Document ID: EPA-HQ-OPP-2007-1161-0003
Agency: epa
Document Type: Rule
Title: Tetraconazole; Pesticide Tolerances
Posted Date: 2008-11-14T05:00Z

[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Rules and Regulations]               
[Page 67400-67406]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no08-19]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1161; FRL-8386-7]

 
Tetraconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for residues of 
tetraconazole in or on grape. Interregional Research Project Number 4 
(IR-4) requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 14, 2008. Objections and 
requests for hearings must be received on or before January 13, 2009, 
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-2007-1161. 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

[[Page 67401]]

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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@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 electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR site 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2007-1161 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 January 13, 2009.
    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-2007-1161, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of 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 
7E7273) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested 
that 40 CFR 180.557 be amended by establishing a tolerance for residues 
of the fungicide tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-
tetrafluoroethoxy)propyl]-1H-1,2,4-triazole, in or on grape at 0.15 
parts per million (ppm). That notice referenced a summary of the 
petition prepared on behalf of IR-4 by Isagro, S.p.A, the registrant, 
which is available to the public in the docket, at 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 
revised the tolerance level for grape from 0.15 ppm to 0.20 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 the petitioned-for 
tolerance for residues of tetraconazole on grape at 0.20 ppm. 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

[[Page 67402]]

subgroups of consumers, including infants and children.
    Tetraconazole has low acute toxicity via the oral, dermal and 
inhalation routes. It is a slight eye irritant but not a dermal 
irritant or a dermal sensitizer. The liver and kidney are the primary 
target organs of tetraconazole. In the subchronic, chronic and 
reproduction rat studies, subchronic and carcinogenicity mouse studies, 
and the chronic dog study, increases in liver weight, increases in 
liver serum enzymes or gross and microscopic liver pathology were noted 
at various doses, providing evidence of liver toxicity. There is no 
evidence in the toxicity database that tetraconazole is an immuno- or 
neurotoxicant.
    Tetraconazole is classified as ``likely to be carcinogenic to 
humans'' by the oral route of exposure, based on the occurrence of 
liver tumors in male and female mice. Cancer risk is assessed by EPA 
using the linear low dose extrapolation approach with a potency factor 
(Q1*) of 2.3 x 10-2 milligrams/kilograms/day (mg/
kg/day)-1.
    Oral rat and rabbit developmental toxicity studies showed no 
increased susceptibility of fetuses to tetraconazole. Maternal toxicity 
(decreased body weight gain and food consumption, increased water 
intake and increased liver and kidney weights) and developmental 
toxicity (increased incidence of small fetuses, supranumerary ribs and 
hydroureter and hydronephrosis) occurred at the same dose level in the 
rat study. No developmental toxicity was seen in the rabbit study, 
whereas maternal toxicity (decreased body weight gain) was noted at the 
highest dose tested. Similarly, there was no evidence of increased 
susceptibility of offspring in the 2-generation rat reproduction study. 
Parental toxicity (increased mortality in parental females) was 
observed at a lower dose (4.9 mg/kg/day) than the dose (35.5 mg/kg/day) 
resulting in pup effects (decreased litter weight and mean pup weight 
in litters of all generations before weaning and increased relative 
liver weight at weaning in both sexes of all litters).
    Specific information on the studies received and the nature of the 
adverse effects caused by tetraconazole 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 the document Tetraconazole: Human-Health Risk 
Assessment for New Use on Grapes and a Label Amendment for Pecans, page 
34 in docket ID number EPA-HQ-OPP-2007-1161.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for tetraconazole used for 
human risk assessment can be found at http://www.regulations.gov in the 
document Tetraconazole: Human-Health Risk Assessment for New Use on 
Grapes and a Label Amendment for Pecans, page 12 in docket ID number 
EPA-HQ-OPP-2007-1161.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tetraconazole, EPA considered exposure under the 
petitioned-for tolerance as well as all existing tetraconazole 
tolerances in 40 CFR 180.557. Additional metabolites of toxicological 
concern (M14360-alcohol (free and conjugated), M14360-acid, M14360-DFA, 
and M14360-hydroxydetriazolyl-O-malonyldiglucoside) that are not 
included in the tolerance expression were included in the dietary 
exposure assessments based on the ratio of metabolite to parent found 
in metabolism studies. EPA assessed dietary exposures from 
tetraconazole 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. EPA identified such effects 
(increased incidence of small fetuses and supernumerary ribs) for the 
population subgroup, females 13 years and older; however, no such 
effects were identified for the general population, including infants 
and children.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 Nationwide Continuing Surveys of Food Intakes by Individuals 
(CSFII). As to residue levels in food, EPA assumed tolerance-level 
residues of tetraconazole and 100 percent crop treated (PCT) for all 
existing and new uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. The assessment was refined through the incorporation of 
empirical processing factors, average field trial residues, average 
residues from the feeding studies and projected percent crop treated 
(PPCT) estimates for the feed commodities. 100 PCT was assumed for all 
food commodities.
    iii. Cancer. Tetraconazole is classified as ``likely to be 
carcinogenic to humans'' by the oral route of exposure. Cancer risk 
from tetraconazole exposure is assessed by EPA using the linear low 
dose extrapolation approach with a potency factor (Q1*) of 
2.3 x 10-2 (mg/kg/day)-1. EPA used the same food 
residue estimates as discussed in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information,

[[Page 67403]]

EPA must require pursuant to section 408(f)(1) of FFDCA that data be 
provided 5 years after the tolerance is established, modified, or left 
in effect, demonstrating that the levels in food are not above the 
levels anticipated. For the present action, EPA will issue such Data 
Call-Ins as are required by section 408(b)(2)(E) of FFDCA and 
authorized under section 408(f)(1) of FFDCA. Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require 
registrants to submit data on PCT.
    The Agency used projected percent crop treated (PPCT) information 
as follows:
    In the chronic and cancer dietary assessments, EPA used PPCT for 
the feed commodities derived from peanuts (77%), soybeans (27%) and 
sugar beets (70%). Since tetraconazole was registered for use on these 
crops recently (2007 and 2008), PCT estimates based on actual usage 
data are not sufficient indicators of potential usage on these crops.
    EPA estimates PPCT for a new pesticide use by assuming that the PCT 
during the pesticide's initial 5 years of use on a specific use site 
will not exceed the average PCT of the market leader (i.e., the one 
with the greatest PCT) on that site. Typically, EPA uses USDA/National 
Agriculture Statistic Service (NASS) as the primary source for PCT 
data. When a specific use site is not surveyed by USDA/NASS, EPA uses 
other sources, including proprietary data, and calculates the PCT. 
Comparisons are only made among pesticides of the same pesticide types 
(i.e., the leading fungicide on the use site is selected for comparison 
with the new fungicide). The PCTs included in the average may be for 
the same pesticide, or for different pesticides, since the same, or 
different pesticides, may dominate for each year selected. This PPCT, 
based on the average PCT of the market leader, is appropriate for use 
in chronic dietary risk assessment. The method of estimating a PPCT for 
a new use of a registered pesticide or a new pesticide produces a high-
end estimate that is unlikely, in most cases, to be exceeded during the 
initial 5 years of actual use. The predominant factors that bear on 
whether the estimated PPCT could be exceeded are whether a new 
pesticide use or new pesticide is more efficacious or controls a 
broader spectrum of pests than the dominant pesticide; and/or whether 
there are concerns with pest pressures as indicated in emergency 
exemption requests or other readily available information; and/or other 
factors based on analysis of additional information, such as the total 
crop acreage and the geographical distribution of the crops and pests. 
All information currently available for the predominant factors 
mentioned above or relevant to the case in question have been 
considered for this chemical, and EPA has determined that it is 
unlikely that actual PCT for tetraconazole will exceed the PPCT during 
the next 5 years.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which tetraconazole may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for tetraconazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tetraconazole. Further information regarding EPA's 
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 
tetraconazole for acute exposures are estimated to be 10.45 parts per 
billion (ppb) for surface water and 0.40 ppb for ground water. For 
chronic exposures for non-cancer assessments, EDWCs are estimated to be 
4.68 ppb for surface water and 0.40 ppb for ground water. For chronic 
exposures for cancer assessments, EDWCs are estimated to be 3.29 ppb 
for surface water and 0.40 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 10.45 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 4.68 ppb was used to 
assess the contribution to drinking water. For cancer dietary risk 
assessment, the water concentration of value 3.29 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). Tetraconazole 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.''
    Tetraconazole is a member of the triazole-containing class of 
pesticides. Although conazoles act similarly in fungi by inhibiting 
ergosterol biosynthesis, there is not necessarily a relationship 
between their pesticidal activity and their mechanism of toxicity in 
mammals. Structural similarities do

[[Page 67404]]

not necessarily constitute a common mechanism of toxicity. Evidence is 
needed to establish that the chemicals operate by the same, or 
essentially the same, sequence of major biochemical events (EPA, 2002). 
In conazoles, however, a variable pattern of toxicological responses is 
found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce 
thyroid tumors in rats. Some induce developmental, reproductive, and 
neurological effects in rodents. Furthermore, the conazoles produce a 
diverse range of biochemical events including altered cholesterol 
levels, stress responses, and altered DNA methylation. It is not 
clearly understood whether these biochemical events are directly 
connected to their toxicological outcomes. Thus, there is currently no 
evidence to indicate that conazoles share common mechanisms of toxicity 
and EPA is not following a cumulative risk approach based on a common 
mechanism of toxicity for the conazoles. 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.
    Tetraconazole is a triazole-derived pesticide. This class of 
compounds can form the common metabolite, 1,2,4-triazole (T), and 
several triazole conjugates, including triazole alanine (TA) and 
triazole acetic acid (TAA). To support existing tolerances and to 
establish new tolerances for triazole-derivative pesticides, including 
tetraconazole, EPA conducted a human health risk assessment for 
exposure to T, TA, and TAA resulting from the use of all current and 
pending uses of any triazole-derived fungicide. The risk assessment was 
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 included 
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). In March of 2008, 
EPA updated the triazole risk assessment to include new uses of 
fenbuconazole, ipconazole, metconazole, tebuconazole and uniconazole. 
The updated risk assessment can be found at http://www.regulations.gov 
in the document Dietary Exposure Assessments for the Common Triazole 
Metabolites 1,2,4-Triazole, Triazolylalanine, Triazolylacetic Acid, and 
Triazolylypyruvic Acid; Updated to Include New Uses of Fenbuconazole, 
Ipconazole, Metconazole, Tebuconazole, and Uniconazole; and a Change in 
Plant-back Restriction for Tetraconazole in docket ID number EPA-HQ-
OPP-2007-1199. When EPA updated the triazole risk assessment, it 
considered triazole residues on grapes, because other triazole 
fungicides are already registered for this use site. Triazole residues 
on grapes from the use of tetraconazole are not expected to exceed 
those from the use of other triazole fungicides on grapes; therefore, 
establishing this tolerance for tetraconazole on grape will not 
increase aggregate exposure to the triazole metabolites, and an updated 
triazole risk assessment is unnecessary.

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 pre- and postnatal 
toxicology database for tetraconazole includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. As discussed in section III.A, Toxicological Profile, 
there was no evidence of increased susceptability to tetraconazole of 
in utero rats or rabbits or offspring in these studies. In the rat 
developmental toxicity study, maternal and developmental toxicity 
occurred at the same dose, and in the rabbit study, no developmental 
toxicity was seen at doses that resulted in maternal toxicity. In the 
rat reproduction study, parental toxicity was observed at a lower dose 
than that which resulted in pup effects.
    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 tetraconazole is complete, except for 
immunotoxicity testing. EPA began requiring functional immunotoxicity 
testing of all food and non-food use pesticides on December 26, 2007. 
Since this requirement went into effect well after the tolerance 
petition was submitted, these studies are not yet available for 
tetraconazole. In the absence of specific immunotoxicity studies, EPA 
has evaluated the available tetraconazole toxicity data to determine 
whether an additional database uncertainty factor is needed to account 
for potential immunotoxicity. There was no evidence of adverse effects 
on the organs of the immune system at the LOAEL in any study with 
tetraconazole. In addition, tetraconazole does not belong to a class of 
chemicals (e.g., the organotins, heavy metals, or halogenated aromatic 
hydrocarbons) that would be expected to be immunotoxic. Based on these 
considerations, EPA does not believe that conducting a special series 
870.7800 immunotoxicity study will result in a point of departure less 
than the NOAEL of 0.73 mg/kg/day used in calculating the cPAD for 
tetraconazole; therefore, an additional database uncertainty factor is 
not needed to account for potential immunotoxicity.
    ii. There is no indication that tetraconazole is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that tetraconazole 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 assessment assumed 
tolerance-level residues and 100 PCT. The chronic and cancer dietary 
food exposure assessments were refined using reliable PPCT information 
and anticipated residue values calculated from valid field trial 
results. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to tetraconazole in 
drinking water. Residential exposure to tetraconazole is not expected. 
These assessments will not underestimate the

[[Page 67405]]

exposure and risks posed by tetraconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to tetraconazole will occupy < 1% of the aPAD for females, 13 to 49 
years old, the only population group for which an acute toxicity 
endpoint of concern was identified.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tetraconazole from food and water will utilize 7.7% of the cPAD for 
infants less than 1 year old, the population group receiving the 
greatest exposure. There are no residential uses for tetraconazole.
    3. Short-/intermediate-term risk. Short- and intermediate term 
aggregate exposures take into account short- and intermediate-term 
residential exposure plus chronic exposure from food and water 
(considered to be a background exposure level). Tetraconazole is not 
registered for any use patterns that would result in residential 
exposure. Therefore, the short- and intermediate-term aggregate risk is 
the sum of the risk from exposure to tetraconazole through food and 
water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions described in this unit for the cancer risk assessment, EPA 
has concluded that exposure to tetraconazole from food and water will 
result in a lifetime cancer risk of 3 x 10-6 for the U.S. 
population. EPA generally considers cancer risks in the range of 
10-6 or less to be negligible. The precision which can be 
assumed for cancer risk estimates is best described by rounding to the 
nearest integral order of magnitude on the log scale; for example, 
risks falling between 3.16 x 10-7 and 3.16 x 10-6 
are expressed as risks in the range of 10-6. Considering the 
precision with which cancer hazard can be estimated, the 
conservativeness of low-dose linear extrapolation, and the rounding 
procedure described above, cancer risk should generally not be assumed 
to exceed the benchmark level of concern of the range of 
10-6 until the calculated risk exceeds approximately 3 x 
10-6. Since the calculated cancer risk for tetraconazole 
falls within this range, estimated cancer risk is considered to be 
negligible.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to tetraconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron 
capture detection (GC/ECD)) is available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX, Canadian or Mexican maximum residues levels 
established for tetraconazole.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA has 
revised the tolerance level for grape from 0.15 ppm to 0.20 ppm. EPA 
revised the tolerance level based on analysis 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. The recommended value differs from the value proposed by 
IR-4, because only data from field plots harvested at the proposed pre-
harvest interval (PHI) were used in calculating the tolerance level.

V. Conclusion

    Therefore, a tolerance is established for residues of 
tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-
tetrafluoroethoxy)propyl]-1H-1,2,4-triazole, in or on grape at 0.20 
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

[[Page 67406]]

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: October 31, 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 180.557 is amended by alphabetically adding the following 
commodity to the table in paragraph (a) to read as follows:

Sec.  180.557  Tetraconazole; tolerances for residues.

     (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Grape................................................               0.20
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-26946 Filed 11-13-08; 8:45 am]

BILLING CODE 6560-50-S