[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29251]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Dodine; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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: email@example.com.
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
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.,
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
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)
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
(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
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
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
Dermal intermediate-term (1 to 6 UFA = 10xUFH = 10x.....
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
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
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
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
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
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
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
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
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.
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
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
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
Economic Cooperation and Development (OECD) tolerance
calculation procedures, tolerances for almond hulls were increased.
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;
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
Dated: November 21, 2012.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Amend Sec. 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:
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
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