72232 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 

Commodity Parts per 

million 

Goat, meat byproducts ........... 0 .01 

Grain, aspirated grain fractions ..................................... 10 

Grain, cereal, forage, fodder, 

and straw, group 16, forage 15 

Grain, cereal, forage, fodder, 

and straw, group 16, hay .... 5 

Grain, cereal, forage, fodder, 

and straw, group 16, stover 10 

Grain, cereal, forage, fodder, 

and straw, group 16, straw 2 

Grain, cereal, group 15, except rice and barley ............ 0 .04 

Hog, fat ................................... 0 .01 

Hog, meat ............................... 0 .01 

Hog, meat byproducts ............ 0 .01 

Horse, fat ................................ 0 .01 

Horse, meat ............................ 0 .01 

Horse, meat byproducts ......... 0 .01 

Milk ......................................... 0 .01 

Pea and bean, dried shelled, 

except soybean, subgroup 

6C ........................................ 0 .06 

Poultry, fat .............................. 0 .01 

Poultry, meat .......................... 0 .01 

Poultry, meat byproducts ........ 0 .01 

Rapeseed subgroup 20A ........ 0 .08 

Sheep, fat ............................... 0 .01 

Sheep, meat ........................... 0 .01 

Sheep, meat byproducts ........ 0 .01 

Soybean, forage ..................... 1 

Soybean, hay .......................... 3 

Soybean, hulls ........................ 0 .2 

Soybean, seed ........................ 0 .05 

Vegetable, foliage of legume, 

except soybean, subgroup 

7A ........................................ 40 

Wheat, bran ............................ 0 .06 

Wheat, germ ........................... 0 .09 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–29250 Filed 12–4–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0743; FRL–9364–7] 

Dodine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dodine, (Ndodecyl guanidine acetate) in or on 

multiple commodities and also removes 

multiple, previously established 

tolerances which are identified and 

discussed later in this document. 

Agriphar S.A., c/o Ceres International 

LLC requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 5, 2012. Objections and 

requests for hearings must be received 

on or before February 4, 2013, 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–2011–0743, 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), EPA West 

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: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; email address: 

gibson.tamue@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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2011–0743 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 4, 2013. 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– 

2011–0743, 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.htm. 

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 August 22, 

2012 (77 FR 50661) (FRL–9358–9), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1F7872) by Agriphar S.A., 


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Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 72233 

c/o Ceres International LLC, 1087 

Heartsease Drive, West Chester, PA 

19382. The petition requested that 40 

CFR 180.172 be amended by 

establishing tolerances for residues of 

the fungicide dodine, (N-dodecyl 

guanidine acetate), in or on stone fruits 

(group 12) at 5 parts per million (ppm); 

tree nuts (group 14) at 0.3 ppm; and 

almond, hulls at 20 ppm. The petitioner 

also requested that the tolerances in 40 

CFR 180.172 be amended by removing 

established tolerances for residues of 

dodine as follows: Cherry, sweet at 3 

ppm; cherry, tart at 3 ppm; peach at 5 

ppm; pecan at 0.3 ppm; and walnut at 

0.3 ppm. These tolerances would be 

redundant if the crop group tolerances 

for stone fruits (group 12) and tree nuts 

(group 14) are established. That notice 

referenced a summary of the petition 

prepared by Agriphar S.A., c/o Ceres 

International LLC, 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 raised 

the requested tolerance level for 

almond, hull. The reason for this change 

is 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 dodine, 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with dodine 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. 

Dodine is moderately toxic via the 

acute oral, dermal and inhalation routes 

of exposure. It is a severe eye irritant 

and causes severe dermal irritation; it is 

not a skin sensitizer. A definitive target 

organ has not been identified for 

dodine. The most common effects 

observed in sub-chronic and chronic 

studies were decreases in food 

consumption, body weight and/or body 

weight gain. Possible neurological 

clinical signs (excessive salivation and 

hunched posture/hypoactivity) were 

observed in chronic studies in rats and 

mice but were not dose-related or 

statistically significant. Excessive 

salivation in the chronic study in dogs 

was not consistent with a neurological 

adverse effect since it was seen prior to 

dosing and was a persistent finding 

throughout the study. Therefore, there is 

no evidence of neurotoxicity and the 

acute and subchronic neurotoxicity 

studies are not required (HASPOC, 

October 25, 2012). The current database 

does not indicate concerns for 

immunotoxicity and the registrant has 

agreed to perform an immunotoxicity 

study (OCSPP Guideline 870.7800). 

Therefore, the Food Quality Protection 

Act (FQPA) safety factor is reduced to 

1X. 

There is no evidence of increased 

susceptibility (quantitative or 

qualitative) in pups versus adults based 

on rat and rabbit developmental studies 

and the rat multi-generation 

reproduction study. In rat and rabbit 

prenatal developmental studies, there 

was no toxicity identified in the fetuses 

up to the highest dose tested (HDT). In 

the 2-generation reproduction study, 

decreases in body weight gain and food 

consumption were seen in pups at the 

same dose at which maternal toxicity 

(decreased body weight, body weight 

gain and food consumption) was 

observed. 

There was equivocal evidence of 

carcinogenicity in animal 

carcinogenicity studies; however, a 

weight-of-evidence evaluation of the 

carcinogenic potential of dodine was 

performed, and based on the results it 

was concluded that dodine should be 

classified as Not Likely to be 

Carcinogenic to Humans based on the 

following: 

(1) There was no evidence of tumors 

in male mice or in rats of either sex; 

(2) In female mice, the increase in 

incidence of combined tumors is 

marginal (8.3%) compared to historical 

controls (8%), and there were no preneoplastic lesions that can be associated 

with the tumor response, and therefore 

no evidence that the high dose was 

associated with further progression to 

carcinoma; 

(3) There was no evidence of 

genotoxicity, and therefore no 

mutagenicity concern; and 

(4) The Structure Activity 

Relationship (SAR) assessment does not 

indicate probable carcinogenicity. 

Factors bearing on this weight of the 

evidence determination are described in 

‘‘Dodine: Human Health Risk 

Assessment for Proposed Use Bananas 

and Peanuts,’’ pages 20–21 in docket ID 

number EPA–HQ–OPP–2007–0221, at 

http://www.regulations.gov. In the 

absence of carcinogenicity concern, risk 

assessment using the chronic 

population adjusted dose will be 

protective for any chronic toxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by dodine 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 document 

‘‘Dodine. Amended Human Health Risk 

Assessment to Support Use on Stone 

Fruit and Tree Nut Crops,’’ pages 14 and 

42 in docket ID number EPA–HQ–OPP– 

2011–0743. 

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 


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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 dodine used for human 

risk assessment is shown in the 

following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DODINE FOR USE IN DIETARY AND NONOCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS

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 ............................................. N/A ............................................. No appropriate endpoint for females age 

13–49. 

Acute dietary (General population including infants and 

children).

N/A ............................................. N/A ............................................. No appropriate endpoint identified. 

Chronic dietary (All populations) NOAEL = 2 mg/kg/day ..............

UFA = 10x ..................................

UFH = 10x ..................................

cRfD=0.02 mg/kg/day ................ Chronic toxicity-dog LOAEL = 10 mg/kg/ 

day based on body weight loss in females. 

FQPA SF = 1x ........................... cPAD = 0.02 mg/kg/day.

Incidental oral short-term (1 to 

30 days).

NOAEL = 26 mg/kg/day ............

UFA = 10x ..................................

UFH = 10x ..................................

Residential MOE = 100 ............. 2-Generation Reproduction-rat Offspring 

LOAEL = 53 mg/kg/day based on decreased body weight. 

Incidental oral intermediate-term 

(1 to 6 months).

Dermal short-term (1 to 30 

days).

NOAEL = 200 mg/kg/day (HDT) Residential MOE = 100 ............. 28-Day Dermal Toxicity-rat LOAEL = not 

identified. 

Dermal intermediate-term (1 to 

6 months).

UFA = 10xUFH = 10x.

Inhalation short-term(1 to 30 

days).

Developmental Study Maternal 

NOAEL = 10 mg/kg/day.

IAF = 100% ................................

Residential MOE = 100 ............. Developmental Toxicity Study-rat Maternal LOAEL = 45 mg/kg/day based on 

decreased body weight gain and food 

consumption. 

Inhalation (1 to 6 months) ......... UFA = 10x ..................................

UFH = 10x.

Cancer (oral, dermal, inhalation) Not likely to be carcinogenic to humans. 

FQPA SF = Food Quality Protection Act Safety Factor. HDT= Highest Dose Tested. IAF = inhalation absorption rate. 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 dodine, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing dodine 

tolerances in 40 CFR 180.172. EPA 

assessed dietary exposures from dodine 

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. 

No such effects were identified in the 

toxicological studies for dodine; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Continuing Survey of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed tolerance level 

residues for all treated crops. In terms 

of extent of usage, percent crop treated 

(PCT) information was used for apples, 

cherries, peaches, pears, peanuts, 

pecans, and strawberries. One hundred 

PCT was assumed for the remainder of 

crops. 

iii. Cancer. Based on the data 

discussed in Unit III.A., EPA 

determined that dodine did not pose a 

carcinogenicity concern and that risk 

assessment using the chronic 

population adjusted dose will be 

protective for any chronic toxicity. 

Accordingly, no exposure assessment, 

separate from the chronic assessment, 

was conducted with regard to cancer 

risk. 

iv. PCT information. Section 

408(b)(2)(F) of FFDCA states that the 

Agency may use data on the actual 

percent of food treated for assessing 

chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses as follows: 

The Agency used the following PCT 

information for the currently registered 

uses of dodine: 10% PCT for pecans, 5% 

PCT for cherries and pears, 2.5% PCT 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 72235 

for apples and peanuts along with 1% 

PCT for peaches and strawberries. 

In most cases, EPA uses available data 

from U.S. Department of Agriculture/ 

National Agricultural Statistics Service 

(USDA/NASS), proprietary market 

surveys, and the National Pesticide Use 

Database for the chemical/crop 

combination for the most recent 6–7 

years. EPA uses an average PCT for 

chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 1. 

In those cases, 1% is used as the average 

PCT and 2.5% is used as the maximum 

PCT. EPA uses a maximum PCT for 

acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

sub-populations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which dodine may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for dodine in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of dodine. 

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 FQPA Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of dodine 

for chronic exposures for non-cancer 

assessments are estimated to be 1.79 

parts per billion (ppb) for surface water 

and <0.05 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 1.79 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). 

Dodine is not registered for any 

specific use patterns that would result 

in residential exposure. However, a 

closely related chemical, 

dodecylguanidine hydrochloride (DGH) 

is used as an antimicrobial in 

household, industrial, and commercial 

products having residential and 

occupational exposure potential. DGH is 

used as a bacteriostat in paints and in 

absorbent material in disposal diapers. 

Dodine and DGH have similar chemical 

compositions and properties and are 

therefore considered bio-equivalents. 

Residential painters may have short 

term dermal and inhalation exposure as 

a result of using DGH treated paint. 

Infants and small children may have 

short-, intermediate-, and long-term 

dermal exposure as a result of wearing 

DGH impregnated diapers. The Agency 

believes that a transfer factor of 30% 

does not underestimate exposure in 

determining the amount of DGH 

transferred to infants from diapers based 

on a transfer study using dodine-treated 

paper exposed to extreme conditions. 

Inhalation exposure of infants and 

children is expected to be negligible. 

Although small children may have 

short-term post application oral 

exposure as a result of accidental 

ingestion of paint chips which contain 

DGH, the Agency does not believe that 

this would occur on a regular basis. 

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 dodine to share a 

common mechanism of toxicity with 

any other substances, and dodine does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that dodine 

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. 

There is no evidence (quantitative or 

qualitative) of increased susceptibility 

and no residual uncertainties with 

regard to prenatal and/or postnatal 

toxicity following in utero exposure to 

rats or rabbits. In rat and rabbit prenatal 

developmental studies, there was no 

toxicity identified in the fetuses up to 

the HDT. In the 2-generation 

reproduction study, decreases in body 

weight gain and food consumption were 

seen in pups at the same dose at which 

maternal toxicity (decreased body 

weight, body weight gain and food 

consumption) was observed. 

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: 

The toxicity database for dodine is 

mostly complete. The database contains 

the following toxicity studies: 

i. A sub-chronic mouse toxicity study. 

ii. Chronic rat, mouse, and dog 

toxicity studies. 


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iii. A 28-day dermal and dermal 

penetration studies (rats. 

iv. Prenatal developmental studies 

(rats and rabbits). 

v. A reproduction study in rats. 

There are also acute LD50 studies via 

the oral, dermal and inhalation routes, 

a metabolism study, and a complete 

mutagenicity battery. The current 

database does not indicate neurotoxicity 

or immunotoxicity concerns. Thus, EPA 

has waived the acute and subchronic 

neurotoxicity studies. An 

immunotoxicity study is required 

pursuant to the recent amendment of 

EPA’s data regulations to evaluate the 

potential of a repeated chemical 

exposure to produce adverse effects (i.e., 

suppression) on the immune system. 

However, because no immunotoxicity 

was observed in available toxicity 

studies, EPA has confidence that this 

study is unlikely to change the POD in 

assessing risk to infants and children. 

a. There is no evidence that dodine 

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. 

b. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on Agency 

recommended tolerance-level residues 

and health protective modeling 

assumptions. Although PCT estimates 

were used for crops with existing 

tolerances, the use of tolerance values 

for residue levels will likely 

overestimate actual exposures. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to dodine in drinking water. EPA used 

similarly conservative assumptions to 

assess postapplication exposure of 

children, as well as incidental oral 

exposure of children and incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by dodine. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, dodine is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to dodine from 

food and water will utilize 21% of the 

cPAD for all infants <1 year old, the 

population group receiving the greatest 

exposure. Further, EPA has concluded 

that the combined long-term food, 

water, and dermal exposure for infants 

wearing diapers containing DGH treated 

material results in an aggregate MOE 

greater than 100. Because EPA’s level of 

concern for dodine is for MOEs below 

100, this MOE does not raise a risk 

concern. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures, EPA has 

concluded the combined short- and 

intermediate-term combined food, 

water, and residential exposures 

aggregated result in aggregate MOEs of 

4,200 for adult males handling paint 

and 4,500 for adult females handling 

paint. The exposures do not exceed the 

Agency’s level of concern. EPA has 

concluded that the combined 

intermediate-term food, water, and 

dermal exposure for infants wearing 

diapers containing DGH treated material 

results in aggregate MOEs of 120 when 

using a 30% transfer factor. Because 

EPA’s level of concern for dodine is for 

MOEs below 100, this MOE does not 

raise a risk concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the data discussed 

in Unit III.A., EPA concluded that 

dodine is not expected to pose a cancer 

risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to dodine 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(colormetric method with spectrometric 

detection and various modifications is 

listed in FDA’s Pesticide Analytical 

Manual (PAM), Volume II as Methods I, 

I(a), I(b), and I(d)) is 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 not established MRLs 

for dodine on the tree nut crop group. 

The Codex has established MRLs for 

dodine in or on cherries, sweet and 

cherries, tart at 3 ppm and on peaches 

and nectarines at 5 ppm. The Codex 

MRL for cherries is not harmonized 

with the stone fruit crop group tolerance 

of 5 ppm. 

Harmonization with the Codex MRL 

for cherries is not possible because the 

cherry field trial data shows that 

residues from the domestic, labeled use 

may exceed the 3 ppm Codex MRL 

making it impractical for limits to be 

harmonized based on the proposed 

domestic use pattern. However, the 

cherry data when considered as part of 

the data set to support a stone fruit crop 

group tolerance, indicate that a 5 ppm 

crop group tolerance would be 

appropriate. To harmonize to the best 

extent possible with Codex, the crop 

group tolerance will be set at 5 ppm, 

This at least harmonizes the Codex and 

U.S. tolerances for peaches and 

nectarines. 

C. Revisions to Petitioned-for Tolerances 

Based on the analysis of the residue 

trial data using the Organization for 

Economic Cooperation and 

Development (OECD) tolerance 


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Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Rules and Regulations 72237 

calculation procedures, tolerances for 

almond hulls were increased. 

V. Conclusion 

Therefore, tolerances are established 

for residues of dodine, Ndodecylguanidine acetate, including its 

metabolites and degradates, in or on 

almond, hulls at 30 ppm; fruit, stone, 

crop group 12 at 5.0 ppm; and nuts, tree, 

crop group 14 at 0.3 ppm. This final rule 

removes established tolerances for 

cherry, sweet; cherry, tart; peach; pecan; 

and walnut. 

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 

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: November 21, 2012. 

Lois Rossi, 

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. Amend § 180.172 as follows: 

■ i. Revise the introductory text in 

paragraph (a). 

■ ii. Remove the entries for cherry, 

sweet; cherry, tart; peach, pecan and 

walnut from the table in paragraph (a). 

■ iii. Add alphabetically the entries for 

almond, hull; fruit, stone, crop group 

12; and nuts, tree, crop group 14. 

The additions and revision read as 

follows: 

§ 180.172 Dodine; tolerances for residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

dodine, including its metabolites and 

degradates, in or on the commodities 

listed in the table below. Compliance 

with the tolerance levels specified in the 

table is to be determined by measuring 

only dodine, N-dodecylguanidine 

acetate; in or on the following 

commodities. 

Commodity Parts per 

million 

Almond, hull .......................... 30.0 

* * * * * 

Fruit, stone, crop group 12 ... 5.0 

Nuts, tree, crop group 14 ..... 0.3 

* * * * * 

* * * * * 

[FR Doc. 2012–29251 Filed 12–4–12; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 09–52; FCC 12–127] 

Policies To Promote Rural Radio 

Service and To Streamline Allotment 

and Assignment Procedures 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; petitions for 

reconsideration and clarification. 

SUMMARY: In this document, the 

Commission denied four of six Petitions 

for Reconsideration, Petitions for Partial 

Reconsideration, and Petitions for 

Clarification of the Second Report and 

Order (Second R&O) in this proceeding, 

granting in part and denying in part two 

of the petitions. The Commission 

clarified some of the methodology to be 

used in applying the new rules and 

procedures in the Second R&O, in 

particular the method of counting 

reception services in service gain and 

loss areas, to assist applicants and 

allotment proponents in accurately 

applying the new rules and procedures. 

The Commission also further restricted 

the categories of applicants and 

allotment proponents to whom the new 

rules and procedures apply, finding that 

equitable considerations supported such 

restrictions. In addition to restrictions 

set forth in the Second R&O, the new 

rules will not apply to applications and 

allotment proposals filed before the new 

rules were proposed, or to those 

applications and proposals that have 


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