Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65541 

* * * * * 

[FR Doc. 2018–27610 Filed 12–20–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0562; FRL–9985–52] 

Mefenoxam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mefenoxam in 

or on cacao bean; the fruit, small, vine 

climbing, except grape, subgroup 13– 

07E; and wasabi. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 21, 2018. Objections and 

requests for hearings must be received 

on or before February 19, 2019, 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–2017–0562, 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 Goodis, 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. 

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–2017–0562 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 February 19, 2019. 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– 

2017–0562, 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 January 26, 

2018 (83 FR 3658) (FRL–9971–46), 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 7E8610) by IR–4, IR–4 

Project Headquarters, Rutgers, The State 

University of NJ, 500 College Road East, 

Suite 201 W, Princeton, NJ 08540. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of the fungicide 

mefenoxam, including its metabolites 

and degradates in or on the raw 

agricultural commodities cacao bean, 

bean at 0.2 parts per million (ppm); 

wasabi, tops at 6.0 ppm; wasabi, stem at 

3.0 ppm; and fruit, small, vine climbing, 

except grape, crop subgroup 13–07E at 

0.10 ppm. Additionally, the petition 

requested to amend 40 CFR 180.546 by 

removing the tolerance in or on 

kiwifruit at 0.10 ppm. That document 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

the registrant, which is available in the 

docket, http://www.regulations.gov. One 

comment was received in the docket for 

the notice of filing, but as it raised 

concerns about the Obama 

Administration’s application of the 

National Environmental Protection 

Agency and Endangered Species Act, it 

is not relevant to this tolerance action. 

Based upon review of the data 

supporting the petition, EPA has 

modified the commodity definition for 

cacao and the tolerance level to be 

consistent with the Agency’s policy on 

significant figures. 

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 


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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 mefenoxam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with mefenoxam 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. 

Mefenoxam (metalaxyl-m) is a 

systemic phenylamide fungicide which 

inhibits protein synthesis in fungi. 

Mefenoxam is an R-isomer enriched 

formulation. Metalaxyl is the racemic 

R/S isomer formulation. The Agency 

compared the available chemistry and 

toxicity data for mefenoxam and 

metalaxyl and concluded that metalaxyl 

data may be used in support of 

mefenoxam regulatory actions because 

the two chemicals have similar toxicity. 

Therefore, for the purposes of this 

assessment, mefenoxam will refer to 

both mefenoxam and metalaxyl-m. 

In rat and dog repeat dose (i.e., 

subchronic and chronic) oral toxicity 

studies, there were no indications of 

adverse effects up to the highest dose 

tested (HDT). Adverse effects were only 

observed from acute exposure to rats. In 

the rat developmental toxicity study of 

metalaxyl, maternal toxicity consisted of 

dose-related increased incidence of 

convulsions that occurred shortly after 

dosing, as well as other clinical signs. In 

a range-finding acute neurotoxicity 

study of mefenoxam, females showed 

abnormal functional observation battery 

(FOB) findings at doses lower than 

males, but higher than the rat 

developmental study. However, there 

was no indication of toxicity up to the 

HDT in the mefenoxam subchronic 

neurotoxicity study, which confirms the 

lack of adverse effects observed in all 

other repeat-dose studies. 

There was no indication of 

developmental toxicity in studies of 

mefenoxam or metalaxyl. There was no 

indication of immunotoxicity in a 

mouse immunotoxicity study of 

mefenoxam. Metalaxyl and mefenoxam 

have been classified as ‘‘not likely to be 

carcinogenic in humans’’ based on the 

results of the carcinogenicity study in 

mice and the combined chronic toxicity 

and carcinogenicity study in rats. 

All toxicity endpoints and points of 

departure (PODs) are based on 

convulsions that occurred minutes after 

dosing in the rat developmental toxicity 

study of metalaxyl. This POD is 

appropriate for acute, short-term, and 

intermediate-term exposure scenarios 

via the oral and inhalation routes. No 

hazard was identified for chronic or 

long-term exposure scenarios, or for 

exposure via the dermal route. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by mefenoxam as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Mefenoxam (Metalaxyl-M). Human 

Health Risk Assessment for the 

Establishment of Permanent Tolerances 

and New Uses in/on Wasabi, Cacao, and 

Crop Group Expansion from Kiwifruit to 

Fruit, Small, Vine Climbing, Except 

Grape, Crop Subgroup 13–07E’’ on 

pages 23–21 in docket ID number EPA– 

HQ–OPP–2017–0562. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for mefenoxam used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MEFENOXAM 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 (All Populations) NOAEL = 50 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.5 mg/ 

kg/day.

aPAD = 0.5 mg/kg/ 

day 

Metalaxyl Prenatal Developmental Toxicity—Rat 

LOAEL = 250 mg/kg/day 

Based on dose-related increases in clinical signs of toxicity 

(e.g., post-dosing convulsions). 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MEFENOXAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC 

for risk 

assessment 

Study and 

toxicological effects 

Chronic dietary (All populations) No endpoint was identified. No systemic toxicity was observed in the reproduction and fertility effects study or 

in any of the chronic and subchronic toxicity studies. Toxicity was only evident in gavage-dosed animals. 

Incidental oral short-term (1 to 

30 days) and intermediateterm (1 to 6 months).

NOAEL = 50 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Metalaxyl Prenatal Developmental Toxicity—Rat 

LOAEL = 250 mg/kg/day 

Based on dose-related increases in clinical signs of toxicity 

(e.g., post-dosing convulsions). 

Cancer (Oral, dermal, inhalation).Classification: ‘‘not likely to be carcinogenic to humans’’ based on adequately conducted carcinogenicity studies in rats and mice treated with metalaxyl. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to mefenoxam, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing mefenoxam tolerances in 40 

CFR 180.546. EPA assessed dietary 

exposures from mefenoxam 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 

mefenoxam. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America, 

(NHANES/WWEIA). As to residue levels 

in food, EPA assumed 100 percent crop 

treated (PCT), DEEM default and 

empirical processing factors and 

tolerance level residues. 

ii. Chronic exposure. No chronic 

endpoint was identified and therefore 

no chronic dietary assessment was 

conducted. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that mefenoxam does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

mefenoxam. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency only considered the 

parent compound metalaxyl as a residue 

of concern (ROC). Exposure modeling 

for mefenoxam is not necessary because 

exposure estimates for metalaxyl are 

expected to exceed those for 

mefenoxam, and the two compounds are 

anticipated to behave identically in the 

environment. Therefore, EDWCs 

provided for metalaxyl are protective of 

exposures to mefenoxam through 

drinking water. Maximum annual 

application rates for metalaxyl, up to 

12.3 pounds active ingredient/per Acre 

(lb ai/A), were modeled. These rates are 

approximately twice those of 

mefenoxam. 

The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for mefenoxam/metalaxyl in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of mefenoxam/metalaxyl. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Pesticide Water 

Calculator (PWC version 1.52) the 

estimated drinking water concentrations 

(EDWCs) of mefenoxam/metalaxyl for 

acute exposures are estimated to be 350 

parts per billion (ppb) for surface water 

and 155 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment, the water 

concentration value of 350 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, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Mefenoxam and metalaxyl are 

currently registered for the following 

uses that could result in residential 

exposures: Lawns, ornamentals, 

gardens, and trees. EPA assessed 

residential exposure using the following 

assumptions: For residential handlers, 

all registered metalaxyl and mefenoxam 

product labels with residential use sites 

(lawns, ornamentals and garden and 

trees) require that handlers wear 

specific clothing (e.g., long sleeve shirt/ 

long pants) and chemical resistance 

gloves. Therefore, EPA has made the 

assumption that these products are not 

for homeowner use, and has not 

conducted a quantitative residential 

handler assessment. 

There is potential for residential postapplication exposures to mefenoxam 

(metalaxyl-m). Since no dermal 

endpoints were identified, only 

incidental oral post-application 

exposures to small children ages 1 to <2 

have been assessed. Metalaxyl and 

mefenoxam are registered for use on 

home lawns; therefore, there is the 

potential for incidental oral exposure 

(hand-to-mouth, object-to-mouth, soil 

ingestion and granular ingestion). 

The recommended residential 

exposure for use in the children 1 to <2 

years old aggregate assessment reflects 

hand-to-mouth incidental oral 

exposures from treated turf using a 

liquid formulation. Ingestion of granules 

is considered an episodic event and not 

a routine behavior. Because the Agency 


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does not believe that this would occur 

on a regular basis, the concern for 

human health is related to acute 

poisoning rather than short-term residue 

exposure. Therefore, an acute dietary 

dose is used to estimate exposure and 

risk resulting from episodic ingestion of 

granules. For these same reasons, the 

episodic ingestion scenario was not 

included in the aggregate assessment. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/ 

standard-operating-proceduresresidential-pesticide. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

metalaxyl and mefenoxam and any 

other substances and metalaxyl and 

mefenoxam do not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has not 

assumed that metalaxyl and mefenoxam 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence for qualitative or 

quantitative offspring susceptibility in 

developmental toxicity studies in 

rabbits and rats, or in the reproduction 

and fertility effects study in rats. In 

adult rats treated with metalaxyl or 

mefenoxam, clinical signs and abnormal 

Functional Observation Battery (FOB) 

findings were noted only after a bolus 

gavage dose, but not in repeated dose 

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. That decision is 

based on the following findings: 

i. The toxicity databases for 

mefenoxam and metalaxyl are complete. 

ii. In the rat prenatal developmental 

toxicity with metalaxyl, maternal 

animals exhibited clinical signs 

indicative of neurobehavioral effects as 

previously discussed. 

In the range-finding acute 

neurotoxicity study with mefenoxam, 

females exhibited abnormal functional 

observation battery (FOB) findings at 

doses lower than in males. In the 

subchronic neurotoxicity study with 

mefenoxam, there were no indications 

of neurotoxicity up to the HDT. In 

metalaxyl and mefenoxam treated adult 

animals, clinical signs and abnormal 

FOB findings were noted. However, a 

developmental neurotoxicity (DNT) 

study is not required for metalaxyl or 

mefenoxam because (1) there are no 

indications of increased susceptibility 

for infants or children; (2) the 

convulsions observed in the rat prenatal 

developmental toxicity study occurred 

in the maternal animals with no effects 

being observed in the young; (3) the 

convulsions occurred only after a bolus 

dose; (4) the available developmental 

and range-finding acute neurotoxicity 

studies provided clear NOAELs and 

LOAELs for evaluating effects; (5) the 

current POD is below the level at which 

any effects were seen in either study, 

and (6) there were no other indications 

of neurotoxicity in the mefenoxam or 

metalaxyl databases, which include a 

subchronic (adult rat) neurotoxicity 

study for mefenoxam. Therefore, there is 

no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

mefenoxam or metalaxyl 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 mefenoxam 

and metalaxyl in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by mefenoxam or metalaxyl. 

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 

mefenoxam will occupy 21% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

chronic exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

repeated exposure was identified and no 

chronic dietary endpoint was selected. 

Therefore, mefenoxam is not expected 

to pose a chronic risk. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Mefenoxam and metalaxyl are 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to mefenoxam and metalaxyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in an 

aggregate MOE of 538 for children. 


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Because EPA’s level of concern for 

mefenoxam is a MOE of 100 or below, 

this MOE is not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, mefenoxam is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

mefenoxam is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to mefenoxam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methods are 

available for determination of the 

residues of concern in crop 

commodities. The enforcement methods 

are common moiety methods which 

determine residues of metalaxyl/ 

mefenoxam and metabolites that are 

convertible to 2,6-dimethylaniline (2,6– 

DMA). These methods include: (1) 

Method I in PAM, Vol. II (Method AG– 

348), which determines residues in 

plant commodities using a gas-liquid 

chromatography procedure employing 

an alkali flame ionization detector 

(GLC/AFID); (2) Method AG–395 

(submitted for inclusion in PAM, Vol. II 

as Method III), an improved version of 

Method AG–348, which determines 

residues in plant commodities using 

GLC/nitrogen phosphorus detection 

(NPD); and (3) the multiresidue method 

in PAM, Vol. I, Section 302 (Protocol D). 

Method 456–98, a chiral liquid 

chromatography/mass spectrometric 

detection (LC/MS) method, is available 

to distinguish between R- and Senantiomers, to determine whether 

metalaxyl or mefenoxam was applied. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

No Codex MRLs have been 

established for wasabi. The tolerances 

for the fruit, small, vine climbing, 

except grape, subgroup 13–07E and 

cacao bean are harmonized with Codex. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency revised the petitioned-for 

tolerance on cacao to correct for the 

significant figures based on current 

practice, and to correct the commodity 

definition to reflect the common 

commodity vocabulary currently used 

by the Agency. 

V. Conclusion 

Therefore, tolerances are established 

for residues of mefenoxam, including its 

metabolites and degradates, in or on 

cacao, dried bean at 0.20 ppm; the fruit, 

small, vine climbing, except grape, 

subgroup 13–07E at 0.10 ppm; wasabi, 

stem at 3.0 ppm; and wasabi, tops at 6.0 

ppm. Additionally, the existing 

tolerance for kiwifruit at 0.10 ppm is 

removed as unnecessary due to the 

establishment of the new tolerances. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). This action 

does not contain any information 

collections subject to OMB approval 

under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501 et seq.), nor does 

it require any special considerations 

under Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This 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). 


amozie on DSK3GDR082PROD with RULES
65546 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 6, 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 § 180.546: 

■ i. Remove the entry ‘‘Kiwifruit’’ from 

the table in paragraph (a). 

■ ii. Add alphabetically the entries 

‘‘Cacao, dried bean’’; ‘‘Fruit, small, vine 

climbing, except grape, subgroup 13– 

07E’’; ‘‘Wasabi, stem’’; and ‘‘Wasabi, 

tops’’ to the table in paragraph (a). 

The additions read as follows: 

§ 180.546 Mefenoxam; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

*****

Cacao, dried bean .................... 0.20 

*****

Fruit, small, vine climbing, except grape, subgroup 13–07E 0.10 

*****

Wasabi, stem ............................ 3.0 

Wasabi, tops ............................. 6.0 

* * * * * 

[FR Doc. 2018–27764 Filed 12–20–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0587; FRL–9987–34] 

Tolfenpyrad; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tolfenpyrad in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project No. 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 21, 2018. Objections and 

requests for hearings must be received 

on or before February 19, 2019 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–2017–0587, 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 Goodis, 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 https://

www.epa.gov/aboutepa/about-officechemical-safety-and-pollutionprevention-ocspp. 

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–2017–0587 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 

February 19, 2019. 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– 

2017–0587, 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 https://

www.epa.gov/dockets/where-sendcomments-epa-dockets. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 


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