Document ID: EPA-HQ-OPP-2010-0385-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Cyprodinil
Posted Date: 2011-02-02T05:00Z

[Federal Register Volume 76, Number 22 (Wednesday, February 2, 2011)]
[Rules and Regulations]
[Pages 5691-5696]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2157]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0385; FRL-8860-3]

Cyprodinil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends tolerances for residues of cyprodinil 
in or on fruit, pome, group 11 and apple wet pomace. This regulation 
also establishes tolerances for meat byproducts of cattle, goats, 
horses and sheep. Syngenta Crop Protection requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 2, 2011. Objections and 
requests for hearings must be received on or before April 4, 2011, 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-2010-0385. 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: Lisa Jones, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9424; e-mail address: jones.lisa@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 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.

[[Page 5692]]

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://www.gpoaccess.gov/ecfr.

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-2010-0385 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 
April 4, 2011. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0385, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of June 8, 2010 (75 FR 32466) (FRL-8827-5), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 0F7696) 
by Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC 27409. The 
petition requested that 40 CFR 180.532 be amended by raising tolerances 
for residues of the fungicide cyprodinil, in or on fruit, pome, group 
11 from 0.1 parts per million (ppm) to 1.7 ppm. That notice referenced 
a summary of the petition prepared by Syngenta Crop Protection, 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 
increased the tolerance for apple, wet pomace from 0.15 ppm to 4.6 ppm. 
EPA has also established tolerances for meat byproducts of cattle, 
goats, horses, and sheep at 0.02 ppm. 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 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 cyprodinil including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with cyprodinil 
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.
    Cyprodinil has low acute toxicity via the oral, dermal, and 
inhalation routes. Cyprodinil is mildly irritating to the eyes and 
negligibly irritating to the skin. It is a dermal sensitizer. The major 
target organs of cyprodinil are the liver in both rats and mice and the 
kidney in rats. Liver effects observed consistently in subchronic and 
chronic studies in rats and mice include increased liver weights, 
increases in serum clinical chemistry parameters associated with 
adverse effects on liver function, hepatocyte hypertrophy, and 
hepatocellular necrosis. Adverse kidney effects include tubular lesions 
and inflammation following subchronic exposure of male rats. The 
hematopoietic system also appeared to be a target of cyprodinil, 
causing mild anemia in rats exposed subchronically. Chronic effects in 
dogs were limited to decreased body-weight gain, decreased food 
consumption and decreased food efficiency. There was no evidence of 
increased susceptibility in the developmental rat or rabbit study 
following in utero exposure or in the 2-generation reproduction study 
following prenatal or postnatal exposure. There was no evidence of 
neuropathological or other neurological effects in the available 
subchronic neurotoxicity study. The results of a preliminary 
immunotoxicity study provided no evidence for immunotoxicity. There was 
no evidence of carcinogenic potential in either the rat chronic 
toxicity/carcinogenicity or mouse carcinogenicity studies.

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 (LOC) 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

[[Page 5693]]

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 cyprodinil used for 
human risk assessment is discussed in Unit III.A of the final rule 
published in the Federal Register of April 28, 2010 (75 FR 22242) (FRL-
8818-8).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyprodinil, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyprodinil tolerances in 40 CFR 
180.532. EPA assessed dietary exposures from cyprodinil 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. Such effects were identified 
for cyprodinil. In estimating acute dietary exposure, EPA used the 
Dietary Exposure Evaluation Model-Food Consumption Intake Database 
(DEEM-FCIDTM, Version 2.03), which uses food consumption 
data from the U. S. Department of Agriculture (USDA) Continuing Surveys 
of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. As to 
residue levels in food, EPA performed a screening level acute dietary 
exposure analysis for the population subgroup females 13 to 49 only. No 
acute endpoint was identified for the remaining population subgroups. 
Tolerance level residues and 100 percent crop treated (PCT) assumptions 
were used. DEEM default and empirical processing factors were used to 
modify the tolerance values.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the DEEM-FCIDTM, Version 2.03, which 
uses food consumption data from the USDA 1994-1996 and 1998 CSFII. A 
moderately refined chronic dietary exposure analysis was performed for 
the general U.S. population and various population subgroups. Average 
field trial residues for pome fruit, tolerance level residues for the 
remaining commodities, and 100 PCT assumptions were used. DEEM default 
and empirical processing factors were used.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or non-linear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or non-linear approach is used and a cancer RfD is calculated 
based on an earlier non-cancer key event. If carcinogenic mode of 
action data are not available, or if the mode of action data determine 
a mutagenic mode of action, a default linear cancer slope factor 
approach is utilized. Data summarized in Table 2 of the document 
``Human Health Risk--Cyprodinil Increased Pome Fruit Tolerance'', pp. 
24 through 29, in docket ID number EPA-HQ-OPP-2010-0385 at http://www.regulations.gov, showed no evidence of carcinogenic potential in 
either the rat chronic toxicity/carcinogenicity or mouse 
carcinogenicity studies. EPA therefore concluded that cyprodinil does 
not pose a cancer risk to humans. Therefore a dietary exposure 
assessment for the purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (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.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for cyprodinil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cyprodinil. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models the estimated drinking water concentrations (EDWCs) of 
cyprodinil for acute exposures are 34.79 parts per billion (ppb) for 
surface water and 0.0861 ppb for ground water and for chronic exposures 
for non-cancer assessments are estimated to be 24.65 ppb for surface 
water and 0.0861 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 34.79 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 24.65 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). Cyprodinil 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 cyprodinil to share a common mechanism of 
toxicity with any other substances, and cyprodinil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyprodinil 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

[[Page 5694]]

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. The database is considered 
adequate for selection of study endpoints and determination of a dose/
response to characterize the potential prenatal or postnatal toxicity 
of cyprodinil to infants and children. No increase in susceptibility 
was seen in developmental toxicity studies in rat and rabbit or 
reproductive toxicity studies in the rat. Toxicity to offspring was 
observed at dose levels the same or greater than those causing maternal 
or parental toxicity. Based on the results of developmental and 
reproductive toxicity studies, there is not a concern for increased 
qualitative and/or quantitative susceptibility following in utero 
exposure to cyprodinil.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X . That decision is based on the following 
findings:
    i. The toxicology database for cyprodinil is largely complete, 
missing only the recently-required acute neurotoxicity study and the 
functional immunotoxicity study. EPA has determined that an additional 
uncertainty factor is not needed to account for the lack of these 
studies for the following reasons:
    The functional immunotoxicity study for cyprodinil is not expected 
to alter the RfD. A preliminary immunotoxicity study was submitted. The 
study did not meet all requirements, but is considered Upgradeable/
Guideline. The registrant must either submit a required Natural Killer 
cell activity assay or provide justification that it is not needed. 
Otherwise, the results of the preliminary study provided no evidence of 
immunotoxicity. Specifically, there were no treatment-related effects 
on absolute, adjusted, or relative spleen or thymus weights; no effects 
on specific activity or total activity of splenic IgM antibody-forming 
cells to the T cell-dependent antigen sRBC. There is no evidence in the 
other existing studies that cyprodinil targets the immune system. No 
other immunotoxicity studies have been submitted.
    The acute neurotoxicity study is not expected to alter the RfD for 
cyprodinil because the available data show no evidence of neurotoxic 
potential for cyprodinil. The NOAEL from an acute study is unlikely to 
be appreciably lower than the NOAEL of 600 mg/kg/day from the 
subchronic neurotoxicity study. Neurotoxicity was not observed in 
subchronic neurotoxicity study or the prenatal developmental toxicity 
studies in rats and rabbits.
    ii. A developmental neurotoxicity study is not required. As noted, 
the available data show no evidence of neurotoxic potential for 
cyprodinil.
    iii. There is no evidence that cyprodinil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessments were performed 
based on 100 PCT and tolerance-level residues. The chronic dietary food 
exposure assessments were performed based on average field trial 
residues for pome fruit, tolerance level residues for the remaining 
commodities, and 100 PCT assumptions. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to cyprodinil in drinking water. These assessments 
will not underestimate the exposure and risks posed by cyprodinil.

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 population adjusted dose (aPAD) and chronic population adjusted 
dose (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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to cyprodinil will occupy 4% of the aPAD for females 13 to 49 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyprodinil from food and water will utilize 86% of the cPAD for 
children 1 to 2 years old the population group receiving the greatest 
exposure.
    3. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyprodinil is not expected to pose a cancer risk to humans.
    4. 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 cyprodinil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate High Performance Liquid Chromatography, using ultra-violet 
detection (HPLC/UV) methods with column switching (Syngenta Methods AG-
631 and AG-631B) are available for enforcing tolerances of cyprodinil 
on plant commodities. The level of quantitation (LOQs) for these 
methods range from 0.01 to 0.05 ppm depending on the plant commodities. 
Method AG-631B also contains procedures for confirmatory analysis by 
gas chromatography with nitrogen phosphorus detection (GC/NPD).
    An adequate HPLC/mass spectrometry method (GRM010.01A) is also 
available for enforcing tolerances in livestock commodities. This 
method determines residues of both parent and the metabolite CGA-304075 
(free and conjugated), expressed as parent. The LOQ is 0.01 ppm for 
each analyte for a combined LOQ of 0.02 ppm.
    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

    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

[[Page 5695]]

(MRLs) established by the Codex Alimentarius Commission (Codex), as 
required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 
U.N. 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 established MRLs for residues of cyprodinil in/on 
apple (0.05 mg/kg, the LOQ) and pear (1 mg/kg). There is also a 
currently established Canadian MRL for residues of cyprodinil in/on 
pome fruit (0.1 ppm); but none is established in Mexico. It is not 
possible to harmonize with Codex and Canadian MRLs for residues of 
cyprodinil in/on pome fruit commodities because the proposed use in the 
United States results in residue levels greater than the Codex and 
Canadian MRLs due to the shorter preharvest interval in the United 
States.

C. Revisions to Petitioned-For Tolerances

    Based on the submitted apple field trial and available apple 
processing data, the currently established tolerance for residues of 
cyprodinil in apple wet pomace will need to be increased from 0.15 ppm 
to 4.6 ppm to cover the proposed amended uses of cyprodinil on pome 
fruit. Additionally, the Agency has determined the currently 
established 0.02 ppm tolerance level for meat byproducts of cattle, 
goats, horses, and sheep are adequate but the currently established 
tolerance expression for livestock commodities should be changed to 
reflect measurements of both parent and metabolite CGA-304075.

V. Conclusion

    Therefore, tolerances are established for residues of cyprodinil, 
in or on pome fruit at 1.7 ppm and in apple wet pomace at 4.6 ppm. 
Tolerances are also established for cyprodinil and (free and 
conjugated) CGA-304075, expressed in parent equivalents on meat 
byproducts of cattle, goats, horses, and sheep at 0.02 ppm.

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) (Pub. L. 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: January 24, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.532 is amended by revising paragraph (a) to read:

Sec.  180.532  Cyprodinil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide cyprodinil, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only cyprodinil 
4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond.....................................................         0.02
Almond, hulls..............................................         8.0
Apple, wet pomace..........................................         4.6
Avocado....................................................         1.2
Bean, dry..................................................         0.6
Bean, succulent............................................         0.6
Brassica, head and stem, subgroup 5A.......................         1.0
Brassica, leafy greens, subgroup 5B........................        10.0

[[Page 5696]]

 
Bushberry subgroup 13B.....................................         3.0
Caneberry subgroup 13A.....................................        10
Canistel...................................................         1.2
Canola, seed \1\...........................................         0.03
Citrus, dried pulp.........................................         8.0
Citrus, oil................................................       340
Fruit, pome................................................         1.7
Fruit, stone...............................................         2.0
Grape......................................................         2.0
Grape, raisin..............................................         3.0
Herb subgroup 19A, dried, except parsley...................        15.0
Herb subgroup 19A, fresh, except parsley...................         3.0
Juneberry..................................................         3.0
Kiwifruit..................................................         1.8
Leafy greens subgroup 4A, except spinach 35................        30
Lemon......................................................         0.60
Lime.......................................................         0.60
Lingonberry................................................         3.0
Longan.....................................................         2.0
Lychee.....................................................         2.0
Mango......................................................         1.2
Onion, bulb................................................         0.60
Onion, green...............................................         4.0
Papaya.....................................................         1.2
Parsley, dried leaves......................................       170
Parsley, leaves............................................        35
Pistachio..................................................         0.10
Pulasan....................................................         2.0
Rambutan...................................................         2.0
Salal......................................................         3.0
Sapodilla..................................................         1.2
Sapote, black..............................................         1.2
Sapote, mamey..............................................         1.2
Spanish lime...............................................         2.0
Star apple.................................................         1.2
Strawberry.................................................         5.0
Tomatillo..................................................         0.45
Tomato.....................................................         0.45
Tomato, paste..............................................         1.0
Turnip, greens.............................................        10.0
Vegetable, cucurbit, group 9...............................         0.70
Vegetable, leaves of root and tuber, group 2...............        10
Vegetable, root, except sugarbeet, subgroup 1B 41..........         0.75
Watercress.................................................        20
------------------------------------------------------------------------
\1\ Import only.

    (2) Tolerances are established for residues of the fungicide 
cyprodinil, including its metabolites and degradates, in the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
cyprodinil 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine and free 
and conjugated CGA-304075 4-(4-cyclopropyl-6-methyl-pyrimidin-2-
ylamino)-phenol, calculated as the stoichiometric equivalent of 
cyprodinil.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts.....................................        0.02
Goat, meat byproducts.......................................        0.02
Horse, meat byproducts......................................        0.02
Sheep, meat byproducts......................................        0.02
------------------------------------------------------------------------

* * * * *

[FR Doc. 2011-2157 Filed 2-1-11; 8:45 am]
BILLING CODE 6560-50-P