

[Federal Register: July 11, 2007 (Volume 72, Number 132)]
[Rules and Regulations]               
[Page 37641-37646]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy07-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0331; FRL-8130-5]

 
Cymoxanil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cymoxanil in or on grape, hop, and caneberry. The Interregional 
Research Project (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 11, 2007. Objections and 
requests for hearings must be received on or before September 10, 2007, 
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-2006-0331. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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 Building), 2777 S. Crystal Drive, 
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: Shaja R. Brothers, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
brothers.shaja@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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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

[[Page 37642]]

be affected. The North American 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 an electronic copy of this Federal 
Register document through the electronic docket 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 the FFDCA, 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-2006-0331 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 September 10, 2007.
    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-2006-0331, 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 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 May 10, 2006, (71 FR 27247) (FRL-8067-
5), and November 15, 2006, (71 FR 66522) (FRL-8101-8) EPA issued 
notices pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of pesticide petitions PP 5E7000 
(grape and hop), and PP 6E7100 (caneberry) by the IR-4, 500 College 
Road East, Suite 201 W, Princeton, NJ 08540. The petitions requested 
that 40 CFR 180.503(a) be amended by establishing tolerances for 
residues of the fungicide cymoxanil, in or on grape (east of the Rocky 
Mountains) at 1.0 parts per million (ppm); hop, dried cones at 5.0 ppm; 
and caneberry at 4.0 ppm. These notices referenced a summary of the 
petitions prepared by Dupont, the registrant, which is available to the 
public in the docket, http://www.regulations.gov. Comments were 

received from a private citizen on the notice of filing for grape; and 
hop, dried cones. EPA's response to comment is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the 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 the 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 the 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....'' These provisions were added to the FFDCA by the Food 
Quality Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of the FFDCA, and the factors 
specified in 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 the petitioned-for tolerance 
for residues of cymoxanil on grape at 0.10 ppm; hop, dried cone at 7.0 
ppm; and caneberry at 4.0 ppm. EPA's assessment of exposures and risks 
associated with establishing these tolerances follow.

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-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
 The referenced document is available in the docket 

established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2006-0331 in that docket. Please refer to the 
Human Health Risk Assessment for Cymoxanil for New section 3 Uses in/on 
Grapes (East of the Rocky Mountains); Hop, dried cones; and Caneberry 
Subgroup 13A on pages 16-19.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from 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) is 
sometimes used for risk assessment. Uncertainty/safety factors (UF) are 
used in conjunction with the LOC 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

[[Page 37643]]

unknowns. Safety is assessed for acute and chronic risks by comparing 
aggregate 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 LOC by all applicable 
uncertainty/safety factors. Short-term, intermediate, and long-term 
risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the margin of exposure (``MOE'') called for by the product 
of all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for cymoxanil used for 
human risk assessment can be found at http://www.regulations.gov in the Human 

Health Risk Assessment for Cymoxanil for New section 3 Uses in/on 
Grapes (East of the Rocky Mountains); Hop, dried cone; and Caneberry 
Subgroup 13A, pages 19-20 in Docket ID EPA-HQ-OPP-2006-0331.

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(a)). 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 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. 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 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 for grape juice and raisin.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Nationwide CSFII. As to residue levels in food, EPA used 
tolerance level residues for all commodities except lettuce, hops and 
grapes. Average residues from field trials were used for lettuce, hops 
and grapes. DEEM 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. Exposure 
estimates were further refined using screening-level PCT (% CT) data 
for several registered commodities. For all other commodities, 
including the proposed new uses, 100 %CT was assumed.
    iii. Cancer. EPA has classified cymoxanil as a ``not likely'' human 
carcinogen. Therefore, a cancer dietary exposure analysis was not 
performed.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the 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 pursuant to section 408(f)(1) 
require 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 section 
408(b)(2)(E) of the FFDCA and authorized under section 408(f)(1) of the 
FFDCA. Data will be required to be submitted no later than 5 years from 
the date of issuance of this tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if:
    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 
such pesticide residue;
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group; and
    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 section 408(b)(2)(F) 
of the FFDCA, 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%.
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available federal, state, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of five percent except for those situations in which 
the average PCT is less than one. In those cases < 1% is used as the 
average and < 2.5% is used as the maximum. EPA uses a maximum PCT for 
acute dietary risk analysis. The maximum PCT figure is the single 
maximum value reported overall from available federal, state, and 
private market survey data on the existing use, across all years, and 
rounded up to the nearest multiple of five percent. In most cases, EPA 
uses available data from USDA/National Agricultural Statistics Service 
(USDA/NASS), Proprietary Market Surveys, and the National Center for 
Food and Agriculture Policy (NCFAP) for the most recent six years.
    The Agency believes that the three conditions have been met. With 
respect to Condition 1, 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 2 and 
3, 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 
information on the regional consumption of food to which cymoxanil may 
be applied in a particular area.

[[Page 37644]]

    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for cymoxanil in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate 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
.

    The Agency calculated screening level surface and ground water 
estimates for cymoxanil using FQPA Index Reservoir Screening Tool 
(FIRST (version 1.0)), and SCI-GROW (Screening Concentration In GROund 
Water) models, respectively. The proposed application rates for use on 
grape and hop are higher than the rates evaluated previously. Estimated 
drinking water concentrations were estimated based on the newly 
proposed application rate for grape (0.25 lbs per acre, 10 times), 
which was the highest application rate reported for the new proposed 
uses.
    Based on the FIRST and SCI-GROW models, the estimated environmental 
concentrations (EECs) of cymoxanil for acute and chronic exposures are 
0.019 parts per billion (ppb), and 0.0001 ppb, respectively for surface 
water. The EECs for groundwater (acute and chronic) are estimated to be 
0.000003 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 0.019 ppb was used to 
access the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.0001 ppb was used to 
access 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 use on any sites that would result in residential 
exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to cymoxanil and 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 not assumed that cymoxanil has 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 of the FFDCA provides that EPA shall 
apply an additional (``10X'') tenfold 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional uncertainty/safety 
factors and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is an indication of 
increased susceptibility (qualitative and quantitative) of rats and 
rabbits to in utero exposure to cymoxanil. In the rat developmental 
toxicity study, decreased fetal body weights and skeletal malformations 
were observed at 25 mg/kg/day LOAEL, which is below the maternal 
toxicity of 75 mg/kg/day LOAEL. In the rabbit developmental study 
increased skeletal malformations were observed at 8 mg/kg/day LOAEL, 
also below the maternal NOAEL of 32 mg/kg/day. In the 2-generation 
reproduction study there was an indication of increased qualitative 
susceptibility in the offspring, since there was decreased pup 
viability at a dose that produced less severe effects in maternal 
animals.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for the infants and children FQPA safety factor to be 
reduced to 1X for acute dietary exposures. The EPA believes that this 
will be protective of infants and children based on the following 
findings:
    i. The toxicity database for cymoxanil is complete for dietary risk 
assessment.
    ii. Although there is qualitative evidence of increased 
susceptibility in the prenatal developmental studies in rats and 
rabbits, the risk assessment team did not identify any residual 
uncertainties 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, tolerance-level residues, and DEEM default processing 
factors for all registered and proposed commodities. Conservative 
ground and surface water modeling estimates were also used and 
incorporated directly in the DEEM analysis. The Agency has determined 
with reasonably certainty that the identified assessment will not 
underestimate the exposure and risks posed by cymoxanil. However, the 
10X FQPA safety factor was retained for chronic dietary exposure 
because a LOAEL was used to extrapolate a NOAEL for the chronic 
toxicity study in the dog.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate 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 LOC by all applicable 
uncertainty/safety factors. For linear cancer risks, EPA calculates the 
probability of additional cancer cases given aggregate exposure. Short-
term, intermediate, and long-term risks are evaluated by comparing 
aggregate exposure to the LOC to ensure that the margin of exposure 
(``MOE'') called for by the product of all applicable uncertainty/
safety factors is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to cymoxanil will occupy 72% of the aPAD for the population group 
(females 13-49 years old).
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded

[[Page 37645]]

that exposure to cymoxanil from food and water will utilize 51% of the 
cPAD for children 1-2 years old, the subpopulation group with greatest 
exposure. There are no residential uses for cymoxanil that result in 
chronic residential exposure to cymoxanil.
    3. Short and intermediate-term risks. Short and Intermediate-term 
aggregate exposures takes into account residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level). Cymoxanil is not registered for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which do not exceed the 
Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. EPA has classified 
cymoxanil as a ``not likely'' human carcinogen. Therefore, cymoxanil is 
not expected to pose a cancer risk.
    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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (high performance liquid 
chromatography with ultra violet detection (HPLC/UV) and (HPLC/MS) 
using (mass spectroscopy) on grape, caneberry, and hop, respectively) 
are available to enforce the tolerance expression. The methods 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 for CODEX maximum residue levels established for 
cymoxanil on grape; hop, dried cone; and caneberry.

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 in which the new cymoxanil tolerances are intended, 
and
    2. Cymoxanil is toxic to aquatic plants, bees, and birds, and 
therefore has potential 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 harms to human health and does not permit consideration of 
effects on the environment or the availability of other registered 
products.

V. Conclusion

    The proposed hop, dried cone tolerance was revised from 5.0 to 7.0 
ppm based on submitted field trial residues. For grape, the proposed 
tolerance of 1.0 was lowered to 0.10 ppm. The residue field trials 
indicate 0.10 ppm as the appropriate regional tolerance for grape. 
Therefore, tolerances are established for residues of cymoxanil, 2-
cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) acetamide in or on 
grape (east of the Rocky Mountains) at 0.10 ppm; hop, dried cone at 7.0 
ppm; and caneberry at 4.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 the 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 the 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 6, 
2000) do not apply to this rule. In addition, This 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: July 3, 2007.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 37646]]

PART 180--[AMENDED]

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

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

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2. Section 180.503 is amended by revising the table in paragraph (a); 
and by adding text to paragraph (c) to read as follows:


Sec.  180.503  Cymoxanil, tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Caneberry............................................                4.0
Hop, dried cones.....................................                7.0
Lettuce, head........................................                4.0
Lychee\1\............................................                1.0
Potato...............................................               0.05
Vegetable, cucurbit, group 9.........................               0.05
Vegetable, fruiting, group 8.........................                0.2
------------------------------------------------------------------------
\1\ There is no U.S. registration for lychee.

* * * * *
    (c) Tolerances with a regional registration. Tolerances with a 
regional registration as defined in Sec.  180.1(n) are established for 
the residues of the fungicide cymoxanil, 2-cyano -N- 
[(ethylamino)carbonyl]-2-(methoxyimino) acetamide) in or on the raw 
agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Grape................................................               0.10
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-13419 Filed 7-10-07; 8:45 am]

BILLING CODE 6560-50-S
