Document ID: EPA-HQ-OPP-2011-0743-0007
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Dodine
Posted Date: 2012-12-05T05:00Z

[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Rules and Regulations]
[Pages 72232-72237]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29251]

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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.

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SUMMARY: This regulation establishes tolerances for residues of dodine, 
(N-dodecyl 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.,

[[Page 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 
pre-neoplastic 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-observed-adverse-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

[[Page 72234]]

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 Non-Occupational Human
                                             Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of  N/A....................  N/A....................  No appropriate endpoint
 age).                                                                                    for females age 13-49.
Acute dietary (General population      N/A....................  N/A....................  No appropriate endpoint
 including infants and children).                                                         identified.
Chronic dietary (All populations)....  NOAEL = 2 mg/kg/day....  cRfD=0.02 mg/kg/day....  Chronic toxicity-dog
                                       UFA = 10x..............                            LOAEL = 10 mg/kg/day
                                       UFH = 10x..............                            based on body weight
                                                                                          loss in females.
                                       FQPA SF = 1x...........  cPAD = 0.02 mg/kg/day..
Incidental oral short-term (1 to 30    NOAEL = 26 mg/kg/day...  Residential MOE = 100..  2-Generation
 days).                                UFA = 10x..............                            Reproduction-rat
                                       UFH = 10x..............                            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    Residential MOE = 100..  28-Day Dermal Toxicity-
                                        (HDT).                                            rat LOAEL = not
                                                                                          identified.
Dermal intermediate-term (1 to 6       UFA = 10xUFH = 10x.....
 months).
Inhalation short-term(1 to 30 days)..  Developmental Study      Residential MOE = 100..  Developmental Toxicity
                                        Maternal NOAEL = 10 mg/                           Study-rat Maternal
                                        kg/day.                                           LOAEL = 45 mg/kg/day
                                       IAF = 100%.............                            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

[[Page 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 non-occupational, 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.

[[Page 72236]]

    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

[[Page 72237]]

calculation procedures, tolerances for almond hulls were increased.

 V. Conclusion

    Therefore, tolerances are established for residues of dodine, N-
dodecylguanidine 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]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Amend Sec.  180.172 as follows:
0
i. Revise the introductory text in paragraph (a).
0
ii. Remove the entries for cherry, sweet; cherry, tart; peach, pecan 
and walnut from the table in paragraph (a).
0
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:

Sec.  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.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             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