[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Rules and Regulations]
[Pages 26158-26164]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10214]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0588; FRL-9909-72]


Fenoxaprop-ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
fenoxaprop-ethyl (FE), in or on grass hay. Interregional Research 
Project Number 4 (IR-4) requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 7, 2014. Objections and 
requests for hearings must be received on or before July 7, 2014 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-2012-0588, 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), EPA West 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 (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

[[Page 26159]]


FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

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 
Printing 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-2012-0588 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 
July 7, 2014. 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-2012-0588, 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 September 28, 2012 (77 FR 59578) (FRL-
9364-6), 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 
2E8051) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.430 be amended by 
establishing tolerances for residues of the herbicide fenoxaprop-ethyl, 
[()-ethyl 2-[4- [(6-chloro-2-
benzoxazolyl)oxy]phenoxy]propanoate] and its metabolites 2-[4-[(6:-
chloro-2-benzoxazolyl) oxy]phenoxy] propanoic acid and 6-chloro-2,3-
dihydrobenzoxazol-2-one, each expressed as the parent compound, in or 
on grass, hay at 0.15 part per million (ppm). Based on the regional 
residue data submitted from Washington and Oregon, and the petitioner's 
intent for this to be a regional pesticide tolerance, the tolerance is 
being established as a ``Tolerance with regional registration'' with 
use restricted to Oregon, Washington, and Utah. That document 
referenced a summary of the petition prepared by Bayer CropScience, the 
registrant, which is available in the docket, http://www.regulations.gov.
    Comments were received on the notice of filing. EPA response to 
those comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the level at which the tolerance is being established. The 
reason for this change is explained in Unit IV.D.

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 fenoxaprop-p-ethyl (FPE) 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with FPE 
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.
    FPE is an enriched isomer formulation (95% d and 5% l enantiomers) 
based on the previously registered product FE which is a 50:50 racemic 
mixture of d and l enantiomers. FE is no longer a registered active 
ingredient. The toxicology database for FPE is complete based on 
studies submitted for both FPE and FE. Based on the analysis of the 
submitted studies, EPA found that the toxicological effects of FE and 
FPE across species, duration, and route of exposure are similar. Most

[[Page 26160]]

of the toxicological data available involved testing of the FE, not 
FPE. However, EPA has concluded that the similarity between the FE and 
FPE data is such that the database for FE could be bridged with FPE.
    The major target organs following short-term and long-term oral 
administration of FE and FPE in rats and mice are the liver and 
kidneys, with rats being the most sensitive species. The primary toxic 
effect is altered lipid metabolism characterized by decreased lipids 
and cholesterol, and increased liver weights in rats, and slightly 
increased lipids, cholesterol, proteins, and liver weights in mice. 
Additionally, increased enzyme activity (aspartate amino transferase 
(ASAT), alanine amino transferase (ALAT), and alkaline phosphatase 
(ALP)), hypertrophy, and single cell necrosis were observed in mice. In 
the kidneys, increases in ketones and kidney weights were observed in 
rats and evidence of proximal renal tubular injury were observed in 
mice following 90-day administration of FPE. However, no effects on the 
kidneys were observed following chronic administration of FE to rats, 
mice, or dogs. In both species, males were slightly more sensitive to 
the liver effects of FE and FPE. It is also important to note that no 
increases in toxicity are observed over time for FE when comparing the 
28-day and 90-day subchronic studies, the 2-generation reproductive 
toxicity study, and the 2-year chronic toxicity/carcinogenicity study 
in rats, or in FPE when comparing the 28-day and 90-day subchronic 
toxicity studies in rats.
    FPE has low acute toxicity following the oral, dermal, and 
inhalation routes of exposure. No evidence of immunotoxicity, 
reproductive or neurological toxicity was identified in the database. 
Developmental toxicity occurred in rats as evidenced by skeletal 
anomalies (longitudinally displaced, fragmented, fused, dysplastic 
sternebrae or dislocated sternebrae) and skeletal retardations (weak or 
non-ossification of one or several cranial bones). Developmental 
effects only occurred in the rat in the presence of maternal toxicity 
(decreased body weight, body weight gain, and heart weight). No 
developmental effects were identified in rabbits. In mice, a treatment-
related increase in tumor incidence of hepatocellular adenomas and 
carcinomas, mainly adenomas, was observed in males at 320 ppm (30%) 
compared to the control (2%). In addition, microscopic pathology 
indicated that hepatocellular hypertrophy was observed in the majority 
of treated animals (both sexes). There was, however, no evidence of a 
mutagenic effect in a comprehensive battery of genetic toxicology 
assays with both isomers. No evidence of tumors was identified in rats.
    The only tumor response induced by FE/FPE occurred in the liver of 
male mice; no liver tumors were seen in the female mice or in the 
guideline chronic/carcinogenicity study in male and female rats. The 
tumors were benign with no progression to malignancy. Mutagenicity has 
been ruled out as a mode of action (MOA) for this response. The 
presence of a single non-mutagenic tumor type in one sex and species--
here, benign liver tumors in the male mouse, a common tumor in mice--
provides no more than a weak suggestion of possible carcinogenic 
effects and thus does not support a linear assessment of risk based on 
the tumor incidence. Given the doses at which the benign mouse tumors 
were seen, EPA concludes that the chronic reference dose (cRfD) for FPE 
will adequately protect for all chronic toxicity, including 
carcinogenicity, that could result from exposure to FE/FPE.
    The Agency has waived the requirements for acute and subchronic 
neurotoxicity studies based on the following rationale:
    1. The lack of neurotoxicity in the available toxicology database 
for FE and FPE.
    2. The target organs of FPE and FE are the kidney and liver, and 
the mechanism of action for FPE and the chemical class do not target 
the nervous system.
    3. Developmental effects and decreased total blood lipids/
cholesterol are the most sensitive effects seen in the FE database and 
provide the most sensitive POD for risk assessment.
    4. There is low concern for neurotoxicity in other members of this 
class of chemicals (i.e., the arloxy phenoxy-propionate class).
    Specific information on the studies received and the nature of the 
adverse effects caused by FPE 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 titled ``Fenoxaprop-p-ethyl. 
Registration Review Preliminary Risk Assessment and Proposed New Use on 
Grass Grown for Seed'' on pages 52-57 in docket ID number EPA-HQ-OPP-
2012-0588.

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 (LOC) 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for FPE used for human 
risk assessment is shown in Table 1 of this unit.

[[Page 26161]]



      Table 1--Summary of Toxicological Doses and Endpoints for FPE for Use in Human Health Risk Assessment
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                                   POD and uncertainty/   RfD, PAD, LOC for
        Exposure/scenario             safety factors       risk  assessment     Study and toxicological effects
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Acute dietary (general population     No appropriate endpoint attributable to a single dose was identified. An
 including infants and children                            acute RfD was not established.
 and females 13-50 years of age).
                                  ------------------------------------------------------------------------------
Chronic dietary (all populations)  NOAEL = 1.5 mg/kg/    Chronic RfD = 0.015  Chronic toxicity/carcinogenicity
                                    day.                  mg/kg/day.           (rat) 2-generation reproductive
                                   UFA = 10x...........  cPAD = 0.015 mg/kg/   toxicity (rat).
                                   UFH = 10x...........   day.                LOAEL = 9 mg/kg/day, based on
                                   FQPA SF = 1x........                        decreased serum lipids and
                                                                               cholesterol, and altered liver
                                                                               weights.
                                  ------------------------------------------------------------------------------
Incidental oral short-term.......  NOAEL = 6 mg/kg/day.  LOC for MOE = 100..  28-day oral toxicity (rat).
(1 to 30 days)...................  UFA = 10x...........                       LOAEL = 26 mg/kg/day, based on
                                   UFH = 10x...........                        altered lipid metabolism
                                   FQPA SF = 1x........                        (decreased HDL-cholesterol, HDL-
                                                                               phospholipids, and total lipids,
                                                                               increased triglycerides, and
                                                                               ketonuria) and increased liver
                                                                               and kidney weights.
                                  ------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   Dermal study NOAEL =  LOC for MOE = 100..  28-day dermal toxicity (rat).
 and intermediate-term (1 to 6      20 mg/kg/day.                             LOAEL = 100 mg/kg/day, based on
 months).                          UFA = 10x...........                        non-regenerative anemia,
                                   UFH = 10x...........                        decreased serum cholesterol,
                                   FQPA SF = 1x........                        total lipids, and protein (beta 1
                                                                               globulins), and increased liver
                                                                               and kidney weights were observed.
                                                                               Additionally, cholesterol
                                                                               remained decreased following a 15-
                                                                               day recovery period.
                                  ------------------------------------------------------------------------------
Inhalation short-term (1-30 days)  Inhalation study.     LOC for MOE = 30...  21-day inhalation toxicity (rat).
 and intermediate-term (1-6         NOAEL = 0.07 mg/L                         LOAEL = 0.3 mg/L (males only)
 months).                           (males) 0.3 mg/L                           Based on slight normocytic
                                    (females).                                 anemia, decreases in serum
                                   UFA = 3x............                        cholesterol and total lipids, and
                                   UFH = 10x...........                        increases in liver weight and
                                   FQPA SF = 1x........                        urea nitrogen.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)   Quantification of risk using a non-linear approach; i.e., RfD, for FPE will
                                    adequately account for all chronic toxicity, including carcinogenicity, that
                                                         could result from exposure to FPE.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to FPE, EPA considered exposure under the petitioned-for 
tolerances as well as all existing FE tolerances in 40 CFR 180.430. EPA 
assessed dietary exposures from FPE and FE 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.
    No such effects were identified in the toxicological studies for 
FPE; therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA use an unrefined analysis based on 
tolerance-level residues, 100 percent crop treated (PCT) assumptions, 
and Dietary Exposure Evaluation Model (DEEM) default processing 
factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to FPE. Cancer risk was assessed using the same exposure 
estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
FPE or FE. Tolerance level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency has identified 
FPE and its three degradates, fenoxaprop-p acid ((D+)-2-[4-(6-chloro-2-
benzoxazolyloxy) phenoxy] propanoate, AE F088406), chlorobenzoxazolone 
(4-(6-chloro-2-benzoxazolyloxy) phenol, AE F054014), and 4-(6-chloro-2-
benzoxazolyloxy) phenol (AE F040356), as residues of concern in 
drinking water. The parent plus the three degradates were assessed 
using a total toxic residue (TTR) approach.
    The Agency used screening level water exposure models in the 
dietary exposure analysis and risk assessment for FPE and its three 
degradates in drinking water. These simulation models take into account 
data on the physical, chemical, and fate/transport characteristics of 
FPE and its three degradates. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier 1 Rice Model and Pesticide Root Zone Model Ground 
Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of 
FPE and its degradates (TTR) for

[[Page 26162]]

chronic exposure assessments are estimated to be 68.6 parts per billion 
(ppb) for surface water and 0.032 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 68.6 ppb was used to 
assess the contribution to drinking water.
    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). FPE is currently 
registered for the following uses that could result in residential 
exposures: Residential turf and home garden. EPA assessed residential 
exposure using the following assumptions: For residential handlers, 
both short-term dermal and short-term inhalation exposure is expected 
as a result of applying FPE to ornamentals and turf.
    There is the potential for short-term dermal and incidental short-
term oral post-application exposure for individuals exposed as a result 
of being in an environment that has been previously treated with FPE. 
The quantitative exposure/risk assessment for residential post-
application exposures is based on the following scenarios:

 Adults High Contact Lawn Activities
 Children 1 to <2 years old High Contact Lawn Activities
 Adults Mowing Turf
 Children 11 to <16 years old Mowing Turf
 Adults Ornamental Garden Activities
 Children 6 to <11 years old Ornamental Garden Activities

    The most conservative residential exposure scenario for adults 
reflects dermal exposure from post-application exposure to turf and 
gardens. The most conservative residential exposure for children 
reflects dermal and hand-to-mouth exposures from post-application high 
contact lawn activity exposure from turf applications.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 FPE to share a common mechanism of toxicity with 
any other substances, and FPE does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that FPE 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 Web site at http://www.epa.gov/pesticides/cumulative.

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. The available data do not 
provide evidence of any increased susceptibility in the offspring in 
either of the two developmental toxicity studies for FPE or in the 2-
generation reproduction study for FE. Delayed ossification was the 
primary effect in the developmental toxicity study and only occurred in 
the presence of maternal toxicity and a clearly defined NOAEL and LOAEL 
were achieved.
    In the rat developmental toxicity study with FPE, longitudinally 
displaced, fragmented, fused, dysplastic sternebrae or dislocated 
sternebrae and weak or non-ossification of one or several cranial bones 
were noted at 100 mg/kg (highest dose tested). These incidences 
occurred only in the presence of maternal toxicity (decreased 
gestational body weights, body weight gains, and food consumption). No 
developmental effects occurred in rabbits. In the 2-generation rat 
reproductive toxicity study on FE, no reproductive or developmental 
effects were observed. An increase in ALP activity and liver weights 
were identified in the offspring at 9.0 mg/kg. These effects occurred 
in the presence of parental toxicity (increased liver weight and 
decreased lipids) and are consistent with hepatotoxicity, the primary 
toxic effect of FPE, observed across the database.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for FPE is complete.
    ii. There is no indication that FPE is a neurotoxic chemical and 
there is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity.
    iii. There is no evidence that FPE results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to FPE in drinking water. 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 FPE.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
FPE is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for

[[Page 26163]]

chronic exposure, EPA has concluded that chronic exposure to FPE and FE 
from food and water will utilize 28% of the cPAD for all infants less 
than 1 year old, the population group receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of FPE is not 
expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    FPE is currently registered for uses that could result in short-
term residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to FPE.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate worst case MOEs of 249 
for adults and 302 for children. Because EPA's level of concern for FPE 
is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, FPE is 
not registered for any use patterns that would result in intermediate-
term residential exposure. Intermediate-term risk is assessed based on 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk 
assessment for evaluating intermediate-term risk for FPE.
    5. Aggregate cancer risk for U.S. population. EPA considers the 
chronic aggregate risk assessment to be protective of any aggregate 
cancer risk.
    6. 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 FPE and FE residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron 
capture detection (GD-ECD) method, based on Hoechst HRAV Analytical 
Method HRAV-4B) is available to enforce the tolerance expression.

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.
    The Codex has not established a MRL for FPE in or on grass hay.

C. Response to Comments

    Two comments that were received were not related to FPE and 
therefore, do not need to be addressed here. A third comment was 
received stating that FPE is an endocrine disruptor and America does 
not need any more of those. In the available toxicity studies on FPE, 
there was no estrogen, androgen, and/or thyroid mediated toxicity. The 
Agency currently has no evidence that FPE is an endocrine disruptor.

D. Revisions to Petitioned-For Tolerances

    EPA has modified the tolerance from the proposed level of 0.15 ppm 
to 0.09 ppm for the following reason: The method used for data-
collection (as well as tolerance enforcement) converts the residues of 
concern for FPE to acyl 6-chlorobenzoxazolone for detection. It is 
necessary to then convert this residue value to parent equivalents. 
Since the residues found on grass, hay were less than the limit of 
quantitation (LOQ) of 0.05 ppm for acyl 6-chlorobenzoxazolone, EPA 
multiplied this 0.05 ppm value by the ratio of the molecular weights 
(1.71) to arrive at a recommended tolerance of 0.09 ppm.

V. Conclusion

    Therefore, a tolerance with regional registration is established 
for residues of fenoxaprop-ethyl, [()-ethyl 2-[4- [(6-
chloro-2-benzoxazolyl)oxy]phenoxy]propanoate] and its metabolites 2-[4-
[(6:-chloro-2-benzoxazolyl) oxy]phenoxy] propanoic acid and 6-chloro-
2,3-dihydrobenzoxazol-2-one, each expressed as the parent compound, in 
or on grass, hay at 0.09 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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). This final rule 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 tolerance 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 final rule 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

[[Page 26164]]

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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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: April 29, 2014.
Lois Rossi,
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.  180.430, revise paragraph (c) to read as follows:


Sec.  180.430  Fenoxaprop-ethyl; tolerances for residues.

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in Sec.  180.1(l), are established 
for residues of the herbicide fenoxaprop-ethyl, including its 
metabolites and degradates, in or on the commodities in the table in 
this paragraph when fenoxaprop-ethyl is used in the states of Oregon, 
Washington, and Utah. Compliance with the tolerance levels specified in 
this paragraph is to be determined by measuring only the sum of 
fenoxaprop-ethyl, ()-ethyl 2-[4-[(6-chloro-2-
benzoxazolyl)oxy]phenoxy]propanoate, and its metabolites, 2-[4-[(6-
chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid and 6-chloro-2,3-
dihydrobenzoxazol-2-one, calculated as the stoichiometric equivalent of 
fenoxaprop-ethyl, in or on the commodity

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Grass, hay..............................................            0.09
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-10214 Filed 5-6-14; 8:45 am]
BILLING CODE 6560-50-P