
[Federal Register: August 27, 2008 (Volume 73, Number 167)]
[Rules and Regulations]               
[Page 50548-50553]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au08-3]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1069; FRL-8377-8]

 
Cyprodinil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on 
tomato; tomatillo; tomato, paste; avocado; sapote, black; canistel; 
sapote, mamey; mango; papaya; sapodilla; star apple; parsley, leaves; 
parsley, dried leaves; vegetable, leaves of root and tuber, group 2; 
vegetable, root, except sugarbeet, subgroup 1B; lemon; lime; citrus, 
dried pulp; citrus, oil; kiwifruit; onion, bulb; onion, green; 
strawberries; vegetable, cucurbit, group 9; and meat byproducts of 
cattle, goats, horses and sheep. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 27, 2008. Objections and 
requests for hearings must be received on or before October 27, 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-2007-1069. 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 website 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 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 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 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-2007-1069 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 October 27, 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-2007-1069, 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'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 January 23, 2008 (73 FR 3964) (FRL-8345-
7), 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 
7E7235) by Interregional, Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 
40 CFR 180.532 be

[[Page 50549]]

amended by establishing tolerances for residues of the fungicide 
cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on 
the food commodities tomato at 0.40 parts per million (ppm); tomatillo 
at 0.40 ppm; tomato, paste at 1.0 ppm; avocado at 1.2 ppm; sapote, 
black at 1.2 ppm; canistel at 1.2 ppm; sapote, mamey at 1.2 ppm; mango 
at 1.2 ppm; papaya at 1.2 ppm; sapodilla at 1.2 ppm; star apple at 1.2 
ppm; herbs subgroup19A, fresh at 25 ppm; herbs subgroup 19A, dried at 
170 ppm; vegetable, root and tuber, group, leaves at 9.0 ppm; 
vegetable, root, except sugarbeet subgroup at 0.60 ppm; lemon at 0.6 
ppm; lime at 0.6 ppm; kiwifruit at 1.8 ppm; onion, dry bulb at 0.50 
ppm; onion, green at 1.2 ppm; strawberry at 7.0 ppm; and cucurbits at 
0.40 ppm. That notice referenced a summary of the petition prepared by 
IR-4, the registrant, which is available to the public in the docket, 
http://www.regulations.gov. Comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
revising some of the items as proposed in this Unit. The reason for 
these changes is 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 cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-
2-pyrimidinamine on tomato; tomatillo; tomato, paste; avocado; sapote, 
black; canistel; sapote, mamey; mango; papaya; sapodilla; star apple; 
parsley, leaves; parsley, dried leaves; vegetable, leaves of root and 
tuber, group 2; vegetable, root, except sugarbeet, subgroup 1B; lemon; 
lime; citrus, dried pulp; citrus, oil; kiwifruit; onion, bulb; onion, 
green; strawberries; vegetable, cucurbit, group 9; and meat byproducts 
of cattle, goats, horses and sheep. EPA's assessment of exposures and 
risks associated with establishing 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.
    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 were consistent among male and female 
rats and mice in both subchronic and chronic studies and typically 
included increased liver weights along with increases in serum clinical 
chemistry parameters associated with adverse effects on liver function 
(i.e., increased cholesterol and phospholipid levels). Microscopic 
lesions in rats and mice included hepatocyte hypertrophy and 
hepatocellular necrosis. In the kidneys, adverse effects were 
manifested as chronic tubular lesions and chronic kidney inflamation 
following subchronic exposure of male rats. Chronically, cyprodinil 
caused increased kidney weights and progressive nephropathy in male 
rats. Chronic effects in dogs were limited to decreased body-weight 
gain, decreased food consumption and decreased food efficiency. Liver 
toxicity was not seen in the dog. The hematopoietic system also 
appeared to be a target of cyprodinil, causing mild anemia in rats 
exposed subchronically. There was no evidence of carcinogenic potential 
in either the rat chronic toxicity/carcinogenicity or mouse 
carcinogenicity studies and no concern for mutagenicity. 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. No clinical signs of 
toxicity suggestive of neurobehavioral alterations nor evidence of 
neuropathological effects were observed in the available oral-toxicity 
studies. There was also no evidence of a neurodevelopmental effect in 
the rat or rabbit developmental toxicity studies or in the rat 2-
generation reproductive-toxicity study.
    Specific information on the studies received and the nature of the 
adverse effects caused by cyprodinil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document Cyprodinil Human Health Risk Assessment 
for the uses in/on tomato, avocado, herbs, root vegetables, leaves of 
root and tuber vegetables, lemon, lime, cucurbits, kiwifruit, green and 
dry bulb onions, and strawberries, page 16 in docket ID number EPA-HQ-
OPP-2007-1069.

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 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 the LOAEL of concern are identified 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-
term, intermediate-term, 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).

[[Page 50550]]

    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 cyprodinil used for 
human risk assessment can be found at http://www.regulations.gov in 
document Cyprodinil Human Health Risk Assessment for the uses in/on 
tomato, avocado, herbs, root vegetables, leaves of root and tuber 
vegetables, lemon, lime, cucurbits, kiwifruit, green and dry bulb 
onions, and strawberries, page 22 in docket ID number EPA-HQ-OPP-2007-
1069.

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.
    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 used tolerance-
level residues, DEEM default processing factors and assumed 100 percent 
crop treated (PCT) for all existing and proposed commodities.
    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, DEEM default processing factors, and assumed 100 PCT for all 
existing and proposed commodities.
    iii. Cancer An aggregate exposure assessment for the purpose of 
assessing cancer risk was not performed because cyprodinil has been 
classified as ``not likely to be carcinogenic to humans.''
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for cyprodinil. Tolerance level residues and 100 PCT were assumed for 
all existing and proposed food commodities.
    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.
    For surface water the Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) Tier 2 aquatic models were used, and for 
ground water, the Tier 1 aquatic model Screening Concentration in 
Ground Water (SCI-GROW) was utilized. For the assessment, maximum 
application rates and minimum intervals between applications were used. 
The Agency has concluded that the transformation product CGA-249287 of 
cyprodinil is of potential concern for drinking water sources. 
Therefore, estimated drinking water concentrations (EDWCs) of CGA-
249287 were also simulated using the PRZM/EXAMS and SCI-GROW models. 
For surface water, this degradate was modeled individually, as opposed 
to the use of the total residue approach due to the fact that only one 
degradate was modeled and sufficient information was available for the 
modeling.
    Based on the Tier 2 PRZM/EXAMS and the Tier 1 SCI-GROW models, the 
EDWCs of cyprodinil and its transformation product CGA-249287 for acute 
exposures are estimated to be 34.56 parts per billion (ppb) for surface 
water and 0.108 ppb for ground water. For chronic exposures for non-
cancer assessments the concentrations are estimated to be 20.05 ppb for 
surface water and 0.108 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 34.56 ppb was used to 
assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 20.05 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).
    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 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 (MOS) 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 MOS 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 SF when reliable data available 
to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There are no concerns or 
residual uncertainties for prenatal and/or postnatal exposure.
    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 toxicity database for cyprodinil is complete.
    ii. There is no indication that cyprodinil is a neurotoxic chemical 
and

[[Page 50551]]

there is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity.
    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. EPA made conservative (protective) assumptions in the ground 
water and surface water modeling used to assess exposure to cyprodinil 
in drinking water. EPA used similarly conservative assumptions to 
assess postapplication exposure of children as well as incidental oral 
exposure of toddlers. 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 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-term, intermediate-term, 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. 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 13-49 years old, 
the only population group of concern.
    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 67% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for cyprodinil.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Cyprodinil is not registered for any use patterns that would result 
in residential exposure. Therefore, the short-term aggregate risk is 
the sum of the risk from exposure to cyprodinil through food and water 
and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Cyprodinil is not registered for any use patterns that would result 
in intermediate-term residential exposure. Therefore, the intermediate-
term aggregate risk is the sum of the risk from exposure to cyprodinil 
through food and water, which has already been addressed, and will not 
be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in mice and rats at doses that were judged 
to be adequate to assess the carcinogenic potential, cyprodinil was 
classified as ``not likely to be carcinogenic to humans.'' Therefore, 
cyprodinil is not expected to pose a cancer risk to humans.
    6. 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 enforcement methodology (high performance liquid 
chromatography with ultraviolet detector (HPLC/UV)) is available to 
enforce the tolerance expression on plant commodities. In addition, a 
high performance liquid chromatography with mass spectrometry (HPLC/MS) 
method (Method No. GRM010.01A) is available for determining residues of 
cyprodinil and its metabolite CGA-304075 (free+conjugated) in livestock 
commodities. These 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 established or proposed Canadian or Mexican MRLs for 
cyprodinil on any of the plant commodities of interest in these 
petitions. There are Codex MRLs for tomato, bulb onion, cucurbit, and 
summer squash. Tomato has a proposed tolerance of 0.45 ppm and a Codex 
MRL of 0.5 ppm, therefore no change in the tolerance is necessary for 
harmonization purposes. The Codex MRLs for bulb onion at 0.3 ppm (vs 
4.0 ppm for green onion and 0.60 ppm for dry bulb onion), cucurbit at 
0.2 ppm (vs 0.70 ppm for cucurbit vegetables), and summer squash at 0.2 
ppm (vs 1.0 ppm for head and stem Brassica, 5A) were established based 
on application levels from 0.21 to 0.26x the domestic rate. 
Harmonization of U.S. tolerances on these commodities is not possible 
at this time.
    Codex MRLs have been established for livestock commodities, and 
these MRLs are set at the method LOQ. For both the Canadian and Codex 
MRLs, the regulated residues include cyprodinil per se. As the U.S. 
definition for cyprodinil residues in livestock commodities is 
different than those established for Canada and Codex, harmonization of 
U.S. tolerances on livestock commodities is not possible at this time.

C. Response to Comments

    EPA received one comment to the Notice of Filing that had a general 
objection to ``this product being allowed on food.'' The comment 
contained no scientific data or other substantive evidence to rebut 
this conclusion or the Agency's finding that there is a reasonable 
certainty that no harm will result from aggregate exposure to 
cyprodinil from the establishment of these tolerances. The Agency has 
received these same or similar comments from this commenter on numerous 
previous occasions. Refer to Federal Register 70 FR 37686 (June 30, 
2005), 70 FR 1354 (January 7, 2005), and 69 FR 63096 (October 29, 2004) 
for the Agency's previous responses to these objections.

D. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petitions, EPA 
determined that separate tolerances are needed for fresh parsley at 35 
ppm; dried parsley at 170 ppm; citrus, dry pulp at 8.0 ppm; citrus, oil 
at 340 ppm; and meat byproducts of cattle, goats, horses and sheep at 
0.02 ppm. EPA is establishing those tolerances in this action. In 
addition, EPA revised the tolerances for tomato from 0.40 ppm to 0.45 
ppm; tomatillo from 0.40 ppm to 0.45 ppm; herb subgroup 19A fresh from 
25 ppm to 3 ppm and re-naming herb subgroup 19A fresh, except parsley; 
herb subgroup 19A dried from 170 ppm to 15 ppm and re-naming herb 
subgroup 19A, dried, except parsley; leaves of root and tuber 
vegetables from 9.0 ppm to 10 ppm; root vegetables, except sugar

[[Page 50552]]

beet subgroup from 0.60 ppm to 0.75 ppm; cucurbits from 0.40 to 0.70 
ppm. EPA revised these tolerance levels based on analyses of the 
residue field trial data using the Agency's Tolerance Spreadsheet in 
accordance with the Agency's Guidance for Setting Pesticide Tolerances 
Based on Field Trial Data.

V. Conclusion

    Therefore, tolerances are established for residues of cyprodinil, 
4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on the food 
commodities tomato at 0.45 ppm; tomatillo at 0.45 ppm; tomato, paste at 
1.0 ppm; avocado at 1.2 ppm; sapote, black at 1.2 ppm; canistel at 1.2 
ppm; sapote, mamey at 1.2 ppm; mango at 1.2 ppm; papaya at 1.2 ppm; 
sapodilla at 1.2 ppm; star apple at 1.2 ppm; parsley, leaves at 35 ppm; 
parsley, dried leaves at 170 ppm; vegetable, leaves of root and tuber, 
group 2 at 10 ppm; vegetable, root, except sugarbeet, subgroup 1B at 
0.75 ppm; lemon at 0.60 ppm; lime at 0.60 ppm; citrus, dried pulp at 
8.0 ppm; citrus, oil at 340 ppm; kiwifruit at 1.8 ppm; onion, bulb at 
0.60 ppm; onion, green at 4.0 ppm; strawberry at 5.0 ppm; vegetable, 
cucurbit, group 9 at 0.70 ppm; and meat byproducts of cattle, goats, 
horses and sheep at 0.02 ppm.
    Also, the following entries in the table in paragraph (a)(1) are 
changed to read as follows: ``herb subgroup 19A, fresh'' is amended to 
``herb subgroup 19A, fresh, except parsley''; ``herb subgroup 19A, 
dried'' is amended to ``herb subgroup 19 A, dried, except parsley''..
    Further, the following entry is removed from the table in paragraph 
(a)(1): ``Carrot'' because of the establishment of the vegetable, root 
tolerance by this action.
    And lastly, the following entries are removed from the table in 
paragraph (a)(2): ``Onion, bulb'' ``onion, green'', and ``strawberry'' 
because permanent tolerances are being established by this action.

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, 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: August 15, 2008.
Lois Rossi,
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 180.532 is amended as follows:
    i. Paragraph (a)(2) is removed.
    ii. Paragraph (a)(1) is redesignated as paragraph (a).
    iii. Newly designated paragraph (a) is amended in the table by 
removing the commodity ``Carrot''; by revising the commodities ``Herb 
subgroup 19A, dried'' and ``Herb subgroup 19A, fresh'' to read ``Herb, 
subgroup 19A, dried, except parsley'' and ``Herb, subgroup 19A, fresh, 
except parsley'' respectively; and by alphabetically adding 
commodities.
    The amendments read as follows:


Sec.  180.532  Cyprodinil; tolerances for residues.

    (a) General. * * *

[[Page 50553]]



------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Avocado........................................                      1.2
                                * * * * *
Canistel.......................................                      1.2
                                * * * * *
Cattle, meat byproducts........................                     0.02
Citrus, dried pulp.............................                      8.0
Citrus, oil....................................                      340
                                * * * * *
Goat, meat byproducts..........................                     0.02
                                * * * * *
Horse, meat byproducts.........................                     0.02
                                * * * * *
Kiwifruit......................................                      1.8
                                * * * * *
Lemon..........................................                     0.60
Lime...........................................                     0.60
                                * * * * *
Mango..........................................                      1.2
Onion, bulb....................................                     0.60
Onion, green...................................                      4.0
Papaya.........................................                      1.2
Parsley, dried leaves..........................                      170
Parsley, leaves................................                       35
                                * * * * *
Sapodilla......................................                      1.2
Sapote, black..................................                      1.2
Sapote, mamey..................................                      1.2
Sheep, meat byproducts.........................                     0.02
                                * * * * *
Star apple.....................................                      1.2
Strawberry.....................................                      5.0
Tomatillo......................................                     0.45
Tomato.........................................                     0.45
Tomato, paste..................................                      1.0
                                * * * * *
Vegetable, cucurbit, group 9...................                     0.70
Vegetable, leaves of root and tuber, group 2...                       10
Vegetable, root, except sugarbeet, subgroup 1B.                     0.75
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-19747 Filed 8-26-08; 8:45 am]

BILLING CODE 6560-50-S
