Document ID: EPA-HQ-OPP-2005-0097-0003
Agency: epa
Document Type: Rule
Title: Tebuconazole; Pesticide Tolerances
Posted Date: 2008-05-14T04:00Z

[Federal Register: May 14, 2008 (Volume 73, Number 94)]
[Rules and Regulations]               
[Page 27748-27756]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my08-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0097; FRL-8364-6]

 
Tebuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tebuconazole in or on wheat, barley, and tree nuts. Bayer CropScience 
LP requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

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-2005-0097. 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: Tracy Keigwin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6605; e-mail address: keigwin.tracy@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

[[Page 27749]]

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-2005-0097 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.
    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-2005-0097, 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 May 18, 2005 (70 FR 28257) (FRL-7708-5), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 7F4895) 
by Bayer CropScience LP, P.O. Box 12014, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.474 be amended by establishing tolerances for residues of the 
fungicide tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1- 
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities 
nut, tree, group 14 at 0.05 ppm; almond, hulls at 5.0 ppm; pistachio at 
0.05 ppm; barley, hay at 6.0 ppm; barley, straw at 1.4 ppm; wheat, 
forage at 3.0 ppm; wheat, hay at 6.0 ppm; wheat, straw at 1.4 ppm. That 
notice referenced a summary of the petition prepared by Bayer 
CropScience LP, 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 has 
modified the proposed tolerances as follows: Almond, hulls at 6.0 ppm; 
barley, grain at 0.15 ppm, barley, hay at 7.0 ppm; barley, straw at 3.5 
ppm; wheat grain at 0.05 ppm, wheat, hay at 7.0 ppm; wheat, straw at 
1.5 ppm; and a separate pistachio tolerance is not needed. 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 tebuconazole. 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.
    Tebuconazole has low acute toxicity by the oral or dermal route of 
exposure, and moderate toxicity by the inhalation route. It is not a 
dermal sensitizer or a dermal irritant; however, it is slightly to 
mildly irritating to the eye. The main target organs are the liver, the 
adrenals, the hematopoetic system and the nervous system. Effects on 
these target organs were seen in both rodent and non-rodent species. In 
addition, ocular lesions are seen in dogs (including lenticular 
degeneration and increased cataract formation) following subchronic or 
chronic exposure.
    Oral administration of tebuconazole caused developmental toxicity 
in all species evaluated (rat, rabbit, and mouse), with the most 
prominent effects seen in the developing nervous system. In the 
available toxicity studies on tebuconazole, there was no 
toxicologically significant evidence of endocrine disruptor effects. 
Tebuconazole was classified as a Group C - possible human carcinogen, 
based on an increase in the incidence of hepatocellular adenomas, 
carcinomas and combined adenomas/carcinomas in male and female mice. 
Submitted mutagenicity studies did not demonstrate any evidence of 
mutagenic potential for tebuconazole. Tebuconazole shares common 
metabolites with other triazole-derivative chemicals, including free 
triazole (1,2,4-triazole) and triazole-conjugated plant metabolites 
(such as triazole alanine). These common metabolites have been the 
subject of separate risk assessments.
    Specific information on the studies received and the nature of the 
adverse effects caused by tebuconazole 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 entitled Tebuconazole: Human Health 
Risk Assessment to support tolerances in/on Asparagus, Barley, Beans, 
Beets, Brassica leafy greens, Bulb Vegetables, Coffee (import), 
Commercial Ornamentals, Corn, Cotton, Cucurbits, Hops, Lychee, Mango, 
Okra, Pome fruit, Soybean, Stone fruit, Sunflower, Tree Nut Crop Group, 
Turf, Turnips and Wheat, pages 79-107 in docket ID number EPA-HQ-OPP-
2005[dash]0097.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure

[[Page 27750]]

(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 tebuconazole used for 
human risk assessment is shown in Table 1 of this unit.

      Table 1. -- Summary of Toxicological Doses and Endpoints for Tebuconazole for Use in Dietary and Non-
                                   Occupational Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                                                          RfD, PAD, Level of       Study and
        Exposure/Scenario         Point of Departure   Uncertainty/FQPA    Concern for Risk      Toxicological
                                                        Safety Factors        Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General            LOAEL = 8.8 mg/kg/  UFA= 10x            Acute RfD = 0.029   Developmental
 Population, including Infants     day                UFH=10x...........   mg/kg/day           Neurotoxicity
 and Children)                    UF = 300..........  FQPA(UFL)= 3x.....  aPAD = 0.029 mg/kg/  Study - Rat.
                                                                           day.               LOAEL = 8.8 mg/kg/
                                                                                               day based on
                                                                                               decreases in body
                                                                                               weights, absolute
                                                                                               brain weights,
                                                                                               brain
                                                                                               measurements and
                                                                                               motor activity in
                                                                                               offspring.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All              LOAEL = 8.8 mg/kg/  UFA= 10x            Chronic RfD =       Developmental
 Populations)                      day                UFH=10x...........   0.029mg/kg/day      Neurotoxicity
                                  UF = 300..........  FQPA(UFL)= 3x.....  cPAD =0.029 mg/kg/   Study - Rat.
                                                                           day.               LOAEL = 8.8 mg/kg/
                                                                                               day based on
                                                                                               decreases in body
                                                                                               weights, absolute
                                                                                               brain weights,
                                                                                               brain
                                                                                               measurements and
                                                                                               motor activity in
                                                                                               offspring.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-/           LOAEL = 8.8 mg/kg/  UFA= 10x            Residential LOC     Developmental
 Intermediate-Term (1-30 days/1-   day                UFH=10x...........   for MOE = 300       Neurotoxicity
 6 months)                        UF = 300..........  FQPA(UFL)= 3x.....                       Study - Rat.
                                                                                              LOAEL = 8.8 mg/kg/
                                                                                               day based on
                                                                                               decreases in body
                                                                                               weights, absolute
                                                                                               brain weights,
                                                                                               brain
                                                                                               measurements and
                                                                                               motor activity in
                                                                                               offspring.
----------------------------------------------------------------------------------------------------------------
Dermal Short-/Intermediate-Term   LOAEL = 8.8 mg/kg/  UFA= 10x            Residential LOC     Developmental
 (1-30 days/1-6 months)            day                UFH=10x...........   for MOE = 300       Neurotoxicity
                                  UF = 300..........  FQPA (UFL)= 3x....                       Study - Rat.
                                                      DAF = 23.1%.......                      LOAEL = 8.8 mg/kg/
                                                                                               day based on
                                                                                               decreases in body
                                                                                               weights, absolute
                                                                                               brain weights,
                                                                                               brain
                                                                                               measurements and
                                                                                               motor activity in
                                                                                               offspring.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-/Intermediate-   LOAEL = 8.8 mg/kg/  UFA= 10x            Residential LOC     Developmental
 Term (1-30 days/1-6 months)       day                UFH=10x...........   for MOE = 300       Neurotoxicity
                                  UF = 300..........  FQPA (UFL)= 3x....                       Study - Rat.
                                                      Inhalation and                          LOAEL = 8.8 mg/kg/
                                                       oral toxicity are                       day based on
                                                       assumed to be                           decreases in body
                                                       equivalent.                             weights, absolute
                                                                                               brain weights,
                                                                                               brain
                                                                                               measurements and
                                                                                               motor activity in
                                                                                               offspring.
----------------------------------------------------------------------------------------------------------------

[[Page 27751]]

Cancer (oral, dermal,                Classification: Group C- possible human carcinogen based on statistically
 inhalation)                        significant increase in the incidence of hepatocellular adenoma, carcinoma,
                                    and combined adenoma/carcinomas in both sexes of NMRI mice. Considering that
                                     there was no evidence of carcinogenicity in rats, there was no evidence of
                                       genotoxicity for tebuconazole, and tumors were only seen at a high and
                                    excessively toxic dose in mice, EPA concluded that the chronic RfD would be
                                     protective of any potential carcinogenic effect. The chronic RfD value is
                                     0.029 mg/kg/day which is approximately 9600 fold lower than the dose that
                                                     would induce liver tumors (279 mg/kg/day).
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to
  extrapolate a NOAEL. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic).
  RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. DAF = dermal
  absorption factor.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tebuconazole, EPA considered exposure under the petitioned-
for tolerances, including other pending petitions, as well as all 
existing tebuconazole tolerances in (40 CFR 180.474). EPA assessed 
dietary exposures from tebuconazole 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, anticipated residues 
for bananas, grapes, raisins, nectarines, peaches and peanut butter 
were derived using the latest USDA Pesticide Data Program (PDP) 
monitoring data from 2002- 2006. Anticipated residues for all other 
registered and proposed food commodities were based on field trial 
data. For uses associated with PP 7F4895, 100% Crop treated was 
assumed. DEEM (ver. 7.81) default processing factors were assumed for 
processed commodities associated with petition 7F4895. For several 
other uses EPA used percent crop treated (PCT) data as specified in 
Unit III.C.1.iv.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the same assumptions as stated in Unit III. C.1.i. 
for acute exposure.
    iii. Cancer. As explained in Unit III.B., the chronic risk 
assessment is considered to be protective of any cancer effects; 
therefore, a separate quantitative cancer dietary risk assessment was 
not conducted.
    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, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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 FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information for tebuconazole on grapes, grape, 
raisin, nectarine, oats, peach, and peanuts. The PCT for each crop is 
as follows: Grapes: 25%; grape, raisin: 25%; nectarine 25%; oats 2.5%; 
peach: 20%; and peanuts 45%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6 years. 
EPA uses an average PCT for chronic dietary risk analysis. The average 
PCT figure for each existing use is derived by combining available 
public and private market survey data for that use, averaging across 
all observations, and rounding to the nearest 5%, except for those 
situations in which the average PCT is less than one. In those cases, 
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA 
uses a maximum PCT for acute dietary risk analysis. The maximum PCT 
figure is the highest observed maximum value reported within the recent 
6 years of available public and private market survey data for the 
existing use and rounded up to the nearest multiple of 5%.
    The Agency used projected percent crop treated (PPCT) information 
for tebuconazole on cherries (pre-harvest) and cherries (post-harvest). 
The PCT for each crop is as follows: Cherries, pre-harvest: acute 
assessment 42%, chronic assessment 37%; Cherries, post-harvest: acute 
assessment 100%, chronic assessment 66%. EPA estimates PPCT for a new 
pesticide use by assuming that its actual PCT during the initial five 
years of use on a specific use site will not exceed the recent PCT of 
the market leader (i.e., the one with the greatest PCT) on that site. 
An average market leader PCT, based on three recent surveys of 
pesticide usage, if available, is used for chronic risk assessment,

[[Page 27752]]

while the maximum PCT from the same three recent surveys, if available, 
is used for acute risk assessment. The average and maximum market 
leader PCTs may each be based on one or two surveys if three are not 
available. 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 market leader PCTs 
used to determine the average and the maximum may be each for the same 
pesticide or for different pesticides since the same or different 
pesticides may dominate for each year. Typically, EPA uses USDA/NASS as 
the source for raw PCT data because it is publicly available. When a 
specific use site is not surveyed by USDA/NASS, EPA uses other sources 
including proprietary data.
    An estimated PPCT, based on the average PCT of the market leaders, 
is appropriate for use in chronic dietary risk assessment, and an 
estimated PPCT, based on the maximum PCT of the market leaders, is 
appropriate for use in acute dietary risk assessment. This method of 
estimating PPCTs for a new use of a registered pesticide or a new 
pesticide produces high-end estimates that are unlikely, in most cases, 
to be exceeded during the initial five years of actual use. Predominant 
factors that bear on whether the PPCTs could be exceeded may include 
PCTs of similar chemistries, pests controlled by alternatives, pest 
prevalence in the market and other factors. All relevant information 
currently available for predominant factors have been considered for 
tebuconazole on cherries, resulting in adjustments to the initial 
estimates for three crops to account for lack of confidence in 
projections based on less than three observations, old data and/or data 
based on expert opinion.
    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, or conservative estimates based on 
information from agricultural experts. 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 tebuconazole 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 tebuconazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tebuconazole. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
tebuconazole for acute exposures are estimated to be 78.5 parts per 
billion (ppb) for surface water and 1.56 ppb for ground water. The 
EDWCs for chronic, non-cancer are estimated to be 44.9 ppb for surface 
water and 1.56 ppb for ground water. The EDWCs for chronic, cancer 
exposures are estimated to be 32.3 ppb for surface water and 1.56 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 78.5 ppb was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment (which is protective of any possible cancer effects), the 
water concentration value of 44.9 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).
    Tebuconazole is currently registered for uses that could result in 
residential exposures. Short-term dermal and inhalation exposures are 
possible for residential adult handlers mixing, loading, and applying 
tebuconazole products outdoors to ornamental plants. Short- and 
intermediate-term dermal postapplication exposures to adults during 
golfing and children playing on treated wood structures are also 
possible. Children may also be exposed via the incidental oral route 
when playing on treated wood structures. Long-term exposure is not 
expected. As a result, risk assessments have been completed for 
residential handler scenarios as well as residential postapplication 
scenarios.
    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.''
    Tebuconazole is a member of the triazole-containing class of 
pesticides. Although conazoles act similarly in plants (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 not 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. 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 procedures 
for cumulating effects from substances found to have a common mechanism 
of toxicity, see EPA's website at http://www.epa.gov/pesticides/
cumulative.
    Triazole-derived pesticides 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 tebuconazole, 
EPA conducted a human health risk assessment for exposure to

[[Page 27753]]

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 as of September 1, 2005. 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 September 1, 2005 risk assessment 
can be 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 Triazolylypyruvic 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-
2005-0097.

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 toxicity database for 
tebuconazole is complete, and includes prenatal developmental toxicity 
studies in three species (mouse, rat, and rabbit), a reproductive 
toxicity study in rats, acute and subchronic neurotoxicity studies in 
rats, and a developmental neurotoxicity study in rats. The data from 
prenatal developmental toxicity studies in mice and a developmental 
neurotoxicity (DNT) study in rats indicated an increased quantitative 
and qualitative susceptibility following in utero exposure to 
tebuconazole. The NOAELs/LOAELs for developmental toxicity in the mouse 
study were found at dose levels less than those that induces maternal 
toxicity or in the presence of slight maternal toxicity. In the DNT 
study, the LOAEL at which developmental toxicity was seen was below the 
NOAEL for maternal animals. No NOAEL was identified for the offspring 
in this study. There was no indication of increased quantitative 
susceptibility in the rat and rabbit developmental toxicity studies, 
the NOAELs for developmental toxicity were comparable to or higher than 
the NOAELs for maternal toxicity. In all three species, however, there 
was indication of increased qualitative susceptibility. For most 
studies, minimal maternal toxicity was seen at the LOAEL (consisting of 
increases in hematological findings in mice, increased liver weights in 
rabbits and rats, and decreased body weight gain/food consumption in 
rats) and did not increase substantially in severity at higher doses; 
however, there was more concern for the developmental effects at each 
LOAEL which included increases in runts, increased fetal loss, and 
malformations in mice, increased skeletal variations in rats, and 
increased fetal loss and frank malformations in rabbits. Additionally, 
more severe developmental effects (including frank malformations) were 
seen at higher doses in mice, rats and rabbits. In the developmental 
neurotoxicity study, maternal toxicity was seen only at the high dose 
(decreased body weights, body weight gains, and food consumption, 
prolonged gestation with mortality, and increased number of dead 
fetuses), while offspring toxicity (including decreases in body weight, 
brain weight, brain measurements and functional activities) was seen at 
all doses.
    Available data indicated greater sensitivity of the developing 
organism to exposure to tebuconazole, with the exception of the effects 
seen in the DNT study, the degree of concern is low and there are no 
residual uncertainties because the toxic endpoints in the pre- and 
post-natal developmental toxicity studies were well characterized with 
clear NOAELs established and the endpoint used for all risk assessments 
is protective of the effects seen in these studies.
    There is concern with regard to the DNT study because of the 
failure to achieve a NOAEL in that study. This concern is addressed by 
a retention of FQPA SF in the form of UFL of 3X. Reduction 
of the FQPA safety factor from 10 to 3X is based on a Benchmark Dose 
(BMD) analysis of the datasets relevant to the adverse offspring 
effects (decreased body weight and brain weight) seen at the LOAEL in 
the DNT study. All of the BMDLs (the lower limit of a one-sided 95% 
confidence interval on the BMD) modeled successfully on statistically 
significant effects are 1-2X lower than the LOAEL. The results indicate 
that an extrapolated NOAEL is not likely to be 10X lower than the LOAEL 
and that use of a FQPA safety factor of 3X would not underestimate 
risk. Using a 3X FQPA safety factor in the risk assessment (8.8 mg/kg/
day / 3x = 2.9 mg/kg/day) is further supported by other studies in the 
tebuconazole toxicity database (with the lowest NOAELs being 3 and 2.9 
mg/kg/day, from a developmental toxicity study in mice and a chronic 
toxicity study in dogs, respectively [respective LOAELs 10 and 4.5 mg/
kg/day]).
    3. Conclusion. The Agency has determined that reliable data show 
that it would be safe for infants and children to reduce the FQPA SF to 
3x for all potential exposure scenarios. That decision is based on the 
following findings:
    i. The toxicity database for tebuconazole is complete and includes 
an acceptable rat developmental neurotoxicity study.
    ii. Although there is qualitative evidence of increased 
susceptibility in the prenatal developmental studies in rats, mice, and 
rabbits, and in the 2-generation reproduction study in rats, EPA did 
not identify any residual uncertainties or concerns with regard to 
these studies after establishing toxicity endpoints and traditional UFs 
to be used in the risk assessment of tebuconazole.
    iii. A concern was identified with regard to the failure to 
identify a NOAEL for the development effects found in the DNT study. A 
FQPA safety factor of 3X was found sufficient to protect infants and 
children based on the BMD analysis summarized in Unit III.D.2.
    iv. There are no residual uncertainties identified in the exposure 
databases. Although the acute and chronic food exposure assessments are 
refined, EPA believes that the assessments are based on reliable data 
and will not underestimate exposure/risk. The drinking water estimates 
were derived from conservative screening models. The residential 
exposure assessment utilizes reasonable high-end variables set out in 
EPA's Occupational/Residential Exposure SOPs (Standard Operating 
Procedures). The aggregate assessment is based upon reasonable worst-
case residential assumptions, and

[[Page 27754]]

is also not likely to underestimate exposure/risk to any subpopulation, 
including those comprised of infants and children.

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 tebuconazole will occupy 53% of the aPAD for the population group 
(all infants less than 1 year old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
tebuconazole from food and water will utilize 4% of the cPAD for the 
U.S. population and 11% of the cPAD for the most highly exposed 
population group (infants less than 1 year old).
    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). Tebuconazole 
is currently registered for uses that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to tebuconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the short-term aggregate MOE 
from dietary exposure (food + drinking water) and non-occupational/
residential handler exposure for adults using a hose-end sprayer on 
ornamentals is 400. The short-term aggregate MOE from dietary exposure 
and exposure from golfing is 1,800. The short-term aggregate MOE to 
children from dietary exposure and exposure from wood surfaces treated 
at the above ground use rate is 530. The short-term aggregate MOE to 
children from dietary exposure and exposure to wood surfaces treated at 
the below ground use rate is 230. The combined and aggregate MOEs for 
wood treated for below ground uses exceed the Agency's LOC of 300, and 
indicate a potential risk of concern. However, the MOE of 230 is based 
on the assumption that 100% of a child's exposure is to below ground 
wood. In reality, the probability and frequency of children contacting 
wood intended for below ground use is reasonably assumed to be small 
and incidental compared to wood intended for above ground uses. Treated 
wood intended for below ground use is the 4 inch X 4 inch support beams 
for decks and playsets, while treated wood intended for above ground 
use is the decking and connecting wood. Therefore, the majority of 
contact is reasonably assumed to be to wood intended for above ground 
uses. The combined/aggregate MOEs for wood treated for above ground 
uses does not exceed the LOC, and exposure to above ground wood is 
expected to more closely represent actual exposures to children. 
Therefore, the Agency considers this assessment to be a conservative 
screening level assessment.
    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). Tebuconazole is currently registered for uses that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to tebuconazole.
    Since the POD, relevant exposure scenarios and exposure assumptions 
used for intermediate-term aggregate risk assessments are the same as 
those used for short-term aggregate risk assessments, the short-term 
aggregate risk assessments represent and are protective of both short- 
and intermediate-term exposure durations.
    5. Aggregate cancer risk for U.S. population. Tebuconazole is 
classified as a Group C Carcinogen-Possible Human Carcinogen based on 
statistically significant increase in the incidence of hepatocellular 
adenoma, carcinoma, and combined adenoma/carcinomas in both sexes of 
NMRI mice. The Agency believes that the chronic RfD is protective of 
the cancer effects because the increased incidences of hepatocellular 
adenoma, carcinomas, and combined adenoma/carcinoma were seen only at 
the highest dose 1,500 ppm (279 mg/kg/day for males and 365.5 mg/kg/day 
for females) in the mouse carcinogenicity study. The dose was 
considered excessive. There was no evidence of carcinogenicity in rats, 
and no evidence of genotoxicity for tebuconazole. The chronic RfD value 
is 0.029 mg/kg/day which is approximately 9,600 fold lower than the 
dose that would induce liver tumors (279 mg/kg/day).
    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 tebuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate GC/NPD and LC/MS/MS methods are available for both 
collecting and enforcing tolerances for tebuconazole and its 
metabolites in plant commodities, livestock matrices and processing 
studies. The methods have been adequately validated by an independent 
laboratory in conjunction with a previous petition. 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 currently Codex, Canadian and Mexican maximum residue 
limits (MRLs) for residues of tebuconazole in/on a variety of plant and 
livestock commodities. The tolerance definition for residues in plants 
is tebuconazole, per se, for Codex, Canada, and Mexico. For livestock 
commodities, the tolerance expression is for the combined residues of 
tebuconazole and HWG 2061 in the U.S. and Canada, and tebuconazole, per 
se, for Codex. Where possible, the proposed tolerances levels have been 
harmonized with the MRLs from Canada, Mexico, and Codex

C. Response to Comments

     The Agency received a comment from a citizen of New Jersey. The 
commenter questioned the necessity of using taxpayer money through the 
agency of the Interregional Research Project No. 4 to develop 
pesticides, challenged the appropriateness of conducting some of the 
tebuconazole field trials outside of the United States, expressed 
concern over whether specific warnings were given to residents of New 
Jersey prior to conducting field trials in that State, and

[[Page 27755]]

worried that students at Rutgers University may have been injured in 
the tebuconazole toxicological tests on animals that were performed at 
that facility.
    In response, EPA notes that although IR-4 has petitioned for other 
tebuconazole tolerances it was not a petitioner as to the tolerances 
being established today. The notice cited by the commenter contained 
petitions from both IR-4 and a pesticide manufacturer. EPA is only 
acting today on the petition from the pesticide manufacturer. IR-4 was 
established by the U.S. Department of Agriculture to help minor 
acreage, specialty crop producers obtain EPA tolerances and new 
registered uses of pesticides. As to the commenter's concern with field 
trials that were conducted in countries other than the United States, 
the field trials that are referenced do not involve the tolerances 
being acted on in this rulemaking. EPA notes, however, that frequently 
field trials are conducted in other countries as well as in the United 
States so that EPA can understand the range of pesticide residues that 
may be present on a food. Similarly, the field trial conducted in New 
Jersey was for a tolerance that is not involved in today's action. 
EPA's regulations governing use of pesticides under experimental use 
permits can be found at 40 CFR part 172. EPA also has regulations 
governing the toxicological data testing laboratories that are designed 
to insure data quality (40 CFR part 160). Federal jurisdiction 
concerning the safety of workers in testing laboratories would be under 
the Occupational Safety and Health Administration in the U.S. 
Department of Labor. EPA has responded to similar comments from this 
commenter on previous occasions. Refer to 70 FR 37686 (June 30, 2005), 
70 FR 1354 (January 7, 2005), and 69 FR 63083 (October 29, 2004).

D. Revisions to Petitioned-For Tolerances

     Based upon review of the data supporting the petition, EPA 
determined that the proposed tolerances should be revised as follows: 
Almond, hulls increased from 5.0 ppm to 6.0 ppm; barley, hay increased 
from 6.0 ppm to 7.0 ppm; barley, straw increased from 1.4 ppm to 3.5 
ppm; wheat, hay increased from 6.0 to 7.0 ppm; and wheat, straw 
increased from 1.4 ppm to 1.5 ppm. EPA revised these tolerance levels 
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 Standard 
Operating Procedure (SOP). Additionally, tolerances were not proposed, 
but are required for barley, grain at 0.15 ppm based on detectable 
residues using the Agency's Tolerance Spreadsheet and wheat, grain at 
0.05 ppm, because tolerances are needed even with residues are non-
detectable. Also, a separate tolerance is not needed for pistachios, as 
they are considered under the nut, tree, group 14.

V. Conclusion

    Therefore, tolerances are established for residues of the fungicide 
tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities 
nut, tree, group 14 at 0.05 ppm; almond, hulls at 6.0 ppm; barley, 
grain at 0.15 ppm; barley, hay at 7.0 ppm; barley, straw at 3.5 ppm; 
wheat, forage at 3.0 ppm; wheat, grain at 0.05 ppm; wheat, hay at 7.0 
ppm; and wheat, straw at 1.5 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, 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: May 2, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

[[Page 27756]]

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 180.474 is amended in paragraph (a)(1) in the table by 
alphabetically adding the commodities Almond, hulls and Nut, tree, 
group 14 and by revising the following commodities to read as follows:

Sec.  180.474  Tebuconazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls........................................                6.0
                                * * * * *
Barley, grain........................................               0.15
Barley, hay..........................................                7.0
Barley, straw........................................                3.5
                                * * * * *
Nut, tree, group 14..................................               0.05
                                * * * * *
Wheat, forage........................................                3.0
Wheat, grain.........................................               0.05
Wheat, hay...........................................                7.0
Wheat, straw.........................................                1.5
------------------------------------------------------------------------

* * * * *

[FR Doc. E8-10506 Filed 5-13-08; 8:45 am]

BILLING CODE 6560-50-S