[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Rules and Regulations]
[Pages 39605-39610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17192]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0429; FRL-9980-47]


Picoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
picoxystrobin in or on multiple commodities that are identified and 
discussed later in this document. E.I. DuPont De Nemours and Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective August 10, 2018. Objections and 
requests for hearings must be received on or before October 9, 2018, 
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-2017-0429, 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 (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.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2017-0429 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 
October 9, 2018. 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-2017-0429, 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 November 27, 2017 (82 FR 56017) (FRL-
9968-55), 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 
7F8557) by E.I. Du Pont De Nemours and Company, Chestnut Run Plaza, 974 
Centre Road, Wilmington, DE 19805. The petition requested 40 CFR 
180.669 be amended by establishing tolerances for residues of the 
fungicide picoxystrobin, methyl ([alpha]E)-[alpha]-(methoxymethylene)-
2-[[[6-(trifluoromethyl)-2-pyridinyl]oxy]methyl]benzeneacetate, in or 
on alfalfa, forage at 4 parts per million (ppm); alfalfa, hay at 5 ppm; 
alfalfa, seed at 9 ppm; almond hulls at 15 ppm; cotton, gin by-products 
at 40 ppm; cottonseed (Crop Subgroup 20C) at 4 ppm; grass, forage 
(Grown for Seed) at 40 ppm; grass, hay (Grown for Seed) at 80 ppm; head 
lettuce at 7 ppm; onion, bulb (Crop Subgroup 3-07A) at 0.8 ppm; onion, 
green (Crop Subgroup 3-07B) at 15 ppm; pea and bean, succulent shelled 
(Crop Subgroup 6B) at 3 ppm; peanut at 0.1 ppm; peanut, hay at 40 ppm; 
sunflower (Crop Subgroup 20B) at 3 ppm; tree nut except hulls (Crop 
Group 14-12) at 0.15 ppm; vegetable, brassica head and stem (Crop Group 
5-16) at 5 ppm; vegetable, cucurbit (Crop Group 9) at 0.7 ppm; 
vegetable, fruiting (Crop Group 8-10) at 1.5 ppm; vegetable, leaf 
petiole (Crop Subgroup 22B) at 40 ppm; vegetable, leafy except head 
lettuce (Crop Group 4-16) at 60 ppm; vegetable, leaves of root and 
tuber (Crop Group 2) at 40 ppm; vegetable, legume, edible podded (Crop 
Subgroup 6A) at 4 ppm; vegetable, root (Crop Subgroup 1A) at 0.6 ppm; 
and vegetable, tuberous and corm (Crop Subgroup 1C) at 0.06 ppm. That 
document referenced a summary of the petition prepared by E.I. Du Pont 
De Nemours and Company, the registrant, which is available in the 
docket, http://www.regulations.gov.

[[Page 39606]]

Comments were received on the notice of filing. EPA's response to these 
comments is discussed in Unit IV.C.
    Notice of this same petition was provided again in the Federal 
Register of January 26, 2018 (83 FR 3658) (FRL-9971-46). The only 
difference between the two notifications is that the second 
notification spelled out the analytical method, whereas the November 
2017 notification used just the abbreviations. Both documents provided 
notice for the same petition and same tolerances. That document is also 
available in the docket, http://www.regulations.gov. One comment was 
received on this second notification, but it did not raise any issues 
relevant to this rulemaking.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances at levels lower than requested, except for the 
commodities of alfalfa forage, hay, and seed, and using commodity terms 
consistent with the Agency's food and feed commodity vocabulary. The 
reasons for these changes are 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 picoxystrobin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with picoxystrobin 
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.
    The most consistently observed effects of picoxystrobin exposure 
across species, genders, and treatment durations were decreased body-
weight, body-weight gain and food consumption, and diarrhea. The 
effects on body-weight and food consumption were consistent with the 
commonly observed findings for compounds that disrupt the mitochondria 
respiration system and the resulting disruption of energy production. 
Similar to some other strobilurins, picoxystrobin causes intestinal 
disturbance as indicated by increased incidence of diarrhea or duodenum 
mucosal thickening. These intestinal effects appeared to be related to 
the irritating action on the mucus membranes as demonstrated by severe 
eye irritation effect seen in the primary eye irritation study on 
picoxystrobin.
    In the rat, developmental toxicity was expressed as misaligned 5th 
sternebrae at doses causing maternal toxicity (i.e. diarrhea and 
decreased body weight gain, and food consumption). In the rabbit, 
developmental toxicity seen at doses causing maternal toxicity (i.e. 
decreased body weight and clinical signs of toxicity) consisted of long 
13th rib length and incompletely ossified odontoids and 27 pre-pelvic 
vertebrae. In the reproduction study, parental/systemic toxicity 
manifested as decreased body weight and body weight gain in both the 
parents and offspring; no reproductive toxicity was seen.
    There was no evidence that picoxystrobin directly affects the 
nervous system; behavioral changes observed in the acute and subchronic 
neurotoxicity studies were attributed to general malaise. Picoxystrobin 
has no effects on the immune system in rats and mice, and is not 
mutagenic or genotoxic. No adverse dermal or systemic effects were 
identified in the rat following dermal exposure at the limit-dose. In 
the inhalation toxicity study, rats showed no portal of entry, 
respiratory or systemic toxicity. Chronic picoxystrobin exposure 
induced a treatment-related increase in testicular interstitial cell 
benign tumors in male rats at the high-dose only. No tumors were seen 
in female rats or in male and female mice, and there is no mutagenic 
concern. Based on this information, EPA has classified picoxystrobin as 
``suggestive evidence of carcinogenic potential'', for which 
quantification of cancer risk based on a non-linear approach (i.e., the 
chronic reference doses (RfD)) is appropriate. Use of the chronic RfD 
will adequately account for all chronic toxicity, including 
carcinogenicity, that could result from exposure to picoxystrobin. 
Specific information on the studies received and the nature of the 
adverse effects caused by picoxystrobin 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 document ``Picoxystrobin: Human Health Risk 
Assessment for Proposed New Uses on Root Vegetables, Subgroup 1A; 
Tuberous and Corm Vegetables, Subgroup 1C; Leaves of Root and Tuber 
Vegetables, Group 2; Bulb Onion, Subgroup 3-07A; Green Onion, Subgroup 
3-07B; Leafy Vegetables, except Head Lettuce, Group 4-16; Head and Stem 
Brassica Vegetables, Group 5-16; Edible Podded Legume Vegetables, 
Subgroup 6A; Succulent Shelled Pea and Bean, Subgroup 6B; Fruiting 
Vegetables, Group 8-10; Cucurbit Vegetables, Group 9; Tree Nuts, Group 
14-12; Sunflower, Subgroup 20B; Cottonseed, Subgroup 20C; Leaf Petiole 
Vegetables, Subgroup 22B; Head Lettuce; Almond; Alfalfa; Peanut; and 
Grass, Forage, Fodder, and Hay, Group 17'' in docket ID number EPA-HQ-
OPP-2017-0429.

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

[[Page 39607]]

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 picoxystrobin used for human risk 
assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Picoxystrobin for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary (Females 13-50 years of      An acute dietary risk assessment is not required since no endpoint
 age).                                     attributable to a single exposure was identified from the relevant
                                                                        studies.
                                      --------------------------------------------------------------------------
Acute dietary (General population      UFA = 10x..............  Acute RfD/aPAD = 0.2 mg/ Acute Neurotoxicity--
 including infants and children).      UFH = 10x..............   kg/day.                  Rat
                                       FQPA SF/UFL = 10x......                           LOAEL = 200 mg/kg/day
                                                                                          based on low arousal
                                                                                          and decreased motor
                                                                                          activities in males,
                                                                                          decreased rearing in
                                                                                          females, in addition
                                                                                          to decreased
                                                                                          bodyweight gain and
                                                                                          food consumption in
                                                                                          both sexes on Day 1.
Chronic dietary (All populations)....  NOAEL= 4.6 mg/kg/day     Chronic RfD = 0.046 mg/  Chronic Toxicity--Dog
                                        UFA = 10x.               kg/day.                 LOAEL = 15.7 mg/kg/day
                                       UFH = 10x..............  cPAD = 0.046 mg/kg/day.   based on decreased
                                       FQPA SF = 1x...........                            body weights, body
                                                                                          weight gains, and food
                                                                                          consumption in both
                                                                                          sexes.
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....   ``Suggestive Evidence of Carcinogenic Potential'' based on tumors in one
                                             species and one sex: a treatment-related increase in testicular
                                         interstitial cell benign tumors in high dose male rats. Quantification
                                              of cancer risk is based on a non-linear (i.e., RfD) approach.
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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). UFL = use of a LOAEL to extrapolate a NOAEL.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to picoxystrobin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing picoxystrobin 
tolerances in 40 CFR 180.669. EPA assessed dietary exposures from 
picoxystrobin 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 picoxystrobin. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America, (NHANES/WWEIA). As to residue levels in food, 
EPA's assumption of this dietary assessment included tolerance-level 
residues for all crops. In addition, default processing factors and 
100% percent crop treated (PCT) were assumed for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used tolerance-level 
residues for all crops. In addition, default processing factors and 100 
PCT were assumed for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a linear (RfD) approach is appropriate for assessing 
cancer risk to picoxystrobin. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for picoxystrobin. Tolerance-level residues and/or 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for picoxystrobin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of picoxystrobin. 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 Surface Water Concentration Calculator (SWCC) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of picoxystrobin for acute 
exposures are estimated to be 15.7 parts per billion (ppb) for surface 
water and 1.40 ppb for ground water. Chronic exposures for non-cancer 
assessments are estimated to be 5.53 ppb for surface water and 1.36 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 15.7 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 5.53 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,

[[Page 39608]]

indoor pest control, termiticides, and flea and tick control on pets).
    Picoxystrobin is not registered for any specific use patterns that 
would result in residential exposure.
    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 
picoxystrobin to share a common mechanism of toxicity with any other 
substances, and picoxystrobin does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that picoxystrobin 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://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 Food Quality 
Protection Act Safety Factor (FQPA 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 prenatal and postnatal 
toxicity studies include rat and rabbit prenatal developmental studies 
in addition to reproduction and fertility effects studies in rats. In 
the rat- and rabbit-developmental toxicity studies, developmental 
toxicity was expressed as skeletal variations at doses causing maternal 
toxicity (i.e. diarrhea, decreased body-weight, body-weight gain, food 
consumption, and clinical signs of toxicity). In the reproduction 
study, parental/systemic toxicity manifested as decreased body-weight 
and body-weight gain in both the parents and offspring. No evidence of 
increased susceptibility/sensitivity is seen in any of these studies.
    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 for chronic dietary. For acute dietary 
exposures for the general population, including infants and children 
where the acute neurotoxicity study is used as an endpoint for risk 
assessment, EPA is retaining a 10x FQPA SF. That decision is based on 
the following findings:
    i. The toxicity database for picoxystrobin is complete, except for 
the lack of a NOAEL in the acute neurotoxicity test, which is used to 
establish a toxicological endpoint for acute dietary exposure 
scenarios.
    ii. Although there is some effect on behavior after exposure to 
picoxystrobin, EPA has concluded that picoxystrobin is not a neurotoxic 
chemical due to lack of neuropathological findings; there is no need 
for a developmental neurotoxicity study or additional UFs to account 
for neurotoxicity.
    iii. There is no evidence that picoxystrobin 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 picoxystrobin in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
picoxystrobin.

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 picoxystrobin will occupy 23% of the aPAD for children 1-2 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 
picoxystrobin from food and water will utilize 36% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for picoxystrobin.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no short-term or intermediate-term adverse effect was 
identified and picoxystrobin is not registered for any residential 
uses, picoxystrobin is not expected to pose a short- or intermediate-
term risk.
    4. Aggregate cancer risk for U.S. population. The Agency considers 
the chronic aggregate risk assessment, making use of the cPAD, to be 
protective of any aggregate cancer risk. As chronic risks are below the 
Agency's level of concern, the Agency concludes there is no cancer risk 
of concern from aggregate exposure to picoxystrobin.
    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 picoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography with tandem mass spectrometry (HPLC/ESI-MS/MS)) is 
available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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).

[[Page 39609]]

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 picoxystrobin.

C. Response to Comments

    Comments were received in response to the Notices of Filing of E.I. 
Du Pont De Nemours and Company's petition. Two comments were filed 
within the comment period, one irrelevant and one expressing confusion 
about whether this action duplicated a previous action. The comment 
copied an excerpt from a tolerance rulemaking that was finalized in 
2012; the tolerances requested in this petition are not the same as 
those finalized in 2012. Several other comments were submitted after 
the comment period had closed.

D. Revisions to Petitioned-For Tolerances

    The Agency has revised several of the commodity definitions to be 
consistent with the food and feed commodity vocabulary the Agency uses 
to establish tolerances. The Agency is also establishing tolerance 
levels that are slightly lower than the petitioner requested because 
Agency calculated tolerances (except alfalfa and sorghum) using 
proportionality to extrapolate data which would be reflective of a 1x 
maximum annual application rate rather the exaggerated application 
rates in the field trial studies for the following commodities: Almond 
hulls at 15 ppm to almond, hulls at 7.0 ppm; cotton, gin by-products at 
40 ppm to cotton gin byproducts at 20 ppm; cottonseed (Crop Subgroup 
20C) at 4 ppm to cottonseed subgroup 20C at 2.0 ppm; head lettuce at 7 
ppm to lettuce, head at 4.0 ppm; onion, bulb (Crop Subgroup 3-07A) at 
0.8 ppm to onion, bulb, subgroup 3-07A at 0.50 ppm; onion, green (Crop 
Subgroup 3-07B) at 15 ppm to onion, green, subgroup 3-07B at 10 ppm; 
pea and bean, succulent shelled (Crop Subgroup 6B) at 3 ppm to pea and 
bean, succulent shelled, subgroup 6B at 0.90 ppm; peanut at 0.1 ppm to 
0.05 ppm; peanut, hay at 40 ppm to 30 ppm; sunflower (Crop Subgroup 
20B) at 3 ppm to sunflower subgroup 20B to 2.0 ppm; tree nut except 
hulls (Crop Group 14-12) at 0.15 ppm to nut, tree, group 14-12 at 0.08 
ppm; vegetable, brassica head and stem (Crop Group 5-16) at 5 ppm to 
vegetable, brassica, head and stem, group 5-16 at 2.0 ppm; vegetable, 
cucurbit (Crop Group 9) at 0.7 ppm to vegetable, cucurbit, group 9 at 
0.30 ppm; vegetable, fruiting (Crop Group 8-10) at 1.5 ppm to 
vegetable, fruiting, group 8-10 at 0.70 ppm; vegetable, leaf petiole 
(Crop Subgroup 22B) at 40 ppm to leaf petiole vegetable subgroup 22B at 
20 ppm; vegetable, leafy except head lettuce (Crop Group 4-16) at 60 
ppm to vegetable, leafy, group 4-16, except lettuce, head at 30 ppm; 
vegetable, leaves of root and tuber (Crop Group 2) at 40 ppm to 
vegetable, leaves of root and tuber, group 2 at 30 ppm; vegetable, 
legume, edible podded (Crop Subgroup 6A) at 4 ppm to vegetable, legume, 
edible podded, subgroup 6A at 2.0 ppm; vegetable, root (Crop Subgroup 
1A) at 0.6 ppm to vegetable, root, subgroup 1A at 0.50 ppm; and 
vegetable, tuberous and corm (Crop Subgroup 1C) at 0.06 ppm to 
vegetable, tuberous and corm, subgroup 1C at 0.03 ppm.
    For alfalfa, forage, hay, and seed, the tolerances have been 
modified to represent the appropriate number of significant figures; 
however, the numerical value is no different than requested by the 
petition.
    The petition requested ``grass, forage (Grown for Seed)'' at 40 ppm 
and ``grass, hay (Grown for Seed)'' at 80 ppm. Because ``grass grown 
for seed'' is ambiguous, the Agency is establishing individual 
tolerances for the hay and forage forms of specific grasses for which 
residue data were submitted and that are grown for seed purposes: 
Bluegrass, forage at 30 ppm; bluegrass, hay at 60 ppm, bromegrass, 
forage at 30 ppm; bromegrass, hay at 60 ppm; fescue, forage at 30 ppm; 
fescue, hay at 60 ppm; orchardgrass, forage at 30 ppm; orchardgrass, 
hay at 60 ppm; ryegrass, forage at 30 ppm; ryegrass, hay at 60 ppm; 
switchgrass, forage at 30 ppm; and switchgrass, hay at 60 ppm.
    EPA is also establishing tolerances for beet, sugar, dried pulp at 
1.5 ppm and potato, wet peel at 0.10 ppm, pursuant to 40 CFR 
180.40(f)(1)(i)(A). These tolerances are necessary to cover 
concentrated residues in processed commodities of raw agricultural 
commodities contained in subgroups 1A and 1C, respectively.

V. Conclusion

    Therefore, tolerances are established for residues of 
picoxystrobin, methyl ([alpha]E)-[alpha]-(methoxymethylene)-2-[[[6-
(trifluoromethyl)-2-pyridinyl]oxy]methyl]benzeneacetate, in or on 
alfalfa, forage at 4.0 ppm; alfalfa, hay at 5.0 ppm; alfalfa, seed at 
9.0 ppm; almond, hulls at 7.0 ppm; beet, sugar, dried pulp at 1.5 ppm; 
bluegrass, forage at 30 ppm; bluegrass, hay at 60 ppm; bromegrass, 
forage at 30 ppm; bromegrass, hay at 60 ppm; cotton, gin byproducts at 
20 ppm; cottonseed subgroup 20C at 2.0 ppm; fescue, forage at 30 ppm; 
fescue, hay at 60 ppm; leaf petiole vegetable subgroup 22B at 20 ppm; 
lettuce, head at 4.0 ppm; nut, tree, group 14-12 at 0.08 ppm; onion, 
bulb, subgroup 3-07A at 0.50 ppm; onion, green, subgroup 3-07B at 10 
ppm; orchardgrass, forage at 30 ppm; orchardgrass, hay at 60 ppm; pea 
and bean, succulent shelled, subgroup 6B at 0.90 ppm; peanut at 0.05 
ppm; peanut, hay at 30 ppm; potato, wet peel at 0.10 ppm; ryegrass, 
forage at 30 ppm; ryegrass, hay at 60 ppm; sunflower subgroup 20B to 
2.0 ppm; switchgrass, forage at 30 ppm; switchgrass, hay at 60 ppm; 
vegetable, brassica, head and stem, group 5-16 at 2.0 ppm; vegetable, 
cucurbit, group 9 at 0.30 ppm; vegetable, fruiting, group 8-10 at 0.70 
ppm; vegetable, leafy, group 4-16, except lettuce, head at 30 ppm; 
vegetable, leaves of root and tuber, group 2 at 30 ppm; vegetable, 
legume, edible podded, subgroup 6A at 2.0 ppm; vegetable, root, 
subgroup 1A at 0.50 ppm; and vegetable, tuberous and corm, subgroup 1C 
at 0.03 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

[[Page 39610]]

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: July 25, 2018.
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.  180.669, add alphabetically the following commodities: 
Alfalfa, forage; Alfalfa, hay; Alfalfa, seed; Almond, hulls; Beet, 
sugar, dried pulp; Bluegrass, forage; Bluegrass, hay; Bromegrass, 
forage; Bromegrass, hay; Cotton, gin byproducts; Cottonseed subgroup 
20C; Fescue, forage; Fescue, hay; Leaf petiole vegetable subgroup 22B; 
Lettuce, head; Nut, tree, group 14-12; Onion, bulb, subgroup 3-07A; 
Onion, green, subgroup 3-07B; Orchardgrass, forage; Orchardgrass, hay; 
Pea and bean, succulent shelled, subgroup 6B; Peanut; Peanut, hay; 
Potato, wet peel; Ryegrass, forage; Ryegrass, hay; Sunflower subgroup 
20B; Switchgrass, forage; Switchgrass, hay; Vegetable, brassica, head 
and stem, group 5-16; Vegetable, cucurbit, group 9; Vegetable, 
fruiting, group 8-10; Vegetable, leafy, group 4-16, except lettuce, 
head; Vegetable, leaves of root and tuber, group 2; Vegetable, legume, 
edible podded, subgroup 6A; Vegetable, root, subgroup 1A; and 
Vegetable, tuberous and corm, subgroup 1C to the table in paragraph (a) 
to read as follows:


Sec.  180.669  Picoxystrobin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................         4.0
Alfalfa, hay................................................         5.0
Alfalfa, seed...............................................         9.0
Almond, hulls...............................................         7.0
 
                                * * * * *
Beet, sugar, dried pulp.....................................         1.5
Bluegrass, forage...........................................          30
Bluegrass, hay..............................................          60
Bromegrass, forage..........................................          30
Bromegrass, hay.............................................          60
 
                                * * * * *
Cotton, gin byproducts......................................          20
Cottonseed subgroup 20C.....................................         2.0
 
                                * * * * *
Fescue, forage..............................................          30
Fescue, hay.................................................          60
 
                                * * * * *
Leaf petiole vegetable subgroup 22B.........................          20
Lettuce, head...............................................         4.0
 
                                * * * * *
Nut, tree, group 14-12......................................        0.08
Onion, bulb, subgroup 3-07A.................................        0.50
Onion, green, subgroup 3-07B................................          10
Orchardgrass, forage........................................          30
Orchardgrass, hay...........................................          60
 
                                * * * * *
Pea and bean, succulent shelled, subgroup 6B................        0.90
Peanut......................................................        0.05
Peanut, hay.................................................          30
Potato, wet peel............................................        0.10
 
                                * * * * *
Ryegrass, forage............................................          30
Ryegrass, hay...............................................          60
 
                                * * * * *
Sunflower subgroup 20B......................................         2.0
Switchgrass, forage.........................................          30
Switchgrass, hay............................................          60
 
                                * * * * *
Vegetable, brassica, head and stem, group 5-16..............         2.0
Vegetable, cucurbit, group 9................................        0.30
 
                                * * * * *
Vegetable, fruiting, group 8-10.............................        0.70
Vegetable, leafy, group 4-16, except lettuce, head..........          30
Vegetable, leaves of root and tuber, group 2................          30
Vegetable, legume, edible podded, subgroup 6A...............         2.0
Vegetable, root, subgroup 1A................................        0.50
Vegetable, tuberous and corm, subgroup 1C...................        0.03
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-17192 Filed 8-9-18; 8:45 am]
 BILLING CODE 6560-50-P


