
[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Rules and Regulations]               
[Page 58880-58886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc08-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1191; FRL-8382-9]

 
Cymoxanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cymoxanil in or on bulb onion subgroup 3-07A; green onion subgroup 3-
07B; leafy greens subgroup 4A; leaf petioles subgroup 4B; cilantro 
leaves; and caneberry subgroup 13-07A. The Interregional Research 
Project (IR-4) requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA). This regulation also deletes the tolerances 
for caneberry and head lettuce.

DATES: This regulation is effective October 8, 2008. Objections and 
requests for hearings must be received on or before December 8, 2008, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-1191. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American

[[Page 58881]]

Industrial Classification System (NAICS) codes have been provided to 
assist you and others in determining whether this action might apply to 
certain entities. If you have any questions regarding the applicability 
of this action to a particular entity, consult the person listed under 
FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-1191 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before December 8, 2008.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-1191, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW, Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of March 12, 2008 (73 FR 13225) (FRL-8354-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
7E7282 and 7E7283) by IR-4, 500 College Rd. East, Suite 201 W, 
Princeton, NJ 08540. The petitions requested that 40 CFR 180.503 be 
amended by establishing tolerances for residues of the fungicide 
cymoxanil, (2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) 
acetamide), in or on bulb vegetables group 3-07 at 1.1 parts per 
million (ppm); leafy greens subgroup 4A at 19 ppm; cilantro leaves at 
19 ppm; caneberry subgroup 13-07A at 4 ppm (PP 7E7283); and leaf 
petioles subgroup 4B at 6.0 ppm (PP 7E7282). That notice referenced a 
summary of the petition prepared by IR-4 and DuPont, the registrant, 
which is available to the public in the docket, http://
www.regulations.gov. Several comments were received from a private 
citizen objecting to the sale of the pesticide and animal testing. The 
Agency has received these same comments from this commenter on numerous 
previous occasions. Refer to Federal Register 70 FR 37686 (June 30, 
2005), 70 FR 1354 (January 7, 2005), 69 FR 63096-63098 (October 29, 
2004) for the Agency's response to these objections.
    Based upon review of the data supporting the petition, EPA has 
determined that the tolerance levels for bulb vegetables should be set 
as follows: bulb onion subgroup 3-07A at 0.05 ppm; green onion subgroup 
3-07B at 1.1 ppm. The reasons for this change are explained in Unit 
IV.D.

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 
tolerances for residues of cymoxanil on bulb onion subgroup 3-07A at 
0.05 ppm; green onion subgroup 3-07B at 1.1 ppm; leafy greens subgroup 
4A at 19 ppm; leaf petioles subgroup 4B at 6.0 ppm; cilantro leaves at 
19 ppm; and caneberry subgroup 13-07A at 4.0 ppm. EPA's assessment of 
exposures and risks associated with establishing these tolerances 
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. Specific information on the studies received and the nature 
of the adverse effects caused by cymoxanil as well as the no-observed-
adverse-effect-levels (NOAELs) and the lowest-observed-adverse-effect-
levels (LOAELs) from the toxicity studies can be found at http://
www.regulations.gov in document Cymoxanil; Human Health Risk Assessment 
for Proposed Uses on Bulb Vegetables (Crop Group 3-07), Leafy Greens 
(Subgroup 4A), and Leaf Petioles (Subgroup 4B), page 16 in docket ID 
number EPA-HQ-OPP-2007-1191.
    Cymoxanil has low acute toxicity via oral, dermal, and inhalation 
routes of exposure. It is a mild skin irritant, not a skin sensitizer, 
and non-irritating to the eye. Systemic toxicity, as evidenced by 
decreased body weights, body weight gains, and food consumption, was 
observed in subchronic, chronic, developmental, reproductive and 
neurotoxicity studies across species. The dog appears to be the most 
sensitive species for cymoxanil-induced toxicity

[[Page 58882]]

with the thymus gland identified as a target organ in this species 
during subchronic and chronic exposures. No evidence of immunotoxicity 
was observed following subchronic exposure of rats up to 108 
milligrams/kilograms/day (mg/kg/day) in males and 117 mg/kg/day in 
females (108/117 (M/F)) or mice up to 218/552 (M/F) mg/kg/day, 
respectively. In a 21-day dermal toxicity study in rats, no systemic 
toxicity was observed up to the limit dose. In a subchronic 
neurotoxicity study in rats, systemic toxicity was observed at 102/137 
mg/kg/day (M/F); however, no neurotoxicity and/or neuropathology were 
observed up to 224/333 mg/kg/day (M/F; highest dose tested). In 
addition, no evidence of neurotoxicity was observed in the 
developmental toxicity studies in rats or rabbits, the 2-generation 
reproduction study in rats, the subchronic or chronic dog studies, or 
the 18-month mouse carcinogenicity study. However, in the combined 
chronic toxicity/carcinogenicity study in rats, clinical signs of 
hyperactivity and aggressiveness in males (>=30.3 mg/kg/day), as well 
as retinal atrophy in both sexes (>=30.3 mg/kg/day) were observed.
    Increased susceptibility of rats and rabbits was observed following 
in utero exposure to cymoxanil. In acceptable developmental toxicity 
studies in both of these species, developmental effects were seen at 
doses below those that caused maternal toxicity. In the rat 
developmental toxicity studies, skeletal anomalies, delays in skeletal 
ossification, and/or increases in overall malformations were observed 
at lower doses than those at which maternal toxicity was observed. In a 
rabbit developmental study, increased skeletal malformations were 
observed at 8 mg/kg/day (LOAEL), which was also below the maternal 
NOAEL of 32 mg/kg/day. Cleft palate was also observed in fetuses at 32 
mg/kg/day. In the first 2-generation reproduction toxicity study 
(1993), decreased pup viability (PND 0-4) was observed at maternally 
toxic doses. In a second 2-generation reproduction toxicity study 
(2001), decreased body weight was observed during lactation in both 
F1 and F2 offspring at a dose that was lower than 
that at which parental toxicity was observed. The increased 
susceptibility of offspring observed in this study was concordant with 
the results obtained in the developmental toxicity studies. In a 
developmental neurotoxicity study, offspring toxicity - adverse effects 
included decreased pup survival, decreased pup weight and body weight 
gain during early lactation, increases in morphometric measurements 
(anterior/posterior cerebrum for males, cerebellar height for females) 
at PND 79-83, and decreased retention in the water maze task for adult 
females - was observed at the same dose as maternal toxicity (slight 
decreases in body weight, body weight gain during gestation, and food 
consumption). The LOAEL for both maternal animals and offspring was 100 
mg/kg/day. No residual uncertainties exist in the database for pre-/
post-natal toxicity, and the endpoints selected for risk assessment are 
considered protective of effects observed in offspring in developmental 
and reproduction toxicity studies. The endpoints selected for risk 
assessment are further described in section 3.5 of the document: 
Cymoxanil; Human Health Risk Assessment for Proposed Uses on Bulb 
Vegetables (Crop Group 3-07), Leafy Greens (Subgroup 4A), and Leaf 
Petioles (Subgroup 4B), page 13 in docket ID number EPA-HQ-OPP-2007-
1191.
    Cymoxanil was not carcinogenic in rats and mice and is classified 
as ``not likely to be carcinogenic to humans.'' The available studies 
indicate that cymoxanil is not mutagenic in bacteria or cultured 
mammalian cells. There is, however, evidence of clastogenic activity 
and induction of unscheduled DNA synthesis in vitro. In contrast, 
cymoxanil was neither clastogenic nor aneugenic in vivo in mouse bone 
marrow cells and did not induce a genotoxic response in rat somatic or 
germinal cells. The negative results from the in vivo mouse bone marrow 
micronucleus assay support the lack of a carcinogenic effect in long-
term rat and mouse feeding studies.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    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 
greater than that 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 cymoxanil used for 
human risk assessment can be found at http://www.regulations.gov in 
document Cymoxanil; Human Health Risk Assessment for Proposed Uses on 
Bulb Vegetables (Crop Group 3-07), Leafy Greens (Subgroup 4A), and Leaf 
Petioles (Subgroup 4B), page 16 in docket ID number EPA-HQ-OPP-2007-
1191.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cymoxanil, EPA considered exposure under the petitioned-for 
tolerances as well as all existing cymoxanil tolerances in (40 CFR 
180.503). EPA assessed dietary exposures from cymoxanil 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. An acute endpoint of concern 
was not identified for the general U.S. population. Therefore, an acute 
dietary exposure assessment was performed only for Females 13-49 Years 
Old, based upon the NOAEL of 4 mg/kg/day from the rabbit developmental 
toxicity study. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels

[[Page 58883]]

in food, EPA assumed that cymoxanil residues were present in all 
registered and proposed food commodities at tolerance levels, and 100 
percent crop treated (PCT) for all commodities. Dietary Exposure 
Evaluation Model (DEEM) version 7.81 default processing factors were 
used for all registered and proposed commodities except grapes. 
Processing factors for grape juice (1.4x) and raisins (1x) were derived 
from grape processing data.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used tolerance level 
residues or anticipated residues (field trial residues) and PCT. 
Anticipated residues were calculated from average field trial data for 
cilantro leaves, chive, grape, green onion, hops, leaf petioles, and 
leafy greens. DEEM 7.81 default processing factors were used for all 
commodities except grapes. Processing factors for grape juice (1.4x) 
and raisins (1x) were derived from grape processing data.
    iii. Cancer. Cymoxanil was not carcinogenic in rats and mice. EPA 
classified cymoxanil as ``not likely'' to be a human carcinogen; 
therefore a cancer dietary exposure assessment was not performed.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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 used PCT information as follows: Cucumber, head lettuce, 
pepper, potato, and tomato at 10%; pumpkin, squash, and watermelon at 
1%.
    In most cases, EPA uses available data from United States 
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 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 one. 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 subpopulations 
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 cymoxanil 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 cymoxanil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cymoxanil. 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 First Index Reservoir Screening Tool (FIRST), and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of cymoxanil for acute 
exposures are estimated to be 9.3 parts per billion (ppb) for surface 
water and 0.0018 ppb for ground water. EDWCs of cymoxanil for chronic 
exposures for non-cancer assessments are estimated to be 0.05 ppb for 
surface water and 0.0018 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 9.3 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 0.05 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). Cymoxanil is not 
registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found cymoxanil to share a common mechanism of toxicity 
with any other substances, and cymoxanil does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that cymoxanil does not 
have

[[Page 58884]]

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 website 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 an indication of 
increased susceptibility of rats and rabbits to in utero exposure to 
cymoxanil. In several developmental toxicity studies in the rat and 
rabbit, developmental toxicity was observed at doses that were lower 
than those that caused maternal toxicity. In the rat developmental 
toxicity studies, skeletal anomalies, delays in skeletal ossification, 
and/or increases in overall malformations were observed at lower doses 
than those at which maternal toxicity was observed. However, in the 
developmental neurotoxicity study in rat, offspring toxicity was 
observed at the same dose as maternal toxicity. In one rabbit 
developmental study, increased skeletal anomalies were observed at 8 
mg/kg/day (LOAEL), which was below the maternal NOAEL of 32 mg/kg/day. 
In a second rabbit developmental toxicity study, an increased incidence 
of visceral and skeletal anomalies was observed at 25 mg/kg bw/day; a 
maternal LOAEL was not observed in this study. In the 2-generation 
reproduction toxicity study, decreased pup body weight was observed at 
a lower dose than that which caused toxicity in adults.
    In the developmental and postnatal studies for which there is 
increased susceptibility, the effects are well characterized and 
conservative NOAELs were established for developmental and offspring 
effects. In addition, the doses selected for risk assessment are based 
on the lowest NOAELs from the developmental and reproductive toxicity 
studies, where appropriate, and are protective of any potential pre- 
and post-natal effects. Therefore, there are low levels of concern and 
no residual uncertainties for pre- and post-natal toxicity.
    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 for acute risk determination. That decision 
is based on the following findings:
    i. The toxicity database for cymoxanil is complete for dietary risk 
assessment and includes a developmental neurotoxicity study.
    ii. Although there is evidence of increased susceptibility in the 
prenatal developmental studies in rats and rabbits, there have not been 
any residual uncertainties identified after establishing toxicity 
endpoints and traditional uncertainty factors to be used in the risk 
assessment of cymoxanil. The degree of concern for pre-and/or postnatal 
toxicity is low.
    iii. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessment was performed 
based on 100 PCT and tolerance-level residues, and DEEM default 
processing factors for all registered and proposed commodities. The 
chronic dietary food assessment was performed incorporating tolerance 
levels or anticipated residues (field trial residues) and PCT 
(potatoes, head lettuce, peppers, tomatoes, watermelon, cucumber, 
pumpkin, and summer and winter squash). EPA believes that the PCT 
estimates used are based on reliable data because PCT estimates are 
derived from Federal and private market survey data, which are reliable 
and have a valid basis. EPA made conservative (protective) assumptions 
in the ground and surface water modeling used to assess exposure to 
cymoxanil in drinking water. These assessments will not underestimate 
the exposure and risks posed by cymoxanil.
    EPA has retained the 10X FQPA safety factor for assessing risk from 
chronic dietary exposure to cymoxanil because the LOAEL from the 
chronic toxicity study in the dog was used to assess chronic dietary 
risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. An acute dietary exposure assessment was performed for 
females 13-49 years old only, since an acute endpoint of concern was 
not identified for the general U.S. population. Using the exposure 
assumptions discussed in this unit for acute exposure, the acute 
dietary exposure to cymoxanil from food and water will occupy 89% of 
the aPAD for females 13-49 years old, the only population subgroup of 
concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cymoxanil from food and water will utilize 74% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
For the general U.S. population, chronic exposure to cymoxanil from 
food and water will utilize 48% of the cPAD. There are no residential 
uses for cymoxanil.
    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). Cymoxanil is not 
registered for any use patterns that would result in residential 
exposure. Therefore, the short- or intermediate-term aggregate risk is 
the sum of the risk from exposure to cymoxanil through food and water 
and will not be greater than the chronic aggregate risk.
    4. Cancer. Because cymoxanil was not carcinogenic in rats and mice, 
EPA concludes that the cancer risk to humans from exposure to cymoxanil 
is negligible.
    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 cymoxanil residues.

[[Page 58885]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography with ultra violet detection (HPLC/UV) and HPLC/MS (mass 
spectroscopy)) is available to enforce the tolerance expression. The 
method may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX maximum residue levels established for cymoxanil 
on any of the commodities for which the tolerances are being 
established.

C. Response to Comments

    Comments were submitted by a private citizen who opposed the 
establishment of cymoxanil tolerances for the following reasons:
     1. The availability of numerous products previously registered for 
the same purpose as the new uses of cymoxanil supported by these 
tolerances, and
     2. Cymoxanil is toxic to aquatic plants, bees, and birds, and 
therefore has potentially harmful effects on the environment.
These comments are considered irrelevant because the safety standard 
for approving tolerances under section 408 of the FFDCA focuses on 
potential harm to human health and does not permit consideration of 
effects on the environment or the availability of other registered 
products. Environmental effects were closely considered in EPA's 
decision to register cymoxanil under the Federal Insecticide, 
Fungicide, and Rodenticide Act.

D. Revisions to Petitioned-For Tolerances

    Because there is a wide variability in the field trial residues, 
EPA has concluded that a group tolerance for bulb vegetables is not 
supported by the available data. Therefore, EPA has determined that the 
proposed tolerance level for bulb vegetables of 1.1 ppm should be 
revised as follows: Bulb onion subgroup 3-07A at 0.05 ppm; green onion 
subgroup 3-07B at 1.1 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of cymoxanil, 
(2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) acetamide), in or on 
bulb onion subgroup 3-07A at 0.05 ppm; green onion subgroup 3-07B at 
1.1 ppm; leafy vegetables subgroup 4A at 19 ppm; cilantro leaves at 19 
ppm; leaf petioles subgroup 4B at 6.0 ppm; and caneberry subgroup 13-
07A at 4.0 ppm. Additionally, the existing entries for ``Caneberry'' 
and ``Lettuce, head'' are deleted.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: September 29, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs

0
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. Section 180.503 is amended in paragraph (a) by revising the 
introductory text, and in the table, by removing the entry for 
``Lettuce, head'', revising the entry for ``Caneberry'' and 
alphabetically adding the following commodities to read as follows:


Sec. 180.503  Cymoxanil; tolerances for residues

    (a) General. Tolerances are established for residues of the 
fungicide, cymoxanil, 2-cyano -N- [(ethylamino)carbonyl]-2-

[[Page 58886]]

(methoxyimino) acetamide, in or on the following food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Caneberry, subgroup 13A-07...........................                4.0
Cilantro, leaves.....................................                 19
                                * * * * *
Leafy greens, subgroup 4A............................                 19
Leaf petioles, subgroup 4B...........................                6.0
                                * * * * *
Onion, bulb, subgroup 3-07A..........................               0.05
Onion, green, subgroup 3-07B.........................                1.1
                                * * * * *
------------------------------------------------------------------------


* * * * *
[FR Doc. E8-23864 Filed 10-7-08; 8:45 am]

BILLING CODE 6560-50-S
