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

* * * * * 

[FR Doc. 2018–17078 Filed 8–9–18; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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/textidx?&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 

(aE)-a-(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. 


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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 noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (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 


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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-andassessing-pesticide-risks/assessinghuman-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

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

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

Acute dietary (General population including infants and children).UFA = 10x ...............................

UFH = 10x 

FQPA SF/UFL = 10x 

Acute RfD/aPAD = 0.2 mg/kg/ 

day.

Acute Neurotoxicity—Rat 

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 UFA

= 10x.

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.046 mg/kg/ 

day.

cPAD = 0.046 mg/kg/day .......

Chronic Toxicity—Dog 

LOAEL = 15.7 mg/kg/day 

based on decreased 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 nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 


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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 rabbitdevelopmental 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). 


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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 

(aE)-a-(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 


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

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 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: 

§ 180.669 Picoxystrobin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

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 

Commodity Parts per 

million 

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 COMMUNICATIONS 

COMMISSION 

47 CFR Part 11 

[PS Docket Nos. 15–94, 15–91; FCC 18– 

94] 

Emergency Alert System; Wireless 

Emergency Alerts 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission (FCC or 

Commission) adopts changes to its rules 

governing the Emergency Alert System 

(EAS) to facilitate ‘‘Live Code Tests’’ of 

the EAS; permit use of the EAS 

Attention Signal and EAS Header Code 


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