Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations 52403 

EPA APPROVED ALBUQUERQUE/BERNALILLO COUNTY, NM REGULATIONS—Continued 

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State approval/effective date 

EPA approval date Explanation 

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Part 61 (20.11.61 NMAC) ............ Prevention of Significant Deterioration.5/29/2015 8/31/2015 [Insert Federal Register citation].

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[FR Doc. 2015–21015 Filed 8–28–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0531; FRL–9932–26] 

Dimethomorph; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes, 

and removes tolerances for residues of 

dimethomorph in or on multiple 

commodities which are identified and 

discussed later in this document. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). EPA is 

correcting the CAS name of 

dimethomorph in 40 CFR 180.493(a), 40 

CFR 180.493(c), and 40 CFR 180.493(d). 

DATES: This regulation is effective 

August 31, 2015. Objections and 

requests for hearings must be received 

on or before October 30, 2015, 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–2014–0531, 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: 

Susan Lewis, 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–2014–0531 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 30, 2015. 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– 

2014–0531, 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 December 

17, 2014 (79 FR 75107) (FRL–9918–90), 

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 4F8281) by BASF 

Corporation, P.O. Box 13528, Research 

Triangle Park, North Carolina, 27709. 

The petition requested that 40 CFR 

180.493 be amended by establishing 

tolerances for residues of the fungicide, 

dimethomorph in or on strawberry at 

1.0 parts per million (ppm) and 

removing the established tolerances for 


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lettuce, head and lettuce, leaf at 10 ppm. 

That document referenced a summary of 

the petition prepared by BASF, the 

registrant, which is available in the 

docket, http://www.regulations.gov. No 

comments were received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerance for residues of 

dimethomorph in or strawberry to 0.90 

ppm and is correcting the CAS name of 

dimethomorph in 40 CFR 180.493(a), 40 

CFR 180.493(c), and 40 CFR 180.493(d) 

to the following introductory tolerance 

expression text: 40 CFR 180.493(a): 

Tolerances are established for residues 

of the fungicide dimethomorph, 4-[3-(4- 

chlorophenyl)-3-(3,4-dimethoxyphenyl)- 

1-oxo-2-propen-1-yl]morpholine, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only dimethomorph in or on 

the commodity. 40 CFR 180.493(c): 

Tolerances with regional registrations 

are established for residues of the 

fungicide dimethomorph, 4-[3-(4- 

chlorophenyl)-3-(3,4-dimethoxyphenyl)- 

1-oxo-2-propen-1-yl]morpholine, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only dimethomorph in or on 

the commodity. 40 CFR 180.493(d): 

Tolerances are established for the 

indirect or inadvertent residues of the 

fungicide dimethomorph, 4-[3-(4- 

chlorophenyl)-3-(3,4-dimethoxyphenyl)- 

1-oxo-2-propen-1-yl]morpholine, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only dimethomorph in or on 

the commodity. 

The reason for these changes are 

explained in Unit IV.C. 

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 dimethomorph 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with dimethomorph 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 target organ 

for dimethomorph is the liver in rats 

and dogs. No biologically significant 

effect was observed in the rat 

subchronic oral toxicity study while 

decreased body weight and increased 

incidence of arteritis in male rats and 

decreased body weights and increased 

incidence of ‘‘ground-glass’’ foci in 

livers of female rats were observed in 

the rat chronic toxicity study. In the dog 

subchronic oral toxicity study, 

decreased absolute and relative prostate 

weights, and slight liver effects were 

observed. No toxicity was observed at 

the limit dose in the rat 28-day dermal 

toxicity study. The developmental 

toxicity studies showed no increased 

sensitivity to offspring of either rats or 

rabbits as demonstrated by the noobserved-adverse-effect-levels 

(NOAELs) equal to or higher than those 

producing toxicity in the maternal 

animals. Likewise, in the 2-generation 

reproduction study, there was no 

toxicity to the offspring at any dose 

lower than that causing parental 

toxicity. There is no evidence that 

dimethomorph is a developmental, or 

reproductive toxicant, and it is not 

neurotoxic or immunotoxic. 

The Agency classified dimethomorph 

as ‘‘not likely to be carcinogenic to 

humans’’ based upon lack of evidence of 

carcinogenicity in rats and mice and no 

evidence of mutagenicity. A quantitative 

cancer risk assessment is not necessary. 

Dimethomorph has low acute toxicity 

by the oral, dermal, or inhalation route 

of exposure (Toxicity Category III or IV). 

It is not an eye or skin irritant, and is 

not a skin sensitizer. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by dimethomorph as well 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Dimethomorph: Human Health 

Risk Assessment to Support 

Establishment of a Permanent Tolerance 

for Residues in/on Strawberry’’ at pages 

29–32 in docket ID number EPA–HQ– 

OPP–2014–0531. 

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://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for dimethomorph used for 

human risk assessment is shown in 

Table 1 of this unit. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIMETHOMORPH 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).

N/A (No appropriate endpoint 

was identified including developmental toxicity 

studies in rats 

and rabbits.).

N/A ........................ N/A. 

Acute dietary (General population including infants and children).LOAEL = 250 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF/UFL = 

10x 

Acute RfD = 0.25 

mg/kg/day.

aPAD = 0.25 mg/

kg/day 

Acute neurotoxicity study in rats. 

MRID 48980106. 

LOAEL = 250 mg/kg/day based on reduced motor activity 

and impairment of gait and rearing in both sexes. 

Chronic dietary (All populations) ............ POD = 11 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.11 

mg/kg/day.

cPAD= 0.11 mg/kg/

day 

Co-critical chronic and carcinogenicity studies in rats 

MRID 42233912, 42233916. 

LOAEL = 46.3 mg/kg/day, based on decreased body 

weight and increases in liver lesions in female rats. 

Incidental oral short-term ....................... NOAEL= 15 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

100.

Subchronic feeding study in dogs. 

MRID 42233908. 

LOAEL = 43 mg/kg/day based on decreased absolute and 

relative prostate weights. 

Dermal short- and intermediate-term ..... N/A (No toxicity 

was observed at 

the limit dose in 

a 28-day dermal 

toxicity study.

No quantitative risk 

assessment is 

necessary since 

no dermal or developmental toxicity concern.).

N/A ........................ N/A. 

Inhalation short- and intermediate-term Oral, NOAEL = 15 

mg/kg/day (inhalation absorption 

factor = 100%).

UFA = 10x 

UFH = 10x 

UFDB = 10x 

LOC for MOE = 

1000.

Subchronic feeding study in dogs. 

MRID 42233908. 

LOAEL = 43 mg/kg/day based on decreased absolute and 

relative prostate weights. 

Cancer (Oral, dermal, inhalation) ........... Classification: This chemical is classified as ‘‘not likely’’ to be a human carcinogen. 

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. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other 

data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). 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 dimethomorph, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing dimethomorph tolerances in 40 

CFR 180.493. EPA assessed dietary 

exposures from dimethomorph 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 dimethomorph. 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/WEIA) 2003–2008. 

The acute analysis assumed 100% crop 

treated (CT), Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM–FCID) Version 3.16 default 

processing factors, and tolerance-level 

residues for all foods. Drinking water 

was incorporated directly into the 

dietary assessment using the surface 

water concentration and the FIRST 

(Food Quality Protection Act (FQPA) 

Index Reservoir Screening Tool) model. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WEIA 2003– 

2008. The chronic analysis assumed 

100% CT, DEEM–FCID Version 3.16 

default processing factors, and 

tolerance-level residues for all foods. 

Drinking water was incorporated 

directly into the dietary assessment 

using the surface water concentration 

and the FIRST model. 


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iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that dimethomorph 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 percent 

crop treated (PCT) information. EPA did 

not use any anticipated residue or PCT 

information in the dietary assessment 

for dimethomorph. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for dimethomorph in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

dimethomorph. 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 FIRST model for surface 

water and Pesticide Root Zone Model 

Ground Water (PRZM GW) for ground 

water, the estimated drinking water 

concentrations (EDWCs) of 

dimethomorph for acute exposures for 

non-cancer assessments are estimated to 

be 81.1 parts per billion (ppb) for 

surface water and 20.1 ppb for ground 

water; and for chronic exposures for 

non-cancer assessments are estimated to 

be 24.7 ppb for surface water and 18.8 

ppb (post breakthrough avg. ppb) and 

14.6 ppb (simulation avg. 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 of 81.1 ppb was 

used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of 24.7 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). 

Dimethomorph 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 dimethomorph to 

share a common mechanism of toxicity 

with any other substances, and 

dimethomorph does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that dimethomorph does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http: 

//www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The toxicology data on dimethomorph 

provides no indication of enhanced 

sensitivity of infants and children based 

on the results from rat or rabbit 

developmental studies as well as a 2- 

generation rat reproduction study. 

3. Conclusion. EPA has determined 

the 10X FQPA SF be retained for acute 

dietary exposure scenario for 

extrapolation of a NOAEL from a 

LOAEL. For other exposure scenarios, 

the FQPA SF is reduced to 1x since 

there is no evidence of increased 

qualitative or quantitative susceptibility 

in the young and exposure estimates are 

unlikely to underestimate risk. 

The above decision is based on the 

following findings: 

i. Although the toxicity database of 

dimethomorph is incomplete because a 

subchronic inhalation study is not 

available, the available toxicity database 

of dimethomorph, including 

developmental toxicity studies in rats 

and rabbits, a 2-generation reproduction 

study in rats, acute and subchronic 

neurotoxicity study in rats, is adequate 

to characterize developmental and 

reproductive effects and to assess the 

qualitative or quantitative susceptibility 

in the young. 

ii. In an acute neurotoxicity study, 

functional observational battery (FOB) 

findings and reduced motor activity 

were observed at ≥ 250 mg/kg on day 0 

only. These findings were considered an 

impairment of the overall condition of 

the animals following a single gavage 

dose, rather than a direct neurotoxic 

effect of dimethomorph based on the 

absence of any neurohistopathological 

changes in the treated animals and the 

transient nature of the observed FOB 

and neurobehavioral assessments. In 

support of this conclusion, no 

neurotoxic effects were observed in rats 

fed dimethomorph up to the highest 

dose tested at 2,400 ppm (178/204 mg/ 

kg/day for males/females, respectively) 

in a 90-day neurotoxicity study. 

Additionally, the toxicology database 

does not reveal evidence of neurotoxic 

clinical signs, changes in brain weight, 

or histopathology of the nervous system 

in any study with dimethomorph. 

iii. There is no evidence that 

dimethomorph 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% CT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

dimethomorph in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by 

dimethomorph. 

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 

dimethomorph will occupy 39% of the 

aPAD for children 3 to 5 years of age, 


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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 dimethomorph 

from food and water will utilize 26% of 

the cPAD for children 1 to 2 years of 

age, the population group receiving the 

greatest exposure. There are no 

residential uses for dimethomorph. 

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). 

A short-term adverse effect was 

identified; however, dimethomorph is 

not registered for any use patterns that 

would result in short-term residential 

exposure. Short-term risk is assessed 

based on short-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for 

dimethomorph. 

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, dimethomorph is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

dimethomorph. 

5. Aggregate cancer risk for U.S. 

population. An aggregate cancer risk 

was not calculated because 

dimethomorph was classified as ‘‘not 

likely to be carcinogenic 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 

dimethomorph residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with ultraviolet 

detection (HPLC/UV) method FAMS 

002–04 and Method M 2577, a gas 

chromatographic (GC) method with 

nitrogen phosphorus detection (NPD)) 

are available to enforce the tolerance 

expression. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has established MRLs for 

dimethomorph in or on strawberry at 

0.05 ppm. These MRLs are different 

than the tolerances established for 

dimethomorph in the United States. 

EPA is not proposing to harmonize the 

U.S. tolerance for residues in strawberry 

with the Codex due to different 

application rates (U.S. application rate, 

219–237 gram active ingredient/hectare, 

and Codex countries’ application rate, 

150 gram active ingredient/hectare). 

C. Revisions to Petitioned-For 

Tolerances 

BASF proposed a tolerance of 

dimethomorph residues on strawberry 

at 1.0 ppm. BASF and EPA used the 

Organization for Economic Cooperation 

& Development (OECD) spreadsheet 

calculator and both determined from the 

data set that a tolerance of 0.90 ppm was 

the recommended OECD calculator 

spreadsheet output. However, BASF 

rounded that value to 1.0 ppm, while 

EPA’s policy is to establish the tolerance 

at the OECD calculator output level 

without rounding; therefore, EPA is 

establishing a tolerance on strawberry at 

0.90 ppm. EPA established the tolerance 

for leafy vegetables (except brassica) 

crop group 4 in the Federal Register on 

May 4, 2012 under docket ID number 

EPA–HQ–OPP–2011–0388. In this 

ruling, the tolerance for vegetable, leafy, 

except brassica, group 4 was established 

at 30.0 ppm. According to 40 CFR 

180.493, the individual tolerances for 

lettuce, head and lettuce, leaf, both at 

10.0 ppm, were not removed. Based 

upon the previous explanation, EPA is 

removing the tolerances for lettuce, 

head at 10.0 ppm and lettuce, leaf at 

10.0 ppm. 

EPA is correcting the CAS name of 

dimethomorph in 40 CFR 180.493(a), 40 

CFR 180.493(c), and 40 CFR 180.493(d). 

The CAS name of dimethomorph is 

currently incorrect (currently is listed as 

the International Union of Pure and 

Applied Chemistry (IUPAC) name (E,Z)- 

4-[3-(4-chlorophenyl)-3-(3,4- 

dimethoxyphenyl) acryloyl]morpholine, 

and is being revised to the correct CAS 

name 4-[3-(4-chlorophenyl)-3-(3,4- 

dimethoxyphenyl)-1-oxo-2-propen-1- 

yl]morpholine)). 

V. Conclusion 

Therefore, EPA is establishing a 

tolerance for residues of the fungicide, 

dimethomorph in or on strawberry at 

0.90 ppm and removing the established 

tolerances for lettuce, head and lettuce 

leaf at 10 ppm. EPA is correcting the 

CAS name of dimethomorph in 40 CFR 

180.493(a), 40 CFR 180.493(c), and 40 

CFR 180.493(d) to the following 

tolerance expressions: 

40 CFR 180.493(a): Tolerances are 

established for residues of the fungicide 

dimethomorph, 4-[3-(4-chlorophenyl)-3- 

(3,4-dimethoxyphenyl)-1-oxo-2-propen1-yl]morpholine, including its 

metabolites and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

dimethomorph in or on the commodity. 

40 CFR 180.493(c): Tolerances with 

regional registrations are established for 

residues of the fungicide 

dimethomorph, 4-[3-(4-chlorophenyl)-3- 

(3,4-dimethoxyphenyl)-1-oxo-2-propen1-yl]morpholine, including its 

metabolites and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

dimethomorph in or on the commodity. 

40 CFR 180.493(d): Tolerances are 

established for the indirect or 

inadvertent residues of the fungicide 

dimethomorph, 4-[3-(4-chlorophenyl)-3- 

(3,4-dimethoxyphenyl)-1-oxo-2-propenVerDate Sep<11>2014 13:58 Aug 28, 2015 Jkt 235001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\31AUR1.SGM 31AUR1

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52408 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Rules and Regulations 

1-yl]morpholine, including its 

metabolites and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

dimethomorph in or on the commodity. 

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). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et se.), 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 

se.), 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 se.). 

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 se.), 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: August 10, 2015. 

Susan Lewis, 

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 § 180.493: 

■ a. Revise the introductory text of 

paragraph (a). 

■ b. Remove the entries in the table in 

paragraph (a) for ‘‘Lettuce, head’’, and 

‘‘Lettuce leaf’’. 

■ c. Add alphabetically the entry for 

‘‘Strawberry’’ to the table in paragraph 

(a). 

■ d. Revise the introductory text of 

paragraphs (c) and (d). 

The additions and revisions read as 

follows: 

§ 180.493 Dimethomorph; tolerances for 

residues. 

(a) * * * 

Tolerances are established for 

residues of the fungicide 

dimethomorph, 4-[3-(4-chlorophenyl)-3- 

(3,4-dimethoxyphenyl)-1-oxo-2-propen1-yl]morpholine, including its 

metabolites and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

dimethomorph in or on the 

commodities. 

Commodity Parts per 

million 

* * * * * 

Strawberry ............................ 0.90 

* * * * * 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registrations are established for residues 

of the fungicide dimethomorph, 4-[3-(4- 

chlorophenyl)-3-(3,4-dimethoxyphenyl)- 

1-oxo-2-propen-1-yl]morpholine, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only dimethomorph in or on 

the commodity. 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent residues of the 

fungicide dimethomorph, 4-[3-(4- 

chlorophenyl)-3-(3,4-dimethoxyphenyl)- 

1-oxo-2-propen-1-yl]morpholine, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only dimethomorph in or on 

the commodity. 

* * * * * 

[FR Doc. 2015–21192 Filed 8–28–15; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 2 and 5 

[ET Docket Nos. 10–236, 06–155; FCC 15– 

76] 

Radio Experimentation and Market 

Trials 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: This document responds to 

three petitions for reconsideration 

seeking to modify certain rules adopted 


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