-limited tolerance for residues of quinclorac in/on cranberry (15.0 ppm).

Under Registration Review of currently registered uses of quinclorac and the DMA salt of quinclorac, HED is recommending no changes to the currently established tolerances in/on the food commodities below for residues of quinclorac, including its metabolites and degradates.

      Barley, grain	2.0 ppm
      Rice, bran	15.0 ppm
      Rice, grain	5.0 ppm
      Sorghum, grain, grain	6.0 ppm
      Wheat, germ	0.75 ppm
      Wheat, grain	0.5 ppm
      Egg	0.05 ppm
      Fat of Cattle, Goat, Horse, Sheep	0.7 ppm
      Fat of Poultry	0.05 ppm
      Meat of Cattle, Goat, Hog, Horse, Poultry, Sheep	0.05 ppm
      Meat byproducts of Cattle, Goat, Horse, Sheep	1.5 ppm
      Milk	0.05 ppm

Under Registration Review of currently registered uses of quinclorac and the DMA salt of quinclorac, HED is recommending lowering the currently established tolerances in/on the food commodities below for residues of quinclorac, including its metabolites and degradates for the purposes of harmonization.

      Hog, fat	 lowered from 0.7 ppm to 0.05 ppm
      Hog, meat byproducts	lowered from 1.5 ppm to 0.05 ppm
      Poultry, meat byproducts	lowered from 0.1 ppm to 0.05 ppm

Residues in Fish

At this time, residues in fish are not deemed an important issue for quinclorac and were not included in the assessment.  The USDA Pesticide Data Program (PDP) did not analyze for residues of quinclorac in catfish tested 2008-2010.  No tolerances are currently established for residues of quinclorac in fish.  However, the currently registered/proposed uses on rice and cranberry are aquatic crops, and HED has determined that label restrictions are needed regarding the uses of quinclorac-treated rice and cranberry fields for aquaculture.  Alternatively, HED has suggested that the petitioner could determine residues of quinclorac in catfish and crayfish raised in quinclorac-treated fields and propose tolerances for these commodities, if necessary.

According to the Quinclorac Summary Document Registration Review: Initial Docket December 2007, bioaccumulation in fish is not expected according to the acceptable fish accumulation study, which showed that after 28 days of exposure, quinclorac did not accumulate in channel catfish.  No bioconcentration factor was reported.  Furthermore, the octanol/water partition coefficient (KOW) of 0.266 also suggests that quinclorac has low potential to bioaccumulate.

3.	Drinking Water Data

The quinclorac drinking water estimates used in these dietary risk assessments were provided by EFED (DP# 397720, M. Lowit/N. Andrews, 8/9/12 and DP# 405093, M. Lowit/N.Andrews, 9/14/12), and incorporated directly into the dietary assessments.  Water residues were incorporated in DEEM-FCID via entry into the food categories "water, direct, all sources" and "water, indirect, all sources."  The estimated drinking water concentrations (EDWCs) from existing and proposed uses of quinclorac for both acute and chronic scenarios in ground and surface water are 0.029 ppm and 0.511 ppm, respectively.

Rice (labeled for a single application of 0.5 lb ai/A) was identified as the use resulting in the highest EDWCs for surface water.  Because the use on rice involves flooding (for which the current Tier II model is not parameterized), the surface water EDWCs were assessed using a Tier I Rice Model, Version 1.0 (May 8, 2007).  Turf grass was identified as the use resulting in the highest EDWCs for ground water.  The EDWC in ground water was assessed using the Tier I Screening Concentration in Ground Water (SCI-GROW, Version 2.3) model.  These models, and their descriptions, are available at the EPA internet website via the web link, http://www.epa.gov/oppefed1/models/water/.  No surface or ground water monitoring data were available for quinclorac.

4.	Percent Crop Treated Information

The acute and chronic assessments are based on the assumption that 100% of all commodities with tolerances will be treated.

5.	DEEM-FCID Program and Consumption Information

Quinclorac acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID, Version 3.16, which incorporates consumption data from USDA's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).  This dietary survey was conducted from 2003 to 2008.  The data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or "matched" in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

6.	Toxicological Information

An appropriate endpoint attributable to a single exposure to assess dietary exposure for the general populations including infants and children was not available from the oral toxicity studies including the rat and rabbit developmental toxicity studies.

An acute dietary POD of 200 mg/kg (NOAEL) for the sub-population females 13-49 years old was selected from a rabbit developmental toxicity study based on increased rate of resorptions and post-implantation loss, a decrease in the number of live fetuses, and reduced fetal body weight seen at 600 mg/kg/day.  A UF 100x (10x for intraspecies variation, 10x for interspecies extrapolation and a 1x FQPA safety factor) was applied to the dose to obtain an acute reference dose/population adjusted dose (aRfD/aPAD) of 2.0 mg/kg.

A chronic dietary POD of 38 mg/kg/day (NOAEL) was selected for the general population from a carcinogenicity study in mice based on effects on body weight.  A UF 100x (10x for intraspecies variation, 10x for interspecies extrapolation and a 1x FQPA factor) was applied to the dose to obtain a chronic reference dose/population adjusted dose (cRfD/cPAD) of 0.38 mg/kg/day.

Quinclorac was classified in 1992 by the HED Cancer Peer Review committee (CPRC) as a group D carcinogen - not classifiable as to human carcinogenicity- based on recommendation by the EPA Scientific Advisory Panel (TXR# 0010416).  This classification was based on equivocal increase in the incidence of one type of benign tumor (pancreatic acinar cell adenomas) in only one sex and one species of animals (male Wistar rats).  A quantification of cancer risk is not warranted because the chronic RfD will adequately account for all chronic effects, including the observed adenomas, likely to result from exposure to quinclorac. There was no evidence of carcinogenicity in mice or female rats.

Toxicological doses and endpoints for dietary human health risk assessments for quinclorac are presented below in Table 1.  For detailed information, please refer to the forthcoming human health risk assessment.

TABLE 1.  Summary of Quinclorac Toxicological Doses and Endpoints for Use in Dietary Human Health Risk Assessments.
Exposure/
Scenario
                              Point of Departure
                        Uncertainty/FQPA Safety Factors
                RfD, PAD, Level of Concern for Risk Assessment
                        Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)
Not applicable.  An endpoint for acute dietary exposure to the general population was not selected because there was no available endpoint that was appropriate for this scenario (effects observed in the available studies are presumed to require more than one exposure).
Acute Dietary
(Females 13-49 years of age)
NOAEL (developmental) = 200 mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x

aRfD =  2.0 mg/kg/day

aPAD = 2.0 mg/kg/day
Developmental toxicity study in rabbits (MRID# 41063525 and 41680501) Developmental toxicity LOAEL =  600 mg/kg/day based on increased early resorptions and postimplantation loss, decreased live fetuses, decreased fetal body weight.  These fetal effects are presumed to occur after a single dose.
Chronic Dietary (All Populations)
NOAEL= 37.5 mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x

cRfD = 0.38
mg/kg/day

cPAD =  0.38 mg/kg/day
Carcinogenicity study in mice MRID # 41063523)
LOAEL = 150 mg/kg/day based on decreased body weight.
Cancer (oral, dermal, inhalation)
Available carcinogenicity studies indicate that there was equivocal evidence of an increase in the incidence of pancreatic acinar cell adenomas in the male rat, but no treatment-associated increases in tumors were observed in female rats or in mice.  A quantification of cancer risk is not warranted because the chronic RfD of 0.375 mg/kg/day is approximately 1200-fold lower than the dose (487 mg/kg/day) that induced the benign pancreatic tumors.  Thus, the chronic RfD will adequately account for all chronic effects, including the observed adenomas, likely to result from exposure to quinclorac.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.

7.	Results/Discussion

HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID analyses estimate the dietary exposure of the US population and various population subgroups.  The results of the acute analysis for females 13-49 are summarized in Table 2 (below).  As shown in Table 2, the risk estimates associated with acute dietary exposure to quinclorac are below HED's LOC.

The acute dietary risk estimate at the 95[th] percentile of exposure is 1.6% of the aPAD for females age 13 to 49.  This is the only population subgroup for which an acute endpoint was selected.

TABLE 2.  Summary of Acute Dietary Exposure and Risk Estimates for Quinclorac.
                              Population Subgroup
                                [Years of Age]
                DEEM Acute Dietary Analysis (95[th] Percentile)

                               aPAD (mg/kg/day)
                         Exposure Estimate (mg/kg/day)
                                    % aPAD
Females [13-49]
                                      2.0
                                   0.032108
                                      1.6
 * NA = Not Applicable.  An appropriate acute endpoint was not identified for these population subgroups.

The chronic dietary risk estimates are less than or equal to 8.9% of the chronic population adjusted dose (cPAD) for all population subgroups as shown in Table 3 (below).  All Infants <1year of age are the most highly-exposed subgroup, utilizing 8.9% of the cPAD, while the general US population utilizes 3.6% of the cPAD.

TABLE 3.  Summary of Chronic Dietary Exposure and Risk Estimates for Quinclorac.
                             Population Subgroup*
                                [Years of Age]
                         DEEM Chronic Dietary Analysis

                               cPAD (mg/kg/day)
                         Exposure Estimate (mg/kg/day)
                                    % cPAD
General US Population
                                     0.38
                                   0.013728
                                      3.6
All Infants [<1]

                                   0.033999
                                      8.9
Children [1-2]

                                   0.023500
                                      6.2
Children [3-5]

                                   0.019280
                                      5.1
Children [6-12]

                                   0.013431
                                      3.5
Youth [13-19]

                                   0.010195
                                      2.7
Adults [20-49]

                                   0.013614
                                      3.6
Adults [50-99]

                                   0.012525
                                      3.3
Females [13-49]

                                   0.012893
                                      3.4
 * Values for the population subgroup with the highest risk are in bold type.

 8.	Characterization of Inputs/Outputs

This assessment is based on tolerance level residues in all agricultural commodities, assumes that all crops with existing or proposed tolerances are treated to a level of 100% and makes use of DEEM default processing factors.  In addition, Tier I drinking water estimates were used.  These assumptions result in highly conservative, health-protective estimates of dietary exposure and risk.

 9.	Conclusions

Generally, the Agency is concerned when dietary risk estimates exceed 100% of the PAD.  All acute and chronic dietary risk estimates for quinclorac are below HED's level of concern.

 10.	List of Attachments
Attachment 1.	Quinclorac Residues Used for Acute and Chronic Dietary Exposure Estimates.
Attachment 2.	Summary of the Acute Dietary Exposure and Risk Estimates for Quinclorac.
Attachment 3.	Summary of the Chronic Dietary Exposure and Risk Estimates for Quinclorac.

Attachment 1.  Quinclorac Residues Used for Acute and Chronic Dietary Exposure Estimates.

U.S. EPA                                                        Ver. 3.16, 03-08-d
DEEM-FCID Acute and Chronic analysis for QUINCLORAC
Residue file name: QUINCLORACDEEM092412INPUT.R08
                                                               Adjust. #2 used
Analysis Date 09-24-2012             Residue file dated: 09-24-2012/10:44:12
Acute Reference dose (RfD) = 2.0 mg/kg bw/day (Females 13-49 only)
Chronic Reference dose (RfD) = 0.38 mg/kg bw/day
Comment:  Tolerances Used for Acute and Chronic Analyses
----------------------------------------------------------------------------------
 Food      Crop                                   Residue       Adj.Factors
EPA Code    Grp  Food Name                        (ppm)        #1         #2
---------- ---- -------------------------------   ---------- ------     ------
1500025000 15   Barley, pearled barley             2.000000   1.000      1.000
1500025001 15   Barley, pearled barley-babyfood    2.000000   1.000      1.000
1500026000 15   Barley, flour                      2.000000   1.000      1.000
1500026001 15   Barley, flour-babyfood             2.000000   1.000      1.000
1500027000 15   Barley, bran                       2.000000   1.000      1.000
3100044000 31   Beef, meat                         0.050000   1.000      1.000
3100044001 31   Beef, meat-babyfood                0.050000   1.000      1.000
3100045000 31   Beef, meat, dried                  0.050000   1.920      1.000
3100046000 31   Beef, meat byproducts              1.500000   1.000      1.000
3100046001 31   Beef, meat byproducts-babyfood     1.500000   1.000      1.000
3100047000 31   Beef, fat                          0.700000   1.000      1.000
3100047001 31   Beef, fat-babyfood                 0.700000   1.000      1.000
3100048000 31   Beef, kidney                       1.500000   1.000      1.000
3100049000 31   Beef, liver                        1.500000   1.000      1.000
3100049001 31   Beef, liver-babyfood               1.500000   1.000      1.000
1302057000 13B  Blueberry                          1.500000   1.000      1.000
1302057001 13B  Blueberry-babyfood                 1.500000   1.000      1.000
4000093000 40   Chicken, meat                      0.050000   1.000      1.000
4000093001 40   Chicken, meat-babyfood             0.050000   1.000      1.000
4000094000 40   Chicken, liver                     0.050000   1.000      1.000
4000095000 40   Chicken, meat byproducts           0.050000   1.000      1.000
4000095001 40   Chicken, meat byproducts-babyfoo   0.050000   1.000      1.000
4000096000 40   Chicken, fat                       0.050000   1.000      1.000
4000096001 40   Chicken, fat-babyfood              0.050000   1.000      1.000
4000097000 40   Chicken, skin                      0.050000   1.000      1.000
4000097001 40   Chicken, skin-babyfood             0.050000   1.000      1.000
1307130000 13G  Cranberry                          1.500000   1.000      1.000
1307130001 13G  Cranberry-babyfood                 1.500000   1.000      1.000
1307131000 13G  Cranberry, dried                   1.500000   1.000      1.000
1307132000 13G  Cranberry, juice                   1.500000   1.100      1.000
1307132001 13G  Cranberry, juice-babyfood          1.500000   1.100      1.000
7000145000 70   Egg, whole                         0.050000   1.000      1.000
7000145001 70   Egg, whole-babyfood                0.050000   1.000      1.000
7000146000 70   Egg, white                         0.050000   1.000      1.000
7000146001 70   Egg, white (solids)-babyfood       0.050000   1.000      1.000
7000147000 70   Egg, yolk                          0.050000   1.000      1.000
7000147001 70   Egg, yolk-babyfood                 0.050000   1.000      1.000
3200169000 32   Goat, meat                         0.050000   1.000      1.000
3200170000 32   Goat, meat byproducts              1.500000   1.000      1.000
3200171000 32   Goat, fat                          0.700000   1.000      1.000
3200172000 32   Goat, kidney                       1.500000   1.000      1.000
3200173000 32   Goat, liver                        1.500000   1.000      1.000
3300189000 33   Horse, meat                        0.050000   1.000      1.000
3800221000 38   Meat, game                         0.050000   1.000      1.000
3600222000 36   Milk, fat                          0.050000   1.000      1.000
3600222001 36   Milk, fat-baby food/infant formu   0.050000   1.000      1.000
3600223000 36   Milk, nonfat solids                0.050000   1.000      1.000
3600223001 36   Milk, nonfat solids-baby food/in   0.050000   1.000      1.000
3600224000 36   Milk, water                        0.050000   1.000      1.000
3600224001 36   Milk, water-babyfood/infant form   0.050000   1.000      1.000
3600225001 36   Milk, sugar (lactose)-baby food/   0.050000   1.000      1.000
3400290000 34   Pork, meat                         0.050000   1.000      1.000
3400290001 34   Pork, meat-babyfood                0.050000   1.000      1.000
3400291000 34   Pork, skin                         0.050000   1.000      1.000
3400292000 34   Pork, meat byproducts              0.050000   1.000      1.000
3400292001 34   Pork, meat byproducts-babyfood     0.050000   1.000      1.000
3400293000 34   Pork, fat                          0.050000   1.000      1.000
3400293001 34   Pork, fat-babyfood                 0.050000   1.000      1.000
3400294000 34   Pork, kidney                       0.050000   1.000      1.000
3400295000 34   Pork, liver                        0.050000   1.000      1.000
6000301000 60   Poultry, other, meat               0.050000   1.000      1.000
6000302000 60   Poultry, other, liver              0.050000   1.000      1.000
6000303000 60   Poultry, other, meat byproducts    0.050000   1.000      1.000
6000304000 60   Poultry, other, fat                0.050000   1.000      1.000
6000305000 60   Poultry, other, skin               0.050000   1.000      1.000
3900312000 39   Rabbit, meat                       0.050000   1.000      1.000
0402322000 4B   Rhubarb                            0.500000   1.000      1.000
1500323000 15   Rice, white                        5.000000   1.000      1.000
1500323001 15   Rice, white-babyfood               5.000000   1.000      1.000
1500324000 15   Rice, brown                        5.000000   1.000      1.000
1500324001 15   Rice, brown-babyfood               5.000000   1.000      1.000
1500325000 15   Rice, flour                        5.000000   1.000      1.000
1500325001 15   Rice, flour-babyfood               5.000000   1.000      1.000
1500326000 15   Rice, bran                        15.000000   1.000      1.000
1500326001 15   Rice, bran-babyfood               15.000000   1.000      1.000
3500339000 35   Sheep, meat                        0.050000   1.000      1.000
3500339001 35   Sheep, meat-babyfood               0.050000   1.000      1.000
3500340000 35   Sheep, meat byproducts             1.500000   1.000      1.000
3500341000 35   Sheep, fat                         0.700000   1.000      1.000
3500341001 35   Sheep, fat-babyfood                0.700000   1.000      1.000
3500342000 35   Sheep, kidney                      1.500000   1.000      1.000
3500343000 35   Sheep, liver                       1.500000   1.000      1.000
1500344000 15   Sorghum, grain                     6.000000   1.000      1.000
1500345000 15   Sorghum, syrup                     6.000000   1.000      1.000
1500381000 15   Triticale, flour                   0.500000   1.000      1.000
1500381001 15   Triticale, flour-babyfood          0.500000   1.000      1.000
5000382000 50   Turkey, meat                       0.050000   1.000      1.000
5000382001 50   Turkey, meat-babyfood              0.050000   1.000      1.000
5000383000 50   Turkey, liver                      0.050000   1.000      1.000
5000383001 50   Turkey, liver-babyfood             0.050000   1.000      1.000
5000384000 50   Turkey, meat byproducts            0.050000   1.000      1.000
5000384001 50   Turkey, meat byproducts-babyfood   0.050000   1.000      1.000
5000385000 50   Turkey, fat                        0.050000   1.000      1.000
5000385001 50   Turkey, fat-babyfood               0.050000   1.000      1.000
5000386000 50   Turkey, skin                       0.050000   1.000      1.000
5000386001 50   Turkey, skin-babyfood              0.050000   1.000      1.000
8601000000 86A  Water, direct, all sources         0.511000   1.000      1.000
8602000000 86B  Water, indirect, all sources       0.511000   1.000      1.000
1500401000 15   Wheat, grain                       0.500000   1.000      1.000
1500401001 15   Wheat, grain-babyfood              0.500000   1.000      1.000
1500402000 15   Wheat, flour                       0.500000   1.000      1.000
1500402001 15   Wheat, flour-babyfood              0.500000   1.000      1.000
1500403000 15   Wheat, germ                        0.750000   1.000      1.000
1500404000 15   Wheat, bran                        0.500000   1.000      1.000
1500405000 15   Wild rice                          5.000000   1.000      1.000

Attachment 2.  Summary of the Acute Dietary Exposure and Risk Estimates for Quinclorac.

U.S. EPA                                                    Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for QUINCLORAC                  NHANES 2003-2008 2-Day
Residue file name: QUINCLORACDEEM092412INPUT.R08           Adjustment factor #2 used.
Analysis Date: 09-24-2012/10:46:50    Residue file dated: 09-24-2012/10:44:12
RAC/FF intake summed over 24 hours
Run Comment: Acute is for Females 13-49 only.
===============================================================================

Summary calculations--per capita:

                   95th Percentile      99th Percentile     99.9th Percentile
                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD
                  ---------- --------  ---------- --------  ---------- --------
Female 13-49:
                    0.032108     1.61    0.043819     2.19    0.060306     3.02

                  Attachment 3.  Summary of the Chronic Dietary Exposure and Risk Estimates for Quinclorac.

U.S. EPA                                                        Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for QUINCLORAC                  NHANES 2003-2008 2-day
Residue file name: QUINCLORACDEEM092412INPUT.R08
                                                     Adjustment factor #2 used.
Analysis Date 09-24-2012/10:45:30     Residue file dated: 09-24-2012/10:44:12
Reference dose (RfD, Chronic) = .38 mg/kg bw/day
COMMENT 1:
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of
           Subgroup                       body wt/day             Rfd
--------------------------------------   -------------       ----------------
Total US Population                         0.013728                 3.6%
Hispanic                                    0.013922                 3.7%
Non-Hisp-White                              0.013714                 3.6%
Non-Hisp-Black                              0.011683                 3.1%
Non-Hisp-Other                              0.018298                 4.8%
Nursing Infants                             0.013500                 3.6%
Non-Nursing Infants                         0.043154                11.4%
Female 13+ PREG                             0.012415                 3.3%
Children 1-6                                0.020422                 5.4%
Children 7-12                               0.012785                 3.4%
Male 13-19                                  0.009941                 2.6%
Female 13-19/NP                             0.010453                 2.8%
Male 20+                                    0.013090                 3.4%
Female 20+/NP                               0.013237                 3.5%
Seniors 55+                                 0.012155                 3.2%
All Infants                                 0.033999                 8.9%
Female 13-50                                0.012889                 3.4%
Children 1-2                                0.023500                 6.2%
Children 3-5                                0.019280                 5.1%
Children 6-12                               0.013431                 3.5%
Youth 13-19                                 0.010195                 2.7%
Adults 20-49                                0.013614                 3.6%
Adults 50-99                                0.012525                 3.3%
Female 13-49                                0.012893                 3.4%

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