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

                                                 	OFFICE OF CHEMICAL SAFETY AND
                                                                                POLLUTION PREVENTION

MEMORANDUM

Date:  		30-NOV-2011

SUBJECT:	Acequinocyl.  Chronic Aggregate Dietary (Food + Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action Use on Succulent Soybean Vegetable; Succulent Shelled Beans; Cowpea Forage; Caneberry Subgroup 13-07A; Melon Subgroup 9A; Cucumber; Cherry; Low-Growing Berry Subgroup 13-07G; and Small Fruit Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F.

PC Code:  006329
DP Barcode:  D389990
Decision No.:  448205
Registration No.:  66330-38
Petition No.:  1E7864
Regulatory Action:  Section 3
Risk Assessment Type:  Dietary
Case No.:  7621
TXR No.:  NA
CAS No.:  57960-19-7
MRID No.:  NA
40 CFR:  §180.599

FROM:	Sarah J. Levy, Chemist
      Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P)

THROUGH:	Doug Dotson, Ph.D., Chemist
            Amelia Acierto, Chemist
            Dietary Exposure Science Advisory Council (DESAC)/HED (7509P)

                  and

            George F. Kramer, Ph.D., Branch Senior Scientist
            RAB1/HED (7509P)

TO:		Sarah J. Levy, Chemist/Risk Assessor
		RAB1/HED (7509P)

            and

      Barbara Madden, RM 05
      Registration Division (RD; 7505P)

Executive Summary

A chronic aggregate dietary (food + drinking water) exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model (DEEM-FCID[(TM)], Version 2.03) which uses food consumption data from the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analysis was performed to support a requested Section 3 registration use of the miticide acequinocyl (2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione) on the following crops:  succulent soybean vegetable; succulent shelled  beans; cowpea forage; caneberry subgroup 13-07A; melon subgroup 9A; cucumber; cherry; low-growing berry subgroup 13-07G; and small fruit vine climbing, except fuzzy kiwifruit, subgroup 13-07F.  An acute dietary assessment was not conducted for acequinocyl because an endpoint of concern attributable to a single dose was not identified; therefore, an aRfD was not established.  A cancer dietary assessment was not conducted because acequinocyl was classified as not likely to be carcinogenic to humans.

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

Tolerance-level residues and 100 percent crop treated (%CT) data were used in the chronic dietary assessment.  DEEM ver. 7.81 default processing factors were used with the exception of those for grape juice and raisins (see "Residue Information" Section of this document for details).  For the chronic dietary assessment, the general U.S. population and all population subgroups have risk estimates that are not of concern to HED.  The chronic dietary risk estimate for the U.S. population is 13% of the chronic population-adjusted dose (cPAD).  The highest exposed population subgroup (children 1-2 years old) occupies 55% of the cPAD.  The use of anticipated residues (ARs), empirical processing factors, and %CT would refine further HED's exposure and risk estimates; however, refinement is not needed at this time.

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 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 acequinocyl was conducted by Sarah Levy (25-AUG-2010; D369101).

II.	Residue Information

Under PP1E7864, the Interregional Research Project No.4 (IR-4), on behalf of the Agricultural Experiment Station of TX, CA, OR, PA, GA, NM, OK, TN, UT, MI, FL, and AZ, is requesting the establishment of tolerances for combined residues of the insecticide acequinocyl, and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone (acequinocyl-OH), expressed as acequinocyl equivalents in/on the following commodities:  succulent soybean vegetable; succulent shelled beans; cowpea forage; caneberry subgroup 13-07A; melon subgroup 9A; cucumber; cherry; low-growing berry subgroup 13-07G; and small fruit vine climbing, except fuzzy kiwifruit, subgroup 13-07F.  No new data were submitted to support tolerances on succulent soybean vegetables, low growing berry 13-07G crop subgroup, or small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit.  The petitioner has requested that existing tolerances be expanded to these respective crops or crop groups.

Permanent tolerances are currently established under 40 CFR §180.599(a) for the combined residues of acequinocyl and its metabolite, acequinocyl-OH, expressed as acequinocyl equivalents, in/on a number of plant and livestock commodities.  Tolerances for plant commodities range from 0.02 ppm (tree nuts and pistachios) to 30 ppm (citrus oil), and tolerances for livestock commodities are established at 0.02 ppm in the fat and liver of cattle, goat, horse, and sheep.

Based on the structural similarity of acequinocyl-OH to parent and the presence of acequinocyl-OH at quantifiable levels in crops, the HED Metabolism Assessment Review Committee (MARC) concluded that parent and acequinocyl-OH are the residues of concern for risk assessment and tolerance expression in apples, oranges, and eggplant commodities (Memo, S. Levy, 07-JAN-2004; D297872).  For purposes of this petition, HED will allow translation of these results to caneberries, cantaloupe, cherry, and cucumber as these are fruit crops.  In addition, HED is willing to translate the results to succulent shelled beans because beans are low-consumption food items.  However, if in the future the petitioner requests new uses where apple, orange, and eggplant metabolism data cannot be translated, HED may ask for additional plant metabolism data.

The qualitative nature of acequinocyl residues in ruminants is understood based on an adequate goat metabolism study (Memo, S. Levy, 10-MAR-2004; D284757).  The metabolism of acequinocyl in goats appears to involve the loss of the acetyloxyl moiety to form acequinocyl-OH and partial cleavage of the dodecyl side chain to form AKM-15.  Opening and degradation of the quinone ring was also evidenced by the presence of AKM-18 and phthalic acid.  The MARC concluded that for tolerance expression, the residues of concern in livestock commodities include parent and acequinocyl-OH.  For risk assessment purposes, the residues of concern in livestock commodities are parent and acequinocyl-OH (for liver and kidney, metabolite AKM-15 is to be included as well (Memo, S. Levy, et al., 07-JAN-2004; D297872)).

Metabolism data on poultry are not required at the present time as none of the proposed or existing uses of acequinocyl are on crops having regulated poultry feedstuffs.

Table 1.  Residues of Concern in Crops, Ruminants, and Drinking Water.
Matrix
Tolerance Expression
Residues for Risk Assessment
Fruit Crops
Acequinocyl + Acequinocyl-OH (R1)
Acequinocyl + Acequinocyl-OH (R1)
Ruminants
Acequinocyl + Acequinocyl-OH (R1)
Acequinocyl + Acequinocyl-OH (R1).  In liver and kidney, also include AKM-15.
Rotational Crops
Not Determined*
Not Determined*
Drinking Water
NA**
Acequinocyl + Acequinocyl-OH (R1)
* A confined rotational crop study has been reviewed and a 30-day plant-back interval has been recommended (Memo, S. Levy, 25-JUN-2008; DP# 351336).
** NA = not applicable.

Residue Data used for the Chronic Assessment:

Tolerance-level residues and 100%CT data were used in the chronic dietary assessment.  DEEM ver. 7.81 default processing factors were used with the exception of those for grape juice and raisins.  As residues were reduced in both grape juice (<0.02x) and raisin (0.15x), separate tolerances are not required for these commodities.  The DEEM ver. 7.81 default processing factors for juice and raisin were set to 1 as concentration was shown not to occur (Memo, S. Levy, 05-SEP-2007; D342805).

As cowpea forage and hay are significant feedstuff for livestock (dairy cattle only), the maximum reasonable balanced diet (MRBD) for acequinocyl was recalculated for this petition using the Agency's most recent guidance on constructing reasonably balanced livestock diets (Science Advisory Council for Chemistry (ChemSAC) memo, 30-JUN-2008).  The beef cattle MRBDs did not need to be recalculated as cowpea forage and hay are not beef feed items.  The feeding study data indicate that the currently established tolerance level of 0.02 ppm for residues in cattle, goat, horse, and sheep fat is appropriate.  Furthermore, the 0.02-ppm residue level is sufficient to cover residues of the additional metabolite (AKM-15) of concern in ruminant liver and kidney.  The established 0.02-ppm residue level in cattle, goat, horse, and sheep liver are appropriate; however, the commodity definition should be changed to "meat byproducts" rather than "liver."  With the establishment of the cattle, goat, horse, and sheep tolerance in meat byproducts, RD should remove the tolerance for liver.  See Table 2 for a summary of the data used in the chronic assessment.

Table 2.  Data and Residue Estimates Used in the Acequinocyl Chronic Dietary Analyses.
Commodity
                                  Data Source
                                    (MRID)
                                      %CT
                              Processing Factors
                        HED-Recommended Tolerance (ppm)
Bean, succulent shelled[1]
                                   48462901

                                      100
                                      NA
                                     0.30
Caneberry subgroup 13-07A
                                   48462902

                                      NA
                                      4.0
Melon subgroup 9A
                                   48462903

                                      NA
                                     0.15
Cucumber
                                   48462905

                                      NA
                                     0.15
Cherry, sweet
                                   48462904

                                      NA
                                     0.50
Cherry, tart[2]

                                      NA
                                      1.0
Soybean, vegetable, succulent
           Translated from established edible-podded bean tolerance

                                      NA
                                     0.25
Low growing berry subgroup13-07G[3]
               Translated from established strawberry tolerance

                                      NA
                                     0.50
Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit
                  Translated from established grape tolerance

                                      NA
                                      1.6
Meat byproducts of cattle, goat, horse, and sheep
                              Extended from liver

                                      NA
                                     0.02
[1]   HED is recommending for cowpea forage and cowpea hay tolerances of 6.0 ppm and 18 ppm, respectively, however, these are feed items and are not in DEEM-FCID[(TM)].
[2]   The value for cherry, tart was used as the input in DEEM-FCID(TM) as the HED-recommended tolerance value was higher than the value for cherry, sweet.
[3]   The established strawberry tolerance is 0.40 ppm; however, for purposes of harmonization with Canada, HED is recommending to increase the tolerance to 0.50 ppm for this crop subgroup.

III.	Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) (M. Lowit, 07-SEP-2011; D389520) and incorporated directly into this dietary assessment.  Water residues were incorporated directly into DEEM-FCID(TM) under the food categories "water, direct, all sources" and "water, indirect, all sources."

Acequinocyl can reach surface water via spray drift and less likely via runoff.  Due to its high Kd values it is expected to exhibit low mobility in soil and low potential to leach into groundwater. Once acequinocyl has entered surface water, it is not likely to persist as it will hydrolyze to form hydroxy-acequinocyl (also known as R-1).

There are no drinking water monitoring data available for acequinocyl or its metabolite acequinocyl-OH (R1), the residues of concern.  Groundwater estimated drinking water concentrations (EDWCs) were generated for acequinocyl using the Screening Concentration in Ground Water (SCI-GROW) Model.  Surface water EDWCs were generated using the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model for all proposed uses except cranberry (cranberries are part of the low growing berries subgroup, 13-07G).  Cranberry harvesting may involve field flooding and PRZM/EXAMS is not currently parameterized to assess this type of scenario; therefore, cranberry was assessed using the provisional cranberry model (note that since the provisional cranberry model only uses a one year simulation, the highest 30-year annual average concentration is not available for the cranberry scenario).

Similar to previous drinking water assessments provided by EFED, two approaches were used in performing the drinking water assessment for proposed acequinocyl uses.  In Approach #1, acequinocyl was conservatively assumed to be stable to all routes of degradation to account for the uncertainties associated with the environmental fate data.  In Approach #2, total (acequinocyl + acequinocyl-OH) residues were modeled with the assumption that the half-lives of acequinocyl and R1 are valid and the total toxic residues were modeled to address toxicity concerns with R1.  The EDWCs are summarized below in Table 3.  Surface water EDWCs for the proposed uses are higher than those previously reported for both approaches.  The ground water EDWC for the current assessment is the same as the last assessment.

Table 3.  Recommended EDWCs of Acequinocyl Derived from the Previous Uses.
                         Drinking water source (model)
                           Proposed Use/Scenario[3]
                  EDWCs from Surface Water Sources (ug/L) 1,2

                                  Approach 1
                      (assume no acequinocyl degradation)
                                  Approach 2
                         (combined acequinocyl and R1)

                              1-in-10 year acute
                             1-in-10 year chronic
                                 30-year mean
                              1-in-10 year acute
                             1-in-10 year chronic
                                 30-year mean
Surface water
(PRZM/EXAMS)
Cherry/MI cherry
                                6.69 (25.89)[4]
                                     6.69
                                  (17.84)[4]
                                6.69 (10.19)[4]
                                     5.59
                                     0.42
                                     0.26
Surface water
(PRZM/EXAMS)
Small fruit (vine climbing, except fuzzy kiwifruit, 13-07F)/NY grape
                                6.69 (23.12)[4]
                                     6.69
                                  (15.34)[4]
                                     6.69
                                   (9.57)[4]
                                     4.22
                                     0.38
                                     0.27
Surface water
(Provisional Cranberry Model)
Cranberry/Provisional Cranberry Model
                                     4.24
                                     3.75
                                      --
                                    3.81[5]
                                    1.36[5]
                                      --
Groundwater (SCIGROW)
All proposed uses
                                 3.6 x 10[-3]
                               <3.6 x 10[-3]
                               <3.6 x 10[-3]
                                 3.6 x 10[-3]
                               <3.6 x 10[-3]
                               <3.6 x 10[-3]
[1]   Bolded values are the recommended EDWCs by EFED.
[2]   A default PCA of 0.87 was applied.
[3]   Maximum of 2 applications of 0.3 lb ai/A for all proposed uses.
[4]   EDWC (shown in parentheses) exceeds the solubility limit of acequinocyl (6.69 ug/L at 20°C); therefore, the recommended EDWC is 6.69 ppb.
[5]   Based on a one-year simulation; 1-10 year calculation is not applicable.

Since the surface water EDWCs are higher than the groundwater EDWC, HED selected the surface water value for use in the chronic dietary assessment.  The EDWC derived via Approach #1 represents the upper-bound value (6.69 ppb) while that derived via Approach #2 represents the lower-bound value (1.36 ppb).  The 6.69 ppb value was used in this dietary assessment as this value assures a conservative assessment.

IV.	DEEM-FCID[(TM)] Program and Consumption Information

An acequinocyl chronic dietary exposure assessment was conducted using DEEM-FCID[(TM)], Version 2.03 which incorporates consumption data from USDA's CSFII, 1994-1996 and 1998.  The 1994-96, 98 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 1994-96, 98 CSFII 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+ 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.

V.	Toxicological Information

On 14-OCT-2003, the HED Hazard Identification Assessment Review Committee (HIARC) reviewed the recommendations of the toxicology reviewer for acequinocyl with regard to the acute and chronic RfDs and the toxicological endpoint selection for use as appropriate in occupational/residential exposure risk assessments.  The potential for increased susceptibility of infants and children from exposure to acequinocyl was also evaluated as required by the Food Quality Protection Act (FQPA) of 1996 under the 2002 OPP 10X Guidance.  Table 4 is a summary of the toxicology doses and endpoints selected that are relevant to dietary exposure assessment (13-NOV-2003; TXR# 0052234).  The acequinocyl risk assessment team confirmed that the endpoints selected previously remain appropriate.

Table 4.  Summary of Toxicological Doses and Endpoints for Acequinocyl for Use in Dietary Exposure Risk Assessment.[1]
Exposure/
Scenario
Point of Departure
Uncertainty/
FQPA Safety Factors
RfD, PAD, Level of Concern
Study and Toxicological Effects
Acute Dietary (General Population, including Infants and Children)
N/A
N/A
N/A
An endpoint of concern (effect) attributable to a single dose was not identified in the database.  Quantification of acute risk to general population including infants and children is not required.
Chronic Dietary
(All Populations)
NOAEL= 2.7 mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x

cPAD = cRfD = 0.027 mg/kg/day

18-month carcinogenicity study in mice;
LOAEL=7.0 mg/kg/day based on clinical chemistry and microscopic nonneoplastic lesions (brown pigmented cells and perivascular inflammatory cells in liver)
Cancer (oral, dermal, inhalation)
Classification:  "Not likely to be Carcinogenic to Humans."
    [1]  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, NOAEL = no-observed adverse-effect level, LOAEL = lowest-observed adverse-effect level, RfD = reference dose (a = acute, c = chronic), PAD = population-adjusted dose, N/A = Not Applicable.

VI.	Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID[(TM)] analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 5 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  An acute dietary assessment was not conducted for acequinocyl because an endpoint of concern attributable to a single dose was not identified; therefore, an aRfD was not established.  A cancer dietary assessment was not conducted because acequinocyl was classified as not likely to be carcinogenic to humans.

The chronic dietary exposure assessment (using tolerance level residues and 100% CT information for all registered and proposed uses) was conducted for the general U.S. population and various population subgroups.  Drinking water was incorporated directly into the dietary assessment using the chronic concentration for ground water generated by the PRZM/EXAMS model.  This assessment concludes that the chronic dietary risk estimates are not of concern to HED for the general U.S. population (13% cPAD) and all population subgroups.  The most highly exposed population subgroup is children 1-2 years old at 55% of the cPAD.

 Table 5.  Summary of Dietary (Food + Drinking Water) Exposure and Risk for Acequinocyl.
 Population Subgroup
                               Chronic Dietary[1]

                                Dietary Exposure
                                  (mg/kg/day)
                                     % cPAD
 U.S. Population (total)
                                    0.003627
                                       13
 All Infants (<1 year old)
                                    0.006513
                                       24
 Children 1-2 years old
                                    0.014761
                                       55
 Children 3-5 years old
                                    0.010370
                                       38
 Children 6-12 years old
                                    0.005172
                                       19
 Youth 13-19 years old
                                    0.002825
                                       11
 Adults 20-49 years old
                                    0.002525
                                      9.4
 Adults 50+ years old
                                    0.002473
                                      9.2
 Females 13-49 years old
                                    0.002563
                                      9.5
 [1] Chronic dietary endpoint of 0.027 mg/kg/day applies to the general U.S. population and all population subgroups.  The values for the highest exposed population are bolded.

 VII.		Characterization of Inputs/Outputs

The chronic analysis assumed tolerance-level residues and 100%CT data.  DEEM ver. 7.81 default processing factors were used with the exception of those for grape juice and raisins.  This analysis is considered very conservative and could be refined through the use of ARs for all commodities, %CT data for registered commodities, and/or additional empirical processing factors.

 VIII.		Conclusions

A chronic dietary exposure and risk assessment was conducted for the proposed food uses and permanent tolerances of acequinocyl, including potential exposure from drinking water.

The chronic dietary (food + drinking water) exposure to acequinocyl is below HED's level of concern for the general U.S. population and all population subgroups.  The chronic dietary risk utilized 13% cPAD for the general U.S. population and 55% of the cPAD for children 1-2 years old, the most highly exposed population subgroup.  An acute dietary assessment was not conducted for acequinocyl because an endpoint of concern attributable to a single dose was not identified; therefore, an aRfD was not established.  A cancer dietary assessment was not conducted because acequinocyl was classified as not likely to be carcinogenic to humans.

 IX.		List of Attachments

 Attachment 1:  Chronic Food + Drinking Water Residue Input File.
 Attachment 2:  Chronic Results File.

cc:  M. Lowit (EFED/ERB1; 7507P)
RDI: DESAC (09-NOV-2011); G.F. Kramer (09-NOV-2011)
S. Levy:S10953:PY1:(703)305-0783:7590P
        Attachment 1:  Chronic Food + Drinking Water Residue Input File.

Filename: C:\Documents and Settings\slevy\Desktop\006329c_SL.R98
Chemical: Acequinocyl
RfD(Chronic): .027 mg/kg bw/day  NOEL(Chronic): 2.7 mg/kg bw/day
RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 11-16-2011/08:07:44/8          Program ver. 2.03
Comment: No acute dietary endpoint; not carcinogen.  cRfD=cPAD
--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code    Grp  Commodity Name                    (ppm)       #1    #2
-------- ---- -------------------------------  ----------  ------ ------  -------
06003470 6    Soybean, seed                      0.250000   1.000  1.000  1E7864
06010430 6A   Bean, snap, succulent              0.250000   1.000  1.000  9E7598
06010431 6A   Bean, snap, succulent-babyfood     0.250000   1.000  1.000  9E7598
06020310 6B   Bean, broad, succulent             0.250000   1.000  1.000  1E7864
06020330 6B   Bean, cowpea, succulent            0.250000   1.000  1.000  1E7864
06020370 6B   Bean, lima, succulent              0.250000   1.000  1.000  1E7864
08001480 8    Eggplant                           0.700000   1.000  1.000  9E7598
08002340 8    Okra                               0.700000   1.000  1.000  9E7598
08002700 8    Pepper, bell                       0.700000   1.000  1.000  9E7598
08002701 8    Pepper, bell-babyfood              0.700000   1.000  1.000  9E7598
08002710 8    Pepper, bell, dried                0.700000   1.000  1.000  9E7598
08002711 8    Pepper, bell, dried-babyfood       0.700000   1.000  1.000  9E7598
08002720 8    Pepper, nonbell                    0.700000   1.000  1.000  9E7598
08002721 8    Pepper, nonbell-babyfood           0.700000   1.000  1.000  9E7598
08002730 8    Pepper, nonbell, dried             0.700000   1.000  1.000  9E7598
08003740 8    Tomatillo                          0.700000   1.000  1.000  9E7598
08003750 8    Tomato                             0.700000   1.000  1.000  9E7598
08003751 8    Tomato-babyfood                    0.700000   1.000  1.000  9E7598
08003760 8    Tomato, paste                      0.700000   5.400  1.000  9E7598
08003761 8    Tomato, paste-babyfood             0.700000   5.400  1.000  9E7598
08003770 8    Tomato, puree                      0.700000   3.300  1.000  9E7598
08003771 8    Tomato, puree-babyfood             0.700000   3.300  1.000  9E7598
08003780 8    Tomato, dried                      0.700000  14.300  1.000  9E7598
08003781 8    Tomato, dried-babyfood             0.700000  14.300  1.000  9E7598
08003790 8    Tomato, juice                      0.700000   1.500  1.000  9E7598
09010750 9A   Cantaloupe                         0.150000   1.000  1.000  1E7864
09010800 9A   Casaba                             0.150000   1.000  1.000  1E7864
09011870 9A   Honeydew melon                     0.150000   1.000  1.000  1E7864
09013990 9A   Watermelon                         0.150000   1.000  1.000  1E7864
09014000 9A   Watermelon, juice                  0.150000   1.000  1.000  1E7864
09021350 9B   Cucumber                           0.150000   1.000  1.000  1E7864
10001060 10   Citrus citron                      0.200000   1.000  1.000
10001070 10   Citrus hybrids                     0.200000   1.000  1.000
10001080 10   Citrus, oil                       30.000000   1.000  1.000
10001800 10   Grapefruit                         0.200000   1.000  1.000
10001810 10   Grapefruit, juice                  0.200000   2.100  1.000
10001970 10   Kumquat                            0.200000   1.000  1.000
10001990 10   Lemon                              0.200000   1.000  1.000
10002000 10   Lemon, juice                       0.200000   2.000  1.000
10002001 10   Lemon, juice-babyfood              0.200000   2.000  1.000
10002010 10   Lemon, peel                        0.200000   1.000  1.000
10002060 10   Lime                               0.200000   1.000  1.000
10002070 10   Lime, juice                        0.200000   2.000  1.000
10002071 10   Lime, juice-babyfood               0.200000   2.000  1.000
10002400 10   Orange                             0.200000   1.000  1.000
10002410 10   Orange, juice                      0.200000   1.800  1.000
10002411 10   Orange, juice-babyfood             0.200000   1.800  1.000
10002420 10   Orange, peel                       0.200000   1.000  1.000
10003070 10   Pummelo                            0.200000   1.000  1.000
10003690 10   Tangerine                          0.200000   1.000  1.000
10003700 10   Tangerine, juice                   0.200000   2.300  1.000
11000070 11   Apple, fruit with peel             0.400000   1.000  1.000
11000080 11   Apple, peeled fruit                0.400000   1.000  1.000
11000081 11   Apple, peeled fruit-babyfood       0.400000   1.000  1.000
11000090 11   Apple, dried                       0.400000   8.000  1.000
11000091 11   Apple, dried-babyfood              0.400000   8.000  1.000
11000100 11   Apple, juice                       0.400000   1.300  1.000
11000101 11   Apple, juice-babyfood              0.400000   1.300  1.000
11000110 11   Apple, sauce                       0.400000   1.000  1.000
11000111 11   Apple, sauce-babyfood              0.400000   1.000  1.000
11001290 11   Crabapple                          0.400000   1.000  1.000
11002100 11   Loquat                             0.400000   1.000  1.000
11002660 11   Pear                               0.400000   1.000  1.000
11002661 11   Pear-babyfood                      0.400000   1.000  1.000
11002670 11   Pear, dried                        0.400000   6.250  1.000
11002680 11   Pear, juice                        0.400000   1.000  1.000
11002681 11   Pear, juice-babyfood               0.400000   1.000  1.000
11003100 11   Quince                             0.400000   1.000  1.000
12000900 12   Cherry                             1.000000   1.000  1.000  1E7864
12000901 12   Cherry-babyfood                    1.000000   1.000  1.000  1E7864
12000910 12   Cherry, juice                      1.000000   1.500  1.000  1E7864
12000911 12   Cherry, juice-babyfood             1.000000   1.500  1.000  1E7864
13010550 13A  Blackberry                         4.000000   1.000  1.000  1E7864
13010560 13A  Blackberry, juice                  4.000000   1.000  1.000  1E7864
13010561 13A  Blackberry, juice-babyfood         4.000000   1.000  1.000  1E7864
13010580 13A  Boysenberry                        4.000000   1.000  1.000  1E7864
13011420 13A  Dewberry                           4.000000   1.000  1.000  1E7864
13012080 13A  Loganberry                         4.000000   1.000  1.000  1E7864
13013200 13A  Raspberry                          4.000000   1.000  1.000  1E7864
13013201 13A  Raspberry-babyfood                 4.000000   1.000  1.000  1E7864
13013210 13A  Raspberry, juice                   4.000000   1.000  1.000  1E7864
13013211 13A  Raspberry, juice-babyfood          4.000000   1.000  1.000  1E7864
13020570 13B  Blueberry                          0.500000   1.000  1.000
13020571 13B  Blueberry-babyfood                 0.500000   1.000  1.000
14000030 14   Almond                             0.020000   1.000  1.000
14000031 14   Almond-babyfood                    0.020000   1.000  1.000
14000040 14   Almond, oil                        0.020000   1.000  1.000
14000041 14   Almond, oil-babyfood               0.020000   1.000  1.000
14000590 14   Brazil nut                         0.020000   1.000  1.000
14000680 14   Butternut                          0.020000   1.000  1.000
14000810 14   Cashew                             0.020000   1.000  1.000
14000920 14   Chestnut                           0.020000   1.000  1.000
14001550 14   Filbert                            0.020000   1.000  1.000
14001560 14   Filbert, oil                       0.020000   1.000  1.000
14001850 14   Hickory nut                        0.020000   1.000  1.000
14002130 14   Macadamia nut                      0.020000   1.000  1.000
14002690 14   Pecan                              0.020000   1.000  1.000
14002820 14   Pistachio                          0.020000   1.000  1.000
14003910 14   Walnut                             0.020000   1.000  1.000
21000460 M    Beef, meat byproducts              0.020000   1.000  1.000
21000461 M    Beef, meat byproducts-babyfood     0.020000   1.000  1.000
21000470 M    Beef, fat                          0.020000   1.000  1.000
21000471 M    Beef,fat-babyfood                  0.020000   1.000  1.000
21000480 M    Beef, kidney                       0.020000   1.000  1.000
21000490 M    Beef, liver                        0.020000   1.000  1.000
21000491 M    Beef, liver-babyfood               0.020000   1.000  1.000
23001710 M    Goat, fat                          0.020000   1.000  1.000
23001720 M    Goat, kidney                       0.020000   1.000  1.000
23001730 M    Goat, liver                        0.020000   1.000  1.000
26003400 M    Sheep, meat byproducts             0.020000   1.000  1.000
26003410 M    Sheep, fat                         0.020000   1.000  1.000
26003411 M    Sheep, fat-babyfood                0.020000   1.000  1.000
26003420 M    Sheep, kidney                      0.020000   1.000  1.000
26003430 M    Sheep, liver                       0.020000   1.000  1.000
86010000 O    Water, direct, all sources         0.006690   1.000  1.000  1E7864
86020000 O    Water, indirect, all sources       0.006690   1.000  1.000  1E7864
95001300 O    Cranberry                          0.500000   1.000  1.000  1E7864
95001301 O    Cranberry-babyfood                 0.500000   1.000  1.000  1E7864
95001310 O    Cranberry, dried                   0.500000   1.000  1.000  1E7864
95001320 O    Cranberry, juice                   0.500000   1.100  1.000  1E7864
95001321 O    Cranberry, juice-babyfood          0.500000   1.100  1.000  1E7864
95001750 O    Grape                              1.600000   1.000  1.000
95001760 O    Grape, juice                       1.600000   1.000  1.000
95001761 O    Grape, juice-babyfood              1.600000   1.000  1.000
95001770 O    Grape, leaves                      1.600000   1.000  1.000
95001780 O    Grape, raisin                      1.600000   1.000  1.000
95001790 O    Grape, wine and sherry             1.600000   1.000  1.000
95001880 O    Hop                                4.000000   1.000  1.000  9E7598
95001950 O    Kiwifruit                          1.600000   1.000  1.000  1E7864
95003590 O    Strawberry                         0.500000   1.000  1.000  1E7864
95003591 O    Strawberry-babyfood                0.500000   1.000  1.000  1E7864
95003600 O    Strawberry, juice                  0.500000   1.000  1.000  1E7864
95003601 O    Strawberry, juice-babyfood         0.500000   1.000  1.000  1E7864

                     Attachment 2:  Chronic Results File.

U.S. Environmental Protection Agency                             Ver. 2.00
DEEM-FCID Chronic analysis for ACEQUINOCYL                  (1994-98 data)
Residue file name: C:\Documents and Settings\slevy\Desktop\006329c_SL.R98
                                                Adjustment factor #2 used.
Analysis Date 11-16-2011/09:05:55 esidue file dated: 11-16-2011/08:07:44/8
Reference dose (RfD, Chronic) = .027 mg/kg bw/day
COMMENT 1: No acute dietary endpoint; not carcinogen.  cRfD=cPAD
==========================================================================
                    Total exposure by population subgroup
--------------------------------------------------------------------------
                                                    Total Exposure
                                      -----------------------------------
          Population                         mg/kg             Percent of
           Subgroup                       body wt/day             Rfd
-----------------------------------   -------------       ---------------
U.S. Population (total)                     0.003627                13.4%
U.S. Population (spring season)             0.003565                13.2%
U.S. Population (summer season)             0.003721                13.8%
U.S. Population (autumn season)             0.003572                13.2%
U.S. Population (winter season)             0.003653                13.5%
Northeast region                            0.004098                15.2%
Midwest region                              0.003612                13.4%
Southern region                             0.003232                12.0%
Western region                              0.003850                14.3%
Hispanics                                   0.003984                14.8%
Non-hispanic whites                         0.003597                13.3%
Non-hispanic blacks                         0.003467                12.8%
Non-hisp/non-white/non-black                0.003724                13.8%
All infants (< 1 year)                      0.006513                24.1%
Nursing infants                             0.003204                11.9%
Non-nursing infants                         0.007769                28.8%
Children 1-6  yrs                           0.011306                41.9%
Children 7-12 yrs                           0.004806                17.8%
Females 13-19 (not preg or nursing)         0.002860                10.6%
Females 20+ (not preg or nursing)           0.002497                 9.2%
Females 13-50 yrs                           0.002791                10.3%
Females 13+ (preg/not nursing)              0.002783                10.3%
Females 13+ (nursing)                       0.002812                10.4%
Males 13-19 yrs                             0.002783                10.3%
Males 20+ yrs                               0.002507                 9.3%
Seniors 55+                                 0.002472                 9.2%
Children 1-2 yrs                            0.014761                54.7%
Children 3-5 yrs                            0.010370                38.4%
Children 6-12 yrs                           0.005172                19.2%
Youth 13-19 yrs                             0.002825                10.5%
Adults 20-49 yrs                            0.002525                 9.4%
Adults 50+ yrs                              0.002473                 9.2%
Females 13-49 yrs                           0.002563                 9.5%


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2008-0736; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; The
Metropolitan Washington Nonattainment Area; Determination of Attainment
of the Fine Particle Standard

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to determine that the Metropolitan
Washington, DC-MD-VA nonattainment area for the 1997 fine particle
(PM2.5) National Ambient Air Quality Standard (NAAQS) has attained the
1997 PM2.5 NAAQS.  This proposed determination is based upon quality
assured, quality controlled, and certified ambient air monitoring data
that show that the area has monitored attainment of the 1997 PM2.5 NAAQS
since the 2004 - 2006 monitoring period, and continues to monitor
attainment of the standard based on 2005 - 2007 data.  In addition,
quality controlled and quality assured monitoring data for 2008 that are
available in the EPA Air Quality System (AQS) database, but not yet
certified, show this area continues to attain the 1997 PM2.5 NAAQS.  If
this proposed determination is made final, the requirements for this
area to submit an attainment demonstration and associated reasonably
available measures, a reasonable further progress plan, contingency
measures, and other planning State Implementation Plans (SIPs) related
to attainment of the standard shall be suspended for so long as the area
continues to attain the 1997 PM2.5 NAAQS.

DATES: Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2008-0736 by one of the following methods:

 www.regulations.gov.  Follow the on-line instructions for submitting
comments.

B.    	E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

C.    	Mail:  EPA- R03-OAR-2008-0736, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.   	Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket(s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2008-0736.  EPA's policy is that all comments received will
be included in the public docket without change, and

may be made available online at   HYPERLINK "http://www.regulations.gov"
 www.regulations.gov , including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.  Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov website is an (anonymous access( system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment.  If you send an e-mail comment
directly to EPA without going through  www.regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet.  If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit.  If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.  Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT:  Melissa Linden,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  Throughout this document whenever “we,”
“us,” or “our” is used, we mean EPA.

Organization of this document.  The following outline is provided to aid
in locating information

in this preamble.

I.    What Action is EPA Taking?

II.   What is the Effect of This Action?

III.  What is the Background for This Action?

IV.  What is EPA’s Analysis of the Relevant Air Quality Data?

V.   Proposed Action

VI.  Statutory and Executive Order Reviews

I.  What Action is EPA Taking?

EPA is proposing to determine that the Metropolitan Washington, DC-MD-VA
PM2.5 nonattainment area has attained the 1997 PM2.5 NAAQS.  This
determination is based upon quality assured, quality controlled, and
certified ambient air monitoring data that show the area has monitored
attainment of the 1997 PM2.5 NAAQS since the 2004 – 2006 monitoring
period, and monitoring data that continue to show attainment of the 1997
PM2.5 NAAQS based on the 2005 – 2007 data.  In addition, quality
controlled and quality assured monitoring data for 2008 that are
available in the EPA AQS database, but not yet certified, show this area
continues to attain the 1997 PM2.5 NAAQS.

II.  What is the Effect of This Action?

If this determination is made final, under the provisions of EPA’s
PM2.5 implementation rule (see 40 CFR section 51.1004(c)), the
requirements for the Metropolitan Washington, DC-MD-VA PM2.5
nonattainment area to submit an attainment demonstration and associated
reasonably available control measures, a reasonable further progress
plan, contingency measures, and any other planning SIPs related to
attainment of the 1997 PM2.5 NAAQS would be suspended for so long as the
area continues to attain the 1997 PM2.5 NAAQS.

As further discussed below, the proposed determination would:  (1) for
the Metropolitan Washington, DC-MD-VA nonattainment area, suspend the
requirements to submit an attainment demonstration and associated
reasonably available control measures (RACM) (including reasonably
available control technologies (RACT)), a reasonable further progress
plan (RFP), contingency measures, and any other planning SIPs related to
attainment of  the 1997 PM2.5 NAAQS; (2) continue until such time, if
any, that EPA subsequently determines that the area has violated the
1997 PM2.5 NAAQS; (3) be separate from, and not influence or otherwise
affect, any future designation determination or requirements for the
Metropolitan Washington, DC-MD-VA area based on the 2006 PM2.5 NAAQS;
and (4) remain in effect regardless of whether EPA designates this area
as a nonattainment area for purposes of the 2006 PM2.5 NAAQS.
Furthermore, as described below, any such final determination would not
be equivalent to the redesignation of the area to attainment based on
the 1997 PM2.5 NAAQS.

If this rulemaking is finalized and EPA subsequently determines, after
notice-and-comment rulemaking in the Federal Register, that the area has
violated the 1997 PM2.5 NAAQS, the basis for the suspension of the
specific requirements, set forth at 40 CFR section 51.1004(c), would no
longer exist, and the area would thereafter have to address the
pertinent requirements.

The determination that EPA proposes with this Federal Register notice,
that the air quality data shows attainment of the 1997 PM2.5 NAAQS, is
not equivalent to the redesignation of the area to attainment.  This
proposed action, if finalized, would not constitute a redesignation to
attainment under section 107(d)(3) of the Clean Air Act (CAA), because
we would not yet have an approved maintenance plan for the area as
required under section 175A of the CAA, nor a determination that the
area has met the other requirements for redesignation.  The designation
status of the area would remain nonattainment for the 1997 PM2.5 NAAQS
until such time as EPA determines that

it meets the CAA requirements for redesignation to attainment.

This proposed action, if finalized, is limited to a determination that
the Metropolitan

Washington, DC-MD-VA PM2.5 area has attained the 1997 PM2.5 NAAQS.  The
1997 PM2.5 NAAQS became effective on July 18, 1997 (62 FR 36852) and are
set forth at 40 CFR section 50.7.  The 2006 PM2.5 NAAQS, which became
effective on December 18, 2006 (71 FR 61144) are set forth at 40 CFR
section 50.13.  EPA is currently in the process of making designation
determinations, as required by CAA section 107(d)(1), for the 2006 PM2.5
NAAQS.  EPA has not made any designation determination for the
Metropolitan Washington, DC-MD-VA area based

on the 2006 PM2.5 NAAQS.  This proposed determination, and any final
determination, will have no effect on, and is not related to, any future
designation determination that EPA may make

based on the 2006 PM2.5 NAAQS for the Metropolitan Washington, DC-MD-VA
area.  Conversely, any future designation determination of the
Metropolitan Washington, DC-MD-VA area, based on the 2006 PM2.5 NAAQS,
will not have any effect on the determination proposed

by this notice.

If this proposed determination is made final and the Metropolitan
Washington, DC-MD-VA area continues to demonstrate attainment with the
1997 PM2.5 NAAQS, the requirements for the Metropolitan Washington,
DC-MD-VA area to submit an attainment demonstration and associated
reasonably available control measures, a reasonable further progress
plan, contingency measures, and any other planning SIPs related to
attainment of the 1997 PM2.5 NAAQS would remain suspended, regardless of
whether EPA designates this area as a nonattainment area for purposes of
the 2006 PM2.5 NAAQS.  Once the area is designated for the 2006 NAAQS,
it will have to meet all applicable requirements for that designation.

III.  What is the Background for This Action?

On July 18, 1997 (62 FR 36852), EPA established a health-based PM2.5
NAAQS at 15.0 micrograms per cubic meter (µg/m3) based on a 3-year
average of annual mean PM2.5 concentrations, and a twenty-four hour
standard of 65 µg/m3 based on a 3-year average of the 98th percentile
of 24-hour concentrations.  EPA established the standards based on
significant evidence and numerous health studies demonstrating that
serious health effects are associated with exposures to particulate
matter.  The process for designating areas following promulgation of a
new or revised NAAQS is contained in section 107(d)(1) of the CAA.  EPA
and State air quality agencies initiated the monitoring process for the
1997 PM2.5 NAAQS in 1999, and developed all air quality monitors by
January 2001.  On January 5, 2005 (70 FR 944), EPA published its air
quality designations and classifications for the 1997 PM2.5 NAAQS based
upon

air quality monitoring data from those monitors for calendar years
2001-2003.  These designations became effective on April 5, 2005.  The
Metropolitan Washington, DC-MD-VA (Charles, Frederick, Montgomery,
Prince George’s, Alexandria, Arlington, Fairfax, Loudoun, Prince
William, Falls Church, Manassas, Manassas Park, Fairfax City, and the
District of Columbia) area was designated nonattainment for the 1997
PM2.5 NAAQS (see 40 CFR part 81).

IV.  What is EPA’s Analysis of the Relevant Air Quality Data?

EPA has reviewed the ambient air monitoring data for PM2.5, consistent
with the requirements contained in 40 CFR part 50 and recorded in the
EPA AQS database for the Metropolitan Washington, DC-MD-VA PM2.5
nonattainment area from 2004 through the present time.  On the basis of
that review, EPA has concluded that this area attained the 1997 PM2.5
NAAQS since the 2004 – 2006 monitoring period, and continues to
monitor attainment of the NAAQS based on 2005 – 2007 data.  In
addition, quality controlled and quality assured monitoring data for
2008 that are available in the EPA AQS database, but not yet certified,
show this area continues to attain the 1997 PM2.5 NAAQS.

Under EPA regulations at 40 CFR Part 50, section 50.7:

(1) The annual primary and secondary PM2.5 standards are met when the
annual arithmetic mean concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 15.0 µg/m3.

(2) The 24-hour primary and secondary PM2.5 standards are met when the
98th percentile 24-hour concentration, as determined in accordance with
40 CFR Part 50, Appendix N, is less than or equal to 65 µg/m3.

Table 1 shows the design values for the 1997 Annual PM2.5 NAAQS for the
Metropolitan Washington, DC-MD-VA nonattainment area monitors for the
years 2004 – 2006 and 2005 – 2007.  Table 2 shows the design values
for the 1997 24-Hour PM2.5 NAAQS for these same monitors and the same
3-year periods.

Table 1. Design Values for Counties in the Metropolitan Washington
Nonattainment Area for 1997 PM2.5 NAAQS – Annual Standard

Location	AQS site ID	1997 Annual Attainment Standard	2004 – 2006
Design Values	2005 – 2007 Design Values

District of Columbia	110010041	15	14.4	14.0

District of Columbia	110010042	15	14.5	14.2

District of Columbia	110010043	15	14.0	13.5

Montgomery County, MD	240313001	15	12.5	12.2

Prince George, MD	240338003	15	13.1	12.8

Arlington, VA	510130020	15	14.2	14.0

Fairfax, VA	510590030	15	13.4	13.0

Fairfax, VA	510591005	15	13.6	13.5

Fairfax, VA	510595001	15	13.9	13.7

Loudon, VA	511071005	15	13.6	13.2

Table 2. Design Values for Counties in the Metropolitan Washington
Nonattainment Area for 1997 PM2.5 NAAQS – 24 Hour Standard

Location	AQS site ID	1997 24-Hour Attainment Standard	2004 – 2006
Design Values	2005 – 2007

Design Values

District of Columbia	110010041	65	37	35

District of Columbia	110010042	65	35	33

District of Columbia	110010043	65	34	34

Montgomery County, MD	240313001	65	31	30

Prince George, MD	240338003	65	35	32

Arlington, VA	510130020	65	34	32

Fairfax, VA	510590030	65	35	34

Fairfax, VA	510591005	65	34	32

Fairfax, VA	510595001	65	34	33

Loudon, VA	511071005	65	35	33

EPA’s reviews of these data indicate that the Metropolitan Washington,
DC-MD-VA nonattainment area has met and continues to meet the 1997 PM2.5
NAAQS.  EPA is soliciting public comments on the issues discussed in
this document.  These comments will be considered before taking final
action.

V.   Proposed Action

EPA is proposing to determine that the Metropolitan Washington, DC-MD-VA
nonattainment area for the 1997 PM2.5 NAAQS has attained the 1997 PM2.5
NAAQS and continues to attain the standard based on data through 2008.
As provided in 40 CFR section 51.1004(c), if EPA finalizes this
determination, it would suspend the requirements for this area to submit
an attainment demonstration and associated reasonably available control
measures, a reasonable further progress plan, contingency measures, and
any other planning SIPs related to attainment of the 1997 PM2.5 NAAQS so
long as the area continues to attain the 1997 PM2.5 NAAQS.

VI.  Statutory and Executive Order Reviews

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed 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 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 proposes to make a determination based on air quality data,
and would, if finalized, result in the suspension of certain Federal
requirements.  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.).  Because this rule proposes to make a determination based on air
quality data, and would, if finalized, result in the suspension of
certain Federal requirements, it 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 proposed rule also does not have tribal applications 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 proposed action 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), because it merely
proposes to make a determination based on air quality data and would, if
finalized result in the suspension of certain Federal requirements, and
does not alter the relationship or the distribution of power and
responsibilities established in the CAA.  This proposed rule also is not
subject to Executive Order 13045 “Protection of Children from
Environmental Health Risks” (62 FR 19885, April 23, 1997) because it
proposes to determine that air quality in the affected area is meeting
Federal standards.

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 because it
would be inconsistent with applicable law for EPA, when determining the
attainment status of an area, to use voluntary consensus standards in
place of promulgated air quality standards and monitoring procedures to
other wise satisfy the provisions of the CAA. This proposed rule does
not impose an information collection burden under the provisions of the
Paper Reduction Act of 1995 (44 U.S.C. 3501 et seq.)

Under Executive Order 12898, EPA finds that this rule, pertaining to the
District of Columbia, Maryland and Virginia’s determination of
attainment of the fine particle standard for the Metropolitan
Washington, DC-MD-VA area, involves a proposed determination of
attainment based on air quality data and will not have
disproportionately high and adverse human health or environmental
effects on any communities in the area, including minority and
low-income communities.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Particulate matter,
Reporting and recordkeeping requirements.

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

                                    /s/

__October 9, 2008______________
__________________________

Dated:
            W. T. Wisniewski, Acting

                 Regional Administrator,

                 Region III.

 PAGE

 PAGE   2

 PAGE  13


[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8468-8472]
[FR Doc No: 2020-02037]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0783; FRL-10004-05]

Chlorfenapyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
chlorfenapyr in or on basil, fresh leaves; chive, fresh leaves; and
cucumber and increases the established tolerance on vegetable,
fruiting, group 8-10. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective February 14, 2020. Objections and
requests for hearings must be received on or before April 14, 2020, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0783, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0783 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 14, 2020. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0783, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/

DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 18, 2019 (84 FR 9737) (FRL-9989-
71), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E8717) by IR-4 Headquarters, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.513 be
amended by establishing tolerances for residues of the insecticide
chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluoromethyl)-1H-pyrrole-3-carbonitrile, in or on Basil, fresh
leaves at 80 parts per million (ppm); Chive, fresh leaves at 20 ppm;
Cucumber at 0.5 ppm; and Vegetable, fruiting, group 8-10 at 2.0 ppm.
Upon establishment of the above tolerance, the petitioner requested
removal of the existing tolerance on Vegetable, fruiting, group 8-10 at
1.0 ppm. That document referenced a summary of the petition prepared by
BASF Corporation, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Based upon review of the data supporting the petition and pursuant
to its authority in section 408(d)(4)(A)(i), EPA is establishing the
requested tolerances and one tolerance at a different level than
requested. The reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for chlorfenapyr including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with chlorfenapyr follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Chlorfenapyr has moderate acute toxicity via the oral route of
exposure and low acute toxicity via the dermal and inhalation routes of
exposure. It is a mild eye irritant, but it is not a dermal irritant or
sensitizer. Chlorfenapyr targets the central nervous system (CNS),
inducing neurohistological changes (spongiform myelinopathy of the
brain and spinal cord and vacuolization of the brain, spinal cord, and
optic nerve) from subchronic and chronic dietary administration in mice
and rats. In addition to neuropathology, rats also exhibited
neurobehavioral changes on the day of dosing in the acute neurotoxicity
study. Decreased motor activity was observed in the acute neurotoxicity
study as well as in offspring in the developmental neurotoxicity (DNT)
study. Several rat studies also noted effects in the liver (increased
organ weights and tumors) at similar doses or above those where CNS
effects were seen. The liver was identified in metabolism studies as
the single organ to have the highest recovery of administered dose.
    There was evidence of increased quantitative susceptibility to
offspring in the database as a result of chlorfenapyr exposure. In the
2-generation reproduction study, decreased pup weights were seen at a
lower dose than parental toxicity (decreased body-weight). In the DNT
study, offspring toxicity (decreased motor activity and increased pup
deaths on postnatal days 1-4) was seen in the absence of maternal
toxicity. Additional effects on the CNS (vacuolation of white matter in
the brain and decreased hippocampus size) were also observed in
offspring at a higher dose in this study. There was no evidence of
increased susceptibility to offspring in the developmental toxicity
studies. In both the rat and rabbit developmental toxicity studies,
although no maternal or developmental effects were noted up to the
highest doses tested (HDT), maternal observations are limited in these
developmental studies. Consequently, the data from the DNT are
considered more robust for assessing the effects of chlorfenapyr on the
nervous system.
    Chlorfenapyr has a relatively high octanol-water partition
coefficient and due to its lipophilic nature has been shown to
accumulate in milk in a dietary cow study. Additionally, in the rat
metabolism study, chlorfenapyr was found to accumulate in the fat
tissue, such that females exhibited greater accumulation than males.
This observation suggests chlorfenapyr is capable of accumulating in
breast milk and leading to the early pup deaths seen in the
reproduction toxicity and DNT studies through lactation.
    Furthermore, the lack of toxicity in the rat and rabbit
developmental studies suggests that the early pup deaths in the
reproduction toxicity and DNT studies is the result of postnatal
exposure through lactation.
    EPA has concluded that a nonlinear approach using the chronic RfD
for assessing cancer risk is appropriate for chlorfenapyr. For more
information about this conclusion, see section 4.5.3 in the document
entitled ``SUBJECT: Chlorfenapyr. Human Health Risk Assessment for the
Proposed New Uses on Greenhouse-Grown Basil, Chive, Cucumber, and Small
Tomatoes,'' in docket ID number EPA-HQ-OPP-2018-0783.
    Specific information on the studies received and the nature of the
adverse effects caused by chlorfenapyr as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document entitled ``SUBJECT: Chlorfenapyr.
Human Health Risk Assessment for the Proposed New Uses on Greenhouse-
Grown Basil, Chive, Cucumber, and Small Tomatoes,'' at pages 24-28 in

docket ID number EPA-HQ-OPP-2018-0783.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for chlorfenapyr used for
human risk assessment is discussed in Unit III of the final rule
published in the Federal Register of January 26, 2018 (83 FR 3605)
(FRL-9970-88).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorfenapyr, EPA considered exposure under the petitioned-
for tolerances as well as all existing chlorfenapyr tolerances in 40
CFR 180.513. EPA assessed dietary exposures from chlorfenapyr in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for chlorfenapyr. In estimating acute dietary exposure, EPA used the
Dietary Exposure Evaluation Model--Food Consumption Intake Database
(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) from 2003-
2008. As to residue levels in food, EPA's acute unrefined analysis used
tolerance-level residues and 100% crop-treated (PCT). DEEM processing
factors were set to 1 for all commodities except tomato and peppers.
EPA 2018 default processing factors were used in the acute dietary
analyses for tomato and pepper processed raw agricultural commodities
(RACs) to account for potential imports of foreign agricultural use of
chlorfenapyr.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the 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) from 2003-2008. As to residue levels in food, EPA's
chronic analysis was unrefined and used tolerance-level residues and
100 PCT. DEEM processing factors were set to 1 for all commodities
except tomato and peppers. EPA 2018 default processing factors were
used in the chronic dietary analyses for tomato and pepper processed
RACs to account for potential imports of foreign agricultural use of
chlorfenapyr.
    iii. Cancer. As indicated in Unit III.A., EPA has concluded that a
nonlinear approach using the chronic RfD for assessing cancer risk is
appropriate for chlorfenapyr; therefore, a separate quantitative cancer
risk assessment is not required.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for chlorfenapyr. Tolerance level residues for
proposed and established uses and 100 PCT were assumed for all food
commodities.
    2. Dietary exposure from drinking water. Contamination of drinking
water from chlorfenapyr is not expected to occur since none of the
registered uses (which are all indoor uses) would result in residues in
drinking water. Therefore, a dietary exposure assessment for
chlorfenapyr in drinking water is unnecessary.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Chlorfenapyr is currently registered for the following uses that
could result in residential exposures: Crack/crevice/spot treatment on
indoor and outdoor residential sites (including as a bed bug
treatment). There are no residential uses associated with the
petitioned-for new uses; therefore, an updated residential exposure
assessment was not necessary for the proposed uses. The most
conservative residential exposure scenarios were selected for use in
the aggregate risk assessment. EPA combined post-application dermal and
inhalation exposure from indoor applications (surfaces and mattresses)
to control bed bugs to assess risks to adults and post-application
dermal, inhalation, and hand-to-mouth exposures from indoor
applications (surfaces and mattresses) to control bed bugs to assess
risks to children 1 to <2 years old. The residential exposures are
short- and intermediate-term for incidental oral, dermal and
inhalation. No long-term exposures is expected.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found chlorfenapyr to share a common mechanism of
toxicity with any other substances, and chlorfenapyr does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
chlorfenapyr does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the

case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Although DNT studies show
evidence of neurotoxicity/neuropathology and reproduction studies show
susceptibility/sensitivity to offspring, the effects are well-
characterized with clearly established NOAEL/LOAEL values and selected
endpoints are protective for the observed effects.
    3. Conclusion. EPA determined that the FQPA SF should be reduced to
1X for all exposure scenarios. That decision is based on the following
findings:
    i. The toxicity database for chlorfenapyr is complete.
    ii. Although the central nervous system is the primary target for
chlorfenapyr and neurotoxic effects were observed across studies,
concern is low since the selected PODs are protective of observed
neurotoxic effects.
    iii. Although there is evidence of increased quantitative
susceptibility in available DNT and reproduction studies, concern is
low since the offspring effects are well-characterized with clearly
established NOAEL/LOAEL values and the endpoints selected for risk
assessment are protective of observed offspring effects.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary analysis assumed tolerance-level residues, EPA's
2018 default processing factors (except for tomatoes and peppers), and
100 PCT. The dietary analysis did not include exposure from drinking
water as contamination of drinking water with chlorfenapyr as the
result of all registered uses, including greenhouses or food/feed
handling uses, is not expected to occur. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
chlorfenapyr.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to chlorfenapyr will occupy 75% of the aPAD (at the 95th percentile of
exposure) for children 3 to 5 years old, the population group receiving
the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
chlorfenapyr from food and water will utilize 19% of the cPAD for
children 3 to 5 years old, the population group receiving the greatest
exposure. There are no chronic drinking water or residential exposure
scenarios, therefore, the chronic aggregate risk is equivalent to the
chronic dietary risk which is below the Agency's LOC.
    3. Short- and intermediate-term risks. Short- and intermediate-term
aggregate risk assessments were conducted since there is potential for
short- and intermediate-term post-application exposures from previously
registered uses of chlorfenapyr in residential settings. Short-term
residential exposure estimates were aggregated with the average dietary
exposure to provide a worst-case estimate of short-term aggregate risk
for adults and children 1 to 2 years old (considered protective for
children of all ages). Short-term aggregate MOEs are protective of
intermediate-term exposure durations since the same endpoints and PODs
were selected for both durations. Resulting short-term aggregate MOEs
for adults at 660 and 120 for children (1 to 2 years old) are not of
concern.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit
III, the Agency has determined that quantification of risk using a non-
linear approach (i.e., using a cRfD) adequately accounts for all
chronic toxicity, including carcinogenicity that could result from
exposure to chlorfenapyr. Since there are no chronic risks of concern,
the Agency concludes that aggregate exposure to chlorfenapyr will not
pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to chlorfenapyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The plant analytical enforcement method is designated as M2427, a
gas chromatography/electron-capture detection (GC/ECD) method with a
limit of quantitation (LOQ) of 0.05 ppm. The method has been subjected
to a successful independent laboratory validation (ILV) as well as an
acceptable radio validation using samples obtained from lettuce and
tomato metabolism studies. EPA has concluded that method M2427 is
adequate for data collection and tolerance enforcement purposes.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no Codex maximum residue limits (MRLs) for residues of
chlorfenapyr in/on the proposed commodities.

C. Revisions to Petitioned-For Tolerances

    EPA revised the proposed tolerances for residues of chlorfenapyr on
vegetable, fruiting, group 8-10 based on current OECD rounding classes.
There is no need to remove the existing tolerance for vegetable,
fruiting, group 8-10 at 1.0 ppm; rather EPA is simply amending the
existing tolerance as requested.

V. Conclusion

    Therefore, tolerances are established for residues of the
insecticide chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-
5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile, in or on Basil, fresh
leaves at 80 ppm; Chive, fresh leaves at 20 ppm; and Cucumber at 0.5
ppm; and Vegetable, fruiting, group 8-10 at 2 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: January 24, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.513, amend the table in paragraph (a)(1) as follows:
0
 a. Add alphabetically the entries for ``Basil, fresh leaves'';
``Chive, fresh leaves''; and ``Cucumber''; and
0
 b. Revise the entry for ``Vegetable, fruiting, group 8-10''.
    The additions and revision read as follows:

Sec.  180.513  Chlorfenapyr; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Basil, fresh leaves.........................................          80
Chive, fresh leaves.........................................          20
Cucumber....................................................         0.5

                                * * * * *
Vegetable, fruiting, group 8-10.............................           2
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-02037 Filed 2-13-20; 8:45 am]
 BILLING CODE 6560-50-P