Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 9209 

Subpart AA—Missouri 

■ 2. Section 52.1342 is amended by 

adding paragraph (c) to read as follows: 

§ 52.1342 Control strategy: Ozone. 

* * * * * 

(c) On November 3, 2011 and April 

29, 2014, Missouri submitted requests to 

redesignate the Missouri portion of the 

St. Louis MO–IL area to attainment of 

the 1997 8-hour ozone standard. The 

Missouri portion of the St. Louis MO– 

IL area includes Jefferson, Franklin, St. 

Charles, and St. Louis Counties along 

with the City of St. Louis. As part of the 

redesignation request, the State 

submitted a plan for maintaining the 

1997 8-hour ozone standard through 

2025 in the area as required by Section 

175A of the Clean Air Act. 

PART 81—DESIGNATION OF AREAS 

FOR AIR QUALITY PLANNING 

PURPOSES 

■ 3. The authority citation for part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7401, et seq. 

Subpart C—Section 107 Attainment 

Status Designations 

■ 4. Section 81.326 is amended by 

revising the entry for ‘‘St. Louis MO–IL’’ 

in the table entitled ‘‘Missouri—1997 8- 

Hour Ozone NAAQS (Primary and 

Secondary)’’ to read as follows: 

§ 81.326 Missouri. 

* * * * * 

MISSOURI—1997 8-HOUR OZONE NAAQS 

[Primary and Secondary] 

Designated area 

Designation a Category/Classification 

Date 1 Type Date 1 Type 

*******

St. Louis, MO–IL 

Franklin County .......................... February 20, 2015 ...................... Attainment.

Jefferson County ........................ February 20, 2015 ...................... Attainment.

St. Charles County ..................... February 20, 2015 ...................... Attainment.

St. Louis City .............................. February 20, 2015 ...................... Attainment.

St. Louis County ......................... February 20, 2015 ...................... Attainment.

* * * * * * * 

a Includes Indian Country located in each county or area, except as otherwise specified. 

1This date is June 15, 2004, unless otherwise noted. 

* * * * * 

[FR Doc. 2015–03287 Filed 2–19–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0670; FRL–9922–08] 

Dimethenamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dimethenamid 

in or on cottonseed subgroup 20C and 

cotton, gin byproducts. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 20, 2015. Objections and 

requests for hearings must be received 

on or before April 21, 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–2013–0670, 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 Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&c=ecfr&tpl=/ecfrbrowse/

Title40/40tab_02.tpl. 


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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–2013–0670 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 April 21, 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– 

2013–0670, 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 October 25, 

2013 (78 FR 63938) (FRL–9901–96), 

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 3F8197) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR 180.464 be amended by 

establishing tolerances for residues of 

the herbicide dimethenamid (1(RS)-2- 

chloro-N-[(1-methyl-2-methoxy)ethyl]- 

N-(2,4-dimethylthien-3-yl)acetamide) in 

or on cottonseed, subgroup 20C at 0.01 

parts per million (ppm); cotton, gin 

byproducts at 1.5 ppm; and cotton, seed, 

refined oil at 0.02 ppm. Compliance 

with the tolerance levels is to be 

determined by measuring only parent. 

Tolerances would apply to either 

dimethenamid-P (a 90:10 mixture of Sand R-isomers, a mixture enriched in Sisomer) or dimethenamid (a 50:50 

racemic mixture of S- and R-isomers). 

The enforcement method is not 

enantiomer specific. That document 

referenced a summary of the petition 

prepared by BASF Corporation, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that a separate tolerance in 

cotton, seed, and refined oil is not 

needed. 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 dimethenamid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with dimethenamid 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 existing toxicological database is 

comprised of studies conducted with 

both dimethenamid, which is a racemic 

mixture of S- and R-isomers (50:50, S:R), 

and dimethenamid-P, which is mixture 

of S- and R-isomers enriched in the Sisomer (90:10, S:R). Both sets of data for 

dimethenamid and dimethenamid-P 

show similar toxicity and together are 

adequate for risk assessment. Because of 

the similarity of the two mixtures, EPA 

relies on data for both to assess the 

hazard of each mixture. 

The primary target organ is the liver. 

The toxicity in 90-day feeding studies in 

rats showed decreased body weights, 

increased cholesterol and changes in 

liver weights along with histopathology 

showing microscopic effects 

(centrilobular hypertrophy, periportal 

eosinophilic inclusions and necrosis) in 

the liver. Chronic studies in the rat, 

mouse, and dog showed decreases in 

body weight and food efficiency as 

accompanying effects over time. At 

higher dose levels, liver pathology 

(hepatic lesions, bile duct hyperplasia, 

and tumors), stomach hyperplasia, and 

some indications of kidney effects were 

noted. Two 21-day dermal toxicity 

studies in rabbits were conducted and 

in one of those studies minor skin 

irritation was observed at all doses 

tested and a decrease in body weight 

(bw) gain was also seen at the lowest 

effect level. 

The acute neurotoxicity study 

resulted in effects such as partially 

closed eyelids, lacrimation, and slight 

salivation at the highest dose tested of 

(600 milligrams/kilograms/body weight 

(mg/kg/bw)). There were no treatmentrelated or toxicologically significant 

findings during the gross examination of 

rats or in the microscopic examination 

of neurological tissues. In the 

subchronic neurotoxicity study, there 

were no clinical signs seen and no 

adverse effects seen up to 323/390 mg/ 

kg/bw day. Systemic effects seen were 

renal pelvic dilation in males 

(considered incidental) and a trend of 

higher liver weights in females was 

found at the lowest dose tested and 


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Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 9211 

were not considered adverse nor were 

they corroborated with any other 

guideline studies submitted. There were 

no liver histopathology or clinical 

chemistry measurements in the 

subchronic neurotoxicity study; 

however, the adversity of this finding is 

supported by the observation of 

multiple liver effects (increased 

cholesterol, increased total serum 

protein, increased liver weights, and 

enlarged centrilobular hepatocytes) in 

the 90-day rat study at doses of 98/119 

(Male/Female) milligrams/kilograms/

day (mg/kg/day) and above. There was 

no neurotoxicity observed at higher 

doses nor in other guideline studies. 

Developmental toxicity studies show 

increased post-implantation loss and 

minor skeletal variations in the rat, and 

late resorptions and minor skeletal 

variations in the rabbit at the highest 

dose tested (lowest observed adverse 

effect level: LOAEL, 425 mg/kg/day). In 

the rabbit, the developmental effects 

occurred at the same dose as maternal 

toxicity (LOAEL, 150 mg/kg/day), 

whereas in the rat, the developmental 

toxicity occurred at much higher doses 

than in the dams (LOAEL, 215 mg/kg/ 

day). The chosen no observed adverse 

effect level (NOAEL) of 75 mg/kg/day is 

considered protective for effects seen in 

both studies. The reproduction study 

resulted in decreases in body weight in 

both pups and parental animals at the 

same dose levels. The only other effects 

noted at the LOAEL of 150 mg/kg/day 

were increases in liver weights in both 

male and female parental animals. 

A review of the immunotoxicity study 

resulted in no immunotoxicity effects at 

the limit dose of 1,167 milligrams/

kilograms (mg/kg), although increased 

absolute and relative liver weights were 

seen at this dose level. DimethenamidP is classified as group ‘‘C’’ possible 

human carcinogen, based on weak 

evidence for carcinogenicity. 

The agency concluded that 

quantification of cancer risk using a 

non-linear approach would adequately 

account for all chronic toxicity 

(including carcinogenicity) that could 

result from exposure to dimethenamid 

based on the following weight of 

evidence considerations: 

1. No statistically significant increase 

in liver tumors (only an increasing trend 

for liver tumors in one sex (male) and 

one species (rat)). 

2. No evidence of carcinogenicity in 

male or female mice. 

3. Equivocal evidence for 

mutagenicity. 

4. The POD of 5 mg/kg/day used for 

human health risk assessment is 15-fold 

lower than the dose (75 mg/kg/day) that 

caused the liver tumors and thus 

considered protective for cancer. 

Specific information on the studies 

received and the nature of the adverse 

effects caused as well as the NOAEL and 

the LOAEL from the toxicity studies can 

be found at http://www.regulations.gov 

in document titled, ‘‘Dimethenamid/

Dimethenamid-P. Human Health Risk 

Assessment for Proposed New Use on 

Cottonseed Subgroup 20C.,’’ on pg. 42– 

48, in docket ID number EPA–HQ–OPP– 

2013–0670. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological POD and levels of concern 

(LOC) 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 the NOAEL and the 

LOAEL are identified. 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 

Dimethenamid/Dimethenamid-P used 

for human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIMETHENAMID/DIMETHENAMID-P 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 (General population including infants and 

children).

NOAEL = 200 mg/

kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 2.0 mg/

kg/day.

aPAD = 2.0 mg/kg/

day.

Acute Neurotoxicity. 

LOAEL = 600 mg/kg/day based on lacrimation, salivation, irregular and accelerated respiration, slight tremors, reduced exploration, unsteady gait, and significantly reduced rearing. 

Acute dietary (Females 13–49 

years of age).

NOAEL = 75 mg/kg/

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.75 

mg/kg/day.

aPAD = 0.75 mg/kg/

day.

Developmental Rabbit Study Maternal. LOAEL = 150 mg/kg/

day based on abortions (not considered acute effect). 

Developmental; LOAEL = 150 mg/kg/day based on post-implantation loss. 

Chronic dietary (All populations) NOAEL = 5 mg/kg/

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.05 

mg/kg/day.

cPAD = 0.05 mg/kg/

day.

Chronic/Carcinogenicity Rat Study. 

LOAEL = Male/Female; 36/49 mg/kg/day based on decreased 

body weight and body weight gain in both sexes, increased 

food conversion ratios in females, and increased microscopic 

hepatic lesions in both sexes. 


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9212 Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIMETHENAMID/DIMETHENAMID-P 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 

Incidental oral short-term and 

intermediate-term (1 to 6 

months).

NOAEL = 10 mg/kg/

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Subchronic/Chronic Oral Dog Studies. 

Chronic NOAEL = 10 mg/kg/day. 

Chronic LOAEL = 48.7 mg/kg/day. 

Subchronic NOAEL = 4.72 mg/kg/day. 

Subchronic LOAEL = 33.6 mg/kg/day based on decreased 

body weight in females, increased relative to body liver 

weight in both sexes, increased periportal cytoplasmic 

vacuolation in liver in both sexes, and dilation of liver 

sinusoids in females. 

Dermal short-term (1 to 30 

days) and intermediate-term 

(1–6 months).

NOAEL = 300 mg/

kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 21-Day Dermal Rabbit Study. 

LOAEL = 500 mg/kg/day based on decreased body weight gain 

only (non-specific). 

Inhalation short-term (1 to 30 

days).

NOAEL = 10 mg/kg/

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE= 100 Subchronic/Chronic Oral Dog Studies. 

Chronic NOAEL = 10 mg/kg/day. 

Chronic LOAEL = 48.7 mg/kg/day. 

Subchronic NOAEL = 4.72 mg/kg/day. 

Subchronic LOAEL = 33.6 mg/kg/day based on decreased 

body weight in females, increased relative to body liver 

weight in both sexes, increased periportal cytoplasmic 

vacuolation in liver in both sexes, and dilation of liver 

sinusoids in females. 

Cancer (Oral, dermal, inhalation).‘‘C’’ Possible human carcinogen. The chronic RfD is considered protective of the cancer effects. 

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). 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 dimethenamid-P and/or 

dimethenamid, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

dimethenamid tolerances in 40 CFR 

180.464 which are established for either 

of the herbicides dimethenamid-P (an 

enriched S-isomer with 90:10 mixture of 

the S- and R-isomers) or dimethenamid 

(a 50:50 racemic mixture of the S- and 

R-isomers). Therefore, EPA assessed 

dietary exposures from dimethenamid-P 

and/or dimethenamid 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 dimethenamid and dimethenamid-P. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

2003–2008 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII). The acute dietary analysis was 

conducted for dimethenamid and/or 

dimethenamid-P assuming tolerance 

level residues, default processing 

factors, and 100% crop treated (CT) 

information. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 CSFII. The 

chronic dietary exposure assessment 

was conducted for dimethenamid and/ 

or dimethenamid-P assuming tolerance 

level residues, default processing 

factors, and 100% CT information. 

iii. Cancer. As discussed in Unit III.A, 

EPA has concluded that cancer dietary 

risk concerns due to long-term 

consumption of dimethenamid residues 

are adequately addressed by the chronic 

dietary exposure analysis using the 

reference dose; therefore, a separate 

cancer dietary exposure analysis was 

not performed. 

iv. Anticipated residue and percent 

crop treated (PCT) information. 

Tolerance level residues and 100% CT 

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 dimethenamid-P and/or 

dimethenamid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of 

dimethenamid-P and/or dimethenamid. 

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 

the Pesticide Root Zone Model for 

Ground Water (PRZM–GW), estimated 

drinking water concentrations (EDWCs) 

were calculated for the parent 

compound plus its ethanesulfonic acid 

and oxanilic acid degradates, which are 

residues of concern in drinking water as 

follows: For acute exposures, EDWCs 

are estimated to be 73 parts per billion 

(ppb) for surface water and 153 ppb for 

ground water; for chronic exposures, 

EDWCs for non-cancer assessments are 

estimated to be 27 ppb for surface water 

and 140 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 


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Because there was little difference 

between the maximum EDWCs for acute 

and chronic exposures, the maximum 

water concentration value of 153 ppb 

was used to assess the contribution to 

drinking water for both the acute and 

chronic dietary risk assessments. 

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). Although 

there are no currently registered uses of 

dimethenamid that could result in 

residential exposures, dimethenamid-P 

is currently registered for the following 

uses that could result in residential 

exposures: Turf grass, ornamentals, and 

tree plantations. Only short-term 

residential exposures to dimethenamidP are expected based on the 2012 

Residential Standard Operating 

Procedures (SOPs). Potential exposure/

risk scenarios identified for residential 

handlers include: 

• Mixing/loading/applying liquid 

formulations to lawns/turf with a hoseend and/or backpack sprayer, and a 

manually-pressurized hand wand. 

• Mixing/loading/applying liquid 

formulations to garden/trees with a 

sprinkler can and a hose-end sprayer. 

• Mixing/loading/applying granular 

formulations to lawns/turf with a pushtype rotary sprayer and a belly grinder. 

• Mixing/loading/applying granular 

formulations to garden/trees with a 

shaker can/cup, a spoon or by hand 

dispersal. 

The scenarios, routes of exposure, and 

lifestages of potential post-application 

exposure include: 

• Physical activities on turf: Adults 

(dermal) and children 1 to <2 years old 

(dermal and incidental oral). 

• Mowing: Adults (dermal) and 

children 11 to <16 years old (dermal). 

• Golfing: Adults (dermal), children 

11 to <16 years old (dermal), and 

children 6 to <11 years old (dermal). 

• Contact with Treated Gardens and 

Trees: Adults (dermal) and children 6 to 

<11 years old (dermal). The values used 

for aggregate assessment are based on 

the worst-case residential exposure 

estimates via the inhalation (adult male) 

and oral (child 1 < 2 years old) routes. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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 that 

dimethenamid-P and dimethenamid 

share a common mechanism of toxicity 

with any other substances, or that they 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

dimethenamid-P and dimethenamid do 

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 

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. 

There is no concern for increased 

qualitative and/or quantitative 

susceptibility following in utero (rats 

and rabbits) and pre-and post-natal 

exposure (rats). The NOAEL and LOAEL 

values for the fetal/pup effects observed 

in the developmental study and effects 

seen in the reproduction studies 

occurred at the same doses or higher 

than those which caused maternal 

toxicity. The rabbit developmental 

study was used as an acute dietary 

endpoint for females 13–49 years of age. 

The POD selected for risk assessment 

are protective of effects seen in these 

guideline studies. Therefore, the acute 

and chronic dietary risk assessments are 

protective of potential fetal/offspring 

effects. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA SF to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

dimethenamid and dimethenamid-P is 

complete. 

ii. There is no indication that 

dimethenamid or dimethenamid-P is a 

neurotoxic chemical and there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

dimethenamid or dimethenamid-P 

results in increased susceptibility in 

utero in rat or rabbit 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 which results in 

very high-end estimates of dietary 

exposure. The dietary drinking water 

assessment, which included parent plus 

its ethanesulfonic acid and oxanilic acid 

degradates, utilizes values generated by 

model and associated modeling 

parameters which are designed to 

provide health protective, high-end 

estimates of water concentrations. These 

assessments will not underestimate the 

exposure and risks posed by 

dimethenamid-P and/or dimethenamid 

residues of concern. 

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 

dimethenamid-P and/or dimethenamid 

residues of concern will occupy 1.3% of 

the aPAD for infants <1 year of age, 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 dimethenamidP and dimethenamid residues of 

concern from food and water will utilize 

17% of the cPAD for infants <1 year of 


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9214 Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 

age, the population group receiving the 

greatest exposure. 

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). Dimethenamid-P is 

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 dimethenamid-P. 

Dermal and inhalation exposures to 

handlers were not aggregated because 

the toxicity endpoints for these 

exposure routes are not based on 

common toxicity effects in/of the liver. 

Dermal effects (bw gain) were 

considered to be non-specific. EPA 

aggregated the worst-case residential 

exposure estimates via the inhalation 

(adult male) and oral (child 1 < 2 years 

old) routes. 

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 MOEs of 2,200 for adults and 

1,100 for children 1–2 years old. 

Because EPA’s LOC for dimethenamidP is a MOE of 100 or below, these MOEs 

are 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, dimethenamid-P 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 

dimethenamid-P. 

5. Aggregate cancer risk for U.S. 

population. As indicated in Unit III.A., 

EPA has concluded that the chronic RfD 

would be protective of any cancer 

effects. Based on the results of the 

chronic aggregate risk assessment, EPA 

concludes there is no risk of concern for 

cancer effects from exposure to 

dimethenamid and dimethenamid-P. 

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 

dimethenamid and dimethenamid-P 

residues of concern. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement method is 

available for determining residues of 

dimethenamid in plant commodities. 

The Gas Chromatography/NitrogenPhosphorus Detector (GC/NPD) method 

(AM–0884–0193–1) has been validated 

by the Agency and submitted for 

publication in the Food and Drug 

Administration (FDA) Pesticide 

Analytical Manual (PAM), Volume II. 

The limit of quantitation (LOQ; 

determined as the lowest level of 

method validation, LLMV) is 0.01 ppm. 

This method is not enantiomer specific. 

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 not established a MRL 

for dimethenamid or dimethenamid-P 

in/on members of cottonseed subgroup 

20C and cotton, gin byproducts. 

C. Revisions to Petitioned-For 

Tolerances 

A separate tolerance in cotton, seed, 

refined oil is not needed since the 

exaggerated rate processing study 

demonstrates that the petitioned-for 

tolerance in/on cottonseed subgroup 

20C (0.01 ppm) will be adequate to 

cover potential residues of 

dimethenamid in refined oil. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the herbicide 

dimethenamid, 1(RS)-2-chloro-N-[(1- 

methyl-2-methoxy) ethyl]-N-(2, 4- 

dimethylthien-3-yl) acetamide, applied 

as either the 90:10 or 50:50 S:R isomers, 

in or on cottonseed subgroup 20C at 

0.01 ppm and cotton, gin byproducts at 

1.5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule 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 final rule 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 


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Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations 9215 

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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

(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: February 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 § 180.464, add alphabetically the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.464 Dimethenamid; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Cotton, gin byproducts ......... 1.5 

Cottonseed subgroup 20C ... 0.01 

* * * * * 

* * * * * 

[FR Doc. 2015–03458 Filed 2–19–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0574; FRL–9920–62] 

Bacillus Subtilis Strain IAB/BS03; 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the fungicide 

Bacillus subtilis strain IAB/BS03 in or 

on all food commodities when used in 

accordance with label directions and 

good agricultural practices. 

Investigaciones y Aplicaciones 

Biotechnologicas (IAB, S.L.) submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus subtilis strain 

IAB/BS03. 

DATES: This regulation is effective 

February 20, 2015. Objections and 

requests for hearings must be received 

on or before April 21, 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–2013–0574 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: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

BPPDFRNotices@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 40 CFR part 180 

through the Government Publishing 

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(g), 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–2013–0574 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 April 21, 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 


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