83_FR_39760 83 FR 39605 - Picoxystrobin; Pesticide Tolerances

83 FR 39605 - Picoxystrobin; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 155 (August 10, 2018)

Page Range39605-39610
FR Document2018-17192

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).

Federal Register, Volume 83 Issue 155 (Friday, August 10, 2018)
[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Rules and Regulations]
[Pages 39605-39610]
From the Federal Register Online  [www.thefederalregister.org]
[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: 
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. 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.
----------------------------------------------------------------------------------------------------------------
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: 
residuemethods@epa.gov.

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



                                                                Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Rules and Regulations                                         39605

                                             *      *     *       *      *                           pesticide manufacturer. The following                 information you consider to be CBI or
                                             [FR Doc. 2018–17078 Filed 8–9–18; 8:45 am]              list of North American Industrial                     other information whose disclosure is
                                             BILLING CODE 6560–50–P                                  Classification System (NAICS) codes is                restricted by statute.
                                                                                                     not intended to be exhaustive, but rather               • Mail: OPP Docket, Environmental
                                                                                                     provides a guide to help readers                      Protection Agency Docket Center (EPA/
                                             ENVIRONMENTAL PROTECTION                                determine whether this document                       DC), (28221T), 1200 Pennsylvania Ave.
                                             AGENCY                                                  applies to them. Potentially affected                 NW, Washington, DC 20460–0001.
                                                                                                     entities may include:                                   • Hand Delivery: To make special
                                             40 CFR Part 180                                            • Crop production (NAICS code 111).                arrangements for hand delivery or
                                                                                                        • Animal production (NAICS code                    delivery of boxed information, please
                                             [EPA–HQ–OPP–2017–0429; FRL–9980–47]
                                                                                                     112).                                                 follow the instructions at http://
                                             Picoxystrobin; Pesticide Tolerances                        • Food manufacturing (NAICS code                   www.epa.gov/dockets/contacts.html.
                                                                                                     311).                                                   Additional instructions on
                                             AGENCY:  Environmental Protection                          • Pesticide manufacturing (NAICS                   commenting or visiting the docket,
                                             Agency (EPA).                                           code 32532).                                          along with more information about
                                             ACTION: Final rule.                                                                                           dockets generally, is available at http://
                                                                                                     B. How can I get electronic access to                 www.epa.gov/dockets.
                                             SUMMARY:   This regulation establishes                  other related information?
                                             tolerances for residues of picoxystrobin                   You may access a frequently updated                II. Summary of Petitioned-For
                                             in or on multiple commodities that are                  electronic version of EPA’s tolerance                 Tolerance
                                             identified and discussed later in this                  regulations at 40 CFR part 180 through                   In the Federal Register of November
                                             document. E.I. DuPont De Nemours and                    the Government Printing Office’s e-CFR                27, 2017 (82 FR 56017) (FRL–9968–55),
                                             Company requested these tolerances                      site at http://www.ecfr.gov/cgi-bin/text-             EPA issued a document pursuant to
                                             under the Federal Food, Drug, and                       idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  FFDCA section 408(d)(3), 21 U.S.C.
                                             Cosmetic Act (FFDCA).                                   40tab_02.tpl. To access the OCSPP test                346a(d)(3), announcing the filing of a
                                             DATES: This regulation is effective                     guidelines referenced in this document                pesticide petition (PP 7F8557) by E.I. Du
                                             August 10, 2018. Objections and                         electronically, please go to http://                  Pont De Nemours and Company,
                                             requests for hearings must be received                  www.epa.gov/ocspp and select ‘‘Test                   Chestnut Run Plaza, 974 Centre Road,
                                             on or before October 9, 2018, and must                  Methods and Guidelines.’’                             Wilmington, DE 19805. The petition
                                             be filed in accordance with the                                                                               requested 40 CFR 180.669 be amended
                                                                                                     C. How can I file an objection or hearing             by establishing tolerances for residues of
                                             instructions provided in 40 CFR part
                                                                                                     request?                                              the fungicide picoxystrobin, methyl
                                             178 (see also Unit I.C. of the
                                             SUPPLEMENTARY INFORMATION).                               Under FFDCA section 408(g), 21                      (aE)-a-(methoxymethylene)-2-[[[6-
                                             ADDRESSES: The docket for this action,                  U.S.C. 346a, any person may file an                   (trifluoromethyl)-2-
                                             identified by docket identification (ID)                objection to any aspect of this regulation            pyridinyl]oxy]methyl]benzeneacetate, in
                                             number EPA–HQ–OPP–2017–0429, is                         and may also request a hearing on those               or on alfalfa, forage at 4 parts per
                                             available at http://www.regulations.gov                 objections. You must file your objection              million (ppm); alfalfa, hay at 5 ppm;
                                             or at the Office of Pesticide Programs                  or request a hearing on this regulation               alfalfa, seed at 9 ppm; almond hulls at
                                             Regulatory Public Docket (OPP Docket)                   in accordance with the instructions                   15 ppm; cotton, gin by-products at 40
                                             in the Environmental Protection Agency                  provided in 40 CFR part 178. To ensure                ppm; cottonseed (Crop Subgroup 20C) at
                                             Docket Center (EPA/DC), West William                    proper receipt by EPA, you must                       4 ppm; grass, forage (Grown for Seed) at
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                 identify docket ID number EPA–HQ–                     40 ppm; grass, hay (Grown for Seed) at
                                                                                                     OPP–2017–0429 in the subject line on                  80 ppm; head lettuce at 7 ppm; onion,
                                             Constitution Ave. NW, Washington, DC
                                                                                                     the first page of your submission. All                bulb (Crop Subgroup 3–07A) at 0.8 ppm;
                                             20460–0001. The Public Reading Room
                                                                                                     objections and requests for a hearing                 onion, green (Crop Subgroup 3–07B) at
                                             is open from 8:30 a.m. to 4:30 p.m.,
                                                                                                     must be in writing, and must be                       15 ppm; pea and bean, succulent
                                             Monday through Friday, excluding legal
                                                                                                     received by the Hearing Clerk on or                   shelled (Crop Subgroup 6B) at 3 ppm;
                                             holidays. The telephone number for the
                                                                                                     before October 9, 2018. Addresses for                 peanut at 0.1 ppm; peanut, hay at 40
                                             Public Reading Room is (202) 566–1744,
                                                                                                     mail and hand delivery of objections                  ppm; sunflower (Crop Subgroup 20B) at
                                             and the telephone number for the OPP
                                                                                                     and hearing requests are provided in 40               3 ppm; tree nut except hulls (Crop
                                             Docket is (703) 305–5805. Please review
                                                                                                     CFR 178.25(b).                                        Group 14–12) at 0.15 ppm; vegetable,
                                             the visitor instructions and additional
                                                                                                       In addition to filing an objection or               brassica head and stem (Crop Group 5–
                                             information about the docket available
                                                                                                     hearing request with the Hearing Clerk                16) at 5 ppm; vegetable, cucurbit (Crop
                                             at http://www.epa.gov/dockets.
                                                                                                     as described in 40 CFR part 178, please               Group 9) at 0.7 ppm; vegetable, fruiting
                                             FOR FURTHER INFORMATION CONTACT:
                                                                                                     submit a copy of the filing (excluding                (Crop Group 8–10) at 1.5 ppm;
                                             Michael L. Goodis, P.E., Registration                                                                         vegetable, leaf petiole (Crop Subgroup
                                                                                                     any Confidential Business Information
                                             Division (7505P), Office of Pesticide                                                                         22B) at 40 ppm; vegetable, leafy except
                                                                                                     (CBI)) for inclusion in the public docket.
                                             Programs, Environmental Protection                                                                            head lettuce (Crop Group 4–16) at 60
                                                                                                     Information not marked confidential
                                             Agency, 1200 Pennsylvania Ave. NW,                                                                            ppm; vegetable, leaves of root and tuber
                                                                                                     pursuant to 40 CFR part 2 may be
                                             Washington, DC 20460–0001; main                                                                               (Crop Group 2) at 40 ppm; vegetable,
                                                                                                     disclosed publicly by EPA without prior
                                             telephone number: (703) 305–7090;                                                                             legume, edible podded (Crop Subgroup
                                                                                                     notice. Submit the non-CBI copy of your
                                             email address: RDFRNotices@epa.gov.                                                                           6A) at 4 ppm; vegetable, root (Crop
                                                                                                     objection or hearing request, identified
                                             SUPPLEMENTARY INFORMATION:                                                                                    Subgroup 1A) at 0.6 ppm; and vegetable,
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                                                                                                     by docket ID number EPA–HQ–OPP–
                                             I. General Information                                  2017–0429, by one of the following                    tuberous and corm (Crop Subgroup 1C)
                                                                                                     methods:                                              at 0.06 ppm. That document referenced
                                             A. Does this action apply to me?                          • Federal eRulemaking Portal: http://               a summary of the petition prepared by
                                               You may be potentially affected by                    www.regulations.gov. Follow the online                E.I. Du Pont De Nemours and Company,
                                             this action if you are an agricultural                  instructions for submitting comments.                 the registrant, which is available in the
                                             producer, food manufacturer, or                         Do not submit electronically any                      docket, http://www.regulations.gov.


                                        VerDate Sep<11>2014   16:07 Aug 09, 2018   Jkt 244001   PO 00000   Frm 00025   Fmt 4700   Sfmt 4700   E:\FR\FM\10AUR1.SGM   10AUR1


                                             39606              Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Rules and Regulations

                                             Comments were received on the notice                    A. Toxicological Profile                              concern. Based on this information, EPA
                                             of filing. EPA’s response to these                         EPA has evaluated the available                    has classified picoxystrobin as
                                             comments is discussed in Unit IV.C.                     toxicity data and considered its validity,            ‘‘suggestive evidence of carcinogenic
                                                Notice of this same petition was                     completeness, and reliability as well as              potential’’, for which quantification of
                                             provided again in the Federal Register                                                                        cancer risk based on a non-linear
                                                                                                     the relationship of the results of the
                                             of January 26, 2018 (83 FR 3658) (FRL–                                                                        approach (i.e., the chronic reference
                                                                                                     studies to human risk. EPA has also
                                             9971–46). The only difference between                                                                         doses (RfD)) is appropriate. Use of the
                                                                                                     considered available information
                                             the two notifications is that the second                                                                      chronic RfD will adequately account for
                                                                                                     concerning the variability of the
                                             notification spelled out the analytical                                                                       all chronic toxicity, including
                                                                                                     sensitivities of major identifiable
                                             method, whereas the November 2017                                                                             carcinogenicity, that could result from
                                                                                                     subgroups of consumers, including
                                             notification used just the abbreviations.                                                                     exposure to picoxystrobin. Specific
                                                                                                     infants and children.
                                             Both documents provided notice for the                                                                        information on the studies received and
                                                                                                        The most consistently observed
                                             same petition and same tolerances. That                                                                       the nature of the adverse effects caused
                                                                                                     effects of picoxystrobin exposure across
                                             document is also available in the                                                                             by picoxystrobin as well as the no-
                                                                                                     species, genders, and treatment
                                             docket, http://www.regulations.gov. One                                                                       observed-adverse-effect-level (NOAEL)
                                                                                                     durations were decreased body-weight,
                                             comment was received on this second                                                                           and the lowest-observed-adverse-effect-
                                                                                                     body-weight gain and food
                                             notification, but it did not raise any                                                                        level (LOAEL) from the toxicity studies
                                                                                                     consumption, and diarrhea. The effects
                                             issues relevant to this rulemaking.                                                                           can be found at http://
                                                Based upon review of the data                        on body-weight and food consumption
                                                                                                                                                           www.regulations.gov in document
                                             supporting the petition, EPA is                         were consistent with the commonly
                                                                                                                                                           ‘‘Picoxystrobin: Human Health Risk
                                             establishing tolerances at levels lower                 observed findings for compounds that
                                                                                                                                                           Assessment for Proposed New Uses on
                                             than requested, except for the                          disrupt the mitochondria respiration
                                                                                                                                                           Root Vegetables, Subgroup 1A;
                                             commodities of alfalfa forage, hay, and                 system and the resulting disruption of
                                                                                                                                                           Tuberous and Corm Vegetables,
                                             seed, and using commodity terms                         energy production. Similar to some
                                                                                                                                                           Subgroup 1C; Leaves of Root and Tuber
                                             consistent with the Agency’s food and                   other strobilurins, picoxystrobin causes
                                                                                                                                                           Vegetables, Group 2; Bulb Onion,
                                             feed commodity vocabulary. The                          intestinal disturbance as indicated by                Subgroup 3–07A; Green Onion,
                                             reasons for these changes are explained                 increased incidence of diarrhea or                    Subgroup 3–07B; Leafy Vegetables,
                                             in Unit IV.D.                                           duodenum mucosal thickening. These                    except Head Lettuce, Group 4–16; Head
                                                                                                     intestinal effects appeared to be related             and Stem Brassica Vegetables, Group 5–
                                             III. Aggregate Risk Assessment and                      to the irritating action on the mucus
                                             Determination of Safety                                                                                       16; Edible Podded Legume Vegetables,
                                                                                                     membranes as demonstrated by severe                   Subgroup 6A; Succulent Shelled Pea
                                                Section 408(b)(2)(A)(i) of FFDCA                     eye irritation effect seen in the primary             and Bean, Subgroup 6B; Fruiting
                                             allows EPA to establish a tolerance (the                eye irritation study on picoxystrobin.                Vegetables, Group 8–10; Cucurbit
                                             legal limit for a pesticide chemical                       In the rat, developmental toxicity was             Vegetables, Group 9; Tree Nuts, Group
                                             residue in or on a food) only if EPA                    expressed as misaligned 5th sternebrae                14–12; Sunflower, Subgroup 20B;
                                             determines that the tolerance is ‘‘safe.’’              at doses causing maternal toxicity (i.e.              Cottonseed, Subgroup 20C; Leaf Petiole
                                             Section 408(b)(2)(A)(ii) of FFDCA                       diarrhea and decreased body weight                    Vegetables, Subgroup 22B; Head
                                             defines ‘‘safe’’ to mean that ‘‘there is a              gain, and food consumption). In the                   Lettuce; Almond; Alfalfa; Peanut; and
                                             reasonable certainty that no harm will                  rabbit, developmental toxicity seen at                Grass, Forage, Fodder, and Hay, Group
                                             result from aggregate exposure to the                   doses causing maternal toxicity (i.e.                 17’’ in docket ID number EPA–HQ–
                                             pesticide chemical residue, including                   decreased body weight and clinical                    OPP–2017–0429.
                                             all anticipated dietary exposures and all               signs of toxicity) consisted of long 13th
                                             other exposures for which there is                      rib length and incompletely ossified                  B. Toxicological Points of Departure/
                                             reliable information.’’ This includes                   odontoids and 27 pre-pelvic vertebrae.                Levels of Concern
                                             exposure through drinking water and in                  In the reproduction study, parental/                     Once a pesticide’s toxicological
                                             residential settings, but does not include              systemic toxicity manifested as                       profile is determined, EPA identifies
                                             occupational exposure. Section                          decreased body weight and body weight                 toxicological points of departure (POD)
                                             408(b)(2)(C) of FFDCA requires EPA to                   gain in both the parents and offspring;               and levels of concern to use in
                                             give special consideration to exposure                  no reproductive toxicity was seen.                    evaluating the risk posed by human
                                             of infants and children to the pesticide                   There was no evidence that                         exposure to the pesticide. For hazards
                                             chemical residue in establishing a                      picoxystrobin directly affects the                    that have a threshold below which there
                                             tolerance and to ‘‘ensure that there is a               nervous system; behavioral changes                    is no appreciable risk, the toxicological
                                             reasonable certainty that no harm will                  observed in the acute and subchronic                  POD is used as the basis for derivation
                                             result to infants and children from                     neurotoxicity studies were attributed to              of reference values for risk assessment.
                                             aggregate exposure to the pesticide                     general malaise. Picoxystrobin has no                 PODs are developed based on a careful
                                             chemical residue . . . . ’’                             effects on the immune system in rats                  analysis of the doses in each
                                                Consistent with FFDCA section                        and mice, and is not mutagenic or                     toxicological study to determine the
                                             408(b)(2)(D), and the factors specified in              genotoxic. No adverse dermal or                       dose at which no adverse effects are
                                             FFDCA section 408(b)(2)(D), EPA has                     systemic effects were identified in the               observed (the NOAEL) and the lowest
                                             reviewed the available scientific data                  rat following dermal exposure at the                  dose at which adverse effects of concern
                                             and other relevant information in                       limit-dose. In the inhalation toxicity                are identified (the LOAEL). Uncertainty/
                                             support of this action. EPA has                         study, rats showed no portal of entry,                safety factors are used in conjunction
                                             sufficient data to assess the hazards of                respiratory or systemic toxicity. Chronic             with the POD to calculate a safe
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                                             and to make a determination on                          picoxystrobin exposure induced a                      exposure level—generally referred to as
                                             aggregate exposure for picoxystrobin                    treatment-related increase in testicular              a population-adjusted dose (PAD) or a
                                             including exposure resulting from the                   interstitial cell benign tumors in male               reference dose (RfD)—and a safe margin
                                             tolerances established by this action.                  rats at the high-dose only. No tumors                 of exposure (MOE). For non-threshold
                                             EPA’s assessment of exposures and risks                 were seen in female rats or in male and               risks, the Agency assumes that any
                                             associated with picoxystrobin follows.                  female mice, and there is no mutagenic                amount of exposure will lead to some


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                                                                 Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Rules and Regulations                                                     39607

                                             degree of risk. Thus, the Agency                           EPA uses in risk characterization and a                     human-health-risk-pesticides. A
                                             estimates risk in terms of the probability                 complete description of the risk                            summary of the toxicological endpoints
                                             of an occurrence of the adverse effect                     assessment process, see http://                             for picoxystrobin used for human risk
                                             expected in a lifetime. For more                           www2.epa.gov/pesticide-science-and-                         assessment is shown in Table 1 of this
                                             information on the general principles                      assessing-pesticide-risks/assessing-                        unit.

                                              TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PICOXYSTROBIN FOR USE IN HUMAN HEALTH RISK
                                                                                         ASSESSMENT
                                                                                                            Point of departure and                     RfD, PAD, LOC for risk
                                                              Exposure/scenario                                                                                                      Study and toxicological effects
                                                                                                           uncertainty/safety factors                       assessment

                                             Acute dietary (Females 13–50 years of age) ...             An acute dietary risk assessment is not required since no endpoint attributable to a single expo-
                                                                                                                                  sure was identified from the relevant studies.

                                             Acute dietary (General population including in-            UFA = 10x ...............................   Acute RfD/aPAD = 0.2 mg/kg/      Acute Neurotoxicity—Rat
                                               fants and children).                                     UFH = 10x                                     day.                           LOAEL = 200 mg/kg/day
                                                                                                        FQPA SF/UFL = 10x                                                              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 UFA                    Chronic RfD = 0.046 mg/kg/       Chronic Toxicity—Dog
                                                                                                         = 10x.                                       day.                           LOAEL = 15.7 mg/kg/day
                                                                                                        UFH = 10x                                   cPAD = 0.046 mg/kg/day .......     based on decreased body
                                                                                                        FQPA SF = 1x                                                                   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.
                                                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 ex-
                                             trapolate a NOAEL.


                                             C. Exposure Assessment                                        ii. Chronic exposure. In conducting                      picoxystrobin. Further information
                                                                                                        the chronic dietary exposure assessment                     regarding EPA drinking water models
                                                1. Dietary exposure from food and
                                                                                                        EPA used the food consumption data                          used in pesticide exposure assessment
                                             feed uses. In evaluating dietary
                                                                                                        from the USDA 1994–1996 and 1998                            can be found at http://www.epa.gov/
                                             exposure to picoxystrobin, EPA
                                                                                                        CSFII. As to residue levels in food, EPA                    oppefed1/models/water/index.htm.
                                             considered exposure under the                                                                                             Based on the Surface Water
                                                                                                        used tolerance-level residues for all
                                             petitioned-for tolerances as well as all                                                                               Concentration Calculator (SWCC) and
                                                                                                        crops. In addition, default processing
                                             existing picoxystrobin tolerances in 40                                                                                Pesticide Root Zone Model Ground
                                                                                                        factors and 100 PCT were assumed for
                                             CFR 180.669. EPA assessed dietary                                                                                      Water (PRZM GW), the estimated
                                                                                                        all commodities.
                                             exposures from picoxystrobin in food as                       iii. Cancer. Based on the data                           drinking water concentrations (EDWCs)
                                             follows:                                                   summarized in Unit III.A., EPA has                          of picoxystrobin for acute exposures are
                                                i. Acute exposure. Quantitative acute                   concluded that a linear (RfD) approach                      estimated to be 15.7 parts per billion
                                             dietary exposure and risk assessments                      is appropriate for assessing cancer risk                    (ppb) for surface water and 1.40 ppb for
                                             are performed for a food-use pesticide,                    to picoxystrobin. Cancer risk was                           ground water. Chronic exposures for
                                             if a toxicological study has indicated the                 assessed using the same exposure                            non-cancer assessments are estimated to
                                             possibility of an effect of concern                        estimates as discussed in Unit III.C.1.ii.,                 be 5.53 ppb for surface water and 1.36
                                             occurring as a result of a 1-day or single                 chronic exposure.                                           ppb for ground water.
                                             exposure. Such effects were identified                        iv. Anticipated residue and PCT                             Modeled estimates of drinking water
                                             for picoxystrobin. In estimating acute                     information. EPA did not use                                concentrations were directly entered
                                             dietary exposure, EPA used food                            anticipated residue and/or PCT                              into the dietary exposure model. For
                                             consumption information from the                           information in the dietary assessment                       acute dietary risk assessment, the water
                                             United States Department of Agriculture                    for picoxystrobin. Tolerance-level                          concentration value of 15.7 ppb was
                                             (USDA) National Health and Nutrition                       residues and/or 100 PCT were assumed                        used to assess the contribution to
                                             Examination Survey, What We Eat in                         for all food commodities.                                   drinking water. For chronic dietary risk
                                             America, (NHANES/WWEIA). As to                                2. Dietary exposure from drinking                        assessment, the water concentration of
                                             residue levels in food, EPA’s
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                                                                                                        water. The Agency used screening-level                      value 5.53 ppb was used to assess the
                                             assumption of this dietary assessment                      water exposure models in the dietary                        contribution to drinking water.
                                             included tolerance-level residues for all                  exposure analysis and risk assessment                          3. From non-dietary exposure. The
                                             crops. In addition, default processing                     for picoxystrobin in drinking water.                        term ‘‘residential exposure’’ is used in
                                             factors and 100% percent crop treated                      These simulation models take into                           this document to refer to non-
                                             (PCT) were assumed for all                                 account data on the physical, chemical,                     occupational, non-dietary exposure
                                             commodities.                                               and fate/transport characteristics of                       (e.g., for lawn and garden pest control,


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                                             39608              Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Rules and Regulations

                                             indoor pest control, termiticides, and                  and body-weight gain in both the                      picoxystrobin will occupy 23% of the
                                             flea and tick control on pets).                         parents and offspring. No evidence of                 aPAD for children 1–2 years old, the
                                                Picoxystrobin is not registered for any              increased susceptibility/sensitivity is               population group receiving the greatest
                                             specific use patterns that would result                 seen in any of these studies.                         exposure.
                                             in residential exposure.                                   3. Conclusion. EPA has determined                     2. Chronic risk. Using the exposure
                                                4. Cumulative effects from substances                that reliable data show the safety of                 assumptions described in this unit for
                                             with a common mechanism of toxicity.                    infants and children would be                         chronic exposure, EPA has concluded
                                             Section 408(b)(2)(D)(v) of FFDCA                        adequately protected if the FQPA SF                   that chronic exposure to picoxystrobin
                                             requires that, when considering whether                 were reduced to 1x for chronic dietary.               from food and water will utilize 36% of
                                             to establish, modify, or revoke a                       For acute dietary exposures for the                   the cPAD for children 1–2 years old, the
                                             tolerance, the Agency consider                          general population, including infants                 population group receiving the greatest
                                             ‘‘available information’’ concerning the                and children where the acute                          exposure. There are no residential uses
                                             cumulative effects of a particular                      neurotoxicity study is used as an                     for picoxystrobin.
                                             pesticide’s residues and ‘‘other                        endpoint for risk assessment, EPA is                     3. Short- and intermediate-term risk.
                                             substances that have a common                           retaining a 10x FQPA SF. That decision                Short- and intermediate-term aggregate
                                             mechanism of toxicity.’’ EPA has not                    is based on the following findings:                   exposure takes into account residential
                                             found picoxystrobin to share a common                      i. The toxicity database for                       exposure plus chronic exposure to food
                                             mechanism of toxicity with any other                    picoxystrobin is complete, except for                 and water (considered to be a
                                             substances, and picoxystrobin does not                  the lack of a NOAEL in the acute                      background exposure level). Because no
                                             appear to produce a toxic metabolite                    neurotoxicity test, which is used to                  short-term or intermediate-term adverse
                                             produced by other substances. For the                   establish a toxicological endpoint for                effect was identified and picoxystrobin
                                             purposes of this tolerance action,                      acute dietary exposure scenarios.                     is not registered for any residential uses,
                                             therefore, EPA has assumed that                            ii. Although there is some effect on               picoxystrobin is not expected to pose a
                                             picoxystrobin does not have a common                    behavior after exposure to                            short- or intermediate-term risk.
                                             mechanism of toxicity with other                        picoxystrobin, EPA has concluded that                    4. Aggregate cancer risk for U.S.
                                             substances. For information regarding                   picoxystrobin is not a neurotoxic                     population. The Agency considers the
                                             EPA’s efforts to determine which                        chemical due to lack of                               chronic aggregate risk assessment,
                                             chemicals have a common mechanism                       neuropathological findings; there is no               making use of the cPAD, to be protective
                                             of toxicity and to evaluate the                         need for a developmental neurotoxicity                of any aggregate cancer risk. As chronic
                                             cumulative effects of such chemicals,                   study or additional UFs to account for                risks are below the Agency’s level of
                                             see EPA’s website at http://                            neurotoxicity.                                        concern, the Agency concludes there is
                                             www.epa.gov/pesticides/cumulative.                         iii. There is no evidence that                     no cancer risk of concern from aggregate
                                                                                                     picoxystrobin results in increased                    exposure to picoxystrobin.
                                             D. Safety Factor for Infants and
                                                                                                     susceptibility in in utero rats or rabbits               5. Determination of safety. Based on
                                             Children
                                                                                                     in the prenatal developmental studies or              these risk assessments, EPA concludes
                                               1. In general. Section 408(b)(2)(C) of                in young rats in the 2-generation
                                             FFDCA provides that EPA shall apply                                                                           that there is a reasonable certainty that
                                                                                                     reproduction study.                                   no harm will result to the general
                                             an additional tenfold (10X) margin of                      iv. There are no residual uncertainties
                                             safety for infants and children in the                                                                        population, or to infants and children
                                                                                                     identified in the exposure databases.                 from aggregate exposure to
                                             case of threshold effects to account for                The dietary food exposure assessments
                                             prenatal and postnatal toxicity and the                                                                       picoxystrobin residues.
                                                                                                     were performed based on 100 PCT and
                                             completeness of the database on toxicity                tolerance-level residues. EPA made                    IV. Other Considerations
                                             and exposure unless EPA determines                      conservative (protective) assumptions in
                                             based on reliable data that a different                                                                       A. Analytical Enforcement Methodology
                                                                                                     the ground and surface water modeling
                                             margin of safety will be safe for infants               used to assess exposure to picoxystrobin                 Adequate enforcement methodology
                                             and children. This additional margin of                 in drinking water. These assessments                  (high-performance liquid
                                             safety is commonly referred to as the                   will not underestimate the exposure and               chromatography with tandem mass
                                             Food Quality Protection Act Safety                      risks posed by picoxystrobin.                         spectrometry (HPLC/ESI–MS/MS)) is
                                             Factor (FQPA SF). In applying this                                                                            available to enforce the tolerance
                                             provision, EPA either retains the default               E. Aggregate Risks and Determination of               expression.
                                             value of 10X, or uses a different                       Safety                                                   The method may be requested from:
                                             additional safety factor when reliable                     EPA determines whether acute and                   Chief, Analytical Chemistry Branch,
                                             data available to EPA support the choice                chronic dietary pesticide exposures are               Environmental Science Center, 701
                                             of a different factor.                                  safe by comparing aggregate exposure                  Mapes Rd., Ft. Meade, MD 20755–5350;
                                               2. Prenatal and postnatal sensitivity.                estimates to the acute PAD (aPAD) and                 telephone number: (410) 305–2905;
                                             The prenatal and postnatal toxicity                     chronic PAD (cPAD). For linear cancer                 email address: residuemethods@
                                             studies include rat and rabbit prenatal                 risks, EPA calculates the lifetime                    epa.gov.
                                             developmental studies in addition to                    probability of acquiring cancer given the
                                             reproduction and fertility effects studies                                                                    B. International Residue Limits
                                                                                                     estimated aggregate exposure. Short-,
                                             in rats. In the rat- and rabbit-                        intermediate-, and chronic-term risks                   In making its tolerance decisions, EPA
                                             developmental toxicity studies,                         are evaluated by comparing the                        seeks to harmonize U.S. tolerances with
                                             developmental toxicity was expressed                    estimated aggregate food, water, and                  international standards whenever
                                             as skeletal variations at doses causing                                                                       possible, consistent with U.S. food
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                                                                                                     residential exposure to the appropriate
                                             maternal toxicity (i.e. diarrhea,                       PODs to ensure that an adequate MOE                   safety standards and agricultural
                                             decreased body-weight, body-weight                      exists.                                               practices. EPA considers the
                                             gain, food consumption, and clinical                       1. Acute risk. Using the exposure                  international maximum residue limits
                                             signs of toxicity). In the reproduction                 assumptions discussed in this unit for                (MRLs) established by the Codex
                                             study, parental/systemic toxicity                       acute exposure, the acute dietary                     Alimentarius Commission (Codex), as
                                             manifested as decreased body-weight                     exposure from food and water to                       required by FFDCA section 408(b)(4).


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                                                                Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Rules and Regulations                                       39609

                                             The Codex Alimentarius is a joint                       head and stem (Crop Group 5–16) at 5                  dried pulp at 1.5 ppm; bluegrass, forage
                                             United Nations Food and Agriculture                     ppm to vegetable, brassica, head and                  at 30 ppm; bluegrass, hay at 60 ppm;
                                             Organization/World Health                               stem, group 5–16 at 2.0 ppm; vegetable,               bromegrass, forage at 30 ppm;
                                             Organization food standards program,                    cucurbit (Crop Group 9) at 0.7 ppm to                 bromegrass, hay at 60 ppm; cotton, gin
                                             and it is recognized as an international                vegetable, cucurbit, group 9 at 0.30                  byproducts at 20 ppm; cottonseed
                                             food safety standards-setting                           ppm; vegetable, fruiting (Crop Group 8–               subgroup 20C at 2.0 ppm; fescue, forage
                                             organization in trade agreements to                     10) at 1.5 ppm to vegetable, fruiting,                at 30 ppm; fescue, hay at 60 ppm; leaf
                                             which the United States is a party. EPA                 group 8–10 at 0.70 ppm; vegetable, leaf               petiole vegetable subgroup 22B at 20
                                             may establish a tolerance that is                       petiole (Crop Subgroup 22B) at 40 ppm                 ppm; lettuce, head at 4.0 ppm; nut, tree,
                                             different from a Codex MRL; however,                    to leaf petiole vegetable subgroup 22B at             group 14–12 at 0.08 ppm; onion, bulb,
                                             FFDCA section 408(b)(4) requires that                   20 ppm; vegetable, leafy except head                  subgroup 3–07A at 0.50 ppm; onion,
                                             EPA explain the reasons for departing                   lettuce (Crop Group 4–16) at 60 ppm to                green, subgroup 3–07B at 10 ppm;
                                             from the Codex level. The Codex has not                 vegetable, leafy, group 4–16, except                  orchardgrass, forage at 30 ppm;
                                             established a MRL for picoxystrobin.                    lettuce, head at 30 ppm; vegetable,                   orchardgrass, hay at 60 ppm; pea and
                                                                                                     leaves of root and tuber (Crop Group 2)               bean, succulent shelled, subgroup 6B at
                                             C. Response to Comments
                                                                                                     at 40 ppm to vegetable, leaves of root                0.90 ppm; peanut at 0.05 ppm; peanut,
                                                Comments were received in response                   and tuber, group 2 at 30 ppm; vegetable,              hay at 30 ppm; potato, wet peel at 0.10
                                             to the Notices of Filing of E.I. Du Pont                legume, edible podded (Crop Subgroup                  ppm; ryegrass, forage at 30 ppm;
                                             De Nemours and Company’s petition.                      6A) at 4 ppm to vegetable, legume,                    ryegrass, hay at 60 ppm; sunflower
                                             Two comments were filed within the                      edible podded, subgroup 6A at 2.0 ppm;                subgroup 20B to 2.0 ppm; switchgrass,
                                             comment period, one irrelevant and one                  vegetable, root (Crop Subgroup 1A) at                 forage at 30 ppm; switchgrass, hay at 60
                                             expressing confusion about whether this                 0.6 ppm to vegetable, root, subgroup 1A               ppm; vegetable, brassica, head and stem,
                                             action duplicated a previous action. The                at 0.50 ppm; and vegetable, tuberous                  group 5–16 at 2.0 ppm; vegetable,
                                             comment copied an excerpt from a                        and corm (Crop Subgroup 1C) at 0.06                   cucurbit, group 9 at 0.30 ppm;
                                             tolerance rulemaking that was finalized                 ppm to vegetable, tuberous and corm,                  vegetable, fruiting, group 8–10 at 0.70
                                             in 2012; the tolerances requested in this               subgroup 1C at 0.03 ppm.                              ppm; vegetable, leafy, group 4–16,
                                             petition are not the same as those                         For alfalfa, forage, hay, and seed, the            except lettuce, head at 30 ppm;
                                             finalized in 2012. Several other                        tolerances have been modified to                      vegetable, leaves of root and tuber,
                                             comments were submitted after the                       represent the appropriate number of                   group 2 at 30 ppm; vegetable, legume,
                                             comment period had closed.                              significant figures; however, the                     edible podded, subgroup 6A at 2.0 ppm;
                                             D. Revisions to Petitioned-For                          numerical value is no different than                  vegetable, root, subgroup 1A at 0.50
                                             Tolerances                                              requested by the petition.                            ppm; and vegetable, tuberous and corm,
                                                                                                        The petition requested ‘‘grass, forage             subgroup 1C at 0.03 ppm.
                                                The Agency has revised several of the                (Grown for Seed)’’ at 40 ppm and ‘‘grass,
                                             commodity definitions to be consistent                  hay (Grown for Seed)’’ at 80 ppm.                     VI. Statutory and Executive Order
                                             with the food and feed commodity                        Because ‘‘grass grown for seed’’ is                   Reviews
                                             vocabulary the Agency uses to establish                 ambiguous, the Agency is establishing                    This action establishes tolerances
                                             tolerances. The Agency is also                          individual tolerances for the hay and                 under FFDCA section 408(d) in
                                             establishing tolerance levels that are                  forage forms of specific grasses for                  response to a petition submitted to the
                                             slightly lower than the petitioner                      which residue data were submitted and                 Agency. The Office of Management and
                                             requested because Agency calculated                     that are grown for seed purposes:                     Budget (OMB) has exempted these types
                                             tolerances (except alfalfa and sorghum)                 Bluegrass, forage at 30 ppm; bluegrass,               of actions from review under Executive
                                             using proportionality to extrapolate data               hay at 60 ppm, bromegrass, forage at 30               Order 12866, entitled ‘‘Regulatory
                                             which would be reflective of a 1x                       ppm; bromegrass, hay at 60 ppm; fescue,               Planning and Review’’ (58 FR 51735,
                                             maximum annual application rate rather                  forage at 30 ppm; fescue, hay at 60 ppm;              October 4, 1993). Because this action
                                             the exaggerated application rates in the                orchardgrass, forage at 30 ppm;                       has been exempted from review under
                                             field trial studies for the following                   orchardgrass, hay at 60 ppm; ryegrass,                Executive Order 12866, this action is
                                             commodities: Almond hulls at 15 ppm                     forage at 30 ppm; ryegrass, hay at 60                 not subject to Executive Order 13211,
                                             to almond, hulls at 7.0 ppm; cotton, gin                ppm; switchgrass, forage at 30 ppm; and               entitled ‘‘Actions Concerning
                                             by-products at 40 ppm to cotton gin                     switchgrass, hay at 60 ppm.                           Regulations That Significantly Affect
                                             byproducts at 20 ppm; cottonseed (Crop                     EPA is also establishing tolerances for            Energy Supply, Distribution, or Use’’ (66
                                             Subgroup 20C) at 4 ppm to cottonseed                    beet, sugar, dried pulp at 1.5 ppm and                FR 28355, May 22, 2001) or Executive
                                             subgroup 20C at 2.0 ppm; head lettuce                   potato, wet peel at 0.10 ppm, pursuant                Order 13045, entitled ‘‘Protection of
                                             at 7 ppm to lettuce, head at 4.0 ppm;                   to 40 CFR 180.40(f)(1)(i)(A). These                   Children from Environmental Health
                                             onion, bulb (Crop Subgroup 3–07A) at                    tolerances are necessary to cover                     Risks and Safety Risks’’ (62 FR 19885,
                                             0.8 ppm to onion, bulb, subgroup 3–07A                  concentrated residues in processed                    April 23, 1997), nor is it considered a
                                             at 0.50 ppm; onion, green (Crop                         commodities of raw agricultural                       regulatory action under Executive Order
                                             Subgroup 3–07B) at 15 ppm to onion,                     commodities contained in subgroups 1A                 13771, entitled ‘‘Reducing Regulations
                                             green, subgroup 3–07B at 10 ppm; pea                    and 1C, respectively.                                 and Controlling Regulatory Costs’’ (82
                                             and bean, succulent shelled (Crop                                                                             FR 9339, February 3, 2017). This action
                                             Subgroup 6B) at 3 ppm to pea and bean,                  V. Conclusion                                         does not contain any information
                                             succulent shelled, subgroup 6B at 0.90                     Therefore, tolerances are established              collections subject to OMB approval
                                             ppm; peanut at 0.1 ppm to 0.05 ppm;                     for residues of picoxystrobin, methyl                 under the Paperwork Reduction Act
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                                             peanut, hay at 40 ppm to 30 ppm;                        (aE)-a-(methoxymethylene)-2-[[[6-                     (PRA) (44 U.S.C. 3501 et seq.), nor does
                                             sunflower (Crop Subgroup 20B) at 3                      (trifluoromethyl)-2-                                  it require any special considerations
                                             ppm to sunflower subgroup 20B to 2.0                    pyridinyl]oxy]methyl]benzeneacetate, in               under Executive Order 12898, entitled
                                             ppm; tree nut except hulls (Crop Group                  or on alfalfa, forage at 4.0 ppm; alfalfa,            ‘‘Federal Actions to Address
                                             14–12) at 0.15 ppm to nut, tree, group                  hay at 5.0 ppm; alfalfa, seed at 9.0 ppm;             Environmental Justice in Minority
                                             14–12 at 0.08 ppm; vegetable, brassica                  almond, hulls at 7.0 ppm; beet, sugar,                Populations and Low-Income


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                                             39610              Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Rules and Regulations

                                             Populations’’ (59 FR 7629, February 16,                   Dated: July 25, 2018.                                                                                              Parts per
                                                                                                                                                                                       Commodity
                                             1994).                                                  Michael Goodis,                                                                                                       million
                                                Since tolerances and exemptions that                 Director, Registration Division, Office of
                                                                                                     Pesticide Programs.                                                Lettuce, head ..............................               4.0
                                             are established on the basis of a petition
                                             under FFDCA section 408(d), such as                       Therefore, 40 CFR chapter I is                                      *          *        *               *               *
                                             the tolerances in this final rule, do not               amended as follows:                                                Nut, tree, group 14–12 ...............                 0.08
                                             require the issuance of a proposed rule,                                                                                   Onion, bulb, subgroup 3–07A ....                       0.50
                                             the requirements of the Regulatory                      PART 180—[AMENDED]                                                 Onion, green, subgroup 3–07B ..                          10
                                             Flexibility Act (RFA) (5 U.S.C. 601 et                                                                                     Orchardgrass, forage ..................                  30
                                                                                                     ■ 1. The authority citation for part 180                           Orchardgrass, hay ......................                 60
                                             seq.), do not apply.
                                                                                                     continues to read as follows:
                                                This action directly regulates growers,                                                                                    *           *              *               *        *
                                                                                                         Authority: 21 U.S.C. 321(q), 346a and 371.
                                             food processors, food handlers, and food                                                                                   Pea and bean, succulent
                                             retailers, not States or tribes, nor does               ■ 2. In § 180.669, add alphabetically the                            shelled, subgroup 6B ..............                  0.90
                                             this action alter the relationships or                  following commodities: Alfalfa, forage;                            Peanut ........................................        0.05
                                             distribution of power and                               Alfalfa, hay; Alfalfa, seed; Almond,                               Peanut, hay ................................             30
                                                                                                     hulls; Beet, sugar, dried pulp; Bluegrass,                         Potato, wet peel ..........................            0.10
                                             responsibilities established by Congress
                                             in the preemption provisions of FFDCA                   forage; Bluegrass, hay; Bromegrass,
                                                                                                     forage; Bromegrass, hay; Cotton, gin                                 *          *            *               *            *
                                             section 408(n)(4). As such, the Agency                                                                                     Ryegrass, forage ........................                  30
                                                                                                     byproducts; Cottonseed subgroup 20C;
                                             has determined that this action will not                                                                                   Ryegrass, hay .............................                60
                                                                                                     Fescue, forage; Fescue, hay; Leaf petiole
                                             have a substantial direct effect on States
                                                                                                     vegetable subgroup 22B; Lettuce, head;                               *          *          *               *              *
                                             or tribal governments, on the
                                                                                                     Nut, tree, group 14–12; Onion, bulb,                               Sunflower subgroup 20B ............                        2.0
                                             relationship between the national
                                                                                                     subgroup 3–07A; Onion, green,                                      Switchgrass, forage ....................                   30
                                             government and the States or tribal
                                                                                                     subgroup 3–07B; Orchardgrass, forage;                              Switchgrass, hay ........................                  60
                                             governments, or on the distribution of
                                                                                                     Orchardgrass, hay; Pea and bean,
                                             power and responsibilities among the                                                                                          *         *         *              *                *
                                                                                                     succulent shelled, subgroup 6B; Peanut;
                                             various levels of government or between                                                                                    Vegetable, brassica, head and
                                                                                                     Peanut, hay; Potato, wet peel; Ryegrass,
                                             the Federal Government and Indian                                                                                            stem, group 5–16 ....................                 2.0
                                                                                                     forage; Ryegrass, hay; Sunflower
                                             tribes. Thus, the Agency has determined                                                                                    Vegetable, cucurbit, group 9 ......                    0.30
                                                                                                     subgroup 20B; Switchgrass, forage;
                                             that Executive Order 13132, entitled                    Switchgrass, hay; Vegetable, brassica,
                                             ‘‘Federalism’’ (64 FR 43255, August 10,                                                                                       *         *           *               *             *
                                                                                                     head and stem, group 5–16; Vegetable,                              Vegetable, fruiting, group 8–10 ..                     0.70
                                             1999) and Executive Order 13175,                        cucurbit, group 9; Vegetable, fruiting,                            Vegetable, leafy, group 4–16,
                                             entitled ‘‘Consultation and Coordination                group 8–10; Vegetable, leafy, group 4–                               except lettuce, head ................                    30
                                             with Indian Tribal Governments’’ (65 FR                 16, except lettuce, head; Vegetable,                               Vegetable, leaves of root and
                                             67249, November 9, 2000) do not apply                   leaves of root and tuber, group 2;                                   tuber, group 2 .........................                 30
                                             to this action. In addition, this action                Vegetable, legume, edible podded,                                  Vegetable, legume, edible pod-
                                             does not impose any enforceable duty or                 subgroup 6A; Vegetable, root, subgroup                               ded, subgroup 6A ...................                  2.0
                                             contain any unfunded mandate as                                                                                            Vegetable, root, subgroup 1A ....                      0.50
                                                                                                     1A; and Vegetable, tuberous and corm,                              Vegetable, tuberous and corm,
                                             described under Title II of the Unfunded                subgroup 1C to the table in paragraph
                                             Mandates Reform Act (UMRA) (2 U.S.C.                                                                                         subgroup 1C ...........................              0.03
                                                                                                     (a) to read as follows:
                                             1501 et seq.).                                                                                                                 *             *             *            *         *
                                                This action does not involve any                     § 180.669 Picoxystrobin; tolerances for
                                                                                                     residues.
                                             technical standards that would require                                                                                     *       *        *        *         *
                                             Agency consideration of voluntary                           (a) * * *                                                      [FR Doc. 2018–17192 Filed 8–9–18; 8:45 am]
                                             consensus standards pursuant to section                                                                                    BILLING CODE 6560–50–P
                                                                                                                                                         Parts per
                                             12(d) of the National Technology                                       Commodity                             million
                                             Transfer and Advancement Act
                                             (NTTAA) (15 U.S.C. 272 note).                           Alfalfa, forage .............................                4.0   FEDERAL COMMUNICATIONS
                                                                                                     Alfalfa, hay ..................................              5.0   COMMISSION
                                             VII. Congressional Review Act                           Alfalfa, seed ................................               9.0
                                                                                                     Almond, hulls ..............................                 7.0   47 CFR Part 11
                                               Pursuant to the Congressional Review
                                             Act (5 U.S.C. 801 et seq.), EPA will                       *         *            *               *              *         [PS Docket Nos. 15–94, 15–91; FCC 18–
                                             submit a report containing this rule and                Beet, sugar, dried pulp ...............                      1.5   94]
                                             other required information to the U.S.                  Bluegrass, forage .......................                     30
                                             Senate, the U.S. House of                               Bluegrass, hay ............................                   60   Emergency Alert System; Wireless
                                             Representatives, and the Comptroller                    Bromegrass, forage ....................                       30   Emergency Alerts
                                                                                                     Bromegrass, hay ........................                      60
                                             General of the United States prior to                                                                                            Federal Communications
                                                                                                                                                                        AGENCY:
                                             publication of the rule in the Federal                     *         *        *              *                   *      Commission.
                                             Register. This action is not a ‘‘major                  Cotton, gin byproducts ...............                       20 ACTION: Final rule.
                                             rule’’ as defined by 5 U.S.C. 804(2).                   Cottonseed subgroup 20C .........                            2.0
                                                                                                                                                                              In this document, the Federal
                                                                                                                                                                        SUMMARY:
daltland on DSKBBV9HB2PROD with RULES




                                             List of Subjects in 40 CFR Part 180                        *        *              *               *             *
                                                                                                                                                                   Communications Commission (FCC or
                                                                                                     Fescue, forage ............................                30
                                               Environmental protection,                             Fescue, hay ................................               60 Commission) adopts changes to its rules
                                             Administrative practice and procedure,                                                                                governing the Emergency Alert System
                                             Agricultural commodities, Pesticides                       *            *              *               *         *    (EAS) to facilitate ‘‘Live Code Tests’’ of
                                             and pests, Reporting and recordkeeping                  Leaf petiole vegetable subgroup                               the EAS; permit use of the EAS
                                             requirements.                                             22B ..........................................           20 Attention Signal and EAS Header Code



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Document Created: 2018-08-10 01:56:27
Document Modified: 2018-08-10 01:56:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael L. Goodis, P.E., Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation83 FR 39605 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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