[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Rules and Regulations]
[Pages 17144-17146]
[FR Doc No: 2017-07035]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2013-0772; FRL-9960-94-Region 4]

Air Plan Approval; North Carolina; Motor Vehicle Emissions
Control Program; Correcting Amendment

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

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SUMMARY: This direct final action, taken under the authority of the
Clean Air Act (CAA or Act), corrects an error in previously promulgated
rules approving certain elements of the North Carolina state
implementation plan (SIP). The error relates to the North Carolina
SIP's Motor Vehicle Emissions Control Standard rules and the correction
removes a provision of the State's otherwise federally-enforceable
regulations that could result in infringement upon the sovereign
immunity of Federal facilities. The intended effect is to ensure that
the North Carolina SIP is correctly identified in the applicable part
of the Code of Federal Regulations and to eliminate the possibility of
such infringement.

DATES: This direct final rule is effective June 9, 2017 without further
notice, unless EPA receives adverse comment by May 10, 2017. If EPA
receives such comments, it will publish a timely withdrawal of the
direct final rule in the Federal Register and inform the public that
the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2013-0772 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Mrs. Sheckler can be reached via phone at<PHONE_NUMBER> or
electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 182(b)(4) of the CAA requires areas that are designated as
moderate, serious, or severe ozone nonattainment to establish a motor
vehicle inspection and maintenance (I/M) program to ensure that
specified gasoline-fueled motor vehicles do not exceed prescribed
emissions thresholds by requiring that vehicles undergo periodic
emissions testing, including mandatory repairs for vehicles found to
exceed these thresholds. This emissions testing ensures that vehicles
are well maintained and operating as designed.
    The North Carolina I/M program began in 1982 in Mecklenburg County
utilizing a ``tail-pipe'' emissions test. From 1986 through 1991 the
program expanded to include eight additional counties (Wake, Forsyth,
Guilford, Durham, Gaston, Cabarrus, Orange and Union County). In 1999,
the North Carolina General Assembly passed legislation to expand the
coverage area for the I/M program in order to gain additional emission
reductions to achieve the 1997 8-hour ozone national ambient air
quality standards in the State. This legislation expanded the I/M
program from nine counties to 48 counties by adding several counties
approximately every six months from July 1, 2003, to July 1, 2006. The
I/M program in the expanded coverage area used on-board diagnostic
(OBD) rather than tail-pipe testing. On August 7, 2002, North Carolina
submitted a SIP revision to amend the I/M regulations included in the
SIP at that time to, among other things, expand the counties subject to
the I/M program as discussed above, require OBD in the subject counties
for all model year (MY) 1996 and newer light duty gasoline vehicles,
and terminate the tail-pipe testing program on January 1, 2006, for the
nine counties subject to continued tail-pipe testing of MY 1995 and
older vehicles.
    EPA approved these changes to North Carolina's I/M program into the
SIP on October 30, 2002. See 67 FR 66056. North Carolina submitted
additional SIP revisions related to the State's I/M program on January
31, 2008, May 24, 2010, October 11, 2013, and February 11, 2014. EPA
approved North Carolina's January 31, 2008, May 24, 2010, October 11,
2013, and February 11, 2014, SIP revisions pertaining to state rule
changes to the State's I/M program on February 5, 2015. See 80 FR 6455.

II. Error Correction

    The CAA sets forth requirements for Federal facilities which are
located in I/M program areas. These requirements in section 118(c) and
(d) apply to both Federal fleet and Federal employee vehicles. Congress
intended in that section that Federal facilities located in I/M program
areas demonstrate compliance with certain local and State I/M
requirements. When EPA published the I/M rule in 1992, see 57 FR 52950,
the Agency interpreted CAA section 118(c) and (d) as a partial waiver
of the Federal government's sovereign immunity, thereby allowing States
to regulate Federal facilities in their I/M programs.\1\ Accordingly,
EPA established certain SIP requirements for Federal facilities in the
I/M rule. Since that time, the Department of Justice (DOJ) has found
that sections 118(c) and (d) do not waive sovereign immunity for the
Federal government and thus states are without authority to enforce the
section 118(c) and (d) requirements for Federal facilities.\2\ Further,
DOJ found that the express waiver of sovereign immunity in section
118(a) extends only to nondiscriminatory requirements (i.e., each
agency and employee of the Federal government ``shall be subject to,
and comply with, all Federal, State, interstate, and local
requirements, administrative authority, and process and sanctions
respecting the control and abatement of air pollution in the same

manner, and to the same extent as any nongovernmental entity.''). As
explained below, section 118(a)'s immunity waiver does not extend to
State I/M requirements that, like the North Carolina provision at issue
here, are imposed upon Federal entities in a different manner or to a
different extent than nongovernmental entities.
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    \1\ See letter from Gay MacGregor, Director, Regional and State
Programs Division, EPA Office of Air and Radiation, to Mary Jo
Leugers, Virginia Office of the Attorney General (August 28, 1998)
(MacGregor Letter).
    \2\ See letter from Lois J. Schiffer, Assistant Attorney
General, Department of Justice Environment and Natural Resources
Division, to Scott Fulton, Acting General Counsel, EPA (July 29,
1998) (Schiffer Letter).
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    North Carolina's regulation 15A NCAC 02D.1002(a)(3) identifies
vehicles that are operated on a Federal installation and that meet the
requirements of 40 CFR 51.356(a)(4) as subject to the State motor
vehicle emission standard. This North Carolina regulation thus subjects
certain vehicles operated on Federal installations to State I/M
requirements that do not apply in the same manner and to the same
extent to nongovernmental entities, and it is inconsistent with the
waiver of immunity in section 118(a). As noted in the MacGregor Letter
addressing the issue, removing Federal facility I/M requirements from
SIPs will in no way impact the emissions reductions credits the States
earn for their I/M programs; pursuant to section 118(a), Federal
agencies are required to comply with air pollution control programs to
the same extent as nongovernmental entities and thus will continue to
be subject to programs of general applicability. EPA is therefore
removing from the federally-approved North Carolina SIP regulation 15A
NCAC 02D.1002(a)(3) because that regulation does not apply to vehicles
operated on Federal installations in the same manner and to the same
extent as vehicles owned or operated by nongovernmental entities.

III. Final Action

    Pursuant to CAA section 110(k)(6), EPA rescinds its previous
approval of NCAC 02D.1002(a)(3), a provision that sets forth additional
requirements under the vehicle I/M program for motor vehicles operated
on Federal installations that do not apply to nongovernmental entities
and thus is inconsistent with CAA section 118(a). This action will not
result in increases in emissions that would interfere with attainment
or maintenance of any NAAQS or with any other applicable requirement of
the CAA.

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely corrects North Carolina's EPA-approved SIP by removing the
State's regulation 15A NCAC 02D.1002 (a)(3), which listed Federal
facilities as applicable to the state motor vehicle emission standard
and 40 CFR 51.356(a)(4), by removing it from the federally-approved
portion of the North Carolina SIP to be consistent with CAA 118. It
imposes no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
Furthermore, this action does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This rule also does not have Federalism
implications because it does not have substantial direct effects on the
states, on the relationship between the national government and the
states, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This rule merely removes North Carolina
regulation 15A NCAC 02D.1002 (a)(3) from the federally approved portion
of the North Carolina SIP to be consistent with CAA 118; it also does
not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. This rule also is
not subject to Executive Order 13045 ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it is not economically significant. In addition, this
rule does not involve technical standards, thus the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply. This rule also does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 9, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. See CAA section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by Reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: March 15, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42.U.S.C. 7401 et seq.

Subpart II--North Carolina

0
2. Section 52.1770(c) is amended by revising the entry for ``Sect
.1002'' to read as follows:

Sec.  52.1770  Identification of plan.

* * * * *
    (c) * * *

                                Table 1--EPA Approved North Carolina Regulations
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                                                            State
         State citation              Title/subject     effective date    EPA approval date       Explanation
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                                Subchapter 2D Air Pollution Control Requirements
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                                                  * * * * * * *
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                             Section .1000 Motor Vehicle Emissions Control Standards
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                                                  * * * * * * *
Sect .1002.....................  Applicability.......        1/1/2014  4/10/2017 [Insert     Paragraph (a)(3) of
                                                                        Federal Register      Section .1002 is
                                                                        citation].            hereby rescinded
                                                                                as this paragraph
                                                                                is inconsistent
                                                                                with the limits on
                                                                                the waiver of
                                                                                sovereign immunity
                                                                                established in
                                                                                section 118(a) of
                                                                                the CAA.

                                                  * * * * * * *
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* * * * *
[FR Doc. 2017-07035 Filed 4-7-17; 8:45 am]
BILLING CODE 6560-50-P


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

	OFFICE OF	CHEMICAL SAFETY AND	POLLUTION PREVENTION

Date:		08-MAY-2013

            Subject:	Fenpyroximate.  Petition for the Establishment of Permanent Tolerances for Residues in/on Stone Fruits (Group 12-12), Tuberous and Corm Vegetables (Subgroup 1C), and Small Vine Climbing Fruits Except Kiwifruit (Subgroup 13-07F).  Acute and Chronic Dietary Exposure and Risk Assessments.

PC Code:  129131
DP Barcode:  D405718
Decision No.:  468635
Registration Nos:  71711-19, 71711-4
Petition No.:  2E8072
Regulatory Action:  Sec. 3 Registration
Risk Assessment Type:  Dietary
Case No.:  7432
TXR No.:  NA
CAS No.:  134098-61-6 (E-isomer)
MRID No.:  None
40 CFR:  §180.566

From:		George F. Kramer, Ph.D., Senior Chemist
		Risk Assessment Branch 1 (RAB1)
		Health Effects Division (HED; 7509P)

Through:		Julie L. Van Alstine, MPH, Environmental Health Scientist
		Thurston Morton, Chemist
            Dietary Exposure Science Advisory Council (DESAC)/HED (7509P)
                  and
		Dana M. Vogel, Acting Branch Chief, RAB1
		Associate Division Director, HED (7509P)

         To:		Jennifer R. Tyler, Risk Assessor
		RAB1/HED (7509P)
            and
      Barbara Madden/Sidney Jackson, RM 05
      Registration Division (RD; 7505P)

Executive Summary

Acute and chronic aggregate dietary (food + drinking water) exposure and risk assessments were conducted for fenpyroximate using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID, ver. 3.16) which incorporates consumption data from United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008).  The analyses were performed to support Section 3 use requests on stone fruits (group 12-12), small vine climbing fruits except kiwifruit (subgroup 13-07F), and tuberous and corm vegetables (subgroup 1C).
Acute Dietary (Food + Drinking Water) Exposure Results and Characterization

Separate acute dietary risk analyses were conducted for females 13-49 years old and for the general U.S. population, as separate endpoints of concern attributable to a single dose were identified.  Both acute analyses assumed 100% crop treated (CT), tolerance-level residues for all commodities.  DEEM (ver. 7.81) default processing factors were assumed for all commodities excluding apple, pear, and grape juice (0.11x); grape, raisin (2.7x); orange, grapefruit, tangerine, lemon, and lime juice (0.06x); tomato paste (1.0x) and puree (1.0x); dried plum (1.0x); and peppermint and spearmint oil (0.08x).  The acute analyses incorporated the estimated drinking water concentrations (EDWCs) provided by Environmental Fate and Effects Division (EFED).  An EDWC of 0.043 ppm was used in the acute analyses, as this was the highest (i.e., most conservative) estimate.

The resulting acute food plus drinking water risk estimates are not of concern to HED (<100% acute population-adjusted dose (aPAD)) at the 95[th] percentile of the exposure.  The resulting acute risk estimate is 13% of the aPAD at the 95[th] percentile of the exposure distribution for females 13 to 49 years old.  The highest acute exposure estimate for the U.S. population or population subgroup is children 1-2 years old, which resulted in a risk estimate of 6.2% aPAD.

Chronic Dietary (Food + Drinking Water) Exposure Results and Characterization

The chronic analysis assumed DEEM (ver. 7.81) default processing factors, 100% CT, tolerance-level residues for all commodities, and DEEM (ver. 7.81) default processing factors for most commodities (see above).  The chronic analysis also incorporated EDWCs provided by EFED (an EDWC of 0.0086 ppm was used in the chronic analysis).  The resulting chronic risk estimates are not of concern to HED.  The most highly exposed population was children 1-2 years old utilizing 15% of the chronic PAD (cPAD).

A chronic cancer dietary assessment was not conducted since it was determined that fenpyroximate is not a possible human carcinogen.

I.  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 PAD.  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty and/or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  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 fenpyroximate was conducted by S. Levy (23-MAY-2012; DP# 391844).
II.  Residue Information

Fenpyroximate is a contact insecticide/miticide used for the control of leafhoppers, mealybugs, and mites.  Fenpyroximate is a mitochondrial electron-transport inhibitor (METI) which acts by targeting proton-translocating NADH:Q oxidoreductase and blocking ubiquinone reduction.

Residues of Concern:  Acceptable plant metabolism studies with fenpyroximate on apples, citrus, cotton, and grapes were previously submitted.  HED has determined (Memo, J. Stokes, 12-AUG-2003; D292639) that the residues of concern for plants for the purposes of tolerance enforcement and risk assessment are fenpyroximate 4-[[[(E)-[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)
methylene]amino]oxy] methyl]benzoate plus its Z-isomer (also called metabolite M-1 or 4-[[[(Z)-[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]amino]oxy]methyl]benzoate).

 The nature of residue in lactating goats is understood.  The HED Metabolism Assessment Review Committee (MARC) concluded that for milk and the fat, meat, and meat byproducts (excluding liver and kidney) of cattle, goat, horse, and sheep, the parent compound, and its metabolites (E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene aminooxymethyl]benzoic acid and (E)-1,1-dimethylethyl-2-hydroxyethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene] amino]oxy]methyl]benzoate, calculated as the parent compound, are the residues of concern (Memo, J. Stokes, 12-AUG-2003; D292639).  Additionally, the residues of concern for cattle, goat, horse, and sheep liver and kidney are fenpyroximate and its metabolite (E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene aminooxymethyl]benzoic acid, calculated as the parent compound.

 For drinking water, the residues of concern for risk assessment include the parent, M-1 and M-3.

Established/Recommended Tolerances:  Fenpyroximate tolerances are established in 40 CFR §180.566.  Tolerances for residues in/on plant commodities are expressed in terms of the combined residues of fenpyroximate and its Z-isomer.  Permanent tolerances for residues in/on plant commodities, under §180.566(a)(1), range from 0.10 ppm to 20 ppm.  Tolerances for residues in/on milk and the fat, meat, and meat byproducts (excluding liver and kidney) of cattle, goat, horse, and sheep are listed in 40 CFR §180.566(a)(2) and are expressed in terms of the combined residues of fenpyroximate and its metabolites (E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene aminooxymethyl]benzoic acid and (E)-1,1-dimethylethyl-2-hydroxyethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate, calculated as the parent compound.  Tolerances for residues in cattle, goat, horse, and sheep liver and kidney are listed under 40 CFR §180.566(a)(3) at 0.25 ppm and are expressed in terms fenpyroximate and its metabolite (E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene aminooxymethyl]benzoic acid, calculated as the parent compound.  A time-limited tolerance for residues in/on honey at 0.10 ppm with a 12/31/13 expiration date is listed in 40 CFR §180.566(b) under a Section 18 Emergency Exemption.

The Interregional Project No. 4 (IR-4) has proposed a Section 3 Registration for application of fenpyroximate to stone fruits (group 12-12), small vine climbing fruits except kiwifruit (subgroup 13-07F), and tuberous and corm vegetables (subgroup 1C).  IR-4, requests the establishment of tolerances for the combined residues of the insecticide fenpyroximate in/on the following raw agricultural commodities (RACs).

                                   Commodity
                        HED-Recommended Tolerance (ppm)
Fruit, stone, group 12-12
                                      2.0
Vegetable, tuberous and corm, subgroup lC
                                     0.10
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F
                                      1.0

No new residue data were submitted to support tolerance on small vine climbing fruits except kiwifruit (subgroup 13-07F).  IR-4 has requested that the established tolerance for residues in/on grape be expanded to its respective crop group.

 Residues used in the Acute and Chronic Analysis:  These analyses employed established and HED-recommended tolerance-level residues for all commodities and DEEM (ver. 7.81) default processing factors for all commodities excluding apple, pear, and grape juice (0.11x); grape, raisin (2.7x); orange, grapefruit, tangerine, lemon, and lime juice (0.06x); tomato paste (1.0x) and puree (1.0x); dried plum (1.0x); and peppermint and spearmint oil (0.08x).

 III.  EDWCs

Drinking water residues were incorporated directly into the acute and chronic dietary analyses ("water, direct, all sources" and "water, indirect, all sources") and were provided by EFED (Memo, G. Orrick, 20-SEP-2012; D404840).  The EDWCs were screening-level estimates generated with the Food Quality Protection Act (FQPA) Index Reservoir Screening Tool (FIRST) and a Provisional Cranberry Model for fenpyroximate and its metabolites (M-1 and M-3) in surface water and with Screening Concentration in Ground Water (SCI-GROW) for ground water.  Although the current and proposed end-use labels that result in the highest exposure are for ornamentals (an application rate to ornamentals of 0.343 lbs ai/A with a maximum application of 0.686 lbs ai/A), the use scenario with the highest acute and chronic EDWCs are for the cranberry scenario (see Table 1).

Table 1.  Maximum Screening EDWCs of Fenpyroximate for Current and Proposed Uses.[1]
                         Drinking Water Source (model)
                           Use (Maximum Annual Rate)
           Upper-Bound Estimated Drinking Water Concentrations (ppb)

                             Acute (peak exposure)
                        Chronic (annual mean exposure)
Surface Water (FIRST)
Ornamentals (0.69 lb ai/A)
                                      29
                                      1.9
Surface Water (Cranberry model)
Cranberries (0.20 lb ai/A)
                                      43
                                      8.6
Groundwater (SCI-GROW)
Ornamentals (0.69 lb ai/A)
                                   <0.27
  [1]  Maximum values in bold.

Surface water EDWCs of 0.043 ppm and 0.0086 ppm were used in the acute and chronic analyses, respectively, as these values were the highest and provided a more conservative approach.

IV.  DEEM-FCID Program and Consumption Information

Fenpyroximate acute and chronic dietary exposure assessments were conducted using DEEM-FCID (ver. 3.16) which incorporates consumption data from USDA's 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.  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 item 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.

 V.  Toxicological Information

 The toxicological endpoints as presented in the previous risk assessment are summarized below in Table 2.

Table 2.  Summary of Toxicological Dose and Endpoints for Fenpyroximate for Use in Dietary Risk Assessment[1].
Exposure
Scenario
Point of Departure
Uncertainty/FQPA Safety Factors
Study and Toxicological Effects
Acute Dietary
(Females 13-49 years old)
                                  NOAEL = 5.0
                                   mg/kg bw
UF = 100X
(for inter- and intra-species extrapolation)

FQPA SF = 1X
aRfD = aPAD = 0.05 mg/kg bw
Prenatal Developmental Toxicity Study - Rat
LOAEL = 25 mg/kg/day based on increase in the fetal incidence of additional thoracic ribs.
Acute Dietary
(General population)
                             NOAEL = 37.5 mg/kg bw
UF = 100X
(for inter- and intra-species extrapolation)

FQPA SF = 1X
aRfD = aPAD = 0.375 mg/kg bw
Acute Neurotoxicity Study  -  Rat
LOAEL = 150 mg/kg bw based on decreased motor activity (total activity counts and total time spent in movement) in both sexes, and a reduction in auditory startle response in females at 24 hours post dose, and mild dehydration in males.
Chronic Dietary
(All populations)
                                  NOAEL = 5.0
                                   mg/kg/day

UF = 100X
(for inter- and intra-species extrapolation)

FQPA SF = 1X
cRfD = cPAD
 = 0.05 mg/kg/day
Chronic toxicity - Dog
LOAEL = 15 mg/kg/day based on an increased incidence of bradycardia, diarrhea, and decreases in cholesterol, body-weight gain, and food consumption (M); vomiting, diarrhea, excess salivation and decrease cholesterol in females.
Cancer
(Oral, dermal, inhalation)
Classification:  "Not likely to be carcinogen," cancer risk assessment is not required.
[1]  NOAEL = no-observed adverse-effect level, LOAEL = lowest-observed adverse-effect level, RfD = reference dose, PAD = population-adjusted dose (a = acute, c = chronic), MOE = margin of exposure, UF = uncertainty factor, SF = safety factor.

 VI.  Results/Discussion

 Acute and chronic analyses were performed using DEEM-FCID (ver. 3.16).  DEEM-FCID (ver. 3.16) estimates the dietary exposure of the U.S. population and various population subgroups.  The results reported are for the general U.S. population, all infants (<1 year old), children 1-2 years old, children 3-5 years old, children 6-12 years old, youth 13-19 years old, females 13-49 years old, adults 20-49 years old, and adults 50-99 years old.

The resulting acute food plus drinking water risk estimates are not of concern to HED (<100% aPAD) at the 95[th] percentile of the exposure.  The resulting acute risk estimate is 13% of the aPAD at the 95[th] percentile of the exposure distribution for females 13 to 49 years old.  The highest acute exposure estimate for the U.S. population or population subgroup is children 1-2 years old, which resulted in a risk estimate of 6.2% aPAD.

The resulting chronic exposure estimates are not of concern to HED.  The most highly exposed population was children 1-2 years old utilizing 15% of the cPAD (see Table 3 for a summary of the results).  A chronic cancer dietary assessment was not conducted since it was determined that fenpyroximate is not a possible human carcinogen.

 Table 3.  Summary of Dietary (Food + Drinking Water) Exposure and Risk for Fenpyroximate.
                             Population Subgroup[1]
                                Acute Dietary[2]
                                (95 Percentile)
                               Chronic Dietary[3]
                                     Cancer

                                    Dietary
                              Exposure (mg/kg/day)
                                     % aPAD
                                Dietary Exposure
                                  (mg/kg/day)
                                     % cPAD
                                Dietary Exposure
                                  (mg/kg/day)
                                      Risk
General U.S. Population
                                    0.008312
                                      2.2
                                   0.002208
                                      4.4
                                       NA
                                       NA
All Infants (<1 year old)
                                    0.022585
                                      6.0
                                   0.004700
                                      9.4

 Children 1-2 years old
                                    0.023191
                                      6.2
                                    0.007336
                                       15

 Children 3-5 years old
                                    0.016596
                                      4.4
                                    0.005098
                                       10

 Children 6-12 years old
                                    0.009835
                                      2.6
                                    0.002723
                                      5.4

 Youth 13-19 years old
                                    0.005336
                                      1.4
                                    0.001394
                                      2.8

 Adults 20-49 years old
                                    0.006565
                                      1.8
                                    0.001712
                                      3.4

 Adults 50-99 years old
                                    0.006917
                                      1.8
                                    0.002013
                                      4.0

 Females 13-49 years old
                                    0.006685
                                       13
                                    0.001693
                                      3.4

 [1]  The values for the highest exposed population for each type of risk assessment is bolded.
 [2]  Separate acute toxicity endpoints were determined for females 13-49 years old and the general U.S. population and all population subgroups (see Table 2).
 [3]  Chronic dietary endpoint of 0.05 mg/kg/day applies to the general U.S. population and all population subgroups.

 VII.  Characterization of Inputs/Outputs

The acute and chronic analyses assumed tolerance-level residues, 100% CT, DEEM (ver. 7.81) default processing factors for all commodities excluding apple, pear, and grape juice (0.11x); grape, raisin (2.7x); orange, grapefruit, tangerine, lemon, and lime juice (0.06x); tomato paste (1.0x) and puree (1.0x); dried plum (1.0x); and peppermint and spearmint oil (0.08x).  These analyses are considered very conservative and could be refined through the use of anticipated-residue estimates (ARs) for all commodities, percent market share data for the proposed commodities, %CT data for registered commodities, and/or additional empirical processing factors.  However, at this time refinement is not necessary.

 VIII.  Conclusions

The acute and chronic dietary exposure and risk assessments were conducted using DEEM-FCID, ver. 3.16.  DEEM-FCID incorporates food consumption data from the USDA's NHANES/WWEIA.

Separate acute dietary risk analyses were conducted for females 13-49 years old and for the general U.S. population, as separate endpoints of concern attributable to a single dose were identified.  Both acute analyses assumed tolerance-level residues, 100% CT, DEEM (ver. 7.81) default processing factors for all commodities excluding apple, pear, and grape juice (0.11x); grape, raisin (2.7x); orange, grapefruit, tangerine, lemon, and lime juice (0.06x); tomato paste (1.0x) and puree (1.0x); dried plum (1.0x); and peppermint and spearmint oil (0.08x).  The acute analyses also incorporated the drinking water estimates provided by EFED.  The EDWCs were unrefined estimates for surface water calculated using the Provisional Cranberry Model for fenpyroximate and its metabolites (an EDWC of 0.043 ppm was used in the acute analyses).  The resulting acute food plus drinking water risk estimates are not of concern to HED (<100% aPAD) at the 95[th] percentile of the exposure distribution for females 13 to 49 years old or the general U.S. population.  The resulting acute risk estimate is 13% of the aPAD at the 95[th] percentile of the exposure distribution for females 13 to 49 years old.  The highest acute exposure estimate for the U.S. population or population subgroup is children 1-2 years old, which resulted in a risk estimate of 6.2% aPAD.

The chronic analysis assumed tolerance-level residues, 100% CT, DEEM (ver. 7.81) default processing factors for most commodities (see above).  The chronic analysis also incorporated the drinking water estimates provided by EFED.  The EDWCs were unrefined estimates for surface water calculated using the Provisional Cranberry Model for fenpyroximate and its metabolites (an EDWC of 0.0086 ppm was used in the chronic analysis).  The resulting chronic risk estimates are not of concern to HED.  The most highly exposed population was children 1-2 years old utilizing 15% of the cPAD.

Attachments
 Attachment 1:  DEEM-FCID Acute Food + Drinking Water Residue Input File.
 Attachment 2:  DEEM-FCID Acute Exposure Estimates for Females 13-49 Years Old.
 Attachment 3:  DEEM-FCID Acute Exposure Estimates for the General U.S. Population Subgroup.
 Attachment 4:  DEEM-FCID Chronic Food + Drinking Water Residue Input File.
 Attachment 5:  DEEM-FCID Chronic Exposure Estimates.

cc:  G. Kramer (RAB1)
RDI:  DE SAC Reviewers (28-JAN-2013)
G.F. Kramer:S10957:PY-S:(703)305-5079:7509P:RAB1
    Attachment 1:  DEEM-FCID Acute Food + Drinking Water Residue Input File.

Filename: C:\Documents and Settings\gkramer\My Documents\Gk\#$Fenpyroximate\129131a.R08
Chemical: Fenpyroximate
RfD(Chronic): .05 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .375 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 01-24-2013/14:17:01       Program ver. 3.16, 03-08-d
Comment: New uses; added additional acute endpt. for general population
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2
---------- ---- -------------------------------  ----------  ------ ------  -------
0103015000 1CD  Arrowroot, flour                   0.100000   1.000  1.000
0103015001 1CD  Arrowroot, flour-babyfood          0.100000   1.000  1.000
0103017000 1CD  Artichoke, Jerusalem               0.100000   1.000  1.000
0103082000 1CD  Cassava                            0.100000   1.000  1.000
0103082001 1CD  Cassava-babyfood                   0.100000   1.000  1.000
0103139000 1CD  Dasheen, corm                      0.100000   1.000  1.000
0103166000 1CD  Ginger                             0.100000   1.000  1.000
0103166001 1CD  Ginger-babyfood                    0.100000   1.000  1.000
0103167000 1CD  Ginger, dried                      0.100000   1.000  1.000
0103296000 1C   Potato, chips                      0.100000   1.000  1.000
0103297000 1C   Potato, dry (granules/ flakes)     0.100000   6.500  1.000
0103297001 1C   Potato, dry (granules/ flakes)-b   0.100000   6.500  1.000
0103298000 1C   Potato, flour                      0.100000   6.500  1.000
0103298001 1C   Potato, flour-babyfood             0.100000   6.500  1.000
0103299000 1C   Potato, tuber, w/peel              0.100000   1.000  1.000
0103299001 1C   Potato, tuber, w/peel-babyfood     0.100000   1.000  1.000
0103300000 1C   Potato, tuber, w/o peel            0.100000   1.000  1.000
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.100000   1.000  1.000
0103366000 1CD  Sweet potato                       0.100000   1.000  1.000
0103366001 1CD  Sweet potato-babyfood              0.100000   1.000  1.000
0103371000 1CD  Tanier, corm                       0.100000   1.000  1.000
0103387000 1CD  Turmeric                           0.100000   1.000  1.000
0103406000 1CD  Yam, true                          0.100000   1.000  1.000
0103407000 1CD  Yam bean                           0.100000   1.000  1.000
0601043000 6A   Bean, snap, succulent              0.400000   1.000  1.000
0601043001 6A   Bean, snap, succulent-babyfood     0.400000   1.000  1.000
0801374000 8A   Tomatillo                          0.200000   1.000  1.000
0801375000 8A   Tomato                             0.200000   1.000  1.000
0801375001 8A   Tomato-babyfood                    0.200000   1.000  1.000
0801376000 8A   Tomato, paste                      0.200000   1.000  1.000
0801376001 8A   Tomato, paste-babyfood             0.200000   1.000  1.000
0801377000 8A   Tomato, puree                      0.200000   1.000  1.000
0801377001 8A   Tomato, puree-babyfood             0.200000   1.000  1.000
0801378000 8A   Tomato, dried                      0.200000  14.300  1.000
0801378001 8A   Tomato, dried-babyfood             0.200000  14.300  1.000
0801379000 8A   Tomato, juice                      0.200000   1.500  1.000
0801380000 8A   Tomato, Tree                       0.200000   1.000  1.000
0802148000 8BC  Eggplant                           0.200000   1.000  1.000
0802234000 8BC  Okra                               0.200000   1.000  1.000
0802270000 8B   Pepper, bell                       0.200000   1.000  1.000
0802270001 8B   Pepper, bell-babyfood              0.200000   1.000  1.000
0802271000 8B   Pepper, bell, dried                0.200000   1.000  1.000
0802271001 8B   Pepper, bell, dried-babyfood       0.200000   1.000  1.000
0802272000 8BC  Pepper, nonbell                    0.200000   1.000  1.000
0802272001 8BC  Pepper, nonbell-babyfood           0.200000   1.000  1.000
0802273000 8BC  Pepper, nonbell, dried             0.200000   1.000  1.000
0901075000 9A   Cantaloupe                         0.100000   1.000  1.000
0901187000 9A   Honeydew melon                     0.100000   1.000  1.000
0901399000 9A   Watermelon                         0.100000   1.000  1.000
0901400000 9A   Watermelon, juice                  0.100000   1.000  1.000
0902135000 9B   Cucumber                           0.400000   1.000  1.000
1001106000 10A  Citron                             0.500000   1.000  1.000
1001107000 10A  Citrus hybrids                     0.500000   1.000  1.000
1001108000 10A  Citrus, oil                       10.000000   1.000  1.000
1001240000 10A  Orange                             0.500000   1.000  1.000
1001241000 10A  Orange, juice                      0.500000   0.060  1.000
1001241001 10A  Orange, juice-babyfood             0.500000   0.060  1.000
1001242000 10A  Orange, peel                       0.500000   1.000  1.000
1001369000 10A  Tangerine                          0.500000   1.000  1.000
1001370000 10A  Tangerine, juice                   0.500000   0.060  1.000
1002197000 10B  Kumquat                            0.500000   1.000  1.000
1002199000 10B  Lemon                              0.500000   1.000  1.000
1002200000 10B  Lemon, juice                       0.500000   0.060  1.000
1002200001 10B  Lemon, juice-babyfood              0.500000   0.060  1.000
1002201000 10B  Lemon, peel                        0.500000   1.000  1.000
1002206000 10B  Lime                               0.500000   1.000  1.000
1002207000 10B  Lime, juice                        0.500000   0.060  1.000
1002207001 10B  Lime, juice-babyfood               0.500000   0.060  1.000
1003180000 10C  Grapefruit                         0.500000   1.000  1.000
1003181000 10C  Grapefruit, juice                  0.500000   0.060  1.000
1003307000 10C  Pummelo                            0.500000   1.000  1.000
1100007000 11   Apple, fruit with peel             0.300000   1.000  1.000
1100008000 11   Apple, peeled fruit                0.300000   1.000  1.000
1100008001 11   Apple, peeled fruit-babyfood       0.300000   1.000  1.000
1100009000 11   Apple, dried                       0.300000   8.000  1.000
1100009001 11   Apple, dried-babyfood              0.300000   8.000  1.000
1100010000 11   Apple, juice                       0.300000   0.110  1.000
1100010001 11   Apple, juice-babyfood              0.300000   0.110  1.000
1100011000 11   Apple, sauce                       0.300000   1.000  1.000
1100011001 11   Apple, sauce-babyfood              0.300000   1.000  1.000
1100129000 11   Crabapple                          0.300000   1.000  1.000
1100173500 11   Goji berry                         0.200000   1.000  1.000
1100210000 11   Loquat                             0.300000   1.000  1.000
1100266000 11   Pear                               0.300000   1.000  1.000
1100266001 11   Pear-babyfood                      0.300000   1.000  1.000
1100267000 11   Pear, dried                        0.300000   6.250  1.000
1100268000 11   Pear, juice                        0.300000   0.110  1.000
1100268001 11   Pear, juice-babyfood               0.300000   0.110  1.000
1100310000 11   Quince                             0.300000   1.000  1.000
1201090000 12A  Cherry                             2.000000   1.000  1.000
1201090001 12A  Cherry-babyfood                    2.000000   1.000  1.000
1201091000 12A  Cherry, juice                      2.000000   1.500  1.000
1201091001 12A  Cherry, juice-babyfood             2.000000   1.500  1.000
1202012000 12B  Apricot                            2.000000   1.000  1.000
1202012001 12B  Apricot-babyfood                   2.000000   1.000  1.000
1202013000 12B  Apricot, dried                     2.000000   6.000  1.000
1202014000 12B  Apricot, juice                     2.000000   1.000  1.000
1202014001 12B  Apricot, juice-babyfood            2.000000   1.000  1.000
1202230000 12B  Nectarine                          2.000000   1.000  1.000
1202260000 12B  Peach                              2.000000   1.000  1.000
1202260001 12B  Peach-babyfood                     2.000000   1.000  1.000
1202261000 12B  Peach, dried                       2.000000   7.000  1.000
1202261001 12B  Peach, dried-babyfood              2.000000   7.000  1.000
1202262000 12B  Peach, juice                       2.000000   1.000  1.000
1202262001 12B  Peach, juice-babyfood              2.000000   1.000  1.000
1203285000 12C  Plum                               2.000000   1.000  1.000
1203285001 12C  Plum-babyfood                      2.000000   1.000  1.000
1203286000 12C  Plum, prune, fresh                 2.000000   1.000  1.000
1203286001 12C  Plum, prune, fresh-babyfood        2.000000   1.000  1.000
1203287000 12C  Plum, prune, dried                 2.000000   1.000  1.000
1203287001 12C  Plum, prune, dried-babyfood        2.000000   1.000  1.000
1203288000 12C  Plum, prune, juice                 2.000000   1.400  1.000
1203288001 12C  Plum, prune, juice-babyfood        2.000000   1.400  1.000
1302057000 13B  Blueberry                          1.000000   1.000  1.000
1302057001 13B  Blueberry-babyfood                 1.000000   1.000  1.000
1302174000 13B  Gooseberry                         1.000000   1.000  1.000
1304175000 13D  Grape                              1.000000   1.000  1.000
1304176000 13D  Grape, juice                       1.000000   0.110  1.000
1304176001 13D  Grape, juice-babyfood              1.000000   0.110  1.000
1304179000 13D  Grape, wine and sherry             1.000000   1.000  1.000
1307130000 13G  Cranberry                          1.000000   1.000  1.000
1307130001 13G  Cranberry-babyfood                 1.000000   1.000  1.000
1307131000 13G  Cranberry, dried                   1.000000   1.000  1.000
1307132000 13G  Cranberry, juice                   1.000000   1.100  1.000
1307132001 13G  Cranberry, juice-babyfood          1.000000   1.100  1.000
1307359000 13G  Strawberry                         1.000000   1.000  1.000
1307359001 13G  Strawberry-babyfood                1.000000   1.000  1.000
1307360000 13G  Strawberry, juice                  1.000000   1.000  1.000
1307360001 13G  Strawberry, juice-babyfood         1.000000   1.000  1.000
1400003000 14   Almond                             0.100000   1.000  1.000
1400003001 14   Almond-babyfood                    0.100000   1.000  1.000
1400004000 14   Almond, oil                        0.100000   1.000  1.000
1400004001 14   Almond, oil-babyfood               0.100000   1.000  1.000
1400059000 14   Brazil nut                         0.100000   1.000  1.000
1400068000 14   Butternut                          0.100000   1.000  1.000
1400081000 14   Cashew                             0.100000   1.000  1.000
1400092000 14   Chestnut                           0.100000   1.000  1.000
1400155000 14   Hazelnut                           0.100000   1.000  1.000
1400156000 14   Hazelnut, oil                      0.100000   1.000  1.000
1400185000 14   Hickory nut                        0.100000   1.000  1.000
1400213000 14   Macadamia nut                      0.100000   1.000  1.000
1400269000 14   Pecan                              0.100000   1.000  1.000
1400282000 14   Pistachio                          0.100000   1.000  1.000
1400391000 14   Walnut                             0.100000   1.000  1.000
1500120000 15   Corn, field, flour                 0.020000   1.000  1.000
1500120001 15   Corn, field, flour-babyfood        0.020000   1.000  1.000
1500121000 15   Corn, field, meal                  0.020000   1.000  1.000
1500121001 15   Corn, field, meal-babyfood         0.020000   1.000  1.000
1500122000 15   Corn, field, bran                  0.020000   1.000  1.000
1500123000 15   Corn, field, starch                0.020000   1.000  1.000
1500123001 15   Corn, field, starch-babyfood       0.020000   1.000  1.000
1500124000 15   Corn, field, syrup                 0.020000   1.500  1.000
1500124001 15   Corn, field, syrup-babyfood        0.020000   1.500  1.000
1500125000 15   Corn, field, oil                   0.050000   1.000  1.000
1500125001 15   Corn, field, oil-babyfood          0.050000   1.000  1.000
1500126000 15   Corn, pop                          0.020000   1.000  1.000
2003128000 20C  Cottonseed, oil                    0.100000   1.000  1.000
2003128001 20C  Cottonseed, oil-babyfood           0.100000   1.000  1.000
3100044000 31   Beef, meat                         0.030000   1.000  1.000
3100044001 31   Beef, meat-babyfood                0.030000   1.000  1.000
3100045000 31   Beef, meat, dried                  0.030000   1.920  1.000
3100046000 31   Beef, meat byproducts              0.030000   1.000  1.000
3100046001 31   Beef, meat byproducts-babyfood     0.030000   1.000  1.000
3100047000 31   Beef, fat                          0.030000   1.000  1.000
3100047001 31   Beef, fat-babyfood                 0.030000   1.000  1.000
3100048000 31   Beef, kidney                       0.250000   1.000  1.000
3100049000 31   Beef, liver                        0.250000   1.000  1.000
3100049001 31   Beef, liver-babyfood               0.250000   1.000  1.000
3200169000 32   Goat, meat                         0.030000   1.000  1.000
3200170000 32   Goat, meat byproducts              0.030000   1.000  1.000
3200171000 32   Goat, fat                          0.030000   1.000  1.000
3200172000 32   Goat, kidney                       0.250000   1.000  1.000
3200173000 32   Goat, liver                        0.250000   1.000  1.000
3300189000 33   Horse, meat                        0.030000   1.000  1.000
3500339000 35   Sheep, meat                        0.030000   1.000  1.000
3500339001 35   Sheep, meat-babyfood               0.030000   1.000  1.000
3500340000 35   Sheep, meat byproducts             0.030000   1.000  1.000
3500341000 35   Sheep, fat                         0.030000   1.000  1.000
3500341001 35   Sheep, fat-babyfood                0.030000   1.000  1.000
3500342000 35   Sheep, kidney                      0.250000   1.000  1.000
3500343000 35   Sheep, liver                       0.250000   1.000  1.000
3600222000 36   Milk, fat                          0.015000   1.000  1.000
3600222001 36   Milk, fat-baby food/infant formu   0.015000   1.000  1.000
3600223000 36   Milk, nonfat solids                0.015000   1.000  1.000
3600223001 36   Milk, nonfat solids-baby food/in   0.015000   1.000  1.000
3600224000 36   Milk, water                        0.015000   1.000  1.000
3600224001 36   Milk, water-babyfood/infant form   0.015000   1.000  1.000
3600225001 36   Milk, sugar (lactose)-baby food/   0.015000   1.000  1.000
8601000000 86A  Water, direct, all sources
                   110-Uncooked; Fresh or N/S; Cook Meth N/S
                                                   0.043000   1.000  1.000
8602000000 86B  Water, indirect, all sources       0.043000   1.000  1.000
9500020000 O    Avocado                            0.150000   1.000  1.000
9500074000 O    Canistel                           0.150000   1.000  1.000
9500177000 O    Grape, leaves                      1.000000   1.000  1.000
9500178000 O    Grape, raisin                      1.000000   2.700  1.000
9500186000 O    Honey                              0.100000   1.000  1.000
9500186001 O    Honey-babyfood                     0.100000   1.000  1.000
9500188000 O    Hop                               10.000000   1.000  1.000
9500215000 O    Mango                              0.150000   1.000  1.000
9500215001 O    Mango-babyfood                     0.150000   1.000  1.000
9500216000 O    Mango, dried                       0.150000   1.000  1.000
9500217000 O    Mango, juice                       0.150000   1.000  1.000
9500217001 O    Mango, juice-babyfood              0.150000   1.000  1.000
9500245000 O    Papaya                             0.150000   1.000  1.000
9500245001 O    Papaya-babyfood                    0.150000   1.000  1.000
9500246000 O    Papaya, dried                      0.150000   1.800  1.000
9500247000 O    Papaya, juice                      0.150000   1.500  1.000
9500275000 O    Peppermint                         7.000000   1.000  1.000
9500276000 O    Peppermint, oil                    7.000000   0.080  1.000
9500333000 O    Sapote, Mamey                      0.150000   1.000  1.000
9500352000 O    Spearmint                          7.000000   1.000  1.000
9500353000 O    Spearmint, oil                     7.000000   0.080  1.000
9500372000 O    Tea, dried                        20.000000   1.000  1.000
9500373000 O    Tea, instant                      20.000000   1.000  1.000
 Attachment 2:  DEEM-FCID Acute Exposure Estimates for Females 13 to 49 Years Old.

EPA                                                         Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for FENPYROXIMATE               NHANES 2003-2008 2-Day
Residue file: 129131a.R08                             Adjustment factor #2 used.
Analysis Date: 02-01-2013/11:22:40    Residue file dated: 02-01-2013/11:17:00
RAC/FF intake summed over 24 hours
Run Comment: "New uses; added additional acute endpt. for general population"
===============================================================================

Summary calculations--per capita:

                   95th Percentile      99th Percentile     99.9th Percentile
                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD
                  ---------- --------  ---------- --------  ---------- --------
Female 13-49:
                    0.006685    13.37    0.010890    21.78    0.018888    37.78
Attachment 3:  DEEM-FCID Acute Exposure Estimates for the General U.S. Population Subgroups.

EPA                                                         Ver. 3.16, 03-08-d
DEEM-FCID ACUTE Analysis for FENPYROXIMATE               NHANES 2003-2008 2-Day
Residue file: 129131a.R08                             Adjustment factor #2 used.
Analysis Date: 02-01-2013/11:21:36    Residue file dated: 02-01-2013/11:17:00
RAC/FF intake summed over 24 hours
Run Comment: "New uses; added additional acute endpt. for general population"
===============================================================================

Summary calculations--per capita:

                   95th Percentile      99th Percentile     99.9th Percentile
                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD
                  ---------- --------  ---------- --------  ---------- --------
Total US Population:
                    0.008312     2.22    0.015331     4.09    0.031367     8.36
All Infants:
                    0.022585     6.02    0.038089    10.16    0.064723    17.26
Children 1-2:
                    0.023191     6.18    0.035415     9.44    0.059443    15.85
Children 3-5:
                    0.016596     4.43    0.023834     6.36    0.041924    11.18
Children 6-12:
                    0.009835     2.62    0.017059     4.55    0.029926     7.98
Youth 13-19:
                    0.005336     1.42    0.009026     2.41    0.018289     4.88
Adults 20-49:
                    0.006565     1.75    0.010483     2.80    0.018315     4.88
Adults 50-99:
                    0.006917     1.84    0.011416     3.04    0.017527     4.67

   Attachment 4:  DEEM-FCID Chronic Food + Drinking Water Residue Input File.

Filename: C:\Documents and Settings\gkramer\My Documents\Gk\#$Fenpyroximate\129131C.R08
Chemical: Fenpyroximate
RfD(Chronic): .05 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): .375 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 02-01-2013/11:15:04       Program ver. 3.16, 03-08-d
Comment: New uses; added additional acute endpt. for general population
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2
---------- ---- -------------------------------  ----------  ------ ------  -------
0103015000 1CD  Arrowroot, flour                   0.100000   1.000  1.000
0103015001 1CD  Arrowroot, flour-babyfood          0.100000   1.000  1.000
0103017000 1CD  Artichoke, Jerusalem               0.100000   1.000  1.000
0103082000 1CD  Cassava                            0.100000   1.000  1.000
0103082001 1CD  Cassava-babyfood                   0.100000   1.000  1.000
0103139000 1CD  Dasheen, corm                      0.100000   1.000  1.000
0103166000 1CD  Ginger                             0.100000   1.000  1.000
0103166001 1CD  Ginger-babyfood                    0.100000   1.000  1.000
0103167000 1CD  Ginger, dried                      0.100000   1.000  1.000
0103296000 1C   Potato, chips                      0.100000   1.000  1.000
0103297000 1C   Potato, dry (granules/ flakes)     0.100000   6.500  1.000
0103297001 1C   Potato, dry (granules/ flakes)-b   0.100000   6.500  1.000
0103298000 1C   Potato, flour                      0.100000   6.500  1.000
0103298001 1C   Potato, flour-babyfood             0.100000   6.500  1.000
0103299000 1C   Potato, tuber, w/peel              0.100000   1.000  1.000
0103299001 1C   Potato, tuber, w/peel-babyfood     0.100000   1.000  1.000
0103300000 1C   Potato, tuber, w/o peel            0.100000   1.000  1.000
0103300001 1C   Potato, tuber, w/o peel-babyfood   0.100000   1.000  1.000
0103366000 1CD  Sweet potato                       0.100000   1.000  1.000
0103366001 1CD  Sweet potato-babyfood              0.100000   1.000  1.000
0103371000 1CD  Tanier, corm                       0.100000   1.000  1.000
0103387000 1CD  Turmeric                           0.100000   1.000  1.000
0103406000 1CD  Yam, true                          0.100000   1.000  1.000
0103407000 1CD  Yam bean                           0.100000   1.000  1.000
0601043000 6A   Bean, snap, succulent              0.400000   1.000  1.000
0601043001 6A   Bean, snap, succulent-babyfood     0.400000   1.000  1.000
0801374000 8A   Tomatillo                          0.200000   1.000  1.000
0801375000 8A   Tomato                             0.200000   1.000  1.000
0801375001 8A   Tomato-babyfood                    0.200000   1.000  1.000
0801376000 8A   Tomato, paste                      0.200000   1.000  1.000
0801376001 8A   Tomato, paste-babyfood             0.200000   1.000  1.000
0801377000 8A   Tomato, puree                      0.200000   1.000  1.000
0801377001 8A   Tomato, puree-babyfood             0.200000   1.000  1.000
0801378000 8A   Tomato, dried                      0.200000  14.300  1.000
0801378001 8A   Tomato, dried-babyfood             0.200000  14.300  1.000
0801379000 8A   Tomato, juice                      0.200000   1.500  1.000
0801380000 8A   Tomato, Tree                       0.200000   1.000  1.000
0802148000 8BC  Eggplant                           0.200000   1.000  1.000
0802234000 8BC  Okra                               0.200000   1.000  1.000
0802270000 8B   Pepper, bell                       0.200000   1.000  1.000
0802270001 8B   Pepper, bell-babyfood              0.200000   1.000  1.000
0802271000 8B   Pepper, bell, dried                0.200000   1.000  1.000
0802271001 8B   Pepper, bell, dried-babyfood       0.200000   1.000  1.000
0802272000 8BC  Pepper, nonbell                    0.200000   1.000  1.000
0802272001 8BC  Pepper, nonbell-babyfood           0.200000   1.000  1.000
0802273000 8BC  Pepper, nonbell, dried             0.200000   1.000  1.000
0901075000 9A   Cantaloupe                         0.100000   1.000  1.000
0901187000 9A   Honeydew melon                     0.100000   1.000  1.000
0901399000 9A   Watermelon                         0.100000   1.000  1.000
0901400000 9A   Watermelon, juice                  0.100000   1.000  1.000
0902135000 9B   Cucumber                           0.400000   1.000  1.000
1001106000 10A  Citron                             0.500000   1.000  1.000
1001107000 10A  Citrus hybrids                     0.500000   1.000  1.000
1001108000 10A  Citrus, oil                       10.000000   1.000  1.000
1001240000 10A  Orange                             0.500000   1.000  1.000
1001241000 10A  Orange, juice                      0.500000   0.060  1.000
1001241001 10A  Orange, juice-babyfood             0.500000   0.060  1.000
1001242000 10A  Orange, peel                       0.500000   1.000  1.000
1001369000 10A  Tangerine                          0.500000   1.000  1.000
1001370000 10A  Tangerine, juice                   0.500000   0.060  1.000
1002197000 10B  Kumquat                            0.500000   1.000  1.000
1002199000 10B  Lemon                              0.500000   1.000  1.000
1002200000 10B  Lemon, juice                       0.500000   0.060  1.000
1002200001 10B  Lemon, juice-babyfood              0.500000   0.060  1.000
1002201000 10B  Lemon, peel                        0.500000   1.000  1.000
1002206000 10B  Lime                               0.500000   1.000  1.000
1002207000 10B  Lime, juice                        0.500000   0.060  1.000
1002207001 10B  Lime, juice-babyfood               0.500000   0.060  1.000
1003180000 10C  Grapefruit                         0.500000   1.000  1.000
1003181000 10C  Grapefruit, juice                  0.500000   0.060  1.000
1003307000 10C  Pummelo                            0.500000   1.000  1.000
1100007000 11   Apple, fruit with peel             0.300000   1.000  1.000
1100008000 11   Apple, peeled fruit                0.300000   1.000  1.000
1100008001 11   Apple, peeled fruit-babyfood       0.300000   1.000  1.000
1100009000 11   Apple, dried                       0.300000   8.000  1.000
1100009001 11   Apple, dried-babyfood              0.300000   8.000  1.000
1100010000 11   Apple, juice                       0.300000   0.110  1.000
1100010001 11   Apple, juice-babyfood              0.300000   0.110  1.000
1100011000 11   Apple, sauce                       0.300000   1.000  1.000
1100011001 11   Apple, sauce-babyfood              0.300000   1.000  1.000
1100129000 11   Crabapple                          0.300000   1.000  1.000
1100173500 11   Goji berry                         0.200000   1.000  1.000
1100210000 11   Loquat                             0.300000   1.000  1.000
1100266000 11   Pear                               0.300000   1.000  1.000
1100266001 11   Pear-babyfood                      0.300000   1.000  1.000
1100267000 11   Pear, dried                        0.300000   6.250  1.000
1100268000 11   Pear, juice                        0.300000   0.110  1.000
1100268001 11   Pear, juice-babyfood               0.300000   0.110  1.000
1100310000 11   Quince                             0.300000   1.000  1.000
1201090000 12A  Cherry                             2.000000   1.000  1.000
1201090001 12A  Cherry-babyfood                    2.000000   1.000  1.000
1201091000 12A  Cherry, juice                      2.000000   1.500  1.000
1201091001 12A  Cherry, juice-babyfood             2.000000   1.500  1.000
1202012000 12B  Apricot                            2.000000   1.000  1.000
1202012001 12B  Apricot-babyfood                   2.000000   1.000  1.000
1202013000 12B  Apricot, dried                     2.000000   6.000  1.000
1202014000 12B  Apricot, juice                     2.000000   1.000  1.000
1202014001 12B  Apricot, juice-babyfood            2.000000   1.000  1.000
1202230000 12B  Nectarine                          2.000000   1.000  1.000
1202260000 12B  Peach                              2.000000   1.000  1.000
1202260001 12B  Peach-babyfood                     2.000000   1.000  1.000
1202261000 12B  Peach, dried                       2.000000   7.000  1.000
1202261001 12B  Peach, dried-babyfood              2.000000   7.000  1.000
1202262000 12B  Peach, juice                       2.000000   1.000  1.000
1202262001 12B  Peach, juice-babyfood              2.000000   1.000  1.000
1203285000 12C  Plum                               2.000000   1.000  1.000
1203285001 12C  Plum-babyfood                      2.000000   1.000  1.000
1203286000 12C  Plum, prune, fresh                 2.000000   1.000  1.000
1203286001 12C  Plum, prune, fresh-babyfood        2.000000   1.000  1.000
1203287000 12C  Plum, prune, dried                 2.000000   1.000  1.000
1203287001 12C  Plum, prune, dried-babyfood        2.000000   1.000  1.000
1203288000 12C  Plum, prune, juice                 2.000000   1.400  1.000
1203288001 12C  Plum, prune, juice-babyfood        2.000000   1.400  1.000
1302057000 13B  Blueberry                          1.000000   1.000  1.000
1302057001 13B  Blueberry-babyfood                 1.000000   1.000  1.000
1302174000 13B  Gooseberry                         1.000000   1.000  1.000
1304175000 13D  Grape                              1.000000   1.000  1.000
1304176000 13D  Grape, juice                       1.000000   0.110  1.000
1304176001 13D  Grape, juice-babyfood              1.000000   0.110  1.000
1304179000 13D  Grape, wine and sherry             1.000000   1.000  1.000
1307130000 13G  Cranberry                          1.000000   1.000  1.000
1307130001 13G  Cranberry-babyfood                 1.000000   1.000  1.000
1307131000 13G  Cranberry, dried                   1.000000   1.000  1.000
1307132000 13G  Cranberry, juice                   1.000000   1.100  1.000
1307132001 13G  Cranberry, juice-babyfood          1.000000   1.100  1.000
1307359000 13G  Strawberry                         1.000000   1.000  1.000
1307359001 13G  Strawberry-babyfood                1.000000   1.000  1.000
1307360000 13G  Strawberry, juice                  1.000000   1.000  1.000
1307360001 13G  Strawberry, juice-babyfood         1.000000   1.000  1.000
1400003000 14   Almond                             0.100000   1.000  1.000
1400003001 14   Almond-babyfood                    0.100000   1.000  1.000
1400004000 14   Almond, oil                        0.100000   1.000  1.000
1400004001 14   Almond, oil-babyfood               0.100000   1.000  1.000
1400059000 14   Brazil nut                         0.100000   1.000  1.000
1400068000 14   Butternut                          0.100000   1.000  1.000
1400081000 14   Cashew                             0.100000   1.000  1.000
1400092000 14   Chestnut                           0.100000   1.000  1.000
1400155000 14   Hazelnut                           0.100000   1.000  1.000
1400156000 14   Hazelnut, oil                      0.100000   1.000  1.000
1400185000 14   Hickory nut                        0.100000   1.000  1.000
1400213000 14   Macadamia nut                      0.100000   1.000  1.000
1400269000 14   Pecan                              0.100000   1.000  1.000
1400282000 14   Pistachio                          0.100000   1.000  1.000
1400391000 14   Walnut                             0.100000   1.000  1.000
1500120000 15   Corn, field, flour                 0.020000   1.000  1.000
1500120001 15   Corn, field, flour-babyfood        0.020000   1.000  1.000
1500121000 15   Corn, field, meal                  0.020000   1.000  1.000
1500121001 15   Corn, field, meal-babyfood         0.020000   1.000  1.000
1500122000 15   Corn, field, bran                  0.020000   1.000  1.000
1500123000 15   Corn, field, starch                0.020000   1.000  1.000
1500123001 15   Corn, field, starch-babyfood       0.020000   1.000  1.000
1500124000 15   Corn, field, syrup                 0.020000   1.500  1.000
1500124001 15   Corn, field, syrup-babyfood        0.020000   1.500  1.000
1500125000 15   Corn, field, oil                   0.050000   1.000  1.000
1500125001 15   Corn, field, oil-babyfood          0.050000   1.000  1.000
1500126000 15   Corn, pop                          0.020000   1.000  1.000
2003128000 20C  Cottonseed, oil                    0.100000   1.000  1.000
2003128001 20C  Cottonseed, oil-babyfood           0.100000   1.000  1.000
3100044000 31   Beef, meat                         0.030000   1.000  1.000
3100044001 31   Beef, meat-babyfood                0.030000   1.000  1.000
3100045000 31   Beef, meat, dried                  0.030000   1.920  1.000
3100046000 31   Beef, meat byproducts              0.030000   1.000  1.000
3100046001 31   Beef, meat byproducts-babyfood     0.030000   1.000  1.000
3100047000 31   Beef, fat                          0.030000   1.000  1.000
3100047001 31   Beef, fat-babyfood                 0.030000   1.000  1.000
3100048000 31   Beef, kidney                       0.250000   1.000  1.000
3100049000 31   Beef, liver                        0.250000   1.000  1.000
3100049001 31   Beef, liver-babyfood               0.250000   1.000  1.000
3200169000 32   Goat, meat                         0.030000   1.000  1.000
3200170000 32   Goat, meat byproducts              0.030000   1.000  1.000
3200171000 32   Goat, fat                          0.030000   1.000  1.000
3200172000 32   Goat, kidney                       0.250000   1.000  1.000
3200173000 32   Goat, liver                        0.250000   1.000  1.000
3300189000 33   Horse, meat                        0.030000   1.000  1.000
3500339000 35   Sheep, meat                        0.030000   1.000  1.000
3500339001 35   Sheep, meat-babyfood               0.030000   1.000  1.000
3500340000 35   Sheep, meat byproducts             0.030000   1.000  1.000
3500341000 35   Sheep, fat                         0.030000   1.000  1.000
3500341001 35   Sheep, fat-babyfood                0.030000   1.000  1.000
3500342000 35   Sheep, kidney                      0.250000   1.000  1.000
3500343000 35   Sheep, liver                       0.250000   1.000  1.000
3600222000 36   Milk, fat                          0.015000   1.000  1.000
3600222001 36   Milk, fat-baby food/infant formu   0.015000   1.000  1.000
3600223000 36   Milk, nonfat solids                0.015000   1.000  1.000
3600223001 36   Milk, nonfat solids-baby food/in   0.015000   1.000  1.000
3600224000 36   Milk, water                        0.015000   1.000  1.000
3600224001 36   Milk, water-babyfood/infant form   0.015000   1.000  1.000
3600225001 36   Milk, sugar (lactose)-baby food/   0.015000   1.000  1.000
8601000000 86A  Water, direct, all sources
                   110-Uncooked; Fresh or N/S; Cook Meth N/S
                                                   0.008600   1.000  1.000
8602000000 86B  Water, indirect, all sources       0.008600   1.000  1.000
9500020000 O    Avocado                            0.150000   1.000  1.000
9500074000 O    Canistel                           0.150000   1.000  1.000
9500177000 O    Grape, leaves                      1.000000   1.000  1.000
9500178000 O    Grape, raisin                      1.000000   2.700  1.000
9500186000 O    Honey                              0.100000   1.000  1.000
9500186001 O    Honey-babyfood                     0.100000   1.000  1.000
9500188000 O    Hop                               10.000000   1.000  1.000
9500215000 O    Mango                              0.150000   1.000  1.000
9500215001 O    Mango-babyfood                     0.150000   1.000  1.000
9500216000 O    Mango, dried                       0.150000   1.000  1.000
9500217000 O    Mango, juice                       0.150000   1.000  1.000
9500217001 O    Mango, juice-babyfood              0.150000   1.000  1.000
9500245000 O    Papaya                             0.150000   1.000  1.000
9500245001 O    Papaya-babyfood                    0.150000   1.000  1.000
9500246000 O    Papaya, dried                      0.150000   1.800  1.000
9500247000 O    Papaya, juice                      0.150000   1.500  1.000
9500275000 O    Peppermint                         7.000000   1.000  1.000
9500276000 O    Peppermint, oil                    7.000000   0.080  1.000
9500333000 O    Sapote, Mamey                      0.150000   1.000  1.000
9500352000 O    Spearmint                          7.000000   1.000  1.000
9500353000 O    Spearmint, oil                     7.000000   0.080  1.000
9500372000 O    Tea, dried                        20.000000   1.000  1.000
9500373000 O    Tea, instant                      20.000000   1.000  1.000
              Attachment 5:  DEEM-FCID Chronic Exposure Estimates.

EPA                                                             Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for FENPYROXIMATE               NHANES 2003-2008 2-day
Residue file name: C:\Documents and Settings\gkramer\My Documents\Gk\#$Fenpyroximate\129131C.R08
                                                     Adjustment factor #2 used.
Analysis Date 02-01-2013/11:19:11     Residue file dated: 02-01-2013/11:15:04
Reference dose (RfD, Chronic) = .05 mg/kg bw/day
COMMENT 1: New uses; added additional acute endpt. for general population
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of
           Subgroup                       body wt/day             Rfd
--------------------------------------   -------------       ----------------
Total US Population                         0.002208                 4.4%
Hispanic                                    0.002196                 4.4%
Non-Hisp-White                              0.002285                 4.6%
Non-Hisp-Black                              0.001775                 3.5%
Non-Hisp-Other                              0.002235                 4.5%
Nursing Infants                             0.003063                 6.1%
Non-Nursing Infants                         0.005431                10.9%
Female 13+ PREG                             0.001848                 3.7%
Children 1-6                                0.005749                11.5%
Children 7-12                               0.002458                 4.9%
Male 13-19                                  0.001337                 2.7%
Female 13-19/NP                             0.001458                 2.9%
Male 20+                                    0.001755                 3.5%
Female 20+/NP                               0.001911                 3.8%
Seniors 55+                                 0.002081                 4.2%
All Infants                                 0.004700                 9.4%
Female 13-50                                0.001695                 3.4%
Children 1-2                                0.007336                14.7%
Children 3-5                                0.005098                10.2%
Children 6-12                               0.002723                 5.4%
Youth 13-19                                 0.001394                 2.8%
Adults 20-49                                0.001712                 3.4%
Adults 50-99                                0.002013                 4.0%
Female 13-49                                0.001693                 3.4%

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