Document ID: EPA-HQ-OPP-2008-0149-0001
Agency: epa
Document Type: Rule
Title: Cyproconazole; Pesticide Tolerance
Posted Date: 2008-05-14T04:00Z

[Federal Register: May 14, 2008 (Volume 73, Number 94)]
[Rules and Regulations]               
[Page 27756-27761]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my08-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0149; [FRL-8362-9]

 
 Cyproconazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the free and 
conjugated residues of cyproconazole, [alpha]-(4-chlorophenyl)-[alpha]-
(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol in or on aspirated 
grain fractions; field corn, forage, grain and stover; soybean, seed, 
forage, hay and oil; wheat, forage, hay, straw, grain, grain, milled by 
products; fat of cattle, goat, horse and sheep; and meat byproducts 
(except liver) of cattle, goat, horse and sheep. Additionally, this 
regulation establishes tolerances for cyproconazole and its metabolite, 
[delta]-(4-chlorophenyl)-[beta],[delta]-dihydroxy-[gamma]-methyl-1H-
1,2,4-triazole-1-hexenoic acid in or on milk and for cyproconazole and 
its metabolite, 2-(4-chlorophenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-
butane-2,3-diol in or on liver of cattle, goat, hog, horse, and sheep. 
Syngenta Crop Protection, Inc., requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective May 14, 2008. Objections and 
requests for hearings must be received on or before July 14, 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-2008-0149. 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: Mary L. Waller, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; e-mail address: waller.mary@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 
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-2008-0149 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 July 14, 2008.

[[Page 27757]]

    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-2008-0149, 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 November 22, 2006 (71 FR 67575) (FRL-
8089-9), 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 
6F7072) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR 180.485 be amended by 
establishing tolerances for residues of the fungicide cyproconazole, in 
or on the following commodities: Soybean, seed at 0.05 parts per 
million (ppm); soybean, forage at 1.0 ppm; soybean, hay at 2.5 ppm; 
corn, field, grain at 0.02 ppm; corn, field, forage at 0.6 ppm; corn, 
field, stover at 1.5 ppm; wheat, straw at 1.0 ppm; wheat, grain at 0.05 
ppm; wheat, forage at 1.0 ppm; wheat, hay at 1.5 ppm; aspirated grain 
fractions at 0.6 ppm; cattle, fat at 0.01 ppm; cattle, liver at 0.3 
ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts (except liver) 
at 0.01 ppm; milk at 0.01 ppm; goat, fat at 0.01 ppm; goat, liver at 
0.3 ppm; goat, meat at 0.01 ppm; goat, meat byproducts (except liver) 
at 0.01 ppm; hog, fat at 0.01 ppm; hog, liver at 0.3 ppm; hog meat at 
0.01 ppm; hog, meat byproducts (except liver) at 0.01 ppm; horse, liver 
at 0.3 ppm; horse, meat at 0.01 ppm; horse, meat byproducts (except 
liver) at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, kidney at 0.3 ppm; 
sheep, meat at 0.01 ppm; and sheep, meat byproducts (except liver) at 
0.01 ppm. This notice included a summary of the petition prepared by 
Syngenta Crop Protection, Inc., the registrant. 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 
concluded that the preferred chemical name for cyproconazole is 
``[alpha]-(4-chlorophenyl)-[alpha]-(1-cyclopropylethyl)-1H-1,2,4-
triazole-1-ethanol.'' 40 CFR 180.485 is being revised to use this 
terminology. Also, EPA determined that the time-limited tolerance 
established for soybean seed under 40 CFR 180.485(b) can be deleted 
given that a tolerance for soybean seed without time limitation is 
being established in section (a).
    Additionally, EPA has determined that, as a result of the 
tolerances sought in this petition, a tolerance is needed for the 
combined free and conjugated residues of cyproconazole [alpha]-(4-
chlorophenyl)-[alpha]-(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol 
and its metabolite [[delta]-(4-chlorophenyl)-[beta],[delta]-dihydroxy-
[gamma]-methyl-1H-1,2,4-triazole-1-hexenoic acid in or on the 
commodity: Milk at 0.02 ppm and that tolerances are needed for the 
combined free and conjugated residues of cyproconazole [[alpha]-(4-
chlorophenyl)-[alpha]-(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol 
and its metabolite [2-(4-chlorophenyl)-3-cyclopropyl-1-[1,2,4]triazol-
1-yl-butane-2,3-diol in or on the commodities: Liver of cattle, goat, 
horse, and sheep at 0.50 ppm and hog liver at 0.01 ppm.

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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for-tolerance. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Specific information on the studies received and the nature of the 
adverse effects caused by cyproconazole 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 in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as ``Cyproconazole: Human-Health Risk Assessment for 
Proposed Uses'' in that docket.

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 NOAEL in the toxicology study identified as appropriate for 
use in risk assessment. However, if a NOAEL cannot be determined, the 
LOAEL is sometimes used for risk assessment. Uncertainty/safety factors 
(UFs) 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 unknowns. Safety is assessed for 
acute

[[Page 27758]]

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 UFs. Short-term, intermediate-term, 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 UFs 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 cyproconazole used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Cyproconazole Human Health Risk Assessment for Proposed Uses 
on Corn, Soybean and Wheat'' in docket ID number EPA-HQ-OPP-2008-0149.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyproconazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing cyproconazole 
tolerances in 40 CFR 180.485. EPA assessed dietary exposures from 
cyproconazole 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 U.S. 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 all foods for which 
there are tolerances were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting this chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996, 
or 1998 CSFII. As to residue levels in food, EPA assumed all foods for 
which there are tolerances were treated and contain tolerance-level 
residues.
    iii. Cancer. Cyproconazole has been classified by the Agency as 
``Not Likely to be Carcinogenic to Humans''. The decision was based on 
the weight of evidence that supports a non-genotoxic mitogenic mode of 
action for cyproconazole. Therefore, a cancer dietary exposure 
assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for cyproconazole 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 cyproconazole. 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 FQPA Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of cyproconazole for 
acute exposures are estimated to be 1.14 parts per billion (ppb) for 
surface water and 0.05 ppb for ground water. The EECs for chronic 
exposures are estimated to be 0.11 ppb for surface water and 0.05 ppb 
for ground 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).
     Cyproconazole 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 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 for cyproconazole and any other 
substance. Other than as discussed below for the cyproconazole 
metabolite 1,2,4-triazole for the purposes of this tolerance action, 
therefore, EPA has assumed that cyproconazole 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 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative/.
    Cyproconazole is a triazole-derived pesticide. This class of 
compounds can form the common metabolite 1,2,4-triazole and two 
triazole conjugates (triazole alanine and triazole acetic acid). To 
support existing tolerances and to establish new tolerances for 
triazole-derivative pesticides, including cyproconazole, EPA conducted 
a human health risk assessment for exposure to 1,2,4-triazole, triazole 
alanine, and triazole acetic acid resulting from the use of all current 
and pending uses of any triazole-derived fungicide. The risk assessment 
is a highly conservative, screening-level evaluation in terms of 
hazards associated with common metabolites (e.g., use of a maximum 
combination of uncertainty factors) and potential dietary and non-
dietary exposures (i.e., high end estimates of both dietary and non-
dietary exposures). In addition, the Agency retained the additional 10X 
FQPA safety factor for the protection of infants and children. The 
assessment includes evaluations of risks for various subgroups, 
including those comprised of infants and children. The Agency's 
complete risk assessment is found in the propiconazole reregistration 
docket at http://www.regulations.gov (docket ID EPA-HQ-OPP-2005-0497). 
An addendum to the risk assessment, ``Dietary Exposure Assessments for 
the Common Triazole Metabolites 1,2,4-triazole, Triazolylalanine, 
Triazolylacetic Acid and Triazolyl Pyruvic Acid; Updated to Include New 
Uses of Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and 
Uniconazole'' can be found at http://www.regulations.gov in docket ID 
EPA-HQ-OPP-2008-0149.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of 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

[[Page 27759]]

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 UFs and/or special FQPA safety 
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility in the developmental study in rats or in the 
2-generation reproduction study in rat. There is no concern for the 
increased susceptibility in the New Zealand white (NZW) rabbit study 
since clear NOAELs/LOAELs were established for maternal and 
developmental toxicities and malformations were observed at doses 
higher than the dose that produced marginal maternal toxicity. The 
concern is low for the increased susceptibility in the Chinchilla 
rabbit study since the incidences of hydrocephaly were low, there was 
no dose response, high concentration of the vehicle (CMC) used, and the 
hydrocephaly was not seen at the same doses in the NZW strain of 
rabbit. Therefore, there is no residual uncertainty for prenatal and/or 
postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for cyproconazole is complete.
    ii. There is no indication that cyproconazole is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. Although there is qualitative evidence of increased 
susceptibility in the prenatal developmental studies in rats and 
rabbits, EPA did not identify any residual uncertainties after 
establishing toxicity endpoints and selecting traditional UFs to be 
used in the risk assessment of cyproconazole.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated (CT) and tolerance-level residues. Conservative 
ground water and surface water modeling estimates were used. There are 
no residential uses of cyproconazole.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC 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 cyproconazole will occupy 3% 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 that exposure to 
cyproconazole from food and water will utilize 13% of the cPAD for the 
population group (children 1 - 2 years old). There are no residential 
uses for cyproconazole that result in chronic residential exposure to 
cyproconazole.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Cyproconazole 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.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Cyproconazole 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 
LOC.
    5. Aggregate cancer risk for U.S. population. Cancer risk is 
expected to be negligible because EPA concluded that cyproconazole is 
not likely to be a human carcinogen.
    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 cyproconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method AM-0842-0790-0 for determining cyproconazole in plant 
commodities is an improved version of the current enforcement, which 
allows for use of either Nitrogen-Phosphorous Detection (NPD) or Mass-
Selective Detection (MSD). As this method is superior to the current 
enforcement method, it will be forwarded to FDA to either replace or 
supplement the existing tolerance enforcement method for plant 
commodities. The liguid chromotography with tandem mass spectrometry 
(LC-MS/MS) method (Syngenta Method RAM 499/01) for determining 
cyproconazole in livestock commodities has undergone a successful 
Independent Laboratory Validation (ILV) trial and radiovalidation 
trial. Therefore, a copy of the method will be forwarded to the 
Analytical Chemistry Branch for evaluation as an enforcement method. 
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.
    As metabolites in liver and in milk need to be included in the 
tolerance expression, enforcement methods will be required for these 
residues. Methods have been sent to the Analytical Chemistry Branch for 
evaluation.

B. International Residue Limits

    There are no established or proposed Canadian or Codex maximum 
residue limits (MRLs) for cyproconazole on food or feed crops. Mexico 
has established tolerances for cyproconazole at 0.05 ppm in barley and 
wheat grain, which is equivalent to the recommended U.S. tolerance for 
wheat grain. Therefore, there are generally no questions about the 
compatibility of the proposed tolerances with international tolerances. 
However, EPA notes that Japan has established numerous tolerances for 
cyproconazole, including MRLs on wheat (0.2 ppm), corn (0.1 ppm), and 
soybeans (0.05 ppm).

C. Response to Comment

    Comments were received on the notice of filing. EPA has responded 
to similar comments from the commenter on previous occasions. Refer to 
Federal Register cites: 70 FR 37686 (June 30, 2005); 70 FR 1354 
(January 7, 2005); and 69 FR 63083 (October 29, 2004).

V. Conclusion

    Therefore, the tolerance is established for free and conjugated 
residues of

[[Page 27760]]

cyproconazole, [alpha]-(4-chlorophenyl)-[alpha]-(1-cyclopropylethyl)-
1H-1,2,4-triazole-1-ethanol in or on the following commodities at the 
indicated tolerance levels in parts per million.
    Aspirated grain fractions . . . 2.5
    Corn, field, forage, . . . 0.60
    Corn, field, grain . . . 0.01
    Corn, field, stover . . . 1.2
    Fat of cattle, goat, horse and sheep. . . 0.01
    Meat byproducts (except liver) of cattle, goat, horse and sheep . . 
.0.01
    Soybean, seed . . . 0.05
    Soybean, forage . . . 1.0
    Soybean hay . . .3.0
    Soybean, oil . . . 0.10
    Wheat, forage . . . 0.80
    Wheat, hay . . . 1.3
    Wheat, straw . . . 0.90
    Wheat, grain . . . 0.05
    Wheat, grain, milled byproducts . . . 0.10
    A tolerance is also established for the combined free and 
conjugated residues of cyproconazole [[alpha]-(4-chlorophenyl)-[alpha]-
(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol] and its metabolite 
[[delta]-(4-chlorophenyl)-[beta],[delta]-dihydroxy-[gamma]-methyl-1H-
1,2,4-triazole-1-hexenoic acid in or on the following commodity:
    Milk. . . 0.02
    Also, tolerances are established for the combined free and 
conjugated residues of cyproconazole [alpha]-(4-chlorophenyl)-[alpha]-
(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol and its metabolite [2-
(4-chlorophenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butane-2,3-diol in 
or on the following commodities:
    Liver of cattle, goat, horse, and sheep . . . 0.50
    Hog liver . . . 0.01

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 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 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 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: May 6, 2008.
Deborah McCall,
Acting Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.485 is amended by revising paragraph (a) and removing 
the text from paragraph (b) and reserving to read as follows:

Sec.  180.485  Cyproconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for the free and 
conjugated residues of the fungicide cyproconazole, [alpha]-(4-
chlorophenyl)-[alpha]-(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol, 
in or on the following food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Aspirated grain fractions............................                2.5
Cattle, fat..........................................               0.01
Cattle, meat byproducts (except liver)...............               0.01
Coffee bean, green (Imported)\1\.....................                0.1
Corn, field, forage..................................               0.60
Corn, field, grain...................................               0.01
Corn, field, stover..................................                1.2
Goat, fat............................................               0.01
Goat, meat byproducts (except liver).................               0.01
Horse, fat...........................................               0.01
Horse, meat byproducts (except liver)................               0.01
Sheep, fat...........................................               0.01
Sheep, meat byproducts (except liver)................               0.01
Soybean, forage......................................                1.0
Soybean, hay.........................................                3.0
Soybean, oil.........................................               0.10
Soybean, seed........................................               0.05
Wheat, forage........................................               0.80
Wheat, grain.........................................               0.05
Wheat, grain, milled byproducts......................               0.10
Wheat, hay...........................................                1.3
Wheat, straw.........................................               0.90
------------------------------------------------------------------------
\1\There are no U.S. registrations as of February 15, 2008 for use on
  coffee bean.

    (2) A tolerance is established for the combined free and conjugated 
residues

[[Page 27761]]

of cyproconazole [alpha]-(4-chlorophenyl)-[alpha]-(1-cyclopropylethyl)-
1H-1,2,4-triazole-1-ethanol] and its metabolite [[delta]-(4-
chlorophenyl)-[beta],[delta]-dihydroxy-[gamma]-methyl-1H-1,2,4-
triazole-1-hexenoic acid in or on the following commodity:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Milk.................................................               0.02
------------------------------------------------------------------------

    (3) Tolerances are established for the combined free and conjugated 
residues of cyproconazole [alpha]-(4-chlorophenyl)-[alpha]-(1-
cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol and its metabolite 2-(4-
chlorophenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butane-2,3-diol in or 
on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, liver........................................               0.50
Goat, liver..........................................               0.50
Hog, liver...........................................               0.01
Horse, liver.........................................               0.50
Sheep, liver.........................................               0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. E8-10829 Filed 5-13-08; 8:45 am]

BILLING CODE 6560-50-S